Plant Protection Products Regulations, 2009 (L.N. 358 of 2009)

B 4390 VERŻJONI ELETTRONIKA L.N. 358 of 2009 PESTICIDES CONTROL ACT (CAP. 430) Plant Protection Products Regulations, 2009 IN exercise of the powers conferred by articles 4 and 5 of the Pesticides Control Act, the Minister for Resources and Rural Affairs, in consultation with the Prime Minister and with the Minister for Social Policy, has made the following regulations: 1. (1) The title of these regulations is the Plant Protection Products Regulations, 2009. (2) The scope of these Regulations is to transpose Commission Directive 1991/414/EC of 15 July 1991 concerning the placing of plant protection products on the market as last amended by Commission Directive 2009/82/EC of 13 July 2009 and Council Directive 79/117/EEC of 21 December 1978 prohibiting the placing on the market and use of plant protection products containing certain active substances. (3) These regulations concern the authorization, placing on the market, use and control of plant protection products in commercial form and the placing on the market and control of active substances intended for a use specified in regulation 2 (1). (4) These regulations shall apply without prejudice to the Dangerous Substances and Preparations Regulations, 2007 (L.N. 10 of 2007), and, where active substances are concerned, without prejudice to the provisions concerning classification, packaging and labeling in terms of The Dangerous Substances (Notification) Regulations, 2001 (L.N. 318 of 2001). (5) These regulations apply to the authorization to place on the market plant protection products containing or composed of genetically modified organisms, provided that authorization to release them into the environment has been granted after the risk to the environment has been assessed in accordance with the provisions of Deliberate Release into the Environment of Genetically Modified Organisms Regulations, 2002 (L.N. 170 of 2002). (6) These regulations shall apply without prejudice to Council Regulation (EC) No 304/2003 of the European Parliament Title and scope. B 4391VERŻJONI ELETTRONIKA and of the Coucil of 28 January 2003 concerning the export and import of dangerous chemicals. 2. For the purposes of these regulations the following definitions shall apply: “active substances” means substances or micro organisms including viruses, having general or specific action: (a) against harmful organisms; or (b) on plants, parts of plants or plant products; “advertising” in relation to plant protection products includes any form of door-to-door information, canvassing activity or inducement designed to promote the supply, sale or use of plant protection products and without prejudice to the generality of the foregoing in particular includes: (a) the advertising of plant protection products to the general public or to persons who may be expected to use or supply these products, (b) the provision of inducements to prescribe or supply plant protection products, by way of a gift, offer or promise of any benefit or bonus, whether in money or in kind, except when the intrinsic value of such an inducement is minimal, and (c) sponsorship of any meeting attended by persons authorised to deal or who generally use these products, but shall exclude: (i) the labelling and the accompanying package leaflets, which are subject to the provisions of regulations 15 and 16, (ii) correspondence, even if accompanied by material of a non-promotional nature, which is in reply to a specific question about a particular plant protection product, and (iii) factual, informative, announcement or reference material relating to pack changes, Definitions. B 4392 VERŻJONI ELETTRONIKA adverse-effect warnings as part of general precautions, trade catalogues, price lists and other material of a similar nature provided that such material does not include any product claim; “animals” means animals belonging to species normally fed and kept or consumed by man; “authorization of a plant protection product” means administrative act by which the Director responsible for pesticides within the Malta Standards Authority, hereinafter referred to as the Directorate following an application submitted by an applicant, for the placing on the market of a plant protection product; “authorized representative” means any person duly authorized by the Director to act on his behalf for any of the purposes referred to in these regulations; “dealing” means any activity in the manufacture, import, export, transport, storage, distribution, presenting for sale or sale of any plant protection product; “environment” means water, air, land, wild species of fauna and flora, and any interrelationship between them, as well as any relationship with living organisms; “harmful organisms” means pests of plants or plant products belonging to the animal or plant kingdom, and also viruses, bacteria and mycoplasmas and other pathogens; “high-risk plant protection product” means any plant protection product classified as toxic or highly toxic product in accordance with regulation 19 of these regulations; “integrated control” means the rational application of a combination of biological, biotechnological, chemical, cultural or plant-breeding measures whereby the use of chemical plant protection products is limited to the strict minimum necessary to maintain the pest population at levels below those causing economically unacceptable damage or loss; B 4393VERŻJONI ELETTRONIKA “manufacturer” means the holder of a manufacturing process for the manufacturing of a plant protection product; “manufacturing” shall have the same meaning as is assigned to it in the Act; “minor crop” means any crop that is cultivated in Malta except tomatoes, potatoes or grapes; “placing on the market” means any supply, whether in return for payment or free of charge, other than for storage followed by consignment from the territory of the Community or disposal. Importation of a plant protection product shall be deemed to constitute placing on the market for the purposes of these regulations; “plant products” means products in the unprocessed state or having undergone only simple preparation such as milling, drying or pressing, derived from plants, but excluding plants themselves as defined in point 6; “plant protection products” means active substances and preparations containing one or more active substances, put up in the form in which they are supplied to the user, intended to: (a) protect plants or plant products against all harmful organisms or prevent the action of such organisms, in so far as such substances or preparations are not otherwise defined below; (b) influence the life processes of plants, other than as a nutrient, such as growth regulators; (c) preserve plant products, in so far as such substances or products are not subject to special Council or Commission provisions on preservatives; (d) destroy undesired plants; or (e) destroy parts of plants, check or prevent undesired growth of plants; B 4394 VERŻJONI ELETTRONIKA “plants” means live plants and live parts of plants, including fresh fruit and seeds; “preparations” means mixtures or solutions composed of two or more substances of which at least one is an active substance, intended for use as plant protection products; “professional user” means any person who acts as a farmer or gardener and is authorized to purchase, transport, store and use plant protection products in accordance with these regulations. This does not apply for domestic use; “professional users of high risk plant protection products” means any person who is authorized to purchase, transport, store and use high risk plant protection product; “recognised country” means any member state of the European Community; “residues of plant protection products” means one or more substances present in or on plants or products of plant origin, edible animal products or elsewhere in the environment and resulting from the use of a plant protection product, including their metabolites and products resulting from their degradation or reaction; “substances” means chemical elements and their compounds, as they occur naturally or by manufacture, including any impurity inevitable resulting from the manufacturing process; “the Act” means the Pesticides Control Act; 3. (1) Plant protection products shall not be placed on the market and used unless these have been authorized by the Director in accordance with these regulations, except where the intended use is covered by regulation 18. (2) The Director shall not, on the grounds that a plant protection product is not authorized for use in Malta, impede the production, storage or movement of such products intended for use in another Member State, provided that: General provisions. B 4395VERŻJONI ELETTRONIKA (a) the product is authorized in another Member State, and (b) the inspection requirements laid down by the Member States in order to ensure compliance with sub regulation (1) hereof are satisfied. (3) Plant protection products must be used properly. Proper use shall include compliance with the conditions established in accordance with regulation 4 and specified on the labelling, and the application of the principles of good plant protection practice as well as, whenever possible, the principles of integrated pest control. (4) Active substances shall not be placed on the market unless: (a) they are classified, packaged and labelled in accordance with, The Dangerous Substances (Notification) Regulations, 2001 (L.N. 318 of 2001) and (b) where the active substance was not on the market by 26 July 1993, a dossier has to be forwarded to the Member States and to the Commission, in accordance with regulation 5, with the declaration that the active substance is intended for a use specified in regulation 2 (16). This condition shall not apply to active substances intended for a use under regulation 18. 4. (1) A plant protection product shall not be authorized unless: (a) its active substances are listed in Schedule I and any conditions laid down therein are fulfilled, and, with regard to the following points (b), (c), (d) and (e), pursuant to the uniform principles provided for in Schedule VI; (b) sohowever that, with regard to paragraph (a) hereof, it is established, in the light of current scientific and technical knowledge and shown from appraisal of the dossier provided for in Schedule III, that when used in accordance with regulation 3 (3), and having regard to all normal conditions under which it shall be used, and to the consequences of its use: Granting, review and withdrawal of authorizations of plant protection products. B 4396 VERŻJONI ELETTRONIKA (i) it is sufficiently effective; (ii) it has no unacceptable effect on plants or plant products; (iii) it does not cause unnecessary suffering and pain to vertebrates to be controlled; (iv) it has no harmful effect on human or animal health, directly or indirectly (e.g. through drinking water, food or feed) or on groundwater; (v) it has no unacceptable influence on the environment, having particular regard to its fate and distribution in the environment, particularly the contamination of water, including drinking water and groundwater, and its impact on non-target species; (c) the nature and quantity of its active substances and, where appropriate, any toxicologically or ecotoxicologically significant impurities and co-formulants can be determined by appropriate methods; (d) its residues, resulting from authorized uses, and which are of toxicological or environmental significance, can be determined by appropriate methods in general use; (e) its physical and chemical properties have been determined and deemed acceptable for the purposes of the appropriate use and storage of the product; (f) where appropriate, the MRLs for the agricultural products affected by the use referred to in the authorisation have been set or modified in accordance with Regulation (EC) No 396/2005. (2) The authorization must stipulate the requirements relating to the placing on the market and use of the product or at least those aimed at ensuring compliance with the provisions of regulation 4 (1) (b). (3) The director shall ensure that compliance with the requirements set out in regulation 4 (1) (b) to (f) is established by official or officially recognized tests and analyses carried out under agricultural, plant health and environmental conditions relevant to B 4397VERŻJONI ELETTRONIKA use of the plant protection product in question and representative of those prevailing where the product is intended to be used. (4) Without prejudice to regulation 4 (5) and regulation 4 (6), authorizations shall be granted for a fixed period of up to 10 years only, determined by the Director; these may be renewed after verification that the conditions imposed in regulation 4 (1) are still satisfied. When an application for the renewal has been made, renewal may be granted for the period which is required by the Director to carry out the necessary verifications. (5) Authorizations may be reviewed at any time if there are indications that any of the requirements referred to in regulation 4 (1) are no longer satisfied. In such instances the Director may require the applicant for authorization or party to whom an extension of the field of application was granted in accordance with regulation 9 to submit further information necessary for the review. The authorization may, where necessary, be extended for the period necessary to complete a review and provide such further information. (6) (a) Without prejudice to Decisions already taken pursuant to regulation 10, an authorization shall be cancelled if it is established that the requirements for obtaining the authorization are not or are no longer satisfied, or that false or misleading particulars were supplied concerning the facts on the basis of which the authorization was granted, or it shall be modified if it is established that on the basis of developments in scientific and technical knowledge the manner of use and amounts used can be modified. (b) An authorization may also be cancelled or modified at the request of the holder of the authorization, who shall state the reasons therefore. Amendments can be granted only if it is established that the requirements of regulation 4 (1) continue to be satisfied. (c) Where an authorization is withdrawn by the Director, the holder of the authorization shall be informed immediately in writing with detailed reasons on which such a decision was based and the Director shall publish such withdrawal by notice in the Gazette. Moreover, the Director may grant a period of grace for the disposal, storage, placing on the market and use of existing stocks, of a length in accordance with the reason for the withdrawal, without prejudice to any period provided for by a decision taken under regulations 22 and 24 of these regulations, or B 4398 VERŻJONI ELETTRONIKA regulation 6 (1) or regulation 8 (1) or (2) of these regulations. (7) Without prejudice to any other provision made by or under the Act, it shall be the duty of any person holding an authorization granted to him in accordance with these regulations to: (a) inform the Director in writing, as soon as practicable of any change in any information provided to the Director for the granting of an authorization; (b) inform the Director, as soon as practicable of any unexpected adverse effect on the environment or the ecosystem as a result of the use, dispersal, dumping, disposal or otherwise of the plant protection product; (c) inform the Director, as soon as practicable of any unexpected adverse effect on any human being or animal consuming any plant or plant product having any residue related to the plant protection product; (d) allow the Director or his authorized representative access to the land or premises at any reasonable time; (e) comply with any provision made by or under the Act. 5. (1) (a) By virtue of current scientific and technical knowledge, an active substance shall be included in Schedule I to these regulations, if they have been included in Annex I to Council Directive of 15 July 1991 concerning the placing of plant protection products on the market (91/414/EEC). (b) The following conditions have to be fulfilled: (i) their residues, consequent on application consistent with good plant protection practice, do not have any harmful effects on human or animal health or on groundwater or any unacceptable influence on the environment, and the said residues, in so far as they are of toxicological or environmental significance, can be measured by methods in general use; and (ii) their use, consequent on application consistent with good plant protection practice, does not have any harmful Inclusion of active substances in Schedule I. B 4399VERŻJONI ELETTRONIKA effects on human or animal health or any unacceptable influence on the environment as provided for in regulation 4 (1) (b) (iv) and (v). (2) For inclusion of an active substance in Schedule I, the following shall be taken into particular account: (a) where relevant, an acceptable daily intake (ADI) for man; (b) an acceptable operator exposure level if necessary; (c) where relevant, an estimate of its fate and distribution in the environment and its impact on non-target species. (3) For the first inclusion of an active substance which was not yet on the market by 26 July 1993, the requirements shall be deemed to be satisfied where this has been established for at least one preparation containing the said active substance. (4) Inclusion of an active substance in Schedule I shall be subject to requirements such as: (a) the minimum degree of purity of the active substance, (b) the nature and maximum content of certain impurities, (c) restrictions arising from evaluation of the information referred to in regulation 6, taking account of the agricultural, plant health and environmental, including climatic, conditions in question, (d) type of preparation, (e) the manner of use. 5. On request, the inclusion of a substance in Schedule I may be renewed once or more for periods not exceeding 10 years; such inclusion may be reviewed at any time if there are indications that the criteria referred to in regulations 5 (1) and (2) are no longer satisfied. Renewal shall be granted for the period necessary to complete a review, where an application has been made for such B 4400 VERŻJONI ELETTRONIKA renewal in sufficient time, and in any case not less than two years before the entry is due to lapse, and shall be granted for the period necessary to provide information requested in accordance with regulation 6 (2). 6. (1) Upon receiving an application in such form and manner and with such timeframe the Director may from time to time require, by notice in the Gazette, for the inclusion of an active substance in Schedule I, the Director, shall without undue delay ensure that a dossier which is believed to satisfy the requirements of Schedule II is forwarded by the applicant to the other Member States and to the Commission together with a dossier complying with Schedule III on at least one preparation containing that active substance. (2) If the assessment of the dossier referred to in sub regulation (1) hereof shows that further information is necessary, the applicant may be asked to submit such information. (3) The provisions of this regulation shall also apply if, after inclusion of an active substance in Schedule I, facts emerge that cast doubt on its conformity with the requirements indicated in regulation 5 (1) and (2), or if renewal in accordance with regulation 5 (5) is being considered. 7. The holder of an authorization or those to whom an extension of the field of application has been granted in accordance with regulation 9 (1) must immediately notify the director of all new information on the potentially dangerous effects of any plant protection product, or of residues of an active substance on human or animal health or on groundwater, or their potentially dangerous effects on the environment. The Director shall ensure that the parties concerned immediately notify this information to the other Member States and to the Commission. 8. (1) By way of derogation from regulation 4, to enable a gradual assessment to be made of the properties of new active substances and to make it easier for new preparations to be made available for use in agriculture, the Director may authorize, for a provisional period not exceeding three years, the placing on the market of plant protection products containing an active substance not listed in Schedule I and which was not yet available on the market on 26 July 1993, provided that: Receipt of an application and assessment thereof. Information on potentially harmful effects. Transitional measures and derogations. B 4401VERŻJONI ELETTRONIKA (a) following application of regulation 6 (1) and (2) it is found that the dossier on the active substance satisfies the requirements of Schedule II and III in relation to the projected uses; (b) it is established that the active substance can satisfy the requirements of regulation 5 (1) and that the plant protection product shall be expected to satisfy the requirements of regulation 4 (1) (b) to (f). (2) Following the evaluation of the dossier, it may be decided, that the active substance does not satisfy the requirements specified in regulation 5 (1). In such cases the authorizations shall be withdrawn. (3) By way of derogation from regulation 6, if, on expiry of the three-year period, a decision has not been taken concerning the inclusion of an active substance in Schedule I, a further period may be ordered to enable a full examination to be made of the dossier and, where appropriate, of any additional information requested in accordance with regulation 6 (2): Provided that the provisions of regulation 4 (2), (3), (5) and (6) shall apply to authorizations granted under the terms of this paragraph without prejudice to the foregoing regulations. (4) By way of further derogation from regulation 4, the Director may in special circumstances authorize for a period not exceeding 120 days the placing on the market of plant protection products not complying with regulation 4 for a limited and controlled use if such a measure appears necessary because of an unforeseeable danger which cannot be contained by other means. In this case, the Director shall immediately inform the other Member States and the Commission of its action. 9. (1) (a) Application for authorization of a plant protection product shall be made to the director by or on behalf of the person responsible for first placing it on the market. (b) Official or scientific bodies involved in agricultural activities or professional agricultural organizations and professional users may request that the field of application of a plant protection product already authorized locally be extended to purposes other than those covered by this authorization. Application for authorization. B 4402 VERŻJONI ELETTRONIKA (c) The Director shall grant an extension of the field of application of an authorized plant protection product when it is in the public interest, if: (i) the documentation and information to support an extension of the field of application has been submitted by the applicant, (ii) it has been established that the conditions referred to in regulation 4 (1) (b) (iii), (iv) and (v) are satisfied, (iii) the intended use is minor in nature, and (iv) users are fully and specifically informed as to instructions for use, by means of an addition to the labelling or, failing that, by means of an official publication. (2) Every applicant shall be required to have a permanent office in the Community. (3) Applications for authorizations shall be submitted in the Maltese or English language. Samples of the preparations and of its ingredients may also be requested. (4) Any application for authorization made to the Director shall be accepted and a decision thereon shall be taken within a reasonable period, not exceeding 90 working days provided that the Director has the necessary scientific and technical structures at disposal. Such time shall be suspended until all relevant information is received. (5) A file should be compiled on each application. Each file shall contain at least a copy of the application, a record of the administrative decisions taken concerning the application and concerning the particulars and documentation laid down in regulation 13 (1) together with a summary of the latter. 10. (1) (a) At the request of an authorization for the placing on the market of a plant protection product which is already authorized in another Member State, with specific reference to comparable elements, the applicant must substantiate the claim to comparability with documentary evidence. In such case, except in cases in which the results are not comparable to important agricultural, phytosanitary or environmental conditions, including Mutual recognition of authorizations and abridged authorizations. B 4403VERŻJONI ELETTRONIKA climatic conditions which are relevant to the application of the product, the Director shall: (i) refrain from requiring the repetition of tests and analyses already carried out in connection with the authorization of the product in that Member State, and (ii) to the extent that the uniform principles have been adapted, where the product contains only active substances listed in Schedule I, also authorize the placing of that product on the local market. (b) Authorization may be subject to conditions resulting from the implementation of other measures in accordance with Community law, relating to the conditions for distribution and use of plant protection products intended to protect the health of the distributors, users and workers concerned. (c) Subject to compliance with the Treaty, authorization may also be accompanied by restrictions on use arising from differences in dietary patterns and necessary in order to avoid exposure of consumers of treated products to the risks of dietary contamination in excess of the acceptable daily intake of the residues concerned. (d) Authorization may be subject, with the agreement of the applicant, to changes in the conditions of use in order to render, any non-comparable agricultural, plant health or environmental, including climatic, conditions irrelevant for the purpose of comparability. (2) The Director shall inform the Commission of cases where repetition of a test have been required and of cases when an authorization a plant protection product already authorized in another Member State has been refused, in respect of which the applicant had claimed that the agricultural, plant health and environmental, including climatic, conditions relevant to use of the product in the regions concerned in the Member State where the test was carried out or for which authorization was granted, were comparable to those in Malta. Moreover the Director shall notify the Commission of the grounds on which repetition of the test was required or authorization was refused. (3) In cases where the Director refuses to recognize comparability and accept tests and analyses or authorize the B 4404 VERŻJONI ELETTRONIKA placing on the market of a plant protection product in Malta, the decision as to whether or not comparability exists shall be taken and, if the decision is negative, the Director shall also specify the conditions of use under which the non-comparability may be deemed irrelevant. In this procedure account shall be taken, inter alia, of the serious ecological vulnerability problems that may arise in certain regions or zones thereby requiring, if they do arise, specific protection measures. (4) The Director may authorise the use of an abridged authorisation process in relation to a plant protection product that is identical to another product already authorised for placing on the market in Malta and if such product is placed on the market in a recognized country. (5) For the purposes of this regulation, “identical” means that the product is manufactured by the same or an associated company or under license of such company and, that the formulation of the product and any of its active substances are the same. (6) An application for an authorisation for the placing on the market of a plant protection product in accordance with the provisions of this regulation shall contain, as a minimum, the following information: (a) the trade name of the product to be imported, (b) the authorisation number of the imported product, (c) the original label of the imported product and an official translation of it in the Maltese and English languages, (d) the trade name of the reference product, (e) the authorisation number of the reference product, (f) the trade name with which the product is to be marketed in Malta, (g) the proposed draft label of the product to be marketed in Malta, (h) a sample of the product as it will be marketed in Malta, B 4405VERŻJONI ELETTRONIKA (i) a sample of the package as it will be marketed in Malta, and (j) any other additional information as the Director may deem necessary to establish that the conditions specified in this regulation are satisfied. (7) In establishing whether the conditions of regulation 10 (4) of these regulations are satisfied, the Director may consult with the competent authority of the recognised country in which the plant protection product has been authorised to be placed on the market. (8) If the Director is not fully satisfied that the product is identical, he may carry out such chemical or other analysis of the product with the aim of establishing its identicality. (9) Any authorisation issued in accordance with regulation 10 shall be valid for a maximum period of three years from the date of issue and shall, unless previously revoked, be renewable on application by the holder made at least three months before expiry of the validity period. (10) The Director shall determine the application within a reasonable time not exceeding 45 working days from the date of receipt of an application, Provided that such time may be suspended until all the relevant information is received. 11. (1) Where the Director has valid reasons to consider that a product which it has authorized or is bound to authorize under regulation 10 constitutes a risk to human or animal health or the environment, provisional restriction or prohibitation for the use and, or sale of that product in Malta may be requested. The Director shall immediately inform the Commission and the other Member States of such action and give reasons for the decision. (2) A decision shall be taken on the matter within three months. 12. (1) At least within a period of one month at the end of each quarter, the Director shall inform other Member States and the Commission in writing of any plant protection products which are authorized or withdrawn, in accordance with the provisions of this these regulations, at least indicating: Products causing a health or environmental risk. Exchange of information. B 4406 VERŻJONI ELETTRONIKA (a) the name or business name of the holder of the authorization, (b) the trade name of the plant protection product, (c) the type of preparation, (d) the name and amount of each active substance which it contains, (e) the use or uses for which it is intended, (f) the maximum residue levels provisionally established where they have not already been set by Community rules, (g) where relevant, the reasons for withdrawal of an authorization, (h) the dossier needed for the evaluation of the maximum residue levels provisionally established. (2) The Director shall draw up an annual list of the plant protection products authorized in Malta and shall communicate that list to the other Member States and to the Commission. (3) (a) The Director shall publish in the Gazette a list of all active substances registered in Malta and such publication shall: (i) be issued at least once annually prior to the first day of February of each year, (ii) contain, as a minimum, the information relating to the common name and Chemical Abstracts Service registry number of the active substance, and the classification of the active substance or an indication that the classification of the active substance is still pending. (b) Whenever a new active substance has been registered or the classification of the active substance has changed, the Director shall, by notice in the Gazette, publish in relation to such active substance, the information specified in paragraph (a) (ii) hereof and such publication shall be deemed to amend the list B 4407VERŻJONI ELETTRONIKA of active substances for plant protection products issued under sub regulation (3) (a) hereof. 4. (a) The Director shall publish in the Gazette a list of all plant protection products authorised for marketing or use in Malta and such publication shall (i) be issued at least once annually and prior to the first day of February of each year, (ii) contain, as a minimum, the following information: 1. the name by which the product is to be placed on the market in Malta, 2. the active substance and concentration, 3. the name and postal address of the holder of the authorization, 4. whether the product is a high-risk plant protection product or otherwise, 5. the authorisation number of the product. (b) Whenever an authorisation has been issued in relation to a plant protection product the Director shall, by notice in the Gazette publish in relation to such plant protection product, the information specified in paragraph (a) (ii) hereof and such publication shall be deemed to amend the list of plant protection products issued under paragraph (a) hereof. (c) The Director shall, by notice in the Gazette, as soon as practicable, specify the plant protection product for which the authorisation has been suspended or revoked and such publication shall be deemed to amend the list of plant protection products issued under paragraph (a) hereof. 13. (1) (a) Without prejudice to regulation 10, applicants for authorization of a plant protection product should submit with their application: (i) a dossier satisfying, in the light of current scientific and technical knowledge, the requirements set out in Schedule III; and Data requirements, data protection and confidentiality. B 4408 VERŻJONI ELETTRONIKA (ii) for each active substance in the plant protection product, a dossier satisfying, in the light of current scientific and technical knowledge, the requirements set out in Schedule II. (b) By way of derogation from paragraph (a) hereof and without prejudice to sub-regulation (2), applicants shall be exempted from supplying the information required in paragraph (a) (ii) except for that identifying the active substance if the active substance is already listed in Schedule I, taking into account the conditions of inclusion in Schedule I, and does not differ significantly in degree of purity and nature of impurities, from the composition registered in the dossier accompanying the original application. (2) When issuing an authorization for a plant protection product except in the case where there is a legal agreement between the parties concerned, the Director shall not make use of the information for the benefit of other applicants of: (a) requirements set out in Schedule II: (i) for a period of 10 years from date of the first inclusion in Schedule I of an active substance not on the market on the 26 July 1993; (ii) for periods not exceeding 10 years, from the date when the decision, concerning an active substance which was already on the market on the 26 July 1993; (iii) for a period of five years from the date of a decision, following receipt of further information necessary for first inclusion in Schedule I, or to vary the conditions for, or to maintain the inclusion of an active substance in Schedule I, which has been taken either to vary the conditions for, or to maintain, the inclusion of an active substance in Schedule I, unless the five-year period expires before the period provided for in points i and ii, in which case the period of five years shall be extended so as to expire on the same date as those periods. (b) requirements set out in Schedule III: (i) for a period of 10 years from first authorization of the plant protection product where authorization follows the B 4409VERŻJONI ELETTRONIKA inclusion in Schedule I of any active substance contained in the product; (ii) for periods not exceeding 10 years, after the first authorization of the plant protection product, where that authorization precedes inclusion in Schedule I of any active substance contained in the product. (3) On examination of an application for authorization, the Director shall inform the Commission of instances where consideration of an active substance as listed in Schedule I, which has been produced by a person or manufacturing process other than those specified in the dossier has been taken on the basis of which the active substance was first included in Schedule I. All data regarding the identity and impurities of the active substance shall be transmitted to the Director. (4) By way of derogation from sub-regulation (1) hereto, for active substances already on the market on 26 July 1993, and until the date on which they are included in Schedule I previous national rules concerning data requirements continue to apply, as long as such substances are not included in Schedule I. (5) Notwithstanding regulation 13 (1), and without prejudice to regulation 10, where the active substance is listed in Schedule I: (a) applicants for authorization of plant protection products shall, before carrying out experiments involving vertebrate animals, enquire with the director: (i) whether the plant protection product for which an application is to be made is the same as a plant protection product for which authorization has been granted, and (ii) as to the name and address of the holder or holders of the authorization or authorizations. Such enquiry shall be supported by evidence that the prospective applicant intends to apply for authorization on his own behalf and that the other information specified in sub regulation (1) hereof is available; (b) the Director, if satisfied that the applicant intends B 4410 VERŻJONI ELETTRONIKA to apply, shall provide the name and address of the holder or holders of previous relevant authorizations and shall at the time inform the holders of the authorizations of the name and address of the applicant. (6) The holder or holders of previous authorizations and the applicant shall take all reasonable steps to reach agreement on the sharing of information so as to avoid the duplication of testing on vertebrate animals. (7) Where data is requested on an active substance which has already been placed on the market on 26 July 1993 and with the intention to includ this substance in Schedule I, data holders shall be encouraged to cooperate in the provision of the requested data, with a view to limiting the duplication of testing on vertebrate animals. (8) If, nevertheless, the applicant and holders of previous authorizations of the same product can still not reach an agreement on the sharing of data, national measures obliging the applicant and holders of previous authorizations to share the data with a view to avoiding duplicative testing on vertebrate animals and determine both the procedure for utilizing information, and the reasonable balance of the interests of the parties concerned, may be introduced. 14. (1) Without prejudice to the Freedom of Access to Information on the Environment Regulations, 2005, if the applicant wishes that industrial and commercial secrets on an active substance included in Schedule I or for the authorization of a plant protection product are treated as confidential, the applicant shall make such a request in writing to the Director. The applicant’s request is warranted upon decision taken by the Director or the Commission. (2) Confidentiality shall not apply to: (a) the names and content of the active substance or substances and the name of the plant protection product, (b) the name of other substances which are regarded as dangerous under, the Dangerous Substances (Notification) Regulations, 2001 (L.N. 318 of 2001) and the Dangerous Substances and Preparations Regulations, 2007 (L.N. 10 of 2007), Involvement of industrial and commercial secrets L.N. 116 of 2005. B 4411VERŻJONI ELETTRONIKA (c) physico-chemical data concerning the active substance and plant protection product, (d) any ways of rendering the active substance or plant protection product harmless, (e) a summary of the results of the tests to establish the substance’s or product’s efficacy and harmlessness to humans, animals, plants and the environment, (f) recommended methods and precautions to reduce handling, storage, transport, fire or other hazards, (g) methods of analysis referred to in regulation 4 (1) (c) and (d) and 5 (1), (h) methods of disposal of the product and of its packaging, (i) decontamination procedures to be followed in the case of accidental spillage or leakage, (j) first aid and medical treatment to be given in the case of injury to persons. (3) If the applicant subsequently discloses previously confidential information, he shall be required to inform the director accordingly. 15. Regulation 5 (1) of the Dangerous Substances and Preparations Regulations, 2007 (L.N. 10 of 2007) shall apply to all plant protection products not covered by the Dangerous Substances and Preparations Regulations, 2007 (L.N. 10 of 2007). 16. (1) All packaging of plant protection products must show clearly and indelibly the following: (a) the trade name or designation of the plant protection product; (b) the name and address of the holder of the authorization and the authorization number of the plant protection product and, if different, the name and address of Packaging and Labelling of plant protection product. Packaging of plant protection product. B 4412 VERŻJONI ELETTRONIKA the person responsible for the final packaging and labelling or for the final labelling of the plant protection product on the market; (c) the name and amount of each active substance expressed as provided for in the Dangerous Substances and Preparations Regulations, 2007; (L.N. 10 of 2007). The name must be as given in the list contained in Schedule I of the provisions concerning classification, packaging and labelling of The Dangerous Substances (Notification) Regulations, 2001 (L.N. 318 of 2001) or, if not included therein, its ISO common name. If the latter is not available, the active substance shall be designated by its chemical designation according to IUPAC rules; (d) the net quantity of plant protection product given in legal units of measurement; (e) the formulation batch number or some means of identifying it; (f) the particulars required under the Dangerous Substances and Preparations Regulations, 2007 (L.N. 10 of 2007), and information on first aid; (g) the nature of any special risks for humans, animals or the environment, by means of standard phrases selected as appropriate from those given in Schedule IV; (h) safety precautions for the protection of humans, animals or the environment, in the form of standard phrases selected as appropriate from those given in Schedule V; (i) the type of action of the plant protection product (e.g. insecticide, growth regulator, weedkiller, etc.); (j) the type of preparation (e.g. wettable powder, emulsifiable concentrate, etc.); (k) the uses for which the plant protection product has been authorized and any specific agricultural, plant health and environmental conditions under which the product may be used or should not be used; B 4413VERŻJONI ELETTRONIKA (l) directions for use and the dose rate, additional dosage labeling may be permitted; (m) where necessary, the safety interval for each use between application and: (i) sowing or planting of the crop to be protected, (ii) sowing or planting of succeeding crops, (iii) access by humans or animals, (iv) harvesting, (v) use or consumption; (n) particulars of possible phytotoxicity, varietal susceptibility, and any other direct or indirect adverse side effects on plants or products of plant origin together with the intervals to be observed between application and sowing or planting of: (i) the crop in question, or (ii) subsequent crops; (o) if accompanied by a leaflet, as provided for in sub-regulation (2) hereof, the sentence ‘Read accompanying instructions before use’ and ‘Aqra t-tagħrif mal prodott qabel tużah”; (p) directions for safe disposal of the plant protection product and of the packaging; and (q) the expiry date relevant to normal conditions of storage where the shelf life of the product is limited to less than two years. (2) The requirements in sub-regulation (1) (l), (m) and (n) may be indicated on a separate leaflet accompanying the package if the space available on the package is too small. Such a leaflet shall be regarded as part of the label for the purposes of these regulations. B 4414 VERŻJONI ELETTRONIKA (3) Taking account of the rules in force within their territories regarding the supply of certain plant protection products to certain categories of users, pending Community harmonization, the Director shall require that it be indicated on the label whether a product is restricted to certain categories of users. (4) In no circumstances shall the label of the packaging of a plant protection product bear the indications ‘non toxic’, ‘harmless’, or similar indications. However, information to the effect that the plant protection product may be used when bees or other non-target species are active, or when crops or weeds are in flower or other such phrases to protect bees or other non target species may be given on the label, if the authorization relates explicitly to use during the season for bees or other specified organisms and presents minimal hazard to them. (5) The label shall be resistant to exposure under normal conditions of storage, handling or use and shall ensure that its contents will remain clear and legible throughout the expected product shelf life. (6) The labels shall be printed in the Maltese and English language. (7) (a) By way of derogation from sub-regulation (1) (g) and (h), additional phrases may be clearly and indelibly marked on packaging where they are deemed to be necessary for the protection of human beings, animals or the environment. (b) In such case that the Director shall notify the other Member States and the Commission forthwith of each derogation granted and shall forward the additional phrase or phrases and the reasons for these requirements. (c) A decision shall be taken that the additional phrase or phrases is or are justified and hence that Schedules IV and V shall be amended accordingly, or that any such phrase may no longer be required. Such phrases may be maintained until such time as a decision has been taken. 17. (1) The Director shal l make the necessary arrangements for plant protection products which have been placed on the market and for their use to be officially checked to see whether they comply with the requirements of these regulations Control measures. B 4415VERŻJONI ELETTRONIKA and in particular with the requirements of the authorization and information appearing on the label. (2) The Director shall report annually before 1 August to the other Member States and the Commission on the results of the inspection measures taken in the previous year. 18. (1) Any experiment or test for research or development purposes involving the release into the environment of an unauthorized plant protection product shall only be carried out after authorization for trial purposes has been granted and under controlled conditions and for limited quantities and areas. (2) (a) The persons concerned shall submit an application to the director, within 90 working days before the commencement of the experiment or test, together with a dossier containing all the available data to permit an assessment to be made of possible effects on human or animal health or the possible impact on the environment. (b) If the proposed experiments or tests referred to in sub-regulation (1) are liable to have harmful effects on human or animal health or to have an unacceptable adverse influence on the environment, the Director may either prohibit them or permit them subject to such conditions as it considers necessary to prevent those consequences. (3) Paragraph (b) of sub-regulation (2) hereof shall not apply if the Director has granted the person concerned the right to undertake certain experiments and tests and has determined the conditions under which the experiments and tests have to be undertaken. (4) Common conditions shall be adopted for the application of this regulation, in particular the maximum quantities of pesticides that may be released during experiments covered by sub-regulation (1), and for the minimum data to be submitted in accordance with sub-regulation (2). (5) This regulation shall not apply to experiments or tests covered by Part B of Biosafety Co-ordinating Committee Regulations, 2002 (L.N. 290 of 2002). 19. (1) Professional users shall attend a course of instruction which is recognised by the director. Professional users Research and Development. Professional users and high risk plant protection products. B 4416 VERŻJONI ELETTRONIKA of plant protection products shall be authorized to purchase, use, transport and store plant protection products by the Director upon receipt of an application together with proof of successful completion of the course. (2) Any plant protection product that contains any active substance classified as an active substance that may only be incorporated in a high-risk plant protection product for placing on the market shall be designated as a high-risk plant protection product. (3) A high-risk plant protection product shall only be used by a recognized professional user of high risk plant protection products appointed in accordance with sub-regulation (6). (4) Dealers in high-risk plant protection products shall only provide, sell or otherwise supply high-risk plant protection products to another authorised dealer or to a professional user of high risk plant protection products. (5) The Director may, from time to time by notice in the Gazette, establish the records that shall be kept and maintained in respect of high risk plant protection products by any dealer authorised in accordance with these regulations: Provided that as a minimum, such records shall include the following details: (a) the name of the high risk plant protection product being dealt or otherwise handled by the dealer, (b) the quantities and batch number of the high risk plant protection product being dealt or otherwise handled by the dealer, and (c) details to identify from where and when he has obtained the plant protection product and to whom he has sold the product. (6) No person shall use or allow to be used any plant protection product that is designated as a high-risk plant protection product unless the user is authorised as a professional user of a high risk plant protection product in accordance with the provisions of these regulations. B 4417VERŻJONI ELETTRONIKA (7) Any person wishing to qualify as a professional user of high risk plant protection product shall attend a course of instruction regarding the safe use and handling of a high risk plant protection product. Provided that such course is recognised by the Director for the purpose of appointing a professional user of a high risk plant protection product in accordance with these regulations. (8) On successful completion of a course of instruction, the Director shall, upon receipt of a written application and proof of the successful completion of the course of instruction, authorise the successful candidate to act as a professional user of a high risk plant protection product: Provided that such authorisation shall specify the high risk plant protection product or class, group or category of high risk plant protection products the professional user is authorised to procure and use: Provided further that the mentioned plant protection products have been covered by type and content of the course of instruction. (9) Any authorisation issued in accordance with sub regulation (1) and (8) of this regulation shall be subject to any such condition or conditions that the Director may deem necessary for satisfying the provisions made by or under of the Act during the course of business of the professional users. (10) If professional users have been convicted of an offence against any of these regulations, the Director shall revoke the authorisation. (11) Any authorisation issued by the Director in accordance with sub-regulations (1) and (8) of these regulations shall be valid for a period not exceeding two years as may be specified in the authorization: Provided that the Director may extend the validity of any such authorisation upon the submission of an application for its renewal submitted to him in accordance with sub-regulation (12) of these regulations and if he is satisfied that the conditions established by sub-regulation (8) of these regulations are still being complied with. B 4418 VERŻJONI ELETTRONIKA (12) On the expiry of an authorisation, the Director shall issue a renewal of the authorization if: (a) he has received an application for renewal in such form and in such manner and within such time as the Director may from time to time require by notice in the Gazette, (b) he is satisfied that the conditions detailed in sub regulation (12) of these regulations are still being complied with: Provided that the Director may request the applicant to provide additional information as he may deem necessary prior to the renewal or otherwise of the authorization: Provided further that any renewal of any authorisation shall be subject to any condition as the Director may deem appropriate. (13) Where an application for renewal has been submitted to the Director, the validity of the authorisation granted in accordance with sub-regulation (12) shall be deemed to continue to have effect until such time as the Director has determined the application for renewal. (14) Any authorisation issued in accordance with sub regulations (1) and (8) of these regulations may be suspended or revoked by the Director if it is established that: (a) any information or particular supporting the application for an authorisation was incorrect, false or misleading, or (b) any requirement as detailed in sub-regulations (1) and (8) of these regulations is no longer satisfied, or (c) the holder of the authorisation requests that the Director revokes the authorization. (15) Where the Director suspends or revokes an authorisation, he shall notify the holder of the authorisation in writing of such suspension or revocation with detailed reasons on which such a decision was based and shall inform authorised dealers in plant protection products or active substances of such suspension or revocation. B 4419VERŻJONI ELETTRONIKA (16) The Director may, upon the written request of the holder of the authorisation, and if he is satisfied that such modification is justified, modify an authorisation to act as a professional user. (17) Any request for a modification to the authorisation in accordance with sub-regulation (2) of this regulation shall be made by the holder of the authorisation on such form and such manner and within such time as the Director may, from time to time require by notice in the Gazette. (18) The Director may, from time to time by notice in the Gazette, establish the records that must be kept and maintained by any professional user who is authorized in accordance with these regulations. (19) Such records shall in respect of high risk plant protection products procured by the professional user of high risk plant protection products include: (a) the name of the high risk plant protection product, (b) the quantities and batch number of the high risk plant protection product procured, (c) details to identify the place from where and the date on which he has procured the product. (20) In respect of high risk plant protection products used by the professional user, the following records shall also be kept: (a) the name of the high risk plant protection product, (b) the quantities and batch number of the high risk plant protection product being used in a particular instance, (c) details to identify the location or crop on which the product was used, (d) the date on which the product was applied in the particular location. (21) Any professional user shall ensure that all necessary and indicated precautions are taken in order to B 4420 VERŻJONI ELETTRONIKA minimise the risk of unwanted effects to humans, animals and the environment that may result from the use or disposal of the plant protection product or its packaging. (22) The Director shall publish annually in the Gazette a list of all persons authorised to act as professional users of high risk plant protection products in accordance with the provisions of these regulations. (23) Such list as is referred to in sub-regulation (22) shall contain the following information: (a) the name, surname and postal address of the professional user, (b) the high risk plant protection products covered by the authorization, (c) the date and validity of the authorisation. 20. (1) No person shall promote, deal or dispose of any: (a) active substance unless this is registered in accordance with these regulations, (b) plant protection product unless this is authorised for placing on the market in Malta in accordance with these regulations, unless he is in possession of an authorisation to deal in active substances or plant protection products granted to him in accordance with sub-regulation (2) of this regulation. (2) Any application for the granting of an authorisation to deal in plant protection products or active substances shall be made in writing to the Director and shall contain such information, documents, samples and other material as provided by or under the Act. (3) Any application shall as a minimum satisfy the following requirements: (a) the nature of any activity related to the dealing of plant protection products the applicant wishes to undertake, (b) the place where such activity is to take place, and Dealing in plant protection products. B 4421VERŻJONI ELETTRONIKA suitable information, documentation and evidence as may be required in order to show that such place is suitable and sufficient for that purpose, (c) evidence to show that the place where such activity is to take place has the necessary equipment and control facilities as may be required by or under the Act, (d) evidence to show that the health and safety of staff shall be protected and ensured at all times, (e) the name and postal address and any other contact details of the applicant, (f) the name of at least one person who is qualified to ensure that the activity complies with any provisions made by or under the Act at all times, and that persons under his charge have the necessary skills required to carry out the tasks assigned to them: Provided that any person who has successfully completed any course recognised by the Director as sufficient for the purposes of this paragraph shall be considered to be qualified for the purposes of this paragraph of this sub regulation (g) any other information, documentation or evidence as may be required by the Director or by any provision made by or under the Act and, (h) in the case of an application for the manufacture of a plant protection product, the name of the plant protection product and any formulation which is to be, or is intended to be manufactured, assembled or in any way modified including details of the type and concentration of any active substance to be found within the formulation. (4) The Director shall determine the application within a reasonable time not exceeding 45 working days from the date of receipt of an application: Provided that such time shall be suspended until all the relevant information is received. B 4422 VERŻJONI ELETTRONIKA (5) Where an application has been made to the Director for the granting of an authorisation to deal in accordance with this regulation, the Director may, before determining the application, request the applicant to submit such further information relating to the application as he may consider necessary and where any such request has been made, the provision of sub-regulation (3) of this regulation shall be suspended until the additional information has been submitted. (6) Any authorisation issued in accordance with this regulation shall be made in writing and it shall be subject to any such condition that the Director may deem necessary so that the business of dealing shall be carried out in accordance with the provisions made by or under the Act. (7) Any authorisation issued by the Director in accordance with sub-regulation (3) of this regulation shall be valid for such period not exceeding three years as may be specified in the authorization: Provided that the Director may extend the validity of any such authorisation upon the submission of an application for its renewal to him in accordance with sub-regulation (9) of this regulation and if he is satisfied that the conditions established by sub-regulation (3) of this regulation are still being complied with. (8) Without prejudice to sub-regulation (9) of this regulation, and if the Director suspects that any of the conditions established by sub-regulation (3) of this regulation is no longer satisfied, the Director: (a) shall require the holder of the authorisation to submit such further information as may be necessary to establish compliance with the provisions of sub-regulation (3) of this regulation or such other information as may be reasonably required, (b) may carry out any inspection, review or test that he deems necessary, (c) may suspend the authorisation in accordance with sub-regulation (9) of this regulation. B 4423VERŻJONI ELETTRONIKA (9) Any authorisation issued in accordance with sub regulation (3) of this regulation may be suspended or revoked by the Director if it is established that: (a) any information or particular supporting the application for an authorisation was incorrect, false or misleading, or (b) any requirement as detailed in sub-regulation (3) of this regulation is no longer satisfied, or (c) the applicant for authorisation requests the Director to revoke the authorisation to deal in plant protection products or active substances, or (d) the activity is being carried out in contravention of any provision made by or under the Act. (10) Where the Director suspends or revokes an authorisation, he shall notify the holder in writing of the authorisation relating to such suspension or revocation, also providing reasons on which such a decision was based. (11) (a) On the expiry of an authorisation, the Director shall renew the authorisation if: (i) he has received an application for renewal in such form and in such manner and within such time as the Director may, from time to time, require by notice in the Gazette, (ii) he is satisfied that the conditions detailed in sub regulation (2) of this regulation are still being complied with: Provided that the Director may request the applicant to provide additional information as he may deem necessary prior to the renewal or otherwise of the authorization: Provided further that any renewal of any authorisation may be subject to any such condition as the Director may deem appropriate. (b) Without prejudice to the provisions of sub regulation (8) of this regulation, the Director may, upon the written request of the holder of the authorisation, modify an authorisation to carry out a dealing activity if the Director is satisfied that such B 4424 VERŻJONI ELETTRONIKA modification is justified and appropriate, and where relevant, that it reflects current scientific opinion. (12) Without prejudice to the provisions of sub regulation (9) of this regulation, the Director may modify the original authorization if he considers that any condition on which the authorisation was based in accordance with sub-regulation (3) of this regulation has been substantially altered. (13) Any request for a modification to the authorisation shall be made by the holder of the authorisation on such form and in such manner and within such time as the Director may, from time to time, require by notice in the Gazette. (14) Without prejudice to any other provision made by or under the Act, it shall be the duty of any person holding an authorisation granted to him in accordance with sub-regulation (3) of this regulation to: (a) keep such records and in such manner as the Director may from time to time establish by notice in the Gazette Provided that the Director may establish different records for different types of dealing activities; (b) inform the Director in writing and as soon as practicable, of any change in any information provided to the Director for the granting of the authorization; (c) allow the Director or his authorised representative access to the land or premises where dealing is carried out at any reasonable time; (d) make available to the Director or his authorized representative such records which he may require; and (e) comply with any provision made by or under the Act. (15) The Director shall publish annually in the Gazette a list of all persons authorised to act as dealers in accordance with the provisions of these regulations. B 4425VERŻJONI ELETTRONIKA (16) Such list shall contain the following information: (a) the name, surname and postal address of the authorized dealer or corporation, (b) the postal address of any premises used by the dealer for the purposes of carrying out his business, (c) the date and validity of the authorisation. (17) Any supplier of plant protection products shall exercise general supervision over his employees and shall, before requiring or permitting any of such employees to handle or to apply any plant protection product: (a) provide such employees with proper training in the safe handling and application of plant protection products, (b) ensure that any safety precaution set out in the label, or otherwise prescribed, is understood and complied with, (c) ensure that such workers wear suitable protective clothing provided by him. (18) Where a supplier of plant protection products has even the slightest suspicion that any plant protection product has caused any poisoning, he shall immediately notify the appropriate health authority. (19) (a) Any person authorised to deal in plant protection products shall notify the Director of any consignment of any authorized plant protection product or active substance he brings into Malta. (b) Such notice shall be submitted in such form and in such manner and within such time as the Director may from time to time require by notice in the Gazette. (c) The information supplied in relation to a plant protection product or active substance shall include the following as a minimum: (a) the name of the product and the batch number, B 4426 VERŻJONI ELETTRONIKA (b) the authorisation number, (c) the country of origin, (d) the quantity of the consignment, (e) the date and place of bringing into Malta. (20) No person shall advertise or cause to be advertised any plant protection product in any manner whatsoever unless such advertising has been authorised by the Director. (21) (a) The Director shall, from time to time by notice in the Gazette, establish the form, content, manner and time for the submission of an application for the issue of an authorisation for the advertising of a plant protection product. (b) The Director shall authorise the advertising of a plant protection product if: (i) he has received an application in accordance with sub-regulation (3) of this regulation; (ii) he is satisfied that the advertising sufficiently represents the content and conditions of the authorization; (iii) the advertising does not make use of any statement which cannot be technically proven; (iv) the advertising does not include any statement which is false or otherwise misleading; (v) the advertising does not encourage the use of the plant protection product for any purpose or circumstance or instruction other than that specified by the authorisation for the plant protection product; (vi) the advertising does not contain any wording or statement which claims or implies the absolute safety of the plant protection product and in particular shall not include any of the words “harmless” or “non-toxic” or any similar phrase unless such words are used within a context to give information regarding the properties of the product; B 4427VERŻJONI ELETTRONIKA (vii) the advertising contains a suitable warning against the improper use of the product and shall encourage the use of the plant protection product in accordance with the instructions found on the label or packaging. 21. No plant protection produts containing one or more of the active substances listed in Schedule VII may either be placed on the market or used. This shall not apply to plant protection products which contain negligible impurities because of the nature of the manufacturing process, provided that they have no harmful effects on human beings, animals or the environment 22. (1) By way of derogation from regulation 21, the Director may temporarily authorize to permit the placing on the market or the use in Malta of plant protection products containing certain of the active substances listed in the first coloumn of Schedule VII in the cases set out in the second coloumn thereof. (2) The director shall inform the other Member States and the Commission of any cases in which this regulation is applied and, if the Commission so requests, shall provided it with details of the extens to which each such active substance is used. 23. Regulations 21 and 22 shall not apply to plant protection products intended for: (a) purposes of research or analysis or (b) export to third countries. 24. If necessary, the Director may also authorize plant protection products referred to in regulation 22, in accordance with regulation 8 (2) of these regulations. 25. The sanctions applicable for the infringement of any provision of these regulations shall be those provided for in Part 9 of the Act. 26. The Plant Protection Products Regulations, 2004 are hereby being revoked. Plant Protection Products containing active substances. Derogation from regulation 21. Non-Applicability of regulations 21 and 22. Director’s Authorizations. Applicable sanctions. Revokes L.N. 115 of 2004. SCHEDULE I ACTIVE SUBSTANCES AUTHORISED FOR USE IN PLANT PROTECTION PRODUCTS General provisions applying to all substances listed in this Schedule: For the implementation of the uniform principles of Schedule VI in relation to each substance, the conclusions of the review report on it, and in particular the Appendices I and II thereof, as finalised in the Standing Committee on Plant Health on the date indicated under‘specific provisions’for that substance shall be taken into account. The Director shall keep available all review reports (except for confidential information within the meaning of regulation 14 of these regulations) for consultation by any interested parties or shall make it available to them on specific request. Number Common name, identification, numbers IUPAC name Purity Entry into force Expiration of inclusion Specific provisions 1 Imazalil CAS No 73790-28-0, 35554-44-0 CIPAC No 335 (+)-1-(ß-allyloxy 2,4 dichlorophenylethy l)imidazole or (+) allyl 1-(2,4-dichloro phenyl)-2-imidazol 1-ylethyl ether 975 g/kg 1 January 1999 31 December 2011 Only uses as fungicide may be authorized. For the following uses the following particular conditions apply: —post-harvest fruit, vegetable and potato treatments may only be authorised when an appropriate decontamination system is available or a risk assessment has demonstrated to the authorizing Member State that the discharge of the treatment solution does not have an unacceptable risk to the environment and in particular to aquatic organisms, —post-harvest treatment of potatoes may only be authorised when a risk assessment has demonstrated to the authorizing Member State that the discharge of the processing waste from treated potatoes does not have an unacceptable risk to aquatic organisms, —outdoor foliar uses may only be authorised when a risk assessment has demonstrated to the authorizing Member State that the use has no unacceptable effects on human and animal health and the environment. Date of Standing Committee on Plant Health at which the review report was finalised: 11 July 1997. 2 Azoxystrobin CAS No 131860-33-8 CIPAC No 571 Methyl (E)-2-{2[6 (2-cyanophenoxy) pyrimidin-4-yloxy] phenyl}-3-methoxya crylate 930 g/kg (Z isomer max. 25 g/kg) 1 July 1998 31 December 2011 Only uses as fungicide may be authorised. In the decision making according to the Uniform Principles particular attention should be given to the impact on aquatic organisms. Author isation conditions should include appropriate risk mitigation measures. Date of Standing Committee on Plant Health at which the review report was finalised: 22 April 1998. Number Common name, identification, numbers IUPAC name Purity Entry into force Expiration of inclusion Specific provisions 3 Kresoxim-Methyl CAS No 143390-89-0 CIPAC No 568 Methyl (E)-2-meth oxyimino-2-[2-(o tolyloxymethyl) phenyl]acetate 910 g/kg 1 February 1999 31 December 2011 Only uses as fungicide may be authorised. In their decision making according to the Uniform Principles Member States shall pay particular attention to the protection of groundwater under vulnerable conditions. Date of Standing Committee on Plant Health at which the review report was finalised: 16 October 1998. 4 Spiroxamine CAS No 1181134-30-8 CIPAC No 572 (8-tert-Butyl-1,4 dioxa-spiro [4.5] decan-2-ylmethyl) ethyl-propyl-amine 940 g/kg (diaster eomers A and B combined) 1 September 1999 31 December 2011 Only uses as a fungicide may be authorised. In their decision making according to the Uniform Principles Member States: —must pay particular attention to operator safety and must ensure that the conditions of authorisation include appropriate protective measures, and, —must pay particular attention to the impact on aquatic organisms and must ensure that the conditions of authorisation include, where appropriate, risk mitigation measures. Date of Standing Committee on Plant Health at which the review report was finalised: 12 May 1999. 5 Azimsulfuron CAS No 120162-55-2 CIPAC No 584 1-(4,6-dimethoxypyr imidin-2-yl)-3-[1 methyl-4-(2-methyl 2H-tetrazol-5-yl) pyrazol-5 ylsulfonyl]-urea 980 g/kg 1 October 1999 31 December 2011 Only uses as herbicide may be authorised. Aerial applications may not be authorised. In their decision making according to the Uniform Principles Member States must pay particular attention to the impact on aquatic organisms and terrestrial non-target plants and must ensure that the conditions of authorisation include, where appropriate, risk mitigation measures (e.g. in rice cultivation minimum holding periods for water prior to discharge). Date of Standing Committee on Plant Health at which the review report was finalised: 2 July 1999. Number Common name, identification, numbers IUPAC name Purity Entry into force Expiration of inclusion Specific provisions 6 Fluroxypyr CAS No 69377-81-7 CIPAC No 431 4-amino-3,5 dichloro-6-fluoro-2 pyridyloxyacetic acid 950 g/kg 1 December 2000 31 December 2011 Only uses as herbicide may be authorised. In their decision making according to the Uniform Principles Member States: —shall take into account the additional information requested in point 7 of the Review Report, —must pay particular attention to the protection of groundwater, —must pay particular attention to the impact on aquatic organisms and must ensure that the conditions of authorisation include, where appropriate, risk mitigation measures. Member States shall inform the Commission if the requested additional trials and information as outlined in point 7 of the Review Report were not submitted by 1 December 2000. Date of Standing Committee on Plant Health at which the review report was finalised: 30 November 1999. 7 Metsulfuron-methyl CAS No 74223-64-6 EEC No 441 Methyl-2-(4 methoxy-6-methyl 1,3,5,-triazin-2-ylcar bamoylsulfamoyl) benzoate 960 g/kg 1.7.2001 30.6.2011 Only uses as herbicide may be authorised In their decision making according to the uniform principles, Member States: —must pay particular attention to the protection of groundwater, —must pay particular attention to the impact on aquatic organisms and must ensure that the conditions of authorisation include, where appropriate, risk mitigation measures Date of Standing Committee on Plant Health at which the review report was finalised: 16.6.2000 8 Prohexadione Calcium CAS No 127277-53-6 CIPAC No 567 Calcium 3,5-dioxo-4 propionylcyclohexa necarboxylate 890 g/kg 1 October 2000 31 December 2011 Only uses as plant growth regulator may be authorised. Date of Standing Committee on Plant Health at which the review report was finalised: 16 June 2000. 9 Triasulfuron CAS No 82097-50-5 CIPAC No 480 1-[2-(2-chloroethox y)phenylsulfonyl]-3 (4-methoxy-6 methyl-1,3,5-triazin 2-yl)urea 940 g/kg 1.8.2001 31.7.2011 Only uses as herbicide may be authorised In their decision making according to the uniform principles, Member States: —must pay particular attention to the protection of groundwater, —must pay particular attention to the impact on aquatic organisms and must ensure that the conditions of authorisation include, where appropriate, risk mitigation measures Date of Standing Committee on Plant Health at which the review report was finalised: 13.7.2000 Number Common name, identification, numbers IUPAC name Purity Entry into force Expiration of inclusion Specific provisions 10 Esfenvalerate CAS No 66230-04-4 CIPAC No 481 (S)-a-Cyano-3 phenoxybenzyl-(S) 2-(4-chlorophenyl)-3 methylbutyrate 830 g/kg 1.8.2001 31.7.2011 Only uses as insecticide may be authorised In their decision making according to the uniform principles, Member States: —must pay particular attention to the potential impact on aquatic organisms and non-target arthropods and must ensure that the conditions of authorisation include, where appropriate, risk mitigation measures Date of Standing Committee on Plant Health at which the review report was finalised: 13.7.2000 11 Bentazone CAS No 25057-89-0 CIPAC No 366 3-isopropyl-(1H) 2,1,3-benzothia diazin-4-(3H)-one 2,2-dioxide 960 g/kg 1.8.2001 31.7.2011 Only uses as herbicide may be authorised In their decision-making according to the uniform principles, Member States must pay particular attention to the protection of groundwater Date of Standing Committee on Plant Health at which the review report was finalised: 13.7.2000 12 Lambda-cyhalothrin CAS No 91465-08-6 CIPAC No 463 A 1:1 mixture of: (S)-a-cyano-3 phenoxybenzyl (Z) (1R,3R)-3-(2-chloro 3,3,3-trifluoro propenyl)-2,2 dimethylcyclopropa necarboxylate, and (R)-a-cyano-3 phenoxybenzyl (Z) (1S,3S)-3-(2-chloro 3,3,3-trifluoro propenyl)-2,2 dimethylcyclopropa necarboxylate 810 g/kg 1.1.2002 31.12.2011 Only uses as insecticide may be authorised In their decision-making according to the uniform principles, Member States: —must pay particular attention to operator safety, —must pay particular attention to the potential impact on aquatic organisms and non-target arthropods including bees and must ensure that the conditions of authorisation include, where appropriate, risk mitigation measures, —must pay particular attention to the residues in food and especially the acute effects thereof Date of Standing Committee on Plant Health at which the review report was finalised: 19.10.2000 Number Common name, identification, numbers IUPAC name Purity Entry into force Expiration of inclusion Specific provisions 13 Fenhexamid CAS No 126833-17-8 CIPAC No 603 N-(2,3-dichloro-4 hydroxyphenyl)-1 methylcyclohexane carboxamide =950 g/kg (2) 1 June 2001 31 May 2011 Only uses as a fungicide may be authorised. In decision making according to the Uniform Principles Member States must pay particular attention to the potential impact on aquatic organisms and must ensure that the conditions of authorisation include, where appropriate, risk mitigation measures. Date of Standing Committee on Plant Health at which the review report was finalised: 19 October 2000 14 Amitrole CAS No 61-82-5 CIPAC No 90 H-[1,2,4]-triazole-3 ylamine 900 g/kg 1.1.2002 31.12.2011 Only uses as herbicide may be authorised For the implementation of the uniform principles of Schedule VI, the conclusions of the review report on amitrole, and in particular Appendices I and II thereof, as finalised in the Standing Committee on Plant Health on 12 December 2000 shall be taken into account. In this overall assessment Member States: —must pay particular attention to the protection of operators —must pay particular attention to the protection of the groundwater in vulnerable areas, in particular with respect to non-crop uses —must pay particular attention to the protection of beneficial arthropods —must pay particular attention to the protection of birds and wild mammals. Use of amitrole during the breeding season may only be authorised when an appropriate risk assessment has demonstrated that there is no unacceptable impact and when the conditions of authorisation include, where appropriate, risk mitigation measures 15 Diquat CAS No 2764-72-9 (ion), 85-00-7 (dibromide) CIPAC No 55 9,10-Dihydro-8a,10a diazoniaphenanthrene ion (dibromide) 950 g/kg 1.1.2002 31.12.2011 On the basis of currently available information, only uses as terrestrial herbicide and desiccant may be authorised. Uses in aquatic weed control shall not be authorised For the implementation of the uniform principles of Schedule VI, the conclusions of the review report on diquat, and in particular Appendices I and II thereof, as finalised in the Standing Committee on Plant Health on 12 December 2000 shall be taken into account. In this overall assessment Member States: —must pay particular attention to the potential impact on aquatic organisms and must ensure that the conditions of authorisation include, where appropriate, risk mitigation measures —must pay particular attention to operator safety as related to non professional use and must ensure that the conditions of authorisation include, where appropriate, risk mitigation measures Number Common name, identification, numbers IUPAC name Purity Entry into force Expiration of inclusion Specific provisions 16 Pyridate CAS No 55512-33.9 CIPAC No 447 6-Chloro-3-phenyl pyridazin-4-yl S octyl thiocarbonate 900 g/kg 1.1.2002 31.12.2011 Only uses as herbicide may be authorised For the implementation of the uniform priciples of Schedule VI, the conclusions of the review report on pyridate, and in particular Appendices I and II thereof, as finalised in the Standing Committee on Plant Health on 12 December 2000 shall be taken into account. In this overall assessment Member States: —must pay particular attention to the protection of groundwater —must pay particular attention to the potential impact on aquatic organisms and must ensure that the conditions of authorisation include, where appropriate, risk mitigation measures 17 Thiabendazole CAS No 148-79-8 CIPAC No 323 2-Thiazol-4-yl-1H benzimidazole 985 g/kg 1.1.2002 31.12.2011 Only uses as fungicide may be authorised. Foliar spray applications shall not be authorised For the implementation of the uniform priciples of Schedule VI, the conclusions of the review report on thiabendazole, and in particular Appendices I and II thereof, as finalised in the Standing Committee on Plant Health on 12 December 2000 shall be taken into account. In this overall assessment Member States: —must pay particular attention to the protection of aquatic and sediment-dwelling organisms and must ensure that the conditions of authorisation include, where appropriate, risk mitigation measures Suitable risk mitigation measures (e.g. depuration with diatom earth or activated carbon) have to be implemented to protect surface waters from unacceptable levels of contamination via wastewater 18 Paecilomyces fumo soroseus Apopka strain 97, PFR 97 or CG 170, ATCC20874 Not applicable The absence of secondary meta bolites should be checked in each fermentation broth by HPLC 1 July 2001 30 June 2011 Only uses as an insecticide may be authorised Each fermentation broth should be checked by HPLC to ensure that no secondary metabolites are present Date of Standing Committee on Plant Health at which the review report was finalised: 27 April 2001 Number Common name, identification, numbers IUPAC name Purity Entry into force Expiration of inclusion Specific provisions 19 DPX KE 459 (flupyr sulfuron-methyl) CAS No 144740-54-5 CIPAC No 577 2-(4,6-dimethoxypyr imidin-2-ylcarba moylsulfamoyl)-6 trifluromethylnico tinate monosodium salt 903 g/kg (3) 1 July 2001 30 June 2011 Only uses as a herbicide may be authorised. In decision-making according to the Uniform Principles Member States must pay particular attention to the protection of groundwater. Date of Standing Committee on Plant Health at which the review report was finalised: 27 April 2001. 20 Acibenzolar-s-methyl CAS No 135158-54-2 CIPAC No 597 Benzo[1,2,3]thia diazole-7-carbothioic acid S-methyl ester 970 g/kg 1 November 2001 31 October 2011 Only uses as a plant activator may be authorised. Date of Standing Committee on Plant Health at which the review report was finalised: 29 June 2001. 21 Cyclanilide CAS No 113136-77-9 CIPAC No 586 Not available 960 g/kg 1 November 2001 31 October 2011 Only uses as a plant growth regulator may be authorised. The maximum content of the impurity 2,4-dichloroaniline (2,4 DCA) in the active substance as manufactured should be 1 g/kg. Date of Standing Committee on Plant Health at which the review report was finalised: 29 June 2001. 22 Ferric phosphate CAS No 10045-86-0 CIPAC No 629 Ferric phosphate 990 g/kg 1 November 2001 31 October 2011 Only uses as a molluscicide may be authorised. Date of Standing Committee on Plant Health at which the review report was finalised: 29 June 2001 23 Pymetrozine CAS No 123312-89-0 CIPAC No 593 (E)-6-methyl-4 [(pyridin-3-ylmetyle ne)amino]-4,5 dihydro-2H-[1,2,4] triazin-3 one 950 g/kg 1 November 2001 31 October 2011 Only uses as an insecticide may be authorised. In decision-making according to the uniform principles Member States must pay particular attention to the protection of aquatic organisms. Date of Standing Committee on Plant Health at which the review report was finalised: 29 June 2001. 24 Pyraflufen-ethyl CAS No 129630-19-9 CIPAC No 605 Ethyl-2-chloro-5-(4 chloro-5-difluoro methoxy-1 mhypyrazol-3-yl)-4 fluorophenoxyacetate 956 g/kg 1 November 2001 31 October 2011 Only uses as a herbicide may be authorised. In decision-making according to the uniform principles Member States must pay particular attention to the protection of algae and aquatic plants and should apply, where appropriate, risk mitigation measures. Date of Standing Committee on Plant Health at which the review report was finalised: 29 June 2001. Number Common name, identification, numbers IUPAC name Purity Entry into force Expiration of inclusion Specific provisions 25 Glyphosate CAS No 1071-83-6 CIPAC No 284 N-(phosphono methyl)-glycin 950 g/kg 1 July 2002 30 June 2012 Only uses as herbicide may be authorised For the implementation of the uniform principles of Schedule VI, the conclusions of the review report on glyphosate, and in particular Appendices I and II thereof, as finalised in the Standing Committee on Plant Health on 29 June 2001 shall be taken into account. In this overall assessment Member States: —must pay particular attention to the protection of the groundwater in vulnerable areas, in particular with respect to non-crops uses 26 Thifensulfuron-methyl CAS No 79277-27-3 CIPAC No 452 Methyl 3-(4 methoxy-6-methyl 1,3,5-triazin-2-ylcar bamoyl-sulfamoyl) thiophene-2 carboxylate 960 g/kg 1 July 2002 30 June 2012 Only uses as herbicide may be authorised. For the implementation of the uniform principles of Schedule VI, the conclusions of the review report on thifensulfuron-methyl, and in particular Appendices I and II thereof, as finalised in the Standing Committee on Plant Health on 29 June 2001 shall be taken into account. In this overall assessment Member States: —must pay particular attention to the protection of groundwater, —must pay particular attention to the impact on aquatic plants and must ensure that the conditions of authorisation include, where appropriate, risk mitigation measures 27 2,4-D CAS No 94-75-7 CIPAC No 1 (2,4-dichloro phenoxy) acetic acid 960 g/kg 1.10.2002 30.9.2012 Only uses as herbicide may be authorised For the implementation of the uniform principles of Schedule VI, the conclusions of the review report on 2,4-D, and in particular Appendices I and II thereof, as finalised in the Standing Committee on Plant Health on 2 October 2001 shall be taken into account. In this overall assessment Member States: —must pay particular attention to the protection of the groundwater, when the active substance is applied in regions with vulnerable soil and/or climatic conditions —must pay particular attention to the dermal absorption —must pay particular attention to the protection of non-target arthropods and must ensure that the conditions of authorisation include, where appropriate, risk mitigation measures Number Common name, identification, numbers IUPAC name Purity Entry into force Expiration of inclusion Specific provisions 28 Isoproturon CAS No 34123-59-6 CIPAC No 336 3-(4-isopropyl phenyl)-1,1 dimethylurea 970 g/kg 1 January 2003 31 December 2012 Only uses as herbicide may be authorised For the implementation of the uniform principles of Schedule VI, the conclusions of the review report on isoproturon, and in particular Appendices I and II thereto, as finalised in the Standing Committee on Plant Health on 7 December 2001 shall be taken into account. In this overall assessment Member States: —must pay particular attention to the protection of the groundwater, when the active substance is applied in regions with vulnerable soil and/or climatic conditions or at use rates higher than those described in the review report and must apply risk mitigation measures, where appropriate, —must pay particular attention to the protection of aquatic organisms and must ensure that the conditions of authorisation include, where appropriate, risk mitigation measures 29 Ethofumesate CAS No 26225-79-6 CICAP No 223 (±)-2-ethoxy-2,3 dihydro-3,3 dimethylbenzofuran 5-ylmethanesulfonate 960 g/kg 1 March 2003 28 February 2013 Only uses as herbicide may be authorised For the implementation of the uniform principles of Schedule VI, the conclusions of the review report on ethofumesate, and in particular Appendices I and II thereof, as finalised in the Standing Committee on the Food Chain and Animal Health on 26 February 2002 shall be taken into account. In this overall assessment Member States may pay particular attention to the protection of the groundwater, when the active substance is applied in regions with vulnerable soil and/or climatic conditions and must apply risk mitigation measures, where appropriate. 30 Iprovalicarb CAS No 140923-17-7 CICAP No 620 {2-Methyl-1-[1-(4 methylphenyl)ethyl carbonyl] propyl} carbamic acid isopro pylester 950 g/kg (provi sional sp ecifi cation) 1 July 2002 30 June 2011 Only uses as fungicide may be authorised. For the implementation of the uniform principles of Schedule VI, the conclusions of the review report on iprovalicarb, and in particular Appendices I and II thereof, as finalised in the Standing Committee on the Food Chain and Animal Health on 26 February 2002 shall be taken into account. In this overall assessment: —the specification of the technical material as commercially manu factured must be confirmed and supported by apporpriate analytical data. The test material used in the toxicity dossier should be compared and verified against this specification of the technical material, —Member States must pay particular attention to the protection of operators. Number Common name, identification, numbers IUPAC name Purity Entry into force Expiration of inclusion Specific provisions 31 Prosulfuron CAS No 94125-34-5 CICAP No 579 1-(4-methoxy-6 methyl-1,3,5-triazin 2-yl)-3-[2-(3,3,3 trifluoropropyl) phenylsulfonyl]-urea 950 g/kg 1 Juli 2002 30 June 2011 Only uses as herbicide may be authorised. For the implementation of the uniform principles of Schedule VI, the conclusions of the review report on prosulfuron, and in particular Appendices I and II thereof, as finalised in the Standing Committee on the Food Chain and Animal Health on 26 February 2002 shall be taken into account. In this overall assessment Member States: —must carefully consider the risk to aquatic plants if the active substance is applied adjacent to surface waters. Risk mitigation measures should be applied where appropriate, —must pay particular attention to the protection of groundwater, when the active substance is applied in regions with vulnerable soil and/or climate conditions. Risk mitigation measures should be applied where appropriate. 32 Sulfosulfuron CAS No 141776-32-1 CICAP No 601 1-(4,6-dimethoxypyr imidin-2-yl)-3-[2 ethanesulfonyl imidazo[1,2 a]pyridine) sulfo nyl]urea 980 g/kg 1 July 2002 30 June 2011 Only uses as a herbicide may be authorised. For the implementation of the uniform principles of Schedule VI, the conclusions of the review report on sulforsulfuron, and in particular Appendices I and II thereof, as finalised in the Standing Committee on the Food Chain and Animal Health on 26 February 2002 shall be taken into account. In this overall assessment: —Member States must pay particular attention to the protection of aquatic plants and algae. Where apporpriate, risk mitigation measures should be applied, —Member States must pay particular attention to the protection of the groundwater, when the active substance is applied in regions with vulnerable soil and/or climatic conditons. Number Common name, identification, numbers IUPAC name Purity Entry into force Expiration of inclusion Specific provisions 33 Cinidon-ethyl CAS No 142891-20-1 CIPAC No 598 (Z)-ethyl 2-chloro-3 [2-chloro-5 (cyclohex-1-ene-1,2 dicarboximido)phe nyl]acrylate 940 g/kg 1 October 2002 30 September 2012 Only uses as herbicide may be authorised. For the implementation of the uniform principles of Schedule VI, the conclusions of the review report on cinidon-ethyl, and in particular Appendices I and II thereof, as finalised in the Standing Committee on the Food Chain and Animal Health on 19 April 2002 shall be taken into account. In this overall assessment Member States: —should pay particular attention to the potential for groundwater contamination, when the active substance is applied in regions with vulnerable soil (e.g. soils with neutral or high pH values) and/or climatic conditions, —should pay particular attention to the protection of aquatic organisms. Conditions of authorisation must include risk-mitigation measures, where appropriate. 34 Cyhalofop butyl CAS No 122008-85-9 CIPAC No 596 Butyl-(R)-2-[4(4 cyano-2-fluoro phenoxy) phenoxy] propionate 950 g/kg 1 October 2002 30 September 2012 Only uses as herbicide may be authorised. For the implementation of the uniform principles of Schedule VI, the conclusions of the review report on cyhalofop butyl, and in particular Appendices I and II thereof, as finalised in the Standing Committee on the Food Chain and Animal Health on 19 April 2002 shall be taken into account. In this overall assessment: —Member States must carefully consider the potential impact of aerial applications to non-target organisms and in particular to aquatic species. Conditions of authorisation must include restrictions or risk mitigation measures, where appropriate, —Member States must carefully consider the potential impact of terrestrial applications on aquatic organisms within paddy fields. Conditions of authorisation must include risk-mitigation measures, where appropriate. Number Common name, identification, numbers IUPAC name Purity Entry into force Expiration of inclusion Specific provisions 35 Famoxadone CAS No 131807-57-3 CIPAC No 594 3-anilino-5-methyl-5 (4-phenoxyphenyl) 1,3-oxazolidine-2,4 dione 960 g/kg 1 October 2002 30 September 2012 Only uses as fungicide may be authorised. For the implementation of the uniform principles of Schedule VI, the conclusions of the review report on famoxadone, and in particular Appendices I and II thereof, as finalised in the Standing Committee on the Food Chain and Animal Health on 19 April 2002 shall be taken into account. In this overall assessment: —Member States must pay particular attention to potential chronic risks of the parent substance or metabolites to earthworms, —Member States must pay particular attention to the protection of aquatic organisms and must ensure that the conditions of authorisation include, where appropriate, risk-mitigation measures, —Member States should pay particular attention to the protection of operators. 36 Florasulam CAS No 145701-23-1 CIPAC No 616 2',6', 8-Trifluoro-5 methoxy-[1,2,4] triazolo [1,5-c] pyri midine-2-sulphona nilide 970 g/kg 1 October 2002 30 September 2012 Only uses as herbicide may be authorised. For the implementation of the uniform principles of Schedule VI, the conclusions of the review report on florasulam, and in particular Appendices I and II thereof, as finalised in the Standing Committee on the Food Chain and Animal Health on 19 April 2002 shall be taken into account. In this overall assessment Member States: —should pay particular attention to the potential for groundwater contamination, when the active substance is applied in regions with vulnerable soil and/or climatic conditions. Conditions of authorisation must include risk-mitigation measures, where appropriate. 37 Metalaxyl-M CAS No 70630-17-0 CIPAC No 580 Methyl(R)-2-{[(2,6 dimethylphenyl) methoxy-acetyl] amino} propionate 910 g/kg 1 October 2002 30 September 2012 Only uses as fungicide may be authorised. For the implementation of the uniform principles of Schedule VI, the conclusions of the review report on Metalaxyl-M, and in particular Appendices I and II thereof, as finalised in the Standing Committee on the Food Chain and Animal Health on 19 April 2002 shall be taken into account. In this overall assessment: —particular attention should be given to the potential for groundwater contamination by the active substance or its degradation products CGA 62826, and CGA 108906 when the active substance is applied in regions with vulnerable soil and/or climatic conditions. Risk-mitigation measures should be applied, where appropriate. Number Common name, identification, numbers IUPAC name Purity Entry into force Expiration of inclusion Specific provisions 38 Picolinafen CAS No 137641-05-5 CIPAC No 639 4'-Fluoro-6-[(a,a,a trifluoro-m-tolyl)ox y]picolinanilide 970 g/kg 1 October 2002 30 September 2012 Only uses as herbicide may be authorised. For the implementation of the uniform principles of Schedule VI, the conclusions of the review report on picolinafen, and in particular Appendices I and II thereof, as finalised in the Standing Committee on the Food Chain and Animal Health on 19 April 2002 shall be taken into account. In this overall assessment Member States: —must pay particular attention to the protection of aquatic organisms. Conditions of authorisation should include risk-mitigation measures, where appropriate. 39 Flumioxazine CAS No 103361-09-7 CICAP No 578 N-(7-fluoro-3,4 dihydro-3-oxo-4 prop-2-ynyl-2H-1,4 benzoxazin-6-yl)cy clohex-1-ene-1,2 dicarboximide 960 g/kg 1 January 2003 31 December 2012 Only uses as herbicide may be authorised. For the implementation of the uniform principles of Schedule VI, the conclusions of the review report on flumioxazine, and in particular Appendices I and II thereof, as finalised in the Standing Committee on the Food Chain and Animal Health on 28 June 2002 shall be taken into account. In this overall assessment Member States: —must carefully consider the risk to aquatic plants and algae. Conditions of authorisation must include risk mitigation measures, where appropriate. 40 Deltamethrin CAS No 52918-63-5 CIPAC No 333 (S)-a-cyano-3 phenoxybenzyl (1R,3R)-3-(2,2-dibro movinyl)-2,2 dimethylcyclo propane carboxylate 980 g/kg 1 November 2003 31 October 2013 Only uses as insecticide may be authorised For the implementation of the uniform principles of Schedule VI, the conclusions of the review report on deltamethrin, and in particular Appendices I and II thereof, as finalised in the Standing Committee on Plant Health on 18 October 2002 shall be taken into account. In this overall assessment Member States: —must pay particular attention to the operator safety and must ensure that the conditions of authorisation include appropriate protective measures, —should observe the acute dietary exposure situation of consumers in view of future revisions of maximum residue levels, —must pay particular attention to the protection of aquatic organisms, bees and non-target arthropods and must ensure that the conditions of authorisation include risk mitigation measures, where appropriate. Number Common name, identification, numbers IUPAC name Purity Entry into force Expiration of inclusion Specific provisions 41 Imazamox CAS No 114311-32-9 CIPAC No 619 (±)-2-(4-isopropyl-4 methyl-5-oxo-2 imidazolin-2-yl)-5 (methoxymethyl) nicotinic acid 950 g/kg 1 July 2003 30 June 2013 Only uses as herbicide may be authorised. For the implementation of the uniform principles of Schedule VI, the conclusions of the review report on imazamox, and in particular Appendices I and II thereof, as finalised in the Standing Committee on the Food Chain and Animal Health on 3 December 2002 shall be taken into account. In this overall assessment Member States should pay particular attention to the potential for groundwater contamination, when the active substance is applied in regions with vulnerable soil and/or climate conditions. Risk mitigation measures should be applied where appropriate. 42 Oxasulfuron CAS No 144651-06-9 CIPAC No 626 Oxetan-3-yl 2[(4,6 dimethylpyrimidin-2 yl) carbamoyl sulfamoyl] benzoate 960 g/kg 1 July 2003 30 June 2013 Only uses as herbicide may be authorised. For the implementation of the uniform principles of Schedule VI, the conclusions of the review report on oxasulfuron, and in particular Appendices I and II thereof, as finalised in the Standing Committee on the Food Chain and Animal Health on 3 December 2002 shall be taken into account. —Member States must pay particular attention to the protection of groundwater, when the active substance is applied in regions with vulnerable soil and/or climate conditions. Risk mitigation measures should be applied, where appropriate. 43 Ethoxysulfuron CAS No 126801-58-9 CIPAC No 591 3-(4,6-dimethoxypyr imidin-2-yl)-1-(2 ethoxyphenoxy sulfonyl)urea 950 g/kg 1 July 2003 30 June 2013 Only uses as herbicide may be authorised. For the implementation of the uniform principles of Schedule VI, the conclusions of the review report on ethoxysulfuron, and in particular Appendices I and II thereof, as finalised in the Standing Committee on the Food Chain and Animal Health on 3 December 2002 shall be taken into account. Member States should pay particular attention to the protection of non target aquatic plants and algae in drainage canals. Risk mitigation measures should be applied where appropriate. Number Common name, identification, numbers IUPAC name Purity Entry into force Expiration of inclusion Specific provisions 44 Foramsulfuron CAS No 173159-57-4 CIPAC No 659 1-(4,6-dimethoxypyr imidin-2-yl)-3-(2 dimethylcarbamoyl 5-formamidophenyl sulfonyl)urea 940 g/kg 1 July 2003 30 June 2013 Only uses as herbicide may be authorised. For the implementation of the uniform principles of Schedule VI, the conclusions of the review report on foramsulfuron, and in particular Appendices I and II thereof, as finalised in the Standing Committee on the Food Chain and Animal Health on 3 December 2002 shall be taken into account. In this overall assessment Member States should pay particular attention to the protection of aquatic plants. Risk mitigation measures should be applied, where appropriate. 45 Oxadiargyl CAS No 39807-15-3 CIPAC No 604 5-tert-butyl-3-(2,4 dichloro-5-propargy loxyphenyl)-1,3,4 oxadiazol-2-(3H)-one 980 g/kg 1 July 2003 30 June 2013 Only uses as herbicide may be authorised. For the implementation of the uniform principles of Schedule VI, the conclusions of the review report on oxadiargyl, and in particular Appendices I and II thereof, as finalised in the Standing Committee on the Food Chain and Animal Health on 3 December 2002 shall be taken into account. In this overall assessment Member States should pay particular attention to the protection of algae and aquatic plants. Risk mitigation measures should be applied where appropriate. 46 Cyazofamid CAS No 120116-88-3 CIPAC No 653 4-chloro-2cyano N,N-dimethyl-5-P tolylimidazole -1 sulfonamide 935 g/kg 1 July 2003 30 June 2013 Only uses as fungicide may be authorised. For the implementation of the uniform principles of Schedule VI, the conclusions of the review report on cyazofamid, and in particular Appendices I and II thereof, as finalised in the Standing Committee on the Food Chain and Animal Health on 3 December 2002 shall be taken into account. In this overall assessment —Member States must pay particular attention to the protection of aquatic organisms; —Member States must pay particular attention to the degradation kinetics of the metabolite CTCA in soil, especially for Northern European regions. Risk mitigation measures or use restrictions should be applied where appropriate. Number Common name, identification, numbers IUPAC name Purity Entry into force Expiration of inclusion Specific provisions 47 2,4-DB CAS No 94-82-6 CIPAC No 83 4-(2,4-dichloro phenoxy) butyric acid 940 g/kg 1 January 2004 31 December 2013 Only use as herbicide may be authorised For the implementation of the uniform principles of Schedule VI, the conclusions of the review report on 2,4-DB, and in particular Appendices I and II thereof, as finalised in the Standing Committee on the Food Chain and Animal Health on 3 December 2002 shall be taken into account. In this overall assessment Member States: must pay particular attention to the protection of groundwater when the active substance is applied in regions with vulnerable soil and/or climatic conditions. Risk mitigation measures should be applied, where appropriate. 48 Beta-cyfluthrin CAS No 68359-37-5 (unstated stereochemistry) CIPAC No 482 (1RS,3RS;1RS,3SR) 3- (2,2-dichlor ovinyl)-2,2-dimethyl cyclopropanecar boxylic acid (SR)-a cyano- (4-fluoro-3 phenoxy-phenyl) methyl ester 965 g/kg 1 January 2004 31 December 2013 Only use as insecticide may be authorised Uses other than ornamental in greenhouses and seed treatment are currently not adequately supported and have not shown to be acceptable under the criteria required by Schedule VI. To support authorisations for such uses, data and information to prove their acceptability to human consumers and the environment will have to be generated and submitted to the Member States. This will be the case in particular for data to assess in all detail the risks of outdoor foliar uses and the dietary risks of foliar treatment in edible crops. For the implementation of the uniform principles of Schedule VI, the conclusions of the review report on beta-cyfluthrin, and in particular Appendices I and II thereof, as finalised in the Standing Committee on the Food Chain and Animal Health on 3 December 2002 shall be taken into account. In this overall assessment: Member States must pay particular attention to the protection of non-target arthropods. Conditions of authorisation should include adequate risk mitigation measures. 1991L 0414 1991L 0414 Number Common name, identification, numbers IUPAC name Purity Entry into force Expiration of inclusion Specific provisions 49 Cyfluthrin CAS No 68359-37-5 (unstated stereochemistry) CIPAC No 385 (RS),-a-cyano-4 fluoro-3-phenoxy benzyl (1RS,3RS;1RS,3SR) 3-(2,2-dichlor ovinyl)-2,2-dimethy cyclopropanecar boxylate 920 g/kg 1 January 2004 31 December 2013 Only use as insecticide may be authorised Uses other than ornamental in greenhouses and seed treatment are currently not adequately supported and have not shown to be acceptable under the criteria required by Schedule VI. To support authorisations for such uses, data and information to prove their acceptability to human consumers and the environment will have to be generated and submitted to the Member States. This will be the case in particular for data to assess in all detail the risks of outdoor foliar uses and the dietary risks of foliar treatment in edible crops. For the implementation of the uniform principles of Schedule VI, the conclusions of the review report on cyfluthrin, and in particular Appendices I and II thereof, as finalised in the Standing Committee on the Food Chain and Animal Health on 3 December 2002 shall be taken into account. In this overall assessment: Member States must pay particular attention to the protection of non- target arthropods. Conditions of authorisation should include adequate risk mitigation measures. 50 Iprodione CAS No 36734-19-7 CIPAC No 278 3-(3,5-dichloro phenyl)-N-isopropyl 2,4-dioxo-imidazo lidine-1-carboximide 960 g/kg 1 January 2004 31 December 2013 Only use as fungicide may be authorised For the implementation of the uniform principles of Schedule VI, the conclusions of the review report on iprodione, and in particular Appendices I and II thereof, as finalised in the Standing Committee on the Food Chain and Animal Health on 3 December 2002 shall be taken into account. In this overall assessment, Member States: —should pay particular attention to the potential for ground water contamination when the active substance is applied at high use rates (in particular use in turf) on acidic soils (pH below 6) under vulnerable climatic conditions, —must carefully consider the risk to aquatic invertebrates if the active substance is applied directly adjacent to surface waters. Risk mitigation measures should be applied, where appropriate. 51 Linuron CAS No 330-55-2 CIPAC No 76 3-(3,4-dichloro phenyl)-1-methoxy 1-methylurea 900 g/kg 1 January 2004 31 December 2013 Only use as herbicide may be authorised For the implementation of the uniform principles of Schedule VI, the conclusions of the review report on linuron, and in particular Appendices I and II thereof, as finalised in the Standing Committee on the Food Chain and Animal Health on 3 December 2002 shall be taken into account. In this overall assessment Member States: —must pay particular attention to the protection of wild mammals, non target arthropods and aquatic organisms. Conditions of author isation should include risk mitigation measures, where appropriate, —must pay particular attention to the protection of operators. Number Common name, identification, numbers IUPAC name Purity Entry into force Expiration of inclusion Specific provisions 52 Maleic hydrazide CAS No 123-33-1 CIPAC No 310 6-hydroxy-2H pyridazin-3-one 940 g/kg The active substance shall comply with Council Directive 79/117/EEC, as amended 1 January 2004 31 December 2013 Only use as growth regulator may be authorised For the implementation of the uniform principles of Schedule VI, the conclusions of the review report on maleic hydrazide, and in particular Appendices I and II thereof, as finalised in the Standing Committee on the Food Chain and Animal Health on 3 December 2002 shall be taken into account. In this overall assessment Member States: —must pay particular attention to the protection of non-target arthropods and must ensure that the conditions of authorisation include risk mitigation measures, where appropriate, —must pay particular attention to the potential for groundwater contamination, when the active substance is applied in regions with vulnerable soil and/or climatic conditions. Risk mitigation measures should be applied, where appropriate. 53 Pendimethalin CAS No 40487-42-1 CIPAC No 357 N-(1-ethylpropyl) 2,6-dinitro-3,4 xylidene 900 g/kg 1 January 2004 31 December 2013 Only use as herbicide may be authorised For the implementation of the uniform principles of Schedule VI, the conclusions of the review report on pendimethalin, and in particular Appendices I and II thereof, as finalised in the Standing Committee on the Food Chain and Animal Health 3 December 2002 shall be taken into account. In this overall assessment Member States: —must pay particular attention to the protection of aquatic organisms and non-target terrestrial plants. Conditions of authorisation must include risk mitigation measures, where appropriate, —must pay particular attention to the possibility of short-range transport of the active substance in air. 1991L 0414 Number Common name, identification, numbers IUPAC name Purity Entry into force Expiration of inclusion Specific provisions 54 Propineb CAS No: 12071-83-9 (monomer), 9016-72-2 (homo polymer) CIPAC No: 177 Polymeric zinc 1,2 propylenebis(dithio carbamate) The technical active substance should comply with the FAO specification 1 April 2004 31 March 2014 Only uses as fungicide may be authorised For the implementation of the uniform principles of Schedule VI, the conclusions of the review report on propineb, and in particular Appendices I and II thereto, as finalised in the Standing Committee on the Food Chain and Animal Health on 26 February 2003 shall be taken into account. In this overall assessment: —Member States should pay particular attention to the potential for ground water contamination when the active substance is applied in regions with vulnerable soils and/or extreme climatic conditions —Member States should pay particular attention to the protection of small mammals, aquatic organisms and non-target arthropods. Conditions of authorisation should include risk mitigation measures, where appropriate —Member States should observe the acute dietary exposure situation of consumers in view of future revisions of maximum residue levels 55 Propyzamide CAS No: 23950-58-5 CIPAC No: 315 3,5-dichloro-N-(1,1 dimethyl-prop-2 ynyl)benzamide 920 g/kg 1 April 2004 31 March 2014 Only uses as herbicide may be authorised For the implementation of the uniform principles of Schedule VI, the conclusions of the review report on propyzamide, and in particular Appendices I and II thereof, as finalised in the Standing Committee on Plant Health 26 February 2003 shall be taken into account. In this overall assessment, Member States: —must pay particular attention to the protection of operators and must ensure that conditions of authorisation include risk mitigation measures, where appropriate —must pay particular attention to the protection of birds and wild mammals in particular if the substance is applied during the breeding season. Conditions of authorisation should include risk mitigation measures, where appropriate Number Common name, identification, numbers IUPAC name Purity Entry into force Expiration of inclusion Specific provisions 56 Mecoprop CAS No 7085-19-0 CIPAC No 51 (RS)-2-(4-chloro-o tolyloxy)-propionic acid 930 g/kg 1 June 2004 31 May 2014 Only uses as herbicide may be authorised. For the implementation of the uniform principles of Schedule VI, the conclusions of the review report on mecoprop, and in particular Appendices I and II thereof, as finalised in the Standing Committee on the Food Chain and Animal Health on 15 April 2003 shall be taken into account. In this overall assessment: —Member States should pay particular attention to the potential for groundwater contamination, when the active substance is applied in regions with vulnerable soil and/or climatic conditions. Conditions of authorisation should include risk mitigation measures, where appropriate, —Member States should pay particular attention to the protection of non-target arthropods. Risk mitigation measures should be applied, where appropriate. 57 Mecoprop-P CAS No 16484-77-8 CIPAC No 475 (R)-2-(4-chloro-o tolyloxy)-propionic acid 860 g/kg 1 June 2004 31 May 2014 Only uses as herbicide may be authorised. For the implementation of the uniform principles of Schedule VI, the conclusions of the review report on mecoprop-P, and in particular Appendices I and II thereof, as finalised in the Standing Committee on the Food Chain and Animal Health on 15 April 2003 shall be taken into account. In this overall assessment: —Member States should pay particular attention to the potential for groundwater contamination, when the active substance is applied in regions with vulnerable soil and/or climatic conditions. Conditions of authorisation should include risk mitigation measures, where appropriate. Number Common name, identification, numbers IUPAC name Purity Entry into force Expiration of inclusion Specific provisions 58 Propiconazole CAS No 60207-90-1 CIPAC No 408 (±)-1-[2-(2,4-dichlor ophenyl)-4-propyl 1,3-dioxolan-2 ylmethyl]-1H-1,2,4 triazole 920 g/kg 1 June 2004 31 May 2014 Only uses as fungicide may be authorised. For the implementation of the uniform principles of Schedule VI, the conclusions of the review report on propiconazole, and in particular Appendices I and II thereof, as finalised in the Standing Committee on the Food Chain and Animal Health on 15 April 2003 shall be taken into account. In this overall assessment: —Member States should pay particular attention to the protection of non target arthropods and aquatic organisms. Conditions of authorisation should include risk mitigation measures, where appropriate, —Member States should pay particular attention to the protection of soil organisms for applications rates exceeding 625 g a.i./ha (e.g. uses in lawn). Conditions of authorisation should include risk mitigation measures (e.g. spotwise application scheme), where appropriate. 59 Trifloxystrobin CAS No 141517-21-7 CIPAC No 617 Methyl (E)-methox yimino-{(E)-a-[1-a (a,a,a-trifluoro-m tolyl)ethylideneami nooxyl]-o-tolyl}a cetate 960 g/kg 1 October 2003 30 September 2013 Only use as fungicide may be authorised. For the implementation of the uniform principles of Schedule VI, the conclusions of the review report on trifloxystrobin, and in particular Appendices I and II thereof, as finalised in the Standing Committee on the Food Chain and Animal Health on 15 April 2003 shall be taken into account. In this overall assessment: —Member States should pay particular attention to the protection of groundwater, when the active substance is applied in regions with vulnerable soil and/or climate conditions. Risk mitigation measures should be applied and/or monitoring programs may be initiated where appropriate. 60 Carfentrazone ethyl CAS No 128639-02.1 CIPAC No 587 Ethyl (RS)-2-chloro 3-[2-chloro-5-(4 difluoromethyl-4,5 dihydro-3-methyl 5oxo-1H 1,2,4 triazol-1-yl)-4-fluoro phenyl]propionate 900 g/kg 1 October 2003 30 September 2013 Only use as herbicide may be authorised. For the implementation of the uniform principles of Schedule VI, the conclusions of the review report on carfentrazone-ethyl, and in particular Appendices I and II thereof, as finalised in the Standing Committee on the Food Chain and Animal Health on 15 April 2003 shall be taken into account. In this overall assessment: —Member States should pay particular attention to the protection of groundwater, when the active substance is applied in regions with vulnerable soil and/or climate conditions. Risk mitigation measures should be applied where appropriate. Number Common name, identification, numbers IUPAC name Purity Entry into force Expiration of inclusion Specific provisions 61 Mesotrione CAS No 104206-8 CIPAC No 625 2-(4-mesyl-2-nitro benzoyl) cyclo hexane -1,3-dione 920 g/kg The manufac turing impurity 1 cyano-6-(methyl sulfonyl)-7-nitro 9H-xanthen-9-one is considered to be of toxico logical concern and must remain below 0.0002 % (w/w) in the technical product. 1 October 2003 30 September 2013 Only use as herbicide may be authorised. For the implementation of the uniform principles of Schedule VI, the conclusions of the review report on mesotrione, and in particular Appendices I and II thereof, as finalised in the Standing Committee on the Food Chain and Animal Health on 15 April 2003 shall be taken into account. 62 Fenamidone CAS No 161326-34-7 CIPAC No 650 (S)-5-methyl-2 methylthio-5-phenyl 3-phenylamino-3,5 dihydroimidazol-4 one 975 g/kg 1 October 2003 30 September 2013 Only use as fungicide may be authorised. For the implementation of the uniform principles of Schedule VI, the conclusions of the review report on fenamidone, and in particular Appendices I and II thereof, as finalised in the Standing Committee on the Food Chain and Animal Health on 15 April 2003 shall be taken into account. In this overall assessment Member States: —should pay particular attention to the protection of groundwater, when the active substance is applied in regions with vulnerable soil and/or climate conditions, —should pay particular attention to the protection of non-target arthropods, —should pay particular attention to the protection of aquatic organisms. Risk mitigation measures should be applied where appropriate. Number Common name, identification, numbers IUPAC name Purity Entry into force Expiration of inclusion Specific provisions 63 Isoxaflutole CAS No 141112-29-0 CIPAC No 575 5-cyclopropyl-4-(2 methylsulfonyl-4 trifluoromethyl benzoyl) isoxazole 950 g/kg 1 October 2003 30 September 2013 Only use as herbicide may be authorised. For the implementation of the uniform principles of Schedule VI, the conclusions of the review report on isoxaflutole, and in particular Appendices I and II thereof, as finalised in the Standing Committee on the Food Chain and Animal Health on 15 April 2003 shall be taken into account. In this overall assessment Member States: —must pay particular attention to the protection of groundwater, when the active substance is applied in regions with vulnerable soil and/or climate conditions. Risk mitigation measures or monitoring programs should be applied where appropriate. 64 Flurtamone CAS No 96525-23-4 (RS)-5-methylamino 2-phenyl-4-(a,a,a trifluoro-m-tolyl) furan-3 (2H)-one 960 g/kg 1 January 2004 31 December 2013 Only uses as herbicide may be authorised. For the implementation of the uniform principles of Schedule VI, the conclusions of the review report on flurtamone, and in particular Appendices I and II thereof, as finalised in the Standing Committee on the Food Chain and Animal Health on 4 July 2003 shall be taken into account. In this overall assessment Member States: —should pay particular attention to the protection of groundwater, when the active substance is applied in regions with vulnerable soil and/or climate conditions, —should pay particular attention to the protection of algae and other aquatic plants. Risk mitigation measures should be applied where appropriate. 65 Flufenacet CAS No 142459-58-3 CIPAC No 588 4'-fluoro-N isopropyl-2-[5 (trifluoromethyl) 1,3,4-thiadiazol-2 yloxy]acetanilide 950 g/kg 1 January 2004 31 December 2013 Only uses as herbicide may be authorised. For the implementation of the uniform principles of Schedule VI, the conclusions of the review report on flufenacet, and in particular Appendices I and II thereof, as finalised in the Standing Committee on the Food Chain and Animal Health on 4 July 2003 shall be taken into account. In this overall assessment Member States: —should pay particular attention to the protection of groundwater, when the active substance is applied in regions with vulnerable soil and/or climate conditions, —should pay particular attention to the protection of algae and aquatic plants, —should pay particular attention to the protection of operators. Risk mitigation measures should be applied where appropriate. Number Common name, identification, numbers IUPAC name Purity Entry into force Expiration of inclusion Specific provisions 66 Iodosulfuron CAS No 185119-76-0 (parent) 144550-36-7 (iodo sulfuron-methyl-sodium) CIPAC No 634 (parent) 634.501 (iodosulfuron methyl-sodium) 4-iodo-2-[3-(4 methoxy-6-methyl 1,3,5-triazin-2-yl) ureidosulfonyl] benzoate 910 g/kg 1 January 2004 31 December 2013 Only uses as herbicide may be authorised. For the implementation of the uniform principles of Schedule VI, the conclusions of the review report on iodosulfuron, and in particular Appendices I and II thereof, as finalised in the Standing Committee on the Food Chain and Animal Health on 4 July 2003 shall be taken into account. In this overall assessment Member States: —should pay particular attention to the potential of iodosulfuron and its metabolites for groundwater contamination, when the active substance is applied in regions with vulnerable soil and/or climate conditions, —should pay particular attention to the protection of aquatic plants. Risk mitigation measures should be applied where appropriate. 67 Dimethenamid-p CAS No 163515-14-8 CIPAC No 638 S-2-chloro-N-(2,4 dimethyl-3-thienyl) N-(2-methoxy-1 methylethyl) acetamide 890 g/kg (preli minary value based on a pilot plant) 1 January 2004 31 December 2013 Only uses as herbicide may be authorised. For the implementation of the uniform principles of Schedule VI, the conclusions of the review report on dimethenamid-p, and in particular Appendices I and II thereof, as finalised in the Standing Committee on the Food Chain and Animal Health on 4 July 2003 shall be taken into account. In this overall assessment Member States: —should pay particular attention to the potential of the metabolites of dimethenamid-p for groundwater contamination, when the active substance is applied in regions with vulnerable soil and/or climate conditions, —should pay particular attention to the protection of aquatic ecosystems, especially of aquatic plants. Risk mitigation measures should be applied where appropriate. The Member States shall inform the Commission in accordance with regulation 13(3) on the specification of the technical material as commercially manufactured. Number Common name, identification, numbers IUPAC name Purity Entry into force Expiration of inclusion Specific provisions 68 Picoxystrobin CAS No 117428-22-5 CIPAC No 628 Methyl (E)-3 methoxy-2-{2-[6 (trifluoromethyl) -2 pyridyloxymethyl] phenyl} acrylate 950 g/kg (preli minary value based on a pilot plant) 1 January 2004 31 December 2013 Only uses as fungicide may be authorised. For the implementation of the uniform principles of Schedule VI, the conclusions of the review report on picoxystrobin, and in particular Appendices I and II thereof, as finalised in the Standing Committee on the Food Chain and Animal Health on 4 July 2003 shall be taken into account. In this overall assessment Member States: —should pay particular attention to the protection of groundwater, when the active substance is applied in regions with vulnerable soil and/or climate conditions, —should pay particular attention to the protection of soil organisms, —should pay particular attention to the protection of aquatic ecosystems. Risk mitigation measures should be applied where appropriate. The Member States shall inform the Commission in accordance with regulation 13(3) on the specification of the technical material as commercially manufactured. 69 Fosthiazate CAS No 98886-44-3 CIPAC No 585 (RS)-S-sec-butyl O ethyl 2-oxo-1,3-thia zolidin-3-ylphospho nothioate 930 g/kg 1 January 2004 31 December 2013 Only uses as insecticide or nematicide may be authorised. For the implementation of the uniform principles of Schedule VI, the conclusions of the review report on fosthiazate, and in particular Appendices I and II thereof, as finalised in the Standing Committee on the Food Chain and Animal Health on 4 July 2003 shall be taken into account. In this overall assessment Member States —should pay particular attention to the protection of groundwater, when the active substance is applied in regions with vulnerable soil and/or climate conditions; —should pay particular attention to the protection of birds and wild mammals in particular if the substance is applied during the breeding season; —should pay particular attention to the protection of non-target soil organisms. Risk mitigation measures should be applied where appropriate. In order to mitigate the potential risk to small birds, product authorisations must require that a very high level of incorporation of granules into soil is achieved. The Member States shall inform the Commission in accordance with regulation 13(3) on the specification of the technical material as commercially manufactured. Number Common name, identification, numbers IUPAC name Purity Entry into force Expiration of inclusion Specific provisions 70 Silthiofam CAS No 175217-20-6 CIPAC No 635 N-allyl-4,5-dimethyl 2-(trimethylsi lyl)thiophene-3 carboxamide 950 g/kg 1 January 2004 31 December 2013 Only uses as fungicide may be authorised. Uses other than seed treatments are currently not adequately supported by data. To support authorisations for such uses, data and information to prove their acceptability for consumers, operators and the environment will have to be generated and submitted to the Member States. For the implementation of the uniform principles of Schedule VI, the conclusions of the review report on silthiofam, and in particular Appendices I and II thereof, as finalised in the Standing Committee on the Food Chain and Animal Health on 4 July 2003 shall be taken into account. In this overall assessment Member States must pay particular attention to the protection of operators. Risk mitigation measures must be applied, where appropriate. 71 Coniothyrium minitans Strain CON/M/91-08 (DSM 9660) CIPAC No 614 Not applicable For details on purity and production control see Review Report 1 January 2004 31 December 2013 Only uses as fungicide may be authorised. When granting authorisations, the conclusions of the review report on Coniothyrium minitans, and in particular Appendices I and II thereof, as finalised in the Standing Committee on the Food Chain and Animal Health on 4 July 2003 shall be taken into account. In this overall assessment: —Member States must pay particular attention to the operator and worker safety and must ensure that the conditions of authorization include appropriate protective measures. 72 Molinate CAS No 2212-67-1 CIPAC No 235 S-ethyl azepane-1 carbothioate; S-ethyl perhydroa zepine-1 carbothioate; S-ethyl perhydroa zepine-1-thiocar boxilate 950 g/kg 1 August 2004 31 July 2014 Only uses as herbicide may be authorised. For the implementation of the uniform principles of Schedule VI, the conclusions of the review report on molinate, and in particular Appendices I and II thereof, as finalised in the Standing Committee on the Food Chain and Animal Health on 4 July 2003 shall be taken into account. In this overall assessment: —Member States should pay particular attention to the potential for groundwater contamination, when the active substance is applied in regions with vulnerable soil and/or climatic conditions. Conditions of authorisation should include risk mitigation measures, where appropriate, —Member States should pay particular attention to the possibility of short-range transport of the active substance in air. Number Common name, identification, numbers IUPAC name Purity Entry into force Expiration of inclusion Specific provisions 73 Thiram CAS No 137-26-8 CIPAC No 24 tetramethylthiuram disulfide; bis (dimethylthiocar bamoyl)-disulfide 960 g/kg 1 August 2004 31 July 2014 Only uses as fungicide or as repellent may be authorised. For the implementation of the uniform principles of Schedule VI, the conclusions of the review report on thiram, and in particular Appendices I and II thereof, as finalised in the Standing Committee on the Food Chain and Animal Health on 4 July 2003 shall be taken into account. In this overall assessment: —Member States should pay particular attention to the protection of aquatic organisms. Risk mitigation measures should be applied, where appropriate, —Member States should pay particular attention to the protection of small mammals and birds when the substance is used as a seed treatment in spring uses. Risk mitigation measures should be applied, where appropriate. 74 Ziram CAS No 137-30-4 CIPAC No 31 Zinc bis (dimethyl dithiocarbamate) 950 g/kg (FAO specification) Arsenic: maximum 250 mg/kg Water: maximum 1,5 % 1 August 2004 31 July 2014 Only uses as fungicide or as repellent may be authorised. For the implementation of the uniform principles of Schedule VI, the conclusions of the review report on ziram, and in particular Appendices I and II thereof, as finalised in the Standing Committee on the Food Chain and Animal Health on 4 July 2003 shall be taken into account. In this overall assessment: —Member States should pay particular attention to the protection of non target arthropods and aquatic organisms. Risk mitigation measures should be applied, where appropriate, —Member States should observe the acute dietary exposure situation of consumers in view of future revisions of Maximum Residue Levels. Number Common name, identification, numbers IUPAC name Purity Entry into force Expiration of inclusion Specific provisions 75 Paraquat CAS No 4685-14-7 CIPAC No 56 1,1'-dimethyl-4,4' bipyridinium 500 g/l (expressed as paraquat dichloride) 1 November 2004 31 October 2014 Only uses as herbicide may be authorised. The following uses must not be authorised: —knapsack and handheld applications in home gardening, neither by amateur nor by professional users, —use via broadcast air-assisted application equipment, —ultra low volume applications. For the implementation of the uniform principles of Schedule VI, the conclusions of the review report on paraquat, and in particular Appendices I and II thereof, as finalised in the Standing Committee on the Food Chain and Animal Health on 3 October 2003, shall be taken into account. In this overall assessment Member States must pay particular attention to the protection of: —operators, in particular for knapsack and handheld applications, —ground-nesting birds. Where use scenarios indicate the potential for exposure of eggs a risk assessment should be conducted and, where appropriate, risk mitigation applied, —aquatic organisms. Conditions of authorisation should include risk mitigation measures, where appropriate, —hares. Where use scenarios indicate the potential for exposure of hares, a risk assessment should be conducted and, where appropriate, risk mitigation applied. Member States shall ensure that the authorisation holders report at the latest on 31 March each year until 2008 on incidences of operator health problems and impact on hares in one or more representative areas of use, which should be supplemented by sales data and a survey of use patterns, so that a realistic picture of the toxicological and ecological impact of paraquat can be obtained. Member States must ensure that technical concentrates shall contain an effective emetic. Liquid formulations shall contain an effective emetic, blue/green colorants and stenching or other olfactory alerting agent or agents. Other safeners, such as thickeners, may also be included. In doing so they shall take account of the FAO specification. Number Common name, identification, numbers IUPAC name Purity Entry into force Expiration of inclusion Specific provisions 76 Mesosulfuron CAS No 400852-66-6 CIPAC No 441 2-[(4,6-dimethoxy pyrimidin-2-ylcarba moyl)sulfamoyl]-a (methanesulfo namido)-p-toluic acid 930 g/kg 1 April 2004 31 March 2014 Only use as herbicide may be authorised. For the implementation of the uniform principles of Schedule VI, the conclusions of the review report on mesosulfuron, and in particular Appendices I and II thereof, as finalised in the Standing Committee on the Food Chain and Animal Health on 3 October 2003 shall be taken into account. In this overall assessment Member States: —should pay particular attention to the protection of aquatic plants; —should pay particular attention to the potential of mesosulfuron and its metabolites for groundwater contamination, when the active substance is applied in regions with vulnerable soil and/or climate conditions. Risk mitigation measures should be applied where appropriate. 77 Propoxycarbazone CAS No 145026-81-9 CIPAC No 655 2-(4,5-dihydro-4 methyl-5-oxo-3 propoxy-1H-1,2,4 triazol-1-yl) carboxa midosulfonylben zoicacid-methylester = 950 g/kg (expressed as propoxy carbazone sodium) 1 April 2004 31 March 2014 Only uses as herbicide may be authorised. For the implementation of the uniform principles of Schedule VI, the conclusions of the review report on propoxycarbazone, and in particular Appendices I and II thereto, as finalised in the Standing Committee on the Food Chain and Animal Health on 3 October 2003 shall be taken into account. In this overall assessment Member States —should pay particular attention to the potential of propoxycarbazone and its metabolites for groundwater contamination, when the active substance is applied in regions with vulnerable soil and/or climate conditions, —should pay particular attention to the protection of aquatic ecosystems, especially of aquatic plants. Risk mitigation measures should be applied where appropriate. 78 Zoxamide CAS No 156052-68-5 CIPAC No 640 (RS)-3,5-Dichloro N (3-chloro-1-ethyl-1 methylacetonyl)-p toluamide 950 g/kg 1 April 2004 31 March 2014 Only use as fungicide may be authorised. For the implementation of the uniform principles of Schedule VI, the conclusions of the review report on zoxamide, and in particular Appendices I and II thereof, as finalised in the Standing Committee on the Food Chain and Animal Health on 3 October 2003 shall be taken into account. Number Common name, identification, numbers IUPAC name Purity Entry into force Expiration of inclusion Specific provisions 79 Chlorpropham CAS No 101-21-3 CIPAC No 43 Isopropyl 3-chloro phenylcarbamate 975 g/kg 1 February 2005 31 January 2015 Only uses as herbicide and sprout suppression may be authorised. For the implementation of the uniform principles of Schedule VI, the conclusions of the review report on chlorpropham, and in particular Appendices I and II thereof, as finalised in the Standing Committee on the Food Chain and Animal Health on 28 November 2003 shall be taken into account. In this overall assessment Member States should pay particular attention to the protection of operators, consumers and non target arthropods. Conditions of authorisation should include risk mitigation measures, where appropriate. 80 Benzoic acid CAS No 65-85-0 CIPAC No 622 benzoic acid 990 g/kg 1 June 2004 31 May 2014 Only uses as disinfectant may be authorised. For the implementation of the uniform principles of Schedule VI, the conclusions of the review report on benzoic acid, and in particular Appendices I and II thereof, as finalised in the Standing Committee on the Food Chain and Animal Health on 28 November 2003 shall be taken into account. 81 Flazasulfuron CAS No 104040-78-0 CIPAC No 595 1-(4,6 dimethoxypyr imidin-2-yl)-3-(3 trifluoromethyl-2 pyridylsulpho nyl)urea 940 g/kg 1 June 2004 31 May 2014 Only uses as herbicide may be authorised. For the implementation of the uniform principles of Schedule VI, the conclusions of the review report on flazasulfuron, and in particular Appendices I and II thereto, as finalised in the Standing Committee on the Food Chain and Animal Health on 28 November 2003 shall be taken into account. In this overall assessment Member States —should pay particular attention to the potential for groundwater contamination, when the active substance is applied in regions with vulnerable soil and/or climate conditions, —should pay particular attention to the protection of aquatic plants. Risk mitigation measures should be applied where appropriate. The Member States shall inform the Commission in accordance with regulation 13(3) on the specification of the technical material as commercially manufactured. Number Common name, identification, numbers IUPAC name Purity Entry into force Expiration of inclusion Specific provisions 82 Pyraclostrobin CAS No 175013-18-0 CIPAC No 657 methyl N-(2-{[1-(4 chlorophenyl)-1H pyrazol-3-yl]oxy methyl}phenyl) N methoxy carbamate 975 g/kg The manufac turing impurity dimethylsulfate (DMS) is condidered to be of toxicological concern and must not exceed a concentration of 0,0001 % in the technical product 1 June 2004 31 May 2014 Only uses as fungicide may be authorised. For the implementation of the uniform principles of Schedule VI, the conclusions of the review report on pyraclostrobin, and in particular Appendices I and II thereto, as finalised in the Standing Committee on the Food Chain and Animal Health on 28 November 2003 shall be taken into account. In this overall assessment Member States —should pay particular attention to the protection of aquatic organisms, especially fish, —should pay particular attention to the protection of terrestrial arthropods and earthworms. Risk mitigation measures should be applied where appropriate. The Member States shall inform the Commission in accordance with regulation 13(5) on the specification of the technical material as commercially manufactured. 83 Quinoxyfen CAS No 124495-18-7 CIPAC No 566 5, 7-dichloro-4 (ρ fluorophenoxy) quinoline 970 g/kg 1 September 2004 31 August 2014 Only uses as fungicide may be authorised. For the implementation of the uniform principles of Schedule VI, the conclusions of the review report on quinoxyfen, and in particular Appendices I and II thereto, as finalised in the Standing Committee on the Food Chain and Animal Health on 28 November 2003, shall be taken into account. Member States should pay particular attention to the protection of aquatic organisms. Risk mitigation measures must be applied and monitoring programmes must be initiated in vulnerable zones where appropriate. Number Common name, identification, numbers IUPAC name Purity Entry into force Expiration of inclusion Specific provisions 84 Alpha-cypermethrin CAS No 67375-30-8 CIPAC No Racemate comprising (S)-a- cyano-3 phenoxybenzyl-(1R) cis-3-(2,2-dichlor ovinyl)-2,2-dimethyl cyclopropane carboxylate and (R)-a- cyano-3 phenoxybenzyl-(1S) cis-3-(2,2-dichlor ovinyl)-2,2-dimethyl cyclopropane carboxylate (= cis-2 isomer pair of cypermethrin) 930 g/kg CIS-2 1 March 2005 28 February 2015 Only uses as insecticide may be authorised. For the implementation of the uniform principles of Schedule VI, the conclusions of the review report on alpha-cypermethrin, and in particular Appendices I and II thereof, as finalised in the Standing Committee on the Food Chain and Animal Health on 13 February 2004 shall be taken into account. In this overall assessment: —Member States must pay particular attention to the protection of aquatic organisms, bees and non-target arthropods and must ensure that the conditions of authorisation include risk mitigation measures. —Member States must pay particular attention to the operator safety and must ensure that the conditions of authorisation include appropriate protective measures. 85 Benalaxyl CAS No 71626-11-4 CIPAC No 416 Methyl N-phenyla cetyl–N-2, 6–xylyl–DL alaninate 960 g/kg 1 March 2005 28 February 2015 Only uses as fungicide may be authorised. For the implementation of the uniform principles of Schedule VI, the conclusions of the review report on benalaxyl, and in particular Appendices I and II thereto, as finalised in the Standing Committee on the Food Chain and Animal Health on 13 February 2004 shall be taken into account. In this overall assessment Member States should pay particular attention to the potential for groundwater contamination, when the active substance is applied in regions with vulnerable soil and/or climatic conditions. Conditions of authorisation should include risk mitigation measures, where appropriate. 86 Bromoxynil CAS No 1689-84-5 CIPAC No 87 3,5 dibromo–4 hydroxybenzonitrile 970 g/kg 1 March 2005 28 February 2015 Only uses as herbicide may be authorised. For the implementation of the uniform principles of Schedule VI, the conclusions of the review report on bromoxynil, and in particular Appendices I and II thereto, as finalised in the Standing Committee on the Food Chain and Animal Health on 13 February 2004 shall be taken into account. In this overall assessment Member States must pay particular attention to the protection of birds and wild mammals, in particular if the substance is applied in winter, and of aquatic organisms. Conditions of authorisation should include risk mitigation measures, where appropriate. Number Common name, identification numbers IUPAC name Purity Entry into force Expiration of inclusion Specific provisions 87 Desmedipham CAS No 13684-56-5 CIPAC No 477 ethyl 3'-phenylcarba moyloxycarbanilate ethyl 3-phenylcarba moyloxyphenylcar bamate Min. 970 g/kg 1 March 2005 28 February 2015 Only uses as herbicide may be authorised. For the implementation of the uniform principles of Schedule VI, the conclusions of the review report on desmedipham, and in particular Appendices I and II thereto, as finalised in the Standing Committee on the Food Chain and Animal Health on 13 February 2004 shall be taken into account. In this overall assessment Member States should pay particular attention to the protection of aquatic organisms and earthworms. Risk mitigation measures should be applied if appropriate 88 Ioxynil CAS No 13684-83-4 CIPAC No 86 4- hydroxy- 3,5- di iodobenzonitrile 960 g/kg 1 March 2005 28 February 2015 Only uses as herbicide may be authorised. For the implementation of the uniform principles of Schedule VI, the conclusions of the review report on ioxynil, and in particular Appendices I and II thereto, as finalised in the Standing Committee on the Food Chain and Animal Health on 13 February 2004 shall be taken into account. In this overall assessment Member States must pay particular attention to the protection of birds and wild mammals in particular if the substance is applied in winter and to aquatic organisms. Conditions of authorisation should include risk mitigation measures, where appropriate. 89 Phenmedipham CAS No 13684-63-4 CIPAC No 77 methyl 3-(3-methyl carbaniloyloxy)carba nilate; 3-methoxycarbonyla minophenyl 3' methylcarbanilate Min. 970 g/kg 1 March 2005 28 February 2015 Only uses as herbicide may be authorised. For the implementation of the uniform principles of Schedule VI, the conclusions of the review report on phenmedipham, and in particular Appendices I and II thereto, as finalised in the Standing Committee on the Food Chain and Animal Health on 13 February 2004 shall be taken into account. In this overall assessment Member States should pay particular attention to the protection of aquatic organisms. Conditions of authorisation should include risk mitigation measures, where appropriate. Number Common name, identification numbers IUPAC name Purity Entry into force Expiration of inclusion Specific provisions 90 Pseudomonas chlor oraphis Strain: MA 342 CIPAC No 574 Not applicable The amount of the secondary meta bolite 2,3 deepoxy-2,3 didehydro rhizoxin (DDR) in the fermentate at the point of formulation of the product must not exceed the LOQ (2 mg/l). 1 October 2004 30 September 2014 Only uses as fungicide for seed dressing in closed seed dressing machinery may be authorised. When granting authorisations, the conclusions of the review report on Pseudomonas chlororaphis, and in particular Appendices I and II thereof, as finalised in the Standing Committee on the Food Chain and Animal Health on 30 March 2004 shall be taken into account. In this overall assessment, Member States should pay particular attention to the safety of operators and workers. Risk mitigation measures should be applied where appropriate. 91 Mepanipyrim CAS No 110235-47-7 CIPAC No 611 N-(4-methyl-6 prop 1-ynylpyrimidin-2 yl)aniline 960 g/kg 1 October 2004 30 September 2014 Only uses as fungicide may be authorised. For the implementation of the uniform principles of Schedule VI, the conclusions of the review report on mepanipyrim, and in particular Appendices I and II thereof, as finalised in the Standing Committee on the Food Chain and Animal Health on 30 March 2004 shall be taken into account. In this overall assessment Member States should pay particular attention to the protection of aquatic organisms. Risk mitigation measures should be applied where appropriate. 92 Acetamiprid CAS No 160430-64-8 CIPAC No Not yet allocated (E)-N1-[(6-chloro 3 pyridyl)methyl]-N2 cyano-N1 methylace tamidine =990 g/kg 1 January 2005 31 December 2014 Only uses as insecticide may be authorised. For the implementation of the uniform principles of Schedule VI, the conclusions of the review report on Acetamiprid, and in particular Appendices I and II thereof, as finalised in the Standing Committee on the Food Chain and Animal Health on 29 June 2004 shall be taken into account. In this overall assessment Member States —should pay particular attention to worker exposure, —should pay particular attention to the protection of aquatic organisms. Risk mitigation measures should be applied where appropriate. 1991L 0414 Number Common name, identification numbers IUPAC name Purity Entry into force Expiration of inclusion Specific provisions 93 Thiacloprid CAS No 111988-49-9 CIPAC No 631 (Z)-N-{3-[(6 Chloro 3-pyridinyl)methyl] 1,3-thiazolan-2 yliden}cyanamide =975 g/kg 1 January 2005 31 December 2014 Only uses as insecticide may be authorised. For the implementation of the uniform principles of Schedule VI, the conclusions of the review report on Thiacloprid, and in particular Appendices I and II thereof, as finalised in the Standing Committee on the Food Chain and Animal Health on 29 June 2004 shall be taken into account. In this overall assessment Member States —should pay particular attention to the protection of non-target arthropods, —should pay particular attention to the protection of aquatic organisms, —should pay particular attention to the potential for groundwater contamination, when the active substance is applied in regions with vulnerable soil and/or climatic conditions. Risk mitigation measures should be applied where appropriate. 94 Ampelomyces quisqualis Strain: AQ 10 Culture collection No CNCM I-807 CIPAC No Not allocated Not applicable 1 April 2005 31 March 2015 Only uses as fungicide may be authorised. When granting authorisations, the conclusions of the review report on Ampelomyces quisqualis, and in particular Appendices I and II thereof, as finalised in the Standing Committee on the Food Chain and Animal Health on 8 October 2004 shall be taken into account. 95 Imazosulfuron CAS No: 122548-33-8 CIPAC No: 590 1-(2-chloroi midazo[1,2 a]pyridin-3-ylsul phonyl)-3-(4,6 dimethoxypyrimidin 2-yl)urea =980 g/kg 1 April 2005 31 March 2015 Only uses as herbicide may be authorised. For the implementation of the uniform principles of Schedule VI, the conclusions of the review report on imazosulfuron, and in particular Appendices I and II thereof, as finalised in the Standing Committee on the Food Chain and Animal Health on 8 October 2004 shall be taken into account. In this overall assessment Member States should pay particular attention to the protection of aquatic and terrestrial non-target plants. Risk mitigation measures should be applied where appropriate. Number Common name, identification numbers IUPAC name Purity Entry into force Expiration of inclusion Specific provisions 96 Laminarin CAS No: 9008-22-4 CIPAC No: 671 (1›3)-ß-D-glucan (according to IUPAC-IUB Joint Commission on Biochemical Nomen clature) =860 g/kg on dry matter 1 April 2005 31 March 2015 Only uses as elicitor of the crop's self-defence mechanisms may be authorised. For the implementation of the uniform principles of Schedule VI, the conclusions of the review report on laminarin, and in particular Appendices I and II thereof, as finalised in the Standing Committee on the Food Chain and Animal Health on 8 October 2004 shall be taken into account. 97 Methoxyfenozide CAS No: 161050-58-4 CIPAC No: 656 N-tert-Butyl-N’-(3 methoxy-o-toluoyl) 3,5-xylohydrazide =970 g/kg 1 April 2005 31 March 2015 Only uses as insecticide may be authorised. For the implementation of the uniform principles of Schedule VI, the conclusions of the review report on methoxyfenozide, and in particular Appendices I and II thereof, as finalised in the Standing Committee on the Food Chain and Animal Health on 8 October 2004 shall be taken into account. In this overall assessment Member States should pay particular attention to the protection of terrestrial and aquatic non-target arthropods. Risk mitigation measures should be applied where appropriate. 98 S-metolachlor CAS No: 87392-12-9 (S-isomer) 178961-20-1 (R-isomer) CIPAC No: 607 Mixture of: (aRS, 1 S)-2-chloro N-(6-ethyl-o-tolyl) N-(2-methoxy-1 methylethyl)ace tamide (80-100 %) and: (aRS, 1 R)-2-chloro N-(6-ethyl-o-tolyl) N-(2-methoxy-1 methylethyl)ace tamide (20-0 %) =960 g/kg 1 April 2005 31 March 2015 Only uses as herbicide may be authorised. For the implementation of the uniform principles of Schedule VI, the conclusions of the review report on s-metolachlor, and in particular Appendices I and II thereof, as finalised in the Standing Committee on the Food Chain and Animal Health on 8 October 2004 shall be taken into account. In this overall assessment Member States —should pay particular attention to the potential for groundwater contamination, particularly of the active substance and its metabolites CGA 51202 and CGA 354743, when the active substance is applied in regions with vulnerable soil and/or climatic conditions, —should pay particular attention to the protection of aquatic plants. Risk mitigation measures should be applied where appropriate. 99 Gliocladium cate nulatum Strain: J1446 Culture collection No DSM 9212 CIPAC No Not allocated Not applicable 1 April 2005 31 March 2015 Only uses as fungicide may be authorised. When granting authorisations, the conclusions of the review report on Gliocladium catenulatum, and in particular Appendices I and II thereof, as finalised in the Standing Committee on the Food Chain and Animal Health on 30 March 2004 shall be taken into account. In this overall assessment, Member States should pay particular attention to the protection of operators and workers. Risk mitigation measures should be applied where appropriate. Number Common name, identification numbers IUPAC name Purity Entry into force Expiration of inclusion Specific provisions 100 Etoxazole CAS No: 153233-91-1 CIPAC No: 623 (RS)-5-tert-butyl-2 [2-(2,6-difluoro phenyl)-4,5-dihydro 1,3-oxazol-4-yl] phenetole =948 g/kg 1 June 2005 31 May 2015 Only uses as acaricide may be authorised. For the implementation of the uniform principles of Schedule VI, the conclusions of the review report on etoxazole, and in particular Appendices I and II thereof, as finalised in the Standing Committee on the Food Chain and Animal Health on 3 December 2004 shall be taken into account. In this overall assessment Member States should pay particular attention to the protection of aquatic organisms. Risk mitigation measures should be applied where appropriate. 101 Tepraloxydim CAS No: 149979-41-9 CIPAC No: 608 (EZ)-(RS)-2-{1 [(2E)-3-chloroally loxyimino]propyl}-3 hydroxy-5-perhy dropyran-4-ylcy clohex-2-en-1-one =920 g/kg 1 June 2005 31 May 2015 Only uses as herbicide may be authorised. For the implementation of the uniform principles of Schedule VI, the conclusions of the review report on tepraloxydim, and in particular Appendices I and II thereof, as finalised in the Standing Committee on the Food Chain and Animal Health on 3 December 2004 shall be taken into account. In this overall assessment, Member States should pay particular attention to the protection of terrestrial non-target arthropods. Risk mitigation measures should be applied where appropriate. 102 Chlorothalonil CAS No 1897-45-6 CIPAC No 288 Tetrachloroisophtha lonitrile 985 g/kg —Hexachloro benzene: not more than 0,04 g/kg —Decachlorobi phenyl: not more than 0,03 g/kg 1 March 2006 28 February 2016 PART A Only uses as fungicide may be authorised. PART B For the implementation of the uniform principles of Schedule VI, the conclusions of the review report on chlorothalonil, and in particular Appendices I and II thereof, as finalised in the Standing Committee on the Food Chain and Animal Health on 15 February 2005 shall be taken into account. In this overall assessment Members States must pay particular attention to the protection of: —aquatic organisms, —groundwater, in particular with regards to the active substance and its metabolites R417888 and R611965 (SDS46851), when the substance is applied in regions with vulnerable soil and/or climate conditions. Conditions of use should include risk mitigation measures, where appropriate. Number Common name, identification numbers IUPAC name Purity Entry into force Expiration of inclusion Specific provisions 103 Chlorotoluron (unstated stereochemistry) CAS No 15545-48-9 CIPAC No 217 3-(3-chloro-p-tolyl) 1,1-dimethylurea 975 g/kg 1 March 2006 28 February 2016 PART A Only uses as herbicide may be authorised PART B For the implementation of the uniform principles of Schedule VI, the conclusions of the review report on chlorotoluron, and in particular Appendices I and II thereof, as finalised in the Standing Committee on the Food Chain and Animal Health on 15 February 2005 shall be taken into account. In this overall assessment Member States must pay particular attention to the protection of groundwater, when the active substance is applied in regions with vulnerable soil and/or climate conditions. Conditions of authorisation should include risk mitigation measures, where appropriate 104 Cypermethrin CAS No 52315-07-8 CIPAC No 332 (RS)-a-cyano-3 phenoxybenzyl (1RS)-cis, trans-3 (2,2-dichlorovinyl) 2,2-dimethylcyclo propane carboxylate (4 isomer pairs: cis 1, cis-2, trans-3, trans-4) 900 g/kg 1 March 2006 28 February 2016 PART A Only uses as insecticide may be authorised PART B For the implementation of the uniform principles of Schedule VI, the conclusions of the review report on cypermethrin, and in particular Appendices I and II thereof, as finalised in the Standing Committee on the Food Chain and Animal Health on 15 February 2005 shall be taken into account. In this overall assessment —Member States must pay particular attention to the protection of aquatic organisms, bees and non-target arthropods. Conditions of authorisation should include risk mitigation measures, where appropriate, —Member States must pay particular attention to the operator safety. Conditions of authorisation should include protective measures, where appropriate Number Common name, identification numbers IUPAC name Purity Entry into force Expiration of inclusion Specific provisions 105 Daminozide CAS No 1596-84-5 CIPAC No 330 N-dimethylaminosuc cinamic acid 990 g/kg Impurities: —N-nitrosodi methylamine: not more than 2,0 mg/kg —1,1-dimethyl hydrazide: not more than 30 mg/kg 1 March 2006 28 February 2016 PART A Only uses as growth regulator in non-edible crops may be authorised PART B For the implementation of the uniform principles of Schedule VI, the conclusions of the review report on daminozide, and in particular Appendices I and II thereof, as finalised in the Standing Committee on the Food Chain and Animal Health on 15 February 2005 shall be taken into account. In this overall assessment Member States must pay particular attention to the safety of operators and workers after re-entry. Conditions of authorisation should include protective measures, where appropriate 106 Thiophanate-methyl (unstated stereo chemistry) CAS No 23564-05-8 CIPAC No 262 Dimethyl 4,4’-(o phenylene)bis(3 thioallophanate) 950 g/kg 1 March 2006 28 February 2016 PART A Only uses as fungicide may be authorised PART B For the implementation of the uniform principles of Schedule VI, the conclusions of the review report on thiophanate-methyl , and in particular Appendices I and II thereof, as finalised in the Standing Committee on the Food Chain and Animal Health on 15 February 2005 shall be taken into account. In this overall assessment Member States must pay particular attention to the protection of aquatic organisms, earthworms and other soil macro-organisms. Conditions of authorisation should include risk mitigation measures, where appropriate 107 Tribenuron CAS No 106040-48-6 (tribenuron) CIPAC No 546 2-[4-methoxy-6 methyl-1,3,5-triazin 2-yl(methyl)carba moylsulfamoyl] benzoic acid 950 g/kg (expressed as tribenuron methyl) 1 March 2006 28 February 2016 PART A Only uses as herbicide may be authorised. PART B For the implementation of the uniform principles of Schedule VI, the conclusions of the review report on tribenuron , and in particular Appendices I and II thereof, as finalised in the Standing Committee on the Food Chain and Animal Health on 15 February 2005 shall be taken into account. In this overall assessment Member States must pay particular attention to the protection of non-target terrestrial plants, higher aquatic plants and groundwater in vulnerable situations. Conditions of authorisation should include risk mitigation measures, where appropriate. Number Common name, identification numbers IUPAC name Purity Entry into force Expiration of inclusion Specific provisions 108 MCPA CAS No 94-74-6 CIPAC No 2 4-chloro-o-tolylox yacetic acid =930 g/kg 1 May 2006 30 April 2016 PART A Only uses as herbicide may be authorised PART B For the implementation of the uniform principles of Schedule VI, the conclusions of the review report on MCPA, and in particular Appendices I and II thereof, as finalised in the Standing Committee on the Food Chain and Animal Health on 15 April 2005 shall be taken into account Member States should pay particular attention to the potential for groundwater contamination, when the active substance is applied in regions with vulnerable soil and/or climatic conditions. Conditions of authorisation should include risk mitigation measures, where appropriate Member States must pay particular attention to the protection of aquatic organisms and must ensure that the conditions of authorisation include risk mitigation measures, where appropriate, such as buffer zones 109 MCPB CAS No 94-81-5 CIPAC No 50 4-(4-chloro-o-toly loxy)butyric acid =920 g/kg 1 May 2006 30 April 2016 PART A Only uses as herbicide may be authorised PART B For the implementation of the uniform principles of Schedule VI, the conclusions of the review report on MCPB, and in particular Appendices I and II thereof, as finalised in the Standing Committee on the Food Chain and Animal Health on 15 April 2005 shall be taken into account Member States should pay particular attention to the potential for groundwater contamination, when the active substance is applied in regions with vulnerable soil and/or climatic conditions. Conditions of authorisation should include risk mitigation measures, where appropriate Member States must pay particular attention to the protection of aquatic organisms and must ensure that the conditions of authorisation include risk mitigation measures, where appropriate, such as buffer zones 1991L 0414 Number Common name, identification numbers IUPAC name Purity Entry into force Expiration of inclusion Specific provisions 110 Bifenazate CAS No 149877-41-8 CIPAC No 736 Isopropyl 2-(4-meth oxybiphenyl-3-yl)hy drazinoformate =950 g/kg 1 December 2005 30 November 2015 PART A Only uses as acaricide may be authorised. PART B In assessing applications to authorise plant protection products containing bifenazate for uses other than on ornamental plants in greenhouses, Member States shall pay particular attention to the criteria in regulation 4(1)(b), and shall ensure that any necessary data and information is provided before such an authorization is granted. For the implementation of the uniform principles of Schedule VI, the conclusions of the review report on bifenazate, and in particular Appendices I and II thereof, as finalised in the Standing Committee on the Food Chain and Animal Health on 3 June 2005 shall be taken into account. 111 Milbemectin Milbemectin is a mixture of M.A3and M.A4 CAS No M.A3: 51596-10-2 M.A4: 51596-11-3 CIPAC No 660 M.A3: (10E,14E,16E,22Z) (1R,4S,5’S,6R,6’R,8 R,13R,20R,21R,24 S)-21,24-dihydroxy 5’,6’,11,13,22-penta methyl-3,7,19-trioxa tetracyclo[15.6.1.14,8.0 20,24] pentacosa 10,14,16,22-tetraene 6-spiro-2’-tetrahy dropyran-2-one M.A4: (10E,14E,16E,22Z) (1R,4S,5’S,6R,6’R,8 R,13R,20R,21R,24 S)-6’-ethyl-21,24 dihydroxy 5’,11,13,22-tetra methyl-3,7,19-trioxa tetracyclo[15.6.1. 14,8020,24] pentacosa 10,14,16,22-tetraene 6-spiro-2’-tetrahy dropyran-2-one =950 g/kg 1 December 2005 30 November 2015 PART A Only uses as acaricide or insecticide may be authorised. PART B For the implementation of the uniform principles of Schedule VI, the conclusions of the review report on milbemectin, and in particular Appendices I and II thereof, as finalised in the Standing Committee on the Food Chain and Animal Health on 3 June 2005 shall be taken into account. In this overall assessment Member States should pay particular attention to the protection of aquatic organisms. Risk mitigation measures should be applied where appropriate. 1991L 0414 Number Common name, identification numbers IUPAC name Purity Entry into force Expiration of inclusion Specific provisions 112 Chlorpyrifos CAS No 2921-88-2 CIPAC No 221 O,O-diethyl-O-3,5,6 trichloro-2-pyridyl phosphorothioate =970 g/kg The impurity O,O,O,O tetraethyl dithio pyrophosphate (Sulfotep) was considered of toxicological concern and a maximum level of 3 g/Kg is established. 1 July 2006 30 June 2016 PART A Only uses as insecticide may be authorised. PART B For the implementation of the uniform principles of Schedule VI, the conclusions of the review report on chlorpyrifos, and in particular Appendices I and II thereof, as finalised in the Standing Committee on the Food Chain and Animal Health on 3 June 2005 shall be taken into account. Member States must pay particular attention to the protection of birds, mammals, aquatic organisms, bees and non-target arthropods and must ensure that the conditions of authorisation include risk mitigation measures, where appropriate, such as buffer zones. Member States shall request the submission of further studies to confirm the risk assessment for birds and mammals. They shall ensure that the notifiers at whose request chlorpyrifos has been included in this Schedule provide such studies to the Commission within two years from the entry into force of Directive 72/2005. 113 Chlorpyrifos-methyl CAS No 5598-13-0 CIPAC No 486 O,O-dimethyl-O 3,5,6-trichloro-2 pyridyl phosphor othioate =960 g/kg The impurities O,O,O,O-tetra methyl dithiopyr ophosphate (Sulfotemp) and OOO-trimethyl O-(3,5,6-trichloro 2-pyridinyl) diphosphorodi thioate (Sulfotemp ester) were considered of toxicological concern and a maximum level of 5 g/Kg is established for each impurity. 1 July 2006 30 June 2016 PART A Only uses as insecticide may be authorised. PART B For the implementation of the uniform principles of Schedule VI, the conclusions of the review report on chlorpyrifos-methyl, and in particular Appendices I and II thereof, as finalised in the Standing Committee on the Food Chain and Animal Health on 3 June 2005 shall be taken into account. Member States must pay particular attention to the protection of birds, mammals, aquatic organisms, bees and non-target arthropods and must ensure that the conditions of authorisation include risk mitigation measures, where appropriate, such as buffer zones. Member States shall request the submission of further studies to confirm the risk assessment for birds and mammals in case of outdoor uses. They shall ensure that the notifiers at whose request chlorpyrifos methyl has been included in this Schedule provide such studies to the Commission within two years from the entry into force of Directive 72/2005. 1991L 0414 1991L 0414 Number Common name, identification numbers IUPAC name Purity Entry into force Expiration of inclusion Specific provisions 114 Maneb CAS No 12427-38-2 CIPAC No 61 manganese ethy lenebis (dithiocar bamate) (polymeric ) =860 g/kg The manufac turing impurity ethylene thiourea is considered to be of toxico logical concern and must not exceed 0,5 % of the maneb content. 1 July 2006 30 June 2016 PART A Only uses as fungicide may be authorised. PART B For the implementation of the uniform principles of Schedule VI, the conclusions of the review report on maneb, and in particular Appendices I and II thereof, as finalised in the Standing Committee on the Food Chain and Animal Health on 3 June 2005 shall be taken into account. Member States must pay particular attention to the potential for groundwater contamination when the active substance is applied in regions with vulnerable soils and/or extreme climatic conditions. Member States must pay particular attention to the residues in food and evaluate the dietary exposure of consumers. Member States must pay particular attention to the protection of birds, mammals, aquatic organisms and non-target arthropods and ensure that the conditions of authorisation include risk mitigation measures. Member States shall request the submission of further studies to confirm the risk assessment for birds and mammals and for developmental toxicity. They shall ensure that the notifiers at whose request maneb has been included in this Schedule provide such studies to the Commission within two years from the entry into force of Directive72/2005. 115 Mancozeb CAS No 8018-01-7 (formerly 8065-67-5) CIPAC No 34 Manganese ethy lenebis (dithiocar bamate) (polymeric) complex with zinc salt =800 g/kg The manufac turing impurity ethylene thiourea is considered to be of toxico logical concern and must not exceed 0,5 % of the mancozeb content. 1 July 2006 30 June 2016 PART A Only uses as fungicide may be authorised. PART B For the implementation of the uniform principles of Schedule VI, the conclusions of the review report on mancozeb, and in particular Appendices I and II thereof, as finalised in the Standing Committee on the Food Chain and Animal Health on 3 June 2005 shall be taken into account. Member States must pay particular attention to the potential for groundwater contamination when the active substance is applied in regions with vulnerable soils and/or extreme climatic conditions. Member States must pay particular attention to the residues in food and evaluate the dietary exposure of consumers. Number Common name, identificationnumbers IUPAC name Purity Entry into force Expiration of inclusion Specific provisions Member States must pay particular attention to the protection of birds, mammals, aquatic organisms and non-target arthropods and ensure that the conditions of authorisation include risk mitigation measures. Member States shall request the submission of further studies to confirm the risk assessment for birds and mammals and for developmental toxicity. They shall ensure that the notifiers at whose request mancozeb has been included in this Schedule provide such studies to the Commission within two years from the entry into force of Directive 72/2005.. 116 Metiram CAS No 9006-42-2 CIPAC No 478 Zinc ammoniate ethylenebis(dithiocar bamate)—poly[ ethylenebis(thiuram disulfide)] =840 g/kg The manufac turing impurity ethylene thiourea is considered to be of toxico logical concern and must not exceed 0,5 % of the metiram content. 1 July 2006 30 June 2016 PART A Only uses as fungicide may be authorised. PART B For the implementation of the uniform principles of Schedule VI, the conclusions of the review report on metiram, and in particular Appendices I and II thereof, as finalised in the Standing Committee on the Food Chain and Animal Health on 3 June 2005 shall be taken into account. Member States must pay particular attention to the potential for ground water contamination when the active substance is applied in regions with vulnerable soils and/or extreme climatic conditions. Member States must pay particular attention to the residues in food and evaluate the dietary exposure of consumers. Member States must pay particular attention to the protection of birds, mammals, aquatic organisms and non target arthropods and must ensure that the conditions of authorisation include risk mitigation measures. Member States shall request the submission of further studies to confirm the risk assessment for birds and mammals. They shall ensure that the notifiers at whose request metiram has been included in this Schedule provide such studies to the Commission within two years from the entry into force of Directive 72/2005.. Number Common name, identification numbers IUPAC name Purity Entry into force Expiration of inclusion Specific provisions 117 Oxamyl CAS No 23135-22-0 CIPAC No 342 N,N-dimethyl-2 methylcarbamoylox yimino-2 (methylthio) acetamide 970 g/kg 1 August 2006 31 July 2016 PART A Only uses as nematicide and insecticide may be authorised. PART B For the implementation of the uniform principles of Schedule VI, the conclusions of the review report on oxamyl, and in particular Appendices I and II thereto, as finalised in the Standing Committee on the Food Chain and Animal Health on 15 July 2005 shall be taken into account. In this overall assessment, —Member States must pay particular attention to the protection of birds and mammals, earthworms, aquatic organisms, surface water, and groundwater in vulnerable situations. Conditions of authorisation should include risk mitigation measures, where appropriate. —Member States must pay particular attention to the operator safety. Conditions of authorisation should include protective measures, where appropriate. The concerned Member States shall request the submission of further studies to confirm the risk assessment for ground water contamination in acidic soils, birds and mammals and earthworms. They shall ensure that the notifiers at whose request oxamyl has been included in this Schedule provide such studies to the Commission within two years from the entry into force of Directive 16/2006. 118 1-methylcyclopropene (an ISO Common Name will not be considered for this active substance) CAS No 3100-04-7 CIPAC No not allocated 1-methylcyclo propene =960 g/kg The manufac turing impurities 1-chloro-2 methylpropene and 3-chloro-2 methylpropene are of toxico logical concern and each of them must not exceed 0,5 g/kg in the technical material. 1 April 2006 31 March 2016 PART A Only uses as plant growth regulator for post harvest storage in sealable warehouse may be authorised. PART B For the implementation of the uniform principles of Schedule VI, the conclusions of the review report on 1-methylcyclopropene, and in particular Appendices I and II thereof, as finalised in the Standing Committee on the Food Chain and Animal Health on 23 September 2005 shall be taken into account. Number Common name, identification numbers IUPAC name Purity Entry into force Expiration of inclusion Specific provisions 119 Forchlorfenuron CAS No 68157-60-8 CIPAC No 633 1-(2-chloro-4 pyridinyl)-3 phenylurea =978 g/kg 1 April 2006 31 March 2016 PART A Only uses as plant growth regulator may be authorised. PART B In assessing applications to authorise plant protection products containing forchlorfenuron for uses other than in kiwi plants, Member States shall pay particular attention to the criteria in regulation 4(1)(b), and shall ensure that any necessary data and information is provided before such an authorization is granted. For the implementation of the uniform principles of Schedule VI, the conclusions of the review report on forchlorfenuron, and in particular Appendices I and II thereof, as finalised in the Standing Committee on the Food Chain and Animal Health on 23 September 2005 shall be taken into account. In this overall assessment Member States must pay particular attention to the potential for groundwater contamination, when the active substance is applied in regions with vulnerable soil and/or climatic conditions. Risk mitigation measures should be applied where appropriate. 120 Indoxacarb CAS No 173584-44-6 CIPAC No 612 methyl (S)-N-[7 chloro-2,3,4a,5 tetrahydro-4a-(meth oxycarbony l)indeno[1,2 e][1,3,4]oxadiazin-2 ylcarbonyl]-4' (trifluoromethoxy) carbanilate TC (Technical Material): = 628 g/kg indoxacarb 1 April 2006 31 March 2016 PART A Only uses as insecticide may be authorised. PART B For the implementation of the uniform principles of Schedule VI, the conclusions of the review report on indoxacarb, and in particular Appendices I and II thereof, as finalised in the Standing Committee on the Food Chain and Animal Health on 23 September 2005 shall be taken into account. In this overall assessment Member States must pay particular attention to the protection of aquatic organisms. Conditions of use should include risk mitigation measures, where appropriate. Number Common name, identification numbers IUPAC name Purity Entry into force Expiration of inclusion Specific provisions 121 Warfarin CAS No 81-81-2 CIPAC No 70 (RS)-4-hydroxy-3-(3 oxo-1-phenylbutyl) coumarin 3-(a acetonyl-benzyl)-4 hydroxycoumarin =990 g/kg 1 October 2006 30 September 2013 PART A Only uses as rodenticide in the form of pre-prepared bait, if appropriate, placed in specially constructed hoppers, are authorised. PART B For the implementation of the uniform principles of Schedule VI, the conclusions of the review report on warfarin, and in particular Appendices I and II thereto, as finalised in the Standing Committee on the Food Chain and Animal Health on 23 September 2005, shall be taken into account. In this overall assessment Member States should pay particular attention to the protection of operators, birds and non-target mammals. Risk mitigation measures should be applied where appropriate. 122 Tolylfluanid CAS No 731-27-1 CIPAC No 275 N-dichlorofluoro methylthio-N',N' dimethyl-N-p-tolyl sulfamide 960 g/kg 1 October 2006 30 September 2016 PART A Only uses as fungicide may be authorised. PART B For the implementation of the uniform principles of Schedule VI, the conclusions of the review report on tolylfluanid, and in particular Appendices I and II thereof, as finalised in the Standing Committee on the Food Chain and Animal Health on 23 September 2005 shall be taken into account. In this overall assessment Member States: —must pay particular attention to the protection of herbivorous mammals, aquatic organisms and non-target arthropods (other than bees). Conditions of authorisation should include risk mitigation measures, where appropriate, —must must pay particular attention to the residues in food and evaluate the dietary exposure of consumers. The concerned Member States shall request the submission of further studies to confirm the risk assessment for herbivorous mammals (long term risk). They shall ensure that the notifiers at whose request tolylfluanid has been included in this Schedule provide such studies to the Commission within two years from the entry into force of Directive 06/2006. Number Common name, identification numbers IUPAC name Purity Entry into force Expiration of inclusion Specific provisions 123 Clothianidin CAS No 210880-92-5 CIPAC No 738 (E)-1-(2-chloro-1,3 thiazol-5-ylmethyl) 3-methyl-2-nitrogua nidine =960 g/kg 1 August 2006 31 July 2016 PART A Only uses as insecticide may be authorised. PART B For the implementation of the uniform principles of Schedule VI, the conclusions of the review report on clothianidin, and in particular Appendices I and II thereof, as finalised in the Standing Committee on the Food Chain and Animal Health on 27 January 2006 shall be taken into account. In this overall assessment Member States —must pay particular attention to the protection of groundwater, when the active substance is applied in regions with vulnerable soil and/or climate conditions, —must pay particular attention to the risk to granivorous birds and mammals when the substance is used as a seed dressing. Conditions of use shall include risk mitigation measures, where appropriate. 124 Pethoxamid CAS No 106700-29-2 CIPAC No 655 2-chloro-N-(2-ethox yethyl)-N-(2-methyl 1-phenylprop-1-enyl) acetamide =940 g/kg 1 August 2006 31 July 2016 PART A Only uses as insecticide may be authorised. PART B For the implementation of the uniform principles of Schedule VI, the conclusions of the review report on pethoxamid, and in particular Appendices I and II thereof, as finalised in the Standing Committee on the Food Chain and Animal Health on 27 January 2006 shall be taken into account. In this overall assessment Member States —must pay particular attention to the protection of groundwater, when the active substance is applied in regions with vulnerable soil and/or climate conditions, —must pay particular attention to the protection of the aquatic environment, in particular higher aquatic plants. Conditions of use shall include risk mitigation measures, where appropriate. The Member States shall inform the Commission in accordance with regulation 13(3) on the specification of the technical material as commercially manufactured. Number Common name, identification numbers IUPAC name Purity Entry into force Expiration of inclusion Specific provisions 125 Clodinafop CAS No 114420-56-3 CIPAC No 683 (R)-2-[4-(5-chloro-3 fluoro- 2 pyri dyloxy)-phenoxy] propionic acid = 950 g/kg (expressed as clodinafop propargyl) 1 February 2007 31 January 2017 PART A Only uses as herbicide may be authorised. PART B For the implementation of the uniform principles of Schedule VI, the conclusions of the review report on clodinafop, and in particular Appendices I and II thereof, as finalised in the Standing Committee on the Food Chain and Animal Health on 27 January 2006 shall be taken into account. 126 Pirimicarb CAS No 23103-98-2 CIPAC No 231 2-dimethylamino 5,6-dimethylpyr imidin-4-yl dimethyl carbamate =950 g/kg 1 February 2007 31 January 2017 PART A Only uses as insecticide may be authorised. PART B For the implementation of the uniform principles of Schedule VI, the conclusions of the review report on pirimicarb, and in particular Appendices I and II thereof, as finalised in the Standing Committee on the Food Chain and Animal Health on 27 January 2006 shall be taken into account. Member States must pay particular attention to the safety of operators and ensure that conditions of use prescribe the application of adequate personal protective equipment. Member States must pay particular attention to the protection of aquatic organisms and must ensure that the conditions of authorisation include risk mitigation measures, where appropriate, such as buffer zones. The concerned Member States shall request the submission of further studies to confirm the long term risk assessment for birds and for potential groundwater contamination, in particular concerning metabolite R35140. They shall ensure that the notifiers at whose request pirimicarb has been included in this Schedule provide such studies to the Commission within two years from the entry into force of Directive 39/2006. Number Common name, identification numbers IUPAC name Purity Entry into force Expiration of inclusion Specific provisions 127 Rimsulfuron CAS No 122931-48-0 (rimsulfuron) CIPAC No 716 1-(4-6 dimethoxypyr imidin-2-yl)-3-(3 ethylsulfonyl-2-pyri dylsulfonyl) urea = 960 g/kg (expressed as rimsulfuron) 1 February 2007 31 January 2017 PART A Only uses as herbicide may be authorised. PART B For the implementation of the uniform principles of Schedule VI, the conclusions of the review report on rimsulfuron, and in particular Appendices I and II thereof, as finalised in the Standing Committee on the Food Chain and Animal Health on 27 January 2006 shall be taken into account. Member States must pay particular attention to the protection of non target plants and groundwater in vulnerable situations. Conditions of authorisation should include risk mitigation measures, where appropriate. 128 Tolclofos-methyl CAS No 57018-04-9 CIPAC No 479 O-2,6-dichloro-p tolyl O,O-dimethyl phosphorothioate O-2,6-dichloro-4 methylphenyl O,O dimethyl phosphor othioate =960 g/kg 1 February 2007 31 January 2017 PART A Only uses as fungicide may be authorised. PART B In assessing applications to authorise plant protection products containing tolclofos-methyl for uses other than pre-planting tuber (seed) treatment in potato and soil treatment in lettuce within greenhouses, Member States shall pay particular attention to the criteria in regulation 4(1)(b), and shall ensure that any necessary data and information is provided before such an authorisation is granted. For the implementation of the uniform principles of Schedule VI, the conclusions of the review report on tolclofos-methyl, and in particular Appendices I and II thereof, as finalised in the Standing Committee on the Food Chain and Animal Health on 27 January 2006 shall be taken into account. 129 Triticonazole CAS No 131983-72-7 CIPAC No 652 (±)-(E)-5-(4-chloro benzylidene)-2,2 dimethyl-1-(1H 1,2,4-triazol-1 ylmethyl)cyclo pentanol =950 g/kg 1 February 2007 31 January 2017 PART A Only uses as fungicide may be authorised. PART B In assessing applications to authorise plant protection products containing triticonazole for uses other than seed treatment, Member States shall pay particular attention to the criteria in regulation 4(1) (b), and shall ensure that any necessary data and information is provided before such an authorisation is granted. For the implementation of the uniform principles of Schedule VI, the conclusions of the review report on triticonazole, and in particular Appendices I and II thereof, as finalised in the Standing Committee on the Food Chain and Animal Health on 27 January 2006 shall be taken into account. In this overall assessment Member States: Number Common name, identification numbers IUPAC name Purity Entry into force Expiration of inclusion Specific provisions —must pay particular attention to the operator safety. Conditions of authorisation should include protective measures, where appropriate, —must pay particular attention to the potential for groundwater contamination, in particular from the highly persistent active substance and its metabolite RPA 406341, in vulnerable zones, —must pay particular attention to the protection of granivorous birds (long term risk). Conditions of authorisation should include risk mitigation measures, where appropriate. The concerned Member States shall request the submission of further studies to confirm the risk assessment for granivorous birds. They shall ensure that the notifier at whose request triticonazole has been included in this Schedule provide such studies to the Commission within two years from the entry into force of Directive 39/2006. 130 Dimoxystrobin CAS No 149961-52-4 CIPAC No 739 (E)-o-(2,5-dimethyl phenoxymethyl)-2 methoxyimino-N methylphenylace tamide =980 g/kg 1 October 2006 30 September 2016 PART A Only uses as fungicide may be authorised. PART B In assessing applications to authorise plant protection products containing dimoxystrobin for indoor uses, Member States shall pay particular attention to the criteria in regulation 4(1)(b), and shall ensure that any necessary data and information is provided before such an authorisation is granted. For the implementation of the uniform principles of Schedule VI, the conclusions of the review report on dimoxystrobin, and in particular Appendices I and II thereof, as finalised in the Standing Committee on the Food Chain and Animal Health on 27 January 2006 shall be taken into account. In this overall assessment Member States —must pay particular attention to the protection of groundwater, when the active substance is applied in a situation with a low crop interception factor, or in regions with vulnerable soil and/or climate conditions; —must pay particular attention to the protection of aquatic organisms. Conditions of use shall include risk mitigation measures, where appropriate. The concerned Member States shall request the submission of Number Common name, identification numbers IUPAC name Purity Entry into force Expiration of inclusion Specific provisions —a refined risk assessment for birds and mammals considering the formulated active substance; —a comprehensive aquatic risk assessment considering the high chronic risk to fish and the effectiveness of potential risk mitigation measures, particularly taking into account run-off and drainage. They shall ensure that the notifiers at whose request dimoxystrobin has been included in this Schedule provide such studies to the Commission within two years from the entry into force of Directive 75/2006. 131 Clopyralid CAS No 1702-17-6 CIPAC No 455 3,6-dichloropyridine 2-carboxylic acid =950 g/kg 1 May 2007 30 April 2017 PART A Only uses as herbicide may be authorised. PART B In assessing applications to authorise plant protection products containing clopyralid for uses other than spring applications, Member States shall pay particular attention to the criteria in regualtion 4(1)(b), and shall ensure that any necessary data and information is provided before such an authorisation is granted. For the implementation of the uniform principles of Schedule VI, the conclusions of the review report on clopyralid, and in particular Appendices I and II thereof, as finalised in the Standing Committee on the Food Chain and Animal Health on 4 April 2006 shall be taken into account. In this overall assessment Member States must pay particular attention to: —the protection of non target plants and groundwater under vulnerable conditions. Conditions of authorisation should include risk mitigation measures and monitoring programmes should be initiated to verify potential groundwater contamination in vulnerable zones, where appropriate. The concerned Member States shall request the submission of further studies to confirm the results on animal metabolism. They shall ensure that the notifiers at whose request clopyralid has been included in this Schedule provide such studies to the Commission within two years from the entry into force of Directive 64/2006. 1991L 0414 Number Common name, identification numbers IUPAC name Purity Entry into force Expiration of inclusion Specific provisions 132 Cyprodinil CAS No 121522-61-2 CIPAC No 511 (4-cyclopropyl-6 methyl-pyrimidin 2 yl)-phenyl-amine =980 g/kg 1 May 2007 30 April 2017 PART A Only uses as fungicide may be authorised. PART B For the implementation of the uniform principles of Schedule VI, the conclusions of the review report on cyprodinil, and in particular Appendices I and II thereof, as finalised in the Standing Committee on the Food Chain and Animal Health on 4 April 2006 shall be taken into account. In this overall assessment Member States: —must pay particular attention to the safety of operators and ensure that conditions of use prescribe the application of adequate personal protective equipment, —must pay particular attention to the protection of birds, mammals and aquatic organisms. Conditions of authorisation should include risk mitigation measures, such as buffer zones. The concerned Member States shall request the submission of further studies to confirm the risk assessment for birds and mammals and for possible presence of residues of metabolite CGA 304075 in food of animal origin. They shall ensure that the notifiers at whose request cyprodinil has been included in this Schedule provide such studies to the Commission within two years from the entry into force of Directive 64/2006. 133 Fosetyl CAS No 15845-66-6 CIPAC No 384 Ethyl hydrogen phosphonate = 960 g/kg (expressed as fosetyl-Al) 1 May 2007 30 April 2017 PART A Only uses as fungicide may be authorised. PART B For the implementation of the uniform principles of Schedule VI, the conclusions of the review report on fosetyl, and in particular Appendices I and II thereof, as finalised in the Standing Committee on the Food Chain and Animal Health on 4 April 2006 shall be taken into account. In this overall assessment Member States must pay particular attention to the protection of birds, mammals, aquatic organisms and non-target arthropods. Conditions of authorisation should include risk mitigation measures, where appropriate, such as buffer zone. The concerned Member States shall request the submission of further studies to confirm the risk assessment for non-target arthropods, in particular with regard to in-field recovery, and for herbivorous mammals. They shall ensure that the notifier at whose request fosetyl has been included in this Schedule provide such studies to the Commission within two years from the entry into force of Directive 64/2006. Number Common name, identification numbers IUPAC name Purity Entry into force Expiration of inclusion Specific provisions 134 Trinexapac CAS No 104273-73-6 CIPAC No 732 4-(cyclopropyl hydroxymethylene ) 3,5-dioxo cyclohex anecarboxylic acid = 940g/kg (expressed as trinexapac ethyl) 1 May 2007 30 April 2017 PART A Only uses as plant growth regulator may be authorised. PART B For the implementation of the uniform principles of Schedule VI, the conclusions of the review report on trinexapac, and in particular Appendices I and II thereof, as finalised in the Standing Committee on the Food Chain and Animal Health on 4 April 2006 shall be taken into account. In this overall assessment Member States: —must pay particular attention to the protection of birds and mammals. Conditions of authorisation should include risk mitigation measures, where appropriate. 135 Dichlorprop-P CAS No 15165-67-0 CIPAC No 476 (R)-2-(2,4 dichloro phenoxy) propanoic acid =900 g/kg 1 June 2007 31 May 2017 PART A Only uses as herbicide may be authorised. PART B For the implementation of the uniform principles of Schedule VI, the conclusions of the review report on dichlorprop-P, and in particular Appendices I and II thereof, as finalised in the Standing Committee on the Food Chain and Animal Health on 23 May 2006 shall be taken into account. In this overall assessment Member States: —must pay particular attention to the protection of birds, mammals, aquatic organisms and non-target plants. Conditions of authorisation should include risk mitigation measures, where appropriate. The Member States concerned shall request the submission of further studies to confirm the results on animal metabolism and the risk assessment on acute and short-term exposure for birds and on acute exposure for herbivorous mammals. They shall ensure that the notifiers at whose request dichlorprop-P has been included in this Schedule provide such studies to the Commission within two years of the entry into force of Directive 74/2006. Number Common name, identification numbers IUPAC name Purity Entry into force Expiration of inclusion Specific provisions 136 Metconazole CAS No 125116-23-6 (unstated stereo chemistry) CIPAC No 706 (1RS,5RS:1RS,5S R) 5-(4 chlorobenzyl) 2,2-dimethyl-1 (1H 1,2,4-triazol-1 ylmethyl) cyclo pentanol =940 g/kg (sum ofcis-and trans-isomers) 1 June 2007 31 May 2017 Part A Only uses as fungicide and plant growth regulator may be authorised. Part B For the implementation of the uniform principles of Schedule VI, the conclusions of the review report on metconazole, and in particular Appendices I and II thereof, as finalised in the Standing Committee on the Food Chain and Animal Health on 23 May 2006 shall be taken into account. In this overall assessment: —Member States must pay particular attention to the protection of aquatic organisms, birds and mammals. Conditions of authorisation should include risk mitigation measures, where appropriate, —Member States must pay particular attention to the operator safety. Conditions of authorisation should include protective measures, where appropriate. 137 Pyrimethanil CAS No 53112-28-0 CIPAC No not allocated N-(4,6 dimethylpyr imidin-2-yl) aniline =975 g/kg (themanufac turing impurity cyanamide is considered to be of toxicological concern and must not exceed 0,5 g/kg in the technical material) 1 June 2007 31 May 2017 PART A Only uses as fungicide may be authorised. PART B For the implementation of the uniform principles of Schedule VI, the conclusions of the review report on pyrimethanil, and in particular Appendices I and II thereof, as finalised in the Standing Committee on the Food Chain and Animal Health on 23 May 2006 shall be taken into account. In this overall assessment Member States: —must pay particular attention to the protection of aquatic organisms. Conditions of authorisation should include risk mitigation measures, where appropriate, such as buffer zones, —must pay particular attention to the operator safety and ensure that conditions of use prescribe the application of adequate personal protective equipment. The Member States concerned shall request the submission of further studies to confirm the risk assessment to fish. They shall ensure that the notifiers at whose request pyrimethanil has been included in this Schedule provide such studies to the Commission within two years from the entry into force of Directive 74/2006. Number Common name, identification numbers IUPAC name Purity Entry into force Expiration of inclusion Specific provisions 138 Triclopyr CAS No 055335-06-3 CIPAC No 376 3,5,6-trichloro-2 pyridyloxyacetic acid =960 g/kg (as Triclopyr butoxyethyl ester) 1 June 2007 31 May 2017 PART A Only uses as herbicide may be authorised. PART B In assessing applications to authorise plant protection products containing triclopyr for uses other than spring applications in pasture and grassland, Member States shall pay particular attention to the criteria in regulation 4(1)(b), and shall ensure that any necessary data and information is provided before such an authorisation is granted. For the implementation of the uniform principles of Schedule VI, the conclusions of the review report on triclopyr, and in particular Appendices I and II thereof, as finalised in the Standing Committee on the Food Chain and Animal Health on 23 May 2006 shall be taken into account. In this overall assessment Member States: —must pay particular attention to the protection of groundwater under vulnerable conditions. Conditions of authorisation should include risk mitigation measures and monitoring programmes should be initiated in vulnerable zones, where appropriate, —must pay particular attention to the safety of operators and ensure that conditions of use prescribe the application of adequate personal protective equipment, —must pay particular attention to the protection of birds, mammals, aquatic organisms and non-target plants. Conditions of authorisation should include risk mitigation measures, where appropriate. The Member States concerned shall request the submission of further studies to confirm the acute and long-term risk assessment for birds and mammals and the risk to aquatic organisms from exposure to the metabolite 6-chloro-2-pyridinol. They shall ensure that the notifiers at whose request triclopyr has been included in this Schedule provide such studies to the Commission within two years from the entry into force of Directive 74/2006. Number Common name, identification numbers IUPAC name Purity Entry into force Expiration of inclusion Specific provisions 139 Metrafenone CAS No: 220899-03-6 CIPAC No: 752 3'-bromo-2,3,4,6' tetramethoxy-2',6 dimethylbenzo phenone =940 g/kg 1 February 2007 31 January 2017 PART A Only uses as fungicide may be authorised. PART B For the implementation of the uniform principles of Schedule VI, the conclusions of the review report on metrafenone, and in particular Appendices I and II thereof, as finalised in the Standing Committee on the Food Chain and Animal Health on 14 July 2006 shall be taken into account. The Member States shall inform the Commission in accordance with regulation 13(3) on the specification of the technical material as commercially manufactured. 140 Bacillus subtilis (Cohn 1872) Strain QST 713, identical with strain AQ 713 Culture collection No: NRRL B -21661 CIPAC No: not allocated Not applicable 1 February 2007 31 January 2017 PART A Only uses as fungicide may be authorised. PART B For the implementation of the uniform principles of Schedule VI, the conclusions of the review report on Bacillus subtilis, and in particular Appendices I and II thereof, as finalised in the Standing Committee on the Food Chain and Animal Health on 14 July 2006 shall be taken into account. 1991L 0414 Number Common name, identification numbers IUPAC name Purity Entry into force Expiration of inclusion Specific provisions 141 Spinosad CAS No: 131929-60-7 (Spinosyn A) 131929-63-0 (Spinosyn D) CIPAC No: 636 Spinosyn A: (2R,3aS,5aR,5bS,9 S,13S,14R,16aS,16b R)-2-(6-deoxy-2,3,4 tri-O-methyl-a-L mannopyrano syloxy)-13-(4 dimethylamino 2,3,4,6-tetradeoxy-ß D-erythropyrano syloxy)-9-ethyl 2,3,3a,5a,5b,6,7,9,10,1 1,12,13,14,15,16a,16b hexa- decahydro-14 methyl-1H-8-oxacy clododeca[b]as indacene-7,15-dione Spinosyn D: (2S,3aR,5aS,5bS,9 S,13S,14R,16aS,16b S)-2-(6-deoxy-2,3,4 tri-O-methyl-a-L mannopyrano syloxy)-13-(4 dimethylamino 2,3,4,6-tetradeoxy-ß D-erythropyrano syloxy)-9-ethyl 2,3,3a,5a,5b,6,7,9,10, 11,12,13,14,15,16a,16b hexa- decahydro-4,14 dimethyl-1H-8 oxacyclododeca[b]as indacene-7,15-dione Spinosad is a mixture of 50-95 % spinosyn A and 5 50 % spinosyn D =850 g/kg 1 February 2007 31 January 2017 PART A Only uses as insecticide may be authorised. PART B For the implementation of the uniform principles of Schedule VI, the conclusions of the review report on spinosad, and in particular Appendices I and II thereof, as finalised in the Standing Committee on the Food Chain and Animal Health on 14 July 2006 shall be taken into account. In this overall assessment Member States —must pay particular attention to the protection of aquatic organisms; —must pay particular attention to the risk to earthworms when the substance is used in glasshouses. Conditions of use shall include risk mitigation measures, where appropriate. Number Common name, identification numbers IUPAC name Purity Entry into force Expiration of inclusion Specific provisions 142 Thiamethoxam CAS No: 153719-23-4 CIPAC No: 637 (E,Z)-3-(2-chloro thiazol-5-ylmethyl) 5-methyl [1,3,5]oxadiazinan-4 ylidene-N-nitroamine =980 g/kg 1 February 2007 31 January 2017 PART A Only uses as insecticide may be authorised. PART B For the implementation of the uniform principles of Schedule VI, the conclusions of the review report on thiamethoxam, and in particular Appendices I and II thereof, as finalised in the Standing Committee on the Food Chain and Animal Health on 14 July 2006 shall be taken into account. In this overall assessment Member States: —must pay particular attention to the potential for groundwater contamination, particularly of the active substance and its metabolites NOA 459602, SYN 501406 and CGA 322704, when the active substance is applied in regions with vulnerable soil and/or climatic conditions, —must pay particular attention to the protection of aquatic organisms, —must pay particular attention to the long-term risk to small herbivorous animals if the substance is used for seed treatment. Conditions of use shall include risk mitigation measures, where appropriate. ŃM80 Number Common name, identification numbers IUPAC name Purity Entry into force Expiration of inclusion Specific provisions 143 Fenamiphos CAS No 22224-92-6 CIPAC No 692 (RS)-ethyl 4 methylthio-m-tolyl isopropyl-phosphora midate =940 g/kg 1 August 2007 31 July 2017 PART A Only uses as nematicide applied by drip irrigation in greenhouses with permanent structure may be authorised. PART B For the implementation of the uniform principles of Schedule VI, the conclusions of the review report on fenamiphos, and in particular Appendices I and II thereof, as finalised in the Standing Committee on the Food Chain and Animal Health on 14 July 2006 shall be taken into account. In this overall assessment: —Member States must pay particular attention to the protection of aquatic organisms, soil non-target organisms and groundwater in vulnerable situations. Conditions of authorisation should include risk mitigation measures and monitoring programmes should be initiated to verify potential groundwater contamination in vulnerable zones, where appropriate. 144 Ethephon CAS No 16672-87-0 CIPAC No 373 2-chloroethyl-phos phonic acid = 910 g/kg (technical material—TC) The manufac turing impurities MEPHA (Mono 2-chloroethyl ester, 2-chlor oethyl phosphonic acid) and 1,2 Dichloroethane are of toxico logical concern and must not exceed respec tively 20 g/kg and 0,5 g/kg in the technical material. 1 August 2007 31 July 2017 PART A Only uses as plant growth regulator may be authorised. PART B For the implementation of the uniform principles of Schedule VI, the conclusions of the review report on ethephon, and in particular Appendices I and II thereof, as finalised in the Standing Committee on the Food Chain and Animal Health on 14 July 2006 shall be taken into account. Number Common name, identification numbers IUPAC name Purity Entry into force Expiration of inclusion Specific provisions 147 Flusilazole CAS No 85509-19-9 CIPAC No 435 Bis(4-fluorophenyl)( methyl) (1H-1,2.4 triazol-1-ylmethyl) silane 925 g/kg 1 January 2007 30 June 2008 PART A Only uses as fungicide on the following crops may be authorised: cereals other than rice, maize, rape seed, sugar beet, at rates not exceeding 200 g active substance per hectare per application. The following uses must not be authorised: —air application, —knapsack and hand-held applications, neither by amateur nor by professional users, —home gardening. Member States shall ensure that all appropriate risk mitigation measures are applied. Particular attention must be paid to the protection of: — aquatic organisms. An appropriate distance must be kept between treated areas and surface water bodies. This distance may depend on the application or not of drift reducing techniques or devices, —birds and mammals. Conditions of authorisation shall include risk mitigation measures, such as a judicious timing of the application and the selection of those formulations which, as a result of their physical presentation or the presence of agents that ensure an adequate avoidance, minimise the exposure of the concerned species, —operators, who must wear suitable protective clothing, in particular gloves, coveralls, rubber boots and face protection or safety glasses during mixing, loading, application and cleaning of the equipment, unless the exposure to the substance is adequately precluded by the design and construction of the equipment itself or by the mounting of specific protective components on such equipment. PART B For the implementation of the uniform principles of Schedule VI, the conclusions of the review report on flusilazole, and in particular Appendices I and II thereof, shall be taken into account. Member States must ensure that the authorisation holders report at the latest on 31 December of each year on incidences of operator health problems. Member States may require that elements, such as sales data and a survey of use patterns, are provided so that a realistic picture of the use conditions and the possible toxicological impact of flusilazole can be obtained. Member States shall request the submission of further studies to address the potential endocrine disrupting properties of flusilazole within two years after the adoption of the Test Guidelines on endocrine disruption by the Organisation for Economic Cooperation and Development (OECD). They shall ensure that the notifier at whose request flusilazole has been included in this Schedule provide such studies to the Commission within two years of the adoption of the above test guidelines. Number Common name, identification numbers IUPAC name Purity Entry into force Expiration of inclusion Specific provisions 149 Carbendazim (unstated stereochemistry) CAS No 10605-21-7 CIPAC No 263 Methyl benzi midazol-2-ylcar bamate 980 g/kg 1 January 2007 31 December 2009 PART A Only uses as fungicide on the following crops may be authorized on cereals, rapeseed, sugar beet, maize at rates not exceeding —0,25 kg active substance per hectare per application for cereals and rapeseed, —0,075 kg active substance per hectare per application for sugar beet, —0,1 kg active substance per hectare per application for maize. The following uses must not be authorised: —air application, —knapsack and hand-held applications neither by amateur nor by professional users, —home gardening. Member States shall ensure that all appropriate risk mitigation measures are applied. Particular attention must be paid to the protection of: —aquatic organisms. An appropriate distance must be kept between treated areas and surface water bodies. This distance may depend on the application or not of drift reducing techniques or devices, —earthworms and other soil macro-organisms. Conditions of authorisation shall include risk mitigation measures, such as the selection of the most appropriate combination of numbers and timing of application, rates of application, and, if necessary, the degree of concentration of the active substance, —birds and mammals. Conditions of authorisation shall include risk mitigation measures, such as a judicious timing of the application and the selection of those formulations which, as a result of their physical presentation or the presence of agents that ensure an adequate avoidance, minimise the exposure of the concerned species, —operators, who must wear suitable protective clothing, in particular gloves, coveralls, rubber boots and face protection or safety glasses during mixing, loading, application and cleaning of the equipment, unless the exposure to the substance is adequately precluded by the design and construction of the equipment itself or by the mounting of specific protective components on such equipment. Number Common name, identification numbers IUPAC name Purity Entry into force Expiration of inclusion Specific provisions PART B For the implementation of the uniform principles of Schedule VI, the conclusions of the review report on carbendazim, and in particular Appendices I and II thereof, shall be taken into account. Member States must ensure that the authorisation holders report at the latest on 31 December of each year on incidences of operator health problems. Member States may require that elements, such as sales data and a survey of use patterns, are provided so that a realistic picture of the use conditions and the possible toxicological impact of carbendazim can be obtained. 150 Dinocap CAS No 39300-45-3 (for isomer mixture) CIPAC No 98 2,6-dinitro-4-octyl phenyl crotonates and 2,4-dinitro-6 octylphenyl crotonates in which octyl is a mixture of 1-methylheptyl, 1 ethylhexyl and 1 propylpentyl groups 920 g/kg 1 January 2007 31 December 2009 PART A Only uses as fungicide on the following crop may be authorised: —wine grapes at rates not exceeding 0,21 kg active substance per hectare per application. The following uses must not be authorised: —air application, —knapsack and hand-held applications by amateur users, —home gardening. Member States shall ensure that all appropriate risk mitigation measures are applied. Particular attention must be paid to the protection of: —aquatic organisms. An appropriate distance must be kept between treated areas and surface water bodies. This distance may depend on the application or not of drift reducing techniques or devices, —birds and mammals. Conditions of authorisation shall include risk mitigation measures, such as a judicious timing of the application and the selection of those formulations which, as a result of their physical presentation or the presence of agents that ensure an adequate avoidance, minimise the exposure of the concerned species, —operators, who must wear suitable protective clothing, in particular gloves, coveralls, rubber boots and face protection or safety glasses during mixing, loading, application and cleaning of the equipment, unless the exposure to the substance is adequately precluded by the design and construction of the equipment itself or by the mounting of specific protective components on such equipment, —workers, who must wear suitable protective clothing, in particular gloves, if they must enter a treated area before the specific re-entry period has expired. This re-entry period may not be less than 24 hours. PART B For the implementation of the uniform principles of Schedule VI, the conclusions of the review report on dinocap, and in particular Appendices I and II thereof, shall be taken into account. Member States must ensure that the authorisation holders report at the latest on 31 December of each year on incidences of operator health problems. Member States may require that elements, such as sales data and a survey of use patterns, are provided so that a realistic picture of the use conditions and the possible toxicological impact of dinocap can be obtained. Number Common name, identification numbers IUPAC name Purity Entry into force Expiration of inclusion Specific provisions 151 Captan CAS No 133-06-02 CIPAC No 40 N-(trichloro methylthio)cyclohex 4-ene-1,2-dicar boximide =910 g/kg Impurities: Perchloromethyl mercaptan (R005406): not more than 5 g/kg Folpet: not more than 10 g/kg Carbon tetrachloride not more than 0,1 g/ Kg< 1 October 2007 30 September 2017 PART A Only uses as fungicide can be authorised. PART B In assessing applications to authorise plant protection products containing captan for uses other than tomatoes Member States shall pay particular attention to the criteria in regulation 4(1)(b), and shall ensure that any necessary data and information is provided before such an authorisation is granted. For the implementation of the uniform principles of Schedule VI, the conclusions of the review report on captan, and in particular Appendices I and II thereof, as finalised in the Standing Committee on the Food Chain and Animal Health on 29 September 2006 shall be taken into account. In this overall assessment Member States must pay particular attention to: —the operators and workers safety. Authorised conditions of use must prescribe the application of adequate personal protective equipment and risk mitigation measures to reduce the exposure; —the dietary exposure of consumers in view of future revisions of Maximum Residue Levels; —the protection of groundwater under vulnerable conditions. Conditions of authorisation should include risk mitigation measures and monitoring programmes should be initiated in vulnerable zones, where appropriate; —the protection of birds, mammals and aquatic organisms. Conditions of authorisation should include risk mitigation measures. The Member States concerned shall request the submission of further studies to confirm the long term risk assessment for birds and mammals, as well as the toxicological assessment on metabolites potentially present in groundwater under vulnerable conditions. They shall ensure that the notifiers at whose request captan has been included in this Schedule provide such studies to the Commission within two years from the entry into force of Directive 05/2007. Number Common name, identification numbers IUPAC name Purity Entry into force Expiration of inclusion Specific provisions 152 Folpet CAS No 133-07-3 CIPAC No 75 N-(trichloro methylthio)phtha limide =940 g/kg Impurities: Perchloromethyl mercaptan (R005406): not more than 3,5 g/kg Carbon tetra chloride not more than 4 g/kg 1 October 2007 30 September 2017 PART A Only uses as fungicide can be authorised. PART B In assessing applications to authorise plant protection products containing folpet for uses other than winter wheat Member States shall pay particular attention to the criteria in regulation 4(1)(b), and shall ensure that any necessary data and information is provided before such an authorisation is granted. For the implementation of the uniform principles of Schedule VI, the conclusions of the review report on folpet, and in particular Appendices I and II thereof, as finalised in the Standing Committee on the Food Chain and Animal Health on 29 September 2006 shall be taken into account. In this overall assessment Member States must pay particular attention to: —operators and workers safety. Authorised conditions of use must prescribe the application of adequate personal protective equipment; —the dietary exposure of consumers in view of future revisions of Maximum Residue Levels; —the protection of birds, mammals, aquatic and soil organisms. Conditions of authorisation should include risk mitigation measures. The Member States concerned shall request the submission of further studies to confirm the risk assessment for birds, mammals and earthworms. They shall ensure that the notifiers at whose request folpet has been included in this Schedule provide such studies to the Commission within two years from the entry into force of Directive 05/2007. Number Common name, identification numbers IUPAC name Purity Entry into force Expiration of inclusion Specific provisions 153 Formetanate CAS No 23422-53-9 CIPAC No 697 3-dimethylamino methyleneamino phenyl methylcar bamate =910 g/kg 1 October 2007 30 September 2017 PART A Only uses as insecticide and acaricide may be authorised. PART B In assessing applications to authorise plant protection products containing formetanate for uses other than in field tomatoes and ornamental shrubs Member States shall pay particular attention to the criteria in regulation 4(1)(b), and shall ensure that any necessary data and information is provided before such an authorisation is granted. For the implementation of the uniform principles of Schedule VI, the conclusions of the review report on formetanate, and in particular Appendices I and II thereof, as finalised in the Standing Committee on the Food Chain and Animal Health on 29 September 2006 shall be taken into account. In this overall assessment Member States: —must pay particular attention to the protection of birds, mammals, non-target arthropods and bees and must ensure that the conditions of authorisation include, where appropriate, risk mitigation measures; —must pay particular attention to the operator safety and ensure that conditions of use prescribe the application of adequate personal protective equipment; —must pay particular attention to the dietary exposure of consumers in view of future revisions of Maximum Residue Levels. The Member States concerned shall request the submission of further studies to confirm the risk assessment for birds, mammals and non-target arthropods. They shall ensure that the notifier at whose request formetanate has been included in this Schedule provide such studies to the Commission within two years from the entry into force of Directive 05/2007. Number Common name, identification numbers IUPAC name Purity Entry into force Expiration of inclusion Specific provisions 154 Methiocarb CAS No 2032-65-7 CIPAC No 165 4-methylthio-3,5 xylyl methylcar bamate =980 g/kg 1 October 2007 30 September 2017 PART A Only uses as repellent in seed treatment, insecticide and molluscicide may be authorised. PART B In assessing applications to authorise plant protection products containing methiocarb for uses other than seed treatment in maize Member States shall pay particular attention to the criteria in regulation 4(1)(b), and shall ensure that any necessary data and information is provided before such an authorisation is granted. For the implementation of the uniform principles of Schedule VI, the conclusions of the review report on methiocarb, and in particular Appendices I and II thereof, as finalised in the Standing Committee on the Food Chain and Animal Health on 29 September 2006 shall be taken into account. In this overall assessment Member States: —must pay particular attention to the protection of birds, mammals and non-target arthropods and must ensure that the conditions of authorisation include, where appropriate, risk mitigation measures; —must pay particular attention to the operator and bystander safety and ensure that conditions of use prescribe the application of adequate personal protective equipment; —must pay particular attention to the dietary exposure of consumers in view of future revisions of Maximum Residue Levels. The Member States concerned shall request the submission of further studies to confirm the risk assessment for birds, mammals and non-target arthropods, as well as to confirm the toxicological assessment on metabolites potentially present in crops. They shall ensure that the notifier at whose request methiocarb has been included in this Schedule provide such studies to the Commission within two years from the entry into force of Directive 05/2007. Number Common name, identification numbers IUPAC name Purity Entry into force Expiration of inclusion Specific provisions 155 Dimethoate CAS No 60-51-5 CIPAC No 59 O,O-Dimethyl-S-(N methylcarbamoyl methyl) phosphoro dithioate; 2 Dimethoxy-phosphi nothioylthio-N methylacetamide =950 g/kg Impurities: —omethoate: not more than 2 g/kg —isodimethoate: not more than 3 g/kg 1 October 2007 30 September 2017 Part A Only uses as insecticide may be authorised. Part B For the implementation of the uniform principles of Schedule VI, the conclusions of the review report on dimethoate, and in particular Appendices I and II thereof, as finalised in the Standing Committee on the Food Chain and Animal Health on 24 November 2006 shall be taken into account. In this overall assessment Member States: —must pay particular attention to the protection of birds, mammals, aquatic organisms and other non-target arthropods. Conditions of authorisation should include risk mitigation measures, where appropriate, such as buffer zones and reduction of run-off and drainage inputs to surface water; —must pay particular attention to the dietary exposure of consumers; —must pay particular attention to the operator safety and ensure that conditions of use prescribe the application of adequate personal protective equipment. The Member States concerned shall request the submission of further studies to confirm the risk assessment for birds, mammals and non-target arthropods, as well as to confirm the toxicological assessment on metabolites potentially present in crops. They shall ensure that the notifier at whose request dimethoate has been included in this Schedule provides such studies to the Commission within two years from the entry into force of Directive 27/2005. Number Common name, identification numbers IUPAC name Purity Entry into force Expiration of inclusion Specific provisions 156 Dimethomorph CAS No 110488-70-5 CIPAC No 483 (E,Z)4-[3-(4-chloro phenyl)-3-(3,4 dimethoxyphenyl)a cryloyl]morpholine =965 g/kg 1 October 2007 30 September 2017 Part A Only uses as fungicide may be authorised. Part B For the implementation of the uniform principles of Schedule VI, the conclusions of the review report on dimethomorph, and in particular Appendices I and II thereof, as finalised in the Standing Committee on the Food Chain and Animal Health on 24 November 2006 shall be taken into account. In this overall assessment Member States must pay particular attention to: —the operators and workers safety. Authorised conditions of use must prescribe the application of adequate personal protective equipment; —to the protection of birds, mammals and aquatic organisms. Conditions of authorisation should include risk mitigation measures, where appropriate. 157 Glufosinate CAS No 77182-82-2 CIPAC No 437.007 ammonium(DL) homoalanin-4 yl(methyl)pho sphinate 950 g/kg 1 October 2007 30 September 2017 Part A Only uses as herbicide may be authorised. Part B In assessing applications to authorise plant protection products containing glufosinate for uses other than in apple orchards, notably as regards the operator and consumer exposure, Member States shall pay particular attention to the criteria in regulation 4(1)(b), and shall ensure that any necessary data and information is provided before such an authorisation is granted. For the implementation of the uniform principles of Schedule VI, the conclusions of the review report on glufosinate, and in particular Appendices I and II thereof, as finalised in the Standing Committee on the Food Chain and Animal Health on 24 November 2006 shall be taken into account. In this overall assessment Member States must pay particular attention to: —the operators, workers and bystanders safety. Conditions of authorisation should include protective measures, where appropriate; —the potential for groundwater contamination, when the active substance is applied in regions with vulnerable soil and/or climatic conditions; —the protection of mammals, non-target arthropods and non target plants. Conditions of authorisation should include risk mitigation measures, where appropriate. Number Common name, identification numbers IUPAC name Purity Entry into force Expiration of inclusion Specific provisions The Member States concerned shall request the submission of further studies to confirm the risk assessment for mammals and non-target arthropods in apple orchards. They shall ensure that the notifier at whose request glufosinate has been included in this Schedule provide such studies to the Commission within two years from the entry into force of Directive 25/2007. 158 Metribuzin CAS No 21087-64-9 CIPAC No 283 4-amino-6-tert-butyl 3-methylthio-1,2,4 triazin-5(4H)-one =910 g/kg 1 October 2007 30 September 2017 Part A Only uses as herbicide may be authorised. Part B In assessing applications to authorise plant protection products containing metribuzin for uses other than in post-emergence selective herbicide in potatoes Member States shall pay particular attention to the criteria in regulation 4(1)(b), and shall ensure that any necessary data and information is provided before such an authorisation is granted. For the implementation of the uniform principles of Schedule VI, the conclusions of the review report on metribuzin, and in particular Appendices I and II thereof, as finalised in the Standing Committee on the Food Chain and Animal Health on 24 November 2006 shall be taken into account. In this overall assessment Member States: —must pay particular attention to the protection of algae, aquatic plants, non-target plants outside the treated field and must ensure that the conditions of authorisation include, where appropriate, risk mitigation measures. —must pay particular attention to the operator safety and ensure that conditions of use prescribe the application of adequate personal protective equipment. The Member States concerned shall request the submission of further data to confirm the risk assessment for groundwater. They shall ensure that the notifiers at whose request metribuzin has been included in this Schedule provide such studies to the Commission within two years from the entry into force of Directive 25/2007. Number Common name, identification numbers IUPAC name Purity Entry into force Expiration of inclusion Specific provisions 159 Phosmet CAS No 732-11-6 CIPAC No 318 O,O-dimethyl S phthalimidomethyl phosphorodithioate; N-(dimethoxypho sphinothioylthiome thyl)phatalimide =950 g/kg Impurities: —phosmet oxon: not more than 0,8 g/kg —iso phosmet: not more than 0,4 g/kg 1 October 2007 30 September 2017 Part A Only uses as insecticide and acaricide may be authorised. Part B For the implementation of the uniform principles of Schedule VI, the conclusions of the review report on phosmet, and in particular Appendices I and II thereof, as finalised in the Standing Committee on the Food Chain and Animal Health on 24 November 2006 shall be taken into account. In this overall assessment Member States: —must pay particular attention to the protection of birds, mammals, aquatic organisms, bees and other non-target arthropods. Conditions of authorisation should include risk mitigation measures, where appropriate, such as buffer zones and reduction of run-off and drainage inputs to surface water, —must pay particular attention to the operator safety and ensure that conditions of use prescribe the application of adequate personal and respiratory protective equipment. The Member States concerned shall request the submission of further studies to confirm the risk assessment for birds (acute risk) and herbivorous mammals (long term risk). They shall ensure that the notifier at whose request phosmet has been included in this Schedule provides such studies to the Commission within two years from the entry into force of Directive 25/2007. Number Common name, identification numbers IUPAC name Purity Entry into force Expiration of inclusion Specific provisions 160 Propamocarb CAS No 24579-73-5 CIPAC No 399 Propyl 3-(dimethyla mino)propylcar bamate =920 g/kg 1 October 2007 30 September 2017 Part A Only uses as fungicide may be authorised. Part B In assessing applications to authorise plant protection products containing propamocarb for uses other than foliar applications, Member States shall pay particular attention to the criteria in regulation 4(1)(b), as regards worker exposure and shall ensure that any necessary data and information is provided before such an authorisation is granted. For the implementation of the uniform principles of Schedule VI, the conclusions of the review report on propamocarb, and in particular Appendices I and II thereof, as finalised in the Standing Committee on the Food Chain and Animal Health on 24 November 2006 shall be taken into account. In this overall assessment Member States must pay particular attention to: —the operators and workers safety. Conditions of authorisation should include protective measures, where appropriate; —the transfer of soil residues for rotating or succeeding crops; —the protection of surface and groundwater in vulnerable zones; —the protection of birds, mammals and aquatic organisms. Conditions of authorisation should include risk mitigation measures, where appropriate. Number Common name, identification numbers IUPAC name Purity Entry into force Expiration of inclusion Specific provisions 161 ethoprophos CAS No: 13194-48-4 CIPAC No: 218 O-ethylS,S-dipropyl phosphorodithioate > 940 g/kg 1 October 2007 30 September 2017 PART A Only uses as nematicide and insecticide in soil application can be authorised. Authorisations should be limited to professional users. PART B In assessing applications to authorise plant protection products containing ethoprophos for uses other than potatoes not cultivated for human or animal consumption, Member States shall pay particular attention to the criteria in regulation 4(1)(b), and shall ensure that any necessary data and information is provided before such an authorisation is granted. For the implementation of the uniform principles of Schedule VI, the conclusions of the review report on ethoprophos, and in particular Appendices I and II thereof, as finalised in the Standing Committee on the Food Chain and Animal Health on 16 March 2007 shall be taken into account. In this overall assessment Member States must pay particular attention to: —the residues and evaluate the dietary exposure of consumers in view of future revisions of Maximum Residue Levels, —the operator safety. Authorised conditions of use must prescribe the application of adequate personal and respiratory protective equipment and other risk mitigation measures such as the use of closed transfer system for the distribution of the product, —the protection of birds, mammals, aquatic organisms, surface and groundwater under vulnerable conditions. Conditions of authorisation should include risk mitigation measures, such as buffer zones and the achievement of complete incorporation of granules in the soil. The concerned Member States shall request the submission of further studies to confirm the short and long term risk assessment for birds and for earthworms eating mammals. They shall ensure that the notifiers at whose request ethoprophos has been included in this Schedule provide such studies to the Commission within two years from the entry into force of Directive 52/2007. Number Common name, identification numbers IUPAC name Purity Entry into force Expiration of inclusion Specific provisions 162 pirimiphos-methyl CAS No: 29232-93-7 CIPAC No: 239 O-2-diethylamino-6 methylpyrimidin-4-yl O,O-dimethylpho sphorothioate > 880 g/kg 1 October 2007 30 September 2017 PART A Only uses as insecticide for post-harvest storage can be authorised. PART B In assessing applications to authorise plant protection products containing pirimiphos-methyl for uses other than applications with automated systems in empty cereals storehouses, Member States shall pay particular attention to the criteria in regulation 4(1)(b), and shall ensure that any necessary data and information is provided before such an authorisation is granted. For the implementation of the uniform principles of Schedule VI, the conclusions of the review report on pirimiphos-methyl, and in particular Appendices I and II thereof, as finalised in the Standing Committee on the Food Chain and Animal Health on 16 March 2007 shall be taken into account. In this overall assessment Member States must pay particular attention to: —the operators safety. Authorised conditions of use must prescribe the application of adequate personal protective equipment including respiratory protective equipment and risk mitigation measures to reduce the exposure, —the dietary exposure of consumers in view of future revisions of Maximum Residue Levels. The Member States concerned shall request the submission of further studies to confirm the operator exposure assessment. They shall ensure that the notifiers at whose request pirimiphos-methyl has been included in this Schedule provide such studies to the Commission within two years from the entry into force of Directive 52/2007. Number Common name, identification numbers IUPAC name Purity Entry into force Expiration of inclusion Specific provisions 163 Fipronil CAS No: 120068-37-3 CIPAC No: 581 (±)-5-amino-1-(2,6 dichloro-a,a,a trifluoro-para-tolyl) 4-trifluoromethylsul finylpyrazole-3 carbonitrile =950 g/kg 1 October 2007 30 September 2017 PART A Only uses as insecticide for use as seed treatment may be authorised. The seed coating shall only be performed in professional seed treatment facilities. These facilities must apply the best available techniques in order to ensure that the release of dust clouds during storage, transport and application can be excluded. PART B For the implementation of the uniform principles of Schedule VI, the conclusions of the review report on fipronil, and in particular Appendices I and II thereof, as finalised in the Standing Committee on the Food Chain and Animal Health on 16 March 2007 shall be taken into account. In this overall assessment Member States must pay particular attention to: —the packaging of the marketed products to avoid the generation of photo-degradation products of concern, —the potential for groundwater contamination, especially from metabolites which are more persistent than the parent compound, when the active substance is applied in regions with vulnerable soil and/or climatic conditions, —the protection of granivorous birds and mammals, aquatic organisms, non-target arthropods and honey bees, —the use of adequate equipment ensuring a high degree of incorporation in soil and a minimisation of spillage during application. Conditions of authorisation should include risk mitigation measures, where appropriate. The concerned Member States shall request the submission of further studies to confirm the risk assessment for granivorous birds and mammals, and honey bees, especially bee brood. They shall ensure that the notifier at whose request fipronil has been included in this Schedule provide such studies to the Commission within one year from the entry into force of Directive 52/2007. Number Common name, identification numbers IUPAC name Purity Entry into force Expiration of inclusion Specific provisions 164 Beflubutamid CAS No 113614-08-7 CIPAC No 662 (RS)-N-benzyl-2-(4 fluoro-3-trifluoro methylphenoxy) butanamide =970 g/kg 1 December 2007 30 November 2017 Part A Only uses as herbicide may be authorised. Part B For the implementation of the uniform principles of Schedule VI, the conclusions of the review report on beflubutamid, and in particular Appendices I and II thereof, as finalised in the Standing Committee on the Food Chain and Animal Health on 15 May 2007 shall be taken into account. In this overall assessment Member States: —must pay particular attention to the risk to aquatic organisms. Conditions of use shall include risk mitigation measures, where appropriate. 165 Spodoptera exigua nuclear polyhedrosis virus CIPAC No Not allocated Not applicable 1 December 2007 30 November 2017 Part A Only uses as insecticide may be authorised. Part B For the implementation of the uniform principles of Schedule VI, the conclusions of the review report onSpodoptera exiguaNPV, and in particular Appendices I and II thereof, as finalised in the Standing Committee on the Food Chain and Animal Health on 15 May 2007 shall be taken into account. 166 Prosulfocarb CAS No 52888-80-9 CIPAC No 539 S-benzyl dipro pyl(thiocarbamat) 970 g/kg 1 November 2008 31 October 2018 PART A Only uses as herbicide may be authorised. PART B For the implementation of the uniform principles of Schedule VI, the conclusions of the review report on prosulfocarb, and in particular Appendices I and II thereof, as finalised in the Standing Committee on the Food Chain and Animal Health on 9 October 2007 shall be taken into account. In this overall assessment Member States must pay particular attention to: —the operator safety and ensure that conditions of use prescribe the application of adequate personal protective equipment, —the protection of aquatic organisms and must ensure that the conditions of authorisation include, where appropriate, risk mitigation measures such as buffer zone, —the protection of non-target plants and must ensure that the conditions of authorisation include, where appropriate, risk mitigation measures such as an in-field no spray buffer zone. Number Common name, identification numbers IUPAC name Purity Entry into force Expiration of inclusion Specific provisions 167 Fludioxonil CAS No 131341-86-1 CIPAC No 522 4-(2,2-difluoro-1,3 benzodioxol-4-yl) 1H-pyrrole-3-carbo nitrile 950 g/kg 1 November 2008 31 October 2018 PART A Only uses as fungicide may be authorised. PART B In assessing applications to authorise plant protection products containing fludioxonil for uses other than seed treatment, Member States shall pay particular attention to the criteria in regulation 4(1)(b), and shall ensure that any necessary data and information is provided before such an authorisation is granted and: —must pay particular attention to the potential for groundwater contamination, in particular from the soil photolysis metabolites CGA 339833 and CGA 192155, in vulnerable zones, —must pay particular attention to the protection of fish and aquatic invertebrates. Conditions of authorisation should include risk mitigation measures, where appropriate. For the implementation of the uniform principles of Schedule VI, the conclusions of the review report on fludioxonil, and in particular Appendices I and II thereof, as finalised in the Standing Committee on the Food Chain and Animal Health on 9 October 2007 shall be taken into account. 168 Clomazone CAS No 81777-89-1 CIPAC No 509 2-(2-chlorobenzyl) 4,4-dimethyl-1,2 oxazolidin-3-one 960 g/kg 1 November 2008 31 October 2018 PART A Only uses as herbicide may be authorised. PART B For the implementation of the uniform principles of Schedule VI, the conclusions of the review report on clomazone, and in particular Appendices I and II thereof, as finalised in the Standing Committee on the Food Chain and Animal Health on 9 October 2007 shall be taken into account. In this overall assessment Member States must pay particular attention to: —the operator safety and ensure that conditions of use prescribe the application of adequate personal protective equipment, —the protection of non-target plants and must ensure that the conditions of authorisation include, where appropriate, risk mitigation measures such as buffer zones. Number Common name, identification numbers IUPAC name Purity Entry into force Expiration of inclusion Specific provisions 169 Benthiavalicarb CAS No 413615-35-7 CIPAC No 744 [(S)-1-{[(R)-1-(6 fluoro-1,3 benzothiazol-2 yl)ethyl]carbamoyl} 2-methylpropyl] carbamic acid =910 g/kg The following manufacturing impurities are of toxicological concern and each of them must not exceed a certain amount in the technical material: 6,6'-difluoro-2,2' dibenzothiazole: < 3,5 mg/kg bis(2-amino-5 fluorophenyl) disulfide: < 14 mg/kg 1 August 2008 31 July 2018 Part A Only uses as fungicide may be authorised. Part B For the implementation of the uniform principles of Schedule VI, the conclusions of the review report on benthiavalicarb, and in particular Appendices I and II thereof, as finalised in the Standing Committee on the Food Chain and Animal Health on 22 January 2008 shall be taken into account. In this overall assessment Member States must pay particular attention to the operator safety and the protection of non-target arthropods. Conditions of use shall include adequate risk mitigation measures, where appropriate. In assessing applications to authorise plant protection products containing benthiavalicarb for uses other than in glasshouses, Member States shall pay particular attention to the criteria in regulation 4(1)(b), and shall ensure that any necessary data and information is provided before such an authorisation is granted. The Member States shall inform the Commission in accordance with regulation 13(3) on the specification of the technical material as commercially manufactured. 170 Boscalid CAS No 188425-85-6 CIPAC No 673 2-Chloro-N-(4'-chlor obiphenyl-2-yl)nico tinamide =960 g/kg 1 August 2008 31 July 2018 Part A Only uses as fungicide may be authorised. Part B For the implementation of the uniform principles of Schedule VI, the conclusions of the review report on boscalid, and in particular Appendices I and II thereof, as finalised in the Standing Committee on the Food Chain and Animal Health on 22 January 2008 shall be taken into account. In this overall assessment Member States must pay particular attention —to the operator safety, —to the long term risk to birds and soil organisms, —to the risk of accumulation in soil if the substance is used in perennial crops or in succeeding crops in crop rotation. Conditions of use shall include adequate risk mitigation measures, where appropriate. Number Common name, identification numbers IUPAC name Purity Entry into force Expiration of inclusion Specific provisions 171 Carvone CAS No 99-49-0 (d/l mixture) CIPAC No 602 5-isopropenyl-2 methylcyclohex-2 en-1-one =930 g/kg with a d/l ratio of at least 100:1 1 August 2008 31 July 2018 Part A Only uses as plant growth regulator may be authorised. Part B For the implementation of the uniform principles of Schedule VI, the conclusions of the review report on carvone, and in particular Appendices I and II thereof, as finalised in the Standing Committee on the Food Chain and Animal Health on 22 January 2008 shall be taken into account. In this overall assessment Member States must pay particular attention to the operator safety. Conditions of use shall include risk mitigation measures, where appropriate. 172 Fluoxastrobin CAS No 361377-29-9 CIPAC No 746 (E)-{2-[6-(2-chloro phenoxy)-5-fluoro pyrimidin-4-yloxy] phenyl}(5,6-dihydro 1,4,2-dioxazin-3 yl)methanone O methyloxime =940 g/kg 1 August 2008 31 July 2018 Part A Only uses as fungicide may be authorised. Part B For the implementation of the uniform principles of Schedule VI, the conclusions of the review report on fluoxastrobin, and in particular Appendices I and II thereof, as finalised in the Standing Committee on the Food Chain and Animal Health on 22 January 2008 shall be taken into account. In this overall assessment Member States must pay particular attention to: —the operator safety,in particular when handling the undiluted concentrate. Conditions of use shall include adequate protective measures, such as wearing a face shield, —the protection of aquatic organisms. Risk mitigation measures such as buffer zones shall be applied, where appropriate, —the levels of residues of the metabolites of fluoxastrobin, when straw from treated areas is used as animal feeding stuff. Conditions of use shall include restrictions for feeding to animals, where appropriate, —the risk of accumulation in the soil surface, if the substance is used in perennial crops or in succeeding crops in crop rotation. Conditions of use shall include risk mitigation measures, where appropriate.The concerned Member States shall request the submission of: —data to allow a comprehensive aquatic risk assessment to be made taking into account spray drift, run-off, drainage and the effectiveness of potential risk mitigation measures, —data on toxicity of non-rat metabolites if straw from treated areas is to be used as feedstuff. Number Common name, identification numbers IUPAC name Purity Entry into force Expiration of inclusion Specific provisions They shall ensure that the notifier at whose request fluoxastrobin has been included in this Schedule provide such studies to the Commission within two years from the entry into force of the Directive of inclusion. 173 Paecilomyces lilacinus (Thom) Samson 1974 strain 251 (AGAL: No 89/030550) CIPAC No 753 Not applicable 1 August 2008 31 July 2018 Part A Only uses as nematicide may be authorised. Part B For the implementation of the uniform principles of Schedule VI, the conclusions of the review report onPaecilomyces lilacinus, and in particular Appendices I and II thereof, as finalised in the Standing Committee on the Food Chain and Animal Health on 22 January 2008 shall be taken into account. In this overall assessment Member States must pay particular attention to: —the operator safety (although there was no need to set an AOEL, as a general rule, microorganisms should be considered as potential sensitisers), —the protection of leaf dwelling non-target arthropods. Conditions of use shall include risk mitigation measures, where appropriate. 174 Prothioconazole CAS No 178928-70-6 CIPAC No 745 (RS)-2-[2-(1-chloro cyclopropyl)-3-(2 chlorophenyl)-2 hydroxypropyl]-2,4 dihydro-1,2,4 triazole-3-thione =970 g/kg The following manufacturing impurities are of toxicological concern and each of them must not exceed a certain amount in the technical material: —Toluene: < 5 g/kg —Prothioco nazole-desthio (2-(1-chloro cyclo propyl)1-(2 chloro phenyl)-3 1 August 2008 31 July 2018 Part A Only uses as fungicide may be authorised. Part B For the implementation of the uniform principles of Schedule VI, the conclusions of the review report on prothioconazole, and in particular Appendices I and II thereof, as finalised in the Standing Committee on the Food Chain and Animal Health on 22 January 2008 shall be taken into account. In this overall assessment Member States must pay particular attention to: —the operator safety in spray applications. Conditions of use shall include adequate protective measures, —the protection of aquatic organisms. Risk mitigation measures such as buffer zones shall be applied, where appropriate, —the protection of birds and small mammals. Risk mitigation measures shall be applied, where appropriate. Conditions of use shall include risk mitigation measures, where appropriate. Number Common name, identification numbers IUPAC name Purity Entry into force Expiration of inclusion Specific provisions (1,2,4-triazol 1-yl)-propan 2-ol): < 0,5 g/ kg (LOD) The concerned Member States shall request the submission of: —information to allow the assessment of consumer exposure to triazole metabolite derivatives in primary crops, rotational crops, and products of animal origin, —a comparison of the mode of action of prothioconazole and the triazole metabolite derivatives to allow the assessment of the toxicity resulting from the combined exposure to these compounds, —information to further address the long-term risk to granivorous birds and mammals arising from the use of prothioconazole as a seed treatment. They shall ensure that the notifier at whose request prothioconazole has been included in this Schedule provide such studies to the Commission within two years from the entry into force of the Directive of inclusion. 175 Amidosulfuron CAS No 120923-37-7 CIPAC No 515 3-(4,6-dimethoxypyr imidin-2-yl)-1-(N methyl-N-methyl sulfonyl-aminosulfo nyl)urea or 1-(4,6-dimethoxypyr imidin-2-yl)-3 mesyl(methyl) sulfa moylurea =970 g/kg 1 January 2009 31 December 2018 PART A Only uses as herbicide may be authorised. PART B In assessing applications to authorise plant protection products containing amidosulfuron for uses other than meadows and pasture, Member States shall pay particular attention to the criteria in regulation 4(1)(b), and shall ensure that any necessary data and information is provided before such an authorisation is granted. For the implementation of the uniform principles of Schedule VI, the conclusions of the review report on amidosulfuron, and in particular Appendices I and II thereof, as finalised in the Standing Committee on the Food Chain and Animal Health on 22 January 2008 shall be taken into account. In this overall assessment Member States must pay particular attention to: —the protection of groundwater due to a potential for groundwater contamination by some of the degradation products when it is applied in regions with vulnerable soil and/or climatic conditions, —the protection of aquatic plants. In relation to these identified risks, risk mitigation measures, such as buffer zones, should be applied where appropriate. Number Common name, identification numbers IUPAC name Purity Entry into force Expiration of inclusion Specific provisions 176 Nicosulfuron CAS No 111991-09-4 CIPAC No 709 2-[(4,6-dimethoxy pyrimidin-2-ylcarba moyl)sulfamoyl] N,N-dimethylnicoti namide or 1-(4,6-dimethoxypyr imidin-2-yl)-3-(3 dimethylcarbamoyl 2-pyridylsulfonyl)urea =910 g/kg 1 January 2009 31 December 2018 PART A Only uses as herbicide may be authorised. PART B For the implementation of the uniform principles of Schedule VI, the conclusions of the review report on nicosulfuron, and in particular Appendices I and II thereof, as finalised in the Standing Committee on the Food Chain and Animal Health on 22 January 2008 shall be taken into account. In this overall assessment Member States must pay particular attention to: —the potential exposure of the aquatic environment to metabolite DUDN when nicosulfuron is applied in regions with vulnerable soil conditions, —the protection of aquatic plants and must ensure that the conditions of authorisation include, where appropriate, risk mitigation measures such as buffer zones, —the protection of non-target plants and must ensure that the conditions of authorisation include, where appropriate, risk mitigation measures such as an in-field no-spray buffer zone, —the protection of groundwater and surface water under vulnerable soil and climatic conditions. 177 Clofentezine CAS No 74115-24-5 CIPAC No 418 3,6-bis(2-chloro phenyl)-1,2,4,5 tetrazine =980 g/kg (dry material) 1 January 2009 31 December 2018 PART A Only uses as acaricide may be authorised. PART B For the implementation of the uniform principles of Schedule VI, the conclusions of the review report on clofentezine, and in particular Appendices I and II thereof, as finalised in the Standing Committee on the Food Chain and Animal Health shall be taken into account. 178 Dicamba CAS No 1918-00-9 CIPAC No 85 3,6-dichloro-2-meth oxybenzoic acid =850 g/kg 1 January 2009 31 December 2018 PART A Only uses as herbicide may be authorised. PART B For the implementation of the uniform principles of Schedule VI, the conclusions of the review report on dicamba, and in particular Appendices I and II thereof, as finalised in the Standing Committee on the Food Chain and Animal Health shall be taken into account. Number Common name, identification numbers IUPAC name Purity Entry into force Expiration of inclusion Specific provisions 179 Difenoconazole CAS No 119446-68-3 CIPAC No 687 3-chloro-4 [(2RS,4RS;2RS,4SR) 4-methyl-2-(1H 1,2,4-triazol-1 ylmethyl)-1,3 dioxolan-2-yl]phenyl 4-chlorophenyl ether =940 g/kg 1 January 2009 31 December 2018 PART A Only uses as fungicide may be authorised. PART B For the implementation of the uniform principles of Schedule VI, the onclusions of the review report on difenoconazole, and in particular ppendices I and II thereof, as finalised in the Standing Committee on the Food Chain and Animal Health shall be taken into account. In this overall assessment Member States must pay particular attention to: —the protection of aquatic organisms. Conditions of use shall include adequate risk mitigation measures, where appropriate. 180 Diflubenzuron CAS No 35367-38-5 CIPAC No 339 1-(4-chlorophenyl)-3 (2,6-difluorobenzoyl) urea = 950 g/kg impurity: max. 0,03 g/kg 4-chlor oaniline 1 January 2009 31 December 2018 PART A Only uses as insecticide may be authorised. PART B For the implementation of the uniform principles of Schedule VI, the conclusions of the review report on diflubenzuron, and in particular Appendices I and II thereof, as finalised in the Standing Committee on the Food Chain and Animal Health shall be taken into account. In this overall assessment Member States must pay particular attention to: —the protection of aquatic organisms, —the protection of terrestrial organisms, —the protection of non-target arthropods including bees. Conditions of use shall include adequate risk mitigation measures, where appropriate. 181 Imazaquin CAS No 81335-37-7 CIPAC No 699 2-[(RS)-4-isopropyl 4-methyl-5-oxo-2 imidazolin-2-yl]qui noline-3-carboxylic acid = 960 g/kg (racemic mixture) 1 January 2009 31 December 2018 PART A Only uses as plant growth regulator may be authorised. PART B For the implementation of the uniform principles of Schedule VI, the conclusions of the review report on imazaquin, and in particular Appendices I and II thereof, as finalised in the Standing Committee on the Food Chain and Animal Health shall be taken into account. Number Common name, identification numbers IUPAC name Purity Entry into force Expiration of inclusion Specific provisions 182 Lenacil CAS No 2164-08-1 CIPAC No 163 3-cyclohexyl-1,5,6,7 tetrahydrocyclopen tapyrimidine 2,4(3H)-dione =975 g/kg 1 January 2009 31 December 2018 PART A Only uses as herbicide may be authorised. PART B For the implementation of the uniform principles of Schedule VI, the conclusions of the review report on lenacil, and in particular Appendices I and II thereof, as finalised in the Standing Committee on the Food Chain and Animal Health shall be taken into account. 183 Oxadiazon CAS No 19666-30-9 CIPAC No 213 5-tert-butyl-3-(2,4 dichloro-5-isopro poxyphenyl)-1,3,4 oxadiazol-2(3H)-one =940 g/kg 1 January 2009 31 December 2018 PART A Only uses as herbicide may be authorised. PART B For the implementation of the uniform principles of Schedule VI, the conclusions of the review report on oxadiazon, and in particular Appendices I and II thereof, as finalised in the Standing Committee on the Food Chain and Animal Health shall be taken into account. 184 Picloram CAS No 1918-02-1 CIPAC No 174 4-amino-3,5,6 trichloropyridine-2 carboxylic acid =920 g/kg 1 January 2009 31 December 2018 PART A Only uses as herbicide may be authorised. PART B For the implementation of the uniform principles of Schedule VI, the conclusions of the review report on picloram, and in particular Appendices I and II thereof, as finalised in the Standing Committee on the Food Chain and Animal Health shall be taken into account. 185 Pyriproxyfen CAS No 95737-68-1 CIPAC No 715 4-phenoxyphenyl (RS)-2-(2-pyridylox y)propyl ether =970 g/kg 1 January 2009 31 December 2018 PART A Only uses as insecticide may be authorised. PART B For the implementation of the uniform principles of Schedule VI, the conclusions of the review report on pyriproxyfen, and in particular Appendices I and II thereof, as finalised in the Standing Committee on the Food Chain and Animal Health shall be taken into account. In this overall assessment Member States must pay particular attention to he protection of non-target arthropods including bees. Conditions of use shall include adequate risk mitigation measures, where appropriate. Number Common name, identification numbers IUPAC name Purity Entry into force Expiration of inclusion Specific provisions 186 Bifenox CAS No 42576-02-3 CIPAC No 413 Methyl 5-(2,4 dichlorophenoxy)-2 nitrobenzoate =970 g/kg impu rities: max. 3 g/kg 2,4 dichlorophenol max. 6 g/kg 2,4 dichloroanisole 1 January 2009 31 December 2018 PART A Only uses as herbicide may be authorised. PART B For the implementation of the uniform principles of Schedule VI, the conclusions of the review report on bifenox, and in particular Appendices I and II thereof, as finalised in the Standing Committee on the Food Chain and Animal Health on 14 March 2008 shall be taken into account. In this overall assessment Member States must pay particular attention to: —the operator safety and ensure that conditions of use prescribe the application of adequate personal protective equipment where, —the dietary exposure of consumers to bifenox residues in products of animal origin and in succeeding rotational crops. The Member States concerned shall request the submission of: —information on residues of bifenox and its metabolite hydroxy bifenox acid in food of animal origin and on residues of bifenox in rotational crops, —information to further address the long-term risk to herbivorous mammals arising from the use of bifenox. They shall ensure that the notifier provides such confirmatory data and information to the Commission within two years from the entry into force of Directive 66/2008. 187 Diflufenican CAS No 83164-33-4 CIPAC No 462 2',4'-difluoro-2 (a,a,a-trifluoro-m tolyloxy) nicotina nilide =970 g/kg 1 January 2009 31 December 2018 PART A Only uses as herbicide may be authorised. PART B For the implementation of the uniform principles of Schedule VI, the conclusions of the review report on diflufenican, and in particular Appendices I and II thereof, as finalised in the Standing Committee on the Food Chain and Animal Health on 14 March 2008 shall be taken into account. In this overall assessment Member States must pay particular attention to: —the protection of aquatic organisms. Risk mitigation measures such as buffer zones shall be applied, where appropriate, —the protection of non-target plants. Risk mitigation measures such as an in-field no spray buffer zones shall be applied, where appropriate. Number Common name, identification numbers IUPAC name Purity Entry into force Expiration of inclusion Specific provisions 188 Fenoxaprop-P CAS No 113158-40-0 CIPAC No 484 (R)-2[4-[(6-chloro-2 benzoxazolyl)oxy] phenoxy]-propanoic acid =920 g/kg 1 January 2009 31 December 2018 PART A Only uses as herbicide may be authorised. PART B For the implementation of the uniform principles of Schedule VI, the conclusions of the review report on fenoxaprop-P, and in particular Appendices I and II thereof, as finalised in the Standing Committee on the Food Chain and Animal Health on 14 March 2008 shall be taken into account. In this overall assessment Member States must pay particular attention to: —the operator safety and ensure that conditions of use prescribe the application of adequate personal protective equipment, —the protection of non target plants, —the presence of the safener mefenpyr-diethyl in formulated products as regards operator, worker and bystander exposure, the persistence of the substance and of some of its degradation products in colder zones and areas where anaerobic conditions may occur. Conditions of authorisation should include risk mitigation measures, where appropriate. Number Common name, identification numbers IUPAC name Purity Entry into force Expiration of inclusion Specific provisions 189 Fenpropidin CAS No 67306-00-7 CIPAC No 520 (R,S)-1-[3-(4-tert butylphenyl)-2 methylpropyl] piperidine = 960 g/kg (racemate) 1 January 2009 31 December 2018 PART A Only uses as fungicide may be authorised. PART B For the implementation of the uniform principles of Schedule VI, the conclusions of the review report on fenpropidin, and in particular Appendices I and II thereof, as finalised in the Standing Committee on the Food Chain and Animal Health on 14 March 2008 shall be taken into account. In this overall assessment Member States must pay particular attention to: —the operator and worker safety and ensure that conditions of use prescribe the application of adequate personal protective equipment, —the protection of aquatic organisms and must ensure that the conditions of authorisation include, where appropriate, risk mitigation measures such as buffer zone. The Member States concerned shall request the submission of: —information to further address the long-term risk to herbivorous and insectivorous birds arising from the use of fenpropidin. They shall ensure that the notifier provides such confirmatory data and information to the Commission within two years from the entry into force of Directive 66/2008. 190 Quinoclamine CAS No 2797-51-5 CIPAC No 648 2-amino-3-chloro 1,4-naphthoquinone = 965 g/kg impurity: dichlone (2,3 dichloro-1,4 naphthoquinone) max. 15 g/kg 1 January 2009 31 December 2018 PART A Only uses as herbicide may be authorised. PART B In assessing applications to authorise plant protection products containing quinoclamine for uses other than ornamentals or nursery plants, Member States shall pay particular attention to the criteria in regulation 4(1)(b), and shall ensure that any necessary data and information is provided before such an authorisation is granted. For the implementation of the uniform principles of Schedule VI, the conclusions of the review report on quinoclamine, and in particular Appendices I and II thereof, as finalised in the Standing Committee on the Food Chain and Animal Health on 14 March 2008 shall be taken into account. In this overall assessment Member States must pay particular attention to the operator, worker and bystander safety and ensure that conditions of use prescribe the application of adequate personal protective equipment, the protection of aquatic organisms, the protection of birds and small mammals. Conditions of use shall include adequate risk mitigation measures, where appropriate Number Common name, identification numbers IUPAC name Purity Entry into force Expiration of inclusion Specific provisions 191 Chloridazon CAS No 1698-60-8 CIPAC No 111 5-amino-4-chloro-2 phenylpyridazin 3(2H)-one 920 g/kg The manufac turing impurity 4 amino-5-chloro isomer is considered to be of toxicological concern and a maximum level of 60 g/kg is established. 1 January 2009 31 December 2018 PART A Only uses as herbicide in application max. of 2,6 kg/ha only every third year on the same field may be authorised. PART B For the implementation of the uniform principles of Schedule VI, the conclusions of the review report on chloridazon, and in particular Appendices I and II thereof, as finalised in the Standing Committee on the Food Chain and Animal Health on 4 December 2007 shall be taken into account. In this overall assessment Member States must pay particular attention to: —the operator safety and ensure that conditions of use prescribe the application of adequate personal protective equipment, —the protection of aquatic organisms, —the protection of the groundwater, when the active substance is applied in regions with vulnerable soil and/or climatic conditions. Conditions of authorisation should include risk mitigation measures and monitoring programmes should be initiated to verify potential groundwater contamination from metabolites B and B1 in vulnerable zones, where appropriate. 192 Tritosulfuron CAS No 142469-14-5 CIPAC No 735 1-(4-methoxy-6 trifluoromethyl-1,3,5 triazin-2-yl)-3-(2 trifluoromethyl benzenesulfonyl)urea =960 g/kg The following manufacturing impurity is of toxicological concern and must not exceed a certain amount in the technical material: 2-Amino-4 methoxy-6 (trifluormethyl) 1,3,5-triazine: <0,2 g/kg 1 December 2008 30 November 2018 PART A Only uses as herbicide may be authorised. PART B For the implementation of the uniform principles of Schedule VI, the conclusions of the review report on tritosulfuron, and in particular Appendices I and II thereof, as finalised in the Standing Committee on the Food Chain and Animal Health on 20 May 2008 shall be taken into account. In this overall assessment Member States must pay particular attention to: —the potential for groundwater contamination, when the active substance is applied in regions with vulnerable soil and/or climatic conditions, —the protection of aquatic organisms, —the protection of small mammals. Conditions of use shall include risk mitigation measures, where appropriate. Number Common name, identification numbers IUPAC name Purity Entry into force Expiration of inclusion Specific provisions 193 Flutolanil CAS No 66332-96-5 CIPAC No 524 α,α,α-trifluoro-3′ isopropoxy-otoluanilide ≥ 975 g/kg 1 March 2009 28 February 2019 PART A Only uses as fungicide may be authorised. PART B In assessing applications to authorise plant protection products containing flutolanil for uses other than potato tuber treatment, Member States shall pay particular attention to the criteria in Regulation 4(1)(b), and shall ensure that any necessary data and information is provided before such an authorisation is granted. For the implementation of the uniform principles of Schedule VI, the conclusions of the review report on flutolanil, and in particular Appendices I and II thereof, as finalised in the Standing Committee on the Food Chain and Animal Health on 20 May 2008 shall be taken into account. In this overall assessment Member States must pay particular attention to: — the protection of groundwater, when the active substance is applied in regions with vulnerable soil and/or climatic conditions. Conditions of authorisation should include risk mitigation measures, where appropriate. Number Common name, identification numbers IUPAC name Purity Entry into force Expiration of inclusion Specific provisions 194 Benfluralin CAS No 1861-40-1 CIPAC No 285 N-butyl-N-ethyl α,α,α-trifluoro-2,6 dinitro-p-toluidine ≥ 960 g/kg Impurities: — ethyl-butyl nitrosamine: max. 0,1 mg/kg 1 March 2009 28 February 2019 PART A Only uses as herbicide may be authorised. PART B In assessing applications to authorise plant protection products containing benfluralin for uses other than lettuce and endive, Member States shall pay particular attention to the criteria in Regulation 4(1)(b), and shall ensure that any necessary data and information is provided before such an authorisation is granted. For the implementation of the uniform principles of Schedule VI, the conclusions of the review report on benfluralin, and in particular Appendices I and II thereof, as finalised in the Standing Committee on the Food Chain and Animal Health on 20 May 2008 shall be taken into account. In this overall assessment Member States must pay particular attention to: — the protection of the operators' safety. Authorised conditions of use must prescribe the application of adequate personal protective equipment and risk mitigation measures to reduce the exposure, — the residues in food of plant and animal origin and evaluate the dietary exposure of consumers, — the protection of birds, mammals, surface waters and aquatic organisms. In relation to these identified risks, risk mitigation measures, such as buffer zones, should be applied where appropriate. The Member States concerned shall request the submission of further studies on rotational crops metabolism and to confirm the risk assessment for metabolite B12 and for aquatic organisms. They shall ensure that the notifiers at whose request benfluralin has been included in this Schedule provide such studies to the Commission within two years from the entry into force of Directive 108/2008 Number Common name, identification numbers IUPAC name Purity Entry into force Expiration of inclusion Specific provisions 195 Fluazinam CAS No 79622-59-6 CIPAC No 521 3-chloro-N-(3 chloro-5 trifluoromethyl 2-pyridyl) α,α,α-trifluoro-2, 6 dinitro-p-toluidine ≥ 960 g/kg Impurities: 5-chloro-N-(3 chloro-5 trifluoromethyl 2-pyridyl) α,α,α-trifluoro 4,6 dinitro-o toluidine — not more than 2 g/kg 1 March 2009 28 February 2019 PART A Only uses as fungicide may be authorised. PART B In assessing applications to authorise plant protection products containing fluazinam for uses other than potatoes, Member States shall pay particular attention to the criteria in Regulation 4(1)(b), and shall ensure that any necessary data and information is provided before such an authorization is granted. For the implementation of the uniform principles of Schedule VI, the conclusions of the review report on fluazinam, and in particular Appendices I and II thereof, as finalised in the Standing Committee on the Food Chain and Animal Health on 20 May 2008 shall be taken into account. In this overall assessment Member States must pay particular attention to: — the protection of the operators' and workers' safety. Authorised conditions of use must prescribe the application of adequate personal protective equipment and risk mitigation measures to reduce the exposure, — the residues in food of plant and animal origin and evaluate the dietary exposure of consumers, — the protection of aquatic organisms. In relation to this identified risk, risk mitigation measures, such as buffer zones, should be applied where appropriate. The Member States concerned shall request the submission of further studies to confirm the risk assessment for aquatic organisms and soil macro-organisms. They shall ensure that the notifiers at whose request fluazinam has been included in this Schedule provide such studies to the Commission within two years from the entry into force of Directive 108/2008. Number Common name, identification numbers IUPAC name Purity Entry into force Expiration of inclusion Specific provisions 196 Fuberidazole CAS No 3878-19-1 CIPAC No 525 2-(2′ furyl)benzimidazole ≥ 970 g/kg 1 March 2009 28 February 2019 PART A Only uses as fungicide may be authorised. PART B In assessing applications to authorise plant protection products containing fuberidazole for uses other than seed dressing, Member States shall pay particular attention to the criteria in Regulation 4(1)(b), and shall ensure that any necessary data and information is provided before such an authorisation is granted. For the implementation of the uniform principles of Schedule VI, the conclusions of the review report on fuberidazole, and in particular Appendices I and II thereof, as finalised in the Standing Committee on the Food Chain and Animal Health on 20 May 2008 shall be taken into account. In this overall assessment Member States must pay particular attention to: — the operator safety and ensure that conditions of use prescribe the application of adequate personal protective equipment, — long-term risk to mammals and must ensure that the conditions of authorisation include, where appropriate, risk mitigation measures. In such case the use of adequate equipment ensuring a high degree of incorporation in soil and a minimisation of spillage during application should apply. Conditions of use shall include adequate risk mitigation measures, where appropriate. 197 Mepiquat CAS No 15302-91-7 CIPAC No 440 1,1 dimethylpiperidinium chloride (mepiquat chloride) ≥ 990 g/kg 1 March 2009 28 February 2019 PART A Only uses as plant growth regulator may be authorised. PART B In assessing applications to authorise plant protection products containing mepiquat for uses other than in barley, Member States shall pay particular attention to the criteria in Regulation 4(1)(b), and shall ensure that any necessary data and information is provided before such an authorisation is granted. For the implementation of the uniform principles of Schedule VI, the conclusions of the review report on mepiquat, and in particular Appendices I and II thereof, as finalised in the Standing Committee on the Food Chain and Animal Health on 20 May 2008 shall be taken into account. The Member States must pay particular attention to the residues in food of plant and animal origin and evaluate the dietary exposure of consumers.’ Number Common name, identification numbers IUPAC name Purity Entry into force Expiration of inclusion Specific provisions 198 Diuron CAS No: 330-54-1 CIPAC No: 100 3-(3,4-dichloro phenyl)-1,1 dimethylurea =930 g/kg 1 October 2008 30 September 2018 PART A Only uses as herbicide at rates not exceeding 0,5 kg/ha (areic average) may be authorised. PART B For the implementation of the uniform principles of Schedule VI, the conclusions of the review report on diuron, and in particular Appendices I and II thereof, as finalised in the Standing Committee on the Food Chain and Animal Health on 11 July 2008 shall be taken into account. In this overall assessment Member States must pay particular attention to: —the operator safety where conditions of use shall prescribe the use of personal protective equipment, if appropriate, —the protection of aquatic organisms and non-target plants. Conditions of authorisation shall include risk mitigation measures, where appropriate. 199 Bacillus thuringiensis subsp. aizawai STRAIN: ABTS-1857 Culture collection: No SD 1372, STRAIN: GC-91 Culture collection: No NCTC 11821 Not applicable No relevant impurities 1 May 2009 30 April 2019 PART A Only uses as insecticide may be authorised. PART B For the implementation of the uniform principles of Schedule VI, the conclusions of the review report on Bacillus thuringiensis subsp. Aizawai ABTS-1857 (SANCO/1539/2008) and GC-91 (SANCO/1538/2008) and in particular Appendices I and II thereof, as finalised in the Standing Committee on the Food Chain and Animal Health shall be taken into account. Conditions of use shall include, where appropriate, risk mitigation measures. Number Common name, identification numbers IUPAC name Purity Entry into force Expiration of inclusion Specific provisions 200 Bacillus thuringiensis subsp. israeliensis (serotype H-14) STRAIN: AM65-52 Culture collection: No ATCC-1276 Not applicable No relevant impurities 1 May 2009 30 April 2019 PART A Only uses as insecticide may be authorised. PART B For the implementation of the uniform principles of Schedule VI, the conclusions of the review report on Bacillus thuringiensis subsp. israeliensis (serotype H-14) AM65-52 (SANCO/1540/2008) and in particular Appendices I and II thereof, as finalised in the Standing Committee on the Food Chain and Animal Health shall be taken into account. Conditions of use shall include, where appropriate, risk mitigation measures. 201 Bacillus thuringiensis subsp. kurstaki STRAIN: ABTS 351 Culture collection: No ATCC SD-1275 STRAIN: PB 54 Culture collection: No CECT 7209 STRAIN: SA 11 Culture collection: No NRRL B-30790 STRAIN: SA 12 Culture collection: No NRRL B-30791 STRAIN: EG 2348 Culture collection: No NRRL B-18208 Not applicable No relevant impurities 1 May 2009 30 April 2019 PART A Only uses as insecticide may be authorised. PART B For the implementation of the uniform principles of Schedule VI, the conclusions of the review report on Bacillus thuringiensis subsp. kurstaki ABTS 351 (SANCO/1541/2008), PB 54 (SANCO/1542/2008), SA 11, SA 12 and EG 2348 (SANCO/1543/2008) and in particular Appendices I and II thereof, as finalized in the Standing Committee on the Food Chain and Animal Health shall be taken into account. Conditions of use shall include, where appropriate, risk mitigation measures. Number Common name, identification numbers IUPAC name Purity Entry into force Expiration of inclusion Specific provisions 202 Bacillus thuringiensis subsp. Tenebrionis STRAIN: NB 176 (TM 14 1) Culture collection: No SD 5428 Not applicable No relevant impurities 1 May 2009 30 April 2019 PART A Only uses as insecticide may be authorised. PART B For the implementation of the uniform principles of Schedule VI, the conclusions of the review report on Bacillus thuringiensis subsp. tenebrionis NB 176 (SANCO/1545/2008) and in particular Appendices I and II thereof, as finalized in the Standing Committee on the Food Chain and Animal Health shall be taken into account. Conditions of use shall include, where appropriate, risk mitigation measures. 203 Beauveria bassiana STRAIN: ATCC 74040 Culture collection: No ATCC 74040 STRAIN: GHA Culture collection: No ATCC 74250 Not applicable Max level of beauvericin: 5 mg/kg 1 May 2009 30 April 2019 PART A Only uses as insecticide may be authorised. PART B For the implementation of the uniform principles of Schedule VI, the conclusions of the review report on Beauveria bassiana ATCC 74040 (SANCO/1546/2008) and GHA (SANCO/1547/2008) and in particular Appendices I and II thereof, as finalised in the Standing Committee on the Food Chain and Animal Health shall be taken into account. Conditions of use shall include, where appropriate, risk mitigation measures. 204 Cydia pomonella Granulovirus (CpGV) Not applicable Contaminating microorganisms (Bacillus cereus) < 1 × 106 CFU/g 1 May 2009 30 April 2019 PART A Only uses as insecticide may be authorised. PART B For the implementation of the uniform principles of Schedule VI, the conclusions of the review report on Cydia pomonella Granulovirus (CpGV) (SANCO/1548/2008) and in particular Appendices I and II thereof, as finalised in the Standing Committee on the Food Chain and Animal Health shall be taken into account. Conditions of use shall include, where appropriate, risk mitigation measures. Number Common name, identification numbers IUPAC name Purity Entry into force Expiration of inclusion Specific provisions 205 Lecanicillium muscarium (formerly Verticilium lecanii) STRAIN: Ve 6 Culture collection: No CABI (=IMI) 268317, CBS 102071, ARSEF 5128 Not applicable No relevant impurities 1 May 2009 30 April 2019 PART A Only uses as insecticide may be authorised. PART B For the implementation of the uniform principles of Schedule VI, the conclusions of the review report on Lecanicillium muscarium (formerly Verticilium lecanii) Ve 6 (SANCO/1861/2008) and in particular Appendices I and II thereof, as finalized in the Standing Committee on the Food Chain and Animal Health shall be taken into account. Conditions of use shall include, where appropriate, risk mitigation measures. 206 Metarhizium anisopliae var. anisopliae (formerly Metarhizium anisopliae) STRAIN: BIPESCO 5/F52 Culture collection: No M.a. 43; No 275 86 (acronyms V275 or KVL 275); No KVL 99-112 (Ma 275 or V 275); No DSM 3884; No ATCC 90448; No ARSEF 1095 Not applicable No relevant impurities 1 May 2009 30 April 2019 PART A Only uses as insecticide and acaricide may be authorised. PART B For the implementation of the uniform principles of Schedule VI, the conclusions of the review report on Metarhizium anisopliae var. anisopliae (formerly Metarhizium anisopliae) BIPESCO 5 and F52 (SANCO/1862/2008) and in particular Appendices I and II thereof, as finalised in the Standing Committee on the Food Chain and Animal Health shall be taken into account. Conditions of use shall include, where appropriate, risk mitigation measures. Number Common name, identification numbers IUPAC name Purity Entry into force Expiration of inclusion Specific provisions 207 Phlebiopsis gigantea STRAIN: VRA 1835 Culture collection: No ATCC 90304 STRAIN: VRA 1984 Culture collection: No DSM16201 STRAIN: VRA 1985 Culture collection: No DSM 16202 STRAIN: VRA 1986 Culture collection: No DSM 16203 STRAIN: FOC PG B20/5 Culture collection: No IMI 390096 STRAIN: FOC PG SP log 6 Culture collection: No IMI 390097 STRAIN: FOC PG SP log 5 Culture collection: No IMI390098 STRAIN: FOC PG BU 3 Culture collection: No IMI 390099 STRAIN: FOC PG BU 4 Culture collection: No IMI 390100 STRAIN: FOC PG 410.3 Culture collection: No IMI 390101 STRAIN: FOC PG97/1062/116/1.1 Culture collection: No IMI 390102 STRAIN: FOC PG B22/SP1287/3.1 Culture collection: No IMI 390103 STRAIN: FOC PG SH 1 Culture collection: No IMI 390104 Not applicable No relevant impurities 1 May 2009 30 April 2019 PART A Only uses as fungicide may be authorised. PART B For the implementation of the uniform principles of Schedule VI, the conclusions of the review report on Phlebiopsis gigantea (SANCO/1863/2008) and in particular Appendices I and II thereof, as finalised in the Standing Committee on the Food Chain and Animal Health shall be taken into account. Conditions of use shall include, where appropriate, risk mitigation measures. Number Common name, identification numbers IUPAC name Purity Entry into force Expiration of inclusion Specific provisions STRAIN: FOC PG B22/SP1190/3.2 Culture collection: No IMI 390105 208 Pythium oligandrum STRAINS: M1 Culture collection No ATCC 38472 Not applicable No relevant impurities 1 May 2009 30 April 2019 PART A Only uses as fungicide may be authorised PART B For the implementation of the uniform principles of Schedule VI, the conclusions of the review report on Pythium oligandrum M1 (SANCO/1864/2008) and in particular Appendices I and II thereof, as finalised in the Standing Committee on the Food Chain and Animal Health shall be taken into account. Conditions of use shall include, where appropriate, risk mitigation measures. 209 Streptomyces K61 (formerly S. griseoviridis) STRAIN: K61 Culture collection: No DSM 7206 Not applicable No relevant impurities 1 May 2009 30 April 2019 PART A Only uses as fungicide may be authorised. PART B For the implementation of the uniform principles of Schedule VI, the conclusions of the review report on Streptomyces (formerly Streptomyces griseoviridis) K61 (SANCO/1865/2008), and in particular Appendices I and II thereof, as finalised in the Standing Committee on the Food Chain and Animal Health shall be taken into account. Conditions of use shall include, where appropriate, risk mitigation measures. 210 Trichoderma atroviride (formerly T. harzianum) STRAIN: IMI 206040 Culture collection No IMI 206040, ATCC 20476; STRAIN: T11 Culture collection: No Spanish type culture collection CECT 20498, identical with IMI 352941 Not applicable No relevant impurities 1 May 2009 30 April 2019 PART A Only uses as fungicide may be authorised. PART B For the implementation of the uniform principles of Schedule VI, the conclusions of the review reports on Trichoderma atroviride (formerly T. harzianum) IMI 206040 (SANCO/1866/2008) and T-11 (SANCO/1841/2008) respectively, and in particular Appendices I and II thereof, as finalised in the Standing Committee on the Food Chain and Animal Health shall be taken into account. Conditions of use shall include, where appropriate, risk mitigation measures. Number Common name, identification numbers IUPAC name Purity Entry into force Expiration of inclusion Specific provisions 211 Trichoderma polysporum STRAIN: Trichoderma polysporum IMI 206039 Culture collection No IMI 206039, ATCC 20475 Not applicable No relevant impurities 1 May 2009 30 April 2019 PART A Only uses as fungicide may be authorised. PART B For the implementation of the uniform principles of Schedule VI, the conclusions of the review report on Trichoderma polysporum IMI 206039 (SANCO/1867/2008), and in particular Appendices I and II thereof, as finalised in the Standing Committee on the Food Chain and Animal Health shall be taken into account. Conditions of use shall include, where appropriate, risk mitigation measures. 212 Trichoderma harzianum Rifai STRAIN: Trichoderma harzianum T 22; Culture collection No ATCC 20847 STRAIN: Trichoderma harzianum ITEM 908; Culture collection No CBS 118749 Not applicable No relevant impurities 1 May 2009 30 April 2019 PART A Only uses as fungicide may be authorised. PART B For the implementation of the uniform principles of Schedule VI, the conclusions of the review reports on Trichoderma harzianum T-22 (SANCO/1839/2008) and ITEM 908 (SANCO/1840/208) respectively and in particular Appendices I and II thereof, as finalised in the Standing Committee on the Food Chain and Animal Health shall be taken into account. Conditions of use shall include, where appropriate, risk mitigation measures. 213 Trichoderma asperellum (formerly T. harzianum) STRAIN: ICC012 Culture collection No CABI CC IMI 392716 STRAIN: Trichoderma asperellum (formerly T. viride T25) T11 Culture collection No CECT 20178 STRAIN: Trichoderma asperellum (formerly T. viride TV1) TV1 Culture collection No MUCL 43093 Not applicable No relevant impurities 1 May 2009 30 April 2019 PART A Only uses as fungicide may be authorised. PART B For the implementation of the uniform principles of Schedule VI, the conclusions of the review reports on Trichoderma asperellum (formerly T. harzianum) ICC012 (SANCO/1842/2008) and Trichoderma asperellum (formerly T. viride T25 and TV1) T11 and TV1 (SANCO/1868/2008) and in particular Appendices I and II thereof, as finalised in the Standing Committee on the Food Chain and Animal Health shall be taken into account. Conditions of use shall include, where appropriate, risk mitigation measures. Number Common name, identification numbers IUPAC name Purity Entry into force Expiration of inclusion Specific provisions 214 Trichoderma gamsii (formerly T. viride) STRAINS: ICC080 Culture collection No IMI CC number 392151 CABI Not applicable No relevant impurities 1 May 2009 30 April 2019 PART A Only uses as fungicide may be authorised. PART B For the implementation of the uniform principles of Schedule VI, the conclusions of the review report on Trichoderma viride (SANCO/1868/2008), and in particular Appendices I and II thereof, as finalised in the Standing Committee on the Food Chain and Animal Health shall be taken into account. Conditions of use shall include, where appropriate, risk mitigation measures. 215 Verticillium albo-atrum (formerly Verticillium dahliae) STRAIN: Verticillium albo atrum isolate WCS850 Culture collection No CBS 276.92 Not applicable No relevant impurities 1 May 2009 30 April 2019 PART A Only uses as fungicide may be authorised. PART B For the implementation of the uniform principles of Schedule VI, the conclusions of the review report on Verticillium albo atrum (formerly Verticillium dahliae) WCS850 (SANCO/1870/2008), and in particular Appendices I and II thereof, as finalised in the Standing Committee on the Food Chain and Animal Health shall be taken into account. Conditions of use shall include, where appropriate, risk mitigation measures Number Common name, identification numbers IUPAC name Purity Entry into force Expiration of inclusion Specific provisions 216 Abamectin CAS No 71751-41-2 avermectin B1a CAS No 65195-55-3 Avermectin B1b CAS No 65195-56-4 abamectin CIPAC No 495 AvermectinB1a (10E,14E,16E,22Z) (1R,4S,5′S,6S,6′R,8R,12 S,13S,20R,21R,24S)-6′ [(S)-sec-butyl]-21,24 dihydroxy 5′,11.13,22-tetramethyl 2-oxo-3.7,19 trioxatetracyclo[ 15.6.1.14,8 020,24]pentacosa 10.14,16,22-tetraene-6 spiro-2′-(5′,6′-dihydro 2′Hpyran) 12-yl 2,6-dideoxy-4 O-(2,6-dideoxy-3-O methyl-α-L-arabino hexopyranosyl) 3-O-methyl-α-L arabinohexopyranoside AvermectinB1b (10E,14E,16E,22Z) (1R,4S,5′S,6S,6′R,8R,12 S,13S,20R,21R,24S) 21,24-dihydroxy-6′ isopropyl-5′,11.13,22 tetramethyl-2 oxo-3.7,19 trioxatetracyclo[ 15.6.1.14,8 020,24]pentacosa 10.14,16,22-tetraene-6 spiro-2′-(5′,6′-dihydro 2′Hpyran) 12-yl 2,6-dideoxy-4 O-(2,6-dideoxy-3-O methyl-α-L-arabino hexopyranosyl) 3-O-methyl-α-L arabinohexopyranoside ≥ 850 g/kg 1 May 2009 30 April 2019 PART A Only uses as insecticide, acaricide. PART B In assessing applications to authorise plant protection products containing abamectin foruses other than citrus, lettuce and tomatoes, Member States shall pay particular attention to the criteria in regulation 4(1)(b), and shall ensure that any necessary data and information are provided before such an authorisation is granted. For the implementation of the uniform principles of Schedule VI, the conclusions of the review report on (abamectin), and in particular Appendices I and II thereof, as finalised in the Standing Committee on the Food Chain and Animal Health on 11 July 2008 shall be taken into account.In this overall assessment Member States must pay particular attention to: — the operator safety and ensure that conditions of use prescribe the application of adequate personal protective equipment, — the residues in food of plant origin and evaluate the dietary exposure of consumers, — the protection of bees, non-target arthropods, birds, mammals and aquatic organisms. In relation to these identified risks risk mitigation measures, such as buffer zones, waiting periods, should be applied where appropriate. The Member States concerned shall request the submission of: — further studies on the specification, — information to further address the risk assessment for birds and mammals, — information to address the risk to aquatic organisms with respect to the major soil metabolites, — information to address the risk to groundwater with respect to the metabolite U8. They shall ensure that the notifiers provide such studies to the Commission within two years from the entry into force of Directive 107/2008 Number Common name, identification numbers IUPAC name Purity Entry into force Expiration of inclusion Specific provisions 217 Epoxiconazole CAS No 135319-73-2 (formerly 106325-08-0) CIPAC No 609 (2RS, 3SR)-1-[3-(2 chlorophenyl)-2,3 epoxy-2-(4 fluorophenyl)propyl] 1H-1.2,4-triazole ≥ 920 g/kg 1 May 2009 30 April 2019 PART A Only uses as fungicide may be authorised. PART B For the implementation of the uniform principles of Schedule VI, the conclusions of the review report on epoxiconazole, and in particular Appendices I and II thereof, as finalized in the Standing Committee on the Food Chain and Animal Health on 11 July 2008 shall be taken into account. In this overall assessment Member States must pay particular attention to: — the operator safety and ensure that conditions of use prescribe the application of adequate personal protective equipment where appropriate, — the dietary exposure of consumers to the epoxiconazole (triazole) metabolites, — the potential for long-range transport via air, — the risk to aquatic organisms, birds and mammals. Conditions of authorisation shall include risk mitigation measures, where appropriate. The Member States concerned shall ensure that the notifier submits to the Commission further studies addressing the potential endocrine disrupting properties of epoxiconazole within two years after the adoption of the OECD test guidelines on endocrine disruption or, alternatively, of Community agreed test guidelines. The Member States concerned shall ensure that the notifier presents to the Commission not later than 30 June 2009 a monitoring programme to assess the long-range atmospheric transport of epoxiconazole and related environmental risks. The results of this monitoring shall be submitted as a monitoring report to the Commission by 31 December 2011 at the latest. The concerned Member States shall ensure that the notifier submits within two years from the entry into force of Directive 107/2008, at the latest, information on residues of epoxiconazole metabolites in primary crops, rotational crops and products of animal origin and information to further address the long-term risk to herbivorous birds and mammals. Number Common name, identification numbers IUPAC name Purity Entry into force Expiration of inclusion Specific provisions 218 Fenpropimorph CAS No 67564-91-4 CIPAC No 427 (RS)-cis-4-[3-(4-tert butylphenyl) 2-methylpropyl]-2,6 dimethylmorpholine ≥ 930 g/kg 1 May 2009 30 April 2019 PART A Only uses as fungicide may be authorised. PART B For the implementation of the uniform principles of Schedule VI, the conclusions of the review report on fenpropimorph, and in particular Appendices I and II thereof, as finalized in the Standing Committee on the Food Chain and Animal Health on 11 July 2008 shall be taken into account. In this overall assessment Member States must pay particular attention to: — the operators and workers safety. Authorised conditions of use must prescribe the application of adequate personal protective equipment and risk mitigation measures to reduce the exposure, such as restrictions of the daily work rate, — the protection of the groundwater, when the active substance is applied in regions with vulnerable soil and/or climatic conditions, — the protection of aquatic organisms. Conditions of authorisation should include risk mitigation measures, where appropriate, such as buffer zones, reduction of run-off and drift reduction nozzles. The Member States concerned shall request the submission of further studies to confirm the mobility in soil of the metabolite BF-421-7. They shall ensure that the notifiers at whose request fenpropimorph has been included in this Schedule provide such studies to the Commission within two years from the entry into force of Directive 107/2008. Number Common name, identification numbers IUPAC name Purity Entry into force Expiration of inclusion Specific provisions 219 Fenpyroximate CAS No 134098-61-6 CIPAC No 695 tert-butyl (E)-alpha-(1,3 dimethyl-5 phenoxypyrazol 4-ylmethyleneamino oxy)-ptoluate > 960 g/kg 1 May 2009 30 April 2019 PART A Only uses as acaricide may be authorised. The following uses must not be authorised: — applications in high crops with a high risk of spray drift, for example tractor mounted air-blast sprayer and hand-held applications. PART B For the implementation of the uniform principles of Schedule VI, the conclusions of the review report on fenpyroximate, and in particular Appendices I and II thereof, as finalized in the Standing Committee on the Food Chain and Animal Health on 11 July 2008 shall be taken into account. In this overall assessment Member States must pay particular attention to: — the operator and worker safety and ensure that conditions of use prescribe the application of adequate personal protective equipment, — the impact on aquatic organisms and non-target arthropods and must ensure that the conditions of authorisation include, where appropriate, risk mitigation measures. The Member States concerned shall request the submission of information to further address: — the risk to aquatic organisms from metabolites containing the benzyl moiety, — the risk of biomagnification in aquatic food chains. They shall ensure that the notifiers at whose request fenpyroximate has been included in this Schedule provide such information to the Commission within two years from the entry into force of Directive 107/2008. Number Common name, identification numbers IUPAC name Purity Entry into force Expiration of inclusion Specific provisions 220 Tralkoxydim CAS No 87820-88-0 CIPAC No 544 (RS)-2-[(EZ)-1 (ethoxyimino) propyl]-3-hydroxy-5 mesitylcyclohex-2-en-1 one ≥ 960 g/kg 1 May 2009 30 April 2019 PART A Only uses as herbicide may be authorised. PART B For the implementation of the uniform principles of Schedule VI, the conclusions of the review report on tralkoxydim, and in particular Appendices I and II thereof, as finalised in the Standing Committee on the Food Chain and Animal Health on 11 July 2008 shall be taken into account. In this overall assessment Member States must pay particular attention to: — the protection of the groundwater, in particular from the soil metabolite R173642 when the active substance is applied in regions with vulnerable soil and/or climatic conditions, — the protection of herbivorous mammals. Conditions of use shall include risk mitigation measures, where appropriate. The Member States concerned shall request the submission of: — information to further address the long-term risk to herbivorous mammals arising from the use of tralkoxydim. They shall ensure that the notifiers at whose request tralkoxydim has been included in this Schedule provide such information to the Commission within two years from the entry into force of Directive 107/2008. Number Common name, identification numbers IUPAC name Purity Entry into force Expiration of inclusion Specific provisions 221 Aclonifen CAS No 74070-46-5 CIPAC No 498 2-chloro-6-nitro-3 phenoxyaniline ≥ 970 g/kg The impurity phenol is of toxicological concern and a maximum level of 5 g/kg is established. 1 August 2009 31 July 2019 PART A Only uses as herbicide may be authorised. PART B In assessing applications to authorise plant protection products containing aclonifen for uses other than sunflower, Member States shall pay particular attention to the criteria in Regulation 4(1)(b), and shall ensure that any necessary data and information is provided before such an authorisation is granted. For the implementation of the uniform principles of Schedule VI, the conclusions of the review report on aclonifen, and in particular Appendices I and II thereof, as finalised in the Standing Committee on the Food Chain and Animal Health on 26 September 2008 shall be taken into account. In this overall assessment Member States must pay particular attention to: — the specification of the technical material as commercially manufactured must be confirmed and supported by appropriate analytical data. The test material used in the toxicity dossiers should be compared and verified against this specification of the technical material, — the protection of the operators safety. Authorised conditions of use must prescribe the application of adequate personal protective equipment and risk mitigation measures to reduce the exposure, — the residues in rotational crops and evaluate the dietary exposure of consumers, — the protection of birds, mammals, aquatic organisms and non-target plants. In relation to these identified risks, risk mitigation measures, such as buffer zones, should be applied where appropriate. The Member States concerned shall request the submission of further studies on rotational crops residues and relevant information to confirm the risk assessment for birds, mammals, aquatic organisms and non-target plants. They shall ensure that the notifier provides such confirmatory da and information to the Commission within two years from t entry into force of Directive 116/2008. Number Common name, identification numbers IUPAC name Purity Entry into force Expiration of inclusion Specific provisions 222 Imidacloprid CAS No 138261-41-3 CIPAC No 582 (E)-1-(6-Chloro-3 pyridinylmethyl) N-nitroimidazolidin 2-ylideneamine ≥ 970 g/kg 1 August 2009 31 July 2019 PART A Only uses as insecticide may be authorised. For the protection of non-target organisms, in particular honey bees and birds, for use as seed treatment: — the seed coating shall only be performed in professional seed treatment facilities. These facilities must apply the best available techniques in order to ensure that the release of dust clouds during storage, transport and application can be excluded, — adequate application equipment shall be used to ensure a high degree of incorporation in soil, minimisation of spillage and minimisation of dust clouds emission. Member States shall ensure that the label of treated seed includes the indication that the seeds were treated with imidacloprid and sets out the risk mitigation measures provided for in the authorisation. PART B In assessing applications to authorise plant protection products containing imidacloprid for uses other than tomatoes in glasshouses, Member States shall pay particular attention to the criteria in Regulation 4(1)(b), and shall ensure that any necessary data and information is provided before such an authorisation is granted. For the implementation of the uniform principles of Schedule VI, the conclusions of the review report on imidacloprid, and in particular Appendices I and II thereof, as finalised in the Standing Committee on the Food Chain and Animal Health on 26 September 2008 shall be taken into account. In this overall assessment Member States must pay particular attention to: — the operator and worker safety and ensure that conditions of use prescribe the application of adequate personal protective equipment, — the impact on aquatic organisms, non-target arthropods, earthworms, other soil macroorganisms and must ensure that the conditions of authorisation include, where appropriate, risk mitigation measures, — the protection of honey bees, in particular for spray applications and must ensure that the conditions of authorisation include, where appropriate, risk mitigation measures. The Member States concerned shall request the submission of: — information to further address the risk assessment for operators and workers, Number Common name, identification numbers IUPAC name Purity Entry into force Expiration of inclusion Specific provisions — information to further address the risk to birds and mammals. They shall ensure that the notifier provides such confirmatory data and information to the Commission within two years from the entry into force of Directive 116/2008. 223 Metazachlor CAS No 67129-08-2 CIPAC No 411 2-chloro-N-(pyrazol-1 ylmethyl)acet-2′,6′ xylidide ≥ 940 g/kg The manufacturing impurity toluene is considered to be of toxicological concern and a maximum level of 0,01 % is established. 1 August 2009 31 July 2019 PART A Only uses as herbicide may be authorised; application max. of 1,0 kg/ha only every third year on the same field. PART B For the implementation of the uniform principles of Schedule VI, the conclusions of the review report on metazachlor, and in particular Appendices I and II thereof, as finalised in the Standing Committee on the Food Chain and Animal Health on 26 September 2008 shall be taken into account. In this overall assessment Member States must pay particular attention to: — the operator safety and ensure that conditions of use prescribe the application of adequate personal protective equipment, — the protection of aquatic organisms, — the protection of the groundwater, when the active substance is applied in regions with vulnerable soil and/or climatic conditions. Conditions of authorisation shall include risk mitigation measures and monitoring programmes shall be initiated to verify potential groundwater contamination from the metabolites 479M04, 479M08, 479M09, 479M11 and 479M12 in vulnerable zones, where appropriate. If metazachlor is classified under Directive 67/548/EEC as “limited evidence of a cancerogenic effect”, the Member States concerned shall request the submission of further information on the relevance of the metabolites 479M04, 479M08, 479M09, 479M11 and 479M12 with respect to cancer. They shall ensure that the notifiers provide that information to the Commission within six months from the notification of such a classification decision.’ Number Common name, identification numbers IUPAC name Purity Entry into force Expiration of inclusion Specific provisions 224 Acetic acid CAS No: 64-19-7 CIPAC No: not allocated Acetic acid ≥ 980 g/kg 1 September 2009 31 August 2019 PART A Only uses as herbicide may be authorised. PART B For the implementation of the uniform principles of Schedule VI, the conclusions of the review report on acetic acid (SANCO/2602/2008) and in particular Appendices I and II thereof, as finalised in the Standing Committee on the Food Chain and Animal Health shall be taken into account. Conditions of use shall include, where appropriate, risk mitigation measures. 225 Aluminium ammonium sulphate CAS No: 7784-26-1 CIPAC No: not allocated Aluminium ammonium sulphate ≥ 960 g/kg 1 September 2009 31 August 2019 PART A Only uses as repellent may be authorised. PART B For the implementation of the uniform principles of Schedule VI, theconclusions of the review report on aluminium ammonium sulphate (SANCO/2985/2008) and in particular Appendices I and II thereof, as finalised in the Standing Committee on the Food Chain and Animal Health shall be taken into account. Conditions of use shall include, where appropriate, risk mitigation measures. 226 Aluminium silicate CAS No: 1332-58-7 CIPAC No: not allocated Not available Chemical name: Kaolin ≥ 999,8 g/kg 1 September 2009 31 August 2019 PART A Only uses as repellent may be authorised. PART B For the implementation of the uniform principles of Schedule VI, the conclusions of the review report on aluminium silicate (SANCO/2603/2008) and in particular Appendices I and II thereof, as finalised in the Standing Committee on the Food Chain and Animal Health shall be taken into account. Conditions of use shall include, where appropriate, risk mitigation measures. 227 Ammonium acetate CAS No: 631-61-8 CIPAC No: not allocated Ammonium acetate ≥ 970 g/kg Relevant impurity: Heavy metals as Pb maximum 10 ppm 1 September 2009 31 August 2019 PART A Only uses as attractant may be authorised. PART B For the implementation of the uniform principles of Schedule VI, the conclusions of the review report on ammonium acetate (SANCO/2986/2008) and in particular Appendices I and II thereof, as finalised in the Standing Committee on the Food Chain and Animal Health shall be taken into account. Conditions of use shall include, where appropriate, risk mitigation measures. Number Common name, identification numbers IUPAC name Purity Entry into force Expiration of inclusion Specific provisions 228 Blood meal CAS No: not allocated CIPAC No: not allocated Not available ≥ 990 g/kg 1 September 2009 31 August 2019 PART A Only uses as repellent may be authorised. Blood meal must be in compliance with Regulation (EC) No 1774/2002. PART B For the implementation of the uniform principles of Schedule VI, the conclusions of the review report on blood meal (SANCO/2604/2008) and in particular Appendices I and II thereof, as finalised in the Standing Committee on the Food Chain and Animal Health shall be taken into account. Conditions of use shall include, where appropriate, risk mitigation measures. 229 Calcium carbide CAS No: 75-20-7 CIPAC No: not allocated Calcium carbide Calcium acetylide ≥ 765 g/kg Containing 0,08 0,52 g/kg Calcium Phosphide 1 September 2009 31 August 2019 PART A Only uses as repellent may be authorised. PART B For the implementation of the uniform principles of Schedule VI, the conclusions of the review report on calcium carbide (SANCO/2605/2008) and in particular Appendices I and II thereof, as finalised in the Standing Committee on the Food Chain and Animal Health shall be taken into account. Conditions of use shall include, where appropriate, risk mitigation measures. 230 Calcium carbonate CAS No: 471-34-1 CIPAC No: not allocated Calcium carbonate ≥ 995 g/kg 1 September 2009 31 August 2019 PART A Only uses as repellent may be authorised. PART B For the implementation of the uniform principles of Schedule VI, the conclusions of the review report on calcium carbonate (SANCO/2606/2008) and in particular Appendices I and II thereof, as finalised in the Standing Committee on the Food Chain and Animal Health shall be taken into account. Conditions of use shall include, where appropriate, risk mitigation measures. 231 Carbon dioxide CAS No: 124-38-9 Carbon dioxide ≥ 99,9 % 1 September 2009 31 August 2019 PART A Only uses as fumigant may be authorised. PART B For the implementation of the uniform principles of Schedule VI, the conclusions of the review report on carbon dioxide (SANCO/2987/2008) and in particular Appendices I and II thereof, as finalised in the Standing Committee on the Food Chain and Animal Health shall be taken into account. Conditions of use shall include, where appropriate, risk mitigation measures. Number Common name, identification numbers IUPAC name Purity Entry into force Expiration of inclusion Specific provisions 232 Denathonium benzoate CAS No: 3734-33-6 CIPAC No: not allocated Benzyldiethyl[[2,6 xylylcarbamoyl] methyl]ammonium benzoate ≥ 995 g/kg 1 September 2009 31 August 2019 PART A Only uses as repellent may be authorised. PART B For the implementation of the uniform principles of Schedule VI, the conclusions of the review report on denathonium benzoate (SANCO/2607/2008) and in particular Appendices I and II thereof, as finalized in the Standing Committee on the Food Chain and Animal Health shall be taken into account. Conditions of use shall include, where appropriate, risk mitigation measures. 233 Ethylene CAS No: 74-85-1 CIPAC No: not allocated Ethene ≥ 99 % 1 September 2009 31 August 2019 PART A Only uses as plant growth regulator may be authorised. PART B For the implementation of the uniform principles of Schedule VI, the conclusions of the review report on ethylene (SANCO/2608/2008) and in particular Appendices I and II thereof, as finalised in the Standing Committee on the Food Chain and Animal Health shall be taken into account. Conditions of use shall include, where appropriate, risk mitigation measures. 234 Extract from tea tree CAS No: Tee Tree Oil 68647-73-4 Main components: terpinen-4-ol 562-74-3 γ-terpinene 99-85-4 α-terpinene 99-86-5 1,8-cineol 470-82-6 CIPAC No: not allocated Tee Tree Oil is a complex mixture of chemical substances. Main components: terpinen-4-ol ≥ 300 g/kg γ-terpinene ≥ 100 g/kg α-terpinene ≥ 50 g/kg 1,8-cineol trace 1 September 2009 31 August 2019 PART A Only uses as fungicide may be authorised. PART B For the implementation of the uniform principles of Schedule VI, the conclusions of the review report on extract from tea tree (SANCO/2609/2008) and in particular Appendices I and II thereof, as finalised in the Standing Committee on the Food Chain and Animal Health shall be taken into account. Conditions of use shall include, where appropriate, risk mitigation measures. 235 Fat destilation residues CAS No: not allocated CIPAC No: not allocated Not available ≥ 40 % of cleaved fatty acids Relevant impurity: Ni maximum 200 mg/kg 1 September 2009 31 August 2019 PART A Only uses as repellent may be authorised. Fat destilation residues of animal origin must be in compliance with Regulation (EC) No 1774/ 2002. PART B For the implementation of the uniform principles of Schedule VI, the conclusions of the review report on fat destilation residues (SANCO/2610/2008) and in particular Appendices I and II thereof, as finalized in the Standing Committee on the Food Chain and Animal Health shall be taken into account. Conditions of use shall include, where appropriate, risk mitigation measures. Number Common name, identification numbers IUPAC name Purity Entry into force Expiration of inclusion Specific provisions 236 Fatty acids C7 to C20 CAS No: 112-05-0 (Pelargonic Acid); 67701-09 1 (Fatty acids C7-C18 and C18 unsaturated potassium salts); 124-07-2 (Caprylic Acid); 334-48-5 (Capric Acid); 143-07-7 (Lauric Acid); 112-80-1 (Oleic Acid) 85566-26-3 (Fatty acids C8 C10 Meesters); 111-11-5 (Methyl octanoate); 110-42-9 (Methyl decanoate); CIPAC No: not allocated Nonanoic acid, Caprylic Acid, Pelargonic Acid, Capric Acid, Lauric Acid, Oleic Acid (ISO in each case) Octanoic Acid, Nonanoic Acid, Decanoic Acid, Dodecanoic Acid, cis-9 Octadecenoic Acid (IUPAC in each case) Fatty acids, C7-C10, Me esters ≥ 889 g/kg (Pelargonic Acid) ≥ 838 g/kg fatty acids ≥ 99 % fatty acid methyl esters 1 September 2009 31 August 2019 PART A Only uses as insecticide, acaricide, and herbicide and plant growth regulator may be authorised. PART B For the implementation of the uniform principles of Schedule VI, the conclusions of the review report on fatty acids (SANCO/2610/2008) and in particular Appendices I and II thereof, as finalised in the Standing Committee on the Food Chain and Animal Health shall be taken into account. Conditions of use shall include, where appropriate, risk mitigation measures. 237 Garlic extract CAS No: 8008-99-9 CIPAC No: not allocated Food grade garlic juice concentrate ≥ 99,9 % 1 September 2009 31 August 2019 PART A Only uses as repellent, insecticide and nematicide may be authorised. PART B For the implementation of the uniform principles of Schedule VI, the conclusions of the review report on garlic extract (SANCO/2612/2008) and in particular Appendices I and II thereof, as finalised in the Standing Committee on the Food Chain and Animal Health shall be taken into account. Conditions of use shall include, where appropriate, risk mitigation measures. 238 Gibberellic acid CAS No: 77-06-5 CIPAC No: 307 (3S,3aS,4S,4aS,7S,9aR, 9bR,12S)-7,12 dihydroxy-3-methyl-6 methylene-2 oxoperhydro-4a,7 methano-9b,3-propenol (1,2-b)furan-4 carboxylic acid Alt: (3S,3aR,4S,4aS,6S, 8aR,8bR,11S)-6,11 dihydroxy-3-methyl-12 methylene-2-oxo-4a,6 methano-3,8b-prop lenoperhydroindenol (1,2-b) furan 4-carboxylic acid ≥ 850 g/kg 1 September 2009 31 August 2019 PART A Only uses as plant growth regulator may be authorised. PART B For the implementation of the uniform principles of Schedule VI, the conclusions of the review report on gibberellic acid (SANCO/2613/2008) and in particular Appendices I and II thereof, as finalised in the Standing Committee on the Food Chain and Animal Health shall be taken into account. Conditions of use shall include, where appropriate, risk mitigation measures. Number Common name, identification numbers IUPAC name Purity Entry into force Expiration of inclusion Specific provisions 239 Gibberellins CAS No: GA4: 468-44-0 GA7: 510-75-8 GA4A7 mixture: 8030-53-3 CIPAC No: not allocated GA4: (3S,3aR,4S,4aR,7R,9aR, 9b R,12S)-12-hydroxy-3 methyl-6-methylene-2 oxoperhydro-4a,7 methano 3,9b propanoazuleno[1,2 b]furan-4-carboxylic acid GA7: (3S,3aR,4S,4aR,7R,9aR, 9b R,12S)-12-hydroxy-3 methyl-6-methylene-2 oxoperhydro-4a,7 methano 9b,3 propenoazuleno[1,2 b]furan-4-carboxylic acid Review report (SANCO/2614/2 008). 1 September 2009 31 August 2019 PART A Only uses as plant growth regulator may be authorised. PART B For the implementation of the uniform principles of Schedule VI, the conclusions of the review report on gibberellins (SANCO/2614/2008) and in particular Appendices I and II thereof, as finalised in the Standing Committee on the Food Chain and Animal Health shall be taken into account. Conditions of use shall include, where appropriate, risk mitigation measures. 240 Hydrolised proteins Beet molasses urea hydrolysate Collagen protein hydrolysate CAS No: not allocated CIPAC No: not allocated Not available Beet molasses urea hydrolysate: minimum Crude Protein Equivalent: 360 g/kg (36 % w/w) Collagen protein hydrolysate: organic nitrogen content > 240 g/kg 1 September 2009 31 August 2019 PART A Only uses as attractant may be authorised. Hydrolised proteins of animal origin must be in compliance with Regulation (EC) No 1774/2002 PART B For the implementation of the uniform principles of Schedule VI, the conclusions of the review report on hydrolised proteins (SANCO/2615/2008) and in particular Appendices I and II thereof, as finalised in the Standing Committee on the Food Chain and Animal Health shall be taken into account. Conditions of use shall include, where appropriate, risk mitigation measures. Number Common name, identification numbers IUPAC name Purity Entry into force Expiration of inclusion Specific provisions 241 Iron sulphate Iron(II)sulphate anhydrous: CAS No: 7720-78-7 Iron(II)sulphate monohydrate: CAS No: 17375-41-6 Iron(II)sulphate heptahydrate: CAS No: 7782-63-0 CIPAC No: not allocated Iron (II) sulfate Iron(II)sulphate anhydrous ≥ 367,5 g/kg Iron(II)sulphate monohydrate ≥ 300 g/kg Iron(II)sulphate heptahydrate ≥ 180 g/kg 1 September 2009 31 August 2019 PART A Only uses as herbicide may be authorised. PART B For the implementation of the uniform principles of Schedule VI, the conclusions of the review report on iron sulphate (SANCO/2616/2008) and in particular Appendices I and II thereof, as finalised in the Standing Committee on the Food Chain and Animal Health shall be taken into account. Conditions of use shall include, where appropriate, risk mitigation measures. 242 Kieselgur (Diatomaceous earth) CAS No: 61790-53-2 CIPAC No: 647 Kieselgur (diatomaceous earth) 920 ± 20 g SiO2/kg DE Maximum 0,1 % of particles of Crystalline Silica (with diameter below 50 um.) 1 September 2009 31 August 2019 PART A Only uses as insecticide and acaricide may be authorised. PART B For the implementation of the uniform principles of Schedule VI, the conclusions of the review report on kieselgur (SANCO/2617/2008) and in particular Appendices I and II thereof, as finalised in the Standing Committee on the Food Chain and Animal Health shall be taken into account. Conditions of use shall include, where appropriate, risk mitigation measures. 243 Limestone CAS No: 1317-65-3 CIPAC No: not allocated not available ≥ 980 g/kg 1 September 2009 31 August 2019 PART A Only uses as repellent may be authorised. PART B For the implementation of the uniform principles of Schedule VI, the conclusions of the review report on limestone (SANCO/2618/2008) and in particular Appendices I and II thereof, as finalised in the Standing Committee on the Food Chain and Animal Health shall be taken into account. Conditions of use shall include, where appropriate, risk mitigation measures. 244 Methyl nonyl ketone CAS No: 112-12-9 CIPAC No: not allocated Undecan-2-one ≥ 975g/kg 1 September 2009 31 August 2019 PART A Only uses as repellent may be authorised. PART B For the implementation of the uniform principles of Schedule VI, the conclusions of the review report on methylnonyl ketone (SANCO/2619/2008) and in particular Appendices I and II thereof, as finalised in the Standing Committee on the Food Chain and Animal Health shall be taken into account. Conditions of use shall include, where appropriate, risk mitigation measures. Number Common name, identification numbers IUPAC name Purity Entry into force Expiration of inclusion Specific provisions 245 Pepper CAS No: not allocated CIPAC No: not allocated Black pepper — Piper nigrum It is a complex mixture of chemical substances, the component piperine as marker should be minimum 4 % 1 September 2009 31 August 2019 PART A Only uses as repellent may be authorised. PART B For the implementation of the uniform principles of Schedule VI, the conclusions of the review report on pepper (SANCO/2620/2008) and in particular Appendices I and II thereof, as finalised in the Standing Committee on the Food Chain and Animal Health shall be taken into account. Conditions of use shall include, where appropriate, risk mitigation measures. 246 Plant oils/citronella oil CAS No: 8000-29-1 CIPAC No: not allocated Citronella Oil is a complex mixture of chemical substances. The main components are: Citronellal (3,7 dimethyl-6 octenal). Geraniol ((E)-3,7 dimethyl 2,6-octadien-1-ol). Citronellol (3,7 dimethyl-6 octan-2-ol). Geranyl acetate (3,7 dimethyl-6-octen-1yl acetate). Relevant impurities methyl eugenol and methyl isoeugenol maximum 0,1 %. 1 September 2009 31 August 2019 PART A Only uses as herbicide may be authorised. PART B For the implementation of the uniform principles of Schedule VI, the conclusions of the review report on citronella oil (SANCO/2621/2008) and in particular Appendices I and II thereof, as finalised in the Standing Committee on the Food Chain and Animal Health shall be taken into account. Conditions of use shall include, where appropriate, risk mitigation measures. 247 Plant oils/clove oil CAS No: 94961-50-2 (clove oil) 97-53-0 (Eugenol — main component) CIPAC No: not allocated Clove Oil is a complex mixture of chemical substances. The main component is eugenol. ≥ 800 g/kg 1 September 2009 31 August 2019 PART A Only uses as fungicide and bactericide may be authorised. PART B For the implementation of the uniform principles of Schedule VI, the conclusions of the review report on clove oil (SANCO/2622/2008) and in particular Appendices I and II thereof, as finalised in the Standing Committee on the Food Chain and Animal Health shall be taken into account. Conditions of use shall include, where appropriate, risk mitigation measures. Number Common name, identification numbers IUPAC name Purity Entry into force Expiration of inclusion Specific provisions 248 Plant oils/rape seed oil CAS No: 8002-13-9 CIPAC No: not allocated Rape seed oil Rape seed oil is a complex mixture of fatty acids 1 September 2009 31 August 2019 PART A Only uses as insecticide and acaricide may be authorised. PART B For the implementation of the uniform principles of Schedule VI, the conclusions of the review report on rape seed oil (SANCO/2623/2008) and in particular Appendices I and II thereof, as finalised in the Standing Committee on the Food Chain and Animal Health shall be taken into account. Conditions of use shall include, where appropriate, risk mitigation measures. 249 Plant oils/spear mint oil CAS No: 8008-79-5 CIPAC No: not allocated Spearmint oil ≥ 550 g/kg as LCarvone 1 September 2009 31 August 2019 PART A Only uses as plant growth regulator may be authorised. PART B For the implementation of the uniform principles of Schedule VI, the conclusions of the review report on spearmint oil (SANCO/2624/2008) and in particular Appendices I and II thereof, as finalised in the Standing Committee on the Food Chain and Animal Health shall be taken into account. Conditions of use shall include, where appropriate, risk mitigation measures. 250 Potassium hydrogen carbonate CAS No: 298-14-6 CIPAC No: not allocated Potassium hydrogen carbonate ≥ 99,5 % 1 September 2009 31 August 2019 PART A Only uses as fungicide may be authorised. PART B For the implementation of the uniform principles of Schedule VI, the conclusions of the review report on potassium hydrogen carbonate (SANCO/2625/2008) and in particular Appendices I and II thereof, as finalised in the Standing Committee on the Food Chain and Animal Health shall be taken into account. Conditions of use shall include, where appropriate, risk mitigation measures. 251 Putrescin (1,4 Diaminobutane) CAS No: 110-60-1 CIPAC No: not allocated Butane-1,4-diamine ≥ 990 g/kg 1 September 2009 31 August 2019 PART A Only uses as attractant may be authorised. PART B For the implementation of the uniform principles of Schedule VI, the conclusions of the review report on putrescin (SANCO/2626/2008) and in particular Appendices I and II thereof, as finalised in the Standing Committee on the Food Chain and Animal Health shall be taken into account. Conditions of use shall include, where appropriate, risk mitigation measures. Number Common name, identification numbers IUPAC name Purity Entry into force Expiration of inclusion Specific provisions 252 Pyrethrins CAS No: (A) and (B): Pyrethrins: 8003-34-7 Extract A: extractives of Chrysanthemum cinerariaefolium: 89997-63-7 pyrethrin 1: CAS 121-21-1 pyrethrin 2: CAS 121-29-9 cinerin 1: CAS 25402-06-6 cinerin 2: CAS 121-20-0 jasmolin 1: CAS 4466-14-2 jasmolin 2: CAS 1172-63-0 Extract B: pyrethrin 1: CAS 121-21-1 pyrethrin 2: CAS 121-29-9 cinerin 1: CAS 25402-06-6 cinerin 2: CAS 121-20-0 jasmolin 1: CAS 4466-14-2 jasmolin 2: CAS 1172-63-0 CIPAC No 32 Pyrethrins are a complex mixture of chemical substances. Extract A: ≥ 500 g/kg Pyrethrins Extract B: ≥ 480 g/kg Pyrethrins 1 September 2009 31 August 2019 PART A Only uses as insecticide may be authorised. PART B For the implementation of the uniform principles of Schedule VI, the conclusions of the review report on pyrethrins (SANCO/2627/2008) and in particular Appendices I and II thereof, as finalised in the Standing Committee on the Food Chain and Animal Health shall be taken into account. Conditions of use shall include, where appropriate, risk mitigation measures. 253 Quartz sand CAS No: 14808-60-7 CIPAC No: not allocated Quarz, Quartz, Siliciumdioxid, Silica, Silicon dioxide, SiO2 ≥ 915 g/kg Maximum 0,1 % of particles of Crystalline Silica (with diameter below 50 um.) 1 September 2009 31 August 2019 PART A Only uses as repellent may be authorised. PART B For the implementation of the uniform principles of Schedule VI, the conclusions of the review report on quartz sand (SANCO/2628/2008) and in particular Appendices I and II thereof, as finalised in the Standing Committee on the Food Chain and Animal Health shall be taken into account. Conditions of use shall include, where appropriate, risk mitigation measures. 254 Repellents by smell of animal or plant origin/fish oil CAS No: 100085-40-3 CIPAC No: not allocated Fish Oil ≥ 99 % 1 September 2009 31 August 2019 PART A Only uses as repellent may be authorised. Fish oil must be in compliance with Regulation (EC) No 1774/2002 PART B For the implementation of the uniform principles of Schedule VI, the conclusions of the review report on fish oil (SANCO/2629/2008) and in particular Appendices I and II thereof, as finalised in the Standing Committee on the Food Chain and Animal Health shall be taken into account. Conditions of use shall include, where appropriate, risk mitigation measures. Number Common name, identification numbers IUPAC name Purity Entry into force Expiration of inclusion Specific provisions 255 Repellents by smell of animal or plant origin/sheep fat CAS No: 98999-15-6 CIPAC No: not allocated Sheep Fat Pure sheep fat containing a maximum of 0,18 % w/w/water. 1 September 2009 31 August 2019 PART A Only uses as repellent may be authorised. Sheep fat must be in compliance with Regulation (EC) No 1774/2002 PART B For the implementation of the uniform principles of Schedule VI, the conclusions of the review report on sheep fat (SANCO/2630/2008) and in particular Appendices I and II thereof, as finalised in the Standing Committee on the Food Chain and Animal Health shall be taken into account. Conditions of use shall include, where appropriate, risk mitigation measures. 256 Repellents by smell of animal or plant origin/tall oil crude CAS No: 8002-26-4 CIPAC No: not allocated Tall Oil Crude Tall oil crude is a complex mixture of tall rosin and fatty acids 1 September 2009 31 August 2019 PART A Only uses as repellent may be authorised. PART B For the implementation of the uniform principles of Schedule VI, the conclusions of the review report on tall oil crude (SANCO/2631/2008) and in particular Appendices I and II thereof, as finalised in the Standing Committee on the Food Chain and Animal Health shall be taken into account. Conditions of use shall include, where appropriate, risk mitigation measures. 257 Repellents by smell of animal or plant origin/tall oil pitch CAS No: 8016-81-7 CIPAC No: not allocated Tall Oil Pitch Complex mixture of esters of fatty acids, rosin and small amounts of dimers and trimers of resin acids and fatty acids. 1 September 2009 31 August 2019 PART A Only uses as repellent may be authorised. PART B For the implementation of the uniform principles of Schedule VI, the conclusions of the review report on tall oil pitch (SANCO/2632/2008) and in particular Appendices I and II thereof, as finalised in the Standing Committee on the Food Chain and Animal Health shall be taken into account. Conditions of use shall include, where appropriate, risk mitigation measures. 258 Sea-algae extract (formerly sea algae extract and sea weeds) CAS No: not allocated CIPAC No: not allocated See algae extract See algae extract is a complex mixture. Main components as markers: annitol, fucoidans and alginates. Review report SANCO/2634/20 08 1 September 2009 31 August 2019 PART A Only uses as plant growth regulator may be authorised. PART B For the implementation of the uniform principles of Schedule VI, the conclusions of the review report on sea algae extract (SANCO/2634/2008) and in particular Appendices I and II thereof, as finalised in the Standing Committee on the Food Chain and Animal Health shall be taken into account. Conditions of use shall include, where appropriate, risk mitigation measures. Number Common name, identification numbers IUPAC name Purity Entry into force Expiration of inclusion Specific provisions 259 Sodium aluminium silicate CAS No: 1344-00-9 CIPAC No: not allocated Sodium aluminium silicate: Nax[(AlO2)x(SiO2)y] × zH2O 1 000 g/kg 1 September 2009 31 August 2019 PART A Only uses as repellent may be authorised. PART B For the implementation of the uniform principles of Schedule VI, the conclusions of the review report on sodium aluminium silicate (SANCO/2635/2008) and in particular Appendices I and II thereof, as finalised in the Standing Committee on the Food Chain and Animal Health shall be taken into account. Conditions of use shall include, where appropriate, risk mitigation measures. 260 Sodium Hypochlorite CAS No: 7681-52-9 CIPAC No: not allocated Sodium Hypochlorite 10 % (w/w) expressed as chlorine 1 September 2009 31 August 2019 PART A Only uses as disinfectant may be authorised. PART B For the implementation of the uniform principles of Schedule VI, the conclusions of the review report on sodium hypochlorite (SANCO/2988/2008) and in particular Appendices I and II thereof, as finalised in the Standing Committee on the Food Chain and Animal Health shall be taken into account. Conditions of use shall include, where appropriate, risk mitigation measures. Number Common name, identification numbers IUPAC name Purity Entry into force Expiration of inclusion Specific provisions 261 Straight Chain Lepidopteran Pheromones (E)-5-decen-1-yl acetate CAS No: 38421-90-8 CIPAC No: not allocated (E)-8-dodecen-1-yl acetate CAS No: 38363-29-0 CIPAC No: not allocated (E/Z)-8-dodecen-1-yl acetate CAS No: not available CIPAC No: not available (Z)-8-dodecen-1-yl acetate CAS No: 28079-04-1 CIPAC No: not allocated (Z)-9-dodecen-1-yl acetate CAS No: 16974-11-1 CIPAC No: 422 (E,Z)-7,9-dodecadien-1-yl acetate CAS No: 54364-62-4 CIPAC No: not allocated (E)-11-tetradecen-1-yl acetate CAS No: 33189-72-9 CIPAC No: not allocated (Z)-9-tetradecen-1-yl acetate CAS No: 16725-53-4 CIPAC No: not allocated (Z)-11-tetradecen-1-yl acetate CAS No: 20711-10-8 CIPAC No: not allocated Acetate group: (E)-5-decen-1-yl acetate (E)-8-dodecen-1-yl acetate (E/Z)-8-dodecen-1-yl acetate as individual isomers (Z)-8-dodecen-1-yl acetate (Z)-9-dodecen-1-yl acetate (E,Z)-7,9-dodecadien-1 yl Acetate (E)-11-tetradecen-1-yl acetate (Z)-9-tetradecen-1-yl acetate (Z)-11-tetradecen-1-yl Acetate Review report (SANCO/2633/2 008) 1 September 2009 31 August 2019 PART A Only uses as attractants may be authorised. PART B For the implementation of the uniform principles of Schedule VI, the conclusions of the review report on straight chain lepidopteran pheromones (SANCO/2633/2008) and in particular Appendices I and II thereof, as finalised in the Standing Committee on the Food Chain and Animal Health shall be taken into account. Conditions of use shall include, where appropriate, risk mitigation measures. (Z, E)-9, 12-tetradecadien-1 yl acetate CAS No: 31654-77-0 CIPAC No: not allocated Z-11-hexadecen-1-yl acetate CAS No: 34010-21-4 CIPAC No: not allocated (Z, E)-7, 11-hexadecadien-1 yl acetate CAS No: 51606-94-4 CIPAC No: not allocated (E, Z)-2, 13-octadecadien-1 yl acetate. CAS No: 86252-65-5 CIPAC No: not allocated Alcholol group: (E)-5-decen-1-ol CAS No: 56578-18-8 CIPAC No: not allocated (Z)-8-dodecen-1-ol CAS No: 40642-40-8 CIPAC No: not allocated (E,E)-8,10-dodecadien-1-ol CAS No: 33956-49-9 CIPAC No: not allocated tetradecan-1-ol CAS No: 112-72-1 CIPAC No: not allocated (Z)-11-hexadecen-1-ol CAS No: 56683-54-6 CIPAC No: not allocated Aldehyde group: Z)-7-tetradecenal CAS No: 65128-96-3 CIPAC No: not allocated (Z, E)-9, 12 tetradecadien-1 yl acetate Z-11-hexadecen-1-yl acetate Z, E)-7, 11 hexadecadien-1 yl acetate (E, Z)-2, 13 octadecadien-1 yl acetate. Alcohol group: (E)-5-decen-1-ol (Z)-8-dodecen-1-ol (E,E)-8,10-dodecadien 1-o tetradecan-1-ol (Z)-11-hexadecen-1-ol Aldehyde group: (Z)-7-tetradecenal (Z)-9-hexadecenal CAS No: 56219-04-6 CIPAC No: not allocated (Z)-11-hexadecenal CAS No: 53939-28-9 CIPAC No: not allocated (Z)-13-octadecenal CAS No: 58594-45-9 CIPAC No: not allocated Blends acetates: i) (Z)-8-dodecen-1-yl acetate CAS No: 28079-04-1 CIPAC No: not allocated and ii) Dodecyl acetate CAS No: 112-66-3 CIPAC No: not allocated; i) (Z)-9-dodecen-1-yl acetate CAS No: 16974-11-1 CIPAC No: 422 And ii) Dodecyl acetate CAS No: 112-66-3 CIPAC No: 422; i) (E,Z)-7,9-dodecadien-1-yl acetate CAS No: 55774-32-8 CIPAC No: not allocated And ii) (E,E)-7,9-dodecadien-1-yl acetate CAS No: 54364-63-5 CIPAC No: not allocated; i) (Z,Z)-7,11-hexadecadien 1-yl acetate (Z)-9-hexadecenal (Z)-11-hexadecenal (Z)-13-octadecenal Blends acetates: i) (Z)-8-dodecen-1-yl acetate and ii) Dodecyl acetate; i) (Z)-9-dodecen-1-yl acetate and ii) Dodecyl acetate; i) (E,Z)-7,9-dodecadien 1-yl acetate, and ii) (E,E)-7,9-dodecadien 1-yl acetate; i) (Z,Z)-7,11 hexadecadien 1-yl acetate and ii) (Z,E)-7,11-hexadecadien 1-yl acetate CAS No: i) & ii) 53042-79-8 CAS No: i) 52207-99-5 CAS No: ii) 51606-94-4 CIPAC No: not allocated; Blends aldehydes: i) (Z)-9-hexadecenal CAS No: 56219-04-6 CIPAC No: not allocated And ii) (Z)-11-hexadecenal CAS No: 53939-28-9 CIPAC: not allocated And iii) (Z)-13-octadecenal CAS No: 58594-45-9 CIPAC No: not allocated; Blends mixtures: i) (E)-5-decen-1-yl acetate CAS No: 38421-90-8 CIPAC No: not allocated And ii) (E)-5-decen-1-ol CAS No: 56578-18-8 CIPAC No: not allocated; i) (E/Z)-8-dodecen-1-yl acetate CAS No: as individual isomers CIPAC No: not allocated; And i) (E)-8-dodecen-1-yl acetate CAS No: (E) 38363-29-0 CIPAC No: not allocated And ii) (Z,E)-7,11 hexadecadien 1-yl acetate; Blends aldehydes: i) (Z)-9-hexadecenal and ii) (Z)-11-hexadecenal and iii) (Z)-13-octadecenal; Blends mixtures: i) (E)-5-decen-1-yl acetate and ii) (E)-5-decen-1-ol; i) (E/Z)-8-dodecen-1-yl acetate and i) (E)-8-dodecen-1-yl acetate and And i) (Z)-8-dodecen-1-yl acetate CAS No: (Z) 28079-04-1 CIPAC No: not allocated And ii) (Z)-8-dodecen-1-ol CAS No: ii) 40642-40-8 CIPAC No: not allocated; i) (Z)-11-hexadecenal CAS No: 53939-28-9 CIPAC No: not allocated And ii) (Z)-11-hexadecen-1-yl acetate CAS No: 34010-21-4 CIPAC No: not allocated i) (Z)-8-dodecen-1-yl acetate and ii) (Z)-8-dodecen-1-ol; i) (Z)-11-hexadecenal and ii) (Z)-11-hexadecen-1 yl acetate Number Common name, identification numbers IUPAC name Purity Entry into force Expiration of inclusion Specific provisions 262 Trimethylamine hydrochloride CAS No: 593-81-7 CIPAC No: not allocated Trimethylamine hydrochloride ≥ 988 g/kg 1 September 2009 31 August 2019 PART A Only uses as attractant may be authorised. PART B For the implementation of the uniform principles of Schedule VI, the conclusions of the review report on trimethylamine hydrochloride (SANCO/2636/2008) and in particular Appendices I and II thereof, as finalised in the Standing Committee on the Food Chain and Animal Health shall be taken into account. Conditions of use shall include, where appropriate, risk mitigation measures. 263 Urea CAS No: 57-13-6 CIPAC No: 8352 Urea ≥ 98 % w/w 1 September 2009 31 August 2019 PART A Only uses as attractant and fungicide may be authorised. PART B For the implementation of the uniform principles of Schedule VI, the conclusions of the review report on urea (SANCO/2637/2008) and in particular Appendices I and II thereof, as finalised in the Standing Committee on the Food Chain and Animal Health shall be taken into account. Conditions of use shall include, where appropriate, risk mitigation measures. 264 Z-13-hexadecen-11-yn-1-yl acetate CAS No: 78617-58-0 CIPAC: not allocated Z-13-hexadecen-11-yn 1-yl acetate ≥ 75 % 1 September 2009 31 August 2019 PART A Only uses as attractant may be authorised. PART B For the implementation of the uniform principles of Schedule VI, the conclusions of the review report on Z-13-hexadecen-11 yn-1-yl acetate (SANCO/2649/2008) and in particular Appendices I and II thereof, as finalised in the Standing Committee on the Food Chain and Animal Health shall be taken into account. Conditions of use shall include, where appropriate, risk mitigation measures. 265 Z,Z,Z,Z-7,13,16,19 docosatetraen-1-yl isobutyrate CAS No: 135459-81-3 CIPAC: not allocated Z,Z,Z,Z-7,13,16,19 docosatetraen 1-yl isobutyrate ≥ 90 % 1 September 2009 31 August 2019 PART A Only uses as attractant may be authorised. PART B For the implementation of the uniform principles of Schedule VI, the conclusions of the review report on Z,Z,Z,Z-7,13,16,19 docosatetraen-1-yl isobutyrate (SANCO/2650/2008) and in particular Appendices I and II thereof, as finalised in the Standing Committee on the Food Chain and Animal Health shall be taken into account.Conditions of use shall include, where appropriate, risk mitigation measures. Number Common name, identification numbers IUPAC name Purity Entry into force Expiration of inclusion Specific provisions 266 Aluminium phosphide CAS No 20859-73-8 CIPAC No 227 Aluminium phosphide ≥ 830 g/kg 1 September 2009 31 August 2019 PART A Only uses as insecticide and rodenticide in the form of ready-to use aluminium phosphide containing products may be authorised. As rodenticide only outdoor uses may be authorised. Authorisations should be limited to professional users. PART B For the implementation of the uniform principles of Schedule VI, the conclusions of the review report on aluminium phosphide, and in particular Appendices I and II thereof, as finalised in the Standing Committee on the Food Chain and Animal Health on 28 October 2008 shall be taken into account. In this overall assessment Member States must pay particular attention to: — the protection of consumers and ensure that the spent ready to-use aluminium phosphide containing products are removed from the food commodity in uses against storage pests and subsequently an adequate additional withholding period is applied; — the operator and worker safety and ensure that conditions of use prescribe the application of adequate personal and respiratory protective equipment; — the protection of operators and workers during fumigation for indoor uses; — the protection of workers at re-entry (after fumigation period) for indoor uses; — the protection of bystanders against leaking of gas for indoor uses; — the protection of birds and mammals. Conditions of authorisation should include risk mitigation measures, such as the closure of the burrows and the achievement of complete incorporation of granules in the soil, where appropriate; — the protection of aquatic organisms. Conditions of authorisation should include risk mitigation measures, such as buffer zones between treated areas and surface water bodies, where appropriate. Number Common name, identification numbers IUPAC name Purity Entry into force Expiration of inclusion Specific provisions 267 Calcium phosphide CAS No 1305-99-3 CIPAC No 505 Calcium phosphide ≥ 160 g/kg 1 September 2009 31 August 2019 PART A Only outdoor uses as rodenticide in the form of ready-to-use calcium phosphide containing products may be authorised. Authorisations should be limited to professional users. PART B For the implementation of the uniform principles of Schedule VI, the conclusions of the review report on calcium phosphide, and in particular Appendices I and II thereof, as finalised in the Standing Committee on the Food Chain and Animal Health on 28 October 2008 shall be taken into account. In this overall assessment Member States must pay particular attention to: — the operator and worker safety and ensure that conditions of use prescribe the application of adequate personal and respiratory protective equipment; — the protection of birds and mammals. Conditions of authorisation should include risk mitigation measures, such as the closure of the burrows and the achievement of complete incorporation of granules in the soil, where appropriate; — the protection of aquatic organisms. Conditions of authorisation should include risk mitigation measures, such as buffer zones between treated areas and surface water bodies, where appropriate. Number Common name, identification numbers IUPAC name Purity Entry into force Expiration of inclusion Specific provisions 268 Magnesium phosphide CAS No 12057-74-8 CIPAC No 228 Magnesium phosphide ≥ 880 g/kg 1 September 2009 31 August 2019 PART A Only uses as insecticide and rodenticide in the form of ready-to use magnesium phosphide containing products may be authorised. As rodenticide only outdoor uses may be authorised. Authorisations should be limited to professional users. PART B For the implementation of the uniform principles of Schedule VI, the conclusions of the review report on magnesium phosphide, and in particular Appendices I and II thereof, as finalised in the Standing Committee on the Food Chain and Animal Health on 28 October 2008 shall be taken into account. In this overall assessment Member States must pay particular attention to: — the protection of consumers and ensure that the spent ready to-use magnesium phosphide containing products are removed from the food commodity in uses against storage pests and subsequently an adequate additional withholding period is applied; — the operator safety and ensure that conditions of use prescribe the application of adequate personal and respiratory protective equipment; — the protection of operators and workers during fumigation for indoor uses; — the protection of workers at re-entry (after fumigation period) for indoor uses; — the protection of bystanders against leaking of gas for indoor uses; — the protection of birds and mammals. Conditions of authorisation should include risk mitigation measures, such as the closure of the burrows and the achievement of complete incorporation of granules in the soil, where appropriate; — the protection of aquatic organisms. Conditions of authorisation should include risk mitigation measures, such as buffer zones between treated areas and surface water bodies, where appropriate. Number Common name, identification numbers IUPAC name Purity Entry into force Expiration of inclusion Specific provisions 269 Cymoxanil CAS No 57966-95-7 CIPAC No 419 1-[(E/Z)-2-cyano-2 methoxyiminoacetyl] 3-ethylurea ≥ 970 g/kg 1 September 2009 31 August 2019 PART A Only uses as fungicide may be authorised. PART B For the implementation of the uniform principles of Schedule VI, the conclusions of the review report on cymoxanil, and in particular Appendices I and II thereof, as finalised in the Standing Committee on the Food Chain and Animal Health on 28 October 2008 shall be taken into account. In this overall assessment Member States must pay particular attention to: — the operator and worker safety and ensure that conditions of use prescribe the application of adequate personal protective equipment; — the protection of the groundwater, when the active substance is applied in regions with vulnerable soil and/or climatic conditions; — the protection of aquatic organisms and must ensure that the conditions of authorisation include risk mitigation measures such as buffer zones, where appropriate. 270 Dodemorph CAS No 1593-77-7 CIPAC No 300 cis/trans-[4 cyclododecyl] 2,6-dimethylmorpholine ≥ 950 g/kg 1 September 2009 31 August 2019 PART A Only uses as fungicide on ornamentals in glasshouse may be authorised. PART B For the implementation of the uniform principles of Schedule VI, the conclusions of the review report on dodemorph, and in particular Appendices I and II thereof, as finalised in the Standing Committee on the Food Chain and Animal Health on 28 October 2008 shall be taken into account. In this overall assessment Member States must pay particular attention to: — the operator and worker safety and ensure that conditions of use prescribe the application of adequate personal protective equipment where appropriate; — the protection of the groundwater, when the active substance is applied in regions with vulnerable soil conditions; Conditions of authorisation should include risk mitigation measures, where appropriate Number Common name, identification numbers IUPAC name Purity Entry into force Expiration of inclusion Specific provisions 271 2,5-Dichlorobenzoic acid methylester CAS No 2905-69-3 CIPAC No 686 methyl-2,5 dichlorobenzoate ≥ 995 g/kg 1 September 2009 31 August 2019 PART A Only indoor uses as plant growth regulator and fungicide for grafting of grapevines may be authorised. PART B For the implementation of the uniform principles of Schedule VI, the conclusions of the review report on 2,5-Dichlorobenzoic acid methylester, and in particular Appendices I and II thereof, as finalised in the Standing Committee on the Food Chain and Animal Health on 28 October 2008 shall be taken into account. 272 Metamitron CAS No 41394-05-2 CIPAC No 381 4-amino-4,5-dihydro-3 methyl-6-phenyl-1,2,4 triazin-5-one ≥ 960 g/kg 1 September 2009 31 August 2019 PART A Only uses as herbicide may be authorised. PART B In assessing applications to authorise plant protection products containing metamitron for uses other than on root crops, Member States shall pay particular attention to the criteria in regulation 4(1) (b), and shall ensure that any necessary data and information is provided before such an authorization is granted. For the implementation of the uniform principles of Schedule VI, the conclusions of the review report on metamitron, and in particular Appendices I and II thereof, as finalised in the Standing Committee on the Food Chain and Animal Health on 28 October 2008 shall be taken into account. In this overall assessment Member States must pay particular attention to: — the operator safety and ensure that conditions of use prescribe the application of personal protective equipment where appropriate; — the protection of groundwater, when the active substance is applied in regions with vulnerable soil and/or climatic conditions; — the risk to birds and mammals, and non-target terrestrial plants. Conditions of authorisation shall include risk mitigation measures, where appropriate. The Member States concerned shall request the submission of further information on the impact of soil metabolite M3 on groundwater, on residues in rotational crops, on the long-term risk to insectivorous birds and the specific risk to birds and mammals that may be contaminated by the intake of water in field. They shall ensure that the notifiers at whose request metamitron has been included in this Schedule provide such information to the Commission by 31 August 2011 at the latest. 273 Sulcotrione CAS No 99105-77-8 CIPAC No 723 2-(2-chloro-4 mesylbenzoyl)cyclohexa ne 1,3-dione ≥ 950 g/kg Impurities: — hydrogen cyanide: not more than 80 mg/kg — toluene: not more than 4 g/kg 1 September 2009 31 August 2019 PART A Only uses as herbicide may be authorised. PART B For the implementation of the uniform principles of Schedule VI, the conclusions of the review report on sulcotrione, and in particular Appendices I and II thereof, as finalised in the Standing Committee on the Food Chain and Animal Health on 28 October 2008 shall be taken into account. In this overall assessment Member States must pay particular attention to: — the operator safety and ensure that conditions of use prescribe the application of adequate personal protective equipment where appropriate; — the risk to insectivorous birds, aquatic and terrestrial non target plants, and non-target arthropods. Conditions of authorisation shall include risk mitigation measures, where appropriate. The Member States concerned shall request the submission of further information on the degradation in soil and water of the cyclohexadione moiety and the long-term risk to insectivorous birds. They shall ensure that the notifier at whose request sulcotrione has been included in this Schedule provide such information to the Commission by 31 August 2011 at the latest. Number Common name, identification numbers IUPAC name Purity Entry into force Expiration of inclusion Specific provisions 274 Tebuconazole CAS No 107534-96-3 CIPAC No 494 (RS)-1-p-chlorophenyl 4,4-dimethyl-3-(1H 1,2,4-triazol 1-ylmethyl)-pentan-3-ol ≥ 905 g/kg 1 September 2009 31 August 2019 PART A Only uses as fungicide may be authorised. PART B For the implementation of the uniform principles of Schedule VI, the conclusions of the review report on tebuconazole, and in particular Appendices I and II thereof, as finalised in the Standing Committee on the Food Chain and Animal Health on 28 October 2008 shall be taken into account. In this overall assessment Member States must pay particular attention to: — the operator and worker safety and ensure that conditions of use prescribe the application of adequate personal protective equipment; — the dietary exposure of consumers to the tebuconazole (triazole) metabolites; — the protection of granivorous birds and mammals and herbivorous mammals and must ensure that the conditions of authorisation include, where appropriate, risk mitigation measures. — the protection of aquatic organisms and must ensure that conditions of authorisation include risk mitigation measures such as buffer zones, where appropriate. The Member States concerned shall request the submission of further information to confirm the risk assessment for birds and mammals. They shall ensure that the notifier at whose request tebuconazole has been included in this Schedule provide such information to the Commission by 31 August 2011 at the latest. The Member States concerned shall ensure that the notifier submits to the Commission further information addressing the potential endocrine disrupting properties of tebuconazole within two years after the adoption of the OECD test guidelines on endocrine disruption or, alternatively, of Community agreed test guidelines. Number Common name, identification numbers IUPAC name Purity Entry into force Expiration of inclusion Specific provisions 275 Triadimenol CAS No 55219-65-3 CIPAC No 398 (1RS,2RS;1RS,2SR)-1 (4-chlorophenoxy)-3,3 dimethyl-1-(1H-1,2,4 triazol-1-yl)butan-2-ol ≥ 920 g/kg isomer A (1RS,2SR), isomer B (1RS,2RS) Diastereomer A, RS + SR, range: 70 to 85 % Diastereomer B, RR + SS, range: 15 to 30 % 1 September 2009 31 August 2019 PART A Only uses as fungicide may be authorised. PART B For the implementation of the uniform principles of Schedule VI, the conclusions of the review report on triadimenol, and in particular Appendices I and II thereof, as finalised in the Standing Committee on the Food Chain and Animal Health on 28 October shall be taken into account. In this overall assessment Member States must pay particular attention to: — the presence of N-methylpyrrolidone in formulated products as regards operator, worker and bystander exposure; — the protection of birds and mammals. In relation to these identified risks risk mitigation measures, such as buffer zones, should be applied where appropriate The Member States concerned shall ensure that the notifier submits to the Commission — further information on the specification; — information to further address the risk assessment for birds and mammals. — information to further address the risk of endocrine disrupting effects on fish. They shall ensure that the notifier at whose request triadimenol has been included in this Schedule provide such information to the Commission by 31 August 2011 at the latest. The Member States concerned shall ensure that the notifier submits to the Commission further information addressing the potential endocrine disrupting properties of triadimenol within two years after the adoption of the OECD test guidelines on endocrine disruption or, alternatively, of Community agreed test guidelines.’ Number Common name, identification numbers IUPAC name Purity Entry into force Expiration of inclusion Specific provisions 276 Bensulfuron CAS No 83055-99-6 CIPAC No 502.201 α-[(4,6 dimethoxypyrimidin-2 ylcarbamoyl)sulfamoyl] o-toluic acid (bensulfuron) methyl α-[(4,6 dimethoxypyrimidin 2 ylcarbamoyl)sulfamoyl] o-toluate (bensulfuronmethyl) ≥ 975 g/kg 1 November 2009 31 October 2019 PART A Only uses as a herbicide PART B For the implementation of the uniform principles of Schedule VI, the conclusions of the review report on bensulfuron, and in particular Appendices I and II thereof, as finalised in the Standing Committee on the Food Chain and Animal Health on 8 December 2008 shall be taken into account. In this overall assessment Member States must pay particular attention to the following: — the protection of aquatic organisms; in relation to these identified risks, risk mitigation measures, such as buffer zones, shall be applied where appropriate, — the protection of the groundwater, where the active substance is applied in regions with vulnerable soil and/or climatic conditions. The Member States concerned shall ensure that the notifier submits to the Commission: — further studies on the specification, — information to further address the route and rate of degradation of bensulfuron-methyl under aerobic flooded soil conditions, — information to address the relevance of metabolites for the consumer risk assessment. They shall ensure that the notifiers provide such studies to the Commission by 31 October 2011. Number Common name, identification numbers IUPAC name Purity Entry into force Expiration of inclusion Specific provisions 277 Sodium 5-nitroguaiacolate CAS No 67233-85-6 CIPAC number not allocated Sodium 2-methoxy 5-nitrophenolate ≥ 980 g/kg 1 November 2009 31 October 2019 PART A Only use as plant growth regulator may be authorised. PART B For the implementation of the uniform principles of Schedule VI, the conclusions of the review report on sodium 5 nitroguaiacolate, sodium o-nitrophenolate and sodium p nitrophenolate, and in particular Appendices I and II thereof, as finalised in the Standing Committee on the Food Chain and Animal Health on 2 December 2008 shall be taken into account. In this overall assessment Member States must pay particular attention to: — the specification of the technical material as commercially manufactured must be confirmed and supported by appropriate analytical data. The test material used in the toxicity dossiers should be compared and verified against this specification of the technical material, — the protection of the operators and workers safety. Authorised conditions of use must prescribe the application of adequate personal protective equipment and risk mitigation measures to reduce the exposure, — the protection of the groundwater, when the active substance is applied in regions with vulnerable soil and/or climatic conditions. Conditions of authorisation should include risk mitigation measures, where appropriate. The Member States concerned shall request the submission of further studies to address the risk to groundwater. They shall ensure that the notifiers provide such studies to the Commission by 31 October 2011. Number Common name, identification numbers IUPAC name Purity Entry into force Expiration of inclusion Specific provisions 278 Sodium o-nitrophenolate CAS No 824-39-5 CIPAC number not allocated Sodium 2 nitrophenolate; sodium o-nitrophenolate ≥ 980 g/kg The following impurities are of toxicological concern: Phenol Max content: 0,1 g/kg 2,4 dinitrophenol max content: 0,14 g/kg 2,6 dinitrophenol max content: 0,32 g/kg 1 November 2009 31 October 2019 PART A Only use as plant growth regulator may be authorised. PART B For the implementation of the uniform principles of Schedule VI, the conclusions of the review report on sodium 5 nitroguaiacolate, sodium o-nitrophenolate and sodium p nitrophenolate, and in particular Appendices I and II thereof, as finalised in the Standing Committee on the Food Chain and Animal Health on 2 December 2008 shall be taken into account. In this overall assessment Member States must pay particular attention to: — the specification of the technical material as commercially manufactured must be confirmed and supported by appropriate analytical data. The test material used in the toxicity dossiers should be compared and verified against this specification of the technical material, — the protection of the operators and workers safety. Authorised conditions of use must prescribe the application of adequate personal protective equipment and risk mitigation measures to reduce the exposure, — the protection of the groundwater, when the active substance is applied in regions with vulnerable soil and/or climatic conditions. Conditions of authorisation should include risk mitigation measures, where appropriate. The Member States concerned shall request the submission of further studies to address the risk to groundwater. They shall ensure that the notifiers provide such studies to the Commission by 31 October 2011. Number Common name, identification numbers IUPAC name Purity Entry into force Expiration of inclusion Specific provisions 279 Sodium p-nitrophenolate CAS No 824-78-2 CIPAC number not allocated Sodium 4 nitrophenolate; sodium p-nitrophenolate ≥ 998 g/kg The following impurities are of toxicological concern: Phenol max content: 0,1 g/kg 2,4 dinitrophenol max content: 0,07 g/kg 2,6 dinitrophenol max content: 0,09 g/kg 1 November 2009 31 October 2019 PART A Only use as plant growth regulator may be authorised. PART B For the implementation of the uniform principles of Schedule VI, the conclusions of the review report on sodium 5 nitroguaiacolate, sodium o-nitrophenolate and sodium p nitrophenolate, and in particular Appendices I and II thereof, as finalised in the Standing Committee on the Food Chain and Animal Health on 2 December 2008 shall be taken into account. In this overall assessment Member States must pay particular attention to: — the specification of the technical material as commercially manufactured must be confirmed and supported by appropriate analytical data. The test material used in the toxicity dossiers should be compared and verified against this specification of the technical material, — the protection of the operators and workers safety. Authorised conditions of use must prescribe the application of adequate personal protective equipment and risk mitigation measures to reduce the exposure, — the protection of the groundwater, when the active substance is applied in regions with vulnerable soil and/or climatic conditions. Conditions of authorisation should include risk mitigation measures, where appropriate. The Member States concerned shall request the submission of further studies to address the risk to groundwater. They shall ensure that the notifiers provide such studies to the Commission by 31 October 2011. Number Common name, identification numbers IUPAC name Purity Entry into force Expiration of inclusion Specific provisions 280 Tebufenpyrad CAS No 119168-77-3 CIPAC No 725 N-(4-tert-butylbenzyl) 4-chloro 3-ethyl-1 methylpyrazole-5 carboxamide ≥ 980 g/kg 1 November 2009 31 October 2019 PART A Only uses as acaricide and insecticide may be authorised. PART B In assessing applications to authorise plant protection products containing tebufenpyrad in formulations other than water soluble bags Member States shall pay particular attention to the criteria in Regulation 4(1)(b), and shall ensure that any necessary data and information is provided before such an authorisation is granted. For the implementation of the uniform principles of Schedule VI, the conclusions of the review report on tebufenpyrad, and in particular Appendices I and II thereof, as finalised in the Standing Committee on the Food Chain and Animal Health on 2 December 2008 shall be taken into account. In this overall assessment Member States must pay particular attention to: — the operator and worker safety and ensure that conditions of use prescribe the application of adequate personal protective equipment, — the protection of aquatic organisms and must ensure that conditions of authorisation include risk mitigation measures such as buffer zones, where appropriate, — the protection of insectivorous birds and must ensure that the conditions of authorisation include, where appropriate, risk mitigation measures. The Member States concerned shall ensure that the notifier submits to the Commission: — further information confirming that no relevant impurities are present, — information to further address the risk to insectivorous birds. They shall ensure that the notifier provides such information to the Commission by 31 October 2011.’ Number Common name, identification numbers IUPAC name Purity Entry into force Expiration of inclusion Specific provisions 281 Chlormequat CAS N° 7003-89-6 (chlormequat) CAS N° 999-81-5 (chlormequat chloride) CIPAC N° 143 (chlormequat) CIPAC N° 143.302 (chlormequat chloride) 2 chloroethyltrimethyla mmonium (chlormequat) 2 chloroethyltrimethyla mmonium chloride (chlormequat chloride) ≥ 636 g/kg Impurities 1,2 dichloroethane: max 0.1 g/kg (on the dry chlormequat chloride content) Chloroethene (vinylchloride): max 0.0005 g/kg (on the dry chlormequat chloride content) 1 December 2009 30 November 2019 PART A Only uses as plant growth regulator on cereals may be authorised. PART B In assessing applications to authorise plant protection products containing chlormequat for uses other than in rye and triticale, notably as regards the exposure of consumers, Member States shall pay particular attention to the criteria in Article 4(1)(b), and shall ensure that any necessary data and information is provided before such an authorisation is granted. For the implementation of the uniform principles of Annex VI, the conclusions of the review report on chlormequat, and in particular Appendices I and II thereof, as finalised in the Standing Committee on the Food Chain and Animal Health on 23 January 2009 shall be taken into account. In this overall assessment Member States must pay particular attention to: the operator safety and ensure that conditions of use prescribe the application of adequate personal protective equipment; the protection of birds and mammals; Conditions of authorisation shall include risk mitigation measures, where appropriate. The Member States concerned shall request the submission of further information on the fate and behaviour (adsorption studies to be performed at 20°C, recalculation of the predicted concentrations in groundwater, surface water and sediment), the monitoring methods for determination of the substance in animal products and water, and the risk to aquatic organisms, birds and mammals. They shall ensure that the notifier at whose request chlormequat has been included in this Annex provide such information to the Commission by 30 November 2011 at the latest. Number Common name, identification numbers IUPAC name Purity Entry into force Expiration of inclusion Specific provisions 282 Copper compounds: copper hydroxide CAS N° 20427-59-2 CIPAC N° 44.305 copper oxychloride CAS N° 1332-65-6 or 1332 40-7 CIPAC N° 44.602 Copper oxide CAS N° 1317-39-1 CIPAC N° 44.603 bordeaux mixture CAS N° 8011-63-0 CIPAC N° 44.604 Tribasic copper sulphate CAS N° 12527-76-3 CIPAC N° 44.306 Copper (II) hydroxide Dicopper chloride trihydroxide Copper oxide Not allocated Not allocated ≥ 573 g/kg ≥ 550 g/kg ≥ 820 g/kg ≥ 245 g/kg ≥ 490 g/kg The following impurities are of toxicological concern and must not exceed the levels below: Lead max 0.0005 g/kg of copper content Cadmium max 0.0001 g/kg of copper content Arsenic max 1 December 2009 30 November 2016 PART A Only uses as bactericide and fungicide may be authorised. PART B In assessing applications to authorise plant protection products containing copper for uses other than on tomatoes in greenhouses, Member States shall pay particular attention to the criteria in Article 4(1) (b), and shall ensure that any necessary data and information is provided before such an authorisation is granted. For the implementation of the uniform principles of Annex VI, the conclusions of the review report on copper compounds, and in particular Appendices I and II thereof, as finalised in the Standing Committee on the Food Chain and Animal Health on 23 January 2009 shall be taken into account. In this overall assessment Member States must pay particular attention to: the specification of the technical material as commercially manufactured which must be confirmed and supported by appropriate analytical data. The test material used in the toxicity dossiers should be compared and verified against this specification of the technical material; the operator and worker safety and ensure that conditions of use prescribe the application of adequate personal protective equipment where appropriate; the protection of water and non target organisms. In relation to these identified risks risk mitigation measures, such as buffer zones, should be applied where appropriate; the amount of active substance applied and ensure that the authorised amounts, in terms of rates and number of applications, are the minimum necessary to achieve the desired effects. The concerned Member States shall request the submission of information to further address: 0.0001 g/kg of copper content the risk from inhalation; the risk assessment for non target organisms and for soil and water. They shall ensure that the notifiers at whose request copper compounds have been included in this Annex provides such information to the Commission by 30 November 2011 at the latest. Member States shall initiate monitoring programmes in vulnerable areas where the contamination of the soil compartment by copper is of concern, in order to set, where appropriate, limitations such as maximum application rates. Number Common name, identification numbers IUPAC name Purity Entry into force Expiration of inclusion Specific provisions 283 Propaquizafop CAS N° 111479-05-1 CIPAC N° 173 2 isopropylidenamino oxyethyl (R)-2-[4-(6 chloro-quinoxalin-2 yloxy)phenoxy]propio nate ≥920g/kg Toluene maximum content 5 g/kg 1 December 2009 30 November 2019 PART A Only uses as herbicide may be authorised. PART B For the implementation of the uniform principles of Annex VI, the conclusions of the review report on propaquizafop, and in particular Appendices I and II thereof, as finalised in the Standing Committee on the Food Chain and Animal Health on 23 January 2009 shall be taken into account. In this overall assessment Member States must pay particular attention to: the specification of the technical material as commercially manufactured which must be confirmed and supported by appropriate analytical data. The test material used in the toxicity dossiers should be compared and verified against this specification of the technical material; the operator safety and ensure that conditions of use prescribe the application of adequate personal protective equipment; the protection of aquatic organisms and non-target plants and ensure that conditions of authorisation include risk mitigation measures such as buffer zones, where appropriate; the protection of non-target arthropods and ensure that the conditions of authorisation include, where appropriate, risk mitigation measures. The Member States concerned shall ensure that the notifier submits to the Commission: further information on the relevant impurity Ro 41-5259; information to further address the risk to aquatic organisms and to non-target arthropods. They shall ensure that the notifier provides such information to the Commission by 30 November 2011. Number Common name, identification numbers IUPAC name Purity Entry into force Expiration of inclusion Specific provisions 284 Quizalofop-P: Quizalofop-P-ethyl CAS N°100646-51-3 CIPAC N° 641.202 Quizalofop-P-tefuryl CAS N°119738-06-6 CIPAC N° 641.226 ethyl (R)-2-[4-(6 chloroquinoxalin-2 yloxy)phenoxy] propionate (RS) Tetrahydrofurfuryl (R)-2-[4-(6 chloroquinoxalin-2 yloxy)phenoxy]propio nate ≥ 950 g/kg ≥ 795g/kg 1 December 2009 30 November 2019 PART A Only uses as herbicide may be authorised. PART B For the implementation of the uniform principles of Annex VI, the conclusions of the review report on quizalofop-P, and in particular Appendices I and II thereof, as finalised in the Standing Committee on the Food Chain and Animal Health on 23 January 2009 shall be taken into account. In this overall assessment Member States must pay particular attention to: the operator and worker safety and ensure that conditions of use prescribe the application of adequate personal protective equipment; the protection of non-target plants and ensure that conditions of authorisation include risk mitigation measures such as buffer zones, where appropriate. Conditions of authorisation shall include risk mitigation measures, where appropriate. The Member States concerned shall ensure that the notifiers submit to the Commission further information on non-target arthropods and on the specification of the active substance as manufactured. They shall ensure that the notifiers provide such information to the Commission by 30 November 2011. Number Common name, identification numbers IUPAC name Purity Entry into force Expiration of inclusion Specific provisions 285 teflubenzuron CAS N° 83121-18-0 CIPAC N° 450 1-(3,5-dichloro-2,4 difluorophenyl)-3 (2,6 difluorobenzoyl)urea ≥ 970 g/kg 1 December 2009 30 November 2019 PART A Only uses as insecticide on tomato in glasshouses (on artificial substrate or closed hydroponic systems) may be authorised. PART B For the implementation of the uniform principles of Annex VI, the conclusions of the review report on teflubenzuron, and in particular Appendices I and II thereof, as finalised in the Standing Committee on the Food Chain and Animal Health on 23 January 2009 shall be taken into account. In this overall assessment Member States must pay particular attention to: the operator and workers safety and ensure that . conditions of use prescribe the application of adequate personal protective equipment, where appropriate; the protection of aquatic organisms. Releases from glasshouse application must be minimised and, in any case, should not have the potential to reach in significant levels water bodies in the vicinity; the protection of bees which should be prevented from accessing the glasshouse; the protection of pollinator colonies purposely placed in the glasshouse; the safe disposal of condensation water, drain water and subtract in order to preclude risks to non target organisms and contamination of surface water and groundwater. Conditions of authorisation shall include risk mitigation measures, where appropriate. Number Common name, identification numbers IUPAC name Purity Entry into force Expiration of inclusion Specific provisions 286 zeta-cypermethrin CAS N° 52315-07-8 CIPAC N° 733 Mixture of the stereoisomers (S)-α-cyano-3 phenoxybenzyl (1RS,3RS;1RS,3SR) 3-(2,2-dichlorovinyl) 2,2 dimethylcyclopropan ecarboxylate where the ratio of the (S);(1RS,3RS) isomeric pair to the (S);(1RS,3SR) isomeric pair lies in the ratio range 45-55 to 55-45 respectively ≥ 850 g/kg Impurities: toluene: max 2 g/kg tars: max 12.5 g/kg 1 December 2009 30 November 2019 PART A Only uses as insecticide may be authorised. PART B In assessing applications to authorise plant protection products containing zeta-cypermethrin for uses other than in cereals, notably as regards the exposure of consumers to mPBAldehyde, a degradation product that may be formed during processing, Member States shall pay particular attention to the criteria in Article 4(1)(b), and shall ensure that any necessary data and information is provided before such an authorisation is granted. For the implementation of the uniform principles of Annex VI, the conclusions of the review report on zeta cypermethrin, and in particular Appendices I and II thereof, as finalised in the Standing Committee on the Food Chain and Animal Health on 23 January 2009 shall be taken into account. In this overall assessment Member States must pay particular attention to: the operator safety and ensure that conditions of use prescribe the application of adequate personal protective equipment, where appropriate; the protection of birds, aquatic organisms, bees, non target arthropods and non-target soil macro-organisms. Conditions of authorisation shall include risk mitigation measures, where appropriate. The Member States concerned shall request the submission of further information on the fate and behaviour (aerobic degradation in soil), the long term risk to birds, aquatic organisms and non target arthropods. They shall ensure that the notifier at whose request zeta cypermethrin has been included in this Annex provide such information to the Commission by 30 November 2011 at the latest. Number Common name, identification numbers IUPAC name Purity Entry into force Expiration of inclusion Specific provisions 287 chlorsulfuron CAS N° 64902-72-3 CIPAC N° 391 1-(2 chlorophenylsulfon yl)-3-(4-methoxy-6 methyl 1,3,5-triazin-2 yl)urea ≥ 950g/kg Impurities: 2 Chlorobenzenes ulfonamide (IN-A4097) not more than 5g/kg and 4-methoxy-6 methyl-1,3,5 triazin-2-amine (IN-A4098) not more than 6g/kg 1 January 2010 31 December 2019 PART A Only uses as herbicide may be authorised. PART B For the implementation of the uniform principles of Annex VI, the conclusions of the review report on chlorsulfuron, and in particular Appendices I and II thereof, as finalised in the Standing Committee on the Food Chain and Animal Health on 26 February 2009 shall be taken into account. In this overall assessment Member States must pay particular attention to: the protection of aquatic organisms and non-target plants; in relation to these identified risks, risk mitigation measures, such as buffer zones, shall be applied where appropriate. the protection of the groundwater, when the active substance is applied in regions with vulnerable soil and/or climatic conditions. The Member States concerned shall ensure that the notifier submits to the Commission further studies on the specification by 1 January 2010. If chlorsulfuron is classified under Directive 67/548/EEC as cancinogenic category 3 in accordance with point 4.2.1. of Annex VI to Directive 67/548/EEC, the Member States concerned shall request the submission of further information on the relevance of the metabolites IN A4097, IN-A4098, IN-JJ998, IN-B5528 and IN-V7160 with respect to cancer and ensure that the notifier provides that information to the Commission within six months from the notification of such a classification decision. Number Common name, identification numbers IUPAC name Purity Entry into force Expiration of inclusion Specific provisions 288 Cyromazine: CAS N° 66215-27-8 CIPAC N° 420 N-cyclopropyl 1,3,5-triazine 2,4,6-triamine ≥ 950 g/kg 1 January 2010 31 December 2019 PART A Only uses as insecticide in greenhouses may be authorised. PART B In assessing applications to authorise plant protection products containing cyromazine for uses other than in tomatoes, notably as regards the exposure of consumers, Member States shall pay particular attention to the criteria in Article 4(1)(b), and shall ensure that any necessary data and information is provided before such an authorisation is granted. For the implementation of the uniform principles of Annex VI, the conclusions of the review report on cyromazine, and in particular Appendices I and II thereof, as finalised in the Standing Committee on the Food Chain and Animal Health on 26 February 2009 shall be taken into account. In this overall assessment Member States must pay particular attention to: the protection of groundwater, when the active substance is applied in regions with vulnerable soil and/or climatic conditions; the protection of aquatic organisms; the protection of pollinators. Conditions of authorisation shall include risk mitigation measures, where appropriate. The Member States concerned shall request the submission of further information on the fate and behaviour of the soil metabolite NOA 435343 and on the risk to aquatic organisms. They shall ensure that the notifier at whose request cyromazine has been included in this Annex provide such information to the Commission by 31 December 2011 at the latest. Number Common name, identification numbers IUPAC name Purity Entry into force Expiration of inclusion Specific provisions 289 dimethachlor CAS N° 50563-36-5 CIPAC N° 688 2-chloro-N-(2 methoxyethyl)acet 2´,6´-xylidide ≥ 950g/kg Impurity 2,6 dimethylaniline : Not more than 0.5 g/kg 1 January 2010 31 December 2019 PART A Only uses as herbicide in application max. of 1.0 Kg/ha only every third year on the same field may be authorised. PART B For the implementation of the uniform principles of Annex VI, the conclusions of the review report on dimethachlor, and in particular Appendices I and II thereof, as finalised in the Standing Committee on the Food Chain and Animal Health on 26 February 2009 shall be taken into account. This overall assessment Member States must pay particular attention to: the operator safety and ensure that conditions of use prescribe the application of adequate personal protective equipment; the protection of aquatic organisms and non-target plants; in relation to these identified risks, risk mitigation measures, such as buffer zones, shall be applied where appropriate; the protection of the groundwater, when the active substance is applied in regions with vulnerable soil and/or climatic conditions. Conditions of authorisation shall include risk mitigation measures and monitoring programmes shall be initiated to verify potential groundwater contamination from metabolites CGA 50266, CGA 354742, CGA 102935 and SYN 528702 in vulnerable zones, where appropriate. The Member States concerned shall ensure that the notifier submits to the Commission further studies on the specification by 1 January 2010; If dimethachlor is classified as carcinogenic category 3 in accordance with point 4.2.1. of Annex VI to Directive 67/548/EEC, the Member States concerned shall request the submission of further information on the relevance of the metabolites CGA 50266, CGA 354742, CGA 102935 and SYN 528702 with respect to cancer and ensure that the notifier provides that information to the Commission within six months from the notification of the classification decision concerning that substance. Number Common name, identification numbers IUPAC name Purity Entry into force Expiration of inclusion Specific provisions 290 Etofenprox CAS N° 80844-07-1 CIPAC N° 471 2-(4-ethoxyphenyl) 2-methylpropyl 3 phenoxybenzyl ether ≥ 980 g/kg 1 January 2010 31 December 2019 PART A Only uses as insecticide may be authorised. PART B For the implementation of the uniform principles of Annex VI, the conclusions of the review report on etofenprox, and in particular Appendices I and II thereof, as finalised in the Standing Committee on the Food Chain and Animal Health on 26 February 2009 shall be taken into account. In this overall assessment Member States must pay particular attention to: the operator and worker safety and ensure that conditions of use prescribe the application of adequate personal protective equipment; the protection of aquatic organisms; in relation to these identified risks, risk mitigation measures, such as buffer zones, shall be applied where appropriate; the protection of bees and non-target arthropods; in relation to these identified risks, risk mitigation measures, such as buffer zones, shall be applied where appropriate. The Member State concerned shall ensure that the notifier submits to the Commission further information on the risk to aquatic organisms including the risk to sediment dwellers and biomagnification; the submission of further studies on the endocrine disruption potential in aqutic organisms (fish full life cycle study). They shall ensure that the notifiers provide such studies to the Commission by 31 December 2011. Number Common name, identification numbers IUPAC name Purity Entry into force Expiration of inclusion Specific provisions 291 Lufenuron CAS N° 103055-07-8 CIPAC N° 704 (RS)-1-[2,5-dichloro 4-(1,1,2,3,3,3 hexafluoro propoxy)-phenyl]-3 (2,6-difluorobenzoyl) urea ≥ 970g/kg 1 January 2010 31 December 2019 PART A Only indoor uses or outdoor bait stations as insecticide may be authorised. PART B For the implementation of the uniform principles of Annex VI, the conclusions of the review report on lufenuron, and in particular Appendices I and II thereof, as finalised in the Standing Committee on the Food Chain and Animal Health on 26 February 2009 shall be taken into account. In this overall assessment Member States must pay particular attention to: the high persistency in the environment and the high risk for bioaccumulation and shall ensure that the use of lufenuron has no adverse long-term effects on non-target organisms; the protection of birds, mammals, soil non-target organisms, bees, non-target arthropods, surface waters and aquatic organisms in vulnerable situations. The Member States concerned shall ensure that the notifier submits to the Commission further studies on the specification by 1 January 2010. Number Common name, identification numbers IUPAC name Purity Entry into force Expiration of inclusion Specific provisions 292 Penconazole: CAS N° 66246-88-6 CIPAC N° 446 (RS) 1-[2-(2,4 dichloro-phenyl) phenyl]-1H-[1,2,4] triazole ≥ 950 g/kg 1 January 2010 31 December 2019 PART A Only uses as fungicide in greenhouses may be authorised. PART B For the implementation of the uniform principles of Annex VI, the conclusions of the review report on penconazole, and in particular Appendices I and II thereof, as finalised in the Standing Committee on the Food Chain and Animal Health on 26 February 2009 shall be taken into account. In this overall assessment Member States must pay particular attention to the protection of groundwater, when the active substance is applied in regions with vulnerable soil and/or climatic conditions. Conditions of authorisation shall include risk mitigation measures, where appropriate. The Member States concerned shall request the submission of further information on the fate and behaviour of the soil metabolite U1. They shall ensure that the notifier at whose request penconazole has been included in this Annex provide such information to the Commission by 31 December 2011 at the latest. Number Common name, identification numbers IUPAC name Purity Entry into force Expiration of inclusion Specific provisions 293 Tri-allate CAS N° 2303-17-5 CIPAC N° 97 S-2,3,3-trichloroallyl di-isopropyl (thiocarbamate) ≥ 940g/kg NDIPA (Nitroso diisopropyla mine) max. 0.02 mg/kg 1 January 2010 31 December 2019 PART A Only uses as herbicide may be authorised. PART B For the implementation of the uniform principles of Annex VI, the conclusions of the review report on tri-allate, and in particular Appendices I and II thereof, as finalised in the Standing Committee on the Food Chain and Animal Health on 23 February 2009 shall be taken into account. In this overall assessment Member States must pay particular attention to: the operator safety and ensure that conditions of use prescribe the application of adequate personal protective equipment; the dietary exposure of consumers to residues of tri allate in treated crops as well as in succeeding and rotational crops and in products of animal origin; the protection of aquatic organisms and non-target plants and ensure that conditions of authorisation include risk mitigation measures such as buffer zones, where appropriate; the potential for ground water contamination by the degradation products TCPSA when the active substance is applied in regions with vulnerable soil and/or climatic conditions. Conditions of authorisation must include risk mitigation measures, where appropriate. The Member States concerned shall ensure that the notifier submits to the Commission: further information to assess the primary plant metabolism; further information on the fate and behaviour of the soil metabolite diisopropylamine; further information on the potential for biomagnification in aquatic food chains; information to further address the risk to fish-eating mammals and the long-term risk to earthworms. They shall ensure that the notifier provides such information to the Commission by 31 December 2011. Number Common name, identification numbers IUPAC name Purity Entry into force Expiration of inclusion Specific provisions 294 Triflusulfuron CAS N° 126535-15-7 CIPAC N° 731 2-[4 dimethylamino-6 (2,2,2 trifluoroethoxy) 1,3,5-triazin-2 ylcarbamoylsulfam oyl]-m-toluic acid ≥960g/kg N,N-dimethyl 6-(2,2,2 trifluoroethoxy) 1,3,5-triazine 2,4-diamine Max. 6 g/kg 1 January 2010 31 December 2019 PART A Only uses as a herbicide in application on sugar and fodder beet at max 60 g/ha only every third year on the same field may be authorised. Foliage of treated crops may not be fed to livestock. PART B For the implementation of the uniform principles of Annex VI, the conclusions of the review report on triflusulfuron, and in particular Appendices I and II thereof, as finalised in the Standing Committee on the Food Chain and Animal Health on 26 February 2009 shall be taken into account. In this overall assessment Member States must pay particular attention to: the dietary exposure of consumers to residues of metabolites IN-M7222 and IN-E7710 in succeeding and rotational crops and in products of animal origin; the protection of aquatic organisms and aquatic plants form the risk arising from triflusulfuron and the metabolite IN-66036 and ensure that conditions of authorisation include risk mitigation measures such as buffer zones, where appropriate; the potential for ground water contamination by the degradation products IN-M7222 and IN-W6725 when the active substance is applied in regions with vulnerable soil and/or climatic conditions. Conditions of authorisation must include risk mitigation measures, where appropriate. If triflusulfuron is classified as carcinogenic category 3 in accordance with point 4.2.1. of Annex VI to Directive 67/548/EEC, request the submission of further information on the relevance of the metabolites IN M7222, IN-D8526 and IN-E7710 with respect to cancer. They shall ensure that the notifier provides that information to the Commission within six months from the notification of the classification decision concerning that substance. Number Common name, identification numbers IUPAC name Purity Entry into force Expiration of inclusion Specific provisions 295 Difenacoum CAS N° 56073-07-5 CIPAC N° 514 3 [(1RS,3RS;1RS,3SR) 3-biphenyl-4-yl 1,2,3,4-tetrahydro-1 naphthyl]-4 hydroxycoumarin ≥ 905g/kg 31 December 2009 30 December 2019 PART A Only uses as rodenticide in the form of pre-prepared baits placed in specially constructed, tamper resistant and secured bait boxes are authorised. The nominal concentration of the active substance in the products shall not exceed 50 mg/kg Authorisations shall be limited to professional users. PART B For the implementation of the uniform principles of Annex VI, the conclusions of the review report on difenacoum, and in particular Appendices I and II thereof, as finalised in the Standing Committee on the Food Chain and Animal Health on 26 February 2009 shall be taken into account. In this overall assessment Member States shall pay particular attention to the protection of birds and non-target mammals from primary and secondary poisoning. Risk mitigation measures shall be applied where appropriate. The Member States concerned shall ensure that the notifier submits to the Commission further information on methods for the determination of residues of difenacoum in body fluids. They shall ensure that the notifier provides such information to the Commission by 30 November 2011. The Member States concerned shall ensure that the notifier submits to the Commission further information on the specification of the active substance as manufactured. They shall ensure that the notifier provides such information to the Commission by 1 January 2010. Number Common name, identification numbers IUPAC name Purity Entry into force Expiration of inclusion Specific provisions 296 Didecyldimethylammoniu m chloride CAS: not allocated CIPAC: not allocated Didecyldimethylamm onium chloride is a mixture of alkyl quaternary ammonium salts with typical alkyl chain lengths of C8, C10 and C12, with more than 90% of C10 70% (Technical concentrate) 1 January 2010 31 December 2019 PART A Only uses as bactericide, fungicide, herbicide and algaecide for indoor uses for ornamental plants may be authorised. PART B For the implementation of the uniform principles of Annex VI, the conclusions of the review report on didecyldimethylammonium chloride, and in particular Appendices I and II thereof, as finalised in the Standing Committee on the Food Chain and Animal Health on 13 March 2009 shall be taken into account. In this overall assessment Member States must pay particular attention to: the protection of the operator and worker safety. Authorised conditions of use must prescribe the application of adequate personal protective equipment and risk mitigation measures to reduce the exposure; the protection of aquatic organisms. Conditions of authorisation shall include risk mitigation measures, where appropriate. The Member States concerned shall ensure that the notifier at whose request didecyldimethylammonium chloride has been included in this Annex, submits to the Commission further information on the specification of the active substance as manufactured and on the risk to aquatic organisms. They shall ensure that the notifier provides such information to the Commission by 1 January 2010 and 31 December 2011, respectively. Number Common name, identification numbers IUPAC name Purity Entry into force Expiration of inclusion Specific provisions 297 Sulphur CAS No 7704-34-9 CIPAC No 18 Sulphur ≥ 990g/kg 1 January 2010 31 December 2019 PART A Only uses as fungicide and acaricide may be authorised. PART B For the implementation of the uniform principles of Annex VI, the conclusions of the review report on sulfur, and in particular Appendices I and II thereof, as finalised in the Standing Committee on the Food Chain and Animal Health on 13 March 2009 shall be taken into account. In this overall assessment Member States shall pay particular attention to: the protection of birds, mammals, aquatic organisms and non target arthopods. Conditions of authorisation shall include risk mitigation measures, where appropriate. The Member States concerned shall ensure that the notifier submit to the Commission further information to confirm the risk assessment for birds, mammals, sediment dwelling organisms and non target arthropods. They shall ensure that the notifiers at whose request sulfur has been included in this Annex provide such data to the Commission at latest by 30 June 2011. Number Common name, identification numbers IUPAC name Purity Entry into force Expiration of inclusion Specific provisions 298 Tetraconazole CAS N° 112281-77-3 CIPAC N° 726 (RS)-2-(2,4 dichlorophenyl)-3 (1H-1,2,4-triazol-1 yl)-propyl-1,1,2,2 tetrafluoroethyl ether ≥ 950 g/kg (racemic mixture) Impurity toluene: Not more than 13g/kg 1 January 2010 31 December 2019 PART A Only uses as fungicide in field crops with an application of max. 0.100 Kg/ha every third year on the same field may be authorised. Uses in apples and grapes must not be authorised. PART B For the implementation of the uniform principles of Annex VI, the conclusions of the review report on tetraconazole, and in particular Appendices I and II thereof, as finalised in the Standing Committee on the Food Chain and Animal Health on 26 February 2009 shall be taken into account. In this overall assessment Member States must pay particular attention to: the protection of aquatic organisms and non-target plants; in relation to these identified risks, risk mitigation measures, such as buffer zones, shall be applied where appropriate; the protection of the groundwater, when the active substance is applied in regions with vulnerable soil and/or climatic conditions. The Member States concerned shall request: the submission of further information on a refined consumer risk assessment further information on the specification regarding ecotoxicology; further information on the fate and behaviour of potential metabolites in all relevant compartments; the refined risk assessment of such metabolites to birds, mammals aquatic organisms and non-target arthropods further information on the potential for endocrine disrupting effects to birds, mammals and fish. They shall ensure that the notifier provides such information to the Commission by 31 December 2011 at the latest. SCHEDULE II REQUIREMENTS FOR THE DOSSIER TO BE SUBMITTED FOR THE INCLUSION OF AN ACTIVE SUBSTANCE IN SCHEDULE I INTRODUCTION The information required shall: 1.1. include a technical dossier supplying the information necessary for eval uating the foreseeable risks, whether immediate or delayed, which the substance may entail for humans, animals and the environment and containing at least the information and results of the studies referred to below; 1.2. where relevant, be generated using test guidelines, according to the latest adopted version, referred to or described in this Schedule; in the case of studies initiated before the entry into force of the modification of this Schedule, the information shall be generated using suitable internationally or nationally validated test guidelines or, in the absence thereof, test guidelines accepted by the director; 1.3. in the event of a test guideline being inappropriate or not described, or where another one than those referred to in Annex II of Directive 414/1991 has been used, include a justification, which is acceptable to the director for the guidelines used. In particular, when reference is made in this Schedule to an EEC Method which consists in the transposal of a method developed by an international organization (e.g. OECD), Member States may accept that the required information is generated according to the latest version of that method if at the initiation of the studies the EEC Method has not yet been updated; 1.4. include, when required by the director, a full description of test guidelines used, except if they are referred to or described in this Schedule, and a full description of any deviations from them including a justification, which is acceptable to the director, for these deviations; 1.5. include a full and unbiased report of the studies conducted as well as full description of them or a justification, which is acceptable to the director where: —particular data and information which would not be necessary owing to the nature of the product or its proposed uses, are not provided, or —it is not scientifically necessary, or technically possible to supply infor mation and data; 1.6. where relevant, have been generated in accordance with the requirements of Directive 86/609/EEC. 2.1. Tests and analyses must be conducted in accordance with the principles laid down in Directive 2004/10/EEC where testing is done to obtain data on the properties and/or safety with respect to human or animal health or the environment. 2.2. By way of derogation from point 2.1, the director may provide that tests and analyses, performed in Malta in order to obtain data on the properties and/or safety of the substances with respect to honey-bees and beneficial arthropods other than bees shall be conducted by official or officially recognized testing facilities or organizations which satisfy at least the requirements as set out under points 2.2 and 2.3 of the introduction to Schedule III. This derogation applies to trials actually started on or before 31 December 1999. 2.3. By way of derogation from point 2.1, the Director may provide that supervised residue trials performed in Malta in accordance with the provisions of Section 6‘Residues in or on treated products, food and feed’ on plant protection products containing active substances already on the market two years after notification of the Directive shall be conducted by official or officially-recognized testing facilities or organizations which satisfy at least the requirements under points 2.2 and 2.3 of the introduction to Schedule III. This derogation applies for supervised residue trials actually started on or before 31 December 1997. 2.4. By way of derogation from point 2.1, for active substances consisting of micro-organisms or viruses, tests and analyses done to obtain data on the properties and/or safety with respect to other aspects than human health, may have been conducted by official or officially recognised testing facilities or organisations which satisfy at least the requirements under points 2.2 and 2.3 of the introduction of Schedule III. PART A Chemical substances (1) 1. Identity of the active substance The information provided must be sufficient to identify with precision each active substance, to define it in terms of its specification and to characterize it as to its nature. The information and data referred to, unless otherwise specified, are required for all active substances. 1.1. Applicant (name, address, etc.) The name and address of the applicant (permanent Community address) must be provided as must the name, position, telephone and telefax number of the appropriate person to contact. Where, in addition, the applicant has an office, agent or represen tative in the Member State to which the application for inclusion in Schedule I is submitted, and if different, in the Rapporteur Member State appointed by the Commission, the name and address of the local office, agent or representative must be provided, as must the name, position, telephone and telefax number of the appropriate person to contact. 1.2. Manufacturer (name, address, including location of plant) The name and address of the manufacturer or manufacturers of the active substance must be provided as must the name and address of each manufacturing plant in which the active substance is manufactured. A contact point (preferably a central contact point, to include name, telephone and telefax number) must be provided, with a view to providing updating information and responding to queries arising, regarding manufacturing technology, processes and the quality of product (including where relevant, individual batches). Where following inclusion of the active substances in Schedule I, there are changes in the location or number of manufac-turers, the information required must again be notified to the Commission and the Member States. 1.3. Common name proposed or ISO-accepted, and synonyms The ISO common name, or proposed ISO common name and where relevant, other proposed or accepted common names (synonyms), including the name (title) of the nomenclature authority concerned, must be provided. 1.4. Chemical name (IUPAC and CA nomenclature) The Chemical name as given in Annex I to Directive 67/548/EEC, or, if not included in this Directive, in accordance with both IUPAC and CA nomenclature, must be provided. (1) Substance within the meaning of the definition of Article 2, point 3 of Directive 414/1991. 1.5. Manufacturer's development code number(s) Code numbers used to identify the active substance, and where available, formulations containing the active substance, during development work, must be reported. For each code number reported, the material to which it relates, the period for which it was used, and the Member States or other countries in which it was used and is being used, must be stated 1.6. CAS, EEC and CIPAC numbers (if available) Chemical Abstracts, EEC (EINECS or ELINCS), and CIPAC numbers, where they exist, must be reported. 1.7. Molecular and structural formula, molecular mass The molecular formula, molecular mass and structural formula of the active substance, and where relevant, the structural formula of each stereo and optical isomer present in the active substance, must be provided. 1.8. Method of manufacture (synthesis pathway) of the active substance The method of manufacture, in terms of the identity of the starting materials, the chemical pathways involved, and the identity of by products and impurities present in the final product, must be provided, for each manufacturing plant. Generally process engi neering information is not required. Where the information provided relates to a pilot plant production system, the information required must again be provided once industrial scale production methods and procedures have stabilized. 1.9. Specification of purity of the active substance in g/kg The minimum content in g/kg of pure active substance (excluding inactive isomers) in the manufactured material used for production of formulated products, must be reported. Where the information provided relates to a pilot plant production system, the information required must again be provided to the Commission and the Member States once industrial scale production methods and procedures have stabilized, if production changes result in a changed specification of purity. 1.10. Identity of isomers, impurities and additives (e.g. stabilizers), together with the structural formula and the content expressed as g/kg The maximum content in g/kg of inactive isomers as well as the ratio of the content of isomers/diastereo-isomers, where relevant, must be provided. In addition, the maximum content in g/kg of each further component other than additives, including by-products, and impu rities, must be provided. In the case of additives the content in g/kg must be provided. For each component, present in quantities of 1 g/kg or more, the following information, where relevant, must be provided: —chemical name according to IUPAC and CA nomenclature, —ISO common name or proposed common name if available, —CAS number, EEC (EINECS or ELINCS) number, and CIPAC number if available, —molecular and structural formula, —molecular mass, and —maximum content in g/kg. Where the manufacturing process is such that impurities and by products which are particularly undesirable because of their toxicological, ecotoxicological or environmental properties could be present in the active substance, the content of each such compound must be determined and reported. In such cases, the analytical methods used and the limits of determination, which must be sufficiently low, for each compound of concern, must be reported. Additionally the following information, where relevant, must be provided: —chemical name according to IUPAC and CA nomenclature, —ISO common name or proposed common name if available, —CAS number, EEC (EINECS or ELINCS) number, and CIPAC number if available, —molecular and structural formula, —molecular mass, and —maximum content in g/kg. Where the information provided relates to a pilot plant production system, the information required must again be provided once industrial scale production methods and procedures have stabilized, if production changes result in a changed specification of purity. Where the information provided does not fully identify a component viz. condensates, detailed information on the composition must be provided for each such component. The trade name of components added to the active substance, prior to manufacture of formulated product, to preserve stability and facilitate ease of handling, where they are used, must also be provided. Addi-tionally the following information, where relevant, must be provided for such additives: —chemical name according to IUPAC and CA nomenclature, —ISO common name or proposed common name if available, —CAS number, EEC (EINECS or ELINCS) number, and CIPAC number if available, —molecular and structural formula, —molecular mass, and —maximum content in g/kg. For added components, other than active substance and other than impurities resulting from the manufacturing process, the function of the component (additive) must be given: —antifoaming agent, —antifreeze, —binder, —other (specify), —buffer, —dispersing agent, —stabilizer. 1.11. Analytical profile of batches Representative samples of the active substance must be analysed for content of pure active substance, inactive isomers, impurities and additives, as appropriate. The analytical results reported must include quantitative data, in terms of g/kg content, for all components present in quantities of more than 1 g/kg and typically should account for at least 98 % of the material analysed. The actual content of components which are particularly undesirable because of their toxi-cological, ecotoxicological or environmental properties, must be determined and reported. Data reported must include the results of the analysis of individual samples and a summary of that data, to show the minimum or maximum and typical content of each relevant component, as appropriate. Where an active substance is produced in different plants this information must be provided for each of the plants separately. In addition, where available and relevant, samples of the active substance produced in laboratory scale or pilot production systems, must be analyzed, if such material was used in generating toxicological or ecotoxicological data. 2. Physical and chemical properties of the active substance (i) The information provided, must describe the physical and chemical properties of active substances and together with relevant information, must serve to characterize them. In particular, the information provided must permit: —physical, chemical, and technical hazards associated with active substances, to be identified, —classification of active substance as to hazard, —appropriate restrictions and conditions to be associated with inclusions in Schedule I to be selected, and —appropriate risk and safety phrases to be specified. The information and data referred to are required for all active substances, except where otherwise specified. (ii) The information provided, taken together with that provided for relevant preparations, must permit the physical, chemical hazards associated with preparations, to be identified, permit preparations to be classified, and permit establishment that preparations can be used without unnecessary difficulty, and be such that exposure of man, animals, and the environment is minimized, taking account of manner of use. (iii) The extent to which active substances of which inclusion in Schedule I is sought, comply with relevant FAO specifications, must be stated. Divergences from FAO specifications must be described in detail, and justified. (iv) In certain specified instances, tests must be conducted using purified active substance of stated specification. In such cases the principles of the method(s) of purification must be reported. The purity of such test material, which must be as high as can be achieved using the best available technology, must be reported. A reasoned justification must be provided in cases where the degree of purity achieved is less than 980 g/kg. Such justification must demonstrate that all technically feasible and reasonable possibilities for the production of the pure active substance have been exhausted. 2.1. Melting point and boiling point 2.1.1. The melting point or where appropriate the freezing or solidification point of purified active substance must be determined and reported according to EEC method A 1. Measurements should be taken up to 360oC. 2.1.2. Where appropriate the boiling point of purified active substances must be determined and reported according to EEC method A 2. Measurements should be taken up to 360oC. 2.1.3. Where melting point and/or boiling point cannot be determined because of decomposition or sublimation, the temperature at which decomposition or sublimation occurs, must be reported. 2.2. Relative density In the case of active substances which are liquids or solids, the relative density of the purified active substance must be determined and reported according to EEC method A 3. 2.3. Vapour pressure (in Pa), volatility (e.g. Henry's law constant) 2.3.1. The vapour pressure of purified active substance must be reported according to EEC method A 4. Where vapour pressure is less than 10-5Pa, the vapour pressure at 20 or 25oC may be estimated by a vapour pressure curve. 2.3.2. In the case of active substances which are solids or liquids, volatility (Henry's law constant) of purified active substance must be determined or calculated from its water solubility and vapour pressure and be reported (in Pa m3 mol-1). 2.4. Appearance (physical state, colour and odour; if known) 2.4.1. A description of both the colour, if any, and the physical state of both the active substance as manufactured and purified active substance, must be provided. 2.4.2. A description of any odour associated with the active substance as manufactured and purfied active substance, noted when handling the materials in laboratories or production plants, must be reported. 2.5. Spectra (UV/VIS, IR, NMR, MS), molecular extinction at relevant wavelengths 2.5.1. The following specta including a table of signal characteristica needed for interpretation must be determined and reported: Ultravio let/Visible (UV/VIS), infrared (R), nuclear magnetic resonance (NMR), and mass spectra (MS) of purified active substance and molecular extinction at relevant wavelengths, must be determined and reported. The wavelengths at which UV/visible molecular extinction occurs are to be determined and reported and must include where appropriate a wavelength at the highest absorption value above 290 nm. In the case of active substances which are resolved optical isomers their optical purity must be measured and reported. 2.5.2. The UV/visible absorption spectra, IR, NMR and MS spectra, where necessary for the identification of the impurities considered to be of toxicological, ecotoxicological or environmental significance must be determined and reported. 2.6. Solubility in water including effect of pH (4 to 10) on solubility The water solubility of purified active substances under atmospheric pressure must be determined and reported according to EEC method A 6. These water solubility determinations must be made in the neutral range (i.e. in distilled water in equilibrium with atmospheric carbon dioxide). Where the active substance is capable of forming ions, determinations must also be made in the acidic range (pH 4 to 6) and in the alkaline range (pH 8 to 10), and be reported. Where the stability of the active substance in aqueous media is such that water solubility cannot be determined, a justification based on test data must be provided. 2.7. Solubility in organic solvents The solubility of the active substances as manufactured in the following organic solvents at 15 to 25oC must be determined and reported if less than 250 g/kg; the temperature applied must be specified: —Aliphatic hydrocarbon: preferably n-heptane, —Aromatic hydrocarbon: preferably xylene, —Halogenated hydrocarbon: preferably 1,2-dichlorethane, —Alcohol: preferably methanol or isopropyl alcohol, —Ketone: preferably acetone, —Ester: preferably ethyl acetate. If for a particular active substance, one or more of these solvents is unsuitable (e.g. reacts with test material), alternative solvents can be used instead. In such cases, choices made must be justified in terms of their structure and polarity. 2.8. Partition coefficient n-octanol/water including effect of pH (4 to 10) The n-octanol/water partition coefficient of purified active substance must be determined and reported according to EEC method A 8. The effect of pH (4 to 10) must be investigated when the substance is acidic or basic as defined by its pKa value (< 12 for acids, > 2 for bases). 2.9. Stability in water, hydrolysis rate, photochemical degradation, quantum yield and identity of breakdown product(s), dissociation constant including effect of pH (4 to 9) 2.9.1. The hydrolysis rate of purified active substances (usually radiola belled active substance, > 95 % purity), for each of the pH values 4, 7 and 9, under sterile conditions, in the absence of light, must be determined and report according to EEC method C 7. For substances with a low rate of hydrolysis, the rate can be determined at 50oC, or another appropriate temperature. If degradation is observed at 50oC, degradation rate at another temperature must be determined, and an Arrhenius plot must be constructed to permit an estimate to be made of hydrolysis at 20oC. The identity of hydrolysis products formed and the rate constantly observed, must be reported. The estimated DT 50 value must also be reported. 2.9.2. For compounds with a molar (decadic) absorption coefficient (e)>10 (1 mol-1 cm-1) at a wavelengthλ=290 nm, direct photo transformation in purified (e.g. distilled) water at 20 to 25oC, of purified active substance usually radio labelled using artificial light under sterile conditions, if necessary using a solubilizer, must be determined and reported. Sensitizers such as acetone must not be used as a cosolvent or solubilizer. The light source must simulate sunlight and be equipped with filters to exclude radiation at wave lengthsλ< 290 nm. The identity of breakdown products formed which at any time during the study are present in quantities =10 % of the active substance added, a mass balance to account for at least 90 % of the applied radioactivity, as well as photo-chemical halflife must be reported. 2.9.3. Where necessary to investigate direct phototrans-formation, the quantum yield of direct photodegradation in watermust be determined and reported, together with calculations to estimate theo retical lifetime of the active substance in the top layer of aqueous systems and the real lifetime of the substance. The method is described in the FAO Revised Guidelines on Envi ronmental Criteria for the Registration of Pesticides. 2.9.4. Where dissociation in water occurs, the dissociation constant(s) (pKa values) of the purified active substance must be determined and reported according to OECD Test Guideline 112. The identity of the dissociated species formed, based on theoretical considerations, must be reported. If the active, substance is a salt, the pKa value of the active principle must be given. 2.10. Stability in air, photochemical degradation, identity of breakdown product(s) An estimation of the photochemical oxidative degradation (indirect hototransformation) of the active substance, must be submitted. 2.11. Flammability including auto-flammability 2.11.1. The flammability of active substances as manufactured, which are solids, gases, or are substances which evolve highly flammable gases, must be determined and reported according to EEC method A 10, A 11 or A 12 as as appropriate. 2.11.2. The auto-flamability of active substances as manufactured must be determined and reported according to EEC method A 15 or A 16 as appropriate, and/or, where necessary according to the UN-Bowes Cameron-Cage-Test (UN-Recommendations on the Transport of Dangerous Goods, Chapter 14, No 14.3.4). 2.12. Flash point The flash point of active substances as manufactured with a melting point below 40oC, must be determined and reported according to EEC method A 9; only closed cup methods should be used. 2.13. Explosive properties The explosive properties of active substances as manufactured, must be determined and reported according to EEC method A 14 where necessary. 2.14. Surface tension The surface tension has to be determined and reported according to EEC method A 5. 2.15 Oxidizing properties The oxidizing properties of active substances as manufactured, must be determined and reported according to EEC method A 17, except where examination of its sturctural formula, establishes beyond reasonable doubt that the active substance is incapable of reacting exothermically with a combustible material. In such cases, it is sufficient to provide that information as justification for not deter mining the oxidizing properties of the substance. 3. Further information on the active substance (i) The information provided must describe the intended purposes for which preparations containing the active substance are used, or are to be used and the dose and manner of their use or proposed use. (ii) The information provided must specify the normal methods and precautions to be followed, in the handling, storage and transport of the active substance. (iii) The studies, data and information submitted, together with other relevant studies, data and information, must both specify and justify the methods and precautions to be followed in the event of fire. The possible products of combustion in the event of fire should be estimated, based on the chemical structure and the chemical and physical properties of the active substance. (iv) The studies, data and information submitted, together with other relevant studies, data and information, must demonstrate the suitability of measures proposed for use in emergency situations. (v) The informaton and data referred to are reqired for all active substances, except where otherwise specified. 3.1. Function, e.g. fungicide, herbicide, insecticide, repellant, growth regulator The function must be specified from among the following: —acaricide —bactericide —fungicide —herbicide —insecticide —molluscicide —nematicide —plant growth regulator —repellant —rodenticide —semio-chemicals —talpicide —viricide —other (must be specified) 3.2. Effects on harmful organisms, e.g. contact poison, inhalation poison, stomach poison, fungitoxic, etc. systematic or not in plants 3.2.1. The nature of the effects on harmful organisms must be stated: —contact action —stomach action —inhalation action —fungitoxic action —fungistatic action —desiccant —reproduction inhibitor —other (must be specified) 3.2.2. It must be stated whether or not the active substance is translocated in plants and where relevant whether such translocation is apoplastic, symplastic or both. 3.3. Field of use envisaged, e.g. field, protected crops, storage of plant products, home gardening The field(s) of use, existing and proposed, for preparations containing the active substance must be specified from among the following: —Field use, such as agriculture, horticulture, forestry and viticulture —Protected crops —Amenity —Weed control on non-cultivated areas —Home gardening —House plants —Plant products storage practice —Other (specify) 3.4. Harmful organisms controlled and crops or products protected or treated 3.4.1. Details of existing and the intended use in terms of crops, groups of crops, plants, or plant products treated and where relevant protected, must be provided. 3.4.2. Where relevant, details of harmful organisms against which protection is afforded, must be provided. 3.4.3 Where relevant, effects achieved e.g. sprout suppression, retardation of ripening, reduction in stem length, enhanced fertilization etc., must be reported. 3.5. Mode of action 3.5.1. To the extent that is has elucidated, a statement must be provided as to the mode of action of the active substance in terms, where relevant, of the biochemical and physiological mechanism(s) and biochemical pathway(s) involved. Where available, the results of relevant experimental studies must be reported. 3.5.2. Where it is known that to exert its intended effect, the active substance must be converted to a metabolite or degradation product following application or use of preparations containing it, the following information, cross referenced to and drawing on information provided in the context of paragraphs 5.6, 5.11, 6.1, 6.2, 6.7, 7.1, 7.2 and 9, where relevant, must be provided for active metabolite or degradation product: —chemical name according to IUPAC and CA nomenclature, —ISO common name or proposed common name, —CAS EEC-number EEC (EINECS or ELINCS) number, and CIPAC number if available, —empirical and structural formula, and —molecular mass. 3.5.3. Available information relating to the formation of active metabolites and degradation products, must be provided, to include: —the processes, mechanisms and reactions involved, —kinetic and other data concerning the rate of conversion and if known the rate limiting step, —environmental and other factors effecting the rate and extent of conversion. 3.6. Information on the occurrence or possible occurrence of the devel opment of resistance and appropriate management strategies Where available information on possible occurrence of the devel opment of resistance or cross-resistance must be provided. 3.7. Recommended methods and precautions concerning handling, storage, transport or fire A safety data sheet pursuant to Article 27 of Council Directive 65/548/EEC (1) must be provided for all active substances. 3.8. Procedures for destruction or decontamination 3.8.1. Controlled incineration In many cases the preferred or sole means to safely dispose of active substances, contaminated materials, or contaminated packaging, is through controlled incineration in a licensed incinerator. Where the content of halogens of the active substance is greater than 60 %, the pyrolytic behaviour of the active substance under controlled conditions (including where relevant supply of oxygen and defined residence time), at 800oC and the content of polyhalo genated dibenzo-p-dioxins and dibenzo-furans in the products of pyrolysis must be reported. The application must provide detailed instructions for safe disposal. 3.8.2. Others Other methods to dispose of the active substance, contaminated packaging and contaminated materials, where proposed, must be fully described. Data must be provided for such methods, to establish their effectiveness and safety. 3.9. Emergency measures in case of an accident Procedures for the decontamination of water in case of an accident must be provided. 4. Analytical methods Introduction The provisions of this section only cover analytical methods required for post-registration control and monitoring purposes. For analytical methods used for generation of data as required in this Directive or for other purposes the applicant has to provide a justi fication for the method used; where necessary separate guidance will be developed for such methods on the basis of the same requirements as defined for methods for post-registration control and monitoring purposes. Descriptions of methods must be provided and include details of equipment, materials and conditions used. As far as practicable these methods must employ the simplest approach, involve the minimum cost, and require commonly available equipment. For this section the following applies: Impurities Any component other than the pure active substance which is present in the active substance as manufactured (including non active isomers) originating from the manufacturing process or from degra dation during storage, Relevant impurities Impurities of toxicological and/or ecotox icological or environmental concern, Significant impurities Impurities with a content of=1 g/kg in the active substance as manufactured, Metabolites Metabolites include products resulting from degradation or reaction of the active substance, Relevant metabolites Metabolites of toxicological and/or ecotoxicological or environmental concern. On request the following samples must be provided: (i) analytical standards of the pure active substance; (ii) samples of the active substance as manufactured; (iii) analytical standards of relevant metabolites and all other components included in the residue definition; (iv) if available, samples of reference substances for the relevant impurities. 4.1. Methods for the analysis of the active substance as manufactured For this point the following definitions apply: (i)Specificity Specificity is the ability of a method to distinguish between the analyte being measured and other substances. (ii)Linearity Linearity is defined as the ability of the method, within a given range, to obtain an acceptable linear correlation between the results and the concentration of analyte in samples. (iii)Accuracy The accuracy of a method is defined as the degree to which the determined value of analyte in a sample corresponds to the accepted reference value (for example ISO 5725). (iv)Precision Precision is defined as the closeness of agreement between inde pendent test results obtained under prescribed conditions. Repeatability: Precision under repeatability conditions, i.e. conditions where independent test results are obtained with the same method on identical test material in the same laboratory by the same operator using the same equipment within short intervals of time. The reproducibility is not required for the active substance as manufactured (for definition of reproducibility see ISO 5725). 4.1.1. Methods, which must be described in full, must be provided for the determination of pure active substance in the active substance as manufactured as specified in the dossier submitted in support of inclusion in Annex I to Directive 91/414/EEC. The applicability of existing Cipac methods must be reported. 4.1.2. Methods must also be provided for the determination of significant and/or relevant impurities and additives (e.g. stabilizers) in the active substance as manufactured. 4.1.3. Specificity, linearity, accuracy and repeatability 4.1.3.1. Specificity of methods submitted, must be demonstrated and reported. In addition the extent of interference by other substances present in the active substance as manufactured (e.g. isomers, impurities or additives), must be determined. While interferences due to other components may be identified as systematic errors in the assessment of the accuracy of methods proposed for the determination of pure active substance in the active substance as manufactured, an explanation must be provided for any interference occurring which contributes more than ± 3 % to the total quantity determined. The degree of interference for methods for the determination of impurities must also be demonstrated. 4.1.3.2. The linearity of proposed methods over an appropriate range must be determined and reported. For the determination of pure active substance, the calibration range must extend (by at least 20 %) the highest and lowest nominal content of the analyte in relevant analytical solutions. Duplicate calibration determinations must be made at three or more concentrations. Alternatively, five concen trations, each as single measurements, are acceptable. Reports submitted must include the equation of the calibration line and the correlation coefficient and representative and properly labelled docu mentation from the analysis, e.g. chromatograms. 4.1.3.3. Accuracy is required for methods for the determination of pure active substance and significant and/or relevant impurities in the active substance as manufactured. 4.1.3.4. For the repeatability in the determination of the pure active substance in principle a minimum of five determinations must be made. The relative standard deviation (% RSD) must be reported. Outliers iden tified through an appropriate method (e.g. Dixons or Grubbs test), may be discarded. Where outliers have been discarded, that fact must be clearly indicated. An explanation as to the reason for the occurrence of individual outliers, must be attempted. 4.2. Methods for the determination of residues The methods must be capable of determining the active substance and/or relevant metabolites. For each method and for each relevant representative matrix, the specificity, precision, recovery, and limit of determination must be experimentally determined and reported. In principle, residue methods proposed should be multi-residue methods; a standard multi-residue method must be assessed and reported as to its suitability for residue determination. Where residue methods proposed are not multi-residue methods, or are not compatible with such methods, an alternative method must be proposed. Where this requirement results in an excessive number of methods for individual compounds, a‘common moiety method’may be acceptable. For this section the following definitions apply: (i)Specificity Specificity is the ability of a method to distinguish between the analyte being measured and other substances. (ii)Precision Precision is defined as the closeness of agreement between inde pendent test results obtained under prescribed conditions. Repeatability: Precision under repeatability conditions, i.e. conditions where independent test results are obtained with the same method on identical test material in the same laboratory by the same operator using the same equipment within short intervals of time. Reproducibility: As the definition of reproducibility in relevant publications (for example, in ISO 5725) is in general not prac ticable for residue analytical methods, reproducibility in the context of this Directive is defined as a validation of repeatability of recovery, from representative matrices and at representative levels, by at least one laboratory which is independent from that which initially validated the study (this independent laboratory may be within the same company) (independent laboratory validation). (iii)Recovery The percentage of the amount of active substance or relevant metabolite originally added to a sample of the appropriate matrix which contains no detectable level of the analyte. (iv)Limit of determination The limit of determination (often referred to as limit of quantifi cation) is defined as the lowest concentration tested, at which an acceptable mean recovery is obtained (normally 70 to 110 % with a relative standard deviation of preferably=20 %; in certain justified cases lower or higher mean recovery rates as well as higher relative standard deviations may be acceptable). 4.2.1. Residues in and/or on plants, plant products, foodstuffs (of plant and animal origin), feedingstuffs Methods submitted must be suitable for the determination of all components included in the residue definition as submitted according to the provisions of section 6, points 6.1 and 6.2 in order to enable the Director to determine compliance with established MRL's or to determine dislodgeable residues. The specificity of the methods must enable all components included in the residue definition to be determined, using an additional confir matory method if appropriate. The repeatability must be determined and reported. The replicate analytical portions for test can be prepared from a common field treated sample, containing incurred residues. Alternatively the replicate analytical portions for test can be prepared from a common untreated sample with aliquots fortified at the required level(s). The results from an independent laboratory validation must be reported. The limit of determination including the individual and mean recovery must be determined and reported. The overall relative standard deviation, as well as the relative standard deviation for each fortification level must be experimentally determined and reported. 4.2.2. Residues in soil Methods for analysis of soil for parent compound and/or relevant metabolites must be submitted. The specificity of the methods must enable the parent compound and/or relevant metabolites to be determined, using an additional confirmatory method if appropriate. The repeatability, recovery and the limit of determination including the individual and mean recovery must be determined and reported. The overall relative standard deviation, as well as the relative standard deviation for each fortification level must be experimentally determined and reported. The proposed limit of determination must not exceed a concentration which is of concern with regard to exposure of non-target organisms or because of phytotoxic effects. Normally the proposed limit of determination should not exceed 0,05 mg/kg. 4.2.3. Residues in water (including drinking water, ground water and surface water) Methods for analysis in water for parent compound and/or relevant metabolites must be submitted. The specificity of the methods must enable the parent compound and/or relevant metabolites to be determined, using an additional confirmatory method if appropriate. The repeatability, recovery and the limit of determination including the individual and mean recovvery must be determined and reported. The overall relative standard deviation, as well as the relative standard deviation for each fortification level must be experimentally determined and reported. For drinking water the proposed limit of determination must not exceed 0,1µg/l. For surface water the proposed limit of determination must not exceed a concentration which has an impact on non-target organisms deemed to be unacceptable according to the requirements of Schedule VI. 4.2.4. Residues in air Methods for the analysis in air of the active substance and/or relevant metabolites formed during or shortly after application must be submitted unless it can be justified that exposure of operators, workers or bystanders is not likely to occur. The specificity of the methods must enable the parent compound and/or relevant metabolites to be determined, using an additional confirmatory method if appropriate. The repeatability, recovery and the limit of determination including the individual and mean recovery must be determined and reported. The overall relative standard deviation, as well as the relative standard deviation for each fortification level must be experimentally determined and reported. The proposed limit of determination must take into account relevant health based limit values or relevant exposure levels. 4.2.5. Residues in body fluids and tissues Where an active substance is classified as toxic or highly toxic appropriate analytical methods must be submitted. The specificity of the methods must enable the parent compound and/or relevant metabolites to be determined, using an additional confirmatory method if appropriate. The repeatability; recovery and the limit of determination including the individual and mean recovery must be determined and reported. The overall relative standard deviation, as well as the relative standard deviation for each fortification level must be experimentally determined and reported. 5. Toxicological and metabolism studies Introduction (i) The information provided, taken together with that provided for one or more preparations containing the active substance, must be sufficient to permit an evaluation to be made as to the risks for man, associated with the handling and use of plant protection products containing the active substance, and the risk for man arising from residual traces remaining in food and water. In addition, the information provided must be sufficient to: —permit a decision to be made as to whether, or not, the active substance can be included in Schedule I, — specify appropriate conditions or restrictions to be associated with any inclusion in Schedule I, — classify the active substance as to hazard, — establish a relevant acceptable daily intake (ADI) level for man, — establish acceptable operator exposure level(s) (AOEL), — specify the hazard symbols, the indications of danger, and the risk and safety phrases for the protection of man, animals and the environment to be included in packaging (containers), — identify relevant first aid measures as well as appropriate diagnostic and therapeutic measures to be followed in the event of poisoning in man, and — permit an evaluation to be made as to the nature and extent of the risks for man, animals (species normally fed and kept or consumed by man) and of the risks for other non-target vertebrate species. (ii) There is a need to investigate and report all potentially adverse effects found during routine toxicological investi-gations (including effects on organs and special systems such as immunotoxicity and neurotoxicity) and to undertake and report such additional studies which may be necessary to investigate the probable mechanism involved, to establish Noaels (no observed adverse effect levels), and to assess the significance of these effects. All available biological data and information which is relevant to the assessment of the toxicological profile of the substance tested, must be reported. (iii) In the context of the influence that impurities can have on toxicological behaviour, it is essential that for each study submitted, a detailed description (specification) of the material used, as mentioned under section 1 point 11 be provided. Tests should be conducted using active substance of that specification to be used in the manufacture of preparations to be authorized, except where radiolabelled material is required or permitted. (iv) Where studies are conducted using an active substance produced in the laboratory or in a pilot plant production system, the studies must be repeated using the active substance as manufactured, unless it can be justified that the test material used is essentially the same, for the purposes of toxicological testing and assessment. In cases of uncertainty, appropriate bridging studies must be submitted to serve as a basis for a decision as to the possible need for repetition of the studies. (v) In the case of studies in which dosing extends over a period, dosing should preferably be done using a single batch of active substance if stability permits. (vi) For all studies actual achieved dose in mg/kg body weight, as well as in other convenient units, must be reported. Where dosing via the diet is utilized the test compound must be distributed uniformly in the diet. (vii) Where, as a result of metabolism or other processes in or on treated plants, or as a result of processing of treated products, the terminal residue (to which consumers or workers as defined in Schedule III, point 7.2.3 will be exposed) contains a substance which is not the active substance itself and is not identified as a metabolite in mammals, it will be necessary to carry out toxicity studies on these components of the terminal residue unless it can be demonstrated that consumer or worker exposure to these substances does not constitute a relevant risk to health. Toxicokinetic and meta-bolism studies relating to metabolites and degradation products should only be conducted if toxicity findings of the metabolite cannot be evaluated by the available results relating to the active substance. (viii) The way of administration of the test substance depends on the main exposure routes. In cases where exposure is mainly by the gas phase, it can be more appropriate to perform inhalation studies instead of oral studies. 5.1. Studies on absorption, distribution, excretion and metabolism in mammals Quite limited data, as described below and restricted to one test species (normally the rat) may be all that is required in this area. These data can provide information useful in the design and inter pretation of subsequent toxicity tests. However, it must be remembered that information on interspecies differences may be crucial in extrapolation of animal data to man and information on percutaneous penetration, absorption, distribution, excretion and metabolism may be useful in operator risk assessments. It is not possible to specify detailed data requirements in all areas, since the exact requirements will be dependant upon the results obtained for each particular test substance. Aim of the test: The tests should provide sufficient data to permit: —an evaluation of the rate and extent of absorption, —the tissue distribution and the rate and extent of excretion of the test substance and the relevant metabolites, —the identification of metabolites and the metabolic pathway. The effect of dose level on these parameters and whether results are different after single versus repeated doses, should also be inves tigated. Circumstances in which required A single dose toxicokinetic study in rats (oral route of administration) in at least two dose levels as well as a repeated dose toxicokinetic study in rats (oral route of administration) at a single dose level, must be conducted and reported. It may be necessary in some cases to perform additional studies on another species (such as goat or chicken). Test guideline Commission Directive 87/302/EEC of 18 November 1987 adapting to technical progress for the ninth time Council Directive 67/548/EEC on the approximation of laws, regulations and administrative provisions relating to the classification, packaging and labelling of dangerous substances (1), part B, Toxicokinetics. 5.2. Acute toxicity The studies, data and information to be provided and evaluated must be sufficient to permit the identification of effects following a single exposure to the active substance, and in particular to establish, or indicate: —the toxicity of the active substance; —the time course and characteristics of the effects with full details of behavioural changes and possible gross pathological findings at post-mortem; —where possible mode of toxic action; and —the relative hazard associated with the different routes of exposure. While the emphasis must be on estimating the toxicity ranges involved, the information generated must also permit the active substance to be classified in accordance with Council Directive 67/548/EEC. The information generated through acute toxicity testing is of particular value in assessing hazards likely to arise in accident situations. 5.2.1. Oral Circumstances in which required The acute oral toxicity of the active substance must always be reported. Test guideline The test must be carried out in accordance with the Annex to Commission Directive 92/69/EEC of 31 July 1992 adapting to technical progress for the seventeenth time Council Directive 67/548/EEC on the approximation of laws, regulations and adminis trative provisions relating to the classification, packaging and labelling of dangerous substances (2), Method B1 or B1 bis. 5.2.2. Percutaneous Circumstances in which required The acute percutaneous toxicity of the active substance must always be reported. Test guideline Both local and systemic effects must be investigated. The test must be carried out in accordance with Directive 92/69/EEC method B3. 5.2.3. Inhalation Circumstances in which required The inhalation toxicity of the active substance must be reported where the active substance is: —a gas or liquified gas, —is to be used as a fumigant, —is to be included in a smoke generating, aerosol or vapour releasing preparation, —is to be used with fogging equipment, —has a vapour pressure > 1 10&minus;2Pa and is to be included in preparations to be used in enclosed spaces such as warehouses or glasshouses, —is to be included in preparations which are powders containing a significant proportion of particles of diameter <50µm< (> 1 % on a weight basis), or —is to be included in preparations to be applied in a manner which generates a significant proportion of particles or droplets of diameter < 50µm (> 1 % on a weight basis). Test guideline The test must be carried out in accordance with Directive 92/69/EEC Method B2. 5.2.4. Skin irritation Aim of the test The test will provide the potential of skin irritancy of the active substance including the potential reversibility of the effects observed. Circumstances in which required The skin irritancy of the active substance must be determined except where it is likely, as indicated in the test guideline, that severe skin effects may be produced or that effects can be excluded. Test guideline The acute skin irritation must be carried out in accordance with Directive 92/69/EEC Method B4. 5.2.5. Eye irritation Aim of test The test will provide the potential of eye irritancy of the active substance including the potential reversibility of the effects observed. Circumstances in which required Eye irritation tests must be conducted except where it is likely, as indicated in the test guideline, that severe effects on the eyes may be produced. Test guidelines The acute eye irritation must be determined in accordance with Directive 92/69/EEC Method B5. 5.2.6. Skin sensitization Aim of test The test will provide sufficient information to assess the potential of the active substance to provoke skin sensitization reactions. Circumstances in which required The test must always be carried out except where the substance is a known sensitizer. Test guideline The test must be carried out in accordance with Directive 92/69/EEC Method B6. 5.3. Short-term toxicity Short-term toxicity studies must be designed to provide information as to the amount of the active substance that can be tolerated without toxic effects under the conditions of the study. Such studies provide useful data on the risks for those handling and using preparations containing the active substance. In particular, short-term studies provide an essential insight into possible cumulative actions of the active substance and the risks to workers who may be intensively exposed. In addition short-term studies provide information useful in the design of chronic toxicity studies. The studies, data and information to be provided and evaluated, must be sufficient to permit the identification of effects following repeated exposure to the active substance, and in particular to further establish, or indicate: —the relationship between dose and adverse effects, —toxicity of the active substance including where possible the Noael, —target organs, where relevant, —the time course and characteristics of poisoning with full details of behavioural changes and possible pathological findings at post mortem, —specific toxic effects and pathological changes produced, —where relevant the persistence and reversibility of certain toxic effects observed, following discontinuation of dosing, —where possible, the mode of toxic action, and —the relative hazard associated with the different routes of exposure. 5.3.1. Oral 28-day study Circumstances in which required Although it is not mandatory to perform 28-day short term studies, they can be useful as range finding tests. Where conducted they must be reported, since the results could be of particular value in the identification of adaptive responses which can be masked in chronic toxicity studies. Test guideline The test must be carried out in accordance with Directive 92/69/EEC Method B7. 5.3.2. Oral 90-day study Circumstances in which required The short-term oral toxicity (90 day) of the active substance to both rat and dog, must always be reported. Where there is evidence that the dog is significantly more sensitive and where such data are likely to be of value in extrapolating results obtained to man, a 12-month toxicity study in dogs must be conducted and reported. Test guidelines Directive 87/302/EEC, Part B, sub-chronic oral toxicity test. 5.3.3. Other routes Circumstances in which required For the assessment of operator exposure additional percutaneous studies may be useful. For volatile substances (vapour pressure >10-2Pascal) expert judgment is required to decide whether the short term studies have to be performed by oral or inhalation exposure. Test guidelines —28-day dermal: Directive 92/69/EEC Method B9, —90-day dermal: Directive 87/302/EEC, Part B, sub-chronic dermal toxicity study, —28-day inhalation: Directive 92/69/EEC Method B8, —90-day inhalation: Directive 87/302/EEC, Part B, sub-chronic inhalation toxicity study. 5.4. Genotoxicity testing Aim of the test These studies are of value in: —the prediction of genotoxic potential —the early identification of genotoxic carcinogens —the elucidation of the mechanism of action of some carcinogens To avoid responses that are artifacts of the test system, excessively toxic doses must not be used in either in vitro or in vivo assays for mutagenicity. This approach should be regarded as general guidance. It is important that a flexible approach is adopted, with selection of further tests being' dependant upon interpretation of results at each stage. 5.4.1. In vitro studies Circumstances in which required In vitro mutagenicity tests (bacterial assay for gene mutation, test for clastogenicity in mammalian cells and test for gene mutation in mammalian cells) must always be performed. Test guidelines Acceptable test guidelines are: Directive 92/69/EEC Method B14—Salmonella Typhimurium reverse mutation assay Directive 92/69/EEC Method B10—in vitr omammalian cytogenetic test Directive 87/302/EEC, Part B—in vitro mammalian cell gene mutation test 5.4.2. In vivo studies in somatic cells Circumstances in which required If all the results of the in vitro studies are negative further resting must be done with consideration of other relevant information available (including toxicokinetic, toxicodynamic and physico chemical data and data on analogous substances). The test can be an in vivo study or an in vitro study using a different metabolizing system from that/those previously used. If the in vitro cytogenetic test is positive, an in vivo test using somatic cells (metaphase analysis in rodent bone marrow or micro nucleus test in rodents) must be conducted. If either of the in vitro gene mutation tests are positive, an in vivo test to investigate unscheduled DNA synthesis or a mouse spot test must be conducted. Test guidelines Acceptable test guidelines are: Directive 92/69/EEC Method B12—Micronucleus test, Directive 87/302/EEC Part B—Mouse spot test, Directive 92/69/EEC Method B11—In vivo Mammalian Bone Marrow cytogenetic test, Chromosomal analysis. 5.4.3. In vivo studies in germ cells Circumstances in which required When any result of an in vivo study in somatic cells is positive, in vivo testing for germ cell effects may be justified. The necessity for conducting these tests will have to be considered on a case by case basis, taking into account information regarding toxicokinetics, use and anticipated exposure. Suitable tests would need to examine inter action with DNA (such as the dominant lethal assay), to look at the potential for inherited effects and possibly make a quantitative assessment of heritable effects. It is recognized that in view of their complexity, the use of quantitative studies would require strong justification. 5.5. Long term toxicity and carcinogenicity Aim of the test The long-term studies conducted and reported, taken together with other relevant data and information on the active substance, must be sufficient to permit the identification of effects, following repeated exposure to the active substance, and in particular must be sufficient to: —identify adverse effects resulting from exposure to the active substance, —identify target organs, where relevant, —establish the dose-response relationship, —identify changes in toxic signs and manifestations observed, and —establish the Noael. Similarly, the carcinogenicity studies taken together with other relevant data and information on the active substance, must be sufficient to permit the hazards for humans, following repeated exposure to the active substance, to be assessed, and in particular must be sufficient: —to identify carcinogenic effects resulting from exposure to the active substance, —to establish the species and organ specificity of tumours induced, —to establish the dose-response relationship, and —for non-genotoxic carcinogens, to identify the maximum dose eliciting no adverse effect (threshold dose). Circumstances in which required The long-term toxicity and carcinogenicity of all active substances must be determined. If in exceptional circumstances, it is claimed that such testing is unnecessary, that claim must be fully justified, viz.toxicokinetic data demonstrates that absorption of the active substance does not occur from the gut, through the skin or via the pulmonary system. Test conditions A long-term oral toxicity and carcinogenicity study (two years) of the active substance must be conducted using the rat as test species; these studies can be combined. A carcinogenicity study of the active substance must be conducted using the mouse as test species. Where a non-genotoxic mechanism for carcinogenicity is suggested, a well argued case, supported with relevant experimental data, including that necessary to elucidate the possible mechanism involved, must be provided. While the standard reference points for treatment responses are concurrent control data, historical control data, may be helpful in the interpretation of particular carcinogenicity studies. Where submitted, historical control data should be from the same species and strain, maintained under similar conditions and should be from contemporaneous studies. The information on historical control data provided must include: —identification of species and strain, name of the supplier, and specific colony identification, if the supplier has more than one geographical location, —name of the laboratory and the dates when the study was performed, —description of the general conditions under which animals were maintained, including the type or brand of diet and, where possible, the amount consumed, —approximate age, in days, of the control animals at the beginning of the study and at the time of killing or death, —description of the control group mortality pattern observed during or at the end of the study, and other pertinent observations (e.g. diseases, infections), —name of the laboratory and the examining scientists responsible for gathering and interpreting the pathological data from the study, and —a statement of the nature of the tumours that may have been combined to produce any of the incidence data. The doses tested, including the highest dose tested, must be selected on the basis of the results of short-term testing and where available at the time of planning the studies concerned, on the basis of meta bolism and toxicokinetic data. The highest dose level in the carcino genicity study should elicit signs of minimal toxicity such as slight depression in body-weight gain (less than 10 %), without causing tissue necrosis or metabolic saturation and without substantially altering normal lifespan due to effects other than tumours. If the long-term toxicity study is carried out separately, the highest dose level should elicit definite signs of toxicity without causing excessive lethality. Higher doses, causing excessive toxicity are not considered relevant to evaluations to be made. In the collection of data and compilation of reports, incidence of benign and malignant tumours must not be combined, unless there is clear evidence of benign tumours becoming malignant with time. Similarly, dissimilar, un-associated tumours, whether benign or malignant, occurring in the same organ, must not be combined, for reporting purposes. In the interests of avoiding confusion, termi nology such as that developed by American Society of Toxicologic Pathologists (1), or the Hannover Tumour Registry (RENI) should be used in the nomenclature and reporting of tumours. The system used must be identified. It is essential that biological material selected for histopathological examination includes material selected to provide further information on lesions identified during gross pathological examination. Where relevant to the elucidation of mechanism of action and available, special histological (staining) techniques, histochemical techniques and electron microscopic examinations, must be conducted and reported. Test guideline The studies must be carried out in accordance with Directive 87/302/EEC, part B, Chronic toxicity test, Carcinogenicity test or combined chronic toxicity/carcinogenicity test. (1)Standardized System of Nomenclature and Diagnostic Criteria—Guides for Toxicologic Pathology 5.6. Reproductive toxicity Adverse reproductive effects are of two main types: —impairment of male or female fertility, and —impacts on the normal development of progeny (developmental toxicity). Possible effects on all aspects of reproductive physiology in both males and females, as well as possible effects on pre-natal and post natal development, must be investigated and reported. If in exceptional circumstances, it is claimed that such testing is unne cessary, that claim must be fully justified. While the standard reference point for treatment responses are concurrent control data, historical control data may be helpful in the interpretation of particular reproductive studies. Where submitted, historical control data should be from the same species and strain, maintained under similar conditions and should be from contemporaneous studies. The information on historical control data provided must include: —identification of species and strain, name of the supplier, and specific colony identification, if the supplier has more than one geographical location, —name of the laboratory and the dates when the study was performed, —description of the general conditions under which animals were maintained, including the type or brand of diet and, where possible, the amount consumed, —approximate age, in days, of the control animals at the beginning of the study and at the time of killing or death, —description of the control group mortality pattern observed during or at the end of the study, and other pertinent observations (e.g. diseases, infections), and —name of the laboratory and the examining scientist responsible for gathering and interpreting the toxicological data from the study. 5.6.1. Multi-generation studies Aim of the test The studies reported, taken together with other relevant data and information on the active substance, must be sufficient to permit the identification of effects for reproduction, following repeated exposure to the active substance, and in particular must be sufficient: —to identify direct and indirect effects on reproduction resulting from exposure to the active substance, —to identify any enhancement of general toxic effects (noted during short-term and chronic toxicity testing), —to establish the dose-response relationship, to identify changes in toxic signs and manifestations observed, and —to establish the Noael. Circumstances in which required A reproduction toxicity study in rats over at least two generations must always be reported. Test guideline The tests must be carried out in accordance with Directive 87/302/EEC, Part B, two-generation reproduction toxicity test. In addition organ weight of reproductive organs must be reported. Supplementary studies Where necessary for a better interpretation of the effects on repro duction and as far as this information is not yet available it could be necessary to perform supplementary studies in order to provide the following information: —separate male and female studies, —three segment designs, —dominant lethal assay for male fertility, —cross-matings of treated males with untreated females and vice versa, —effects on spermatogenesis, —effects on oogenesis, —sperm motility, mobility and morphology, and —investigation of hormonal activity. 5.6.2. Developmental toxicity studies Aim of the test The studies reported, taken together with other relevant data and information on the active substance, must be sufficient to permit effects on embryonic and foetal development, following repeated exposure to the active substance, to be assessed, and in particular must be sufficient: —to identify direct and indirect effects on embryonic and foetal development resulting from exposure to the active substance, —to identify any maternal toxicity, —to establish the relationship between observed responses and dose in both dam and offspring, —to identify changes in toxic signs and manifestations observed, and —to establish the Noael. Furthermore, the tests will give additional information on any enhancement of general toxic effects of pregnant animals. Circumstances in which required The tests must always be carried out. Test conditions Developmental toxicity must be determined both to rat and rabbit by the oral route. Malformations and variations should be reported sepa rately. A glossary of terminology and diagnostic principles for malformations and variations must be given in the report. Test guideline The tests must be carried out in accordance with Directive 87/302/EEC, Part B, teratogenicity test—rodent and non-rodent. 5.7. Delayed neurotoxicity studies Aim of the test The test shall provide sufficient data to evaluate if the active substance could provoke delayed neurotoxicity after acute exposure. Circumstances in which required These studies have to be performed for substances of similar or related structures to those capable of inducing delayed neurotoxicity such as organophosphates. Test guidelines The test must be carried out in accordance with OECD Guideline 418. 5.8. Other toxicological studies 5.8.1. Toxicity studies of metabolites as referred to in the introduction point (vii) Supplementary studies, where they relate to substances other than the active substance, are not a routine requirement. Decisions as to the need for supplementary studies must be made on a case by case basis. 5.8.2. Supplementary studies on the active substance In certain cases it can be necessary to carry out supplementary studies to further clarify observed effects. These studies could include: —studies on absorption, distribution, excretion and metabolism, —studies on the neurotoxic potential, —studies on the immunotoxicological potential, —studies on other routes of administration. Decisions as to the need for supplementary studies must be made on a case by case basis, taking into account the results of the available toxicological and metabolism studies and the most important exposure routes. Studies required must be designed on an individual basis, in the light of the particular parameters to be investigated and the objectives to be achieved. 5.9. Medical data Where available, and without prejudice to the provisions of Council Directive 98/24/EEC of 7 April 1998 on the protection of the health and safety of workers from the risks related to chemical agents at work (fourteenth individual Directive within the meaning of Article 16(1) of Directive 89/391/EEC), practical data and information relevant to the recognition of the symptoms of poisoning, and on the effectiveness of first aid and therapeutic measures have to be submitted. More specific references to the investigation for antidotal pharmacology or safety pharmacology using animals should be provided. Where relevant, the effectiveness of potential antagonists to poisoning, should be investigated and reported. Data and information relevant to the effects of human exposure, where available and of the necessary quality, are of particular value, in confirming the validity of extrapolations made and conclusions reached with respect to target organs, dose-response relationships, and the reversibility of toxic effects. Such data can be generated following accidental or occupational exposure. 5.9.1. Medicinal surveillance on manufacturing plant personnel Reports of occupational health surveillance programmes, supported with detailed information on the design of the programme, on exposure to the active substance and exposure to other chemicals, must be submitted. Such reports should, where feasible, include data relevant to the mechanism of action of the active substance. These reports shall, where available, include data from persons exposed in manufacturing plants or after application of the active substance (e.g.: in efficacy trials). Available information on the sensitization including allergenic response of workers and others exposed to the active substance, must be provided, and include where relevant details of any incidence of hypersensitivity. The information provided should include details of frequency, level and duration of exposure, symptoms observed and other relevant clinical information. 5.9.2. Direct observation, e.g.: clinical cases and poisoning incidents Available reports from the open literature, relating to clinical cases and poisoning incidents, where they are from refereed journals or official reports, must be submitted together with reports of any follow-up studies undertaken. Such reports should contain complete descriptions of the nature, level and duration of exposure, as well as the clinical symptoms observed, first aid and therapeutic measures applied and measurements and observations made. Summary and abstract information is not of value. Where supported with the necessary level of detail, such documen tation can be of particular value in confirming the validity of extra polations from animal data to man and in identifying unexpected adverse effects which are specific to humans. 5.9.3. Observations on exposure of the general population and epidemio logical studies if appropriate Where available, and supported with data on levels and duration of exposure, and conducted in accordance with recognized standards (1), epidemiological studies are of particular value and must be submitted. 5.9.4. Diagnosis of poisoning (determination of active substance, meta bolites), specific signs of poisoning, clinical tests A detailed description of the clinical signs and symptoms of poisoning, including the early signs and symptoms and full details of clinical tests useful for diagnostic purposes, where available, must be provided and include full details of the time courses involved relevant to the ingestion, dermal exposure or inhalation of varying amounts of the active substance. 5.9.5. Proposed treatment: first aid measures, antidotes, medical treatment The first aid measures to be used in the event of poisoning (actual and suspected) and in the event of contamination of eyes must be provided. Therapeutic regimes for use in the event of poisoning or contamina tion of eyes, including where available the use of antidotes, must be described in full. Information based on practical experience, where it exists and is available, in other cases on theoretical grounds, as to the effectiveness of alternative treatment regimes, where relevant, must be provided. Contraindications associated with particular regimes, particularly those relating to ‘general medical problems’and conditions, must be described. 5.9.6. Expected effects of poisoning Where known, the expected effects and the duration of these effects following poisoning must be described and include the impact of: —the type, level and duration of exposure, or ingestion, and —varying time periods between exposure, or ingestion, and commencement of treatment. 5.10. Summary of mammalian toxicity and overall evaluation A summary of all data and information provided under paragraphs 5.1 through 5.10, must be submitted, and include a detailed and critical assessment of those data in the context of relevant evaluative and decision making criteria and guidelines, with particular reference to the risks for man and animals that may or do arise, and the extent, quality and reliability of the data base. (1)Guidelines for Good Epidemiology Practices for Occupational and Environmental Research, developed by the Chemical Manufacturers Association's Epidemiology Task Group, as part of the Epidemiology Resource and Information Centre (ERIC),Pilot Project, 1991 Where relevant, in the light of findings with respect to the analytical profile of batches of the active substance (paragraph 1.11) and any bridging studies conducted (paragraphs 5 (iv)), the relevance of the data as submitted to the assessment of the toxicological profile of the active substance as manufactured, must be argued. On the basis of an assessment of the data base, and the relevant decision making criteria and guidelines, justifications must be submitted for the Noaels proposed for each relevant study. On the basis of these data scientifically reasoned proposals for the establishment of ADI and AOEL(s) for the active substance must be submitted. 6. Residues in or on treated products, food and feed Introduction (i) The information provided, taken together with that provided for one or more preparations containing the active substance, must be sufficient to permit an evaluation to be made as to the risks for man, arising from residues of the active substance and relevant metabolites, degradation and reaction products remaining in food. In addition, the information provided must be sufficient to: —permit a decision to be made as to whether, or not, the active substance can be included in Schedule I, —specify appropriate conditions or restrictions to be associated with any inclusion in Schedule I. (ii) A detailed description (specification) of the material used, as provided under Section 1, point 11 must be provided. (iii) Studies should be performed according to the guidance available on regulatory testing procedures for residues of plant protection products in food . (iv) Where relevant, data should be analyzed using appropriate statistical methods. Full details of the statistical analysis should be reported. (v) Stability of residues during storage. If may be necessary to perform studies on the stability of residues during storage. Provided samples are frozen within generally 24 hours after sampling and unless a compound is otherwise known to be volatile or labile, data are not normally required for samples extracted and analysed within 30 days from sampling (six months in the case of radio-labelled material). Studies with non-radio-labelled substances should be carried out with representative substratets and preferably on samples from treated crops or animals with incurred residues. Alternatively, if this is not possible, aliquots of prepared control samples should be spiked with a known amount of chemical before storage under normal storage conditions. Where the degradation during storage is significant (more than 30 %) it may be necessary to change the storage conditions or not to store the samples prior to analysis and repeat and studies where the unsatisfactory storage conditions were used. Detailed information with respect to the sample preparation and storage conditions (temperature and duration) of samples and extracts must be submitted. Storage stability data using sample extracts will also be required unless samples are analysed within 24 hours of extraction. 6.1. Metabolism, distribution and expression of residue in plants Aim of the tests The objectives of these studies are: —to provide an estimate of total terminal residues in the relevant portion of crops at harvest following treatment as proposed, —to identify the major components of the total terminal residue, —to indicate the distribution of residues between relevant crops parts, —to quantify the major components of the residue and to establish the efficiency of extraction procedures for these components, —to decide on the definition and expression of a residue. Circumstances in which required These studies must always be performed unless it can be justified that no residues will remain on plants/plant products which are used as food or feedingstuffs. Test conditions Metabolism studies have to involve crops or categories of crops in which plant protection products containing the active substance in question would be used. If a wide range of uses in different crop categories or in the category fruits is envisaged, studies have to be carried out on at least three crops unless it can be justified that a different metabolism is unlikely to occur. In cases where use is envisaged in different categories of crops, the studies must be repre sentative for the relevant categories. For this purpose crops can be considered as falling into one of five categories: root vegetables, leafy crops, fruits, pulses and oilseeds, cereals. If studies are available for crops from three of these categories and the results indicate that the route of degradation is similar in all three categories then it is unlikely that any more studies will be needed unless it could be expected that a different metabolism will occur. The metabolism studies have also to take into account the different properties of the active substance and the intended method of application. An evaluation of the results from different studies has to be submitted on the point and path of uptake (e.g. via leaves or roots), and on the distribution of residues between relevant parts of the crop at harvest (with particular emphasis on edible parts for man or animals). If the active substance or relevant metabolites are not taken up by the crop, this must be explained. Information on the mode of action and the physico-chemical properties of the active substance may be helpful in assessing trial data. 6.2. Metabolism, distribution and expression of residue in livestock Aim of tests The objectives of these studies are: —to identify the major components of the total terminal residue in edible animal products, —to quantify the rate of degradation and excretion of the total residue in certain animal products (milk or eggs) and excreta, —to indicate the distribution of residues between relevant edible animal products, —to quantify the major components of the residue and to show the efficiency of extraction procedures for these components, —to generate data from which a decision on the need for livestock feeding studies as provided for in point 6.4 can be made, —to decide on the definition and expression of a residue. Circumstances in which required Metabolism studies on animals, such as lactating ruminants (e.g. goat or cow) or laying poultry, are only required when pesticide use may lead to significant residues in livestock feed (=0,1 mg/kg of the total diet as received, except special cases e.g. active substances which accumulate). Where it becomes apparent that metabolic pathways differ significantly in the rat as compared to ruminants a pig study must be conducted unless the expected intake by pigs is not significant. 6.3. Residue trials Aim of the tests The objectives of these studies are: —to quantify the highest likely residue levels in treated crops at harvest or outloading from store following the propopsed good agricultural practice (GAP), and —to determine, when appropriate, the rate of decline of plant protection product deposits. Circumstances in which required These studies must always be performed where the plant protection product will be applied to plants/plant products which are used as food or feedingstuffs or where residues from soil or other substrates can be taken up by such plants except where extrapolation from adequate data on another crop is possible. Residue trial data shall be submitted in the Schedule II dossier for those uses of plant protection products for which authorization is sought at the moment of introduction of a dossier for inclusion of the active substance in Schedule I. Test conditions Supervised trials should corrspond to proposed critical GAP. The test conditions must take into account the highest residues which may reasonably arise (e.g. maximum number of proposed applications, use of the maximum envisaged quantity, shortest pre-harvest intervals, withholding periods or storage periods) but which remain represen-tative of the realistic worst case conditions in which the active substance would be used. Sufficient data must be generated and submitted to confirm that patterns determined hold for the regions and the range of conditions, likely to be encountered in the regions concerned for which its use is to be recommended. When establishing a supervised trial programme, normally factors such as climatic differences existing between production areas, differences in production methods (e.g. outdoor versus glasshouse uses), seasons of production, type of formulations, etc. should be taken into account. In general, for a comparable set of conditions, trials should be carried out over a minimum of two growing seasons. All exceptions should be fully justified. The precise number of trials necessary is difficult to determine in advance of a preliminary evaluation of the trial results. Minimum data requirements only apply where comparability can be established between production areas, e.g. concerning climate, methods and growing seasons of production, etc. Assuming all other variables (climate, etc.) are comparable, a minimum of eight trials represen tative of the proposed growing area is required for major crops. For minor crops normally four trials representative of the proposed growing area are required. Due to the inherently higher level of homogeneity in residues arising from post-harvest treatments or protected crops, trials from one growing season will be acceptable. For post-harvest treatments, in principle a minimum of four trials are required, carried out preferably at different locations with different cultivars. A set of trials has to be carried out for each application method and store type unless the worst case residue situation can be clearly identified. The number of studies per growing season to be performed can be reduced if it can be justified that the residue levels in plants/plant products will be lower than the limit of determination. Where a significant part of the consumable crop is present at the time of application, half of the supervised residue trials reported should include data to show the effect of time on the level of residue present (residue decline studies) unless it can be justified that the consumable crop is not affected by the application of the plant protection product under the proposed conditions of use. 6.4. Livestock feeding studies Aim of the tests The objective of these studies is to determine the residue in products of animal origin which will result from residues in feedingstuffs or fodder crops. Circumstances in which required Feeding studies are only required: —when significant residues (=0,1 mg/kg of the total diet as received, except special cases, such as active substances which accumulate) occur in crops or part of the crop (e.g. trimmings, waste) fed to animals, and —when metabolism studies indicate that significant residues (0,01 mg/kg or above the limit of determination if this would be higher than 0,01 mg/kg) may occur in any edible animal tissue taking into account the residue levels in potential feeding-stuffs obtained at the 1 dose rate. Where appropriate separate feeding studies for lactating ruminant and/or laying poultry should be submitted. Where it appears from the metabolism studies submitted in accordance with the provisions of point 6.2 that metabolic pathways differ significantly in the pig as compared to ruminants, a pig feeding study must be conducted unless the expected intake by pigs is not significant. Test conditions In general, the feed is administered in three dosages (expected residue level, three to five times, and 10 times the expected residue level). When setting the 1 dose, a theoretical feed ration must be compiled. 6.5. Effects of industrial processing and/or household preparations Circumstances in which required The decision as to whether it is necessary to carry out processing studies will depend on: —the importance of a processed product in the human or animal diet, —the level of residue in the plant or plant product to be processed, —the physico-chemical properties of the active substance or relevant metabolites, and —the possibility that degradation products of toxicological signif icance may be found after processing of the plant or plant product. Processing studies are not normally necessary if no significant or no analytically determinable residues occur in the plant or plant product which would be processed, or if the total theoretical maximum daily intake (TMDI) is less than 10 % of the ADI. In addition, processing studies are not normally required for plants or plant products mostly eaten raw except for those with inedible portions such as citrus, banana or kiwi fruit where data on the distribution of the residue in peel/pulp may be required. ‘Significant residues’generally refer to residues above 0,1 mg/kg. If the pesticide concerned has a high acute toxicity and/or a low ADI, consideration must be given to conducting processing studies for determinable residues below 0,1 mg/kg. Studies on the effects on the nature of the residue are not normally required where only simple physical operations, not involving a change in temperature of the plant or the plant product, are involved such as washing, trimming or pressing. 6.5.1. Effects on the nature of the residue Aim of the tests The objective of these studies is to establish whether or not breakdown or reaction products arise from residues in the raw products during processing which may require a separate risk assessment. Test conditions Depending upon the level and chemical nature of the residue in the raw commodity, a set of representative hydrolysis situations (simu lating the relevant processing operations) should be investigated, where appropriate. The effects of process other than hydrolysis, may also have to be investigated, where the properties of the active substance or metabolites indicate that toxicologically significant degradation products may occur as a result of these processes. The studies are normally conducted with a radio-labelled form of the active substance. 6.5.2. Effects on the residue levels Aim of the tests The main objectives of these studies are: —to determine the quantitative distribution of residues in the various intermediate and end products, and to estimate transfer factors, —to enable a more realistic estimate to be made of dietary intake of residues. Test conditions Processing studies should represent household processing and/or actual industrial processes. In the first instance it is usually only necessary to carry out a core set of‘balance studies’representative of the common processes relevant to the plants or plant products containing significant residues. Justi fication should be given for the selection made of these representative process(es). The technology to be used in processing studies should always correspond as closely as possible to the actual conditions that are normally used in practice. A balance sheet should be made in which the mass balance of residues in all intermediate and end products is investigated. In drawing up such a balance sheet any concentrations or reductions in residues in individual products can be recognized and the corresponding transfer factors can also be determined. If the processed plant products play an important part in the diet, and if the‘balance study’indicates that a significant transfer of residue into the processed products could occur, then three‘follow-up studies’to determine residue concentration or dilution factors must be carried out. 6.6. Residues in succeeding crops Aim of the test The objective of these studies is to permit an evaluation of possible residues in succeeding crops. Circumstances in which required Where data generated in accordance with Schedule II, Section 7, point 7.1 or Schedule III, Section 9, point 9.1, shows that significant residues (> 10 % of the applied active substance as a total of unchanged active substance and its relevant metabolites or degradation products) remain in soil or in plant materials, such as straw or organic material up to sowing or planting time of possible succeeding crops, and which could lead to residues above the limit of determination in succeeding crops at harvest, consideration should be given to the residue situation. This should include consideration of the nature of the residue in the succeeding crops and involve at least a theoretical estimation of the level of these residues. If the likelihood of residues in succeeding crops can not be excluded, metabolism and distribution studies should be carried out, if necessary followed by field trials. Test conditions If a theoretical estimation of residues in succeeding crops is done, full details and a justification shall be be given. Metabolism and distribution studies and field trials, if necessary, shall be carried out on representative crops chosen to represent normal agricultural practice. 6.7. Proposed maximum residue levels (MRLs) and residue definiton A full justification for the proposed MRLs must be provided, including, where relevant, full details of the statistical analysis used. When judging which compounds are to be included in the residue definition, account has to be taken of the toxicological significance of the compounds, amounts likely to be present and the practicality of the analytical methods proposed for post-registration control and monitoring purposes. 6.8. Proposed pre-harvest intervals for envisaged uses, or withholding periods or storage periods, in the case of post-harvest uses A full justification for the proposals must be provided. 6.9. Estimation of the potential and actual exposure through diet and other means Consideration will be given to the calculation of a realistic prediction of dietary intake. This may be done in a step-wise fashion leading to an increasingly realistic predictions of intake. Where relevant, other sources of exposure such as residues arising from the use of medicines or veterinary drugs have to be taken into acocunt. 6.10. Summary and evaluation of residue behaviour A summary and evaluation of all data presented in this Section should be carried out according to the guidance given by the competent authority concerning the format of such summaries and evaluations. It should include a detailed and critical assessment of those data in the context of relevant evaluative and decision-making criteria and guidelines, with particular reference to the risks for man and animals that may or do arise, and the extent, quality and reliablity of the data base. In particular, the toxicological significance of any non-mammalian metabolites must be addressed. A schematic diagram should be prepared of the metabolic pathway in plants and animals with a brief explanation of the distribution and chemical changes involved. 7. Fate and behaviour in the environment Introduction (i) The information provided, taken together with that for one or more preparations containing the active substance, must be sufficient to pemit an assessment of the fate and behaviour of the active substance in the environment, and of the non-target species likely to be at risk from exposure to the active substance, its metabolites, degradation and reaction products, where they are of toxicological or environmental significance. (ii) In particular, the information provided for the active substance, together with other relevant information, and that provided for one or more preparations containing it, should be sufficient to: —decide whether, or not, the active substance can be included in Schedule I, —specify appropriate conditions or restrictions to be associated with any inclusion in Schedule I, —classify the active substance as to hazard; —specify the hazard symbols, the indications of danger, and relevant risk and safety phrases for the protection of the envi ronment, which are to be included on packaging (containers), —predict the disribution, fate, and behaviour in the environment of the active substance and relevant metabolites, degradation and reaction products as well as the times courses involved, —identify non-target species and populations for which hazards a rise because of potential exposure, and —identify measures necesary to minimize contamination of the environment and impact on non-target species. (iii) A detailed description (specification) of the material used, as provided for under Section 1, point 11 must be provided. Where testing is done using active substance the material used should be of that specification that will be used in the manu-facture of preparations to be authorized except where radio-labelled material is used. Where studies are conducted using active substance produced in the laboratory or in a pilot plant production system, the studies must be repeated using active substance as manufactured, unless it can be justified that the test material used is essentially the same for the purposes of environmental testing and assessment. (iv) Where radio-labeled test material is used, radio-labels should be positioned at sites (one or more as necessary), to facilitate eluci dation of metabolic and degradative pathways and to facilitate investigation of the distribution of the active substance and of its metabolite, reaction and degradation products in the environ ment. (v) It may be necessary to conduct separate studies for metabolites, degradation or reaction products, where these products can constitute a relevant risk to non-target organisms or to the quality of water, soil and air and where their effects cannot be evaluated by the available results relating to the active substance. Before such studies are performed the information from the Sections 5 and 6 has to be taken into account. (vi) Where relevant, tests should be designed and data analysed using appropriate statistical methods. Full details of the statistical anaylsis should be reported (e.g. all point estimates should be given with confidence intervals, exact p-values should be given rather than stating significant/non significant). 7.1. Fate and behaviour in soil All relevant information on the type and the properties of the soil used in the studies, including pH, organic carbon content, cation exchange capacity, particle size distribution and water holding capacity, particle size distribution and water holding capacity at pF = 0 and pF = 2,5 has to be reported in accordance with relevant ISO or other international standards. The microbial biomass of soils used for laboratory degradation studies must be determined just prior to the commencement and at the end of the study. It is recommended to use as much as possible the same soils throughout all laboratory soil studies. The soils used for degradation or mobility studies must be selected such that they are representative of the range of soils typical of the various Community regions where use exists or is anticipated, and be such that: —they cover a range of organic carbon content, particle size distri bution and pH values; and —where on the basis of other information, degradation or mobility are expected to be pH dependent (e.g. solubility and hydrolysis rate—paragraphs 2.7 and 2.8), they cover the following pH ranges: —4,5 to 5,5 —6 to 7, and —8 (approximately). Soils used must, wherever possible, be freshly sampled. If use of stored soils is unavoidable, storage should be properly carried out for a limited time under defined and reported conditions. Soils stored for longer periods of time can only be used for adsorption/desorption studies. The soil chosen to begin studying should not have extreme charac teristics with respect to parameters such as particle size distribution, organic carbon content and pH. Soils should be collected and handled in accordance with ISO 10381-6(Soil quality—Sampling—Guidance on the collection, handling and storage of soil for the assessment of microbial processes in the laboratory). Any deviations must be reported and justified. Field studies should be carried out in conditions as close to normal agricultural practice as possible on a range of soil types and climatic conditions representative of the area(s) of use. Weather conditions shall be reported in cases where field studies are conducted. 7.1.1. Route and rate of degradation 7.1.1.1. Route of degradation Aim of the tests The data and information provided, together with other relevant data and information, should be sufficient to: —identify, where feasable, the relative importance of the types of process involved (balance between chemical and biological degra-dation), —identify the individual components present which at any time account for more than 10 % of the amount of active substance added, including, where feasible, non-extractable residues, —identify where possible also individual components present which account for less than 10 % of the amount of active substance added, —establish the relative proportions of the components present (mass balance), and —permit the soil residue of concern and to which non-target species are or may be exposed, to be defined. Where a reference is made to non-extractable residues these are defined as chemical species originating from pesticides used according to good agricultural practice that cannot be extracted by methods which do not significantly change the chemical nature of these residues. These non-extractable residues are not considered to include fragments through metabolic pathways leading to natural products. 7.1.1.1.1. Aerobic degradation Circumstances in which required The degradation pathway or pathways must always be reported except where the nature and manner of use of preparations containing the active substance, preclude soil contamination such as uses on stored products or wound healing treatments for trees. Test conditions The degradation pathway or pathways must be reported for one soil. Results obtained must be presented in the form of schematic drawings showing the pathways involved, and in the form of balance sheets which show the distribution of radio-label as a function of time, as between: —active substance, —CO2, —volatile compounds other than CO2, —individual identified transformation products, —extractable substances not identified, and —non-extractable residues in soil. The investigation of degradation pathways must include all feasible steps to characterise and quantify non-extractable residues formed after 100 days when exceeding 70 % of the applied dose of the active substance. The techniques and methodologies applied are best selected on a case-by-case basis. A justification must be provided where the compounds involved are not characterized. The duration of the study is normally 120 days, except where after a shorter period the levels of non-extractable residues and CO2are such that they can be extrapolated in a reliable way to 100 days. Test guideline Setac—Procedures for assessing the environmental fate and ecotoxicity of pesticides (1). (1) Society of Environmental Toxicology and Chemistry (SETAC), 1995. Procedures for assessing the environmental fate and ecotoxicity of pesticides, ISBN 90-5607-002-9. 7.1.1.1.2. Supplementary studies —Anaerobic degradation Circumstances in which required An anaerobic degradation study must be reported unless it can be justified that exposure of the plant protection products containing the active substance to anaerobic conditions is unlikely to occur. Test conditions and test guideline The same provisions as provided for under the corresponding paragraph of point 7.1.1.1.1 apply. —Soil photolysis Circumstances in which required A soil photolysis study must be reported unless it can be justified that deposition of the active substance at the soil surface is unlikely to occur. Test guideline Setac—Procedures for assessing the Environmental fate and ecotoxicity of pesticides. 7.1.1.2. Rate of degradation 7.1.1.2.1. Laboratory studies Aim of the tests The soil degradation studies should provide best possible estimates of the time taken for degradation of 50 % and 90 % (DT50laband DT90lab), of the active substance, and of relevant metabolites, degra dation and reaction products under laboratory conditions. —Aerobic degradation Circumstances in which required The rate of degradation in soil must always be reported, except where the nature and manner of use of plant protection products containing the active substance preclude soil contamination such as uses on stored products or wound healing treatments for trees. Test conditions The rate of aerobic degradation of the active substance in three soil types additional to that referred to in paragraph 7.1.1.1.1. must be reported. In order to investigate the influence of temperature on degra dation, one additional study at 10oC has to be performed on one of the soils used for the investigation of degradation at 20oC until a validated Community calculation model for the extrapolation of degradation rates at low temperatures is available. The duration of the study is normally 120 days except if more than 90 % of the active substance is degraded before that period expires. Similar studies for three soil types must be reported for all relevant metabolites, degradation and reaction products which occur in soil and which at any time during the studies account for more than 10 % of the amount of active substance added, except where their DT50values were able to be determined from the results of the degradation studies with the active substance. Test guideline Setac—Procedures for assessing the environmental fate and ecotoxicity of pesticides. —Anaerobic degradation Circumstances in which required The rate of anaerobic degradation of the active substance must be reported where an anaerobic study has to be performed according to point 7.1.1.1.2. Test conditions The rate of anaerobic degradation of the active substance must be carried out in the soil used in the anaerobic study performed according to point 7.1.1.1.2. The duration of the study is normally 120 days except if more than 90 % of the active substance is degraded before that period expires. Similar studies for one soil must be reported for all relevant metobolites, degradation and reaction products which occur in soil and which at any time during the studies account for more than 10 % of the amount of active substance added, except where their DT50values were able to be determined from the results of the degradation studies with the active substance. Test guideline Setac—Procedures for assessing the environmental fate and ecotoxicity of pesticides. 7.1.1.2.2. Field studies —Soil dissipation studies Aim of the test The soil dissipation studies should provide estimates of the time taken for dissipation of 50 % and 90 % (DT50fand DT90f), of the active substance under field conditions. Where relevant, infor mation on relevant metabolites, degradation and reaction products must be reported. Circumstances in which required The tests have to be conducted in those conditions where DT50lab determined at 20oC and at a moisture content of the soil related to a pF value of 2 to 2,5 (suction pressure) is greater than 60 days. Where plant protection products containing the active substance are intended to be used in cold climatic conditions, the tests have to be conducted where DT50lab, determined at 10 oC and at a moisture content of the soil related to a pF value of 2 to 2,5 (suction pressure) is greater than 90 days. Test conditions Individual studies on a range of representative soils (normally four different types) must be continued until > 90 % of the amount applied have dissipated. The maximum duration of the studies is 24 months. Test guideline SETAC—Procedures for assessing the environmental fate and ecotoxicity of pesticides. —Soil residue studies Aim of the test Soil residue studies should provide estimates of the soil residue levels at harvest or at time of cowing or planting succeeding crops. Circumstances in which required Soil residue studies must be reported where DT50labis greater than one-third of the period between the application and harvest and where absorption by the succeeding crop is possible, except where soil residues at sowing or planting of a succeeding crop can be reliably estimated from the data of the soil dissipation studies or where it can be justified that these residues can not be phytotoxic to or leave unacceptable residues in rotational crops. Test conditions Individual studies must be continued until harvest or time of sowing or planting succeeding crops, unless > 90 % of the amount applied have dissipated. Test guideline SETAC—Procedures for assessing the environmental fate and ecotoxicity of pesticides. —Soil accumulation studies Aim of the tests The tests should provide sufficient data to evaluate the possibility of accumulation of residues of the active substance and of relevant metabolites, degradation and reaction products. Circumstances in which required Where on the basis of soil dissipation studies it is established that DT90f> one year and where repeated application is envisaged, whether in the same growing season or in succeeding years, the possibility of accumulation of residues in soil and the level at which a plateau concentration is achieved must be investigated except where reliable information can be provided by a model calculation or another appropriate assessment. Test conditions Long term field studies must be done on two relevant soils and involve multiple applications. Before performing these studies the applicant shall seek the agreement of the competent authorities on the type of study to be performed. 7.1.2. Adsorption and desorption Aim of the test The data and information provided, together with other relevant data and information, should be sufficient to establish the absorption coef-ficient of the active substance and of relevant metabolites, degra-dation and reaction products. Circumstances in which required The studies must always be reported except where the nature and manner of use of preparations containing the active substance, preclude soil contamination such as uses on stored products or wound healing trees. Testo conditions Studies on the active substance must be reported for four soil types. Similar studies, for at least three soil types, must be reported for all relevant metabolites, degradation and reaction products which in soil degradation studies account at any time for more than 10 % of the amount of active substance added. Test guideline OECD method 106 7.1.3. Mobility in the soil 7.1.3.1. Column leaching studies Aim of the test The test should provide sufficient data to evaluate the mobility and leaching potential of the active substance and if possible of relevant metabolities, degradation and reaction products. Circumstances in which required Studies in four soils must be carried out where in the absorption and desorption studies provided for under point 7.1.2 it is not possible to obtain reliable absorption coefficient values. Test guideline SETAC—Procedures for assessing the environmental fate and ecotoxicity of pesticides. 7.1.3.2. Aged residue column leaching Aim of the test The test should provide sufficient data to estimate the mobility and leaching potential of relevant metabolites, degradation and reaction products. Circumstances in which required The studies must be performed except: —where the nature and manner of use of preparations containing the active substance, preclude soil contamination such as uses on stored products or wound healing treatments for trees, or —where a separate study for the metabolite, degradation or reaction product in accordance to point 7.1.2 or 7.1.3.1 was performed. Test conditions The period(s) of ageing should be determined from inspection of the degradation patterns of active substance and metabolites to ensure that a relevant spectrum of metabolites is present at the time of leaching. Test guideline SETAC—Procedures for assessing the environmental fate and ecotoxicity of pesticides. 7.1.3.3. Lysimeter studies or field leaching studies Aim of the tests The test should provide data on: —the mobility in soil, —the potential for leaching to ground water, —The potential distribution in soil. Circumstances in which requried Expert judgement will be necessary to decide whether lysimeter studies or field leaching studies should be carried out, taking into account the results of degradation and other mobility studies and the predicted environmental concentrations in groundwater (PECGW), calculated in accordance with the provisions of Schedule III, Section 9. The type and conditions of the study to be conducted should be discussed with the competent authorities. Test conditions Great care is necessary in design of both experimental installations and individual studies, to ensure that results obtained can be used for assessment purposes. Studies should cover the realistic worst case situation, taking into account the soil type, climatic conditions, the application rate and the frequency and period of application. Water percolating from soil columns must be analyzed at suitable intervals, while residues in plant material must be determined at harvest. Residues in the soil profile in at least five layers must be determined on termination of experimental work. Intermediate sampling must be avoided, since removal of plants (except for harvesting according to normal agricultural practice) and soil cross influences the leaching process. Precipitation, soil and air temperatures have to be recorded at regular intervals (at least on a weekly base). —Lysimeterstudies Test conditions The minimal depth of the lysimeters should be 100 cm; their maximal depth should be 130 cm. The soil cross must be undis turbed. Soil temperatures must be similar to those pertaining in the field. Where necessary, supplementary irrigation must be provided to ensure optimal plant growth and to ensure that the quantity of infiltration water is similar to that in the regions for which authorization is sought. When during the study the soil has to be disturbed for agricultural reasons it must not be disturbed deeper than 25 cm. —Field leaching studies Test conditions Information on the groundwater table in the experimental fields must be submitted. If soil cracking is observed during the study this must be fully described. Great attention should be given to the number and the location of water collection devices. The placement of these devices in the soil should not result in preferential flow paths. Test guideline SETAC—Procedures for assessing the environmental fate and ecotoxicity of pesticides. 7.2. Fate and behaviour in water and air Aim of the tests The information and data provided, taken together with that provided for one or more preparations containing the active substance, and other relevant information, should be sufficient to establish, or permit estimation of: —persistence in water systems (bottom sediment and water, including suspended particles), —the extent to which water, sediment organisms and air are at risk, —potential for contamination of surface water and groundwater. 7.2.1. Route and rate of degradation in aquatic systemes (as far as not covered by point 2.9) Aim of the tests The data and information provided, together with other relevant data and information, should be sufficient to: —identify the relative importance of the types of processes involved (balance between chemical and biological degradation), —where possible, identify the individual components present, —establish the relative proportions of the components present and their distribution as between water, including suspended particles, and sediment, and —permit the residue of concern and to which non-target species are or may be exposed, to be defined. 7.2.1.1. Hydrolytic degradation Circumstances in which required The test must always be performed for relevant metabolites, degra dation and reaction products which account at any time for more than 10 % of the amount of active substance added unless sufficient information on their degradation is available from the test performed in accordance with point 2.9.1. Test conditions and test guideline The same provisions as provided under the corresponding paragraphs of point 2.9.1 apply. 7.2.1.2. Photochemical degradation Circumstances in which required The test must always be performed for relevant metabolites, degra dation and reaction products which account at any time for more than 10 % of the amount of active substance added unless sufficient information on their degradation is available from the test performed in accordance with points 2.9.2 and 2.9.3. Test conditions and test guideline The same provisions as provided under the corresponding paragraphs of points 2.9.2 and 2.9.3 apply. 7.2.1.3. Biological degradation 7.2.1.3.1.‘Ready biodegradability’ Circumstances in which required The test must always be performed unless it is not required under the provisions of Annex VI to Directive 67/548/EEC for the classification of the active substance. Test guideline EEC method C4. 7.2.1.3.2. Water/sediment study Circumstances in which required The test must be reported unless it can be justified that contamination of surface water will not occur. Test guideline SETAC—Procedures for assessing the environmental fate and ecotoxicity of pesticides. 7.2.1.4. Degradation in the saturated zone Circumstances in which required Transformation rates in the saturated zone of active substances and of relevant metabolites, degradation and reaction products can provide useful information on the fate of these substances in the groundwater. Test conditions Expert judgement is required to decide whether this information is necessary. Before performing these studies the applicant shall seek the agreement of the competent authorities on the type of study to be performed. 7.2.2. Route and rate of degradation in air (as far as not covered by point 2.10) Guidance under development. 7.3. Definition of the residue In the light of the chemical composition of residues occurring in soil, water or air, resulting from use, or proposed use, of a plant protection product containing the active substance a proposal for the definition of the residue must be submitted, taking account of both the levels found and their toxicological and environmental significance. 7.4. Monitoring data Available monitoring data concerning fate and behaviour of the active substance and relevant metabolites, degradation and reaction products must be reported. 8. Ecotoxicological studies Introduction (i) The information provided, taken together with that for one or more preparations containing the active substance, must be sufficient to permit an assessment of the impact on non-target species (flora and fauna), likely to be at risk from exposure to the active substance, its metabolites, degradation and reaction products, where they are of environmental significance. Impact can result from single, prolonged or repeated exposure and can be reversible or irreversible. (ii) In particular, the information provided for the active substance, together with other relevant information, and that provided for one or more preparations containing it, should be sufficient to: —decide whether, or not, the active substance can be included in Schedule I, —specify appropriate conditions or restrictions to be associated with any inclusion in Schedule I, —permit an evaluation of short- and long-term risks for non target species—populations, communities, and processes— as appropriate, —classify the active substance as to hazard, —specify the precautions necessary for the protection of non target species, and —specify the hazard symbols, the indications of danger, and relevant risk and safety phrases for the protection of the envi ronment, to be mentioned on packaging (containers). (iii) There is a need to report all potentially adverse effects found during routine ecotoxicological investigations and to undertake and report, where required by the competent authorities, such additional studies which may be necessary to investigate the probable mechanisms involved and assess the significance of these effects. All available biological data and information which is relevant to the assessment of the ecotoxicological profile of the active substance must be reported. (iv) The information on fate and behaviour in the environment, generated and submitted in accordance with points 7.1 to 7.4, and on residue levels in plants generated and submitted in accordance with point 6 is central to the assessment of impact on non-target species, in that together with information on the nature of the preparation and its manner of use, it defines the nature and extent of potential exposure. The toxicokinetic and toxicological studies and information submitted in accordance with points 5.1 to 5.8 provide essential information as to toxicity to vertebrate species and the mechanisms involved. (v) Where relevant, tests should be designed and data analysed using appropriate statistical methods. Full details of the statistical analysis should be reported (e. g. all point estimates should be given with confidence intervals, exact p-values should be given rather than stating significant/non significant). Test substance (vi) A detailed description (specification) of the material used, as provided for under point 1.11 must be provided. Where testing is done using active substance the material used should be of that specification that will be used in the manufacture of preparations to be authorized except where radiolabelled material is used. (vii) Where studies are conducted using active substance produced in the laboratory or in a pilot plant production system, the studies must be repeated using active substance as manufactured, unless it can be justified that the test material used is essentially the same, for the purposes of ecotoxicological testing and assessment. In cases of uncertainty, appropriate bridging studies must be submitted to serve as a basis for a decision as to the possible need for repetition of the studies. (viii) In the case of studies in which dosing extends over a period, dosing should preferably be done using a single batch of active substance if stability permits. Whenever a study implies the use of different doses, the rela tionship between dose and adverse effect must be reported. (ix) For all feeding studies, average achieved dose must be reported, including where possible the dose in mg/kg body weight. Where dosing via the diet is utilized the test compound must be distributed uniformly in the diet. (x) It may be necessary to conduct separate studies for metabolites, degradation or reaction products, where these products can constitute a relevant risk to non-target organisms and where their effects cannot be evaluated by the available results relating to the active substance. Before such studies are performed the information from points 5, 6 and 7 has to be taken into account. Test organisms (xi) In order to facilitate the assessment of the significance of test results obtained, including the estimation of intrinsic toxicity and the factors affecting toxicity, the same strain (or recorded origin) of each relevant species should, where possible, be used in the various toxicity tests specified. 8.1. Effects on birds 8.1.1. Acute oral toxicity Aim of the test The test should provide, where possible, LD50values, the lethal threshold dose, time courses of response and recovery and the NOEL, and must include relevant gross pathological findings. Circumstances in which required The possible effects of the active substance on birds must be inves tigated except where the active substance is intended solely to be included in preparations for exclusive use in enclosed spaces (e.g. in glasshouses or in food storage practice). Test conditions The acute oral toxicity of active substance to a quail species (Japanese quail(Coturnix coturnix japonica)or Bobwhite quail (Colinus virginianus)or to mallard duck(Anas platyrhynchos)must be determined. The highest dose used in tests need not exceed 2 000 mg/kg body weight. Test guideline Setac—Procedures for assessing the environmental fate and ecotoxicity of pesticides (1). (1) Society of Environmental Toxicology and Chemistry (Setac), 1995.Procedures for Assessing the Environmental Fate and Ecotoxicity of Pesticides,ISBN 90-5607-002-9. 8.1.2. Short-term dietary toxicity Aim of the test The test should provide the short term dietary toxicity (LC50values, lowest lethal concentration (LLC), where possible no observed effect concentrations (NOEC), time courses of response and recovery) and include relevant gross pathological findings. Circumstances in which required The dietary (five-day) toxicity of the active substance to birds must always be investigated on one species except where a study in accordance with the provisions of point 8.1.3 is reported. Where its acute oral NOEL is=500 mg/kg body weight or where the short-term NOEC < 500 mg/kg food the test must be performed on a second species. Test conditions The first species to be studied must be either a quail species or mallard duck. If a second species must be tested it should not be related to the first species tested. Test guideline The test must be carried out in accordance with OECD Method 205. 8.1.3. Subchronic toxicity and reproduction Aim of the test The test should provide the subchronic toxicity and reproductive toxicity of the active substance to birds. Circumstances in which required The subchronic and reproductive toxicity of the active substance to birds must be investigated, unless it can be justified that continued or repeated exposure of adults, or exposure of nest sites during the breeding season is unlikely to occur. Test guideline The test must be carried out in accordance with OECD Method 206. 8.2. Effects on aquatic organisms The data of the tests referred to in points 8.2.1, 8.2.4 and 8.2.6 have to be submitted for every active substance even when it is not expected that plant protection products containing it could reach surface water following the proposed conditions of use. These data are required under the provisions of Annex VI to Directive 67/548/EEC for the classification of the active substance. Data reported must be supported with analytical data on concen trations of the test substance in the test media. 8.2.1. Acute toxicity to fish Aim of the test The test should provide the acute toxicity (LC50), and details of observed effects. Circumstances in which required The test must always be carried out. Test conditions The acute toxicity of the active substance must be determined for rainbow trout(Oncorhynchus mykiss)and for a warm water fish species. Where tests with metabolites, degradation or reaction products have to be performed the species used must be the more sensitive of the two species tested with the active substance. Test guideline The test must be carried out in accordance with the Annex to Commission Directive 92/69/EEC adapting to technical progress for the 17th time Directive 67/548/EEC on the approximation of laws, regulations and administrative provisions relating to the classi fication and labelling of dangerous, substances, Method C1. 8.2.2. Chronic toxicity to fish Circumstances in which required A chronic toxicity study must be carried out unless it can be justified that continued or repeated exposure of fish is unlikely to occur or unless a suitable microsom or mesocosm study is available. Expert judgment is required to decide which test has to be performed. In particular for active substance for which there are indications of particular concerns (related to the toxicity of the active substance for fish or the potential exposure) the applicant shall seek the agreement of the competent authorities on the type of test to be performed. A fish early life stage toxicity test might be appropriate where bioconcentration factors (BCF) are between 100 and 1 000 or where EC50of the active substance < 0,1 mg/l. A fish life cycle test might be appropriate in cases where —the bioconcentration factor is greater tan 1 000 and the elimi nation of the active substance during a depuration phase of 14 days is lower than 95 %, or —the substance is stable in water or sediment (DT90> 100 days). It is not necessary to perform a chronic toxicity test on juvenile fish when a fish early life stage toxicity test or a fish life cycle test has been performed; it is likewise not necessary to perform a fish early life stage toxicity test when a fish life cycle test has been performed. 8.2.2.1. Chronic toxicity test on juvenile fish Aim of the test The test should provide effects on growth, the threshold level for lethal effects and for observed effects, the NOEC and details of observed effects. Test conditions The test must be conducted on juvenile rainbow trout, following exposure of 28 days to the active substance. Data on the effects on growth and behaviour must be generated. 8.2.2.2. Fish early life stage toxicity test Aim of the test The test should provide effects on development, growth and behaviour, the NOEC and details of observed effects on fish early life stages. Test guideline The test must be carried out in accordance with OECD Method 210. 8.2.2.3. Fish life cycle test Aim of the test The test will provide effects on reproduction of the parental and the viability of the filial generation. Test conditions Before performing these studies the applicant shall seek the agreement of the competent authorities on the type and conditions of the study to be performed. 8.2.3. Bioconcentration in fish Aim of the test The test should provide the steady-state bioconcentration factors, uptake rate constants and depuration rate constants, calculated for each test compound, as well as relevant confidence limits. Circumstances in which required The bioconcentration potential of active substances, of metabolites and of degradation and reaction products, likely to partition into fatty tissues (such as log pow=3—see point 2.8 or other relevant indications of bioconcentration), must be investigated and be reported, unless it can be justified that exposure leading to biocon centration is not likely to occur. Test guideline The test must be carried out in accordance with OECD Method 305E. 8.2.4. Acute toxicity to aquatic invertebrates Aim of the test The test should provide the 24 and 48-hour acute toxicity of the active substance, expressed as the median effective concentration (EC50) for immobilization, and where possible the highest concen tration causing no immobilization. Circumstances in which required The acute toxicity must always be determined forDaphnia (preferablyDaphnia magna). Where plant protection products containing the active substance are intended to be used directly on surface water additional data have to be reported on at least one representative species from each of the following groups: aquatic insects, aqautic crustaceans (on a species not related toDaphnia) and aquatic gastropod molluscs. Test guideline The test must be carried out in accordance with Directive 92/69/EEC, Method C2. 8.2.5. Chronic toxicity to aquatic invertebrates Aim of the test The test should provide where possible EC50values for effects such as immobilization and reproduction and the highest concentration at which no effect such as on martality or reproduction occurs (NOEC) and details of observed effects. Circumstances in which required A test onDaphniaand on at least one representative aquatic insect species and an aquatic gastropod mollusc species must be carried out unless it can be justified that continued or repeated exposure is not likely to occur. Test conditions The test withDaphniamust be continued for 21 days. Test guideline The test must be carried out in accordance with OECD Method 202, Part II. 8.2.6. Effects on algal growth Aim of the test The test should procide EC50values for growth and growth rate, NOEC values, and details of observed effects. Circumstances in which required Possible effects on algal growth of active substances must always be reported. For herbicides a test on a second species from a different taxonomic group has to be performed. Test guideline The test must be carried out in accordance with Directive 92/69/EEC, Method C3. 8.2.7. Effects on sediment dwelling organisms Aim of test The test will measure effects on survival and development (including effects on emergence of adults forChironomus),the relevant EC50 values and the NOEC values. Circumstances in which required Where environmental fate and behaviour data required in point 7 report that an active substance is likely to partition to and persist in aquatic sediments, expert judgement should be used to decide whether an acute or a chronic sediment toxicity test in required. Such expert judgement should take into account whether effects on sediment dwelling invertebrates are likely by comparing the aquatic invertebrate toxicity EC50data from points 8.2.4 and 8.2.5 with the predicted levels of the active substances in sediment from data in Schedule III, point 9. Test conditions Before performing these studies the applicant shall seek the agreement of the competent authorities on the type and conditions of the study to be performed. 8.2.8. Aquatic plants A test on aquatic plants has to be performed for herbicides. Before performing these studies the applicant shall seek the agreement of the competent authorities on the type and conditions of the study to be performed. 8.3. Effect on arthropods 8.3.1. Bees 8.3.1.1. Acute toxicity Aim of the test The test should provide the acute oral and contact LD50value of the active substance. Circumstances in which required Potential impact on bees must be investigated, except where preparations containing the active substance are for exclusive use in situations where bees are not likely to be exposed such as: —food storage in enclosed spaces, —non-systemic seed dressings, —non-systemic preparations for application to soil, —non-systemic dipping treatments for transplanted crops and bulbs, —wound sealing and healing treatments, —rodenticidal baits, —use in glasshouses without pollinators. Test guideline The test must be carried out in accordance with EPPO Guideline 170. 8.3.1.2. Bee brood feeding test Aim of the test The test should provide sufficient information to evaluate possible risks from the plant protection product on honeybee larvae. Circumstances in which required The test must be carried out when the active substance may act as an insect growth regulator unless it can be justified that it is not likely that bee brood would be exposed to it. Test guideline The test must be carried out in accordance with ICPBR Method (e.g. P. A. Oomen, A. de Riujter and J. van der Steen. Method for honeybee brood feeding tests with insect growth-regulating insec ticides.EPPO Bulletin,Volume 22, pp 613 to 616, 1992.) 8.3.2. Other arethropods Aim of the test The test should provide sufficient information to evaluate the toxicity (mortality and sublethal effects) of the active substance to selected arthropod species. Circumstances in which required Effects on non-target terrestrial arthropods (e.g. predators or para sitoids of harmful organisms) must be investigated. The information obtained for these species can also be used to indicate the potential for toxicity to other non-target species inhabiting the same environ ment. This information is required for all active substances except where preparations containing the active substance are for exclusive use in situations where non-target arthropods are not exposed such as: —food storage in enclosed spaces, —wound sealing and healing treatments, —rodenticidal baits. Test conditions The test must be performed initially in the laboratory on an artificial substrate (i.e. glass plate or quartz sand, as appropriate) unless adverse effects can be clearly predicted from other studies. In these cases, more realistic substrates may be used. Two sensitive standard species, a parasitoid and predatory mite (e.g. Aphidius rhopalosiphiandTyphlodromus pyri)should be tested. In addition to these, two additional species must also be tested, which should be relevant to the intended use of the substance. Where possible and if appropriate, they should represent the other two major functional groups, ground dwelling predators and foliage dwelling predators. Where effects are observed with species relevant to the proposed use of the product, further testing may be carried out at the extended laboratory/semi-field level. Selection of the relevant test species should follow the proposals outlined in Setac — Guidance document on regulatory testing procedures for pesticides with non-target arthropods (1). Testing must be conducted at rates equivalent to the highest rate of field application to be recommended. Test guideline Where relevant, testing should be done according to appropriate guidelines which satisfy at least the requirements for testing as included in Setac—Guidance document on regulatory testing procedures for pesticides with non-target arthropods. (1) From the Workshop European Standard Characteristics of beneficials Regulatory Testing (Escort), 28 to 30 March 1994, ISBN 0-95-22535-2-6. 8.4. Effects on earthworms 8.4.1. Acute toxicity Aim of the test The test should provide the LC50value of the active substance to earthworms, where possible the highest concentration causing no mortality and the lowest concentration causing 100 % mortality, and must include observed morphological and behavioural effects. Circumstances in which required Effects on earthworms must be investigated, where preparations containing the active substance are applied to soil, or can contaminate soil. Test guideline The test must be carried out in accordance with Commission Directive 88/302/EEC adapting to technical progress for the ninth time Council Directive 67/548/EEC on the approximation of laws, regulations and administrative provisions relating to the classi fication, packaging and labelling of dangerous substances, Part C, Toxicity for earthworms: Artificial soil test. 8.4.2. Sublethal effects Aim of the test The test should provide the NOEC and the effects on growth, repro duction and behaviour. Circumstances in which required Where on the basis of the proposed manner of use of preparations containing the active substance or on the basis of its fate and behaviour in soil (DT90> 100 days), continued or repeated exposure of earthworms to the active substance, or to significant quantities of metabolites, degradation or reaction products, can be anticipated expert judgement is required to decide whether a sublethal test can be useful. Test conditions The test must be carried out onEisenia foetida. 8.5. Effects on soil non-target micro-organisms Aim of the test The test should provide sufficient data to evaluate the impact of the active substance on soil microbial activity, in terms of nitrogen trans formation and carbon mineralization. Circumstances in which required The test must be carried out where preparations containing the active substance are applied to soil or can contaminate soil under practical conditions of use. In the case of active substances intended for use in preparations for soil sterilization, the studies must be designed to measure rates of recovery following treatment. Test conditions Soils used must be freshly sampled agricultural soils. The sites from which soil is taken must not have been treated during the previous two years with any substance that could substantially alter the diversity and levels of microbial populations present, other than in a transitory manner. Test guideline Setac—Procedures for assessing the environmental fate and ecotoxicity of pesticides. 8.6. Effects on other non-target organisms (flora and fauna) believed to be at risk A summary of available data from preliminary tests used to assess the biological activity and dose range finding, whether positive or negative, which may provide information with respect to possible impact on other non-target species, both flora and fauna, must be provided, together with a critical assessment as to its relevance to potential impact on non-target species. 8.7. Effects on biological methods for sewage treatment Effects on biological methods for sewage treatment must be reported where the use of plant protection products containing the active substance can give rise to adverse effects on sewage treatment plants. 9. Summary and evaluation of points 7 and 8 10. Proposals including justification for the proposals for the classifi cation and labelling of the active substance according to Council Directive 67/548/EEC —Hazard symbol(s) —Indications of danger —Risk phrases —Safety phrases 11. A dossier as referred to in Schedule III, part A, for a representative plant protection product PART B Introduction (i) Active substances are defined in regulation 2(4) and include chemical substances and micro-organisms including viruses. This Part provides data requirements for active substances consisting of micro-organisms, including viruses. For the purposes of Schedule II, Part B, the term‘micro-organism’is used and is defined as follows:‘A microbiological entity, cellular or non cellular, capable of replication or of transferring genetic material’. The definition applies to, but is not limited to, bacteria, fungi, protozoa, viruses and viroids. (ii) For all micro-organisms that are subject to application all available relevant knowledge and information in literature should be provided. The most important and informative information is obtained by the char acterisation and identification of a micro-organism. Such information is found in sections 1 to 3 (identity, biological properties and further infor mation) which form the basis for an assessment of human health and environmental effects. Newly generated data from conventional toxicological and/or pathological experiments on laboratory animals are normally required unless the applicant can justify, on the basis of the previous information, that the use of the micro-organism, under the proposed conditions of use, does not have any harmful effects on human and animal health or on groundwater or any unacceptable influence on the environment. (iii) Pending the acceptance of specific guidelines at international level, the information required shall be generated using available test guidelines accepted by the director (e.g. USEPA guideline (1)); where appropriate test guidelines as described in Schedule II, Part A, should be adapted in such a way that they are appropriate for micro-organisms. Testing should include viable and, if appropriate, non-viable micro-organisms, and a blank control. (iv) Where testing is done, a detailed description (specification) of the material used and its impurities, according to the provisions of section 1, point 1.4, must be provided. The material used should be of that specification that will be used in the manufacture of preparations to be authorised. Where studies are conducted using micro-organisms produced in the laboratory or in a pilot plant production system, the studies must be repeated using micro-organisms as manufactured, unless it can be demon strated that the test material used is essentially the same for the purposes of the testing and assessment. (v) Where the micro-organism has been genetically modified, as defined in Directive 2001/18/EC of the European Parliament and of the Council of 12 March 2001 on the deliberate release into the environment of genetically modified organisms and repealing Council Directive 90/220/EEC, a copy of the evaluation of the data concerning the assessment of risk to the environ-ment, as stated in Article 1(3) of Directive 91/414/EEC, has to be submitted. (vi) Where relevant, data should be analysed using appropriate statistical methods. Full details of the statistical analysis should be reported (e.g. all point estimates should be given with confidence intervals, exact p-values should be given rather than stating significant/non significant). (vii) In the case of studies in which dosing extends over a period, dosing should preferably be done using a single batch of the micro-organism, if stability permits. If the studies are not performed using a single batch of the micro organism, the similarity of the different batches has to be stated. Whenever a study implies the use of different doses, the relationship between dose and adverse effect must be reported. (viii) If the plant protection action is known to be due to the residual effect of a toxin/metabolite or if significant residues of toxins/metabolites are to be expected not related to the effect of the active substance, a dossier for the toxin/metabolite has to be submitted in accordance with the requirements of Schedule II, Part A. (1)USEPA Microbial Pesticide Test Guidelines, OPPTS Series 885, February 1996(http://www.epa.gov/oppbppd1/biopesticides/guidelines/series885.htm). 1. IDENTITY OF THE MICRO-ORGANISM The identification together with the characterisation of the micro-organism provides the most important information and is a key point for decision-making. 1.1. Applicant The name and address of the applicant (permanent community address) must be provided, as must the name, position, telephone and fax number of the appropriate person to contact. Where, in addition, the applicant has an office, agent or representative in the Member State to which the application for inclusion in Schedule I is submitted, and if different, in the rapporteur Member State appointed by the Commission, the name and address of the local office, agent or representative must be provided, as must the name, position, telephone and fax number of the appropriate person to contact. 1.2. Producer The name and address of the producer or producers of the micro organism must be provided as must the name and address of each plant in which the micro-organism is produced. A contact point (preferably a central contact point, to include name, telephone and fax number) must be provided, with a view to providing updating information and responding to queries arising, regarding production technology, processes and the quality of product (including where relevant, individual batches). Where, following inclusion of the micro-organism in Schedule I, there are changes in the location or number of producers, the information required must again be notified to the Commission and the Member States. 1.3. Name and species description, strain characterisation (i) The micro-organism should be deposited at an internationally recognised culture collection and given an accession number and these details must be submitted. (ii) Each micro-organism that is subject to the application should be identified and named at the species level. The scientific name and taxonomic grouping, i.e. family, genus, species, strain, serotype, pathovar or any other denomination relevant to the micro organism, must be stated. It must be indicated whether the micro-organism: —is indigenous or non-indigenous at the species level to the intended area of application, —is a wild type, —is a spontaneous or induced mutant, —has been modified, using techniques described in Annex IA, Part 2, and Annex IB to Directive 2001/18/EEC. In the latter two cases, all known differences between the modified micro-organism and the parent wild strain must be provided. iii) Best available technology should be used to identify and charac terise the micro-organism at the strain level. The appropriate test procedures and criteria used for identification (e.g. morphology, biochemistry, serology, molecular identification) must be provided. iv) Common name or alternative and superseded names and code names used during the development, if any, must be provided. (v) Relationships to known pathogens should be indicated. 1.4. Specification of the material used for manufacturing of formulated products 1.4.1. Content of the micro-organism The minimum and maximum content of the micro-organism in the material used for manufacturing of formulated products, must be reported. The content should be expressed in appropriate terms, such as number of active units per volume or weight or any other manner that is relevant to the micro-organism. Where the information provided relates to a pilot plant production system, the information required must again be provided to the Commission and the Member States once industrial scale production methods and procedures have stabilised, if production changes result in a changed specification of purity. 1.4.2. Identity and content of impurities, additives, contaminating micro organisms It is desirable to have a plant protection product without contaminants (including contaminating micro-organisms), if possible. The level and nature of acceptable contaminants should be judged from a risk assessment point of view, by the director. If possible and appropriate, the identity and maximum content of all contaminating micro-organisms, expressed in the appropriate unit, must be reported. The information on identity must be provided where possible as outlined in Schedule II, Part B, section1, point 1.3. Relevant metabolites (i.e. if expected to be of concern to human health and/or the environment) known to be formed by the micro organism should be identified and characterised at different states or growth stages of the micro-organism (see Schedule IIB, Introduction, (viii)). Where relevant detailed information on all components such as condensates, culture medium, etc. must be provided. In the case of chemical impurities that are relevant for human health and/or the environment, the identity and maximum content, expressed in appropriate terms, must be provided. In the case of additives, the identity and content in g/kg must be provided. The information on identity of chemical substances such as additives must be provided as outlined in Schedule II, Part A, section 1, point 1.10. 1.4.3. Analytical profile of batches Where relevant, the same data as outlined in Schedule II, Part A, section 1, point 1.11, have to be reported, using the appropriate units. 2. BIOLOGICAL PROPERTIES OF THE MICRO-ORGANISM 2.1. History of the micro-organism and its uses. Natural occurrence and geographical distribution Familiarity, interpreted as the availability of relevant knowledge of the micro-organism, should be presented. 2.1.1. Historical background The historical background of the micro-organism and its use (tests/re search projects or commercial use) must be provided. 2.1.2. Origin and natural occurrence The geographical region and the place in the ecosystem (e.g. host plant, host animal, or soil from which the micro-organism was isolated) must be stated. The method of isolation of the micro organism should be reported. The natural occurrence of the micro organism in the relevant environment shall be given if possible at strain level. In the case of a mutant, or a genetically modified micro-organism (as defined in Annex IA, Part 2, and Annex IB to Directive 2001/18/EEC), detailed information should be provided on its production and isolation and on the means by which it can be clearly distinguished from the parent wild strain. 2.2. Information on target organism(s) 2.2.1. Description of the target organism(s) Where relevant, details of harmful organisms against which protection is afforded, must be provided. 2.2.2. Mode of action The principal mode of action should be indicated. In connection with the mode of action it should also be stated if the micro-organism produces a toxin with a residual effect on the target organism. In that case, the mode of action of this toxin should be described. If relevant, information on the site of infection and mode of entry into the target organism and its susceptible stages should be given. The results of any experimental studies must be reported. It should be stated by which way an uptake of the micro-organism, or its metabolites (especially toxins) may occur (e.g. contact, stomach, inhalation). It must also be stated whether or not the micro-organism or its metabolites are translocated in plants and, where relevant, how this translocation takes place. In case of pathogenic effect on the target organism, infective dose (the dose needed to cause infection with the intended effect on a target species) and transmissibility (possibility of spread of the micro organism in the target population, but also from one target species to another (target) species) after application under the proposed condition of use shall be indicated. 2.3. Host specificity range and effects on species other than the target harmful organism Any available information on the effects on non-target organisms within the area to which the micro-organism may spread shall be given. The occurrence of non-target organisms being either closely related to the target species or being especially exposed shall be indicated. Any experience of the toxic effect of the active substance or its metabolic products on humans or animals, of whether the organism is capable of colonising or invading humans or animals (including immunosuppressed individuals) and whether it is pathogenic shall be stated. Any experience of whether the active substance or its products may irritate skin, eyes or respiratory organs of humans or animals and whether it is allergenic in contact with skin or when inhaled shall be stated. 2.4. Development stages/life cycle of the micro-organism Information on the life cycle of the micro-organism, described symbiosis, parasitism, competitors, predators, etc., including host organisms, as well as vectors for viruses, must be presented. The generation time and the type of reproduction of the micro organism must be stated. Information on the occurrence of resting stages and their survival time, their virulence and infection potential must be provided. The potential of the micro-organism to produce metabolites, including toxins that are of concern for human health and/or the environment, in its different development stages after the release, must be indicated. 2.5. Infectiveness, dispersal and colonisation ability The persistence of the micro-organism and information on its life cycle under the typical environmental conditions of use must be indicated. In addition, any particular sensitivity of the micro-organism to certain compartments of the environment (e.g. UV light, soil, water) must be stated. The environmental requirements (temperature, pH, humidity, nutrition requirements, etc.) for survival, reproduction, colonisation, damage (including human tissues) and effectiveness of the micro-organism must be stated. The presence of specific virulence factors should be indicated. The temperature range at which the micro-organism grows must be determined, including minimum, maximum and optimum temperatures. This information is of particular value as a trigger for studies of effects on human health (section 5). The possible effect of factors such as temperature, UV light, pH, and the presence of certain substances on the stability of relevant toxins must also be stated. Information on possible dispersal routes of the micro-organism (via air as dust particles or aerosols, with host organisms as vectors, etc.), under typical environmental conditions relevant to the use, must be provided. 2.6. Relationships to known plant or animal or human pathogens The possible existence of one or more species of the genus of the active and/or, where relevant, contaminating micro-organisms known to be pathogenic to humans, animals, crops or other non-target species and the type of disease caused by them shall be indicated. It shall be stated whether it is possible, and if so, by which means to clearly distinguish the active micro-organism from the pathogenic species. 2.7. Genetic stability and factors affecting it Where appropriate, information on genetic stability (e.g. mutation rate of traits related to the mode of action or uptake of exogenous genetic material) under the environmental conditions of proposed use must be provided. Information must also be provided on the micro-organism's capacity to transfer genetic material to other organisms as well as its capacity to being pathogenic for plants, animals or man. If the micro-organism carries relevant additional genetic elements, the stability of the encoded traits should be indicated. 2.8. Information on the production of metabolites (especially toxins) If other strains belonging to the same microbial species as the strain subject to the application are known to produce metabolites (especially toxins) with unacceptable effects on human health and/or the environ-ment during or after application, the nature and structure of this substance, its presence inside or outside the cell and its stability, its mode of action (including external and internal factors of the micro-organism necessary to action) as well as its effect on humans, animals or other non-target species shall be provided. The conditions under which the micro-organism produces the meta bolite(s) (especially toxin(s)) must be described. Any available information on the mechanism by which the micro organisms regulate the production of the(se) metabolite(s) should be provided. Any available information on the influence of the produced meta bolites on the micro-organism's mode of action should be provided. 2.9. Antibiotics and other anti-microbial agents Many micro-organisms produce some antibiotic substances. Inter ference with the use of antibiotics in human or veterinary medicine must be avoided at any stage of the development of a microbial plant protection product. Information on the micro-organism's resistance or sensitivity to anti biotics or other anti-microbial agents must be provided, in particular the stability of the genes coding for antibiotic resistance, unless it can be justified that the micro-organism has no harmful effects on human or animal health, or that it can not transfer its resistance to antibiotics or other anti-microbial agents. 3. FURTHER INFORMATION ON THE MICRO-ORGANISM Introduction i) The information provided must describe the intended purposes for which preparations containing the micro-organism are used, or are to be used and the dose and manner of their use or proposed use. (ii) The information provided must specify the normal methods and precautions to be followed in the handling, storage and transport of the micro-organism. (iii) The studies, data and information submitted, must demonstrate the suitability of measures proposed for use in emergency situations. (iv) The information and data referred to are required for each micro organism, except where otherwise specified. 3.1. Function The biological function must be specified from among the following: —control of bacteria, —control of fungi, —control of insects, —control of mites, —control of molluscs, —control of nematodes, —control of weeds, —other (must be specified). 3.2. Field of use envisaged The field(s) of use, existing and proposed, for preparations containing the micro-organism must be specified from among the following: —field use, such as agriculture, horticulture, forestry, and viticulture, —protected crops (e.g. in greenhouses), —amenity, —weed control on non-cultivated areas, —home gardening, —house plants, —stored products, —other (specify). 3.3. Crops or products protected or treated Details of existing and intended use in terms of crops, groups of crops, plants, or plant products protected, must be provided. 3.4. Method of production and quality control Full information on how the micro-organism is produced in bulk must be provided. Both production method/process and product must be subject to a continuous quality control by the applicant. In particular, the occurrence of spontaneous changing of major characteristics of the micro-organism and of the absence/presence of significant contaminants should be monitored. The quality assurance criteria for the production should be submitted. The techniques used to ensure a uniform product, and the assay methods for its standardisation, maintenance and purity of the micro organism must be described and specified (e.g. HACCP). 3.5. Information on the occurrence or possible occurrence of the devel opment of resistance of the target organism(s) Available information on the possible occurrence of the development of resistance or cross-resistance of the target organism(s) must be provided. Where possible, appropriate management strategies should be described. 3.6. Methods to prevent loss of virulence of seed stock of the micro organism Methods to prevent loss of virulence of starting cultures are to be provided. In addition, any method, if available, that could prevent the micro organism from losing its effects on the target species must be described. 3.7. Recommended methods and precautions concerning handling, storage, transport or fire A safety data sheet similar to that required for chemical active substances in Article 27 of Directive 67/548/EEC (1) must be provided for each micro-organism. 3.8. Procedures for destruction or decontamination In many cases the preferred or sole means of safe disposal of micro organisms, contaminated materials, or contaminated packaging, is through controlled incineration in a licensed incinerator. Methods to dispose safely of the micro-organism or, where necessary, to kill it prior to disposal, and methods to dispose of contaminated packaging and contaminated materials, must be fully described. Data must be provided for such methods to establish their effectiveness and safety. (1) See doc. 6853/VI/98, Concise outline report of the first peer review meeting on micro organisms. 3.9. Measures in case of an accident Information on procedures for rendering the micro-organism harmless in the environment (e.g. water or soil) in case of an accident must be provided. 4. ANALYTICAL METHODS Introduction The provisions of this section only cover analytical methods required for post-registration control and monitoring purposes. Post-approval monitoring might be considered for all areas of risk assessment. This is particularly the case when (strains of) micro organisms that are non-indigenous to the intended area of application are considered for approval. For analytical methods used for generation of data as required in this Directive or for other purposes the applicant has to provide a justification for the method used; where necessary separate guidance will be developed for such methods on the basis of the same requirements as defined for methods for post regis-tration control and monitoring purposes. Descriptions of methods must be provided and include details of equipment, materials and conditions used. The applicability of any internationally recognised method must be reported. As far as practicable these methods must employ the simplest approach, involve the minimum cost, and require commonly available equipment. Data on specifity, linearity, accuracy and repeatability, as defined in Schedule II, Part A, points 4.1 and 4.2, are also required for methods used to analyse micro-organisms and their residues. For this section the following applies: Impurities Any component (including contami nating micro-organisms and/or chemical substances) other than the specified micro-organism, originating from the manufacturing process or from degradation during storage Relevant impurities Impurities, as defined above, that are of concern for human or animal health and/or the environment Metabolites Metabolites include products resulting from degradative and biosynthetic reactions taking place within the micro organism or other organisms used to produce the micro-organism of interest Relevant metabolites Metabolites that are of concern for human or animal health and/or the en vironment Residues Viable micro-organisms and substances produced in significant quantities by these micro-organisms which persist after the disappearance of the micro organisms and are of concern for human or animal health and/or the envi-ronment. On request the following samples must be provided: (i) samples of the micro-organism as manufactured; (ii) analytical standards of relevant metabolites (especially toxins) and all other components included in the residue definition; (iii) if available, samples of reference substances for the relevant impu rities. 4.1. Methods for the analysis of the micro-organism as manufactured —Methods for the identification of the micro-organism. —Methods for providing information on possible variability of seed stock/active micro-organism. —Methods to differentiate a mutant of the micro-organism from the parent wild strain. —Methods for the establishment of purity of seed stock from which batches are produced and methods to control that purity. —Methods to determine the content of the micro-organism in the manufactured material used for the production of formulated products and methods to show that contaminating micro organisms are controlled to an acceptable level. —Methods for the determination of relevant impurities in the manu factured material. —Methods to control the absence and to quantify (with appropriate limits of determination) the possible presence of any human and mammalian pathogens. —Methods to determine storage stability, shelf-life of the micro organism, if appropriate. 4.2. Methods to determine and quantify residues (viable or non-viable) of: —the active micro-organism(s), —relevant metabolites (especially toxins), on and/or in crop, in foodstuffs and feeding stuffs, in animal and human body tissues and fluids, in soil, in water (including drinking water, ground water and surface water) and in air where relevant. Analytical methods for amount or activity of proteinaceous products should also be included, e.g. by testing exponential cultures and culture supernatants in an animal cell bioassay. 5. EFFECTS ON HUMAN HEALTH Introduction (i) Available information based on the properties of the micro organism and corresponding organisms (sections 1 to 3), including health and medical reports may be sufficient for a decision whether the micro-organism would cause health effects (infectious/pathogenic/toxic) in humans or not. (ii) The information provided, taken together with that provided for one or more preparations containing the micro-organism, must be sufficient to permit an evaluation to be made as to the risks for man, directly and/or indirectly associated with the handling and use of plant protection products containing the micro-organism, and the risk for man handling treated products, and the risk for man arising from residual traces or contaminants remaining in food and water. In addition, the information provided must be sufficient to: —permit a decision to be made as to whether, or not, the micro organism can be included in Schedule I, —specify appropriate conditions or restrictions to be associated with any inclusion in Schedule I, —specify risk and safety phrases (once introduced) for the protection of man, animals and the environment to be included on packaging (containers), —identify relevant first aid measures as well as appropriate diag nostic and therapeutic measures to be followed in the event of infection or another adverse effect in man. (iii) All effects found during investigations should be reported. Inves tigations which may be necessary in order to evaluate the probable mechanism involved, and to assess the significance of these effects, must also be performed. (iv) For all studies actual achieved dose in colony forming units per kg body weight (cfu/kg), as well as in other appropriate units, must be reported. (v) Evaluation of the micro-organism should be carried out in a tier wise manner. The first tier (Tier I) includes available basic information and basic studies, which have to be performed for all micro-organisms. Expert judgment will be necessary to decide about the appropriate test programme on a case-by-case basis. Newly generated data from conventional toxicological and/or pathological experiments on laboratory animals are normally required unless the applicant can justify, on the basis of the previous information, that the use of the micro-organism, under the proposed conditions of use, does not have any harmful effects on human and animal health. Pending the acceptance of specific guidelines at international level, the infor-mation required shall be generated using available test guidelines (e.g. USEPA OPPTS Guidelines). Tier II studies must be conducted if tests under Tier I have shown adverse health effects. The type of study to be performed depends on the effects observed in the Tier I studies. Before performing such studies, the applicant shall seek agreement of the competent authorities on the type of study to be performed. TIER I 5.1. Basic information Basic information is required about the micro-organism's potential to cause adverse effects such as ability to colonise, to cause damage and to produce toxins and other relevant metabolites. 5.1.1. Medical data Where available, and without prejudice to the provisions of Article 5 of Council Directive 98/24/EC of 7 April 1998 on the protection of the health and safety of workers from the risks related to chemical agents at work and Directive 2000/54/EC of the European Parliament and of the Council of 18 September 2000 on the protection of workers from risks related to exposure to biological agents at work, practical data and information relevant to the recognition of the symptoms of infection or pathogenicity and on the effectiveness of first aid and therapeutic measures have to be submitted. Where relevant, the effectiveness of potential antagonists, should be inves-tigated and reported. Where relevant, methods to kill or render the micro organism uninfective must be indicated (see section 3, point 3.8). Data and information relevant to the effects of human exposure, where available and of the necessary quality, are of particular value, in confirming the validity of extrapolations made and conclusions reached with respect to target organs, virulence, and the reversibility of adverse effects. Such data can be generated following accidental or occupational exposure. 5.1.2. Medical surveillance on manufacturing plant personnel Available reports of occupational health surveillance programmes, supported with detailed information on the design of the programme and on exposure to the micro-organism must be submitted. Such reports should, where feasible, include data relevant to the mechanism of action of the micro-organism. These reports shall, where available, include data from persons exposed in manufacturing plants or after application of the micro-organism (e.g. in efficacy trials). Special attention should be devoted to those whose susceptibility may be affected, e.g. pre-existing disease, medication, compromised immunity, pregnancy or breast feeding. 5.1.3. Sensitisation/allergenicity observations, if appropriate Available information on the sensitisation and allergenic response of workers, including workers in manufacturing plants, agricultural and research workers and others exposed to the micro-organism must be provided, and include, where relevant, details of any incidences of hypersensitivity and chronic sensitisation. The information provided should include details of frequency, level and duration of exposure, symptoms observed and other relevant clinical observation. Infor mation should be given about whether workers have been subjected to any allergy tests or interviewed about allergenic symptoms. 5.1.4. Direct observation, e.g. clinical cases Available reports from the open literature on the micro-organism or closely related members of the taxonomic group (relating to clinical cases), where they are from reference journals or official reports, must be submitted together with reports of any follow-up studies undertaken. Such reports are of particular value and should contain complete descriptions of the nature, level and duration of exposure, as well as the clinical symptoms observed, first aid and therapeutic measures applied and measurements and observations made. Summary and abstract information is of limited value. If there are animal studies performed, reports relating to clinical cases can be of particular value in confirming the validity of interpretations from animal data to man and in identifying unexpected adverse effects which are specific to humans. 5.2. Basic studies In order to make it possible to correctly interpret the obtained results, it is of greatest importance that the suggested test methods are relevant regarding species sensitivity, administration route, etc., and relevant from a biological and toxicological point of view. The way of admin-istration of the test micro-organism depends on the main exposure routes to humans. To evaluate medium- and long-term effects after acute, sub-acute or semi-chronic exposure to micro-organisms, it is necessary to use the options provided in most of the OECD guidelines, to extend the studies concerned with a recovery period (after which full macroscopic and microscopic pathology is to be performed, including an exploration for micro-organisms in the tissues and organs). This facil-itates the interpretation of certain effects and provides the possibility to recognise infectiveness and/or pathogenicity, which in turn helps taking decisions on other issues such as the necessity to perform long-term studies (carcinogenicity etc., see point 5.3), and whether or not to perform residue studies (see point 6.2). 5.2.1. Sensitisation(1) Aim of the test The test will provide sufficient information to assess the potential of the micro-organism to provoke sensitisation reactions by inhalation as well as with dermal exposure. A maximised test has to be performed. Circumstances in which required(2) Information on sensitisation must be reported. 5.2.2. Acute toxicity, pathogenicity and infectiveness The studies, data and information to be provided and evaluated must be sufficient to permit the identification of effects following a single exposure to the micro-organism, and in particular to establish, or indicate: —the toxicity, pathogenicity and infectiveness of the micro-organism, —the time course and characteristics of the effects with full details of behavioural changes and possible gross pathological findings at post-mortem, —where possible mode of toxic action, —the relative hazards associated with the different routes of exposure, and —blood analyses throughout the studies in order to evaluate the clearance of the micro-organism. Acute toxic/pathogenic effects may be accompanied by infectiveness and/or more long-term effects which cannot be observed immediately. With a view to health evaluation, it is therefore necessary to carry out studies on the ability to infect in connection with oral intake, inha lation and intraperitoneal/subcutaneous injection by test mammals. During the acute toxicity, pathogenicity and infectiveness studies, an estimation of the micro-organism and/or the active toxin clearance in the organs deemed to be relevant for microbial examination (e.g. liver, kidneys, spleen, lungs, brain, blood and site of administration) must be performed. The observations to be made should reflect expert scientific judgement and may include the micro-organism numeration in all the tissues likely to be affected (e.g. showing lesions) and in the main organs: kidneys, brain, liver, lungs, spleen, bladder, blood, lymphatic ganglia, gastrointestinal tract, thymus gland and lesions at the inoculation site in the dead or moribund animals and at interim and final sacrifice. The information generated through acute toxicity, pathogenicity and infectiveness testing is of particular value in assessing hazards likely to arise in accident situations and consumer risks due to exposure to possible residues. (1) The available methods for testing dermal sensitisation are not suitable for testing micro organisms. Sensitisation by inhalation is most probably a greater problem compared with dermal exposure to micro-organisms but so far, there are no validated test methods. Development of these kinds of methods is therefore of great importance. Until then, all micro-organisms should be regarded as potential sensitisers. This approach also takes into consideration immuno-compromised or other sensitive individuals in the population (e.g. pregnant women, new-born children or elderly). (2) As a consequence of the absence of proper test methods all micro-organisms will be labelled as potential sensitisers, unless the applicant wants to demonstrate the non-sensi-tising potential by submitting data. Therefore, this data requirement should be regarded as not obligatory but optional, on a provisional base. 5.2.2.1. A c u t e o r a l t o x i c i t y , p a thogenicity and infec tiveness Circumstances in which required The acute oral toxicity, pathogenicity and infectiveness of the micro organism must be reported. 5.2.2.2. A c u t e i n h a l a t i o n t o x i c i t y , p a t h o g e n i c i t y a n d infectiveness Circumstances in which required The inhalation toxicity (1), pathogenicity and infectiveness of the micro-organism must be reported. (1) An inhalation study may be replaced by an intratracheal study. 5.2.2.3. I n t r a p e r i t o n e a l / s u b c u t a n e o u s s i n g l e d o s e The intraperitoneal/subcutaneous test is considered a highly sensitive assay to elicit in particular infectiveness. Circumstances in which required The intraperitoneal injection is always required for all micro organisms, however, expert judgement may be exercised to evaluate whether subcutaneous injection is preferred instead of intraperitoneal injection if the maximum temperature for growth and multiplication is lower than 37oC. 5.2.3. Genotoxicity testing Circumstances in which required If the micro-organism produces exotoxins according to point 2.8, then these toxins and any other relevant metabolites in the culture medium must also be tested for genotoxicity. Such tests on toxins and meta bolites should be performed using the purified chemical if possible. If basic studies do not indicate that toxic metabolites are formed, studies on the micro-organism itself should be considered depending on expert judgement on the relevance and validity of the basic data. In the case of a virus the risk of insertional mutagenesis in mammal cells or the risk of carcinogenicity has to be discussed. Aim of the test These studies are of value in: —the prediction of genotoxic potential, —the early identification of genotoxic carcinogens, —the elucidation of the mechanism of action of some carcinogens. It is important that a flexible approach is adopted, with selection of further tests being dependent upon interpretation of results at each stage. Test conditions(1) Genotoxicity of cellular micro-organisms will be studied after breaking of the cells, wherever possible. Justification should be provided on the method of sample preparation used. Genotoxicity of viruses should be studied on infectious isolates. (1) As the present test methods are designed to be performed on soluble chemicals, it is necessary that the methods are developed so as to become relevant for micro-organisms. 5.2.3.1.In vitrostudies Circumstances in which required Results ofin vitromutagenicity tests (bacterial assay for gene mutation, test for clastogenicity in mammalian cells and test for gene mutation in mammalian cells) must be provided. 5.2.4. Cell culture study This information must be reported for intracellular replicating micro organisms, such as viruses, viroids or specific bacteria and protozoa, unless the information from sections 1 to 3 clearly demonstrates that the micro-organism does not replicate in warm-blooded organisms. A cell culture study should be performed in human cell or tissue cultures of different organs. Selection can be based on expected target organs after infection. If human cell or tissue cultures of specific organs are not available, other mammal cell and tissue cultures can be used. For viruses, the ability to interact with the human genome is a key consid eration. 5.2.5. Information on short-term toxicity and pathogenicity Aim of the test Short-term toxicity studies must be designed to provide information as to the amount of the micro-organism that can be tolerated without toxic effects under the conditions of the study. Such studies provide useful data on the risks for those handling and using preparations containing the micro-organism. In particular, short-term studies provide an essential insight into possible cumulative actions of the micro-organism, and the risks to workers who may be intensively exposed. In addition short-term studies provide information useful in the design of chronic toxicity studies. The studies, data and information to be provided and evaluated, must be sufficient to permit the identification of effects following repeated exposure to the micro-organism, and in particular to further establish, or indicate: —the relationship between dose and adverse effects, —toxicity of the micro-organism including where necessary the NOAEL for toxins, —target organs, where relevant, —the time course and characteristics of the effects with full details of behavioural changes and possible gross pathological findings at post-mortem, —specific toxic effects and pathological changes produced, —where relevant the persistence and reversibility of certain toxic effects observed, following discontinuation of dosing, —where possible, the mode of toxic action, and —the relative hazard associated with the different routes of exposure. During the short-term toxicity study, an estimation of the micro organism clearance in the main organs must be performed. Investigations should be included for pathogenicity and infectiveness end points. Circumstances in which required The short-term toxicity (minimum 28 days) of the micro-organism must be reported. The choice of test species has to be justified. The choice of study length depends on acute toxicity and clearance data. Expert judgement is required to decide what route of administration is preferable. 5.2.5.1. H e a l t h e f f e c t s a f t e r r e p e a t e d i n h a l a t o r y e x p o s u r e Information on the health effects after repeated inhalatory exposure is considered necessary, particularly for the risk assessment of the occu pational setting. Repeated exposure might influence the clearance capacity (e.g. resistance) of the host (human). Furthermore, for proper risk assessment the toxicity after repeated exposure to contaminants, growth medium, co-formulants and the micro-organism needs to be addressed. It should be kept in mind that the formulants in the plant protection product can influence the toxicity and infectiveness of a micro-organism. Circumstances in which required Information on the short-term infectiveness, pathogenicity and toxicity (respiratory route) of a micro-organism is required, unless the infor mation already provided is sufficient to assess human health effects. This can be the case if it is demonstrated that the test material has no inhalable fraction and/or repeated exposure is not expected. 5.2.6. Proposed treatment: first aid measures, medical treatment The first aid measures to be used in the event of infection and in the event of contamination of eyes must be provided. Therapeutic regimes for use in the event of ingestion or contamination of eyes and skin must be described in full. Information based on practical experience, where it exists and is available, in other cases on theoretical grounds, as to the effectiveness of alternative treatment regimes, where relevant, must be provided. Information on resistance to antibiotics must be provided. (END OF TIER I) TIER II 5.3. Specific toxicity, pathogenicity and infectiveness studies In certain cases, it can be necessary to carry out supplementary studies to further clarify the adverse human effects. In particular, if results from earlier studies indicate that the micro organism may cause long-term health effects, studies on chronic toxicity, pathogenicity and infectiveness, carcinogenicity and repro ductive toxicity must be carried out. Furthermore, where a toxin is produced, kinetic studies must be performed. Studies required must be designed on an individual basis, in the light of the particular parameters to be investigated and the objectives to be achieved. Before performing such studies, the applicant shall seek agreement of the competent authorities on the type of study to be performed. 5.4. In vivostudies in somatic cells Circumstances in which required If all the results of thein vitrostudies are negative further testing must be done with consideration of other relevant information available. The test can be anin vivostudy or anin vitrostudy using a different metabolising system from that/those previously used. If thein vitrocytogenetic test is positive, anin vivotest using somatic cells (metaphase analysis in rodent bone marrow or micronucleus test in rodents) must be conducted. If either of thein vitrogene mutation tests are positive, anin vivotest to investigate unscheduled DNA synthesis or a mouse spot test must be conducted. 5.5. Genotoxicity—In vivostudies in germ cells Aim of the test and test conditions See point 5.4. Circumstances in which required When any result of anin vivostudy in somatic cells is positive,in vitro testing for germ cell effects may be justified. The necessity for conducting these tests will have to be considered on a case-by-case basis, taking into account other relevant information available including use and expected exposure. Suitable tests would need to examine inter-action with DNA (such as the dominant lethal assay), to look at the potential for inherited effects and possibly make a quantitative assessment of heritable effects. It is recognised that in view of their complexity, the use of quantitative studies would require strong justi-fication. (END OF TIER II) 5.6. Summary of mammalian toxicity, pathogenicity and infectiveness and overall evaluation A summary of all data and information provided under points 5.1 through 5.5, must be submitted, and include a detailed and critical assessment of those data in the context of relevant evaluative and decision making criteria and guidelines, with particular reference to the risks for man and animals that may or do arise, and the extent, quality and reliability of the data base. It must be explained whether exposure of animals or humans has any implications for vaccination or serological monitoring. 6. RESIDUES IN OR ON TREATED PRODUCTS, FOOD AND FEED Introduction (i) The information provided, taken together with that for one or more preparations containing the micro-organism, must be sufficient to permit an evaluation to be made as to the risk for man and/or animals, arising from exposure to the micro-organism and its residual traces and metabolites (toxins) remaining in or on plants or plant products. (ii) In addition, the information provided must be sufficient to: —permit a decision to be made as to whether or not the micro organism can be included in Annex I to Directive 91/414/EEC, —specify appropriate conditions or restrictions to be associated with any inclusion in Annex I to Directive 91/414/EEC, —where relevant, set maximum residue levels, preharvest intervals to protect consumers and waiting periods, to protect workers handling the treated crops and products. (iii) For the evaluation of risk arising from residues, experimental data on levels of exposure to the residue may not be required where it can be justified, that the micro-organism and its metabolites are not hazardous to humans in the concentrations that could occur as a result of authorised use. This justification can be based on open literature, on practical experience and on information submitted in sections 1 through 3 and section 5. 6.1. Persistance and likelihood of multiplication in or on crops, feeding stuffs or foodstuffs A substantiated estimation of persistance/competitiveness of the micro-organism and relevant secondary metabolites (especially toxins) in or on the crop under the environmental conditions prevailing at and after the intended use, taking into account in particular the information provided in section 2, has to be delivered. Moreover, the application shall state to which extent and on which basis it is considered that the micro-organism can (or cannot) multiply in or on the plant or plant product or during processing of raw products. 6.2. Further information required Consumers may be exposed to micro organisms for a considerable time as a result of the consumption of treated food commodities; potential effects on the consumers must, therefore, be derived from chronic or semi-chronic studies, so that a toxicological end point, such as the ADI, can be established for risk management. 6.2.1. Non-viable residues A non viable micro-organism is a micro-organism that is not capable of replication or of transferring genetic material. If relevant quantities of the micro-organism or of produced meta bolites, especially toxins, have been found to be persistant in section 2, points 2.4 and 2.5, full experimental residue data as provided for in Schedule II, Part A, section 6, is required, if concentrations of the micro-organism and/or its toxins in or on the treated foodstuffs or feeding-stuffs are expected to occur in concentrations higher than under natural conditions or in a different phenotypic state. In agreement with Directive 91/414/EEC, the conclusion concerning the difference between natural concentrations and an elevated concen tration due to treatment with the micro-organism, is to be based on experimentally obtained data, and not on extrapolations or calculations using models. Before performing such studies, the applicant shall seek agreement of the competent authorities on the type of study to be performed. 6.2.2. Viable residues If the information submitted according to point 6.1 suggests persistance of relevant amounts of the micro-organism in or on treated products, food or feed, possible effects on humans and/or animals must be investigated, unless it can be justified from section 5, that the micro-organism and its metabolites and/or degradation products are not hazardous to humans in the concentrations and of the nature that could occur as a result of authorised use. In agreement with Directive 91/414/EEC, the conclusion concerning the difference between natural concentrations and an elevated concen tration due to treatment with the micro-organism, is to be based on experimentally obtained data, and not on extrapolations or calculations using models. The persistence of viable residues needs special attention if infec tiveness or pathogenicity to mammals have been found in sections 2.3, 2.5 or 5 and/or if any other information suggests a hazard to consumers and/or workers. In this case the competent authorities may require studies similar to those provided for in Part A. Before performing such studies, the applicant shall seek agreement of the competent authorities on the type of study to be performed. 6.3. Summary and evaluation of residue behaviour resulting from data submitted under points 6.1 and 6.2 7. FATE AND BEHAVIOUR IN THE ENVIRONMENT Introduction (i) Information on the origin, the properties, and the survival of the micro-organism and its residual metabolites as well as its intended use form the basis for an assessment of environmental fate and behaviour. Experimental data are normally required unless it can be justified that an assessment of its fate and behaviour in the environment can be performed with the information already available. This justifi cation can be based on open literature, on practical experience and, on information submitted in sections 1 through 6. The function of the micro-organism in environmental processes (as defined in section 2, point 2.1.2) is of particular interest. (ii) The information provided, taken together with other relevant infor mation, and that for one or more preparations containing the micro organism, must be sufficient to permit an assessment of its fate and behaviour as well as that of its residual traces and toxins, where they are of significance for human health and/or the environment. (iii) In particular, the information provided should be sufficient to: —decide whether, or not, the micro-organism can be included in Schedule I, —specify appropriate conditions or restrictions to be associated with any inclusion in Schedule I, —specify the hazard symbols (once introduced), the indications of danger, and relevant risk and safety phrases for the protection of the environment, which are to be included on packaging (containers), —predict the distribution, fate, and behaviour in the environment of the micro-organism and its metabolites as well as the time courses involved, —identify measures necessary to minimise contamination of the environment and impact on non-target species. (iv) Any relevant metabolites (i.e. of concern for human health and/or the environment) formed by the test organism under any relevant environmental conditions should be characterised. If relevant meta bolites are present in or produced by the micro-organism, data as outlined under Schedule II, Part A, point 7 may be required, if all of the following conditions are met: —the relevant metabolite is stable outside the micro-organism, see point 2.8, and —a toxic effect of the relevant metabolite is independent of the presence of the micro-organism, and —the relevant metabolite is expected to occur in the environment in concentrations considerably higher than under natural conditions. (v) Available information on the relationship with naturally occurring wild type relatives should be taken into account. (vi) Before performing studies as referred to below, the applicant shall seek agreement of the competent authorities on whether studies need to be performed and, if so, the type of study to be conducted. The information from the other sections has, also, to be taken into account. 7.1. Persistence and multiplication Where relevant, appropriate information on the persistence and multi plication of the micro-organism, in all environmental compartments has to be given, unless it can be justified that exposure of the particular environmental compartment to the micro-organism is unlikely to occur. Special attention shall be given to —competitiveness under the environmental conditions prevailing at and after the intended use, and —population dynamics in seasonally or regionally extreme climates (particularly hot summer, cold winter and rainfall) and to agri cultural practices applied after intended use. Estimated levels of the specified micro-organism in a time course after use of the product under the proposed conditions of use shall be given. 7.1.1. Soil Information on viability/population dynamics should be reported in several cultivated and uncultivated soils representative of soils typical of the various Community regions where use exists or is anticipated. The provisions on choice of soil and its collection and handling, as referred to in Part A, point 7.1, Introduction, have to be followed. If the test organism is to be used in association with other media, e.g. rockwool, this must be included in the test range. 7.1.2. Water Information should be reported on viability/population dynamics in natural sediment/water systems under both dark and illuminated conditions. 7.1.3. Air In case of particular concerns for operator, worker or bystander exposure, information on the concentrations in air might be necessary. 7.2. Mobility The possible spread of the micro-organism and its degradation products in relevant environmental compartments has to be evaluated, unless it can be justified that exposure of the particular environmental compartments to the micro-organism is unlikely to occur. In this context, the intended use (e.g. field or greenhouse, application to soil or to crops), life cycle stages, including occurrence of vectors, persistence and the ability of the organism to colonise adjacent habitats are of particular interest. The spread, the persistence and probable transport ranges need special attention if toxicity, infectiveness or pathogenicity have been reported or if any other information suggests possible hazard to humans, animals or to the environment. In this case the competent authorities may require studies similar to those provided for in Part A. Before performing such studies, the applicant shall seek agreement of the competent authorities on the type of study to be performed. 8. EFFECTS ON NON-TARGET ORGANISMS Introduction (i) The information on identity, biological properties and further infor mation in sections 1 to 3 and 7 is central to the assessment of impact on non-target species. Additional useful information may be found on fate and behaviour in the environment in section 7 and on residue levels in plants in section 6 which, together with infor mation on the nature of the preparation and its manner of use, defines the nature and extent of potential exposure. The infor mation submitted in accordance with section 5 will provide essential information as to effects to mammals and the mechanisms involved. Experimental data are normally required, unless it can be justified that an assessment of effects on non-target organisms can be performed with the information already available. (ii) The choice of the appropriate non-target organisms for testing of environmental effects should be based on the identity of the micro organism (including the host specificity, mode of action and ecology of the organism). From such knowledge it would be possible to choose the appropriate test-organisms, such as organisms closely related to the target organism. (iii) The information provided, taken together with that for one or more preparations containing the micro-organism, must be sufficient to permit an assessment of the impact on non-target species (flora and fauna), likely to be at risk from exposure to the micro organism, where they are of environmental significance. Impact can result from single, prolonged or repeated exposure and can be reversible or irreversible. (iv) In particular, the information provided for the micro-organism, together with other relevant information, and that provided for one or more preparations containing it, should be sufficient to: —decide whether, or not, the micro-organism can be included in Schedule I, —specify appropriate conditions or restrictions to be associated with any inclusion in Schedule I, —permit an evaluation of short- and long-term risks for non target species—populations, communities, and processes— as appropriate, —classify the micro-organism as to biological hazard, —specify the precautions necessary for the protection of non target species, and —specify the hazard symbols (once introduced), the indications of danger, and relevant risk and safety phrases for the protection of the environment, to be mentioned on packaging (containers). (v) There is a need to report all potentially adverse effects found during routine investigations on environmental effects, to undertake and report, where required by the competent authorities, such additional studies which may be necessary to investigate the probable mechanisms involved and to assess the significance of these effects. All available biological data and information which is relevant to the assessment of the ecology profile of the micro organism must be reported. (vi) For all studies, average achieved dose in cfu/kg body weight as well as in other appropriate units must be reported. (vii) It may be necessary to conduct separate studies for relevant meta bolites (especially toxins), where these products can constitute a relevant risk to non-target organisms and where their effects cannot be evaluated by the available results relating to the micro organism. Before such studies are performed, the applicant shall seek agreement of the competent authorities on whether such studies need to be performed and, if so, the type of study to be conducted. The information from sections 5, 6 and 7 has to be taken into account. (viii) In order to facilitate the assessment of the significance of test results obtained, the same strain (or recorded origin) of each relevant species should, where possible, be used in the various tests specified. (ix) Tests must be performed unless it can be justified that the non target organism will not be exposed to the micro-organism. If it is justified that the micro-organism does not cause toxic effects or is not pathogenic or infective to vertebrates or plants, only reaction to appropriate non-target organisms must be investigated. 8.1. Effects on birds Aim of the test Information on toxicity, infectiveness and pathogenicity to birds must be reported. 8.2. Effects on aquatic organisms Aim of the test Information on toxicity, infectiveness and pathogenicity to aquatic organisms must be reported. 8.2.1. Effects on fish Aim of the test Information on toxicity, infectiveness and pathogenicity to fish must be reported. 8.2.2. Effects on freshwater invertebrates Aim of the test Information on toxicity, infectiveness and pathogenicity to freshwater invertebrates must be reported. 8.2.3. Effects on algae growth Aim of the test Information on effects on algal growth, growth rate and capacity to recover must be reported. 8.2.4. Effects on plants other than algae Aim of the test Information on effects on plants other than algae must be reported. 8.3. Effects on bees Aim of the test Information on toxicity, infectiveness and pathogenicity to bees must be reported. 8.4. Effects on arthropods other than bees Aim of the test Information on toxicity, infectiveness and pathogenicity to arthropods other than bees must be reported. The selection of the test species should be related to the potential use of the plant protection products (e.g. foliar or soil application). Special attention should be given to organisms used for biological control and organisms playing an important role in integrated pest management. 8.5. Effects on earthworms Aim of the test Information on toxicity, infectiveness and pathogenicity to earthworms must be reported. 8.6. Effects on non-target soil micro-organisms Impact on relevant non target micro-organisms and on their predators (e.g. protozoa for bacterial inoculants) should be reported. Expert judgment is required to decide whether additional studies are necessary. Such decision will take into consideration the available information in this and other sections, in particular data on the specificity of the micro-organism, and the expected exposure. Useful information may also be available from the observations carried out in efficacy testing. Special attention should be given to organisms used in integrated crop management (ICM). 8.7. Additional studies The additional studies might include further acute studies on additional species or processes (such as sewage systems) or higher tier studies such as chronic, sub-lethal or reproductive studies on selected non-target organisms. Before performing such studies, the applicant shall seek agreement of the competent authorities on the type of study to be performed. 9. SUMMARY AND EVALUATION OF ENVIRONMENTAL IMPACT A summary and evaluation of all data relevant to the environmental impact, should be carried out according to the guidance given by the competent authority concerning the format of such summaries and evaluations. It should include a detailed and critical assessment of those data in the context of relevant evaluative and decision making criteria and guidelines, with particular reference to the risks for the environment and non-target species that may or do arise, and the extent, quality and reliability of the data base. In particular the following issues should be addressed: —distribution and fate in the environment, and the time courses involved, —identification of non-target species and populations at risk, and the extent of their potential exposure, —identification of precautions necessary to avoid or minimise con tamination of the environment, and for the protection of non-target species. SCHEDULE III REQUIREMENTS FOR THE DOSSIER TO BE SUBMITTED FOR THE AUTHORIZATION OF A PLANT PROTECTION PRODUCT INTRODUCTION The information required shall: 1.1. include a technical dossier supplying the information necessary for evaluating efficacy and the foreseeable risks, whether immediate or delayed, which the plant protection product may entail for humans, animals and the environment and containing at least the information and results of the studies referred to below; 1.2. where relevant, be generated using test guidelines, according to the latest adopted version, referred to or described in this Schedule; in the case of studies initiated before the entry into force of the modification of Annex II of Directive 414/1991, the information shall be generated using suitable inter-nationally or nationally validated test guidelines or, in the absence thereof, test guidelines accepted by the director; 1.3. in the event of a test guideline being inappropriate or not described, or where another one than those referred to in this Schedule has been used, include a justification, which is acceptable to the director for the guidelines used. In particular, when reference is made in this Schedule to an EEC Method which consists in the transposal of a method developed by an international organization (e.g. OECD), the Director may accept that the required information is generated according to the latest version of that method if at the initiation of the studies the EEC Method has not yet been updated; 1.4. include when required by the director, a full description of test guidelines used, except if they are referred to or described in this Schedule, and a full description of any deviations from them including a justification, which is acceptable to the director, for these deviations; 1.5. include a full and unbiased report of the studies conducted as well as a full description of them or a justification, which is acceptable to the director where: —particular data and information which would not be necessary owing to the nature of the product or its proposed uses, are not provided, or —it is not scientifically necessary, or technically possible to supply information and data. 1.6. where relevant, have been generated in accordance with the requirements of Directive 86/609/EEC. 2.1. Tests and analyses must be conducted in accordance with the prin ciples laid down in Directive 2004/10/EC of the European Parliament and of the Council of 11 February 2004 on the harmonisation of laws, regulations and administrative provisions relating to the application of the principles of good laboratory practice and the verification of their applications for tests on chemical substances. 2.2. Tests and analyses, required under the provisions of Section 6 points 6.2 to 6.7 of this Schedule, shall be conducted by official or officially recognized testing facilites or organizations which satisfy at least the following requirements: —have at their disposal sufficient scientific and technical staff, having the necessary education, training, technical knowledge and experience for their assigned functions, —have at their disposal suitable items of equipment required for correct performance of the tests and measurements which it claims to be competent to carry out. This equipment shall be properly maintained and calibrated where appropriate before being put into service and thereafter according to an established programme, —have at their disposal appropriate experimental fields and, where necessary glasshouses, growth cabinets or storage rooms. The en vironment in which the tests are undertaken shall not invalide its results or adversely effect the required accuracy of measurement, —make available to all relevant personnel operating procedures and protocols used for the trials, —make available, where requested by the director, prior to the commencement of a test, detailed information on it, containing at least its location and the plant protection products included in it, —ensure that the quality of the work performed is appropriate to its type, range, volume and intended purpose, — maintain records of all original observations, calculations and derived data,<calibration records and the final test report as long as the product concerned authorized in the Community. 2.3. The Director shall require that officially recognized testing facilities and organizations, and, where requested, official facilities and organi zations: —report to the relevant national authority all detailed information necessary to demonstrate that they can satisfy the requirements provided for in point 2.2, —accept at any time the inspections, which each Member State shall regularly organize on its territory in order to verify the compliance with the requirement as laid down in point 2.2. 2.4. By way of derogation from point 2.1, the Director may apply the provisions of points 2.2 and 2.3, by extension, to tests and analyses performed in Malta in order to obtain data on the properties and/or safety of the preparations with respect to honey-bees and bene-ficial arthropods other than bees and actually started on or before 31 December 1999. 2.5. By way of derogation from point 2.1, the Director may apply the provisions of points 2.2 and 2.3, by extension, to supervised residue trials performed in Malta in accordance with the provisions of Section 8 ‘Residues in or on treated products, food and feed’ with plant protection products containing active substances already on the market two years after notification of the Directive and actually started on or before 31 December 1997. 2.6. By way of derogation from point 2.1, for active substances consisting of micro-organisms or viruses, tests and analyses done to obtain data on the properties and/or safety with respect to other aspects than human health, may have been conducted by official or officially recognised testing facilities or organisations which satisfy at least the requirements under points 2.2 and 2.3 of the introduction of Schedule III. 3. The information required shall include the proposed classification and labelling of the plant protection product in accordance with relevant Community Directives. 4. In individial cases it may be necessary to require certain information as provided for in Schedule II, Part A, for formulants. Before such infor mation will be required and before possible new studies have to be performed, all information on the formulant, made available to the director, will be considered, in particular when: —the use of the formulant is permitted in food, animal feeding stuffs, medicines or cosmetics in accordance with Community legislation, or —a safety data sheet has been submitted for the formulant in accordance with Council Directive 67/548/EEC. Chemical preparations 1. Identity of the plant protection product The information provided, taken together with that provided for the active substance(s), must be sufficient to precisely identify preparations and define them in terms of their specification and nature. The information and data referred to, unless otherwise specified, are required for all plant protection products. 1.1. Applicant (name and address, etc.) The name and address of the applicant (permanent community address) must be provided as must the name, position, telephone and telefax number of the appropriate person to contact. Where in addition, the applicant has an office, agent or representative in the Member State in which the authorization is being sought, the name and address of the local office agent or representative should be provided, as should the name, position, telephone and telefax number of the appropriate person to contact. 1.2. Manufacturer of the preparation and the active substance(s) (names and addresses etc. including location of plants) The name and address of the manufacturer of the preparation and of each active substance in the preparation must be provided as must the name and address of each manufacturing plant in which the preparation and active substance are manufactured. A contact point (preferable a central contact point, to include name, telephone and telefax numbers) must be provided for each. If the active substance originates from a manufacturer from which data according to Schedule II had not been submitted previously, a statement of purity and detailed information on the impurities in Schedule II have to be provided. 1.3. Trade name or proposed trade name, and manufacturer's development code number of the preparation if appropriate All former and current trade names and proposed trade names and development code numbers of the preparation as well as the current names and numbers must be provided. Where trade names and code numbers referred to, relate to similar but different preparations (possibly obsolete), full details of the differences, must be provided. (The proposed trade name may not give rise to confusion with the trade name of already registered plant protection products.) 1.4. Detailed quantitative and qualitative information on the composition of the preparation (active substance(s), and formulants) 1.4.1. For preparations the following information must be reported: —the content of both technical active substance(s) and pure active substance(s); —the content of formulants. The concentrations should be expressed in terms as provided for in Directive 92/45/EEC. 1.4.2. For active substances their ISO common names or proposed ISO common names and their CIPAC numbers, and, where available, the EEC (EINECS or ELINCS) numbers must be provided. Where relevant it must be stated which salt, ester, anion or cation is present. 1.4.3. Formulants must where possible, be identified both by their chemical name as given in Annex I to Directive 67/548/EEC, or, if not included in this Directive, in accordance with both IUPAC and CA nomen clature. Their structure or structural formula must be provided. For each component of the formulants the relevant EEC (EINECS or ELINCS) number and CAS number where they exist, must be provided. Where the information provided does not fully identify a formulant, an appropriate specification must be provided. The trade name of formulants, where they exist, must also be provided. 1.4.4. For formulants the function must be given: —adhesive (sticker), —antifoaming agent, —antifreeze, —binder, —buffer, —carrier, —deodorant, —dispersing agent, —dye, —emetic, —emulsifier, —fertilizer, —preservative, —odourant, —perfume, —propellant, —repellent, —safener, —solvent, —stabilizer, —synergist, —thickener, —wetting agent, —miscellaneous (specify). 1.5. Physical state and nature of the preparation (emulsifiable concentrate, wettable powder, solution etc). 1.5.1. The type and code of preparation must be designated according to the ‘Catalogue of pesticide formulation types and international coding system (GIFAP Technical Monograph No 2. 1989)’. Where a particular preparation is not defined precisely in this publi cation a full description of the physical nature and state of the preparation must be provided, together with a proposal for a suitable description of the type of preparation and a proposal for its definition. 1.6. Function (herbicide, insecticide, etc.) The function must be specified from among the following: —acaricide, —bactericide, —fungicide, —herbicide —insecticide, —molluscicide, —nematicide, —plant growth regulator, —repellant, —rodenticide, —semio-chemicals, —talpicide, —viricide, —other (must be specified). 2. Physical, chemical and technical properties of the plant protection product The extent to which plant protection products for which authorization is sought, comply with relevant FAO specifications as agreed by the Group of Experts on Pesticide Specifications, of the FAO Panel of Experts on Pesticide Specifications, Registration Requirements and Application Standards, must be stated. Divergences from FAO speci fications must be described in detail, and justified. 2.1. Appearance (colour and odour) A description of both the colour and odour, if any, and the physical state of the preparation, must be provided. 2.2. Explosivity and oxidizing properties 2.2.1. The explosive properties of preparations must be reported according to EEC method A 14. Where available thermodynamic information establishes beyond reasonable doubt that the preparation is incapable of exothermic reaction, it is sufficient to provide that information as a justification for not determining the explosive properties of the preparation. 2.2.2. Oxidizing properties of preparations which are solids must be determined and exported according to EEC method A 17. For other preparations the method used must be justified. The oxidizing prop erties do not have to be determined if it can be shown without reasonable doubt on the basis of thermodynamic information, that the preparation is incapable of reacting exothermically with combustible materials. 2.3. Flash point and other indications of flammability or spontaneous ignition The flash point of liquids which contain flammable solvents, must be determined and reported according to EEC Method A 9. The flamm ability of solid preparations and gases must be determined and reported according to EEC methods A 10, A 11 and A 12 as appro priate. The auto-flammability of preparations must be determined and reported in accordance with EEC methods A 15 or A 16 as appro priate, and or, where necessary, according to the UN-Bowes Cameron-Cage-Test (UN-Recommendations on the Transport of Dangerous Goods, Chapter 14, No 14.3.4). 2.4. Acidity/alkalinity and if necessary pH value 2.4.1. In the case of preparations which are acidic (pH < 4) or alkaline (pH > 10) the acidity or alkalinity and the pH value must be determined and reported according to CIPAC Method MT 31 and MT 75 respec tively. 2.4.2. Where relevant (if to be applied as aqueous dilution) the pH of a 1 % aqueous dilution, emulsion or dispersion of the preparation, must be determined and reported according to CIPAC Method MT 75. 2.5. Viscosity and surface tension 2.5.1. In the case of liquid preparations for Ultra Low Volume use (ULV) the kinematic viscosity must be determined and reported according to OECD Test Guideline 114. 2.5.2. For non newtonian liquids the viscosity must be determined and reported together with the test conditions. 2.5.3. In the case of liquid preparations the surface tension has to be determined and reported according to EEC method A 5. 2.6. Relative density and bulk density 2.6.1. The relative density of liquid preparations must be determined and reported according to EEC Method A 3. 2.6.2. The bulk (tap) density of preparations which are powders or granules, must be determined and reported according to CIPAC Methods MT 33, MT 159 or MT 169 as appropriate. 2.7. Storage—stability and shelf-life: Effects of light, temperature and humidity on technical characteristics of the plant protection product 2.7.1. The stability of the preparation after storage for 14 days at 54oC must be determined and reported according to CIPAC Method MT 46. Other times and/or temperatures may be needed (e.g. eight weeks at 40oC or 12 weeks at 35oC or 18 weeks at 30oC) if the preparation is heat sensitive. If the active substance content after the heat stability test has decreased by more than 5 % of the initially found content, the minimum content shall be declared and information on the degradation products shall be supplied. 2.7.2. Additionally in the case of liquid preparations, the effect of low temperatures on stability, must be determined and reported according to CIPAC Methods MT 39, MT 48, MT 51 or MT 54 as appropriate. 2.7.3. The shelf life of the preparation at ambient temperature must be reported. Where shelf life is less than two years, the shelf life in months, with appropriate temperature specifications, must be reported. Useful information is given in GIFAP Monograph No. 17. 2.8. Technical characteristics of the plant protection product The technical characteristics of the preparation must be determined to permit a decision to be made as to its acceptability. 2.8.1. Wettability The wettability of solid preparations which are diluted for use (e.g. wettable powders, water soluble powders, water soluble granules and water dispersible granules), must be determined and reported according to CIPAC Method MT 53.3. 2.8.2. Persistent foaming The persistence of foaming of preparations to be diluted with water, must be determined and reported according to CIPAC Method MT 47. 2.8.3. Suspensibility and suspension stability —The suspensibility of water dispersible products (e.g. wettable powders, water dispersible granules, suspension concentrates) must be determined and reported according to CIPAC Method MT 15, MT 161 or MT 168 as appropriate. —The spontaneity of dispersion of water dispersible products (e.g. suspension concentrates and water dispersible granules) must be determined and reported according to CIPAC Methods MT 160 or MT 174 as appropriate. 2.8.4. Dilution stability The dilution stability of water soluble products must be determined and reported according to CIPAC Method MT 41. 2.8.5. Dry sieve test and wet sieve test In order to ensure that dustable powders have a suitable particle size distribution for ease of application, a dry sieve test must be conducted and reported according to CIPAC Method MT 59.1. In the case of water dispersible products, a wet sieve test must be conducted and reported according to CIPAC Method MT 59.3 or MT 167 as appropriate. 2.8.6. Particle size distribution (dustable and wettable powders, granules), content of dust/fines (granules), attrition and friability (granules) 2.8.6.1. The size distribution of particles in the case of powders, must be determined and reported according to OECD Method 110. The nominal size range of granules for direct application must be determined and reported in accordance with CIPAC MT 58.3, for water dispersible granules in accordance with CIPAC MT 170. 2.8.6.2. The dust content of granular preparations, must be determined and reported according CIPAC Method MT 171. If relevant for operator exposure the particle size of dust must be determined and reported according to OECD Method 110. 2.8.6.3. The friability and attrition characteristics of granules, must be determined and reported once internationally agreed methods are available. Where already data are available they must be reported together with the method used. 2.8.7. Emulsifiability, Re-emulsifiability, emulsion stability 2.8.7.1. The emulsifiability, emulsion stability and re-emul-sifiability of preparations which form emulsions, must be determined and reported according to CIPAC Methods MT 36 or MT 173 as appropriate. 2.8.7.2. The stability of dilute emulsions and of preparations which are emulsions, must be determined and reported according to CIPAC Method MT 20 or MT 173. 2.8.8. Flowability, pourability (rinsability) and dustability 2.8.8.1. The flowability of granular preparations must be determined and reported according to CIPAC Mehtod MT 172. 2.8.8.2. The pourability (including rinsed residue) of suspensions (e.g. suspension concentrates, suspo-emulsions), must be determined and reported according to CIPAC Method MT 148. 2.8.8.3. The dustability of dustable powders following accelerated storage according 2.7.1 must be determined and reported according to CIPAC Method MT 34 or another suitable method. 2.9. Physical and chemical compatibility with other products including plant protection products with which its use is to be authorized 2.9.1. The physical compatibility of tank mixes must be reported based on in-house test methods. A practical test would be an acceptable alter native. 2.9.2. The chemical compatibility of tank mixes must be determined and reported except where examination of the individual properties of the preparations would establish beyond reasonable doubt that there is no possibility of reaction taking place. In such cases it is sufficient to provide that information as justification for not practically deter mining the chemical compatibility. 2.10. Adherence and distribution to seeds In the case of preparations for seed treatment, both distribution and adhesion must be investigated and reported; in the case of distribution according to CIPAC Method MT 175. 2.11. Summary and evaluation of data presented under points 2.1. to 2.10 3. Data on application 3.1. Field of use envisaged, e.g. field, protected crops, storage of plant products, home gardening The field(s) of use, existing and proposed, for preparations containing the active substance must be specified from among the following: —field use, such as agriculture, horticulture, forestry and viticulture, —protected crops, —amenity, —weed control on non-cultivated areas, —home gardening, —house plants, —plant products storage practice, —other (specify). 3.2. Effects on harmful organisms, e.g. contact, inhalation or stomach poison, fungitoxic or fungistatic, etc., systemic or not in plants The nature of the effects on harmful organisms must be stated: —contact action, —stomach action, —inhalation action, —fungitoxic action, —fungistatic action, —desiccant, —reproduction inhibitor, —other (must be specified). It must be stated whether or not the product is translocated in plants. 3.3. Details of intended use e.g. types of harmful organisms controlled and/or plants or plant products to be protected Details of the intended use must be provided. Where relevant, effects achieved e.g. sprout suppression, retardation of ripening, reduction in stem length, enhanced fertilization etc. must be reported. 3.4. Application rate For each method of application and each use, the rate of application per unit (ha, m2,m3) treated, in terms of g or kg of both preparation and active substance, must be provided. Application rates shall normally be expressed in g or kg/ha or in kg/m3 and where appropriate in g or kg/tonne; for protected crops and home gardening use rates shall be expressed in g or kg/100 m2or g or kg/m3. 3.5. Concentration of active substance in material used (e.g. in the diluted spray, baits or treated seed) The content of active substance shall be reported, as appropriate, in g/l, g/kg, mg/kg or in g/tonne. 3.6. Method of application The method of application proposed must be described fully, indi cating the type of equipment to be used, if any, as well as the type and volume of diluent to be used per unit of area or volume. 3.7. Number and timing of applications and duration of protection The maximum number of applications to be used and their timing, must be reported. Where relevant the growth stages of the crop or plants to be protected and the development stages of the harmful organisms, must be indicated. Where possible the interval between applications, in days, must be stated. The duration of protection afforded both by each application and by the maximum number of applications to be used, must be indicated. 3.8. Necessary waiting periods or other precautions to avoid phytotoxic effects on succeeding crops Where relevant, minimum waiting periods between last application and sowing or planting of succeeding crops, which are necessary to avoid phytotoxic effects on succeeding crops, must be stated, and follow from the data provided under paragraph 6.6. Limitations on choice of succeeding crops, if any, must be stated. 3.9. Proposed instructions for use The proposed instructions for use of the preparation, to be printed on labels and leaflets, must be provided. 4. Further information on the plant protection product 4.1. Packaging (type, materials, size etc.), compatibility of the preparation with proposed packaging materials 4.1.1. Packaging to be used must be fully described and specified in terms of the materials used, manner of construction (e.g. extruded, welded etc.), size and capacity, size of opening, type of closure and seals. It must be designed in accordance with the criteria and guidelines specified in the FAO‘Guidelines for the Packaging of Pesticides’. 4.1.2. The suitability of the packaging, including closures, in terms of its strength, leakproofness and resistance to normal transport and handling, must be determined and reported according to ADR Methods 3552, 3553, 3560, 3554, 3555, 3556 3558, or appropriate ADR Methods for intermediate bulk containers, and, where for the preparation child-resistant closures are required, according to ISO standards 8317. 4.1.3. The resistance of the packaging material to its contents must be reported according to GIFAP Monograph No 17. 4.2. Procedures for cleaning application equipment Cleaning procedures for both application equipment and protective clothing must be described in detail. The effectiveness of the cleaning procedure, must be fully investigated and reported. 4.3. Re-entry periods, necessary waiting periods or other precautions to protect man, livestock and the environment The information provided must follow from and be supported by the data provided for the active substance(s) and that provided under sections 7 and 8. 4.3.1. Where relevant pre-harvest intervals, re-entry periods or withholding periods necessary to minimize the presence of residues in or on crops, plants and plant products, or in treated areas or spaces, with a view to protecting man or livestock, must be specified e.g.: —pre-harvest interval (in days) for each relevant crop, —re-entry period (in days) for livestock, to areas to be grazed, —re-entry period (in hours or days) for man to crops, buildings or spaces treated, —withholding period (in days) for animal feedingstuffs, —waiting period (in days), between application and handling treated products, or —waiting period (in days), between last application and sowing or planting succeeding crops. 4.3.2. Where necessary, in the light of the test results, information on any specific agricultural, plant health or environmental conditions under which the preparation shall or shall not be used must be provided. 4.4. Recommended methods and precautions concerning: handling, storage, transport or fire The recommended methods and precautions concerning handling procedures (detailed) for the storage, at both warehouse and user level of plant protection products, for their transport and in the event of fire must be provided. Where available information on combustion products must be provided. The risks likely to arise and the methods and procedures to minimize the hazards arising, must be specified. Procedures to preclude or minimize the generation of waste or leftovers must be provided. Where relevant assessment has to be done according to ISO—TR 9122. Where appropriate the nature and characteristics of protective clothing and equipment proposed must be provided. The data provided must be sufficient to evaluate the suitability and effectiveness under realistic conditions of use (e.g. field or glasshouse circumstances). 4.5. Emergency measures in the case of an accident Whether arising during transport, storage or use, detailed procedures to be followed in the event of an emergency, must be provided; and include: —containment of spillages, —decontamination of areas, vehicles and buildings, —disposal of damaged packaging, adsorbents and other materials, —protection of emergency workers and bystanders, —first aid measures. 4.6. Procedures for destruction or decontamination of the plant protection product and its packaging Procedures for destruction and decontamination must be developed for both small quantities (user level) and large quantities (warehouse level). The procedures must be consistent with provisions in place relating to the disposal of waste and of toxic waste. The means of disposal proposed should be without unacceptable influence on the environment and be the most cost effective and practical means of disposal feasible. 4.6.1. Possibility of neutralization Neutralization procedures (e.g by reaction with alkali to form less toxic compounds) for use in the event of accidental spillages, must where they are feasible, be described. The products produced after neutralization should be practically or theoretically evaluated and reported. 4.6.2. Controlled incineration In many cases the preferred or sole means to safely dispose of active substances as well as plant protection products containing it, contaminated materials, or contaminated packaging, is through controlled incineration in a licensed incinerator. Where the content of halogens of the active substance(s) in the preparation is greater than 60 %, the pyrolytic behaviour of the active substance under controlled conditions (including where relevant supply of oxygen and defined residence time) at 800oC and the content of polyhalogenated dibenzo-p-dioxins and dibenzo-furans in the products of pyrolysis must be reported. The applicant must provide detailed instructions for safe disposal. 4.6.3. Others Other methods to dispose of plant protection products, packaging and contaminated materials, where proposed, must be fully described. Data must be provided for such methods, to establish their effectiveness and safety. 5. Analytical methods Introduction The provisions of this section only cover analytical methods required for post-registration control and monitoring purposes. For analytical methods used for generation of data as required in this Directive or for other purposes the applicant has to provide a justifi cation for the method used; where necessary separate guidance will be developed for such methods on the basis of the same requirements as defined for methods for post-registration control and monitoring purposes. Descriptions of methods must be provided and include details of equipment, materials and conditions used. As far as practicable these methods must employ the simplest approach, involve the minimum cost, and require commonly available equipment. For this section the following applies: Impurities Any component other than the pure active substance which is present in the active substance as manufactured (including non active isomers) originating from the manufac turing process or from degradation during storage Relevant impurities Impurities of toxicological and/or ecotoxico logical or environmental concern Metabolites Metabolites include products resulting from degradation or reaction of the active substance Relevant metabolites Metabolites of toxicological and/or ecotoxi cological or environmental concern On request the following samples must be provided: (i) samples of the preparation; (ii) analytical standards of the pure active substance; (iii) samples of the active substance as manufactured; (iv) analytical standards of relevant metabolites and all other components included in the residue definition; (v) if available, samples of reference substances for the relevant impu rities. For definitions see Schedule II, Section 4, points 4.1 and 4.2. 5.1. Methods for the analysis of the preparation 5.1.1. Methods, which must be described in full, must be provided for the determination of the active substance in the preparation. In the case of a preparation containing more than one active substance a method capable of determining each, in the presence of the other, should be provided. If a combined method is not submitted, the technical reasons must be stated. The applicability of existing Cipac methods must be reported. 5.1.2. Methods must also be provided for the determination in the preparation of relevant impurities, if the composition of the preparation is such that—on the basis of theoretical consideration— such impurities may be formed by its manufacturing process or from degradation during storage. If required, methods for the determination of formulants or constituents of formulants in the preparation must be submitted. 5.1.3. Specificity, linearity, accuracy and repeatability 5.1.3.1. Specificity of methods submitted, must be demonstrated and reported. In addition the extent of interference by other substances present in the preparation must be determined. While interferences due to other components may be identified as systematic errors in the assessment of the accuracy of methods proposed, an explanation must be provided for any interference occurring which contribute more than ± 3 % to the total quantity determined. 5.1.3.2. The linearity of proposed methods over an appropriate range, must be determined and reported. The calibration range must extend (by at least 20 %) the highest and lowest nominal content of the analyte in relevant analytical solutions of the preparation. Duplicate calibration determinations must be made at three or more concentrations. Alter natively, five concentrations, each as single measurements, are acceptable. Reports submitted must include the equation of the cali bration line and the correlation coefficient and representative and properly labelled documentation from the analysis, e.g. chroma tograms. 5.1.3.3. Accuracy will normally only be required for methods for the determi nation of pure active substance and relevant impurities in the preparation. 5.1.3.4. For the repeatability in principle a minimum of five determinations must be made. The relative standard deviation (% RSD) must be reported. Outliers identified through an appropriate method (e.g. Dixons or Grubbs test), may be discarded. Where outliers have been discarded, that fact must be clearly indicated. An explanation as to the reason for the occurrence of individual outliers, must be attempted. 5.2. Analytical methods for the determination of residues Analytical methods for the determination of residues must be submitted unless it is justified that the methods already submitted according to the requirements of Schedule II, Section 4, point 4.2 can be applied. The same provisions as provided in Schedule II, Section 4, point 4.2 apply. 6. Efficacy data General The data supplied must be sufficient to permit an evaluation of the plant protection product to be made. In particular it must be possible to evaluate the nature and extent of benefits that accrue following use of the preparation, where they exist in comparison to suitable reference products and damage thresholds, and to define its conditions of use. The number of trials to be conducted and reported depends mainly on factors such as the extent to which the properties of the actieve substance(s) it contains are known and on the range of conditions that arise, including variability in plant health conditions, climatic differences, the range of agricultural practices, the uniformity of the crops, the mode of application the type of harmful organism and the type of plant protection product. Sufficient data must be generated and submitted to confirm that patterns determined hold for the regions and the range of conditions, likely to be encountered in the regions concerned, for which its use is to be recommended. Where an applicant claims that tests in one or more of the proposed regions of use are unnecessary because conditions are comparable with those in other regions where tests have been carried out, the applicant must substantiate the claim for comparability with documentary evidence. In order to assess seasonal differences, if any, sufficient data must be generated and submitted to confirm the performance of the plant protection product in each agronomically and climatically different region for each particular crop (or commodity)/harmful organism combination. Normally trials on effectiveness or phytotoxicity, where relevant, in at least two growing seasons must be reported. If to the opinion of the applicant the trials from the first season adequately confirm the validity of claims made on the basis of extra polation of results from other crops, commodities or situations or from tests with closely similar preparations, a justification, which is acceptable to the director for not carrying out a second seaons's work must be provided. Conversely, where, because of climatic or plant health conditions or other reasons the data obtained in any particular season are of limited value for the assessment of performance, trials in one or more further seasons must be conducted and reported. 6.1. P r e l i m i n a r y t e s t s Reports in summary form of preliminary tests, including glasshouse and field studies, used to assess the biological activity and dose range finding of the plant protection product and of the active substance(s) it contains, must be submitted when requested by the director. These reports will provide additional information for the director when it evaluates the plant production product. Where this information is not submitted a justification which is acceptable to the director must be provided. 6.2. T e s t i n g e f f e c t i v e n e s s Aim of the tests The tests shall provide sufficient data to permit an evaluation of the level, duration and consistency of control or protection or other intended effects of the plant protection product in comparison to suitable reference products, where they exist. Test conditions Normally a trial consists of three components: test product, reference product and untreated control. The performance of the plant protection product must be investigated in relation to suitable reference products, where they exist. A suitable reference product is defined as an authorized plant protection product which has proved a sufficient performance in practice under the agri cultural, plant health and environmental (including climatic) conditions in the area of proposed use. In general, formulation type, effects on the harmful organisms, working spectrum and method of application should be close to those of the tested plant protection product. Plant protection products must be tested in circumstances where the target harmful organism has been shown to have been present at a level causing or known to cause adverse effects (yield, quality, oper ational benefit) on an unprotected crop or area or on plants or plant products which have not been treated or where the harmful organism is present at such a level that an evaluation of the plant protection product can be made. Trials to provide data on plant protection products for control of harmful organisms must show the level of control of the species of harmful organisms concerned or of species representative of groups for which claims are made. Trials must include the different stages of growth of life cycle of the harmful species, where this is relevant and the different strains or races, where these are likely to show different degrees of susceptibility. Similarly, trials to provide data on plant protection products which are plant growth regulators, must how the level of effects on the species to be treated, and include investigation of differences in the response of a representative sample of the range of cultivars on which its use is proposed. In order to clarify the dose response, dose rates lower than the recom mended one must be included in some trials in order to enable to assess whether the recommended rate is the minimum necessary to achieve the desired effect. The duration of the effects of treatment must be investigated in relation to the control of the target organism or effect on the treated plants or plant products, as appropriate. When more than one application is recommended, trials must be reported which establish the duration of the effects of an application, the number of applications necessary and the desired intervals between them. Evidence must be submitted to show that the dose, timing and method of application recommended give adequate control, protection or have the intended effect in the range of circumstances likely to be encountered in practical use. Unless there are clear indications that the performance of the plant protection production is unlikely to be affected to a significant degree by environmental factors, such as temperature or rain, an investi gation of the effects of such factors on performance must be carried out and reported, particularly where it is known that the performance of chemically related products as so affected. Where proposed label claims include recommendations for the use of the plant protection product with other plant protection product(s) or adjuvant(s) information on the performance of the mixture must be provided. Test guideline Trials must be designed to investigate specified issues, to minimize the effects of random variation between different parts of each site and to enable statistical analysis to be applied to results amenable to such analysis. The design, analysis and reporting of trials must be in accordance with European and Mediterranean Plant Protection Orga nization (EPPO) guidelines 152 and 181. The report shall include a detailed and critical assessment of the data. The trials must be carried out in accordance to specific EPPO guidelines, where available, or when a requires so and when the test is carried out on the territory of this, with guidelines satisfying at least the requirements of the corresponding EPPO guideline. A statistical analysis of results amenable to such analysis must be carried out; where necessary the test guideline used must be adapted to enable such analysis. 6.3. I n f o r m a t i o n o n t h e o c c u r r e n c e o r p o s s i b l e occurrence of the development of resistance Laboratory data and where it exists, field information relating to the occurrence and development of resistance or cross-resistance in popu lations of harmful organisms to the active substance(s), or to related actived substances, must be provided. Where such information is not directly relevant to the uses for which authorization is ought or to be renewed (different species of harmful organism or different crops), it must, if available, nevertheless be provided, as it may provide and indication of the likelihood of resistance developing in the target population. Where there is evidence or information to suggest that, in commercial use, the development of resistance is likely, evidence must be generated and submitted as to the sensitivity of the population of the harmful organism concerned to the plant protection product. In such cases a management strategy designed to minimize the likelihood of resistance or cross-resistance developing in target species must be provided. 6.4. E f f e c t s o n t h e y i e l d o f t r e a t e d p l a n t s o r p l a n t products in terms of quantity and/or quality 6.4.1. Effects on the quality of plants or plant product Aim of the tests The tests shall provide sufficient data to permit an evaluation of the possible occurrence of taint or odour or other quality aspects of plants or plant products after treatment with the plant protection product. Circumstances in which required The possibility of the occurrence of taint or odour in food crops must be investigated and be reported where: —the nature of the products or its use is such that a risk of occurrence of taint or odour might be expected, or —other products based on the same or a closely similar active ingredient have been shown to present a risk of occurrence of taint or odour. The effects of plant protection products on other quality aspects of treated plants or plant products must be investigated and reported where: —the nature of the plant protection product or it use could have an adverse influence on other quality aspects (for example in the case of use of plant growth regulators close or harvest), or —other products based on the same or a closely similar active ingredient have been shown to have an adverse influence on the quality. Testing should be conducted initially on the main crops on which the plant protection product is to be used, at twice the normal rates of application and using, where relevant, the main methods of processing. Where effects are observed it is necessary to perform testing at the normal rate of application. The extent of investigation necessary on other crops will depend on their degree of similarity of the main crops already tested, the quantity and quality of data available on those main crops and how far the manner of use of the plant protection product and methods of processing the crops, are similar. It is generally sufficient to perform the test with the main formulation type to be authorized. 6.4.2. Effects on transformation processes Aim of the tests The tests shall provide sufficient data to permit an evaluation of the possible occurrence of adverse effects after treatment with the plant protection product on transformation processes or on the quality of their products. Circumstances in which required When the treated plants or plant products are normally intended for use in transformation process such as wine making, brewing or bread making and when at harvest significant residues are present, the possi bility of the occurrence of adverse effects must be investigated and reported where: —there are indications that the use of the plant protection product could have an influence on the processes involved (for example in the case of use of plant growth regulators or fungicides close to harvest), or —other products based on the same or a closely similar active ingredient have been shown to have an adverse influence on these processes or its products. It is generally sufficient to perform the test with the main formulation type to be authorized. 6.4.3. Effects on the yield of treated plants or plant products Aim of the tests The test shall provide sufficient data to permit an evaluation of the performance of the plant protection product and of possible occurrence of yield reduction or loss in storage of treated plants or plant products. Circumstances in which required The effects of plant protection products on the yield or yield components of treated plant products must be determined where relevant. When treated plants or plant products are likely to be stored the effect on the yield after storage, including data on starage life must be determined where relevant. This information will normally be available from the tests required under the provisions of point 6.2. 6.5. P h y t o t o x i c i t y t o t a r g e t p l a n t s ( i n c l u d i n g d i f f e r e n t cultivars), or to target plant products Aim of the tests The test shall provide sufficient data to permit an evaluation of the performance of the plant protection product and of the possible occurrence of phytotoxicity after treatment with the plant protection product. Circumstances in which required For herbicides and for other plant protection products for which adverse effects, however transitory, are seen during the trials, performed in accordance to point 6.2, the margins of selectivity on target crops must be established, using twice the recommended rate of application. Where serious phytotoxic effects are seen, an intermediate application rate must also be investigated. Where adverse effects occur, but are claimed to be unimportant in comparison with the benefits of use or transient, evidence to support this claim is required. If necessary yield measurement must be submitted. The safety of a plant protection product to the main cultivars of the main crops for which it is recommended must be demonstrated, including effects of crop growh stage, vigour, and other factors which may influence suspectibility to damage or injury. The extent of investigation necessary on other crops will depend on their degree of similarity to the main crops already tested, the quantity and quality of data available on those main crops and how far the manner of use of the plant protection product, if relevant, is similar. It is generally sufficient to perform the test with the main formulation type to be authorized. Where proposed label claims include recommendations for the use of the plant protection product with other plant protection product(s), the provisions of the previous paragraphs apply for the mixture. Test guideline Observations concerning phytotoxicity must be performed in the tests provided for under point 6.2. Where phytotoxic effects are seen, they must be accurately assessed and recorded in accordance with EPPO guideline 135 or when a Member State requires so and when the test is carried out on the territory of this Member State, with guidelines satisfying at least the requirements of this EPPO guideline. A statistical analysis of results amenable to such analysis must be carried out, where necessary the test guideline used must be adapted to enable such analysis. 6.6. O b s e r v a t i o n s o n u n d e s i r a b l e o r u n i n t e n d e d s i d e effects, e. g. on beneficial and other non-target organisms, on succeeding crops, other plants or parts of treated plants used for propagating purposes (e. g. seeds, cuttings, runners) 6.6.1. Impact on succeeding crops Aim of the information required Sufficient data must be reported to permit an evaluation of possible adverse effects of a treatment with the plant protection product on succeeding crops. Circumstances in which required Where data, generated in accordance with Section 9, point 9.1, shows that signification residues of the active substance, its metabolites or degradation products, which have or may have biological activity on succeeding crops, remain in soil or in plant materials, such as straw or organic material up to sowing or planting time of possible succeeding crops, observations must be submitted on effects on the normal range of succeedings crops. 6.6.2. Impact on other plants, including adjacent crops Aim of the information required Sufficient data must be reported to permit an evaluation of possible adverse effects of a treatment with the plant protection product on other plants, including adjacent crops. Circumstances in which required Observations must be submitted on adverse effects on other plants, including the normal range of adjacent crops, when there are indi cations that the plant protection product could affect these plants via vapour drift. 6.6.3. Impact on treated plants or plant products to be used for propagation Aim of the information required Sufficient data must be reported to permit an evaluation of possible adverse effects of a treatment with the plant protection product on plants or plant products to be used for propagation. Circumstances in which required Observations must be submitted on the impact of plant protection products on plant parts used for propagation except where the proposed uses preclude use on crops intended for production of seeds, cuttings, runners or tubers for planting, as appropriate. (i) for seeds—viability, germination and vigour; (ii) cuttings—rooting and growth rates; (iii) runners—establishment and growth rates; (iv) tubers—sprouting and normal growth. Test guideline Seeds testing shall be done according to ISTA Methods (1). (1) International rules for seed testing, 1985. Proceedings of the International Seed Testing Association,Seed Science and Technology, Volume 13, No 2, 1985 6.6.4. Effects on beneficial and other non-target organisms Any effects, positive or negative, on the incidence of other harmful organisms, observed in the tests performed in accordance with the requirements of this section, shall be reported. Any observed environ-mental effects must also be reported, especially effects on wildlife and/or beneficial organisms. 6.7. S u m m a r y a n d e v a l u a t i o n o f d a t a p r e s e n t e d u n d e r 6.1 to 6.6 A summary of all data and in formations provided under points 6.1 to 6.6 must be provided, together with a detailed and a critical assessment of the data, with particular reference to the benefits that the plant protection product offers, adverse effects that do or may arise and measures necessary to avoid or minimize adverse effects. 7. Toxicological studies For proper evaluation of the toxicity of preparations sufficient infor mation should be available on acute toxicity, irritation and sensiti zation of the active substance. If possible, additional information on mode of toxic action, toxicological profile and all other known toxi cological aspects of the active substance should be submitted. In the context of the influence that impurities and other components can have on toxicological behaviour, it is essential that for each study submitted, a detailed description (specification) of the material used, be provided. Tests must be conducted using the plant protection product to be authorized. 7.1. Acute toxicity The studies, data and information to be provided and evaluated, must be sufficient to permit the identification of effects following a single exposure to the plant protection product, to be assessed, and in particular to establish, or indicate: —the toxicity of the plant protection products, —toxicity of the plant protection product relative to the active substance, —the time course and characteristics of the effect with full details of behavioural changes and possible gross pathological findings at post-mortem, —where possible the mode of toxic action, and —the relative hazard associated with the different routes of exposure. While the emphasis must be on estimating the toxicity ranges involved, the information generated must also permit the plant protection product to be classified in accordance with Council Directive 99/45/EEC. The information generated through acute toxicity testing is of particular value in assessing hazards likely to arise in accident situations. 7.1.1. Oral Circumstances in which required An acute oral test should always be carried out unless the applicant can justify to the satisfaction of the director that Article 3.2 of Council Directive 99/45/EEC can be invoked. Test guidelines The test must be carried out in accordance with Directive 92/69/EEC Method B1 or B1 bis. 7.1.2. Percutaneous Circumstances in which required An acute percutaneous test should always be carried out unless the applicant can justify to the satisfaction of the director that Article 3.2 of Council Directive 1999/45/EEC can be invoked. Test guideline The test must be carried out in accordance with Directive 92/69/EEC Method B3. 7.1.3. Inhalation Aim of the test The test will provide the inhalation toxicity to rats of the plant protection product or of the smoke it generates. Circumstances in which required The test must be carried out where the plant protection product: —is a gas or liquified gas, —is a smoke generating formulation or fumigant, —is used with fogging equipment, —is a vapour releasing preparation, —is an aerosol, —is a powder containing a significant proportion of particles of diameter <50µm (> 1 % on a weight basis), —is to be applied from aircraft in cases where inhalation exposure is relevant, —contains an active substance with a vapour pressure > 1 10-2Pa and is to be used in enclosed spaces such as warehouses or glass houses, —is to be applied in a manner which generates a significant proportion of particles or droplets of diameter <50µm(>1% on a weight basis). Test guideline The test must be carried out in accordance with Directive 92/69/EEC Method B2. 7.1.4. Skin irritation Aim of the test The test will provide the potential of skin irritancy of the plant protection product including the potential reversibility of the effects observed. Circumstances in which required The skin irritancy of the plant protection product must be determined except where it is likely, as indicated in the test guideline, that severe skin effects may be produced or that effects can be excluded. Test guideline The test must be carried out in accordance with Directive 92/69/EEC Method B4. 7.1.5. Eye irritation Aim of the test The test will provide the potential for eye irritation of the plant protection product, including the potential reversibility of the effects observed. Circumstances in which required Eye irritation tests must be conducted except where it is likely, as indicated in the test guideline, that severe effects on the eyes may be produced. Test guideline The eye irritation must be determined in accordance with Directive 92/69/EEC Method B5. 7.1.6. Skin sensitization Aim of the test The test will provide sufficient information to assess the potential of the plant protection product to provoke skin sensitization reactions. Circumstances in which required The tests must always be carried out except where the active substance(s) or co-formulants are known to have sensitizing properties. Test guideline The tests have to be carried out in accordance with Directive 92/69/EEC Method B6. 7.1.7. Supplementary studies for combinations of plant protection products Aim of the test In certain cases it may be necessary to carry out the studies as referred to under points 7.1.1 to 7.1.6 for a combination of plant protection products where the product label includes requirements for use of the plant protection product with other plant protection products and/or with adjuvants as a tank mix. Decisions as to the need for supple mentary studies must be made on a case by case basis, taking into account the results of the acute toxicity studies of the individual plant protection products, the possibility for exposure to the combination of the products concerned and available information or practical experience with the products concerned or similar products. 7.2. Data on exposure When measuring exposure to a plant protection product in the air within the breathing area of operators, bystanders or workers the requirements for measuring procedures described in Annex II A to Council Directive 98/24/EC of 7 April 1998 on the protection of the health and safety of workers from the risks related to chemical agents at workhave to be taken into account. 7.2.1. Operator exposure The risks for those using plant protection products depend on the physical, chemical and toxicological properties of the plant protection product as well as the type of the product (undiluted/diluted), and on the route, the degree and duration of exposure. Sufficient information and data must be generated and reported to permit an assessment of the extent of exposure to the active substance(s) and/or toxicologically relevant compounds in the plant protection product likely to occur under the proposed conditions of use. It must also provide a basis for the selection of the appropriate protective measures including personal protective equipment to be used by operators and to be specified on the label. 7.2.1.1.Estimation of operator exposure Aim of the estimation An estimation shall be made, using where available a suitable calcu lation model, in order to permit an evaluation of the operator exposure likely to arise under the proposed conditions of use. Circumstances in which required An estimation of operator exposure must always be completed. Estimation conditions An estimation shall be made for each type of application method and application equipment proposed for use of the plant protection product taking account of the requirements resulting from the implementation of the classification and labelling provisions of Directive 99/45/EEC for handling the undiluted or diluted product as well as the different types and sizes of containers to be used, mixing, loading operations, application of the plant protection product, the climatic conditions and cleaning and routine maintenance of application equipment. At first an estimation shall be made with the assumption that the operator is not using any personal protective equipment. Where appropriate, a second estimation shall be made with the assumption that the operator is using effective and readily obtainable protective equipment which is feasible to be used by the operator. Where protective measures are specified on the label, the estimation will take these into account. 7.2.1.2. Measurement of operator exposure Aim of the test The test shall provide sufficient data to permit an evaluation of the operator exposure likely to arise under the proposed conditions of use. Circumstances in which required Actual exposure data for the relevant exposure route(s) must be reported where the risk assessment indicates that a health-based limit value is exceeded. This will, for example, be the case when the results of the estimation of operator exposure provided for under point 7.2.1.1 indicate that: —the Acceptable Operator Exposure Level(s) (AOEL) established in the context of inclusion of the active substance(s) in Schedule I, and/or —the Limit Values established for the active substance and/or toxi cologically relevant compound(s) of the plant protection product in accordance with Council Directive 98/24/EEC and Council Directive 2004/37/EC of the European Parliament and of the Council of 29 April 2004 on the protection of workers from the risks related to exposure to carcinogens or mutagens at work, may be exceeded. Actual exposure data must also be reported when no appropriate calculation model or no appropriate data are available to do the estimation provided for under point 7.2.1.1. In cases where dermal exposure is the most important exposure route, a dermal absorption test or the results of a sub-acute dermal study, if not already available, may be a useful alternative test to provide data in order to refine the estimate provided for under point 7.2.1.1. Test conditions The test must be done under realistic exposure conditions taking into account the proposed conditions of use. 7.2.2. Bystander exposure Bystanders can be exposed during the application of plant protection products. Sufficient information and data must be reported to provide a basis for the selection of appropriate conditions of use, including the exclusion of bystanders from treatment areas and separation distances. Aim of the estimation An estimation shall be made, using where available a suitable calcu lation model in order to permit an evaluation of the bystander exposure likely to arise under the proposed conditions of use. Circumstances in which required An estimation of bystander exposure must always be completed. Estimation conditions An estimation of bystander exposure must be made for each type of application method. The estimation shall be made with the assumption that bystanders do not use any personal protective equipment. Measurement of bystander exposure may be required when estimates indicate a cause for concern. 7.2.3. Worker exposure Workers can be exposed following application of plant protection products, when entering treated fields or premises or handling treated plants or plant products on which residues remain. Sufficient information and data must be reported to provide a basis for the selection of appropriate protective measures, including waiting and re-entry periods. 7.2.3.1. Estimation of worker exposure and/or Aim of the estimation An estimation shall be made using where available a suitable calcu lation model, in order to permit an evaluation of the worker exposure likely to arise under the proposed conditions of use. Circumstances in which required The estimation of worker exposure must always be completed. Estimation conditions An estimation of worker exposure must be made for each crop and task to be carried out. At first the estimation shall be made using available data on the exposure to be expected with the assumption that the worker is not using any personal protective equipment. Where appropriate, a second estimation shall be made with the assumption that the worker is using effective and readily obtainable protective equipment which is feasible to be used. Where appropriate, a further estimation shall be made using data generated on the amount of dislodgeable residues under the proposed conditions of use. 7.2.3.2. Measurement of worker exposure Aim of the test The test shall provide sufficient data to permit an evaluation of the worker exposure likely to arise under the proposed conditions of use. Circumstances in which required Actual exposure data for the relevant exposure route(s) must be reported where the risk assessment indicates that a health-based limit value is exceeded. This will, for example, be the case where the results of the estimation of worker exposure provided for under point 7.2.3.1 indicate that: —the AOEL(s) established in the context of inclusion of the active substance(s) in Schedule I, —the Limit Values established for the active substance and/or toxi cologically relevant compound(s) of the plant protection product in accordance with Council Directives 98/24/EEC and 2004/37/EEC, may be exceeded. Actual exposure data must also be reported when no appropriate calculation model or no appropriate data are available to do the estimation provided for under point 7.2.3.1. Where dermal exposure is the most important exposure route, a dermal absorption test, if not already available, may be a useful alternative test to provide data in order to refine the estimate provided for under point 7.1.3.1. Test conditions The test must be done under realistic exposure conditions taking into account the proposed conditions of use. 7.3. Dermal absorption Aim of the test The test shall provide a measurement of the absorption of the active substance and toxicologically relevant compounds through the skin. Circumstances in which required The study must be conducted when dermal exposure is a significant exposure route and where the risk assessment indicates that a health based limit value is exceeded. This will, for example, be the case where the results of the estimation or measurement of operator exposure provided for under points 7.2.1.1 or 7.2.1.2 indicate that: —the AOEL(s) established in the context of inclusion of the active substance(s) in Schedule I, and/or —the limit values established for the active substance and/or toxico logically relevant compound(s) of the plant protection product in accordance with Council Directives 98/24/EEC and 2004/37/EEC may be exceeded. Test conditions In principle data of an in vivo rat skin absorption study must be reported. If, when the results of the estimation using these in vivo skin absorption data are incorporated in the risk assessment, there remains an indication of excessive exposure, it may be necessary to perform an in vivo comparative absorption study on rat and human skin. Test guideline Appropriate elements of OECD guideline 417 are to be used. For the design of the studies it may be necessary to take into account the results of the skin absorption studies with the active substance(s). 7.4. Available toxicological data relating to non-active substances Where available, a copy of the notification and the safety data sheet submitted in the context of Directive 67/548/EEC and Commission Regulation (EC) No 1907/2006 of the European Parliament and of the Council of 18 December 2006 concerning the Registration, Evaluation, Authorisation and Restriction of Chemicals (REACH), establishing a European Chemicals Agency, amending Directive 1999/45/EC and repealing Council Regulation (EEC) No 793/93 and Commission Regulation (EC) No 1488/94 as well as Council Directive 76/769/EEC and Commission Directives 91/155/EEC, 93/67/EEC, 93/105/EC and 2000/21/EC must be submitted for each formulant. All other available information should be submitted. 8. Residues in or on treated products, food and feed Introduction The provisions of Schedule II, Section 6, Introduction apply. 8.1. Metabolism, distribution and expression of residue in plants or livestock Aim of the tests The objectives of these studies are: —to provide an estimate of total terminal residues in the relevant portion of crops at harvest following treatment as proposed, —to quantify the rate of degradation and excretion of the total residue in certain animal products (milk or eggs) and excreta, —to identify the major components of the total terminal residue in crops and in edible animal products respectively, —to indicate the distribution of residues between relevant crop parts and between relevant edible animal products respectively, —to quantify the major components of the residue and to show the efficiency of extraction procedures for these components, —to generate data from which a decision on the need for livestock feeding studies as provided for in point 8.3 can be made, —to decide on the definition and expression of a residue. Circumstances in which required Supplementary metabolism studies only need to be performed where it is not possible to extrapolate from data obtained on the active substance in accordance to the requirements of Schedule II, Section 6, points 6.1 and 6.2. This might be the case for crops or for livestock for which data were not submitted in the framework of inclusion of the active substance in Schedule I or were not necessary for amending the conditions of its inclusion in Schedule I or where it could be expected that a different metabolism will occur. Test conditions The same provisions as provided under the corresponding paragraphs of Schedule II, Section 6, points 6.1 and 6.2 apply. 8.2. Residue trials Aim of the tests The objectives of these studies are: —to quantify the highest likely residue levels in treated crops at harvest or outloading from store following the proposed good agricultural practice (GAP), and —to determine, when appropriate, the rate of decline of pesticide deposits. Circumstances in which required Supplementary residue trials only need to be performed where it is not possible to extrapolate from data obtained on the active substance in accordance to the requirements of Schedule II, Section 6, point 6.3. This might be the case for special formulations, for special application methods or for crops for which data were not submitted in the framework of inclusion of the active substance in Schedule I or were not necessary for amending the conditions of its inclusion in Schedule I. Test conditions The same provisions as provided under the corresponding paragraphs of Schedule II, Section 6, point 6.3 apply. 8.3. Livestock feeding studies Aim of the tests The objective of these studies is to determine the residue in products of animal origin which will result from residues in feedingstuffs or fodder crops. Circumstances in which required Supplementary feeding studies for the purpose of assessing maximum residue levels for products of animal origin are only required where it is not possible to extrapolate from data obtained on the active substance in accordance to the requirements of Schedule II, Section 6, point 6.4. This might be the case where additional fodder crops are to be authorized which leads to an increased intake of residues of livestock for which data were not submitted in the framework of inclusion of the active substance in Schedule I or were not necessary for amending the conditions of its inclusion in Schedule I. Test conditions The same provisions as provided under the corresponding paragraphs of Schedule II, Section 6, point 6.4 apply. 8.4. Effects of industrial processing and/or household preparations Aim of the tests The main objectives of these studies are: —to establish whether or not breakdown or reaction products arise from residues in the raw products during processing which may require a separate risk assessment, —to determine the quantitative distribution of residues in the various intermediate and end products, and to estimate transfer factors, —to enable a more realistic estimate to be made of dietary intake of residues. Circumstances in which required Supplementary studies only need to be performed where it is not possible to extrapolate from data obtained on the active substance in accordance to the requirements of Schedule II, Section 6, point 6.5. This might be the case for crops for which data were not submitted in the framework of inclusion of the active substance in Schedule I or were not necessary for amending the conditions of its inclusion in Schedule I. Test conditions The same provisions as provided under the corresponding paragraphs of Schedule II, Section 6, point 6.5 apply. 8.5. Residues in succeeding crops Aim of the test The objective of these studies is to permit an evaluation of possible residues in succeeding crops. Circumstances in which required Supplementary studies are only required where it is not possible to extrapolate from data obtained on the active substance in accordance to the requirements of Schedule II, Section 6, point 6.6. This might be the case for special formulations, for special application methods or for crops for which data were not submitted in the framework of inclusion of the active substance in Schedule I or were not necessary for amending the conditions of its inclusion in Schedule I. Test conditions The same provisions as provided under the corresponding paragraphs of Schedule II, Section 6, point 6.6 apply. 8.6. Proposed maximum residue levels (MRLs) and residue definition A full justification for the proposed MRLs must be provided, including, where relevant, full details of the statistical analysis used. If the metabolism studies submitted in accordance with the provisions of point 8.1 indicate that the residue definition should be changed taking into account the actual residue definition and the necessary judgement as outlined under the corresponding paragraph of Schedule II, Section 6, point 6.7, a re-evaluation of the active substance may be necessary. 8.7. Proposed pre-harvest intervals for envisaged uses, or withholding periods or storage periods, in the case of post-harvest uses. A full justification for the proposals must be provided. 8.8. Estimation of the potential and actual exposure through diet and other means Consideration will be given to the calculation of a realistic prediction of dietary intake. This may be done in a step-wise fashion leading to an increasingly realistic prediction of intake. Where relevant, other sources of exposure such as residues arising from the use of medicines or veterinary drugs have to be taken into account. 8.9. Summary and evaluation of residue behaviour A summary and evaluation of all data presented in this Section should be carried out according to the guidance given by the competent authority concerning the format of such summaries and evaluations. It should include a detailed and critical assessment of those data in the context of relevant evaluative and decision-making criteria and guidelines, with particular reference to the risks for man and animals that may or do arise, and the extent, quality and reliability of the data base. Where metabolism data have been submitted the toxicological signif icance of any non-mammalian metabolites must be addressed. A schematic diagram should be prepared of the metabolic pathway in plants and animals with a brief explanation of the distribution and chemical changes involved if metabolism data have been submitted. 9. Fate and behaviour in the environment Introduction (i) The information provided, taken together with that for the active substance as provided for in Schedule II, must be sufficient to permit an assessment of the fate and behaviour of the plant protection product in the environment, and of the non-target species likely to be at risk from exposure to it. (ii) In particular, the information provided for the plant protection product, together with other relevant information, and that provided for the active substance, should be sufficient to: —specify the hazard symbols, the indications of danger, and relevant risk and safety phrases for the protection of the envi ronment, which are to be included on packaging (containers), —predict the distribution, fate, and behaviour in the environment as well as the time courses involved, —identify non-target species and populations for which hazards arise because of potential exposure, and —identify measures necessary to minimize contamination of the environment and impact on non-target species. (iii) Where radio-labelled test material is used, the provisions of Schedule II, Chapter 7, introduction, point (iv) apply. (iv) Where relevant tests should be designed and data analysed using appropriate statistical methods. Full details of the statistical analysis should be reported (e.g. all point estimates should be given with confidence intervals, exact p values should be given rather than stating significant/non significant). (v) Predicted environmental concentrations in soil (PECS), water (PECSWand PECGW) and air (PECA). Justified estimates must be made of the expected concentrations of the active substance and relevant metabolites, degradation and reaction products, in soil, groundwater, surface water and air, following use as proposed or already occurring. In addition a realistic worst-case estimation must be made. For the purposes of the estimation of such concentrations the following definitions apply: —Predicted environmental concentration in soil (PECS) The level of residues in the top layer of the soil and to which non-target soil organisms may be exposed (acute and chronic exposure). —Predicted environmental concentration in surface water (PECSW) The level of residues, in surface water to which non-target aquatic organisms may be exposed (acute and chronic exposure). —Predicted environmental concentration in groundwater (PECGW) The level of residues in groundwater. —Predicted environmental concentration in air (PECA) The level of residues in air, to which man, animals and other non-target organisms may be exposed (acute and chronic exposure). For the estimation of these concentrations all relevant information on the plant protection product and on the active substance must be taken into account. A useful approach for these estimations is provided in the EPPO schemes for environmental risk assessment (1). Where relevant the parameters provided for in this section should be used. When models are used for estimation of predicted environmental concentrations they must: —make a best-possible estimation of all relevant processes involved taking into account realistic parameters and assumptions, —where possible be reliably validated with measurements carried out under circumstances relevant for the use of the model, —be relevant to the conditions in the area of use. The information provided must, where relevant, include that referred to in Schedule II, Part A, point 7: and 9.1 Fate and behaviour in soil Where appropriate, the same provisions relating to the information to be provided on the soil used and on its selection apply as provided for under Schedule II, point 7.1. 9.1.1. Rate of degradation in soil 9.1.1.1. Laboratory studies Aim of the test The soil degradation studies should provide best possible estimates of the time taken for degradation of 50 and 90 % (DT50laband DT90lab) of the active substance under laboratory conditions. Circumstances in which required The persistence and behaviour of plant protection products in soil must be investigated unless it is possible to extrapolate from data obtained on the active substance and relevant metabolites, degradation and reaction products in accordance to the requirements of Schedule II, point 7.1.1.2. This extrapolation is, for example, not possible for slow release formulations. Test conditions The rate of aerobic and/or anaerobic degradation in soil must be reported. The duration of the study is normally 120 days except if more than 90 % of the active substance is degraded before that period expires. Test guideline SETAC—Procedures for assessing the environmental fate and ecotoxicity of pesticides. 9.1.1.2. Field studies —Soil dissipation studies Aim of the test The soil dissipation studies should provide best-possible estimates of the time taken for dissipation of 50 and 90 % (DT50fand DT90f), of the active substance under field conditions. Where relevant, information on relevant metabolites, degradation and reaction products must be collected. Circumstances in which required The dissipation and behaviour of plant protection products in soil must be investigated unless it is possible to extrapolate from data obtained on the active substance and relevant metabolites, degra dation and reaction products in accordance to the requirements of Schedule II, point 7.1.1.2. This extrapolation is, for example, not possible for slow-release formulations. Test conditions and test guideline The same provisions as provided under the corresponding paragraph of Schedule II, point 7.1.1.2.2. apply. —Soil residue studies Aim of the test Soil residue studies should provide estimates of the soil residue levels at harvest or at time of sowing or planting succeeding crops. Circumstances in which required Soil residue studies must be reported unless it is possible to extra polate from data obtained on the active substance and relevant metabolites, degradation and reaction products in accordance with the requirements of Schedule II, point 7.1.1.2.2. This extrapo lation is, for example, not possible for slow-release formulations. Test conditions The same provisions as provided under the corresponding paragraph of Schedule II, point 7.1.1.2.2. apply. Test guideline SETAC—Procedures for assessing the environmental fate and ecotoxicity of pesticides. —Soil accumulation studies Aim of the tests The tests should provide sufficient data to evaluate the possibility of accumulation of residues of the active substance and of relevant metabolites, degradation and reaction products. Circumstances in which required Soil accumulation studies must be reported unless it is possible to extrapolate from data obtained on the active substance and relevant metabolites, degradation and reaction products in accordance with the requirements of Schedule II, point 7.1.1.2.2. This extrapolation is, for example, not possible for slow-release formulations. Test conditions The same provisions as provided under the corresponding paragraph of Schedule II, point 7.1.1.2.2. apply. Test guideline SETAC—Procedures for assessing the environmental fate and ecotoxicity of pesticides. 9.1.2. Mobility in the soil Aim of the test The test should provide sufficient data to evaluate the mobility and leaching potential of the active substance and relevant metabolites, degradation and reaction products. 9.1.2.1. Laboratory studies Circumstances in which required The mobility of plant protection products in soil must be investigated unless it is possible to extrapolate from data obtained in accordance with the requirements of Schedule II, points 7.1.2 and 7.1.3.1. This extrapolation is, for example, not possible for slow-release formu lations. Test guideline SETAC—Procedures for assessing the environmental fate and ecotoxicity of pesticides. 9.1.2.2. Lysimeter studies or field leaching studies Aim of the tests The test should provide data on: —the mobility of the plant protection product in soil, —the potential for leaching to ground water, —the potential distribution in soils. Circumstances in which required Expert judgement will be necessary to decide whether field leaching studies or lysimeter studies should be carried out, taking into account the results of degradation and mobility studies and the calculated PECs. The type of study to be conducted should be discussed with the competent authorities. These studies must be performed unless it is possible to extrapolate from data obtained on the active substance and relevant metabolites, degradation and reaction products in accordance with the requirements of Schedule II, point 7.1.3. This extrapolation is, for example, not possible for slow release formulations. Test conditions The same provisions as provided for under the corresponding paragraph of Schedule II, point 7.1.3.3 apply. 9.1.3. Estimation of expected concentrations in soil PECsestimations must relate both to a single application at the highest rate of application for which authorization is sought, and to the maximum number and highest rates of application for which author ization is sought, for each relevant soil tested, and are expressed in terms of mg of active substance and of relevant metabolites, degra dation and reaction products per kg of soil. The factors to be considered in making PECsestimations relate to direct and indirect application to soil, drift, run off, and leaching and include processes such as volatilization, adsorption, hydrolysis, photolysis, aerobic and anaerobic degradation. For the purposes of PECscalculations, the bulk density of soils can be assumed to be 1,5 g/cm3dry weight, while the depth of the soil layer is assumed to be 5 cm for applications at the soil surface and 20 cm when incorporation in the soil is involved. Where ground cover is present at time of application, it is to be assumed that 50 % (minimum) of the applied dose reaches the soil surface unless actual experimental data give more specific information. Initial, short-term and long-term PECscalculations (time weighted averages) must be provided: —initial: immediately after application, —short-term: 24 hours, 2 days and 4 days after last application, —long-term: 7, 28, 50 and 100 days after last application, where relevant. 9.2. Fate and behaviour in water 9.2.1. Estimation of concentrations in groundwater The groundwater contamination routes have to be defined taking into account relevant agricultural, plant health, and environmental (including climatic) conditions. Suitable estimations (calculations) of predicted environmental concen-tration in groundwater PECGW, of active substance and relevant meta-bolites, degradation and reaction products, must be submitted. PEC estimations must relate to the maximum number and highest rates of application, for which authorization is sought. Expert judgment is required to decide if additional field tests could provide useful information. Before performing these studies the applicant shall seek the agreement of the competent authorities on the type of study to be performed. 9.2.2. Impact on water treatment procedures In cases where this information is necessary in the framework of a conditional authorization as meant in Schedule VI, Part C, point 2.5.1.2 (b), the information provided should permit to establish or to estimate effectiveness of water treatment procedures (drinking water and sewage treatment), and impact on such procedures. Before performing any studies the applicant shall seek the agreement of the competent authorities on the type of information to be provided. 9.2.3. Estimation of concentrations in surface water The surface water contamination routes have to be defined taking into account relevant agricultural, plant health, and environmental (including climatic) conditions. Suitable estimations (calculations) of predicted environmental concen-tration in surface water PECsw, of active substance and relevant meta-bolites, degradation and reaction products, must be submitted. PEC estimations must relate to the maximum number and highest rates of application, for which authorization is sought, and be relevant to lakes, ponds, rivers, canals, streams, irrigation/drainage canals and drains. The factors to be considered in making PECswestimations relate to direct application to water, drift, run-off, discharge via drains and atmospheric deposition, and include processes such as volatilization, adsorption, advection, hydrolysis, photolysis, biodegradation, sedimen-tation and re-suspension. Initial, short-term and long-term PECswcalculations relevant to static and slow moving water bodies (time weighted averages) must be provided: —initial: immediately after application, —short-term: 24 hours, 2 days and 4 days after last application, —long-term: 7, 14, 21, 28, and 42 days after last application, where relevant. Expert judgment is required to decide if additional field tests could provide useful information. Before performing these studies the applicant shall seek the agreement of the competent authorities on the type of study to be performed. 9.3. Fate and behaviour in air Guidance under development. 10. Ecotoxicological studies Introduction (i) The information provided, taken together with that for the active substance(s), must be sufficient to permit an assessment of the impact on non-target species (flora and fauna), of the plant protection product, when used as proposed. Impact can result from single, prolonged or repeated exposure, and can be reversible, or irreversible. (ii) In particular, the information provided for the plant protection product, together with other relevant information, and that provided for the active substance, should be sufficient to: —specify the hazard symbols, the indications of danger, and relevant risk and safety phrases for the protection of the envi ronment, to be mentioned on packaging (containers), —permit an evaluation of the short- and long-term risks for non target species—populations, communities, and processes as appropriate, —permit an evaluation of whether special precautions are necessary for the protection of non-target species. (iii) There is a need to report all potentially adverse effects found during routine ecotoxicological investigations and to undertake and report such additional studies which shall be necessary to investigate the mechanisms involved and assess the significance of these effects. (iv) In general, much of the data relating to impact on non-target species, required for authorization of plant protection products, will have been submitted and evaluated for the inclusion of the active substance(s) in Schedule I. The information on fate and behaviour in the environment, generated and submitted in accordance with points 9.1 to 9.3, and on residue levels in plants generated and submitted in accordance with point 8 is central to the assessment of impact on non-target species, in that it provides information on the nature and extent of potential or actual exposure. The final PEC estimations are to be adapted according to the different groups of organisms taking in particular into consideration the biology of the most sensitive species. The toxicological studies and information submitted in accordance with point 7.1 provide essential information as to toxicity to vertebrate species. (v) Where relevant, tests should be designed and data analysed using appropriate statistical methods. Full details of the statistical analysis should be reported (e.g. all point estimates should be given with confidence intervals, exact p-values should be given rather than stating significant/non significant). (vi) Whenever a study implies the use of different doses, the rela tionship between dose and adverse effect must be reported. (vii) Where exposure data are necessary to decide whether a study has to be performed, the data obtained in accordance with the provisions of Schedule III, point 9 should be used. For the estimation of exposure of organisms all relevant infor mation on the plant protection product and on the active substance must be taken into account. A useful approach for these estimations is provided in the EPPO/Council of Europe schemes for environmental risk assessment (1). Where relevant the parameters provided for in this section should be used. Where it appears from available data that the plant protection product is more toxic as the active substance, the toxicity data of the plant protection product have to be used for the calculation of relevant toxicity/exposure ratios. (viii) In the context of the influence that impurities can have on ecotox icological behaviour, it is essential that for each study submitted, a detailed description (specification) of the material used as provided for under point 1.4, be provided. (ix) In order to facilitate the assessment of the significance of test results obtained the same strain of each relevant species should where possible be used in the various toxicity tests specified. (1) OEPP/EPPO (1993). Decision-making schemes for the environmental risk assessment of plant protection products.Bulletin OEPP/EPPO Bulletin 23,1-154 andBulletin 24,1-87. 10.1. Effects on birds Possible effects on birds must be investigated except where the possi bility that birds will be exposed, directly or indirectly, can be ruled out such as for use in enclosed spaces or wound healing treatments. The acute toxicity/exposure ratio (TERa), the short term dietary toxi city/exposure ratio (TERst) and the long term dietary toxicity/exposure ratio (TERlt) must be reported, where: TERa=LD50 (mg a.s./kg body weight) / ETE (mg a.s./kg body weight) TERst=LC50(mg a.s./kg food) / ETE (mg a.s./kg food) TERlt= NOEC (mg a.s./kg food) / ETE (mg a.s./kg food) where ETE = estimated theoretical exposure. In the case of pellets, granules or treated seeds the amount of a.s. in each pellet, granule or seed must be reported as well as the proportion of the LD50for the a.s. in 100 particles and per gram of particles. The size and shape of pellets or granules must be reported. In the case of baits the concentration of a.s. in the bait (mg/kg) must be reported. 10.1.1. Acute oral toxicity Aim of the test The test should provide, where possible, LD50values, the lethal threshold dose, time courses of response and recovery, the NOEL, and must include relevant gross pathological findings. Circumstances in which required The acute oral toxicity of preparations must be reported, where TERa or TERstfor the active substance(s) in birds are between 10 and 100 or where results from mammal testing give evidence of a significantly higher toxicity of the prepration compared to the active substance unless it can be justified that it is not likely that birds are exposed to the plant protection product itself. Test conditions The study must be conducted on the most sensitive species identified in the studies provided for in Schedule II, point 8.1.1 or 8.1.2. 10.1.2. Supervised cage or field trials Aim of the test The test will provide sufficient data to evaluate the nature and the extent of the risk in practical conditions of use. Circumstances in which required Where the TERaand TERstare > 100 and when there is no evidence of risk from any further study on the active substance (e.g. repro-duction study) no further testing is required. In the other cases, expert judgement is necessary to decide whether there is a need to carry out further studies. This expert judgement will take into account, where relevant, foraging behaviour, repellency, alternative food, actual residue content in the food, persistence of the compound in the vege tation, degradation of the formulated product or treated produce, the amount of predation of the food, acceptance of bait, granules or treated seed and the possibility for bioconcentration. Where TERaand TERst=10 or TERlt=5, cage or field trials must be conducted and reported unless a final assessment is possible on the basis of studies according to point 10.1.3. Test conditions Before performing these studies the applicant should seek the agreement of the competent authorities on the type and conditions of the study to be performed. 10.1.3. Acceptance of bait, granules or treated seeds by birds Aim of the test The test will provide sufficient data to evaluate the possibility of consumption of the protection product or plant products treated with it. Circumstances in which required In the case of seed dressings, pellets, baits and preparations which are granules and where TERa=10, acceptability (palatability) tests must be conducted. 10.1.4. Effects of secondary poisoning Expert judgment is required to decide whether the effects of secondary poisoning should be investigated. 10.2. Effects on aquatic organisms Possible effects on aquatic species must be investigated except where the possibility that aquatic species will be exposed can be ruled out. TERaand TERltmust be reported, where: TERa= acute LC50(mg a.s./l)/realistic worst case PECsw(initial or short-term, in mg a.s./l) TERlt= chronic NOEC (mg a.s./l)/long term PECsw(mg a.s./l) 10.2.1. Acute toxicity to fish, aquatic invertebrates or effects on algal growth Circumstances in which required In principle tests should be carried out on one species from each of the three groups of aquatic organisms as referred to in Schedule II, point 8.2 (fish, aquatic invertebrates and algae) in case the plant protection product itself can contaminate water. However where the available information permits to conclude that one of these groups is clearly more sensitive, tests on only the most sensitive species of the relevant group have to be performed. The test must be performed where: —the acute toxicity of the plant protection product can not be predicted on the basis of the data for the active substance which is especially the case if the formulation contains two or more active substances or formulants such as solvents, emulgators, surfactants, dispersants, fertilizers which are able to increase the toxicity in comparison with the active substance, or —the intended use includes direct application on water unless suitable studies referred to under point 10.2.4 are available. Test conditions and test guidelines The relevant provisions as under the corresponding paragraphs of Schedule II, points 8.2.1, 8.2.4 and 8.2.6 apply. 10.2.2. Microcosm or mesocom study Aim of the test The tests must provide sufficient data to evaluate the essential impact on aquatic organisms under field conditions. Circumstances in which required Where TERa=100 or where TERlt=10, expert judgment must be used to decide whether a microcosm or mesocom study is appropriate. This judgment will take into account the results of any additional data over and above those required by the provisions of Schedule II, point 8.2 and of point 10.2.1. Test conditions Before performing these studies the applicant shall seek the agreement of the competent authorities on the specific aims of the study to be performed and consequently on the type and conditions of the study to be performed. The study should include at least the highest likely exposure rate, whether from direct applicaiton, drift, drainage or run-off. The duration of the study must be sufficient to permit evaluation of all effects. Test guideline Appropriate guidelines are included in: Setac—Guidance document on testing procedures for pesticides in freshwater mesocosms/Workshop Huntingdon, 3 and 4 July 1991 or Freshwater field tests for hazard assessment of chemicals—European Workshop on Freshwater Field Tests (EWOFFT). 10.2.3. Residue data in fish Aim of the test The test will provide sufficient data to evaluate the potential for occurrence of residues in fish. Circumstances in which required In general data are available from bioconcentration studies in fish. Where bioconcentration has been observed in the study performed in accordance with Schedule II, point 8.2.3 expert judgement is required to decide whether a long-term microcosm or mesocosm study has to be carried out in order to establish the maximum residues likely to be encountered. Test guideline Setac—Guidance document on testing procedures for pesticides in freshwater mesocosms/Workshop Huntingdon, 3 and 4 July 1991. 10.2.4. Additional studies The studies referred to in Schedule II, points 8.2.2 and 8.2.5 shall be required for particular plant protection products where it is not possible to extrapolate from data obtained in the corresponding studies on the active substance. 10.3. Effects on terrestrial vertebrates other than birds Possible effects on wild vertebrate species must be investigated except where it can be justified that it is not likely that terrestrial vertebrates other than birds are exposed, directly or indirectly. TERa, TERstand TERltmust be reported, where: TERa=LD50(mg a.s./kg body weight) / ETE (mg a.s./kg body weight) TERst= subchronic NOEL (mg a.s./kg food) / ETE (mg a.s./kg food) TERlt= chronic NOEL (mg a.s./kg food) / ETE (mg a.s./kg food) where ETE = estimated theoretical exposure. In principle the evaluation sequence for the assessment of risks to such species is similar to that for birds. In practice it is not often necessary to perform further testing as the studies conducted in accordance with the requirements of Schedule II, point 5 and Schedule III, point 7 would provide the required information. Aim of the test The test will provide sufficient information to evaluate the nature and the extent of risks for terrestrial vertebrates other than birds in practical conditions of use. Circumstances in which required Where TERaand TERst> 100 and where there is no evidence of risk from any further study no further testing is required. In the other cases, expert judgment is necessary to decide whether there is a need to carry out further studies. This expert judgment will take into account, where relevant, foraging behaviour, repellency, alternative food, actual residue content in the food, persistence of the compound in the vege-tation, degradation of the formulated product or treated produce, the amount of predation of the food, acceptance of bait, granules or treated seed and the possibility for bioconcentration. Where TERaand TERst=10 or TERlt=5 cage or field trials or other appropriate studies must be reported. Test conditions Before performing these studies the applicant shall seek the agreement of the competent authorities on the type and conditions of the study to be performed and whether the effects of secondary poisoning should be investigated. 10.4. Effects on bees The possible effects on bees must be investigated except where the product is for exclusive use in situations where bees are not likely to be exposed such as: —food storage in enclosed spaces, —non-systemic seed dressings, —non-systemic preparations for application to soil, —non-systemic dipping treatments for transplanted crops and bulbs, —wound sealing and healing treatments, —rodenticidal baits, —use in glasshouses without pollinators. The hazard quotients for oral and contact exposure (QHOand QHC), must be reported: QHO= dose/oral LD50(µg a.s. per bee) QHC= dose/contact LD50(µg a.s. per bee) where dose= the maximum application rate, for which authorization is sought, in g of active substance per hectare. 10.4.1. Acute oral and contact toxicity Aim of the test The test should provide the LD50values (by oral and contact exposure). Circumstances in which required Testing is required if: —the product contains more than one active substance; —the toxicity of a new formulation cannot be reliably predicted to be either the same or lower than a formulation tested according to the provisions of Schedule II, point 8.3.1.1 or of this point. Test guideline The test must be carried out according to EPPO Guideline 170. 10.4.2. Residue test Aim of the test The test should provide sufficient information to evaluate possible risks to foraging bees from residual traces of plant protection products remaining on crops. Circumstances in which required Where QHC=50, expert judgment is required to decide whether the effect of residues must be determined unless there is evidence that there are no significant residual traces remaining on crops which could affect foraging bees or unless sufficient information is available from cage, tunnel or field tests. Test conditions The median lethal time (LT50) (in hours) following 24-hour exposure to residues on leaves aged during eight hours must be determined, and reported. Where LT50is more than eight hours, no further testing is required. 10.4.3. Cage tests Aim of the test The test should provide sufficient information to evaluate possible risks from the plant protection product for bee survival and behaviour. Circumstances in which required Where QHOand QHCare < 50, further testing is not required except if significant effects are observed in the bee brood feeding test or if there are indications for indirect effects such as delayed action or modifi-cation of bee behaviour, in those cases cage and/or field tests shall be carried out. Where QHOand QHCare > 50, cage and/or field testing is required. Where field testing is conducted and reported in accordance with point 10.4.4, it is not necessary to conduct cage tests. However, cage tests where conducted, must be reported. Test conditions The test should be carried out using healthy bees. If bees have been treated, e.g. with a varroacide, it is necessary to wait for four weeks before using the colony. Test guideline The tests must be conducted in accordance with EPPO Guideline 170. 10.4.4. Field tests Aim of the test The test should provide sufficient information to evaluate possible risks from the plant protection product on bee behaviour, colony survival and development. Circumstances in which required Field tests must be conducted where on the basis of expert judgement, taking into account the proposed manner of use and the fate and behaviour of the active substance, significant effects are observed in cage testing. Test conditions The test should be carried out using healthy honeybee colonies of similar natural strength. If bees have been treated, e.g. with a varroacide, it is necessary to wait for four weeks before using the colony. The tests shall be conducted under conditions reasonably representative of the proposed use. Special effects (larval toxicity, long residual effect, disorienting effects on bees) identified by the field tests may require further investigation using specific methods. Test guideline The tests must be conducted in accordance with EPPO Guideline 170. 10.4.5. Tunnel tests Aim of the test The test should provide sufficient information to evaluate the impact on bees resulting from feeding on contaminated honey dew or flowers. Circumstances in which required Where it is not possible to investigate certain effects in cage or field trials, a tunnel test should be carried out, e.g. in the case of plant protection products intended for control of aphids and other sucking insects. Test conditions The test should be carried out using healthy bees. If bees have been treated, e.g. with a varroacide, it is necessary to wait for four weeks before using the colony. Test guideline The test must be carried out in accordance with EPPO Guideline 170. 10.5. Effects on arthropods other than bees The effects of plant protection products on non-target terrestrial arthropods (e.g. predators or parasitoids of harmful organisms) must be investigated. The information obtained for these species can also be used to indicate the potential for toxicity to non-target species inha-biting the same environment. 10.5.1. Laboratory, extended laboratory and semi-field tests Aim of the test The test should provide sufficient information to evaluate the toxicity of the plant protection product for selected arthropod species that are relevant to the intended use of the product. Circumstances in which required Testing is not required where severe toxicity (> 99 % effect on the organisms compared to control) can be predicted from relevant available data or where the plant protection product is for exclusive use in situations where non-target arthropods are not exposed such as: —food storage in enclosed spaces, —wound sealing and healing treatments, —rodenticidal baits. Testing is required when significant effects on the organisms in comparison with the control are reported in the laboratory tests at the maximum recommended dose, conducted in accordance with the requirements of Schedule II, point 8.3.2. Effects on a particular test species are considered to be significant when they exceed the threshold values as defined in the EPPO schemes for the environmen tal risk assessment unless species-specific threshold values are defined in the respective test guidelines. Testing is also required if: —the product contains more than one active substance, —the toxicity of a new formulation cannot be reliably predicted to be either the same or lower than a formulation tested according to the provisions of Schedule II, point 8.3.2 or of this point, —on the basis of the proposed manner of use or on the basis of the fate and behaviour continued or repeated exposure can be anticipated, —there is a significant change in the proposed use, e.g. from arable crops to orchards, and species relevant to the new use have not previously been tested, —there is an increase in the recommended application rate, above that previously tested under Schedule II. Test conditions Where significant effects were observed in the studies performed in accordance with the requirements of Schedule II, point 8.3.2, or in the case of change of use such as arable crops to orchards, the toxicity of two additional relevant species must be investigated and reported. These must be different to the relevant species already tested under Schedule II, point 8.3.2. For a new mixture or formulation, the toxicity should initially be assessed using the two most sensitive species as identified in studies already performed for which the threshold values were exceeded but effects still remain below 99 %. This will enable a comparison to be made; if it significantly more toxic two species relevant to its proposed use must be tested. Testing must be conducted at a rate equivalent to the maximum rate of application for which authorization is sought. A sequential testing approach should be adopted, i.e. laboratory, and if necessary extended laboratory and/or semi-field. Where there will be more than one application per season, the product should be applied at twice the recommended application rate unless this information is already available from studies performed in accordance with Schedule II, point 8.3.2. Where on the basis of the proposed manner of use or on the basis of the fate and behaviour continued or repeated exposure can be anticipated (such as the product is to be applied more than three times per season with a re-application of 14 days or less), expert judgment is required to examine whether further testing is required, beyond initial laboratory testing, which will reflect the proposed use pattern. These tests shall be performed in the laboratory or under semi-field conditions. When the test is done in the laboratory a realistic substrate such as plant material or a natural soil should be used. However it may be more appropriate to carry out field tests. Test guideline Where relevant testing should be done according to appropriate guidelines which satisfy as least the requirements for testing as included in Setac - Guidance document on regulatory testing procedures for pesticides with non-target arthropods. 10.5.2. Field tests Aim of the test The tests should provide sufficient information to evaluate the risk of the plant protection product for arthropods under field conditions. Circumstances in which required Where significant effects are seen following laboratory and semi-field exposure, or where on the basis of the proposed manner of use or on the basis of the fate and behaviour continued or repeated exposure can be anticipated expert judgment is required to examine whether more extensive testing is necessary to permit an accurate risk assessment. Test conditions The tests must be conducted under representative agricultural conditions and in accordance with the proposed recommendations for use, resulting in a realistic worst case study. A toxic standard should be included in all tests. Test guideline Where relevant testing should be done according to appropriate guidelines which satisfy at least the requirements for testing as included in Setac—Guidance document on regulatory testing procedures for pesticides with non-target arthropods. 10.6. Effects on earthworms and other soil non-target macro organisms, believed to be at risk 10.6.1. Effects on earthworms The possible impact on earthworms must be reported except where it can be justified that it is not likely that earthworms are exposed, directly or indirectly. TERaand TERltmust be reported where: TERa=LC50(mg a.s./kg)/realistic worst case PECs(initial or short term, in mg a.s./kg) TERlt= NOEC (mg a.s./kg)/long term PECs (mg a.s./kg). 10.6.1.1. Acute toxicity tests Aim of the test The test should provide the LC50, where possible the highest concen tration causing no mortality and the lowest concentration causing 100 % mortality and must include observed morphological and beha vioural effects. Circumstances in which required These studies are only required where —the product contains more than one active substance, —the toxicity of a new formulation cannot be reliably predicted from the formulation tested according to the provisions of Schedule II, point 8.4 or of this point. Test guideline The tests must be conducted in accordance to OECD Method 207. 10.6.1.2. Tests for sublethal effects Aim of the test The test should provide the NOEC and the effects on growth, repro duction and behaviour. Circumstances in which required These studies are only required where —the product contains more than one active substance, —the toxicity of a new formulation cannot be reliably predicted from the formulation tested according to the provisions of Schedule II, point 8.4 or of this point, —there is an increase in the recommended application rate, above that previously tested. Test conditions The same provisions as under the corresponding paragraphs of Schedule II, point 8.4.2 apply. 10.6.1.3. Field studies Aim of the test The test should provide sufficient data to evaluate the effects on earthworms in field conditions. Circumstances in which required Where TERlt< 5 a field study to determine effects under practical field conditions must be conducted and reported. Expert judgment is required to decide whether residue contents of earthworms should be investigated. Test conditions Fields selected shall have a reasonable earthworm population. The test must be carried out at the maximum proposed application rate. A toxic reference product must be included in the test. 10.6.2. Effects on other soil non-target macro-organisms Aim of the test The test should provide sufficient data to evaluate the impact of the plant protection product on macro-organisms that contribute to the breakdown of dead plant and animal organic matter. Circumstances in which required Testing is not required where in accordance with Schedule III, point 9.1, it is evident that DT90values are less than 100 days, or the nature and manner of use of the plant protection product are such that exposure does not occur or when data from studies on the active substance performed in accordance with the provisions of Schedule II, points 8.3.2, 8.4 and 8.5 indicate that there is no risk for soil macrofauna, earthworms or soil microflora. Impact on organic matter breakdown must be investigated and reported, where the DT90fvalues determined in field dissipation studies (point 9.1) are > 365 days. 10.7. Effects on soil non-target micro-organisms 10.7.1. Laboratory testing Aim of the test The test should provide sufficient data to evaluate the impact of the plant protection product on soil microbial activity in terms of nitrogen transformation and carbon mineralization. Circumstances in which required Where the DT90fvalues determined in field dissipation studies (point 9.1) are > 100 days, impact on soil non-target micro-organisms must be investigated through laboratory testing. Testing is, however, not required if in the studies performed in accordance with the provisions of Schedule II, point 8.5 deviations from control values in terms of metabolic activity of the microbial biomass after 100 days is < 25 %, and such data are relevant to the uses, nature, and properties of the particular preparation to be authorized. Test guideline Setac—Procedures for assessing the environmental fate and ecotoxicity of pesticides. 10.7.2. Additional testing Aim of the test The test should provide sufficient data to evaluate the impact of the plant protection product under field conditions on microbial activitiy. Circumstances in which required Where at the end of 100 days, measured activity deviates by more than 25 % from the control, in the laboratory testing further testing in the laboratory, under glass and/or in the field may be necessary. 10.8. Available data from biological primary screening in summary form A summary of available data from preliminary tests used to assess the biological activity and dose range finding whether positive or negative, which provides information with respect to possible impact on non/target species, both flora and fauna, must be provided, together with a critical assessment as to its relevance to potential impact on non-target species. 11. Summary and evaluation of points 9 and 10 A summary and evaluation of all data presented in points 9 and 10 should be carried out according to the guidance given by the competent authority concerning the format of such summaries and evaluations. It should include a detailed and critical assessment of those data in the context of relevant evaluative and decision making criteria and guidelines, with particular reference to the risks for the environment and non-target species that may or do arise, and the extent, quality and reliability of the data base. In particular the following issues should be addressed: —predicting distribution and fate in the environment, and the time courses involved, —identifying non-target species and populations at risk, and predicting the extent of potential exposure, —evaluation as to the short- and long-term risks for non-target species—populations, communities, and processes—as appro priate, —evaluation as to the risk of fish kills, and fatalities in large verte brates, or terrestrial predators, regardless of effects at population or community level, and —identification of precautions necessary to avoid or minimize con tamination of the environment, and for the protection of non-target species. 12. Further information 12.1. Information on authorizations in other countries 12.2. Information on established maximum residue limits (MRL) in other countries 12.3. Proposals including justification for the classification and labelling proposed in accordance with Directive 67/548/EEC and Directive 99/45/EEC —Hazard symbol(s) —Indications of danger —Risk phrases —Safety phrases 12.4. Proposals for risk and safety phrases in accordance with regulation 15 (1), (g) and (h) and proposed label 12.5. Specimens of proposed packaging PART B Introduction (i) This Part provides data requirements for the authorisation of a plant protection product based on preparations of micro-organisms including viruses. The term‘micro-organism’as defined in the introduction of Schedule II, Part B, also applies to Schedule III, Part B. (ii) Where relevant, data should be analysed using appropriate statistical methods. Full details of the statistical analysis should be reported (e.g. all point estimates should be given with confidence intervals, exact p-values should be given rather than stating significant/non significant). (iii) Pending the acceptance of specific guidelines at international level, the information required shall be generated using test guidelines accepted by the director (e.g. USEPA guideline (1)); where appropriate test guidelines as described in Schedule II, Part A, should be adapted in such a way that they are appropriate for micro-organisms. Testing should include viable and, if appropriate, non-viable micro-organisms, and a blank control. (iv) Whenever a study implies the use of different doses, the relationship between dose and adverse effect must be reported. (v) Where testing is done, a detailed description (specification) of the material used and its impurities, according to the provisions of section 1, point 1.4, must be provided. (vi) In cases where a new preparation is to be dealt with, extrapolation from Schedule II, Part B, could be acceptable, provided that all the possible effects of the formulants and other components, especially on pathogenicity and infectiveness, are also evaluated. (1)USEPA Microbial Pesticide Test Guidelines, OPPTS Series 885, February 1996(http://www.epa.gov/oppbppd1/biopesticides/guidelines/series885.htm). 1. IDENTITY OF THE PLANT PROTECTION PRODUCT The information provided, taken together with that provided for the micro organism(s), must be sufficient to precisely identify and define preparations. The information and data referred to, unless otherwise specified, are required for all plant protection products. This is with the view to identify if any factor could alter the properties of the micro-organism as a plant protection product in comparison to the micro-organism as such, which is treated in Annex II, Part B, to Directive 91/414/EEC. 1.1. Applicant The name and address of the applicant (permanent community address) must be provided as must the name, position, telephone and fax number of the appropriate person to contact. Where, in addition, the applicant has an office, agent or representative in the Member State in which the authorisation is being sought, the name and address of the local office, agent or representative should be provided, as should the name, position, telephone and fax number of the appropriate person to contact. 1.2. Manufacturer of the preparation and the micro-organism(s) The name and address of the manufacturer of the preparation and of each micro-organism in the preparation must be provided as must the name and address of each manufacturing plant in which the preparation and micro-organism are manufactured. A contact point (preferable a central contact point, to include name, telephone and fax numbers) must be provided for each manufacturer. If the micro-organism originates from a producer from which data according to Schedule II, Part B, had not been submitted previously, detailed information on the name and species description, as required in Schedule II, Part B, section 1.3, and on impurities, as required in Schedule II, Part B, section 1.4, have to be provided. 1.3. Trade name or proposed trade name, and manufacturer's devel opment code number of the preparation if appropriate All former and current trade names and proposed trade names and development code numbers of the preparation referred to in the dossier as well as the current names and numbers must be provided. Full detail of any differences must be provided. (The proposed trade name must not give rise to confusion with the trade name of already authorised plant protection products.) 1.4. Detailed quantitative and qualitative information on the compo sition of the preparation (i) Each micro-organism that is subject to the application should be identified and named at the species level. The micro-organism should be deposited at a recognised culture collection and given an accession number. The scientific name must be stated, as well as the group assignment (bacteria, virus, etc.) and any other denomination relevant to the micro-organism (e.g. strain, serotype). In addition, the development phase of the micro organism (e.g. spores, mycelium) in the marketed product shall be stated. (ii) For preparations the following information must be reported: —the content of the micro-organism(s) in the plant protection product and the content of the micro-organism in the material used for manufacturing of plant protection products. These must include the maximum, minimum and nominal content of the viable and non-viable material, —the content of formulants, —the content of other components (such as by-products, condensates, culture medium, etc.) and contaminating micro organisms, derived from production process. The contents should be expressed in terms as provided for in Article 6(2) of Directive 99/45/EEC for chemicals and appro priate terms for micro-organisms (number of active units per volume or weight or any other manner that is relevant to the micro-organism). (iii) Formulants must where possible, be identified either by their chemical name as given in Annex I to Directive 67/548/EEC, or, if not included in this Legal Notice, in accordance with both IUPAC and CA nomenclature. Their structure or structural formula must be provided. For each component of the formulants the relevant EC (Einecs or Elincs) number and CAS number where they exist, must be provided. Where the information provided does not fully identify a formulant, an appropriate speci fication must be provided. The trade name of formulants, where they exist, must also be provided. (iv) For formulants the function must be given: —adhesive (sticker) —antifoaming agent —antifreeze —binder —buffer —carrier —deodorant —dispersing agent —dye —emetic —emulsifier —fertiliser —odorant —parfume —preservative —propellant —repellent —safener —solvent —stabiliser —synergist —thickener —wetting agent —miscellaneous (specify). (v) Identification of contaminating micro-organisms and other components derived from production process. Contaminating micro-organisms must be identified as outlined in Schedule II, Part B, section 1, point 1.3. Chemicals (inert components, by-products, etc.) must be identified as outlined in Schedule II, Part A, section 1, point 1.10. Where the information provided does not fully identify a component, such as condensate, culture medium, etc., detailed information on the composition must be provided for each such component. 1.5. Physical state and nature of the preparation The type and code of preparation must be designated according to the ‘Catalogue of pesticide formulation types and international coding system (GIFAP Technical Monograph No 2, 1989)’. Where a particular preparation is not defined precisely in this publi cation a full description of the physical nature and state of the preparation must be provided, together with a proposal for a suitable description of the type of preparation and a proposal for its definition. 1.6. Function The biological function must be specified from among the following: —control of bacteria, —control of fungi, —control of insects, —control of mites, —control of molluscs, —control of nematodes, —control of weeds, —other (must be specified). 2. PHYSICAL, CHEMICAL AND TECHNICAL PROPERTIES OF THE PLANT PROTECTION PRODUCT The extent to which plant protection products for which authorisation is sought comply with relevant FAO specifications, as agreed by the Group of Experts on Pesticide Specification of the FAO Panel of Experts on Pesticide Specifications, Registration Requirements and Application Standards, must be stated. Divergences from FAO speci fications must be described in detail, and justified. 2.1. Appearance (colour and odour) A description of both the colour and odour, if any, and the physical state of the preparation, must be provided. 2.2. Storage stability and shelf-life 2.2.1. Effects of light, temperature and humidity on technical characteristics of the plant protection product (i) The physical and biological stability of the preparation at the recommended storage temperature including information on the growth of contaminating micro-organisms must be determined and reported. The conditions under which the test has been performed must be justified. (ii) Additionally in the case of liquid preparations, the effect of low temperatures on physical stability, must be determined and reported according to CIPAC (1) Methods MT 39, MT 48, MT 51 or MT 54 as appropriate. (iii) The shelf life of the preparation at the recommended storage temperature must be reported. Where shelf life is less than two years, the shelf life in months, with appropriate temperature speci-fications, must be reported. Useful information is given in GIFAP (2) Monograph No 17. 2.2.2. Other factors affecting stability Effect of exposure to air, packaging, etc., on the product stability must be explored. 2.3. Explosivity and oxidising properties Explosivity and oxidising properties will be determined as defined in Schedule III, Part A, section 2, point 2.2, unless it can be justified that it is technically or scientifically not necessary to perform such studies. (1) Collaborative International Pesticides Analytical Council. (2) International Group of National Pesticide Manufacturers' Associations. 2.4. Flash point and other indications of flammability or spontaneous ignition Flash point and flammability must be determined, as defined in Schedule III, Part A, section 2, point 2.3, unless it can be justified that it is technically or scientifically not necessary to perform such studies. 2.5. Acidity, alkalinity and if necessary pH value Acidity, alkalinity and pH will be determined as defined in Schedule III, Part A, section 2, point 2.4, unless it can be justified that it is tech nically or scientifically not necessary to perform such studies. 2.6. Viscosity and surface tension Viscosity and surface tension will be determined as defined in Schedule III, Part A, section 2, point 2.5, unless it can be justified that it is technically or scientifically not necessary to perform such studies. 2.7. Technical characteristics of the plant protection product The technical characteristics of the preparation must be determined to permit a decision to be made as to its acceptability. If tests have to be performed, they must be done at temperatures compatible with survival of the micro-organism. 2.7.1. Wettability The wettability of solid preparations which are diluted for use (e.g. wettable powders and water dispersible granules), must be determined and reported according to CIPAC Method MT 53.3. 2.7.2. Persistent foaming The persistence of foaming of preparations to be diluted with water, must be determined and reported according to CIPAC Method MT 47. 2.7.3. Suspensibility and suspension stability —The suspensibility of water dispersible products (e.g. wettable powders, water dispersible granules, suspension concentrates) must be determined and reported according to CIPAC Method MT 15, MT 161 or MT 168 as appropriate. —The spontaneity of dispersion of water dispersible products (e.g. suspension concentrates and water dispersible granules) must be determined and reported according to CIPAC Methods MT 160 or MT 174 as appropriate. 2.7.4. Dry sieve test and wet sieve test In order to ensure that dustable powders have a suitable particle size distribution for ease of application, a dry sieve test must be conducted and reported according to CIPAC Method MT 59.1. In the case of water dispersible products, a wet sieve test must be conducted and reported according to CIPAC Method MT 59.3 or MT 167 as appropriate. 2.7.5. Particle size distribution (dustable and wettable powders, granules), content of dust/fines (granules), attrition and friability (granules) (i) The size distribution of particles in the case of powders, must be determined and reported according to OECD Method 110. The nominal size range of granules for direct application must be determined and reported in accordance with CIPAC MT 58.3, for water dispersible granules in accordance with CIPAC MT 170. (ii) The dust content of granular preparations, must be determined and reported according to CIPAC Method MT 171. If relevant for operator exposure the particle size of dust must be determined and reported according to OECD Method 110. (iii) The friability and attrition characteristics of granules, must be determined and reported once internationally agreed methods are available. Where already data are available they must be reported together with the method used. 2.7.6. Emulsifiability, re-emulsifiability, emulsion stability (i) The emulsifiability, emulsion stability and re-emulsifiability of preparations which form emulsions, must be determined and reported according to CIPAC Method MT 36 or MT 173 as appropriate. (ii) The stability of dilute emulsions and of preparations which are emulsions, must be determined and reported according to CIPAC Method MT 20 or MT 173. 2.7.7. Flowability, pourability (rinsability) and dustability (i) The flowability of granular preparations must be determined and reported according to CIPAC Method MT 172. (ii) The pourability (including rinsed residue) of suspensions (e.g. suspension concentrates, suspo-emulsions), must be determined and reported according to CIPAC Method MT 148. (iii) The dustability of dustable powders must be determined and reported according to CIPAC Method MT 34 or another suitable method. 2.8. Physical, chemical and biological compatibility with other products including plant protection products with which its use is to be authorised 2.8.1. Physical compatibility The physical compatibility of recommended tank mixes must be determined and reported. 2.8.2. Chemical compatibility The chemical compatibility of recommended tank mixes must be determined and reported except where examination of the individual properties of the preparations would establish beyond reasonable doubt that there is no possibility of reaction taking place. In such cases it is sufficient to provide that information as justification for not practically determining the chemical compatibility. 2.8.3. Biological compatibility The biological compatibility of tank mixes must be determined and reported. Effects (e.g. antagonism, fungicidal effects) on the activity of the micro-organism after mixing with other micro-organisms or chemicals must be described. The possible interaction of the plant protection product with other chemical products to be applied on the crops under the expected condition of use of the preparation should be investigated, based on the efficacy data. Intervals between application of the biological pesticide and chemical pesticides should be specified, if appropriate, in order to avoid loss of efficacy. 2.9. Adherence and distribution to seeds In the case of preparations for seed treatment, both distribution and adhesion must be investigated and reported; in the case of distribution according to CIPAC Method MT 175. 2.10. Summary and evaluation of data presented under points 2.1 to 2.9 3. DATA ON APPLICATION 3.1. Field of use envisaged The field(s) of use, existing and proposed, for preparations containing the micro-organism must be specified from among the following: —field use, such as agriculture, horticulture, forestry and viticulture, —protected crops (e.g. in glasshouses), —amenity, —weed control on non-cultivated areas, —home gardening, —house plants, —stored products, —other (specify). 3.2. Mode of action The way by which uptake of the product may occur (e.g. contact, stomach, inhalation) or the pest controlling action (fungitoxic, fungi static action, nutrient competition, etc.) must be stated. It must also be stated whether or not the product is translocated in plants and, where relevant, if such translocation is apoplastic, symplastic or both. 3.3. Details of intended use Details of the intended use, e.g. types of harmful organisms controlled and/or plants or plant products to be protected, must be provided. Intervals between the application of the plant protection product containing micro-organisms and chemical pesticides, or a list with active substances of chemical plant protection products not to be used together with the plant protection product containing micro-organisms on the same crop, should also be provided. 3.4. Application rate For each method of application and each use, the rate of application per unit (ha, m2,m3) treated, in terms of g or kg or l for the preparation and in terms of appropriate units for the micro-organism, must be provided. Application rates shall normally be expressed in g or kg/ha or in kg/m3 and where appropriate in g or kg/tonne; for protected crops and home gardening use rates shall be expressed in g or kg/100 m2or g or kg/m3. 3.5. Content of micro-organism in material used (e.g. in the diluted spray, baits or treated seed) The content of micro-organism shall be reported, as appropriate, in number of active unit/ml or g or any other relevant unit. 3.6. Method of application The method of application proposed must be described fully, indi cating the type of equipment to be used, if any, as well as the type and volume of diluent to be used per unit of area or volume. 3.7. Number and timing of applications and duration of protection The maximum number of applications to be used and their timing, must be reported. Where relevant the growth stages of the crop or plants to be protected and the development stages of the harmful organisms, must be indicated. Where possible and necessary the interval between applications, in days, must be stated. The duration of protection afforded both by each application and by the maximum number of applications to be used, must be indicated. 3.8. Necessary waiting periods or other precautions to avoid phyto pathogenic effects on succeeding crops Where relevant, minimum waiting periods between last application and sowing or planting of succeeding crops, which are necessary to avoid phytopathogenic effects on succeeding crops, must be stated, and follow from the data provided under section 6, point 6.6. Limitations on choice of succeeding crops, if any, must be stated. 3.9. Proposed instructions for use The proposed instructions for use of the preparation, to be printed on labels and leaflets, must be provided. 4. FURTHER INFORMATION ON THE PLANT PROTECTION PRODUCT 4.1. Packaging and compatibility of the preparation with proposed packaging materials (i) Packaging to be used must be fully described and specified in terms of the materials used, manner of construction (e.g. extruded, welded, etc.), size and capacity, size of opening, type of closure and seals. It must be designed in accordance with the criteria and guidelines specified in the FAO‘Guidelines for the Packaging of Pesticides’. (ii) The suitability of the packaging, including closures, in terms of its strength, leakproofness and resistance to normal transport and handling, must be determined and reported according to ADR methods 3552, 3553, 3560, 3554, 3555, 3556, 3558, or appro priate ADR Methods for intermediate bulk containers, and, where for the preparation child-resistant closures are required, according to ISO standard 8317. (iii) The resistance of the packaging material to its contents must be reported according to GIFAP Monograph No 17. 4.2. Procedures for cleaning application equipment Cleaning procedures for both application equipment and protective clothing must be described in detail. The effectiveness of the cleaning procedure must be determined, using e.g. biotests, and reported. 4.3. Re-entry periods, necessary waiting periods or other precautions to protect man, livestock and the environment The information provided must follow from and be supported by the data provided for the micro-organism(s) and that provided under sections 7 and 8. (i) Where relevant pre-harvest intervals, re-entry periods or with holding periods necessary to minimise the presence of residues in or on crops, plants and plant products, or in treated areas or spaces, with a view to protecting man or livestock, must be specified e.g.: —pre-harvest interval (in days) for each relevant crop, —re-entry period (in days) for livestock, to areas to be grazed, —re-entry period (in hours or days) for man to crops, buildings or spaces treated, —withholding period (in days) for animal feedingstuffs, —waiting period (in days), between application and handling treated products. (ii) Where necessary, in the light of the test results, information on any specific agricultural, plant health or environmental conditions under which the preparation shall or shall not be used must be provided. 4.4. Recommended methods and precautions concerning: handling, storage, transport or fire The recommended methods and precautions concerning handling procedures (detailed) for the storage, at both warehouse and user level of plant protection products, for their transport and in the event of fire must be provided. Where relevant, information on combustion products must be provided. The risks likely to arise and the methods and procedures to minimise the hazards arising, must be specified. Procedures to preclude or minimise the generation of waste or leftovers must be provided. Where relevant, assessment has to be done according to ISO TR 9122. The nature and characteristics of protective clothing and equipment proposed must be provided. The data provided must be sufficient to evaluate the suitability and effectiveness under realistic conditions of use (e.g. field or glasshouse circumstances). 4.5. Measures in the case of an accident Whether arising during transport, storage or use, detailed procedures to be followed in the event of an accident, must be provided and include: —containment of spillages, —decontamination of areas, vehicles and buildings, —disposal of damaged packaging, adsorbents and other materials, —protection of emergency workers and bystanders, —first aid measures. 4.6. Procedures for destruction or decontamination of the plant protection product and its packaging Procedures for destruction and decontamination must be developed for both small quantities (user level) and large quantities (warehouse level). The procedures must be consistent with provisions in place relating to the disposal of waste and of toxic waste. The means of disposal proposed should be without unacceptable influence on the environment and be the most cost effective and practical means of disposal feasible. 4.6.1. Controlled incineration In many cases the preferred or sole means to safely dispose of plant protection products and in particular the formulants contained in it, contaminated materials, or contaminated packaging, is through controlled incineration in a licensed incinerator. The applicant must provide detailed instructions for safe disposal. 4.6.2. Others Other methods to dispose of plant protection products, packaging and contaminated materials, where proposed, must be fully described. Data must be provided for such methods, to establish their effectiveness and safety. 5. ANALYTICAL METHODS Introduction The provisions of this section only cover analytical methods required for post-registration control and monitoring purposes. It is desirable to have a plant protection product without contaminants, if possible. The level of acceptable contaminants should be judged from a risk assessment point of view, by the director. Both production and product must be subject to a continuous quality control by the applicant. The quality criteria for the product should be submitted. For analytical methods used for generation of data as required in this Legal Notice or for other purposes the applicant has to provide a justifi-cation for the method used; where necessary separate guidance will be developed for such methods on the basis of the same requirements as defined for methods for post-registration control and monitoring purposes. Descriptions of methods must be provided and include details of equipment, materials and conditions used. The applicability of existing CIPAC methods must be reported. As far as practicable these methods must employ the simplest approach, involve the minimum cost, and require commonly available equipment. For this section the following applies: Impurities Any component (including contami nating micro-organisms and/or chemical substances) other than the specified micro-organism, originating from the manufacturing process or from degradation during storage Relevant impurities Impurities, as defined above, that are of concern for human or animal health and/or the environment Metabolites Metabolites include products resulting from degradative and biosynthetic reactions taking place within the micro organism or other organisms used to produce the micro-organism of interest Relevant metabolites Metabolites that are of concern for human or animal health and/or the en vironment Residues Viable micro-organisms and substances produced in significant quantities by these micro-organisms which persist after the disappearance of the micro organisms and are of concern for human or animal health and/or the en vironment. On request the following samples must be provided: (i) samples of the preparation; (ii) samples of the micro-organism as manufactured; (iii) analytical standards of the pure micro-organism; (iv) analytical standards of relevant metabolites and all other components included in the residue definition; (v) if available, samples of reference substances for the relevant impu rities. 5.1. Methods for the analysis of the preparation —Methods, which must be described in full, must be provided for the identification and the determination of the content of the micro organism in the preparation. In the case of a preparation containing more than one micro-organism, methods capable of identifying and determining the content of each one should be provided. —Methods to establish regular control of the final product (preparation) in order to show that it does not contain other organisms than the indicated ones and to establish its uniformity. —Methods to identify any contaminating micro-organisms of the preparation. —Methods used to determine the storage stability and shelf life of the preparation must be provided. 5.2. Methods to determine and quantify residues Analytical methods for the determination of residues, as defined in Schedule II, Part B, section 4, point 4.2, must be submitted unless it is justified that the information already submitted according to the requirements of Schedule II, Part B, section 4, point 4.2, is sufficient. 6. EFFICACY DATA The provisions for efficacy data have already been adopted under Commission Directive 93/71/EEC. 7. EFFECTS ON HUMAN HEALTH For proper evaluation of the toxicity including potential for patho genicity and infectiveness of preparations sufficient information should be available on acute toxicity, irritation and sensitisation of the micro-organism. If possible, additional information on mode of toxic action, toxicological profile and all other known toxicological aspects of the micro-organism should be submitted. Special attention should be given to co-formulants. While performing toxicology studies, all signs of infection or patho genicity should be noted. Toxicology studies should include clearance studies. In the context of the influence that impurities and other components can have on toxicological behaviour, it is essential that for each study submitted, a detailed description (specification) of the material used, be provided. Tests must be conducted using the plant protection product to be authorised. In particular, it must be clear that the micro organism used in the preparation, and the conditions of culturing it, are the same for which information and data are submitted in the context of Schedule II, Part B. A tiered testing system will be applied to the study of the plant protection product. 7.1. Basic acute toxicity studies The studies, data and information to be provided and evaluated, must be sufficient to permit the identification of effects following a single exposure to the plant protection product, and in particular to establish, or indicate: —the toxicity of the plant protection product, —toxicity of the plant protection product relative to the micro organism, —the time course and characteristics of the effect with full details of behavioural changes and possible gross pathological findings at post-mortem, —where possible the mode of toxic action, and —the relative hazard associated with the different routes of exposure. While the emphasis must be on estimating the toxicity ranges involved, the information generated must also permit the plant protection product to be classified in accordance with Directive 99/45/EEC. The information generated through acute toxicity testing is of particular value in assessing hazards likely to arise in accident situations. 7.1.1. Acute oral toxicity Circumstances in which required An acute oral test should always be carried out unless the applicant can justify to the satisfaction of the director that Article 3(2) of Directive 99/45/EEC can be invoked. Test guideline The test must be carried out in accordance with Method B.1 or B.1bis of Commission Directive 92/69/EEC. 7.1.2. Acute inhalation toxicity Aim of the test The test will provide the inhalation toxicity to rats of the plant protection product. Circumstances in which required The test must be carried out where the plant protection product: —is used with fogging equipment, —is an aerosol, —is a powder containing a significant proportion of particles of diameter < 50 micrometre (> 1 % on a weight basis), —is to be applied from aircraft in cases where inhalation exposure is relevant, —is to be applied in a manner which generates a significant proportion of particles or droplets of diameter < 50 micrometre (> 1 % on a weight basis), —contains a volatile component at greater than 10 %. Test guideline The test must be carried out in accordance with Method B.2 of Directive 92/69/EEC. 7.1.3. Acute percutaneous toxicity Circumstances in which required An acute percutaneous test should always be carried out unless the applicant can justify to the satisfaction of the director that Directive 99/45/EEC can be invoked. Test guideline The test must be carried out in accordance with Method B.3 of Directive 92/69/EEC. 7.2. Additional acute toxicity studies 7.2.1. Skin irritation Aim of the test The test will provide the potential of skin irritancy of the plant protection product including the potential reversibility of the effects observed. Circumstances in which required The skin irritancy of the plant protection product must always be determined, except where the formulants are not expected to be skin irritant or the micro-organism is shown not to be skin irritant or where it is likely, as indicated in the test guideline, that severe skin effects can be excluded. Test guideline The test must be carried out in accordance with Method B.4 of Directive 92/69/EEC. 7.2.2. Eye irritation Aim of the test The test will provide the potential for eye irritation of the plant protection product, including the potential reversibility of the effects observed. Circumstances in which required The eye irritancy of the plant protection product must be determined, where the formulants are suspected to be eye irritant, except where the micro-organism is eye irritant or where it is likely, as indicated in the test guideline, that severe effects on the eyes may be produced. Test guideline The eye irritation must be determined in accordance with Method B.5 of Directive 92/69/EEC. 7.2.3. Skin sensitisation Aim of the test The test will provide sufficient information to assess the potential of the plant protection product to provoke skin sensitisation reactions. Circumstances in which required The test must be carried out where the formulants are suspected to have skin sensitising properties, except where the micro-organism(s) or the formulants are known to have skin sensitising properties. Test guideline The tests have to be carried out in accordance with Method B.6 of Directive 92/69/EEC. 7.3. Data on exposure The risks for those in contact with plant protection products (operators, bystanders, workers), depend on the physical, chemical and toxico-logical properties of the plant protection product as well as the type of the product (undiluted/diluted), formulation type, and on the route, the degree and duration of exposure. Sufficient information and data must be generated and reported to permit an assessment of the extent of exposure to the plant protection product likely to occur under the proposed conditions of use. In the cases where there is particular concern on the possibility of dermal absorption based on the information for the micro-organism available in Schedule II, Part B, section 5, or from the information provided for the preparation in the present section of Schedule III, Part B, further dermal absorption data can be necessary. Results from exposure monitoring during production or use of the product must be submitted. The abovementioned information and data must provide the basis for the selection of appropriate protective measures including personal protective equipment to be used by operators and workers and to be specified on the label. 7.4. Available toxicological data relating to non-active substances A copy of the notification and the safety data sheet submitted in the context of European Parliament and Council Directive 1999/45/EC and Regulation (EC) No 1907/2006 of the European Parliament and of the Council of 18 December 2006 concerning the Registration, Evaluation, Authorisation and Restriction of Chemicals (REACH), establishing a European Chemicals Agency, must be submitted for each formulant. All other available information should be submitted. 7.5. Supplementary studies for combinations of plant protection products Aim of the test In certain cases it may be necessary to carry out the studies as referred to under points 7.1 to 7.2.3 for a combination of plant protection products where the product label includes requirements for use of the plant protection product with other plant protection products and/or with adjuvants as a tank mix. Decisions as to the need for supplementary studies must be made on a case-by-case basis, taking into account the results of the acute toxicity studies of the individual plant protection products, the possibility for exposure to the combi nation of the products concerned and available information or practical experience with the products concerned or similar products. 7.6. Summary and evaluation of health effects A summary of all data and information provided under paragraphs 7.1 through 7.5, must be submitted, and include a detailed and critical assessment of those data in the context of relevant evaluative and decision-making criteria and guidelines, with particular reference to the risks for man and animals that may or do arise, and the extent, quality and reliability of the database. 8. RESIDUES IN OR ON TREATED PRODUCTS, FOOD AND FEED The same provisions as detailed in Schedule II, Part B, section 6, apply; the information required according to this section has to be provided unless it is possible to extrapolate the residue behaviour of the plant protection product on the basis of the data available for the micro-organism. Special attention should be paid towards the influence of formulation substances on the residue behaviour of the micro-organism and its metabolites. 9. FATE AND BEHAVIOUR IN THE ENVIRONMENT The same provisions as detailed in Schedule II, Part B, section 7, apply; the information required according to this section has to be provided unless it is possible to extrapolate the fate and behaviour of the plant protection product in the environment on the basis of the data available in Schedule II, Part B, section 7. 10. EFFECTS ON NON-TARGET ORGANISMS Introduction (i) The information provided, taken together with that for the micro-organism(s), must be sufficient to permit an assessment of the impact on non-target species (flora and fauna), of the plant protection product, when used as proposed. Impact can result from single, prolonged or repeated exposure, and can be reversible, or irreversible. (ii) The choice of the appropriate non-target organisms for testing of environmental effects should be based on the information on the micro-organism, as required in Schedule II, Part B, and on the information on the formulants and other components, as required by sections 1 to 9 of the present Schedule. From such knowledge it would be possible to choose the appropriate test organisms, such as organisms closely related to the target organism. (iii) In particular, the information provided for the plant protection product, together with other relevant information, and that provided for the micro-organism, should be sufficient to: —specify the hazard symbols, the indications of danger, and relevant risk and safety phrases for the protection of the environment, to be mentioned on packaging (containers), —permit an evaluation of the short- and long-term risks for non-target species. —populations, communities, and processes as appropriate, —permit an evaluation whether special precautions are necessary for the protection of non-target species. (iv) There is a need to report all potentially adverse effects found during routine investigations of environmental effects and to undertake and report such additional studies which may be necessary to investigate the mechanisms involved and assess the significance of these effects. (v) In general, much of the data relating to impact on non-target species, required for authorisation of plant protection products, will have been submitted and evaluated for the inclusion of the micro-organism(s) in Schedule I. (vi) Where exposure data are necessary to decide whether a study has to be performed, the data obtained in accordance with the provisions of Schedule III, Part B, section 9, should be used. For the estimation of exposure of organisms all relevant infor mation on the plant protection product and on the micro organism must be taken into account. Where relevant the para meters provided for in this section should be used. Where it appears from available data that the plant protection product has a stronger effect than the micro-organism, the data on effects on non target organisms of the plant protection product have to be used for the calculation of relevant effec-t/exposure ratios. (vii) In order to facilitate the assessment of the significance of test results obtained, the same strain of each relevant species should where possible be used in the various specified tests for effects on non target organisms. 10.1. Effects on birds The same information as provided in Schedule II, Part B, section 8, point 8.1, has to be reported where it is not possible to predict the effects of the plant protection product on the basis of the data available for the micro-organism, unless it can be justified that exposure of birds is unlikely to occur. 10.2. Effects on aquatic organisms The same information as provided in Schedule II, Part B, section 8, point 8.2, has to be reported where it is not possible to predict the effects of the plant protection product on the basis of the data available for the micro-organism, unless it can be justified that exposure of aquatic organisms is unlikely to occur. 10.3. Effects on bees The same information as provided in Schedule II, Part B, section 8, point 8.3, has to be reported where it is not possible to predict the effects of the plant protection product on the basis of the data available for the micro-organism, unless it can be justified that exposure of bees is unlikely to occur. 10.4. Effects on arthropods other than bees The same information as provided in Schedule II, Part B, section 8, point 8.4, has to be reported where it is not possible to predict the effects of the plant protection product on the basis of the data available for the micro-organism, unless it can be justified that exposure of arthropods other than bees is unlikely to occur. 10.5. Effects on earthworms The same information as provided in Schedule II, Part B, section 8, point 8.5, has to be reported where it is not possible to predict the effects of the plant protection product on the basis of the data available for the micro-organism, unless it can be justified that exposure of earthworms is unlikely to occur. 10.6. Effects on soil micro-organisms The same information as provided in Schedule II, Part B, section 8, point 8.6, has to be reported where it is not possible to predict the effects of the plant protection product on the basis of the data available for the micro-organism, unless it can be justified that exposure of non target soil micro-organisms is unlikely to occur. 10.7. Additional studies Expert judgement is required to decide whether additional studies are necessary. Such decision will take into consideration the available information in this and other sections, in particular data on the speci ficity of the micro-organism, and the expected exposure. Useful information may also be available from the observations carried out in efficacy testing. Special attention should be given to possible effects on naturally occurring and deliberately released organisms of importance in IPM. In particular the compatibility of the product with IPM should be taken into consideration. Additional studies might include further studies on additional species or higher tier studies such as studies on selected non-target organisms. Before performing such studies, the applicant shall seek agreement of the competent authorities on the type of study to be performed. 11. SUMMARY AND EVALUATION OF ENVIRONMENTAL IMPACT A summary and evaluation of all data relevant to the environmental impact should be carried out according to the guidance given by the competent authority concerning the format of such summaries and evaluations. It should include a detailed and critical assessment of those data in the context of relevant evaluative and decision making criteria and guidelines, with particular reference to the risks for the environment and non-target species that may or do arise, and the extent, quality and reliability of the database. In particular the following issues should be addressed: —prediction of distribution and fate in the environment, and the time courses involved, —identification of non-target species and populations at risk, and prediction of the extent of potential exposure, —identification of precautions necessary to avoid or minimise con tamination of the environment, and for the protection of non target species. SCHEDULE IV STANDARD PHRASES FOR SPECIAL RISKS FOR HUMANS OR THE ENVIRONMENT AS REFERRED TO IN REGULATION 16 INTRODUCTION The following additional standard phrases are defined to supplement the phrases provided for by Directive 1999/45/EC, which applies to plant-protection products. The provisions of that Directive shall also be used for plant-protection products containing micro-organisms or viruses as active substances. The labelling of products containing these active substances shall also reflect the provisions concerning dermal and respiratory sensitisation testing, which are laid down in Annex IIb and Annex IIIb to Directive 91/414/EEC. The harmonised phrases provide the basis for complementary and specific instructions for use and are, therefore, without prejudice to other elements of regulation 16, in particular regulation 16(1)(k) to (n) and 16(4). 1. Standard phrases for special risks 1.1.Special risks related to humans (RSh) RSh 1 BG: Токсичен при контакт с очите. ES: Tóxico en contacto con los ojos. CS: Toxický při styku s očima. DA: Giftig ved kontakt med øjnene. DE: Giftig bei Kontakt mit den Augen. ET: Mürgine silma sattumisel. EL: Τοξικό όταν έρθει σε επαφή µε τα µάτια. EN: Toxic by eye contact. FR: Toxique par contact oculaire. IT: Tossico per contatto oculare. LV: Toksisks nonākot saskarē ar acīm. LT: Toksiška patekus į akis. HU: Szemmel érintkezve mérgezo. MT: Tossiku meta jmiss ma' l-għajnejn. NL: Giftig bij oogcontact. PL: Dziala toksycznie w kontakcie z oczami. PT: Tóxico por contacto com os olhos. RO: Toxic în contact cu ochii! SK: Jedovatý pri kontakte s očami. SL: Strupeno v stiku z ocmi. FI: Myrkyllistä joutuessaan silmään. SV: Giftigt vid kontakt med ögonen. RSh 2 BG: Може да причини фотосенсибилизация. ES: Puede causar fotosensibilización. CS: Může vyvolat fotosenzibilizaci DA: Kan give overfølsomhed over for sollys/UV-stråling. DE: Sensibilisierung durch Licht möglich. ET: Võib põhjustada valgussensibiliseerimist. EL: Μπορεί να προκαλέσει φωτοευαισθητοποίηση. EN: May cause photosensitisation. FR: Peut entraîner une photosensibilisation. IT: Può causare fotosensibilizzazione. LV: Var izraisit fotosensibilizaciju. LT: Gali sukelti fotosensibilizaciją. HU: Fényérzékenységet okozhat. MT: Jista' jikkawża fotosensitizzazzjoni. NL: Kan fotosensibilisatie veroorzaken. PL: Może powodować nadwrażliwość na światło. PT: Pode causar fotossensibilização. RO: Poate cauza fotosensibilitate! SK: Môže spôsobiť fotosenzibilizáciu. SL: Lahko povzroči preobčutljivost na svetlobo. FI: Voi aiheuttaa herkistymistä valolle. SV: Kan orsaka överkänslighet för solljus/UV-strålning. RSh 3 BG: Контактът с парите причинява изгаряния на кожата и очите, контактът с течността причинява измръзвания. ES: El contacto con los vapores provoca quemaduras de la piel y de los ojos; el contacto con el producto líquido provoca conge-lación. CS: Při styku s parami způsobuje poleptání kůže a očí a při styku s kapalinou způsobuje omrzliny DA: Kontakt med dampe giver ætsninger på hud og øjne, og kontakt med væske giver forfrysninger. DE: Kontakt mit Dämpfen verursacht Verätzungen an Haut und Augen und Kontakt mit der Flüssigkeit verursacht Erfrierungen. ET: Kokkupuude auruga põhjustab põletushaavu nahale ja silmadele ning kokkupuude vedelikuga põhjustab külmumist. EL: Οι ατµοί µπορεί να προκαλέσουν εγκαύµατα στο δέρµα και στα µάτια·η επαφή µε το υγρό µπορεί να προκαλέσει κρυο παγήµατα. EN: Contact with vapour causes burns to skin and eyes and contact with liquid causes freezing. FR: Le contact avec les vapeurs peut provoquer des brûlures de la peau et des yeux; le contact avec le gaz liquide peut causer des engelures. IT: Il contatto con il vapore può causare ustioni della pelle e bruciori agli occhi; il contatto con il liquido può causare congelamento. LV: Saskare ar tvaikiem izraisa ādas un acu apdegumus un saskare ar šķidrumu izraisa apsaldējumus LT: Garai sukelia odos ir akių nudegimą, skystis- nušalimą. HU: Az anyag gőzével való érintkezés a bőr és a szem égési sérülését okozhatja, illetve a folyadékkal való érintkezés fagyást okozhat. MT: Kuntatt mal-fwar jikkawza ħruq fil-ġilda u fl-għajnejn filwaqt li kuntatt mal-likwidu jikkawża iffrizar. NL: Contact met de damp veroorzaakt brandwonden aan huid en ogen; contact met de vloeistof veroorzaakt bevriezing. PL: Kontakt z oparami powoduje poparzenia skóry i oczu, kontakt z cieczą powoduje zamarzanie. PT: O contacto com vapores do produto provoca queimaduras na pele e nos olhos; o contacto com o produto líquido provoca congelação. RO: Contactul cu vaporii cauzează arsuri ale pielii �i ochilor, iar contactul cu lichidul cauzează degerături! SK: Pri kontakte s parou spôsobuje popáleniny pokožky a očí a kontakt s kvapalinou spôsobuje omrzliny. SL: Stik s hlapi povzroča opekline kože in oči, stik s tekočino povzroča ozebline. FI: Kosketus höyryyn voi aiheuttaa palovammoja iholle ja silmiin ja kosketus nesteeseen paleltumavammoja. SV: Kontakt med ångor orsakar frätskador på hud och ögon, kontakt med vätska orsakar förfrysningsskador. 1.2. Special risks related to the environment (RSe) None. 2. Attribution criteria for standard phrases for special risks 2.1. Attribution criteria for standard phrases related to humans RSh 1 Toxic by eye contact. The phrase shall be assigned where an eye irritation test according to Schedule IIIA point 7.1.5 has resulted in overt signs of systemic toxicity (e.g. related to cholinesterase inhibition) or mortality among the animals tested, which is likely to be attributable to absorption of the active substance through the mucous membranes of the eye. The risk phrase shall also be applied if there is evidence in humans for systemic toxicity after eye contact. Eye protection should be specified in these cases, as outlined in the general provisions of Schedule V. RSh 2 May cause photosensitisation. The phrase shall be assigned where there is clear evidence from experi mental systems or documented human exposure that products show photosensitising effects. The phrase shall also be applied to products containing a given active substance or formulation ingredient, which shows photosensitising effects in humans if the product contains this photosensitising component at a concentration of 1 % (w/w) or higher. Personal protective measures should be specified in these cases, as outlined in the general provisions of Schedule V. RSh 3 Contact with vapour causes burns to skin and eyes and contact with liquid causes freezing. The phrase shall be assigned to plant-protection products being formulated as liquefied gas, where appropriate (e.g. preparations of methyl bromide). Personal protective measures should be specified in these cases, as outlined in the general provisions of Schedule V. In cases where R34 or 35 are applied according to Directive 1999/45/EC, the phrase shall not be used. 2.2. Attribution criteria for standard phrases related to the environment None. SCHEDULE V STANDARD PHRASES FOR SAFETY PRECAUTIONS FOR THE PROTECTION OF HUMANS OR THE ENVIRONMENT AS REFERRED TO IN REGULATION 16 INTRODUCTION The following additional standard phrases are defined to supplement the phrases provided for by Directive 1999/45/EC, which applies to plant-protection products. The provisions of that Directive shall also be used for plant-protection products containing micro-organisms or viruses as active substances. The labelling of products containing these active substances shall also reflect the provisions concerning dermal and respiratory sensitisation testing, which are laid down in Annex IIb and Annex IIIb to Directive 91/414/EEC. The harmonised phrases provide the basis for complementary and specific instructions for use and are, therefore, without prejudice to other elements of regulation 16, in particular regulation 16(1)(k) to (n) and 16(4). 1. General provisions All plant-protection products should be labelled with the following phrase, which should be supplemented by the text in parentheses, as appropriate: SP 1 BG: Да не се замърсяват водите с този продукт или с неговата опаковка. (Да не се почиства използваната техника в близост до повърхностни води/Да се избягва замърсяване чрез отточни канали на ферми или пътища.). ES: No contaminar el agua con el producto ni con su envase. [No limpiar el equipo de aplicación del producto cerca de aguas superficiales/Evítese la contaminación a través de los sistemas de evacuación de aguas de las explotaciones o de los caminos.] CS: Neznečišťujte vody přípravkem nebo jeho obalem. (Nečistěte aplikační zařízení v blízkosti povrchových vod/Zabraňte kontaminaci vod splachem z farem a z cest). DA: Undgå forurening af vandmiljøet med produktet eller med beholdere, der har indeholdt produktet. [Rens ikke sprøjteudstyr nær overfladevand/Undgå forurening via dræn fra gårdspladser og veje]. DE: Mittel und/oder dessen Behälter nicht in Gewässer gelangen lassen. (Ausbringungsgeräte nicht in unmittelbarer Nähe von Oberflächengewässern reinigen/Indirekte Einträge über Hofund Straßenabläufe verhindern.) ET: Vältida vahendi või selle pakendi vette sattumist (Seadmeid pinnavee lähedal mitte puhastada/Vältida saastamist läbi lauda ja teede drenaazhide). EL: Μην µολύνετε το νερό µε το προϊόν ή τη συσκευασία του. [Να µην πλένετε τον εξοπλισµό εφαρµογής κοντά σε επιφανειακά ύδατα/Να αποφευχθεί η µόλυνση µέσω των συστηµάτων αποχέτευσης από τις λιθόστρωτες επιφάνειες και τους δρόµους.] EN: Do not contaminate water with the product or its container (Do not clean application equipment near surface water/Avoid contamination via drains from farmyards and roads). FR: Ne pas polluer l'eau avec le produit ou son emballage. [Ne pas nettoyer le matériel d'application près des eaux de surface./ Éviter la contamination via les systèmes d'évacuation des eaux à partir des cours de ferme ou des routes.] IT: Non contaminare l'acqua con il prodotto o il suo contenitore. [Non pulire il materiale d'applicazione in prossimità delle acque di superficie./Evitare la contaminazione attraverso i sistemi di scolo delle acque dalle aziende agricole e dalle strade.] LV: Nepiesārņot ūdeni ar augu aizsardzības līdzekli un tā iepakojumu/ netīrīt smidzināšanas tehniku ūdenstilpju un ūdensteču tuvumā/izsargāties no piesārņošanas caur drenāžu no pagalmiem un ceļiem. LT: Neužteršti vandens augalų apsaugos produktu ar jo pakuote (Neplauti purškimo įrenginių šalia paviršinio vandens telkinių/ vengti taršos per drenažą iš sodybų ar nuo kelių). HU: A termékkel vagy annak tartályával ne szennyezze a vizeket. (A berendezést vagy annak részeit ne tisztítsa felszíni vizek közelében/kerülje a gazdaságban vagy az utakon lévő vízelvezetőkön keresztül való szennyeződést). MT: Tikkontaminax ilma bil-prodott jew il-kontenitur tiegħu (Tnaddafx apparat li jintuża għall-applikazzjoni qrib ilma tax-xita/Ara li ma jkunx hemm kontaminazzjoni minn btieħi u toroq). NL: Zorg ervoor dat u met het product of zijn verpakking geen water verontreinigt. [Reinig de apparatuur niet in de buurt van oppervlaktewater/Zorg ervoor dat het water niet via de afvoer van erven of wegen kan worden verontreinigd.] PL: Nie zanieczyszczać wód produktem lub jego opakowaniem (Nie myć aparatury w pobliżu wód powierzchniowych/Unikać zanieczyszczania wód poprzez rowy odwadniające z gospodarstw i dróg) PT: Não poluir a água com este produto ou com a sua embalagem. [Não limpar o equipamento de aplicação perto de águas de superfície./Evitar contaminações pelos sistemas de evacuação de águas das explorações agrícolas e estradas.] RO: A nu se contamina apa cu produsul sau cu ambalajul său (a nu se curăța echipamentele de aplicare în apropierea apelor de suprafață/a se evita contaminarea prin sistemele de evacuare a apelor din ferme sau drumuri)! SK: Neznečisťujte vodu prípravkom alebo jeho obalom (Nečistite aplikačné zariadenie v blízkosti povrchových vôd/Zabráňte kontaminácii prostredníctvom odtokových kanálov z poľnohospodárskych dvorov a vozoviek). SL: S sredstvom ali njegovo embalažo ne onesnaževati vode. (Naprav za nanašanje ne čistiti ali izplakovati v bližini površinskih voda./Preprečiti onesnaženje preko drenažnih in odtočnih jarkov na kmetijskih zemljiščih in cestah.) FI: Älä saastuta vettä tuotteella tai sen pakkauksella. (Älä puhdista levityslaitteita pintaveden lähettyvillä./Vältä saastumista piha- ja maantieojien kautta.) SV: Förorena inte vatten med produkten eller dess behållare. (Rengör inte sprututrustning i närheten av vattendrag/Undvik förorening via avrinning från gårdsplaner och vägar.) 2. Specific safety precautions 2.1. Safety precautions for operators (SPo) General provisions 1. The Director may identify suitable personal protective equipment for operators and prescribe specific elements of this equipment (e.g. coveralls, apron, gloves, sturdy shoes, rubber boots, face protection, face shield, tightly fitting glasses, hat, hood or respirator of a specified type). Such supplementary safety precautions are without prejudice to the standard phrases applicable according to Directive 1999/45/EC. 2. The Director may further identify the specific tasks which require particular protective equipment, such as mixing, loading or handling the undiluted product, applying or spraying the diluted product, handling recently treated materials like plants or soil or entering recently treated areas. 3. The Director may add specifications of engineering controls, such as: —a closed transfer system must be used when transferring the pesticide from the product container to the spray tank, —the operator must work within a closed cabin (with an air conditioning/air filtration system) during spraying, —engineering controls may replace personal protective equipment if they provide an equal or higher standard of protection. Specific provisions SPo 1 BG: При контакт с кожата, първо да се отстрани продукта със суха кърпа и след това кожата да се измие обилно с вода. ES: En caso de contacto con la piel, elimínese primero el producto con un paño seco y después lávese la piel con agua abundante. CS: Po zasažení kůže přípravek nejdříve odstraňte pomocí suché látky a poté kůži opláchněte velkým množstvím vody. DA: Efter kontakt med huden, fjern først produktet med en tør klud og vask derefter med rigeligt vand. DE: Nach Kontakt mit der Haut zuerst das Mittel mit einem trockenen Tuch entfernen und dann die Haut mit reichlich Wasser abspülen. ET: Nahaga kokkupuutel kõigepealt eemaldada vahend kuiva lapiga ning seejärel pesta nahka rohke veega. EL: Ύστερα από επαφή µε το δέρµα, αφαιρέστε πρώτα το προϊόν µε ένα στεγνό πανί και στη συνέχεια ξεπλύνετε το δέρµα µε άφθονο νερό. EN: After contact with skin, first remove product with a dry cloth and then wash the skin with plenty of water. FR: Après contact avec la peau, éliminer d'abord le produit avec un chiffon sec, puis laver la peau abondamment à l'eau. IT: Dopo il contatto con la pelle, rimuovere il prodotto con un panno asciutto e quindi lavare abbondantemente con acqua. LV: Pēc saskares ar ādu, vispirms notīrīt augu aizsardzības līdzekli no ādas ar sausu drānu un pēc tam mazgāt ādu ar lielu ūdens daudzumu. LT: Patekus ant odos, pirmiausia nuvalyti sausu audiniu, po to gerai nuplauti vandeniu. HU: Bőrrel való érintkezés esetén először száraz ruhával távolítsa el a terméket, majd a szennyeződött bőrt bő vízzel mossa le. MT: Wara kuntatt mal-ġilda, l-ewwel neħħi l-prodott b'xoqqa niexfa u mbgħad aħsel il-ġilda b'ħafna ilma. NL: Na contact met de huid moet u eerst het gewasbeschermingsmiddel met een droge doek verwijderen en daarna de huid met veel water wassen. PL: Po kontakcie ze skórą najpierw usunąć produkt suchą szmatką, a następnie przemyć skórę dużą ilością wody. PT: Em caso de contacto com a pele, remover primeiro o produto com um pano seco e, em seguida, lavar a pele com muita água. RO: Dacă produsul vine în contact cu pielea, îndepărtați produsul cu un material uscat și apoi spălați cu multă apă! SK: Po kontakte s pokožkou najskôr odstráňte prípravok suchou tkaninou a potom opláchnite veľkým množstvom vody. SL: Ob stiku s kožo odstraniti sredstvo s suho krpo in sprati kožo z obilo vode. FI: Ihokosketuksen jälkeen tuote pyyhitään aluksi pois kuivalla kankaalla ja sitten iho pestään runsaalla vedellä. SV: Efter kontakt med huden, avlägsna först produkten med en torr trasa och tvätta sedan med mycket vatten. SPo 2 BG: Цялото защитно облекло да се изпере след употреба. ES: Lávese toda la ropa de protección después de usarla. CS: Veškerý ochranný oděv po použití vyperte. DA: Vask alle personlige værnemidler efter brug. DE: Die gesamte Schutzkleidung muss nach Gebrauch gewaschen werden. ET: Peale kasutamist kogu kaitseriietus pesta. EL: Ξεπλύνετε όλες τις προστατευτικές ενδυµασίες µετά τη χρήση. EN: Wash all protective clothing after use. FR: Laver tous les équipements de protection après utilisation. IT: Lavare tutto l'equipaggiamento di protezione dopo l'impiego. LV: Pēc lietošanas izmazgāt visu aizsargtērpu. LT: Po darbo išskalbti visus apsauginius drabužius. HU: Használat után minden védőruházatot ki kell mosni. MT: Aħsel l-ilbies protettiv wara li-tuża. NL: Was alle beschermende kleding na gebruik. PL: Uprać odzież ochronną po użyciu.. PT: Depois da utilização do produto, lavar todo o vestuário de protecção. RO: A se spăla toate echipamentele de protecție după utilizare! SK: Ochranný odev po aplikácii očistite. SL: Po uporabi oprati vso zaščitno obleko. FI: Kaikki suojavaatteet pestävä käytön jälkeen. SV: Tvätta alla skyddskläder efter användning. SPo 3 BG: След запалване на продукта да не се вдишва дима и третираната зона да се напусне незабавно. ES: Tras el inicio de la combustión del producto, abandónese inmediatamente la zona tratada sin inhalar el humo. CS: Po vznícení přípravku nevdechujte kouř a ihned opusťte ošetřovaný prostor. DA: Efter antænding af produktet, undgå at indånde røgen og forlad det behandlede område øjeblikkeligt. DE: Nach Anzünden des Mittels Rauch nicht einatmen und die behandelte Fläche sofort verlassen. ET: Peale vahendi süttimist suitsu mitte sisse hingata ning käideldud alalt otsekohe lahkuda. EL: Μετά την ανάφλεξη του προϊόντος µην εισπνεύσετε τον καπνό και αποµακρυνθείτε αµέσως από την περιοχή χρήσης. EN: After igniting the product, do not inhale smoke and leave the treated area immediately. FR: Après déclenchement de la fumigation, ne pas inhaler la fumée et quitter la zone traitée immédiatement. IT: Una volta iniziata la combustione, non inalare il fumo e abbandonare immediatamente la zona trattata. LV: Pēc augu aizsardzības līdzekļa aizdedzināšanas, neieelpot dūmus un nekavējoties atstāt apstrādāto platību. LT: Užsidegus neįkvėpti dūmų ir nedelsiant palikti apdorotą plotą. HU: A termék meggyújtása után óvakodjon a keletkező füst belélegzésétől, és azonnal hagyja el a kezelt területet. MT: Wara li tqabbad il-prodott, tiblax id-duħħan u warrab minnufih mill-post li jkun ġie ittrattat. NL Nadat u het product hebt aangestoken, mag u de rook niet inademen en moet u de behandelde ruimte onmiddellijk verlaten. PL Po zapaleniu produktu nie wdychać dymu i niezwłocznie opuścić obszar poddany zabiegowi. PT: Depois de iniciada a fumigação do produto, não inalar os fumos e sair imediatamente da zona em tratamento. RO După fumigarea produsului, nu inhalați fumul și părăsiți imediat zona tratată! SK Po zapálení prípravku, nevdychujte dym a okamžite opustite ošetrovaný priestor. SL Po zažigu sredstva ne vdihavati dima in takoj zapustiti tretirano območje. FI Tuotteen syttyessä vältettävä savun hengittämistä ja poistuttava käsitellyltä alueelta viipymättä. SV När produkten antänts, andas inte in röken och lämna det behandlade området genast. SPo 4 BG: Опаковката да се отвори на открито и при сухо време. ES: El recipiente debe abrirse al aire libre y en tiempo seco. CS Obal s přípravkem musí být otevřen ve venkovním prostředí a za sucha.. DA: Beholderen skal åbnes udendørs og under tørre forhold.. DE: Der Behälters muss im Freien und Trockenen geöffnet werden. ET: Pakend tuleb avada õues ning kuivades tingimustes. EL Το δοχείο πρέπει να ανοιχθεί στο ύπαιθρο και σε συνθήκες ξηρασίας. EN: The container must be opened outdoors and in dry conditions. FR: L'emballage doit être ouvert à l'extérieur par temps sec. IT: L'imballaggio deve essere aperto all'esterno e in condizioni di tempo secco. LV: Iepakojumu atvērt ārpus telpām un sausos apstākļos. LT: Pakuotę atidaryti lauke, esant sausoms oro sąlygoms. HU: A tartályt csak a szabad levegőn, száraz időben lehet kinyitni. MT: Il-kontenitur għandu jinfetaħ f'ambjent miftuħ u xott. NL: De verpakking moet buiten, in droge omstandigheden, worden geopend. PL: Opakowanie otwierać na zewnątrz i w suchych warunkach. PT: Abrir a embalagem ao ar livre e com tempo seco. RO: Ambalajul trebuie deschis în aer liber și pe vreme uscată! SK: Nádobu otvárajte vonku a za suchého pocasia. SL: Embalažo odpreti na prostem in v suhih razmerah. FI: Pakkaus avattava ulkona kuivissa olosuhteissa. SV: Behållaren måste öppnas utomhus och under torra förhål landen. SPo 5 BG Да се проветрят основно/да се посочи време/третираните Площи/оранжериите до изсъхване на разтвора, преди отново да се влезе в тях. ES: Ventilar las zonas/los invernaderos tratados [bien/durante un tiempo especificado/hasta que se haya secado la pulverización] antes de volver a entrar. CS Před opětovným vstupem ošetřené prostory/skleníky [důkladně /uveďte dobu/ do zaschnutí postřikového nánosu] vyvětrejte. DA: De behandlede områder/drivhuse ventileres [grundigt/eller angivelse af tid/indtil sprøjtemidlet er tørret], før man igen går ind i dem. DE: Vor dem Wiederbetreten ist die behandelte Fläche/das Gewächshaus (gründlich/oder Zeit angeben/bis zur Abtrocknung des Spritzbelages) zu lüften. ET: Õhutada käideldud alad/põhjalikult kasvuhooned/määratletud aja jooksul/enne uuesti sisenemist kuni pihustatud vahendi kuivamiseni. EL: Να αερίσετε τους χώρους/τα θερµοκήπια όπου χρησιµοποιήθηκαν φυτοφάρµακα [πλήρως/ή να προσδιοριστεί η χρονική περίοδος/µέχρι να στεγνώσει το προϊόν] πριν ξαναµπείτε. EN: Ventilate treated areas/greenhouses thoroughly/time to be specified/until spray has dried before re-entry. FR: Ventiler [à fond/ou durée à préciser/jusqu'au séchage de la pulvérisation] les zones/serres traitées avant d'y accéder. IT: Ventilare [a fondo/per una durata da specificare/fino all'essic cazione dello spray] le zone serre trattate prima di accedervi. LV: Pirms atgriešanās rūpīgi vēdināt apstrādātās platības/siltumnīcas (norāda laiku) kamēr izsmidzinātais šķidrums nožuvis. LT: Gerai išvėdinti apdorotus plotus/šiltnamius (vėdinimo laikas turi būti nurodytas). Įeiti į apdorotus plotus leidžiama tik visiškai jiems išdžiūvus. HU: A kezelt területet/üvegházakat [alaposan/az előírt időn át/a permet felszáradásáig] szellőztesse az oda való visszatérés elott. MT: Ħalli l-arja tgħaddi minn dawk il-postijiet/serer li ġew ittrattati sew/specifika t-tul ta'ħin/sakemm jinxef il-bexx qabel ma terga' tidħol. NL: Voordat u opnieuw in behandelde ruimten/kassen binnengaat, moet u die [grondig ventileren/gedurende (geef de periode aan) ventileren/ventileren tot de sproeistof is opgedroogd]. PL: Dokładnie wietrzyć obszar poddany zabiegowi/szklarnie/przez określony czas/Przed ponownym wejściem poczekać do wyschnięcia cieczy. PT: Arejar [bem] os locais/estufas tratados [durante (neste caso, precisar o período)/até à secagem do pulverizado] antes de neles voltar a entrar. RO: A se ventila zonele/serele tratate, în întregime/(să se specifice timpul necesar)/până la uscarea produsului pulverizat, înainte de a reintra! SK: Pred ďalším vstupom dôkladne vyvetrajte ošetrovaný priestor/ skleník tak, aby rozprášený roztok prípravku zaschol/ uveďte potrebný čas/. SL: Pred ponovnim vstopom temeljito zračiti tretirane površine/rastlinjake/ določi se čas/dokler se nanešeno sredstvo ne posuši. FI: Käsitellyt alueet/kasvihuoneet/käsiteltyjä alueita/kasvihuoneita tuuletettava (perusteellisesti/tai täsmennetään tuuletusaika/ kunnes tuote on kuivunut) ennen sinne palaamista. SV: Vädra (omsorgsfullt/eller ange tidsperiod/tills produkten torkat) före vistelse i behandlade utrymmen/växthus. 2.2. Safety precautions related to the environment (SPe) SPe 1 BG: С цел опазване на подпочвените води/почвообитаващите организми, да не се прилага този или друг продукт, съдържащ (да се посочи активното вещество или групата активни вещества според случая) повече от (да се посочи срока или честотата). ES: Para proteger [las aguas subterráneas/los organismos del suelo], no aplicar este producto ni ningún otro que contenga (precísese la sustancia o la familia de sustancias, según corresponda) más de (indíquese el tiempo o la frecuencia). CS: Za účelem ochrany podzemních vod/půdních organismů neaplikujte tento ani žádný jiný přípravek obsahující (uveďte účinnou látku nebo popřípadě skupinu účinných látek) déle/více než (uveďte určitou lhůtu nebo četnost aplikací). DA: For at beskytte [grundvandet/jordorganismer] må dette produkt eller andre produkter, der indeholder (angiv navnet på aktivstoffet eller gruppe af aktivstoffer), kun anvendes/ikke anvendes mere end (angiv tidsperiode eller antal behandlinger). DE: Zum Schutz von (Grundwasser/Bodenorganismen) das Mittel ‘…’ oder andere … haltige Mittel (Identifizierung des Wirkstoffes oder einer Wirkstoffgruppe) nicht mehr als … (Angabe der Anwendungshäufigkeit in einem bestimmten Zeitraum) anwenden. ET: Põhjavee/mullaorganismide kaitsmiseks mitte kasutada seda või ükskõik millist muud vahendit, mis sisaldab (määratleda vastavalt toimeaine või aine klass) rohkem kui (periood või määratletav sagedus). EL: Για να προστατέψετε [τα υπόγεια νερά/τους οργανισµούς στο έδαφος] µην χρησιµοποιείτε αυτό ή οποιοδήποτε άλλο προϊόν που περιέχει (προσδιορίστε τη δραστική ουσία ή την κατηγορία των ουσιών αναλόγως) περισσότερο από (να προσδιοριστεί η χρονική περίοδος ή η συχνότητα). EN: To protect groundwater/soil organisms do not apply this or any other product containing(identify active substance or class of substances, as appropriate)more than(time period or frequency to be specified). FR: Pour protéger [les eaux souterraines/les organismes du sol], ne pas appliquer ce produit ou tout autre produit contenant (préciser la substance ou la famille de substances selon le cas) plus de(fréquence à préciser). IT: Per proteggere [le acque sotterranee/gli organismi del suolo] non applicare questo o altri prodotti contenenti(specificare la sostanza attiva o la classe di sostanze, secondo il caso)più di (indicare la durata o la frequenza). LV: Lai aizsargātu gruntsūdeni/augsnes organismus, nelietot augu aizsardzības līdzekli ‘…’ vai citu augu aizsardzības līdzekli, kurš satur ‘…’(norāda darbīgo vielu vai darbīgo vielu grupu) vairāk nekā … (norāda apstrāžu skaitu noteiktā laika periodā). LT: Siekiant apsaugoti požeminį vandenį/dirvos organizmus nenaudoti šio ar bet kurio kito produkto, kurio sudėtyje yra (nurodyti veikliąją medžiagą ar medžiagų grupę, kaip tinka) dažniau kaip (laikas ar dažnumas turi būti nurodytas). HU: A talajvíz/a talaj élő szervezeteinek védelme érdekében ezt vagy (a megfelelő hatóanyag vagy anyagcsoport)-ot tartalmazó bármilyen más készítményt ne használja (az előírt időtartam/ gyakoriság)-nál hosszabb ideig/többször. MT: Sabiex tipproteġi l-ilma tal-pjan/organiżmi fil-ħamrija tapplikax dan il-prodott jew xi prodott ieħor li jkun fih (identifika s-sustanza jew klassi ta' sustanzi attivi kif imiss) iżjed minn (speċifika ż-żmien jew il-frekwenza). NL: Om [het grondwater/de bodemorganismen] te beschermen mag u dit product of andere producten die (geef naar gelang van het geval de naam van de werkzame stof of van de categorie werkzame stoffen) bevatten, niet langer dan gedurende (geef de tijdsduur aan) gebruiken/ten hoogste (geef de frequentie) gebruiken. PL: W celu ochrony wód gruntowych/organizmów glebowych nie stosować tego lub żadnego innego produktu zawierającego (określić substancję aktywną lub klasę substancji, kiedy dotyczy) nie dłużej niż (określony czas)/nie częściej niż (określona częstotliwość). PT: Para protecção [das águas subterrâneas/dos organismos do solo], não aplicar este produto ou qualquer outro que contenha (indicar, consoante o caso, a substância activa ou a família de substâncias activas) durante mais de (período a precisar) ou mais do que (frequência a precisar). RO: Pentru protecția apei freatice/organismelor din sol, nu aplicați acest produs sau alt produs care conține (identificați substanța activă sau clasa corespunzătoare, după caz) mai mult de (să se specifice perioada de timp sau frecvența tratamentelor)! SK: Z dôvodu ochrany podzemnej vody nepoužívajte tento alebo iný prípravok obsahujúci (uveďte účinnú látku alebo skupinu účinných látok) dlhšie ako (upresnite obdobie alebo frekvenciu). SL: Zaradi zaščite podtalnice/talnih organizmov ne uporabljati tega ali drugih sredstev, ki vsebujejo (navede se aktivno snov ali skupino aktivnih snovi) več kot (navede se časovno obdobje ali število tretiranj). FI: (Pohjaveden/maaperän eliöiden) suojelemiseksi vältettävä tämän tai minkä tahansa muun tuotteen, joka sisältää (tapauksen mukaan tehoaine tai aineluokka), käyttöä useammin (ajanjakso tai käyttötiheys). SV: För att skydda (grundvatten/marklevande organismer), använd inte denna produkt eller andra produkter innehållande (ange verksamt ämne eller grupp av ämnen) mer än (ange tidsperiod eller antal behandlingar). SPe 2 BG: Да не са прилага при (да се посочи типа почва или ситуацията) почви, с цел опазване на подпочвените води/водните организми. ES: Para proteger [las aguas subterráneas/los organismos acuáticos], no aplicar en suelos(precísese la situación o el tipo de suelos). CS: Za účelem ochrany podzemních vod/vodních organismů neaplikujte přípravek na půdách (uveďte druh půdy nebo situaci). DA: For at beskytte [grundvandet/organismer, der lever i vand] må dette produkt ikke anvendes (på beskrevet jordtype eller under beskrevne forhold). DE: Zum Schutz von (Grundwasser/Gewässerorganismen) nicht auf (genaue Angabe der Bodenart oder Situation) Böden ausbringen. ET: Põhjavee/veeorganismide kaitsmiseks mitte kasutada (määratleda pinnasetüüp või olukord). EL: Για να προστατέψετε [τα υπόγεια νερά/τους υδρόβιους οργα νισµούς] µην χρησιµοποιείτε το προϊόν αυτό σε εδάφη (προσ διορίστε τον τύπο του εδάφους ή τις ιδιαίτερες συνθήκες). EN: To protect groundwater/aquatic organisms do not apply to (soil type or situation to be specified)soils. FR: Pour protéger [les eaux souterraines/les organismes aqua tiques], ne pas appliquer ce produit sur(type de sol ou situation à préciser). IT: Per proteggere [le acque sotterranee/gli organismi acquatici] non applicare sul suolo(indicare il tipo di suolo o la situazione). LV: Lai aizsargātu gruntsūdeņus/ūdens organismus, nelietot (norāda augsnes tipu vai apstākļus) augsnēs. LT: Siekiant apsaugoti požeminį vandenį/vandens organizmus nenaudoti (nurodyti dirvožemio tipą ar situaciją) dirvožemiuose. HU: A talajvíz/a vízi szervezetek védelme érdekében (az előírt talajtípus vagy helyzet) talajokra ne használja. MT: Biex tipprotġgi l-ilma tal-pjan/organiżmi ta' l-ilma tapplikax f'ħamrija (speċifika t-tip ta' ħamrija jew is-sitwazzjoni). NL: Om [het grondwater/in het water levende organismen] te beschermen mag dit product niet worden gebruikt op (benoem het soort bodem of geef een beschrijving ervan) bodems. PL: W celu ochrony wód gruntowych/organizmów wodnych nie stosować na glebach (określić typ gleby lub warunki glebowe). PT: Para protecção [das águas subterrâneas/dos organismos aquáticos], não aplicar este produto em solos (precisar a situação ou o tipo de solo). RO: Pentru protecția apei freatice/organismelor acvatice, nu aplicați pe sol (să se specifice tipul de sol sau situația în cauză)! SK: Z dôvodu ochrany podzemnej vody/vodných organizmov neaplikujte na (upresnite typ pôdy alebo situáciu) pôdu. SL: Zaradi zaščite podtalnice/vodnih organizmov ne uporabljati na (navede se tip tal ali druge posebne razmere) tleh. FI: (Pohjaveden/vesieliöiden) suojelemiseksi ei saa käyttää (täsmennetään maaperätyyppi tai tilanne)maaperään. SV: För att skydda (grundvatten/vattenlevande organismer), använd inte denna produkt på(ange jordtyp eller markför hållande). SPe 3 BG: Да се осигури нетретирана буферна зона от (да се посочи разстоянието) до неземеделски земи/повърхностни води, с цел опазване на водните организми/растенията, които не са обект на третиране/членестоногите, които не са обект на третиране/насекомите. ES: Para proteger [los organismos acuáticos/las plantas no obje tivo/los artrópodos no objetivo/los insectos], respétese sin tratar una banda de seguridad de(indíquese la distancia) hasta [la zona no cultivada/las masas de agua superficial]. CS: Za účelem ochrany vodních organismů/necílových rostlin/necílových členovců/hmyzu dodržujte neošetřené ochranné pásmo (uveďte vzdálenost) vzhledem k nezemědělské půdě/ povrchové vodě. DA: Må ikke anvendes nærmere end (angiv afstand) fra [vandmiljøet, vandløb, søer m.v./ikke dyrket område] for at beskytte [organismer, der lever i vand/landlevende ikkemålorganismer, vilde planter, insekter og leddyr]. DE: Zum Schutz von (Gewässerorganismen/Nichtzielpflanzen/ Nichtzielarthropoden/Insekten) eine unbehandelte Pufferzone von (genaue Angabe des Abstandes) zu (Nichtkulturland/Oberflächengewässer) einhalten. ET: Veeorganismide/mittetaimsete sihtliikide/mittesihtlülijalgsete/ putukate kaitsmiseks pidada kinni mittepritsitavast puhver-vööndist(määratleda kaugus)põllumajanduses mittekasuta-tavast maast/pinnaseveekogudest. EL: Για να προστατέψετε [τους υδρόβιους οργανισµούς/µη στοχευόµενα φυτά/µη στοχευόµενα αρθρόποδα/έντοµα] να αφήσετε µιαν αψέκαστη ζώνη προστασίας (προσδιορίστε την απόσταση) µέχρι [µη γεωργική γη/σώµατα επιφανειακών υδάτων]. EN: To protect aquatic organisms/non-target plants/non-target arthropods/insects respect an unsprayed buffer zone of (distance to be specified)to non-agricultural land/surface water bodies. FR: Pour protéger [les organismes aquatiques/les plantes non cibles/les arthropodes non cibles/les insectes], respecter une zone non traitée de(distance à préciser)par rapport à [la zone non cultivée adjacente/aux points d'eau]. IT: Per proteggere [gli organismi acquatici/gli insetti/le piante non bersaglio/gli artropodi non bersaglio] rispettare una fascia di sicurezza non trattata di(precisare la distanza)da [zona non coltivata/corpi idrici superficiali]. LV: Lai aizsargātu ūdens organismus/ar lietojumu nesaistītos augus/ar lietojumu nesaistītos posmkājus/kukaiņus, ievērot aizsargjoslu (norāda attālumu) līdz lauksaimniecībā neizmantojamai zemei/ūdenstilpēm un ūdenstecēm. LT: Siekiant apsaugoti vandens organizmus/netikslinius augalus/ netikslinius nariuotakojus/vabzdžius būtina išlaikyti apsaugos zoną (nurodyti atstumą) iki ne žemės ūkio paskirties žemės/paviršinio vandens telkinių. HU: A vízi szervezetek/nem célzott növények/nem célzott ízeltlá búak/rovarok védelme érdekében a nem mezogazdasági föld-területtol/felszíni vizektol(az eloírt távolság)távolságban tartson meg egy nem permetezett biztonsági övezetet. MT: Sabiex tipproteġi organiżmi ta' l-ilma/pjanti mhux immira ti/artropodi/insetti mhux immirati, irrispetta zona konfini ħielsa mill-bexx ta'(specifika d-distanza)minn art mhix agrikola/għadajjar ta' l-ilma fil-wiċċ. NL: Om [in het water levende organismen/niet tot de doelsoorten behorende planten/niet tot de doelsoorten behorende geleedpotigen/ de insecten] te beschermen mag u in een bufferzone van (geef de afstand aan) rond [niet-landbouwgrond/oppervlaktewater] niet sproeien. PL: W celu ochrony organizmów wodnych/roślin nie będących obiektem zwalczania/stawonogów/owadów nie będących obiektem zwalczania konieczne jest określenie strefy buforowej w odległości (określona odległość) od terenów nieużytkowanych rolniczo/zbiorników i cieków wodnych. PT: Para protecção [dos organismos aquáticos/das plantas nãovisadas/ dos insectos/artrópodes não-visados], respeitar uma zona não-pulverizada de (distância a precisar) em relação [às zonas não-cultivadas/às águas de superfície]. RO: Pentru protecția organismelor acvatice/plantelor ne-țintă/artropodelor/ insectelor ne-țintă respectați o zonă tampon netratată de (să se specifice distanța) până la terenul necultivat/ apa de suprafață! SK: Z dôvodu ochrany vodných organizmov/necielených rastlín/ necielených článkonožcov/hmyzu udržiavajte medzi ošetrovanou plochou a neobhospodarovanou zónou/ povrchovými vodnými plochami ochranný pás zeme v dĺžke (upresnite dĺžku). SL: Zaradi zaščite vodnih organizmov/neciljnih rastlin/neciljnih členonožcev/žuželk upoštevati netretiran varnostni pas (navede se razdaljo) do nekmetijske površine/vodne površine. FI: (Vesieliöiden/muiden kuin torjuttavien kasvien/muiden kuin torjuttavien niveljalkaisten/hyönteisten) suojelemiseksi (muun kuin maatalousmaan/pintavesialueiden) väliin on jätettävä (täsmennetään etäisyys) ruiskuttamaton suojavyöhyke. SV: För att skydda (vattenlevande organismer/andra växter än de man avser att bekämpa/andra leddjur än de man avser att bekämpa/insekter), lämna en sprutfri zon på (ange avstånd) till (icke-jordbruksmark/vattendrag). SPe 4 BG: Да не се прилага върху непропускливи повърхности като асфалт, бетон, паваж, железопътни линии и други такива с висок риск за оттичане, с цел опазване на водните орга низми/растенията, които не са обект на третиране. ES: Para proteger [los organismos acuáticos/las plantas no objetivo], no aplicar sobre superficies impermeables como el asfalto, el cemento, los adoquines, [las vías del ferrocarril] ni en otras situaciones con elevado riesgo de escorrentía. CS: Za účelem ochrany vodních organismů/necílových rostlin neaplikujte přípravek na nepropustný povrch, jako je asfalt, beton, dlážděný povrch, železniční trať nebo v jiných případech, kdy hrozí vysoké riziko odplavení.. DA: Må ikke anvendes på befæstede arealer såsom asfalterede, beton-, sten- eller grusbelagte områder og veje [jernbanespor] eller på andre områder, hvorfra der er en stor risiko for runoff til omgivelserne. [For at beskytte organismer, der lever i vand/planter, man ikke ønsker at bekæmpe]. DE: Zum Schutz von (Gewässerorganismen/Nichtzielpflanzen) nicht auf versiegelten Oberflächen wie Asphalt, Beton, Kopfsteinpflaster (Gleisanlagen) bzw. in anderen Fällen, die ein hohes Abschwemmungsrisiko bergen, ausbringen. ET: Veeorganismide/mittesihtliikide kaitsmiseks mitte kasutada läbilaskmatutel pindadel nagu näiteks asfalt, betoon, munakivi, raudteerööpad ning muudes oludes, kus on kõrge lekkimisoht. EL: Για να προστατέψετε [υδρόβιους οργανισµούς/µη στοχευόµενα φυτά] να µην χρησιµοποιείται σε αδιαπέραστες επιφάνειες όπως άσφαλτο, σκυρόδεµα, λιθόστρωτα [σιδηροτροχιές] και άλλες επιφάνειες µε υψηλό κίνδυνο απορροής. EN: To protect aquatic organisms/non-target plants do not apply on impermeable surfaces such as asphalt, concrete, cobble stones, railway tracks and other situations with a high risk of run-off. FR: Pour protéger [les organismes aquatiques/les plantes non cibles], ne pas appliquer sur des surfaces imperméables telles que le bitume, le béton, les pavés, [les voies ferrées] et dans toute autre situation où le risque de ruissellement est important. IT: Per proteggere [gli organismi acquatici/le piante non bersaglio] non applicare su superfici impermeabili quali bitume, cemento, acciottolato, [binari ferroviari] e negli altri casi ad alto rischio di deflusso superficiale. LV: Lai aizsargātu ūdens organismus/ar lietojumu nesaistītos augus, nelietot augu aizsardzības līdzekli uz necaurlaidīgas virsmas, piemēram, asfalta, betona, bruģa, sliežu ceļiem, un citās vietās ar augstu noteces risku. LT: Siekiant apsaugoti vandens organizmus/netikslinius augalus nenaudoti ant nepralaidžių paviršių tokių kaip asfaltas, betonas, grindinio akmenys, geležinkelio bėgių ar kitose situacijose, kuriuose didelė nuotėkio tikimybė. HU: A vízi szervezetek/nem célzott növények védelme érdekében a vizet nem áteresztő felületeken (pl. aszfalt, beton, utcakövezet, vasúti pályák és az elfolyás egyéb veszélye esetén) ne alkalmazza. MT Biex tipproteġi organiżmi ta' l-ilma/pjanti mhux immirati tapplikax fuq ucuħ impermeabbli bħal l-asfalt, konkrit, ċangaturi, linji tal-ferrovija u sitwazzjonijiet oħra b'riskju kbir ta' skul. NL: Om [in het water levende organismen/niet tot de doelsoorten behorende planten] te beschermen mag u dit product niet gebruiken op ondoordringbare oppervlakken, zoals asfalt, beton [,/en] kasseien [en spoorlijnen,] of op andere plaatsen waar het product gemakkelijk kan wegstromen. PL: W celu ochrony organizmów wodnych/roślin nie będących obiektem zwalczania nie stosować na nieprzepuszczalnych powierzchniach, takich jak: asfalt, beton, bruk, torowiska i innych przypadkach, gdy istnieje wysokie ryzyko spływania cieczy. PT: Para protecção [dos organismos aquáticos/das plantas não visadas], não aplicar este produto em superfícies imper meáveis, como asfalto, betão, empedrados [ou linhas de caminho de ferro], nem em qualquer outra situação em que o risco de escorrimentos seja elevado. RO: Pentru protecția organismelor acvatice/plantelor ne-țintă nu aplicați pe suprafețe impermeabile precum asfalt, ciment, pavaj, cale ferată sau în alte situații în care există risc mare de scurgere! SK: Z dôvodu ochrany vodn ch organizmov/necielen ch rastlín neaplikujte na nepriepustné povrchy, ako je asfalt, betón, dlažobné kocky, koľajnice a iné povrchy, pri ktorých je zvýšené riziko stekania vody. SL: Zaradi zaščite vodnih organizmov/neciljnih rastlin ne uporabljati na neprepustnih površinah kot so asfalt, beton, tlak, železniški tiri in drugih površinah, kjer je velika nevarnost odtekanja. FI: (Vesieliöiden/muiden kuin torjuttavien kasvien) suojelemiseksi ei saa käyttää läpäisemättömillä pinnoilla, kuten asvaltilla, betonilla, katukivillä, (rautatiekiskoilla) ja muissa tilanteissa, joissa on suuri huuhtoutumisen vaara. SV: För att skydda (vattenlevande organismer/andra växter än de man avser att bekämpa), använd inte denna produkt på hårdgjorda ytor såsom asfalt, betong, kullersten, (järnvägsspår) och andra ytor med hög risk för avrinning. SPe 5 BG: Продуктът трябва да е напълно инкорпориран в почвата, с цел опазване на птиците/дивите бозайници. Уверете се, че продуктът е напълно инкорпориран и в края на редовете. ES: Para proteger [las aves/los mamíferos silvestres], el producto debe incorporarse completamente al suelo; asegurarse de que se incorpora al suelo totalmente al final de los surcos. CS: Za účelem ochrany ptáků/volně žijících savců musí být přípravek zcela zapraven do půdy; zajistěte, aby byl přípravek zcela zapraven do půdy také na konci výsevních nebo výsadbových řádků. DA: For at beskytte [fugle/vilde pattedyr] skal produktet omhyggeligt graves ned i jorden. Sørg for, at produktet også er helt tildækket for enden af rækkerne. DE: Zum Schutz von (Vögeln/wild lebenden Säugetieren) muss das Mittel vollständig in den Boden eingearbeitet werden; es ist sicherzustellen, dass das Mittel auch am Ende der Pflanzbzw. Saatreihen vollständig in den Boden eingearbeitet wird. ET: Lindude/metsloomade kaitsmiseks peab vahend täielikult mullaga ühinema; tagada vahendi täielik ühinemine ka ridade lõpus. EL: Για να προστατέψετε [πουλιά/άγρια θηλαστικά] το προϊόν πρέπει να καλυφθεί πλήρως από το έδαφος. Βεβαιωθείτε πως το προϊόν έχει καλυφθεί πλήρως στις άκρες των αυλακιών. EN: To protect birds/wild mammals the product must be entirely incorporated in the soil; ensure that the product is also fully incorporated at the end of rows. FR: Pour protéger [les oiseaux/mammifères sauvages], le produit doit être entièrement incorporé dans le sol; s'assurer que le produit est également incorporé en bout de sillons. IT: Per proteggere [gli uccelli/i mammiferi selvatici] il prodotto deve essere interamente incorporato nel terreno; assicurarsi che il prodotto sia completamente incorporato in fondo al solco. LV: Lai aizsargātu putnus/savvaļas zīdītājus, augu aizsardzības līdzekli pilnībā iestrādāt augsnē; nodrošināt līdzekļa pilnīgu iestrādi augsnē arī kultūraugu rindu galos. LT: Siekiant apsaugoti paukščius/laukinius gyvūnus būtina produktą visiškai įterpti į dirvą, užtikrinti, kad produktas būtų visiškai įterptas vagų gale. HU: A madarak/vadon élő emlősök védelme érdekében a terméket teljes egészében be kell dolgozni a talajba; ügyeljen arra, hogy az anyag a sorok végén is teljes egészében be legyen dolgozva. MT: Sabiex tipproteġi għasafar/mammiferi selvaġġi l-prodott għandu jkun inkorporat għal kollox fil-ħamrija; żgura li l prodott ikun ukoll inkorporat għal kollox f'tarf ir-raddi. NL: Om [de vogels/de wilde zoogdieren] te beschermen moet het product volledig in de bodem worden ondergewerkt; zorg ervoor dat het product ook aan het voorend is ondergewerkt. PL: W celu ochrony ptaków/dzikich ssaków produkt musi byc calkowicie przykryty gleba; zapewnicze produkt jest równiez calkowicie przykryty na koncach rzedów. PT: Para protecção [das aves/dos mamíferos selvagens], incorporar totalmente o produto no solo, incluindo no final dos sulcos. RO: Pentru protecția păsărilor/mamiferelor sălbatice, produsul trebuie încorporat în totalitate în sol! A se asigura că produsul este încorporat în totalitate la sfârșitul rândurilor! SK: Z dôvodu ochrany vtákov/divo žijúcich cicavcov sa musí všetok prípravok zakryť pôdou. Presvedčte sa, či je prípravok dobre zakrytý pôdou aj na konci brázdy. SL: Zaradi zaščite ptic/divjih vrst sesalcev je treba sredstvo popolnoma vdelati v tla; zagotoviti, da je sredstvo v celoti vdelano v tla tudi na koncih vrst. FI: (Lintujen/luonnonvaraisten nisäkkäiden) suojelemiseksi tuote on sekoitettava maaperään; varmistettava, että tuote sekoittuu maaperään täysin myös vakojen päässä. SV: För att skydda (fåglar/vilda däggdjur) måste produkten nedmyllas helt och hållet i jorden; se till att produkten även nedmyllas helt i slutet av raderna. SPe 6 BG: Да се отстранят разлетите/разпилените количества, с цел опазване на птиците/дивите бозайници. ES: Para proteger [las aves/los mamíferos silvestres], recójase todo derrame accidental. CS: Za účelem ochrany ptáků/volně žijících savců odstraňte rozsypaný nebo rozlitý přípravek. DA: For at beskytte [fugle/vilde pattedyr] skal alt spildt produkt fjernes. DE: Zum Schutz von (Vögeln/wild lebenden Säugetieren) muss das verschüttete Mittel beseitigt werden. ET: Lindude/metsloomade kaitsmiseks kõrvaldada mahavalgunud vahend. EL: Για να προστατέψετε [πουλιά/άγρια ζώα] µαζέψτε όσο προϊόν έχει χυθεί κατά λάθος. EN: To protect birds/wild mammals remove spillages. FR: Pour protéger [les oiseaux/les mammifères sauvages], récupérer tout produit accidentellement répandu. IT: Per proteggere [gli uccelli/i mammiferi selvatici] recuperare il prodotto fuoriuscito accidentalmente. LV: Lai aizsargātu putnus/savvaļas zīdītājus, novērst izšļakstīšanos. LT: Siekiant apsaugoti paukščius/laukinius gyvūnus pašalinti pabiras ar išsiliejusį produktą. HU: A madarak/vadon élő emlősök védelme érdekében távolítsa el a véletlenül kiömlött anyagot. MT: Neħħi kull tixrid biex tipproteġi l-għasafar/mammiferi selvaggi. NL: Om [de vogels/de wilde zoogdieren] te beschermen moet u gemorst product verwijderen. PL: W celu ochrony ptaków/dzikich ssaków usuwacrozlany/roz sypany produkt. PT: Para protecção [das aves/dos mamíferos selvagens], recolher todo o produto derramado. RO: Pentru protecția păsărilor/mamiferelor sălbatice îndepărtați urmele de produs! SK: Z dôvodu ochrany vtákov/divo žijúcich cicavcov odstráňte náhodne rozsypaný prípravok. SL: Zaradi zaščite ptic/divjih vrst sesalcev odstraniti razsuto sredstvo. FI: Lintujen/luonnonvaraisten nisäkkäiden) suojelemiseksi ympäristöön vahingossa levinnyt tuote poistettava. SV: För att skydda (fåglar/vilda däggdjur), avlägsna spill. SPe 7 BG: Да не се прилага по време на размножителния период на птиците. ES: No aplicar durante el período de reproducción de las aves. CS: Neaplikujte v době hnízdění ptáků. DA: Må ikke anvendes i fuglenes yngletid. DE: Nicht während der Vogelbrutzeit anwenden. ET: Mitte kasutada lindude pesitsusperioodil. EL: Να µην χρησιµοποιείται κατά την περίοδο αναπαραγωγής των πουλιών. EN: Do not apply during the bird breeding period. FR: Ne pas appliquer durant la période de reproduction des oiseaux. IT: Non applicare durante il periodo di riproduzione degli uccelli. LV: Nelietot putnu vairošanās periodā. LT: Nenaudoti paukščių veisimosi laikotarpiu. HU: A madarak költési időszaka alatt nem alkalmazható MT: Tapplikax matul it-tberrik ta' l-għasafar. NL: Niet gebruiken tijdens de vogelbroedperiode. PL: Nie stosować w okresie rozrodczym ptaków. PT: Não aplicar este produto durante o período de reprodução das aves. RO: A nu se aplica produsul în perioada de împerechere a păsărilor! SK: Neaplikujte v čase rozmnožovania vtákov. SL: Ne tretirati v času valjenja ptic. FI: Ei saa käyttää lintujen lisääntymisaikaan. SV: Använd inte denna produkt under fåglarnas häckningsperiod SPe 8 BG: Опасен за пчелите/Да не се прилага при култури по време на цъфтеж, с цел опазване на пчелите и други насекоми опрашители/Да не се използва на места, където има активна паша на пчели/Преместете или покрийте пчелните кошери по време на третирането и за (да се посочи срок) след третиране/Да не се прилага при наличие на цъфтяща плевелна растителност/Плевелите да се унищожат преди цъфтежа им/Да не се прилага преди (да се посочи срок). ES: Peligroso para las abejas./Para proteger las abejas y otros insectos polinizadores, no aplicar durante la floración de los cultivos./No utilizar donde haya abejas en pecoreo activo./Retírense o cúbranse las colmenas durante el tratamiento y durante (indíquese el tiempo) después del mismo./No aplicar cuando las malas hierbas estén en floración./Elimínense las malas hierbas antes de su floración./No aplicar antes de (indíquese el tiempo). CS: Nebezpečný pro včely./Za účelem ochrany včel a jiných hmyzích opylovačů neaplikujte na kvetoucí plodiny./Neaplikujte na místech, na nichž jsou včely aktivní při vyhledávání potravy./Úly musí být během aplikace a po aplikaci (uveďte dobu) přemístěny nebo zakryty./Neaplikujte, jestliže se na pozemku vyskytují kvetoucí plevele./Plevele odstraňte před jejich kvetením./Neaplikujte před (uveďte dobu). DA: Farligt for bier./For at beskytte bier og andre bestøvende insekter må dette produkt ikke anvendes i blomstrende afgrøder./Må ikke anvendes i biernes flyvetid./Tildæk eller flyt bikuber i behandlingsperioden og i (nævn antal timer/dage) efter behandlingen./Må ikke anvendes i nærheden af blomstrende ukrudt./Fjern ukrudt inden blomstring./ Må ikke anvendes inden (tidspunkt). DE: Bienengefährlich./Zum Schutz von Bienen und anderen bestäubenden Insekten nicht auf blühende Kulturen aufbringen./ Nicht an Stellen anwenden, an denen Bienen aktiv auf Futtersuche sind./Bienenstöcke müssen während der Anwendung und für (Angabe der Zeit) nach der Behandlung entfernt oder abgedeckt werden./Nicht in Anwesenheit von blühenden Unkräutern anwenden./Unkräuter müssen vor dem Blühen entfernt werden./Nicht vor (Angabe der Zeit) anwenden. ET: Mesilastele ohtlik/Mesilaste ning muude tolmlevate putukate kaitsmiseks mitte kasutada põllumajanduskultuuride õitsemise ajal/Mitte kasutada aktiivsel korjealal/Kasutamise ajaks ning (määratleda aeg) peale töötlemist tarud eemaldada või katta kinn/Õitseva umbrohu olemasolu korral mitre kasutada/Umbrohi enne õitsemist eemaldada/Mitte kasutada enne (määratleda aeg). EL: Επικίνδυνο για τις µέλισσες. Για να προστατέψετε τις µέλισσες και άλλα έντοµα επικονίασης µην χρησιµοποιείτε το προϊόν σε καλλιέργειες κατά την ανθοφορία./Μην χρησιµοποιείτε το προϊόν κατά την περίοδο που οι µέλισσες συλλέγουν γύρη./Αποµακρύνετε ή καλύψτε τις κυψέλες κατά τη χρήση του προϊόντος και επί (αναφέρατε το χρόνο) µετά τη χρήση./Μην χρησιµοποιείτε το προϊόν κατά την περίοδο ανθοφορίας ζιζανίων./Αποµακρύνετε τα ζιζάνια πριν από την ανθοφορία./Μην το χρησιµοποιείτε πριν (αναφέρατε το χρόνο). EN: Dangerous to bees./To protect bees and other pollinating insects do not apply to crop plants when in flower./Do not use where bees are actively foraging./Remove or cover beehives during application and for(state time)after treatment./Do not apply when flowering weeds are present./Remove weeds before flowering./Do not apply before(state time) FR: Dangereux pour les abeilles./Pour protéger les abeilles et autres insectes pollinisateurs, ne pas appliquer durant la floraison./ Ne pas utiliser en présence d'abeilles./Retirer ou couvrir les ruches pendant l'application et (indiquer la période) après traitement./Ne pas appliquer lorsque des adventices en fleur sont présentes./Enlever les adventices avant leur floraison./Ne pas appliquer avant (indiquer la date). IT: Pericoloso per le api./Per proteggere le api e altri insetti impollinatori non applicare alle colture al momento della fior-itura./Non utilizzare quando le api sono in attività./Rimuovere o coprire gli alveari durante l'applicazione e per(indicare il periodo)dopo il trattamento./Non applicare in presenza di piante infestanti in fiore./Eliminare le piante infestanti prima della fioritura./Non applicare prima di(indicare il periodo). LV: Bīstams bitēm. Lai aizsargātu bites un citus apputeksnētājus, nelietot kultūraugu ziedēšanas laikā. Nelietot vietās, kur bites aktīvi meklē barību. Bišu stropus pārvietot vai pārsegt augu aizsardzības līdzekļa smidzināšanas laikā un … (norāda uz cik ilgu laiku) pēc smidzināšanas darba beigām. Nelietot platībās, kurās ir ziedošas nezāles. Apkarot nezāles pirms ziedēšanas. Nelietot pirms … (norāda laiku). LT: Pavojingas bitėms/Siekiant apsaugoti bites ir kitus apdulkinančius vabzdžius nenaudoti augalų žydėjimo metu/Nenaudoti bičių aktyvaus maitinimosi metu/Pašalinti ar uždengti bičių avilius purškimo metu ar (nurodyti laiką) po purškimo./Nenaudoti kai yra žydinčių piktžolių/Sunaikinti piktžoles iki jų žydėjimo/Nenaudoti iki (nurodyti laiką). HU: Méhekre veszélyes/A méhek és egyéb beporzást végző rovarok védelme érdekében virágzási időszakban nem alkalmazható/ Méhek aktív táplálékszerzési időszaka idején nem alkalmazható/ Az alkalmazás idejére és a kezelés után (megadott időszak) ideig távolítsa el vagy fedje be a méhkaptárakat/ Virágzó gyomnövények jelenléte esetén nem alkalmazható/ Virágzás előtt távolítsa el a gyomnövényeket/(megadott időpont) előtt nem alkalmazható. MT: Perikoluż għan-naħal/Sabiex tħares in-naħal u insetti oħra tad-dakra tapplikax fuq uċuħ tar-raba' meta jkunu bil fjur/Tużax fejn in-naħal ikun qed jirgħa sew/Neħħi jew agħtti l-ġarar tan-naħal waqt l-applikazzjoni u għal (specifika l-hin)wara t-trattament/Tapplikax meta jkun hemm ħaxix ħazin bil-fjur/Neħħi l-ħaxix ħazin qabel ma jwarrad/Tapplikax qabel(specifika l-ħin). NL: Gevaarlijk voor bijen./Om de bijen en andere bestuivende insecten te beschermen mag u dit product niet gebruiken op in bloei staande gewassen./Gebruik dit product niet op plaatsen waar bijen actief naar voedsel zoeken./Verwijder of bedek bijenkorven tijdens het gebruik van het product en gedurende (geef de tijdsduur aan) na de behandeling./Gebruik dit product niet in de buurt van in bloei staand onkruid./Verwijder onkruid voordat het bloeit./Gebruik dit product niet vóór (geef de datum of de periode aan). PL: [Niebezpieczne dla pszczól/W celu ochrony pszczóli innych owadów zapylajacych nie stosowacna rosliny uprawne w czasie kwitnienia/Nie uzywacw miejscach gdzie pszczoly majapozytek/Usuwaclub przykrywacule podczas zabiegu i przez(okreslicczas)po zabiegu/Nie stosowackiedy wystepuja kwitnace chwasty/Usuwacchwasty przed kwitnieniem/Nie stosowacprzed(okreslicczas). PT: Perigoso para as abelhas./Para protecção das abelhas e de outros insectos polinizadores, não aplicar este produto durante a floração das culturas./Não utilizar este produto durante o período de presença das abelhas nos campos./ Remover ou cobrir as colmeias durante a aplicação do produto e durante(indicar o período)após o tratamento./Não aplicar este produto na presença de infestantes em flora-ção./Remover as infestantes antes da floração./Não aplicar antes de(critério temporal a precisar). RO: Periculos pentru albine!/Pentru a proteja albinele și alte insecte polenizatoare nu aplicați pe plante în timpul înfloritului!/ Nu utilizați produsul în timpul sezonului activ al albinelor!/ Îndepărtați sau acoperiți stupii în timpul aplicării și (să se specifice perioada de timp) după tratament!/Nu aplicați produsul în perioada de înflorire a buruienilor!/Distrugeți buruienile înainte de înflorire!/Nu aplicați înainte de (să se specifice perioada de timp)! SK: Nebezpečný pre včely/Z dôvodu ochrany včiel a iného opeľujúceho hmyzu neaplikujte na plodiny v čase kvetu/Nepoužívajte, keď sa v okolí nachádzajú včely/Počas aplikácie a (uveďte čas) po aplikácii úle prikryte alebo presuňte na iné miesto/Neaplikujte, keď sa v okolí nachádzajú kvitnúce buriny/ Odstráňte buriny pred kvitnutím/Neaplikujte pred (uveďte čas). SL: Nevarno za čebele./Zaradi zaščite čebel in drugih žuželk opraševalcev ne tretirati rastlin med cvetenjem./Ne tretirati v času paše čebel./Med tretiranjem in (navede se časovno obdobje) po tretiranju odstraniti ali pokriti čebelje panje./Ne tretirati v prisotnosti cvetočega plevela./Odstraniti plevel pred cvetenjem./Ne tretirati pred (navede se časovno obdobje). FI: Vaarallista mehiläisille./Mehiläisten ja muiden pölyttävien hyönteisten suojelemiseksi ei saa käyttää viljelykasvien kukinta-aikaan./Ei saa käyttää aikana, jolloin mehiläiset lentävät aktiivisesti./Mehiläispesät poistettava tai suojattava levittämisen ajaksi ja (aika) ajaksi käsittelyn jälkeen./Ei saa käyttää, jos alueella on kukkivia rikkakasveja./Poista rikkakasvit ennen kukinnan alkua./Ei saa käyttää ennen (aika). SV: Farligt för bin./För att skydda bin och andra pollinerande insekter, använd inte denna produkt på blommande gröda./Får inte användas där bin aktivt söker efter föda./Avlägsna eller täck över bikupor under behandling och under (ange tidsperiod) efter behandling./Använd inte denna produkt då det finns blommande ogräs./Avlägsna ogräs före blomning./ Använd inte denna produkt före (ange tidsperiod). 2.3. Safety precautions related to good agricultural practice SPa 1 BG: Да не се прилага този или друг продукт, съдържащ (да се посочи активното вещество или групата активни вещества според случая) повече от (да се посочи броя на приложенията или срока), за да се избегне развитието на резистентност. ES: Para evitar la aparición de resistencias, no aplicar este producto ni ningún otro que contenga (indíquese la sustancia activa o la clase de sustancias, según corresponda) más de (indíquese el número de aplicaciones o el plazo). CS: K zabránení vzniku rezistence neaplikujte tento ani ádn jin prípravek, kter obsahuje(uvedte úcinnou látku nebo poprípadeskupinu úcinn ch látek)více/déle ne (uvedtecetnost aplikací nebo lhutu). DA: For at undgå udviklingen af resistens må dette produkt eller andre produkter, der indeholder (angiv aktivstof eller gruppe af aktivstoffer), kun anvendes/ikke anvendes mere end (i tidsperioden eller antal gange). DE: Zur Vermeidung einer Resistenzbildung darf dieses oder irgendein anderes Mittel, welches (entsprechende Benennung des Wirkstoffes oder der Wirkstoffgruppe) enthält, nicht mehr als (Angabe der Häufigkeit oder der Zeitspanne) ausgebracht werden. ET: Resistentsuse tekkimise vältimiseks seda või ükskõik millist muud vahendit mitte kasutada rohkem kui(kasutamiskordade arv või määratletav periood), mis sisaldab(määratleda vastavalt toimeaine või ainete liik). EL: Προκειµένου να µην αναπτυχθεί αντίσταση µην χρησιµοποιείτε αυτό ή οποιοδήποτε άλλο προϊόν που περιέχει (προσδιορίστε τη δραστική ουσία ή την κατηγορία των ουσιών αναλόγως) περισσότερο από (να προσδιοριστεί η συχνότητα) φορές. EN: To avoid the build-up of resistance do not apply this or any other product containing(identify active substance or class of substances, as appropriate) more than (number of applications or time period to be specified). FR: Pour éviter le développement de résistances, ne pas appliquer ce produit ou tout autre contenant (préciser la substance ou la famille de substances selon le cas) plus de (nombre d'appli cations ou durée à préciser). IT: Per evitare l'insorgenza di resistenza non applicare questo o altri prodotti contenenti(indicare la sostanza attiva o la classe di sostanze, a seconda del caso)più di(numero di applicazioni o durata da precisare). LV: Lai izvairītos no rezistences veidošanās, nelietot šo vai jebkuru citu augu aizsardzības līdzekli, kurš satur … (norāda darbīgās vielas vai darbīgo vielu grupas nosaukumu) vairāk nekā … (norāda apstrāžu skaitu vai laiku). LT: Siekiant išvengti atsparumo išsivystymo, nenaudoti šio produkto ar kito produkto, kurio sudėtyje yra (nurodyti veikliają medžiagą ar medžiagų grupę) dažniau kaip (nurodyti apdorojimų skaičių arba laikotarpį). HU: Rezisztancia kialakulásának elkerülése érdekében ezt vagy (a megfelelő hatóanyag vagy anyagcsoport)-ot tartalmazó bármilyen más készítményt ne használja (az előírt kezelésszám vagy időszakok)-nál többször/hosszabb ideig.. MT: Sabiex tevita li tinbena reżistenza tapplikax dan jew xi prodott iehor li jkun fih (identifika s-sustanza jew klassi ta' sustanzi attivi kif imiss) aktar minn (l-għadd ta' applikazzjonijiet jew il-ħin li ghandu jkun speċifikat) NL: Om resistentieopbouw te voorkomen mag u dit product of andere producten die (geef naar gelang van het geval de naam van de werkzame stof of van de categorie werkzame stoffen) bevatten, niet vaker gebruiken dan (geef het aantal toepassingen aan)/niet langer gebruiken dan (geef de tijdsduur aan). PL: W celu uniknięcia powstawania odporności nie stosować tego lub żadnego innego produktu zawierającego (określić substancję aktywną lub klasę substancji, kiedy dotyczy) nie dłużej niż (określony czas)/nie częściej niż (określona częstotliwość). PT: Para evitar o desenvolvimento de resistências, não aplicar este produto ou qualquer outro que contenha (indicar, consoante o caso, a substância activa ou a família de substâncias activas) mais de (número ou período de aplicações a precisar). RO: Pentru a evita apariția rezistenței nu aplicați acest produs sau orice alt produs conținând (să se specifice substanța activă sau clasa de substanțe, după caz) mai mult de (să se specifice numărul de tratamente sau perioada de timp)! SK: Na zabránenie vzniku rezistencie neaplikujte tento alebo iný prípravok obsahujúci (uveďte účinnú látku alebo skupinu látok) dlhšie ako (upresnite počet aplikácií alebo časový úsek). SL: Zaradi preprečevanja nastanka odpornosti ne uporabljati tega ali drugih sredstev, ki vsebujejo (navede se aktivno snov ali skupino aktivnih snovi) več kot (navede se časovno obdobje ali število tretiranj). FI: Resistenssin kehittymisen estämiseksi ei saa käyttää tätä tai mitä tahansa muuta tuotetta, joka sisältää (tapauksen mukaan tehoaine tai aineluokka), käyttöä useammin (käyttötiheys). SV: För att undvika utveckling av resistens använd inte denna produkt eller andra produkter innehållande (ange verksamt ämne eller grupp av ämnen) mer än (ange antal behandlingar eller tidsperiod). 2.4. Specific safety precautions for rodenticides (SPr) SPr 1 BG: Примамките да се поставят така, че да бъде сведен до минимум риска от консумация от други животни. Блоковите примамки да се поставят така, че да не могат да бъдат разнесени от гризачи. ES: Los cebos deben colocarse de forma que se evite el riesgo de ingestión por otros animales. Asegurar los cebos de manera que los roedores no puedan llevárselos. CS: Nástrahy musí být kladeny tak, aby se minimalizovalo riziko požití jinými zvířaty. Zabezpečte nástrahy, aby nemohly být hlodavci rozvlékány. DA: Produktet skal anbringes på en sådan måde, at risikoen for, at andre dyr kan indtage produktet, formindskes mest muligt. F.eks. ved at produktet anbringes inde i en kasse med små indgangshuller til gnaverne eller inde i gnavernes eget gangsystem. Pas på, at produkt i blokform ikke kan flyttes væk af de gnavere, der skal bekæmpes. DE: Die Köder verdeckt und unzugänglich für andere Tiere ausbringen. Köder sichern, so dass ein Verschleppen durch Nagetiere nicht möglich ist. ET: Peibutussööt tuleb ohutult ladustada selliselt, et minimeerida teiste loomade poolt tarbimise ohtu. Peibutussöödabriketid kindlustada selliselt, et närilised neid ära vedada ei saaks. EL: Τα δολώµατα θα πρέπει να τοποθετηθούν µε τρόπο τέτοιο που να ελαχιστοποιηθεί η πιθανότητα να καταναλωθούν από άλλα ζώα. Ασφαλίστε τα δολώµατα έτσι ώστε να µην µπορούν να τα παρασύρουν τα τρωκτικά. EN: The baits must be securely deposited in a way so as to minimise the risk of consumption by other animals. Secure bait blocks so that they cannot be dragged away by rodents. FR: Les appâts doivent être disposés de manière à minimiser le risque d'ingestion par d'autres animaux. Sécuriser les appâts afin qu'ils ne puissent pas être emmenés par les rongeurs. IT: Le esche devono essere disposte in modo da minimizzare il rischio di ingerimento da parte di altri animali. Fissare le esche in modo che non possano essere trascinate via dai roditori. LV: Ēsmu ejā ievietot tā, lai, tā nebūtu pieejama citiem dzīvniekiem. Ēsmu nostiprināt, lai grauzēji to nevarētu aizvilkt. LT: Jaukas turi būti saugiai išdėstytas taip, kad sumažėtų rizika kitiems gyvūnams jį vartoti. Jauko blokai turi būti taip saugomi, kad graužikai negalėtų jų ištampyti. HU: A csalétket úgy kell biztonságosan kihelyezni, hogy a lehető legkisebb legyen annak a veszélye, hogy abból más állatok is fogyasztanak. A csalétket úgy kell rögzíteni, hogy azt a rágcsálók ne hurcolhassák el. MT: Il-lixki għandhom jitqegħdu hekk li jitnaqqas ir-riskju li jkunu mittiekla minn annimali oħrajn. Orbot il-blokki tal lixka sew fejn ikunu biex ma' jiġux mkaxkra minn fuq il post minn rodenti. NL: De lokmiddelen moeten zo worden geplaatst dat het risico dat andere dieren ervan eten zoveel mogelijk wordt beperkt. Maak de blokjes stevig vast, zodat ze niet door de knaag dieren kunnen worden weggesleept. PL: Przynęty muszą być rozłożone w taki sposób, aby zminimalizować ryzyko zjedzenia przez inne zwierzęta. Zabezpieczyć przynętę w ten sposób, aby nie mogła zostać wywleczona przez gryzonie. PT: Colocar os iscos de modo a minimizar o risco de ingestão por outros animais. Fixar os iscos, para que não possam ser arrastados pelos roedores. RO: Momeala trebuie depozitată în condiții de securitate astfel încât să se micșoreze riscul de a fi consumată de către alte animale! A se asigura momeala astfel încât să nu poată fi mutată de către rozătoare! SK: Návnady sa musia umiestnit’ tak, aby sa k nim nedostali iné zvieratá. Zabezpecte návnady tak, aby ich hlodavce nemohli odtiahnut. SL: Vabe je treba nastaviti varno, tako da je tveganje zaužitja za druge živali minimalno. Zavarovati vabe tako, da jih glodalci ne morejo raznesti. FI: Syötit on sijoitettava siten, että ne eivät eiheuta riskiä muille eläimille. Syötit on kiinnitettävä siten, että jyrsijät eivät saa vietyä niitä mukanaan. SV: Betena måste placeras så att andra djur inte kan förtära dem. Förankra betena så att de inte kan släpas iväg av gnagare. SPr 2 BG: Третираните площи трябва да бъдат обозначени в периода на третиране. Да се посочи опасността от отравяне (първично или вторично) с антикоагуланта и да се укаже неговата противоотрова. ES: La zona tratada debe señalizarse durante el tratamiento. Debe advertirse del riesgo de intoxicación (primaria o secundaria) por el anticoagulante así como del antídoto correspondiente. CS: Plocha určená k ošetření musí být během ošetřování označena. Je třeba upozornit na nebezpečí otravy (primární nebo sekundární) antikoagulantem a uvést protijed. DA: Det behandlede område skal afmærkes i behandlingsperioden. Faren for forgiftning (primær eller sekundær) ved indtagelse af antikoaguleringsmidler, samt modgiften herfor, skal nævnes på opslag. DE: Det behandlede område skal afmærkes i behandlingsperioden. Faren for forgiftning (primær eller sekundær) ved indtagelse af antikoaguleringsmidler, samt modgiften herfor, skal nævnes på opslag. ET: Käideldud ala tuleb käitlemisperioodiks märgistada. Antikoa gulandi mürgituse (esmane või teisene) oht ning selle vastane antidoot peab olema ära mainitud. EL: Η περιοχή στην οποία έχει χρησιµοποιηθεί το προϊόν πρέπει να έχει σηµαδευτεί κατά την περίοδο χρήσης. Θα πρέπει να αναφέρεται ο κίνδυνος (πρωτογενούς ή δευτερογενούς) δηλη τηρίασης από το αντιπηκτικό καθώς και το αντίδοτο σε περίπτωση δηλητηρίασης. EN: Treatment area must be marked during the treatment period. The danger from being poisoned (primary or secondary) by the anticoagulant and the antidote against it should be mentioned. FR: La zone de traitement doit faire l'objet d'un marquage pendant la période de traitement. Le risque d'empoison nement (primaire ou secondaire) par l'anticoagulant, ainsi que son antidote doivent être mentionnés. IT: Durante il trattamento la zona interessata deve essere chiar amente segnalata. Il pericolo di avvelenamento (primario o secondario) dovuto all'anticoagulante deve essere evidenziato assieme al relativo antidoto. LV: Apstrādes laikā apstrādājamo platību marķēt. Norādīt saindēšanās (primārās vai sekundārās) apdraudējumu ar antikoagulantu un tā antidotu. LT: Apdorojami plotai turi būti pažymėti visą apdorojimo laikotarpį. Turi būti paminėtas apsinuodijimo antikoaguliantu pavojus (tiesioginis ar netiesioginis) ir nurodytas priešnuodis. HU: A kezelt területet a kezelés ideje alatt külön jelöléssel kell megjelölni. A jelölésben fel kell hívni a figyelmet a véralvadásgátló szertől való mérgeződés veszélyére és annak ellenszerére. MT: Il-post ittrattat għandu jkun immarkat filwaqt li jkun qiegħed jiġi itrattat. Għandu jissemma l-periklu ta' avvelenament (primarju jew sekondarju) bl-antikoagulant u l-antitodu tiegħu. NL: De behandelde zone moet tijdens de verdelgingsperiode worden gemarkeerd. Het risico van een (primaire of secundaire) vergiftiging door het antistollingsmiddel moet worden vermeld, alsmede het tegengif. PL: Obszar poddany zabiegowi musi być oznakowany podczas zabiegu. Niebezpieczeństwo zatrucia (pierwotnego lub wtórnego) antykoagulantem i antidotum powinno być wyszczególnione. PT: Zona de tratament trebuie marcată în timpul perioadei de aplicare! A se menționa riscul de otrăvire (principal și secundar) cu anticoagulant și antitodul specific! RO: Durante o período de tratamento, marcar a zona, com menção ao perigo de envenenamento (primário ou secundário) pelo anticoagulante e indicação do antídoto deste último. SK: Ošetrovaná plocha sa počas ošetrenia musí označiť. Musí sa uviesť nebezpečenstvo možnej otravy (primárnej alebo sekundárnej) antikoagulantami a protilátky. SL: Tretirano območje je treba v času tretiranja označiti. Navesti je treba nevarnost zastrupitve (neposredne ali posredne) z antikoagulanti in ustrezne antidote. FI: Käsiteltävä alue on merkittävä käsittelyaikana. Antikoagu lantin aiheuttama myrkytysvaara (primaarinen tai sekun daarinen) ja vasta-aine mainittava. SV: Det behandlade området skall markeras under behandling sperioden. Faran för förgiftning (primär eller sekundär) av antikoagulanten samt motgift skall anges. SPr 3 BG: Мъртвите гризачи да се отстраняват от третираната площ всеки ден през целия период на третиране. Да не се изхвърлят в кофи за боклук или на сметища. ES: Durante el tratamiento, los roedores muertos deben retirarse diariamente de la zona tratada. No tirarlos en cubos de basura ni en vertederos. CS: Mrtvé hlodavce během doby použití přípravku denně odstraňujte. Neodkládejte je do nádob na odpadky ani na smetiště. DA: Døde gnavere skal fjernes fra behandlingsområdet hver dag. Anbring ikke de døde gnavere i åbne affaldsbeholdere. DE: Tote Nager während der Einsatzperiode täglich entfernen. Nicht in Müllbehältern oder auf Müllkippen entsorgen. ET: Surnud närilised tuleb eemaldada käitlemisalalt käitlemise ajal iga päev. Mitte panna prügikastidesse või prügi maha paneku kohtadesse. EL: Τα νεκρά τρωκτικά πρέπει να αποµακρύνονται καθηµερινά από την περιοχή χρήσης σε όλη τη διάρκεια χρησιµοποίησης του προϊόντος. Να µην τοποθετούνται σε κάδους απορ ριµµάτων ούτε σε σακούλες σκουπιδιών. EN: Dead rodents must be removed from the treatment area each day during treatment. Do not place in refuse bins or on rubbish tips. FR: Les rongeurs morts doivent être retirés quotidiennement de la zone de traitement pendant toute la période du traitement. Ne pas les jeter dans les poubelles ni les décharges. IT: I roditori morti devono essere rimossi quotidianamente dalla zona del trattamento per tutta la durata dello stesso e non devono essere gettati nei rifiuti o nelle discariche. LV: Apstrādes laikā beigtos grauzējus no apstrādātās platības aizvākt katru dienu. Neizmest tos atkritumu tvertnēs vai kaudzēs. LT: Žuvę graužikai turi būti surenkami iš apdoroto ploto kiekvieną dieną viso naikinimo metu. Nemesti i šiukšlių dėžes arba sąvartynus. HU: Az elhullott rágcsálókat a kezelés alatt naponta el kell távolítani a kezelt területről. A tetemeket tilos hulladéktartályban vagy hulladéklerakóban elhelyezni. MT: Għandhom jitneħħew kuljum ir-rodenti mejta mill-post ittrattat. Tarmihomx f'kontenituri taż-żibel jew fuq il miżbliet. NL: Tijdens de verdelgingsperiode moeten de knaagdieren elke dag uit de behandelde zone worden verwijderd. Gooi ze niet in vuilnisbakken of op storten. PL: Martwe gryzonie usuwać z obszaru poddanego zabiegowi każdego dnia. Nie wyrzucać do pojemników na śmieci i nie wywozić na wysypiska śmieci. PT: Durante o período de tratamento, remover diariamente os roedores mortos da zona de tratamento, mas sem os deitar ao lixo ou depositar em lixeiras. RO: Rozătoarele moarte trebuie să fie îndepărtate din zona tratată în fiecare zi în timpul tratamentului! A nu se arunca în recipientele pentru gunoi sau la gropile de gunoi! SK: Mŕtve hlodavce treba z ošetrovanej plochy každý deň odstrániť. Nehádžte ich do odpadových nádob alebo na smetisko. SL: Poginule glodalce je treba odstraniti s tretiranega območja sproti, vsak dan v času tretiranja, vendar ne v zabojnike za odpadke ali odlagališča smeti. FI: Kuolleet jyrsijät on kerättävä käsittelyaikana alueelta päivittäin. Niitä ei saa heittää jätesäiliöihin tai kaatopaikoille. SV: Döda gnagare skall tas bort från behandlingsområdet varje dag under behandlingen. Får inte läggas i soptunnor eller på soptipp. 3. Attribution criteria for standard phrases for specific safety precautions 3.1. INTRODUCTION In general, plant-protection products are only authorised for those specified uses, which are acceptable on the basis of an assessment according to the uniform principles laid down in Schedule VI of this Legal Notice. As far as applicable, the specific safety precautions should reflect the results of such assessments according to the uniform principles and should be applied in particular in those cases where risk-mitigation measures are necessary to prevent unacceptable effects. 3.2. Attribution criteria for standard phrases for safety precautions for operators SPo 1 After contact with skin, first remove product with a dry cloth and then wash the skin with plenty of water. The phrase shall be assigned for plant-protection products containing ingredients which may react violently with water, such as cyanide salts or aluminium phosphide. SPo 2 Wash all protective clothing after use. The phrase is recommended when protective clothing is required to protect operators. It is obligatory for all plant-protection products clas sified as T or T+. SPo 3 After igniting the product, do not inhale smoke and leave the treated area immediately. The phrase shall be assigned to plant-protection products used for fumi gation in cases where the use of a respiratory mask is not warranted. SPo 4 The container must be opened outdoors and in dry conditions. The phrase should be assigned to plant-protection products containing active substances which may react violently with water or damp air, such as aluminium phosphide, or which may cause spontaneous combustion, such as (alkylenebis-) dithiocarbamates. This phrase shall also be assigned to volatile products classified with R20, 23 or 26. Expert judgement must be applied in individual cases, to assess whether the properties of the preparation and the packaging are such as to cause harm to the operator. SPo 5 Ventilate treated areas/greenhouses thoroughly/time to be specifie d/until spray has dried before re-entry. The phrase shall be assigned to plant-protection products used in green houses or other confined spaces, such as stores. 3.3. Attribution criteria for standard phrases for safety precautions for the environment SPe 1 To protect groundwater/soil organisms do not apply this or any other product containing(identify active substance or class of substances, as appropriate)more than(time period or frequency to be specified). The phrase shall be assigned to plant-protection products for which an evaluation according to the uniform principles shows for one or more of the labelled uses that risk-mitigation measures are necessary to avoid accumulation in soil, effects on earthworms or other soil-dwelling organisms or soil microflora and/or contamination of groundwater. SPe 2 To protect groundwater/effects on aquatic organisms do not apply to (soil type or situation to be specified)soils. The phrase shall be assigned as a risk-mitigation measure to avoid any potential contamination of groundwater or surface water under vulnerable conditions (e.g. associated to soil type, topography or for drained soils), if an evaluation according to the uniform principles shows for one or more of the labelled uses that risk-mitigation measures are necessary to avoid unacceptable effects. SPe 3 To protect aquatic organisms/non-target plants/non-target arthropod-s/insects respect an unsprayed buffer zone of(distance to be specified) to non-agricultural land/surface water bodies. The phrase shall be assigned to protect non-target plants, non-target arthropods and/or aquatic organisms, if an evaluation according to the uniform principles shows for one or more of the labelled uses that risk mitigation measures are necessary to avoid unacceptable effects. SPe 4 To protect aquatic organisms/non-target plants do not apply on impermeable surfaces such as asphalt, concrete, cobblestones, railway tracks and other situations with a high risk of run-off. This phrase shall be used to mitigate the risk of run-off in order to protect aquatic organisms or non-target plants. SPe 5 To protect birds/wild mammals the product must be entirely incor porated in the soil; ensure that the product is also fully incorporated at the end of rows. The phrase shall be assigned to plant-protection products, such as granules or pellets, which must be incorporated to protect birds or wild mammals. SPe 6 To protect birds/wild mammals remove spillages. The phrase shall be assigned to plant-protection products, such as granules or pellets, to avoid uptake by birds or wild mammals. It is recommended for all solid formulations, which are used undiluted. SPe 7 Do not apply during bird breeding period. The phrase shall be assigned when an evaluation according to the uniform principles shows that for one or more of the labelled uses such a mitigation measure is necessary. SPe 8 Dangerous to bees/To protect bees and pollinating insects do not apply to crop plants when in flower/Do not use where bees are actively foraging/Remove or cover beehives during application and for(state time)after treatment/Do not apply when flowering weeds are present/Remove weeds before flowering/Do not apply before (state time) The phrase shall be assigned to plant-protection products for which an evaluation according to the uniform principles shows for one or more of the labelled uses that risk-mitigation measures must be applied to protect bees or other pollinating insects. Depending on the use pattern of the plant-protection product, and other relevant national regulatory provisions, the Director may select the appropriate phrasing to mitigate the risk to bees and other pollinating insects and their brood. 3.4. Attribution criteria for standard phrases for safety precautions for good agricultural practice SPa 1 To avoid the build-up of resistance do not apply this or any other product containing(identify active substance or class of substances, as appropriate)more than(number of applications or time period to be specified). The phrase shall be assigned when such a restriction appears necessary to limit the risk of development of resistance. 3.5. Attribution criteria for standard phrases for specific safety precautions for rodenticides SPr 1 The baits must be securely deposited in a way so as to minimise the risk of consumption by other animals. Secure bait blocks so that they cannot be dragged away by rodents. To ensure compliance of operators the phrase should appear prominently on the label, so that misuse is excluded as far as possible. SPr 2 Treatment area must be marked during the treatment period. The danger from being poisoned (primary or secondary) by the antic oagulant and the antidote against it should be mentioned. The phrase should appear prominently on the label, so that accidental poisoning is excluded as far as possible. SPr 3 Dead rodents must be removed from the treatment area each day during treatment. Do not place in refuse bins or on rubbish tips. To avoid secondary poisoning of animals the phrase shall be assigned to all rodenticides containing anticoagulants as active substances. SCHEDULE VI PART I UNIFORM PRINCIPLES FOR EVALUATION AND AUTHORISATION OF CHEMICAL PLANT PROTECTION PRODUCTS CONTENTS A. INTRODUCTION B. EVALUATION 1. General principles 2. Specific principles 2.1. Efficacy 2.2. Absence of unacceptable effects on plants or plant products 2.3. Impact on vertebrates to be controlled 2.4. Impact on human or animal health 2.4.1. arising from the plant protection product 2.4.2. arising from residues 2.5. Influence on the environment 2.5.1. Fate and distribution in the environment 2.5.2. Impact on non-target species 2.6. Analytical methods 2.7. Physical and chemical properties C. DECISION-MAKING 1. General principles 2. Specific principles 2.1. Efficacy 2.2. Absence of unacceptable effects on plants or plant products 2.3. Impact on vertebrates to be controlled 2.4. Impact on human or animal health 2.4.1. arising from the plant protection product 2.4.2. arising from residues 2.5. Influence on the environment 2.5.1. Fate and distribution in the environment 2.5.2. Impact on non-target species 2.6. Analytical methods 2.7. Physical and chemical properties A. INTRODUCTION 1. The principles developed in this Schedule aim to ensure that evaluations and decisions with regard to authorization of plant protection products, provided they are chemical preparations, results in the implementation of the requirements of regulation 4 (1) (b), (c), (d) and (e) of these at the high level of protection of human and animal health and the environment. 2. In evaluating applications and granting authorizations Member States shall: (a)— ensure that the dossier supplied is in accordance with the requirements of Schedule III, at the latest at the time of finalization of the evaluation for the purpose of decision making, without prejudice, where relevant, to the provisions of regulation 13 (1) (a), (2)(b) and (4) of these regulations, —ensure that the data submitted are acceptable in terms of quantity, quality, consistency and reliability and sufficient to permit a proper evaluation of the dossier, —evaluate, where relevant, justifications submitted by the applicant for not supplying certain data; (b) take into account the Schedule II data concerning the active substance in the plant protection product, submitted for the purpose of inclusion of the active substance concerned in Schedule I, and the results of the evaluation of those data, without prejudice, where relevant, to the provisions of regulation 13 (1) (b), (2)(a) and (4) of these regulations; (c) take into consideration other relevant technical or scientific information they can reasonably possess with regard to the performance of the plant protection product or to the poten tially adverse effects of the plant protection product, its components or its residues. 3. Where in the specific principles on evaluation reference is made to Schedule II data, this shall be understood as being the data referred to in point 2 (b). 4. Where the data and information provided are sufficient to permit completion of the evaluation for one of the proposed uses, appli cations must be evaluated and a decision made for the proposed use. Taking account of justifications provided and with the benefit of any subsequent clarifications, the Director shall reject appli cations for which the data gaps are such that it is not possible to finalize the evaluation and to make a reliable decision for at least one of the proposed uses. 5. During the process of evaluation and decision-making, Member States shall cooperate with the applicants in order to resolve any questions on the dossier quickly or to identify at an early stage any additional studies necessary for a proper evaluation of the dossier, or to amend any proposed conditions for the use of the plant protection product or to modify its nature or its composition in order to ensure full satisfaction of the requirements of this Schedule or of these Regulations. The Director shall ITALICly come to a reasoned decision within 12 months of receiving a technically complete dossier. A technically complete dossier is one that satisfies all the requirements of Schedule III. 6. The judgements made by the competent authorities of the Member States during the evaluation and decision-making process must be based on scientific principles, preferably recognized at interna tional level (for example, by the EPPO), and be made with the benefit of expert advice. B. EVALUATION 1. General principles 1. Having regard to current scientific and technical knowledge, The Director shall evaluate the information referred to in Part A, point 2, and in particular: (a) assess the performance in terms of efficacy and phyto toxicity of the plant protection product for each use for which authorization is sought; and (b) identify the harzards arising, assess their significance and make a judgment as to the likely risks to humans, animals or the environment. 2. The director shall have regard to all normal conditions under which the plant protection product shall be used, and to the consequences of its use, the director shall ensure that evaluations carried out have regard to the proposed practical conditions of use and in particular to the purpose of use, the dose, the manner, frequency and timing of applications, and the nature and composition of the preparation. Whenever possible the Director shall also take into account the principles of integrated control. 3. In the evaluation of applications submitted, the Director shall have regard to the agricultural, plant health or environ-mental (including climatic) conditions in the areas of use. 4. In interpreting the results of evaluations, the Director shall take into consideration possible elements of uncertainty in the information obtained during the evaluation, in order to ensure that the chances of failing to detect adverse effects or of under-estimating their importance are reduced to a minimum. The decision-making process shall be examined to identify critical decision points or items of data for which uncertainties could lead to a false classification of risk. The first evaluation made shall be based on the best available data or estimates reflecting the realistic conditions of use of the plant protection product. This should be followed by a repeat evaluation, taking account of potential uncertainties in the critical data and of a range of use conditions that are likely to occur and resulting in a realistic worst-case approach, to determine whether it is possible that the initial evaluation could have been signifi cantly different. 5. Where specific principles of Section 2 provide for the use of calculation models in the evaluation of a plant protection product, those models shall: —make a best possible estimation of all relevant processes involved taking into account realistic parameters and assumptions, —be submitted to an analysis as referred to in B, point 1.4, —be reliably validated with measurements carried out under circumstances relevant for the use of the model, —be relevant to the conditions in the area of use. 6. Where metabolites, degradation or reaction products are referred to in the specific principles, only those that are relevant for the proposed criterion shall be taken into consid eration. 2. Specific priciples The director shall, for the evaluation of the data and information submitted in support of applications, and without prejudice to the general principles of Section 1, implement the following principles. 2.1. Efficacy 2.1.1. Where the proposed use concerns the control of or protection against an organism, the Director shall evaluate the possibility that this organism could be harmful under the agricultural, plant health and environmental (including climatic) conditions in the area of the proposed use. 2.1.2. Where the proposed use concerns an effect other than the control of or protection against an organism, the director shall evaluate whether significant damage, loss or inconvenience could occur under the agricultural, plant health and environmental (including climatic) conditions in the area of proposed use if the plant protection product were not used. 2.1.3. The Director shall evaluate the efficacy data on the plant protection product as provided for in Schedule III having regard to the degree of control or the extent of the effect desired and having regard to the relevant experimental conditions such as: —the choice of the crop or cultivar, —the agricultural and environmental (including climatic) conditions, —the presence and density of the harmful organism, —the development stage of crop and organism, —the amount of the plant protection product used, —if required on the label, the amount of adjuvant added, —the frequency and timing of the applications, —the type of application equipment. 2.1.4. The Director shall evaluate the performance of the plant protection product in a range of agricultural, plant health and environmental (including climatic) conditions likely to be encountered in practice in the area of proposed use and in particular: (i) the level, consistency and duration of the effect sought in relation to the dose in comparison with a suitable reference product or products and an untreated control; (ii) where relevant, effect on yield or reduction of loss in storage, in terms of quantity and/or quality, in comparison with a suitable reference product or products and an untreated control. Where no suitable reference product exists, the Director shall evaluate the performance of the plant protection product to determine whether there is a consistent and defined benefit under the agricultural, plant health and environmental (including climatic) conditions in the area of proposed use. 2.1.5. Where the product label includes requirements for use of the plant protection product with other plant protection products and/or with adjuvants as a tank mix, the Director shall make the evaluations referred to in points 2.1.1 to 2.1.4 in relation to the information supplied for the tank mix. Where the product label includes recommendations for use of the plant protection product with other plant protection products and/or with adjuvants as a tank mix, the Director shall evaluate the appropriateness of the mix and of its conditions of use. 2.2. Absence of unacceptable effects on plants or plant products 2.2.1. The Director shall evaluate the degree of adverse effects on the treated crop after use of the plant protection product according to the proposed conditions of use in comparison, where relevant, with a suitable reference product or products, where they exist, and/or an untreated control. (a) This evaluation will take into consideration the following information: (i) the efficacy data provided for in Schedule III; (ii) other relevant information on the plant protection product such as nature of the preparation, dose, method of application, number and timing of applications; (iii) all relevant information on the active substance as provided for in Schedule II, including mode of action, vapour pressure, volatility and water solubility; (b) This evaluation will include: (i) the nature, frequency, level and duration of observed phytotoxic effects and the agricultural, plant health and environmental (including climatic) conditions that affect them; (ii) the differences between main cultivars with regard to their sensitivity to phytotoxic effects; (iii) the part of the treated crop or plant products where phytotoxic effects are observed; (iv) the adverse impact on the yield of the treated crop or plant products in terms of quantity and/or quality; (v) the adverse impact on treated plants or plant products to be used for propagation, in terms of viability, germi-nation, sprouting, rooting and establishment; (vi) where volatile products are concerned, the adverse impact on adjacent crops. 2.2.2. Where the available data indicate that the active substance or significant metabolites, degradation and reaction products persist in soils and/or in or on plant substances in significant quantities after use of the plant protection product according to the proposed conditions of use, the Director shall evaluate the degree of adverse effects on subsequent crops. This evaluation will be carried out as specified in point 2.2.1. 2.2.3. Where the product label includes requirements for use of the plant protection product with other plant protection products or with adjuvants as a tank mix, the evaluation as specified in point 2.1.1 will be carried out in relation to the information supplied for the tank mix. 2.3. Impact on vertebrates to be controlled Where the proposed use of the plant protection product aims to have an effect on vertebrates, the Director shall evaluate the mechanism by which this effect is obtained and the observed effects on the behaviour and health of the target animals; when the intended effect is to kill the target animal they shall evaluate the time necessary to obtain the death of the animal and the conditions under which death occurs. This evaluation will take into consideration the following infor mation: (i) all relevant information as provided for in Schedule II and the results of the evaluation thereof, including the toxicological and metabolism studies; (ii) all relevant information on the plant protection product as provided for in Schedule III, including toxicological studies and efficacy data. 2.4. Impact on human or animal health 2.4.1. a r i s i n g f r o m t h e p l a n t p r o t e c t i o n p r o d u c t 2.4.1.1. The Director shall evaluate operator exposure to the active substance and/or to toxicologically relevant compounds in the plant protection product likely to occur under the proposed conditions of use (including in particular dose, application method and climatic conditions) using by preference realistic data on exposure and, if such data are not available, a suitable, validated calculation model. (a) This evaluation will take into consideration the following information: (i) the toxicological and metabolism studies as provided for in Schedule II and the results of the evaluation thereof including the acceptable operator exposure level (AOEL). The acceptable operator exposure level is the maximum amount of active substance to which the operator may be exposed without any adverse health effects. The AOEL is expressed as milligrams of the chemical per kilogram body weight of the operator. The AOEL is based on the highest level at which no adverse effect is observed in tests in the most sensitive relevant animal species or, if appropriate data are available, in humans; (ii) other relevant information on the active substances such as physical and chemical properties; (iii) the toxicological studies provided for in Schedule III, including where appropriate dermal absorption studies; (iv) other relevant information as provided for in Schedule III such as: composition of the preparation, nature of the preparation, size, design and type of packaging, field of use and nature of crop or target, method of application including handling, loading and mixing of product, exposure reduction measures recommended, protective clothing recommendations, maximum application rate, minimum spray application volume stated on the label, number and timing of applications; (b) This evaluation shall be made for each type of application method and application equipment proposed for use of the plant protection product as well as for the different types and sizes of containers to be used, taking account of mixing, loading operations, application of the plant protection product and cleaning and routine maintenance of application equipment. 2.4.1.2. The director shall examine information relating to the nature and characteristics of the packaging proposed with particular reference to the following aspects: —the type of packaging, —its dimensions and capacity, —the size of the opening, —the type of closure, —its strength, leakproofness and resistance to normal transport and handling, —its resistance to and compatibility with the contents. 2.4.1.3. The director shall examine the nature and characteristics of the protective clothing and equipment proposed with particular reference to the following aspects: —obtainability and suitability, —ease of wearing taking into account physical stress and climatic conditions. 2.4.1.4. The director shall evaluate the possibility of exposure of other humans (bystanders or workers exposed after the application of the plant protection product) or animals to the active substance and/or to other toxicologically relevant compounds in the plant protection product under the proposed conditions of use. This evaluation will take into consideration the following infor mation: (i) the toxicological and metabolism studies on the active substance as provided for in Schedule II and the results of the evaluation thereof, including the acceptable operator exposure level; (ii) the toxicological studies provided for in Schedule III, including where appropriate dermal absorption studies; (iii) other relevant information on the plant protection product as provided for in Schedule III such as: —re-entry periods, necessary waiting periods or other precautions to protect humans and animals, —method of application, in particular spraying, —maximum application rate, —maximum spray application volume, —composition of the preparation, —excess remaining on plants and plant products after treatment, —further activities whereby workers are exposed. 2.4.2. A r i s i n g f r o m r e s i d u e s 2.4.2.1. The director shall evaluate the specific information on toxi cology as provided for in Schedule II and in particular: —the determination of an acceptable daily intake (ADI), —the identification of metabolites, degradation and reaction products in treated plants or plant products, —behaviour of residues of the active substance and its meta bolites from the time of application until harvest, or in the case of post-harvest uses, until outloading of stored plant products. 2.4.2.2. Prior to evaluating the residue levels in the reported trials or in products of animal origin The director shall examine the following information: —data on the proposed good agricultural practice, including data on application as provided for in Schedule III and proposed pre-harvest intervals for envisaged uses, or with-holding periods or storage periods, in the case of post-harvest uses, —nature of the preparation, —analytical methods and the residue definition. 2.4.2.3. On the basis of suitable statistical models The director shall evaluate the residue levels observed in the reported trials. This evaluation shall be made for each proposed use and shall take into consideration: (i) the proposed conditions of use of the plant protection product; (ii) the specific information on residues in or on treated plants, plant products, food and feed as provided for in Schedule III and the distribution of residues between edible and non-edible parts; (iii) the specific information on residues in or on treated plants, plant products, food and feed as provided for in Schedule II and the results of the evaluation thereof; (iv) the realistic possibilities of extrapolating data from one crop to another. 2.4.2.4. The director shall evaluate the residue levels observed in products of animal origin, taking into consideration the infor mation provided for in Schedule III, Part A, point 8.4 and residues resulting from other uses. 2.4.2.5. The director shall estimate the potential exposure of consumers through diet and, where relevant, other ways of exposure, using a suitable calculation model. This evaluation will take account, where relevant, of other sources of information such as other authorized uses of plant protection products containing the same active substance or which give rise to the same residues. 2.4.2.6. The director shall, where relevant, estimate the exposure of animals, taking into account the residue levels observed in treated plants or plant products intended to be fed to animals. 2.5. Influence on the environment 2.5.1. F a t e a n d d i s t r i b u t i o n i n t h e e n v i r o n m e n t In the evaluation of the fate and distribution of the plant protection product in the environment, The director shall have regard to all aspects of the environment, including biota, and in particular to the following: 2.5.1.1. The director shall evaluate the possibility of the plant protection product reaching the soil under the proposed conditions of use; if this possibility exists they shall estimate the rate and the route of degradation in the soil, the mobility in the soil and the change in the total concentration (extractable and non-extractable (*)) of the active substance and of relevant metabolites, degradation and reaction products that could be expected in the soil in the area of envisaged use after use of the plant protection product according to the proposed conditions of use. (*) Non-extractable residues (sometimes referred to as‘bound’or‘non-extracted’residues) in plants and soils are defined as chemical species originating from pesticides used according to good agricultural practice that cannot be extracted by methods which do not significantly change the chemical nature of these residues. These non-extractable residues are not considered to include fragments through metabolic pathways leading to natural products. This evaluation will take into consideration the following infor mation: (i) the specific information on fate and behaviour in soil as provided for in Schedule II and the results of the evaluation thereof; (ii) other relevant information on the active substance such as: —molecular weight, —solubility in water, —octanol/water partition coefficient, —vapour pressure, —volatilization rate, —dissociation constant, —photodegradation rate and identity of breakdown products, —hydrolysis rate in relation to pH and identity of breakdown products; (iii) all information on the plant protection product as provided for in Schedule III, including the information on distribution and dissipation in soil; (iv) where relevant, other authorized uses of plant protection products in the area of proposed use containing the same active substance or which give rise to the same residues. 2.5.1.2. The director shall evaluate the possibility of the plant protection product reaching the groundwater under the proposed conditions of use; if this possibility exists, they shall estimate, using a suitable calculation model validated at Community level, the concentration of the active substance and of relevant meta bolites, degradation and reaction products that could be expected in the groundwater in the area of envisaged use after use of the plant protection product according to the proposed conditions of use. As long as there is no validated Community calculation model, The director shall base their evaluation especially on the results of mobility and persistance in soil studies as provided for in Schedules II and III. This evaluation will also take into consideration the following information: (i) the specific information on fate and behaviour in soil and water as provided for in Schedule II and the results of the evaluation thereof; (ii) other relevant information on the active substance such as: —molecular weight, —solubility in water, —octanol/water partition coefficient, —vapour pressure, —volatilization rate, —hydrolysis rate in relation to pH and identity of breakdown products, —dissociation constant; (iii) all information on the plant protection product as provided for in Schedule III, including the information on distribution and dissipation in soil and water; (iv) where relevant, other authorized uses of plant protection products in the area of envisaged use containing the same active substance or which give rise to the same residues; (v) where relevant, data on dissipation including transformation and sorption in the saturated zone; (vi) where relevant, data on the procedures for drinking water abstraction and treatment in the area of envisaged use; (vii) where relevant, monitoring data on the presence or absence of the active substance and relevant metabolites, degradation or reaction products in groundwater as a result of previous use of plant protection products containing the same active substance or which give rise to the same residues; such monitoring data shall be interpreted in a consistent scientific way. 2.5.1.3. The director shall evaluate the possibility of the plant protection product reaching surface water under the proposed conditions of use; if this possibility exists they shall estimate, using a suitable calculation model validated at Community level, the short-term and long-term predicted concentration of the active substance and of metabolites, degradation and reaction products that could be expected in the surface water in the area of envisaged use after use of the plant protection product according to the proposed conditions of use. If there is no validated Community calculation model, Member States shall base their evaluation especially on the results of mobility and persistence in soil studies and the information on run-off and drift as provided for in Schedules II and III. This evaluation will also take into consideration the following information: (i) the specific information on fate and behaviour in soil and water as provided for in Schedule II and the results of the evaluation thereof; (ii) other relevant information on the active substance such as: —molecular weight, —solubility in water, —octanol/water partition coefficient, —vapour pressure, —volatilization rate, —hydrolysis rate in relation to pH and identity of breakdown products, —dissociation constant; (iii) all relevant information on the plant protection product as provided for in Schedule III, including the information on distribution and dissipation in soil and water; (iv) possible routes of exposure: —drift, —run-off, —overspray, —discharge via drains, —leaching, —deposit in the atmosphere; (v) where relevant, other authorized uses of plant protection products in the area of envisaged use containing the same active substance or which give rise to the same residues; (vi) where relevant, data on the procedures for drinking water abstraction and treatment in the area of envisaged use. 2.5.1.4. The director shall evaluate the possibility of the plant protection product being dissipated in the air under the proposed conditions of use; if this possibility exists they shall make the best possible estimation, using where appropriate a suitable, validated calculation model, of the concentration of the active substance and of relevant metabolites, degradation and reaction products that could be expected in the air after use of the plant protection product according to the proposed conditions of use. This evaluation will take into consideration the following infor mation: (i) the specific information on fate and behaviour in soil, water and air as provided for in Schedule II and the results of the evaluation thereof; (ii) other relevant information on the active substance such as: — vapour pressure, — solubility in water, — hydrolysis rate in relation to pH and identity of breakdown products, — photochemical degradation in water and air and identity of breakdown products, —octanol/water partition coefficient; (iii) all relevant information on the plant protection product as provided for in Schedule III, including the information on distribution and dissipation in air. 2.5.1.5. The director shall evaluate the procedures for destruction or decontamination of the plant protection product and its packaging. 2.5.2. I m p a c t o nnon-target species When calculating toxicity/exposure ratios The director shall take into consideration toxicity to the most sensitive relevant organism used in the tests. 2.5.2.1. The director shall evaluate the possibility of exposure of birds and other terrestrial vertebrates to the plant protection product under the proposed conditions of use; if this possibility exists they shall evaluate the extent of the short-term and long-term risk to be expected for these organisms, including their reproduction, after use of the plant protection product according to the proposed conditions of use. (a) This evaluation will take into consideration the following information: (i) the specific information relating to toxicological studies on mammals and to the effects on birds and other non-target terrestrial vertebrates, including effects on reproduction, and other relevant information concerning the active substance as provided for in Schedule II and the results of the evaluation thereof; (ii) all relevant information on the plant protection product as provided for in Schedule III, including the information on effects on birds and other non-target terrestrial verte-brates; (iii) where relevant, other authorized uses of plant protection products in the area of envisaged use containing the same active substance or which give rise to the same residues; (b) This evaluation will include: (i) the fate and distribution, including persistence and bioconcentration, of the active substance and of relevant metabolites, breakdown and reaction products in the various parts of the environment after application of the plant protection product; (ii) the estimated exposure of the species likely to be exposed at the time of application or during the period that residues are present, taking into account all relevant routes of exposure such as ingestion of the formulated product or treated food, predation on invertebrates, feeding on vertebrate prey, contact by overspraying or with treated vegetation; (iii) a calculation of the acute, short-term and, where necessary, long-term toxicity/exposure ratio. The toxici-ty/exposure ratios are defined as respectively the quotient of LD50,LC50or non-observable effects of concentration (NOEC) expressed on an active substance basis and the estimated exposure expressed in mg/kg body weight. 2.5.2.2. Member States shall evaluate the possibility of exposure of aquatic organisms to the plant protection product under the proposed conditions of use; if this possibility exists they shall evaluate the degree of short-term and long-term risk to be expected for aquatic organisms after use of the plant protection product according to the proposed conditions of use. (a) This evaluation will take into consideration the following information: (i) the specific information relating to the effects on aquatic organisms as provided for in Schedule II and the results of the evaluation thereof; (ii) other relevant information on the active substance such as: — solubility in water, — octanol/water partition coefficient, — vapour pressure, — volatilization rate, — KOC, — biodegradation in aquatic systems and in particular the ready biodegradability, — photodegradation rate and identity of breakdown products, — hydrolysis rate in relation to pH and identity of breakdown products; (iii) all relevant information on the plant protection product as provided for in Schedule III and in particular the effects on aquatic organisms; (iv) where relevant, other authorized uses of plant protection products in the area of envisaged use, containing the same active substance or which give rise to the same residues; (b) This evaluation will include: (i) the fate and distribution of residues of the active substance and of relevant metabolites, breakdown and reaction products in water, sediment or fish; (ii) a calculation of the acute toxicity/exposure ratio for fish and Daphnia. This ratio is defined as the quotient of respectively acute LC50or EC50and the predicted short-term environmental concentration; (iii) a calculation of the algal growth inhibition/exposure ratio for algae. This ratio is defined as the quotient of the EC50and the predicted short-term environmental concentration; (iv) a calculation of the long-term toxicity/exposure ratio for fish and Daphnia. The long-term toxicity/exposure ratio is defined as the quotient of the NOEC and the predicted long-term environmental concentration; (v) where relevant, the bioconcentration in fish and possible exposure of predators of fish, including humans; (vi) if the plant protection product is to be applied directly to surface water, the effect on the change of surface water quality, such as pH or dissolved oxygen content. 2.5.2.3. The director shall evaluate the possibility of exposure of honeybees to the plant protection product under the proposed conditions of use; if this possibility exists they shall evaluate the short-term and long-term risk to be exptected for honeybees after use of the plant protection product according to the proposed conditions of use. (a) This evaluation will take into consideration the following information: (i) the specific information on toxicity to honeybees as provided for in Schedule II and the results of the evaluation thereof; (ii) other relevant information on the active substance such as: — solubility in water, — octanol/water partition coefficient, — vapour pressure, — photodegradation rate and identity of breakdown products, — mode of action (e. g. insect growth regulating activity); (iii) all relevant information on the plant protection product as provided for in Schedule III, including the toxicity to honeybees; (iv) where relevant, other authorized uses of plant protection products in the area of envisaged use, containing the same active substance or which give rise to the same residues; (b) This evaluation will include: (i) the ratio between the maximum application rate expressed in grammes of active substance per hectare and the contact and oral LD50 expressed in µg of active substance per bee (hazard quotients) and where necessary the persistence of residues on or, where relevant, in the treated plants; (ii) where relevant, the effects on honeybee larvae, honeybee behaviour, colony survival and development after use of the plant protection product according to the proposed conditions of use. 2.5.2.4. The director shall evaluate the possibility of exposure of bene ficial arthropods other than honeybees to the plant protection product under the proposed conditions of use; if this possibility exists they will assess the lethal and sublethal effects on these organisms to be expected and the reduction in their activity after use of the plant protection product according to the proposed conditions of use. This evaluation will take into consideration the following infor mation: (i) the specific information on toxicity to honeybees and other beneficial arthropods as provided for in Schedule II and the results of the evaluation thereof; (ii) other relevant information on the active substance such as: — solubility in water, — octanol/water partition coefficient, — vapour pressure, — photodegradation rate and identity of breakdown products, — mode of action (e. g. insect growth regulating activity); (iii) all relevant information on the plant protection product as provided for in Schedule III such as: — effects on beneficial arthropods other than bees, — toxicity to honeybees, — available data from biological primary screening, — maximum application rate, — maximum number and timetable of applications; (iv) where relevant, other authorized uses of plant protection products in the area of envisaged use, containing the same active substance or which give rise to the same residues. 2.5.2.5. Member States shall evaluate the possibility of exposure of earthworms and other non-target soil macro-organisms to the plant protection product under the proposed conditions of use; if this possibility exists they shall evaluate the degree of short-term and long-term risk to be expected to these organisms after use of the plant protection product according to the proposed conditions of use. (a) This evaluation will take into consideration the following information: (i) the specific information relating to the toxicity of the active substance to earthworms and to other non-target soil macro-organisms as provided for in Schedule II and the results of the evaluation thereof; (ii) other relevant information on the active substance such as: — solubility in water, — octanol/water partition coefficient, — Kd for adsorption, — vapour pressure, — hydrolysis rate in relation to pH and identity of breakdown products, — photodegradation rate and identity of breakdown products, — DT50and DT90for degradation in the soil; (iii) all relevant information on the plant protection product as provided for in Schedule III, including the effects on earthworms and other non-target soil macro-organisms; (iv) where relevant, other authorized uses of plant protection products in the area of envisaged use, containing the same active substance or which give rise to the same residues; (b) This evaluation will include: (i) the lethal and sublethal effects, (ii) the predicted initial and long-term environmental concentration, (iii) a calculation of the actue toxicity/exposure ratio (defined as the quotient of LC50and predicted initial environmen-tal concentration) and of the long-term toxicity/exposure ratio (defined as the quotient of the NOEC and predicted long-term environmental concentration), (iv) where relevant, the bioconcentration and persistence of residues in earthworms. 2.5.2.6. The director shall, where the evaluation carried out under Part B, point 2.5.1.1, does not exclude the possibility of the plant protection product reaching the soil under the proposed conditions of use, evaluate the impact on microbial activity such as the impact on nitrogen and carbon mineralization processes in the soil after use of the plant protection product according to the proposed conditions of use. This evaluation will take into consideration the following infor mation: (i) all relevant information on the active substance, including the specific information relating to the effects of non-target soil micro-organisms as provided for in Schedule II and the results of the evaluation thereof; (ii) all relevant information on the plant protection product as provided for in Schedule III, including the effects on non-target soil micro-organisms; (iii) where relevant, other authorized uses of plant protection products in the area of proposed use, containing the same active substance or which give rise to the same residues; (iv) all available information from biological primary screening. 2.6. Analytical methods The director shall evaluate the analytical methods proposed for post-registration control and monitoring purposes, to determine: 2.6.1. f o r f o r m u l a t i o n a n a l y s i s : the nature and quantity of the active substance(s) in the plant protection product and, where appropriate, any toxicologically, ecotoxicologically or environmentally significant impurities and co-formulants. This evaluation will take into consideration the following infor mation: (i) the data on analytical methods as provided for in Schedule II and the results of the evaluation thereof; (ii) the data on analytical methods as provided for in Schedule III and in particular: — the specificity and linearity of the proposed methods, — the importance of interferences, — the precision of the proposed methods (intra-laboratory repeatability and inter-laboratory reproducibility); (iii) the limit of detection and determination of the proposed methods for impurities. 2.6.2. f o r r e s i d u e a n a l y s i s : the residues of the active substance, metabolites, breakdown or reaction products resulting from authorized uses of the plant protection product and which are of toxicological, ecotoxico logical or environmental significance. This evaluation will take into consideration the following infor mation: (i) the data on analytical methods as provided for in Schedule II and the results of the evaluation thereof; (ii) the data on analytical methods as provided for in Schedule III and in particular: — the specificity of the proposed methods, — the precision of the proposed methods (intra-laboratory repeatability and inter-laboratory reproducibility), — the recovery rate of the proposed methods at appropriate concentrations; (iii) the limit of detection of the proposed methods; (iv) the limit of determination of the proposed methods. 2.7. Physical and chemical properties 2.7.1. The director shall evaluate the actual active substance content of the plant protection product and its stability during storage. 2.7.2. The director shall evaluate the physical and chemical prop erties of the plant protection product and in particular: —where a suitable FAO specification exists, the physical and chemical properties addressed in that specification, —where no suitable FAO specification exists, all the relevant physical and chemical properties for the formulation as referred to in the‘Manual on the development and use of FAO specifications for plant protection products’. This evaluation will take into consideration the following infor mation: (i) the data on the physical and chemical properties of the active substance as provided for in Schedule II and the results of the evaluation thereof; (ii) the data on the physical and chemical properties of the plant protection product as provided for in Schedule III. 2.7.3. Where proposed label claims include requirements or recommen dations for use of the plant protection product with other plant protection products or adjuvants as a tank mix, the physical and chemical compatibility of the products in the mixture must be evaluated. C. DECISION-MAKING 1. General principles 1. Where appropriate, The director shall impose conditions or restrictions with the authorizations they grant. The nature and severity of these measures must be selected on the basis of, and be appropriate to, the nature and extent of the expected advantages and the risks likely to arise. 2. The director shall ensure that, where necessary, decisions taken with respect to the granting of authorizations take account of the agricultural, plant health or environmental (including climatic) conditions in the areas of envisaged use. Such considerations may result in specific conditions and restrictions of use, and, where necessary, in authorization being granted for some but not other areas within the Member State in question. 3. The director shall ensure that the authorized amounts, in terms of rates and number of applications, are the minimum necessary to achieve the desired effect even where higher amounts would not result in unacceptable risks to human or animal health or to the environment. The authorized amounts must be differentiated according to, and be appro-priate to, the agricultural, plant health or environmental (including climatic) conditions in the various areas for which an authorization is granted. However, the rates and the number of applications may not give rise to undesirable effects such as the development of resistance. 4. The director shall ensure that decisions respect the prin-ciples of integrated control if the product is intended to be used in conditions where these principles are relied on. 5. Since the evaluation is to be based on data concerning a limited number of representative species, The director shall ensure that use of plant protection products does not have any long-term repercussions for the abundance and diversity of non-target species. 6. Before issuing an authorization, The director shall ensure that the label of the product: —fulfils the requirements of regulation 16 of these regulations, —also contains the information on protection of users required by Community legislation on worker protection, —specifies in particular the conditions or restrictions under which the plant protection product shall or shall not be used as referred to in points 1, 2, 3, 4 and 5 above. The authorization shall mention the particulars indicated in Article 6 (2) (g) and (h), (3) and (4) of Council Directive 1999/45/EC of the European Parliament and of the Council of 31 May 1999 concerning the approximation of the laws, regulations and administrative provisions of the Member States relating to the classification, packaging and labelling of dangerous preparations (pesticides) and in Article 16 (g) and (h) of Directive 91/414/EEC. 7. Before issuing authorizations, The director shall: (a) ensure that the proposed packaging is in accordance with the provisions of Directive 99/45/EEC; (b) ensure that: — the procedures for destruction of the plant protection product, — the procedures for neutralization of the adverse effects of the product if it is accidentally dispersed, and — the procedures for the decontamination and destruction of the packagings, are in accordance with the relevant regulatory provisions. 8. No authorization shall be granted unless all the requirements referred to in Section 2 are satisfied. However: (a) when one or more of the specific decision-making requirements referred to in Part C, points 2.1, 2.2, 2.3 or 2.7, are not fully satisfied, authorizations shall be granted only where the advantages of the use of the plant protection product under the proposed conditions of use outweight the possible adverse effects of its use. Any restrictions on use of the product relating to non-compliance with some of the afore mentioned requirements must be mentioned on the label, and non compliance with the requirements referred to in point 2.7 must not compromise proper use of the product. These advantages can be in terms of: — advantages for and compatibility with integrated control measures or organic farming, — facilitating strategies to minimize the risk of devel-opment of resistance, — the need for a greater diversity of types of active substances or Biochemical modes of action, e.g. for use in strategies to avoid accelerated breakdown in the soil, — reduced risk for operators and consumers, — reduced contamination of the environment and reduced impact on non-target species; (b) where the criteria referred to in Part C, point 2.6, are not fully satisfied because of limitations in current analytical science and technology, authorization shall be granted for a limited period if the methods submitted prove adequate for the purposes intended. In this case the applicant shall be given a time limit in which to develop and submit analytical methods that are in accordance with the criteria referred to above. The authorization will be reviewed on expiry of the time limit accorded to the applicant; (c) where the reproducibility of the submitted analytical methods referred to in Part C, point 2.6, has only been verified in two laboratories, an authorization shall be granted for one year to permit the applicant to demon-strate the reproducibility of those methods in accordance with agreed criteria. 9. Where an authorization has been granted according to the requirements provided for in this Schedule, the Director may, by virtue of regulation 4 (6): (a) define, where possible, preferably in close co-operation with the applicant, measures to improve the performance of the plant protection product, and/or (b) define, where possible, in close co-operation with the applicant, measures to reduce further the exposure that could occur during and after use of the plant protection product. The director shall inform applicants of any measures identified under (a) or (b) and shall invite applicants to provide any supplementary data and information necessary to demonstrate peformance or potential risks arising under the changed conditions. 2. Specific principles The specific principles shall apply without prejudice to the general principles referred to in Section 1. 2.1. Efficacy 2.1.1. Where the proposed uses include recommendations for the control of or protection against organisms which are not considered to be harmful on the basis of experience acquired or scientific evidence under normal agricultural, plant health and environmental (including climatic) conditions in the areas of proposed use or where the other intended effects are not considered to be beneficial under those conditions, no authori zation shall be granted for those uses. 2.1.2. The level, consistency and duration of control or protection or other intended effects must be similar to those resulting from the use of suitable reference products. If no suitable reference product exists, the plant protection product must be shown to give a defined benefit in terms of the level, consistency and duration of control or protection or other intended effects under the agricultural, plant health and environmental (including climatic) conditions in the area of proposed use. 2.1.3. Where relevant, yield response when the product is used and reduction of loss in storage must be quantitatively and/or quali tatively similar to those resulting from the use of suitable reference products. If no suitable reference product exists, the plant protection product must be shown to give a consistent and defined quantitative and/or qualitative benefit in terms of yield response and reduction of loss in storage under the agri-cultural, plant health and environmental (including climatic) conditions in the area of proposed use. 2.1.4. Conclusions as to the performance of the preparation must be valid for all areas of the Member State in which it is to be authorized, and must hold for all conditions under which its use is proposed, except where the proposed label specifies that the preparation is intended for use in certain specified circum-stances (e.g. light infestations, particular soil types or particular growing conditions). 2.1.5. Where proposed label claims include requirements for use of the preparation with other specified plant protection products or adjuvants as a tank mix, the mixture must achieve the desired effect and comply with the principles referred to in points 2.1.1 to 2.1.4. Where proposed label claims include recommendations for use of the preparation with specified plant protection products or adjuvants as a tank mix, The director shall not accept the recommendations unless they are justified. 2.2. Absence of unacceptable effects on plants or plant products 2.2.1. There must be no relevant phytotoxic effects on treated plants or plant products except where the proposed label indicates appro priate limitations of use. 2.2.2. There must be no reduction of yield at harvest due to phytotoxic effects below that which could be obtained without the use of the plant protection product, unless this reduction is compensated for by other advantages such as an enhancement of the quality of the treated plants or plant products. 2.2.3. There must be no unacceptable adverse effects on the quality of treated plants or plant products, except in the case of adverse effects on processing where proposed label claims specify that the preparation should not be applied to crops to be used for processing purposes. 2.2.4. There must be no unacceptable adverse effects on treated plants or plant products used for propagation or reproduction, such as effects on viability, germination, sprouting, rooting and estab lishment, except where proposed label claims specify that the preparation should not be applied to plants or plant products to be used for propagation or reproduction. 2.2.5. There must be no unacceptable impact on succeeding crops, except where proposed label claims specify that particular crops, which would be affected, should not be grown following the treated crop. 2.2.6. There must be no unacceptable impact on adjacent crops, except where proposed label claims specify that the preparation should not be applied when particular sensitive adjacent crops are present. 2.2.7. Where proposed label claims include requirements for use of the preparation with other plant protection products or adjuvants, as a tank mix, the mixture must comply with the principles referred to in points 2.2.1 to 2.2.6. 2.2.8. The proposed instructions for cleaning the application equipment must be both practical and effective so that they can be applied with ease so as to ensure the removal of residual traces of the plant protection product which could subsequently cause damage. 2.3. Impact on vertebrates to be controlled An authorization for a plant protection product intended to eliminate vertebrates shall be granted only when: —death is synchronous with the extinction of consciousness, or —death occurs immediately, or —vital functions are reduced gradually without signs of obvious suffering. For repellant products, the intended effect shall be obtained without unnecessary suffering and pain for the target animals. 2.4. Impact on human or animal health 2.4.1. a r i s i n g f r o m t h e p l a n t p r o t e c t i o n p r o d u c t 2.4.1.1. No authorization shall be granted if the extent of operator exposure in handling and using the plant protection product under the proposed conditions of use, including dose and appli cation method, exceeds the AOEL. Moreover, the conditions of the authorization shall be in compliance with the limit value established for the active substance and/or toxicologically relevant compound(s) of the product in accordance with Council Directive 98/24/EC of 7 April 1998 on the protection of the health and safety of workers from the risks related to chemical agents at work and in accordance with Directive 2004/37/EC of the European Parliament and of the Council of 29 April 2004 on the protection of workers from the risks related to exposure to carcinogens or mutagens at work (sixth special directive within the meaning of Article 16 (2) of Directive 89/39/EEC). 2.4.1.2. Where the proposed conditions of use require use of items of protective clothing and equipment, no authorization shall be granted unless those items are effective and in accordance with the relevant Community provisions and are readily obtainable by the user and unless it is feasible to use them under the circum stances of use of the plant protection product, taking into account climatic conditions in particular. 2.4.1.3. Plant protection products which because of particular properties or if mishandled or misused could lead to a high degree of risk must be subject to particular restrictions such as restrictions on the size of packaging, formulation type, distribution, use or manner of use. Moreover, plant protection products which are classified as very toxic shall not be authorized for use by non professional users. 2.4.1.4. Waiting and re-entry safety periods or other precautions must be such that the exposure of bystanders or workers exposed after the application of the plant protection product does not exceed the AOEL levels established for the active substance or toxicolo gically relevant compound(s) in the plant protection product nor any limit values established for those compounds in accordance with the Community provisions referred to in point 2.4.1.1. 2.4.1.5. Waiting and re-entry safety periods or other precautions must be established in such a way that no adverse impact on animals occurs. 2.4.1.6. Waiting and re-entry periods or other precautions to ensure that the AOEL levels and limit values are respected must be realistic; if necessary special precautionary measures must be prescribed. 2.4.2. a r i s i n g f r o m r e s i d u e s 2.4.2.1. Authorizations must ensure that residues occurring reflect the minimum quantities of the plant protection product necessary to achieve adequate control corresponding to good agricultural practice, applied in such a manner (including pre-harvest intervals or withholding periods or storage periods) that the residues at harvest, slaughter or after storage, as appropriate, are reduced to a minimum. 2.4.2.2. Where no Community maximum residue limit (MRL) or provisional MRL (at national or at Community level) exists, The director shall establish a provisional MRL in accordance with regulation 4 (1) (f) of these regulations; conclusions as to the levels fixed must be valid for all circumstances which could influence the residue levels in the crop such as timing of appli cation, application rate and frequency or manner of use. (*) A Community MRL will mean an MRL established pursuant to Regulation 396/2005. 2.4.2.3. Where the new circumstances under which the plant protection product is to be used do not correspond to those under which a provisional MRL (at national or at Community level) was estab lished previously, The director shall not grant an authorization for the plant protection product unless the applicant can provide evidence that its recommended use will not exceed that MRL or unless a new provisional MRL has been in accordance with regulation 4 (1) (f) of these regulations. 2.4.2.4. Where a Community MRL exists The director shall not grant an authorization for the plant protection product unless the applicant can provide evidence that its recommended use will not exceed that MRL, or unless a new Community MRL has been established in accordance with the procedure provided for in the relevant Community legislation. 2.4.2.5. In the cases referred to in points 2.4.2.2 and 2.4.2.3, each appli cation for an authorization must be accompanied by a risk assessment taking into account worst-case potential exposure of consumers in the Member State concerned on the basis of good agricultural practice. Taking into account all registered uses, the proposed use cannot be authorized if the best possible estimate of dietary exposure exceeds the ADI. 2.4.2.6. Where the nature of residues is affected during processing, a separate risk assessment shall need to be carried out under the conditions provided for in point 2.4.2.5. 2.4.2.7. Where the treated plants or plant products are intended to be fed to animals, residues occurring shall not have an adverse effect on animal health. 2.5. Influence on the environment 2.5.1. F a t e a n d d i s t r i b u t i o n i n t h e e n v i r o n m e n t 2.5.1.1. No authorization shall be granted if the active substance and, where they are of significance from the toxicological, ecotoxico logical or environmental point of view, metabolites and breakdown or reaction products, after use of the plant protection product under the proposed conditions of use: —during tests in the field, persist in soil for more than one year (i.e. DT90> 1 year and DT50> 3 months), or —during laboratory tests, form non-extractable residues in amounts exceeding 70 % of the initial dose after 100 days with a mineralization rate of less than 5 % in 100 days, unless it is scientifically demonstrated that under field conditions there is no accumulation in soil at such levels that unacceptable residues in succeeding crops occur and/or that unacceptable phytotoxic effects on succeeding crops occur and/or that there is an unacceptable impact on the environment, according to the relevant requirements provided for in points 2.5.1.2, 2.5.1.3, 2.5.1.4 and 2.5.2. 2.5.1.2. No authorization shall be granted if the concentration of the active substance or of relevant metabolites, degradation or reaction products in groundwater, may be expected to exceed, as a result of use of the plant protection product under the proposed conditions of use, the lower of the following limit values: (i) the maximum permissible concentration laid down by Council Directive 98/83/EC of 3 November 1998 on the quality of water intended for human consumption, or (ii) the maximum concentration laid down by the Commission when including the active substance in Schedule I, on the basis of appropriate data, in particular toxicological data, or, where that concentration has not been laid down, the concentration corresponding to one tenth of the ADI laid down when the active substance was included in Schedule I unless it is scientifically demonstrated that under relevant field conditions the lower concentration is not exceeded. 2.5.1.3. No authorization shall be granted if the concentration of the active substance or of relevant metabolites, breakdown or reaction products to be expected after use of the plant protection product under the proposed conditions of use in surface water: —exceeds, where the surface water in or from the area of envisaged use is intended for the abstraction of drinking water, the values fixed by Directive 2000/60/EC of the European Parliament and of the Council of 23 October 2000 establishing a framework for Community action in the field of water policy, or —has an impact deemed unacceptable on non-target species, including animals, according to the relevant requirements provided for in point 2.5.2. The proposed instructions for use of the plant protection product, including procedures for cleaning application equipment, must be such that the likelihood of accidental contamination of surface water is reduced to a minimum. 2.5.1.4. No authorization shall be granted if the airborne concentration of the active substance under the proposed conditions of use is such that either the AOEL or the limit values for operators, bystanders or workers as referred to in Part C, point 2.4.1, are exceeded. 2.5.2. I m p a c t o nnon-target species 2.5.2.1. Where there is a possibility of birds and other non-target terrestrial vertebrates being exposed, no authorization shall be granted if: —the acute and short-term toxicity/exposure ratio for birds and other non-target terrestrial vertebrates is less than 10 on the basis of LD50or the long-term toxicity/exposure ratio is less than 5, unless it is clearly established through an appropriate risk assessment that under field conditions no unacceptable impact occurs after use of the plant protection product according to the proposed conditions of use; —the bioconcentration factor (BCF, related to fat tissue) is greater than 1, unless it is clearly established through an appropriate risk assessment that under field conditions no unacceptable effects occur—directly or indirectly—after use of the plant protection product according to the proposed conditions of use. 2.5.2.2. Where there is a possibility of aquatic organisms being exposed, no authorization shall be granted if: —the toxicity/exposure ratio for fish and Daphnia is less than 100 for acute exposure and less than 10 for long-term exposure, or —the algal growth inhibition/exposure ratio is less than 10, or —the maximum bioconcentration factor (BCF) is greater than 1 000 for plant protection products containing active substances which are readily biodegradable or greater than 100 for those which are not readily biodegradable, unless it is clearly established through an appropriate risk assessment that under field conditions no unacceptable impact on the viability of exposed species (predators) occurs— directly or indirectly—after use of the plant protection product according to the proposed conditions of use. 2.5.2.3. Where there is a possibility of honeybees being exposed, no authorization shall be granted if the hazard quotients for oral or contact exposure of honeybees are greater than 50, unless it is clearly established through an appropriate risk assessment that under field conditions there are no unacceptable effects on honeybee larvae, honeybee behaviour, or colony survival and development after use of the plant protection product according to the proposed conditions of use. 2.5.2.4. Where there is a possibility of beneficial arthropods other than honeybees being exposed, no authorization shall be granted if more than 30 % of the test organisms are affected in lethal or sublethal laboratory tests conducted at the maximum proposed application rate, unless it is clearly established through an appro priate risk assessment that under field conditions there is no unacceptable impact on those organisms after use of the plant protection product according to the proposed conditions of use. Any claims for selectivity and proposals for use in integrated pest management systems shall be substantiated by appropriate data. 2.5.2.5. Where there is a possibility of earthworms being exposed, no authorization shall be granted if the acute toxicity/exposure ratio for earthworms is less than 10 or the long-term toxicity/ex posure ratio is less than 5, unless it is clearly established through an appropriate risk assessment that under field conditions earthworm populations are not at risk after use of the plant protection product according to the proposed conditions of use. 2.5.2.6. Where there is a possibility of non-target soil micro-organisms being exposed, no authorization shall be granted if the nitrogen or carbon mineralization processes in laboratory studies are affected by more than 25 % after 100 days, unless it is clearly established through an appropriate risk assessment that under field conditions there is no unacceptable impact on microbial activity after use of the plant protection product according to the proposed conditions of use, taking account of the ability of micro-organisms to multiply. 2.6. Analytical methods The methods proposed must reflect the state of the art. The following criteria must be met in order to permit validation of the analytical methods proposed for post-registration control and monitoring purposes: 2.6.1. f o r f o r m u l a t i o n a n a l y s i s : the method must be able to determine and to identify the active substance(s) and where appropriate any toxicologically, ecotoxi-cologically or environmentally significant impurities and co-formulants; 2.6.2. f o r r e s i d u e a n a l y s i s : (i) the method must be able to determine and confirm residues of toxicological, ecotoxicological or environmental signif icance; (ii) the mean recovery rates should be between 70 % and 110 % with a relative standard deviation of=20 %; (iii) the repeatability must be less than the following values for residues in foodstuffs: Residue level mg/kg Difference mg/kg Difference in % 0,01 0,1 1 > 1 0,005 0,025 0,125 50 25 12,5 12,5 Intermediate values are determined by interpolation from a log-log graph; (iv) the reproducibility must be less than the following values for residues in foodstuffs: Residue level mg/kg Difference mg/kg Difference in % 0,01 0,1 1 >1 0,01 0,05 0,25 100 50 25 25 Intermediate values are determined by interpolation from a log-log graph; (v) in the case of residue analysis in treated plants, plant products, foodstuffs, feedingstuffs or products of animal origin, except where the MRL or the proposed MRL is at the limit of determination, the sensitivity of the methods proposed must satisfy the following criteria: Limit of determination in relation to the proposed provisional or Community MRL: MRL (mg/kg) limit of determination >0,5 0,5 - 0,05 <0,05 0,1 0,1 - 0,02 LMR 0,5 2.7. Physical and chemical properties 2.7.1. Where an appropriate FAO specification exists, that specification must be met. 2.7.2. Where no appropriate FAO specification exists, the physical and chemical properties of the product must meet the following requirements (a) Chemical properties: Throughout the shelf-life period, the difference between the stated and the actual content of the active substance in the plant protection product must not exceed the following values: Declared content in g/kg or g/l at 20oC Tolerance up to 25 more than 25 up to 100 more than 100 up to 250 more than 250 up to 500 more than 500 ± 15 % homogeneous formulation ± 25 % non-homogeneous formulation ± 10 % ± 6 % ± 5 % ± 25 g/kg or ± 25 g/l (b) Physical properties: The plant protection product must fulfil the physical criteria (including storage stability) specified for the relevant formu lation type in the‘Manual on the development and use of FAO specifications for plant protection products’. 2.7.3. Where the proposed label claims include requirements or recom mendations for use of the preparation with other plant protection products or adjuvants as a tank mix and/or where the proposed label includes indications on the compatibility of the preparation with other plant protection products as a tank mix, those products or adjuvants must be physically and chemically compatible in the tank mix. PART II UNIFORM PRINCIPLES FOR EVALUATION AND AUTHORISATION OF PLANT PROTECTION PRODUCTS CONTAINING MICRO ORGANISMS CONTENTS A. INTRODUCTION B. EVALUATION 1. General principles 2. Specific principles 2.1. Identity 2.1.1.Identity of the micro-organism in the plant protection product 2.1.2.Identity of the plant protection product 2.2. Biological, physical, chemical and technical properties 2.2.1.Biological properties of the micro-organism in the plant protection product 2.2.2.Physical, chemical and technical properties of the plant protection product 2.3. Further information 2.3.1.Quality control of the production of the micro-organism in the plant protection product 2.3.2.Quality control of the plant protection product 2.4. Efficacy 2.5. Identification/detection and quantification methods 2.5.1.Analytical methods for the plant protection product 2.5.2.Analytical methods for the determination of residues 2.6. Impact on human and animal health 2.6.1.Effects on human or animal health arising from the plant protection product 2.6.2.Effects on human or animal health arising from residues 2.7. Fate and behaviour in the environment 2.8. Effects on and exposure of non-target organisms 2.9. Conclusions and proposals C. DECISION-MAKING 1. General principles 2. Specific principles 2.1. Identity 2.2. Biological and technical properties 2.3. Further information 2.4. Efficacy 2.5. Identification/detection and quantification methods 2.6. Impact on human and animal health 2.6.1. Effects on human or animal health arising from the plant protection product 2.6.2. Effects on human or animal health arising from residues 2.7. Fate and behaviour in the environment 2.8. Effects on non-target organisms A. INTRODUCTION 1. The principles developed in Part II of this Schedule aim to ensure that evaluations and decisions with regard to authorisation of plant protection products, provided they are microbial plant protection products, result in the implementation of the requirements of regulation 4(1)(b), (c), (d) and (e) of these regulations at a high level of protection of human and animal health and the environment. 2. In evaluating applications for granting authorisations Member States shall: (a) — ensure that dossiers on microbial plant protection products supplied are in accordance with the requirements of Schedule IIIB, at the latest at the time of finalisation of the evaluation for the purpose of decision-making, without prejudice, where relevant, to the provisions of regulation 13(1)(a), (4) and (6) of these regulations, — ensure that the data submitted are acceptable in terms of quantity, quality, consistency and reliability and sufficient to permit a proper evaluation of the dossier, — evaluate, where relevant, justifications submitted by the applicant for not supplying certain data; (b) take into account the Schedule IIB data concerning the active substance consisting of micro-organisms (including viruses) in the plant protection product, submitted for the purpose of inclusion of the micro-organism concerned in Schedule I, and the results of the evaluation of those data, without prejudice, where relevant, to the provisions of regulation 13(1)(b), (2), (3) and (6) of these regulations; (c) take into consideration other relevant technical or scientific information they can reasonably possess with regard to the performance of the plant protection product or to the poten tially adverse effects of the plant protection product, its components or its metabolites/toxins. 3. Where, in the specific principles on evaluation, reference is made to Schedule IIB data, this shall be understood as being the data referred to in point 2(b). 4. Where the data and information provided are sufficient to permit completion of the evaluation for one of the proposed uses, appli cations must be evaluated and a decision made for the proposed use. Taking account of justifications provided and with the benefit of any subsequent clarifications, The director shall reject appli cations for granting authorisations for which the data gaps are such that it is not possible to finalise the evaluation and to make a reliable decision for at least one of the proposed uses. 5. During the process of evaluation and decision-making, the Member State shall cooperate with the applicants in order to resolve any questions on the dossier quickly or to identify at an early stage any additional studies necessary for a proper evaluation of the dossier, or to amend any proposed conditions for the use of the plant protection product or to modify its nature or its composition in order to ensure full satisfaction of the requirements of this Schedule or of this Legal Notice. The director shall normally come to a reasoned decision within 12 months of receiving a technically complete dossier. A technically complete dossier is one that satisfies all the requirements of Schedule IIIB. 6. The judgements made by the competent authority during the evaluation and decision-making process must be based on scientific principles, preferably recognised at international level, and be made with the benefit of expert advice. 7. A microbial plant protection product may contain viable and non-viable micro-organisms (including viruses) and formulation substances. It may also contain relevant metabolites/toxins produced during growth, residues from the growth medium, and microbial contaminants. The micro-organism, relevant meta bolites/toxins and the plant protection product with residual growth medium and microbial contaminants present must all be evaluated. 8. The director must take into account those guidance documents taken note of in the Standing Committee on the Food Chain and Animal Health (SCFCAH). 9. For genetically modified micro-organisms, Directive 2001/18/EC of the European Parliament and of the Council of 12 March 2001 on the deliberate release into the environment of genetically modified organisms, must be taken into account. The evaluation completed in the framework of that Directive must be provided and taken into account. 10. Definitions and explanations of microbiological terms Antibiosis: A relationship between two or more species in which one species is actively harmed (as by the production of toxins by the harming species). Antigenic: Any substance that, as a result of coming in contact with appropriate cells, induces a state of sensitivity and/or immune responsiveness after a latent period (days to weeks) and which reacts in a demonstrable way with antibodies and/or immune cells of the sensitised subject in vivo or in vitro. Antimicrobial: Antimicrobial agents or antimicrobial(s) refer to naturally occurring, semi-synthetic or synthetic substances that exhibit antimicrobial activity (kill or inhibit the growth of micro organisms). The term Antimicrobial(s) includes: —antibiotics, which refer to substances produced by or derived from micro-organisms, and —anticoccidials, which refer to substances that are active against coccidia, single cell protozoan parasites. CFU: Colony-forming unit; one or more cells that grow to form a single visible colony. Colonisation: Proliferation and persistence of a micro-organism in an environment, such as on external (skin) or internal body surfaces (intestine, lungs). For colonisation, the micro-organism should at least persist for a longer period than expected in a specific organ. The population of micro-organisms may decline but at a slower rate than normal clearance; it may be a steady population or it may be a growing population. Colonisation can be related to harmless and functional micro-organisms as well as to pathogenic micro-organisms. The possible occurrence of effects is not indicated. Ecological niche: Unique environmental position occupied by a particular species, perceived in terms of actual physical space occupied and function performed within the community or ecosystem. Host: An animal (including humans) or plant that harbours or nourishes another organism (parasite). Host specificity: The range of different host-species that can be colonised by a microbial species or strain. A host-specific micro organism colonises or has adverse effects on one or only a small number of different host-species. A non-host-specific micro organism might colonise or might have adverse effects on a broad range of different host-species. Infection: The introduction or entry of a pathogenic micro organism into a susceptible host, whether or not it causes patho logical effects or disease. The organism must enter the body of the host, usually the cells, and be able to reproduce to form new infective units. Simply ingesting a pathogen does not imply infection. Infective: Capable of transmitting an infection. Infectivity: The characteristics of a micro-organism that allow it to infect a susceptible host. Invasion: The entry of a micro-organism into the host body (e.g. actual penetration of the integument, gut epithelial cells, etc.). ‘Primary invasiveness’is a property of pathogenic micro organisms. Multiplication: Ability of a micro-organism to reproduce and increase in numbers during an infection. Mycotoxin: A fungal toxin. Non-viable micro-organism: A micro-organism that is not capable of replication or of transferring genetic material. Non-viable residue: A residue that is not capable of replication or of transferring genetic material. Pathogenicity: The ability of a micro-organism to cause disease and/or inflict damage on the host. Many pathogens cause disease by a combination of (i) toxicity and invasiveness or (ii) toxicity and colonising ability. However, some invasive pathogens cause disease that results from an abnormal reaction of the host's defence system. Symbiosis: A type of interaction between organisms where one organism lives in intimate association with another, which is favourable for both organisms. Viable micro-organism: A micro-organism that is capable of replication or of transferring genetic material. Viable residue: A residue that is capable of replication or of transferring genetic material. Viroid: Any of a class of infectious agents consisting of a small strand of RNA not associated with any protein. The RNA does not code for proteins and is not translated; it is replicated by host cell enzymes. Viroids are known to cause several plant diseases. Virulence: Measurement of the degree of disease producing ability of a micro-organism as indicated by the severity of the disease produced. Measure of the dosage (inoculum size) required to cause a specific degree of pathogenicity. It is measured experimentally by the median lethal dose (LD50)or median infective dose (ID50). B. EVALUATION The objective of an evaluation is to identify and assess, on a scientific basis and until further experience is reached on a case-by-case basis, potential adverse effects on human and animal health and the environment of the use of a microbial plant protection product. The evaluation shall also be carried out in order to identify the need for risk management measures and to identify and recommend suitable measures. Due to the ability of micro-organisms to replicate, there is a clear difference between chemicals and micro-organisms used as plant protection products. Hazards arising are not necessarily of the same nature as those presented by chemicals, especially in relation to the capacity of micro-organisms to persist and multiply in different envir onments. Moreover, micro-organisms consist of a wide range of different organisms, all with their own unique characteristics. These differences between micro-organisms should be taken into account in the evaluation. The micro-organism in the plant protection product should ideally function as a cell factory working directly on the spot where the target organism is harmful. Thus understanding the mode of action is a crucial step in the evaluation process. Micro-organisms may produce a range of different metabolites (e.g. bacterial toxins or mycotoxins) many of which may have toxicological significance, and one or more of which may be involved in the mode of action of the plant protection product. The characterisation and identifi cation of relevant metabolites should be assessed and the toxicity of these metabolites should be addressed. Information on production and/or relevance of metabolites may be deduced from: (a) toxicity studies, (b) biological properties of the micro-organism, (c) relationship to known plant, animal or human pathogens, (d) mode of action, (e) analytical methods. On the basis of this information, metabolites may be considered as possibly being relevant. Therefore potential exposure to these metabolites should be assessed, in order to decide on their relevance. 1. General principles 1.1. Having regard to current scientific and technical knowledge, The director shall evaluate the information provided in accordance with the requirements of Schedule IIB and IIIB and in particular: (a) identify the hazards arising, assess their significance and make a judgement as to the likely risks to humans, animals or the environment; and (b) assess the performance in terms of efficacy and phytotoxici ty/pathogenicity of the plant protection product for each use for which authorisation is sought. 1.2. The quality/methodology of tests, where there are no standardised test methods, must be evaluated and the following characteristics, when available, of the methods described must be assessed: relevance; representativeness; sensitivity; specificity; reproduci bility; interlaboratory validations; predictiveness. 1.3. In interpreting the results of evaluations, The director shall take into consideration possible elements of uncertainty in the information obtained during the evaluation, in order to ensure that the chances of failing to detect adverse effects or of under estimating their importance are reduced to a minimum. The decision-making process shall be examined to identify critical decision points or items of data for which uncertainties could lead to a false classification of risk. The first evaluation made shall be based on the best available data or estimates reflecting the realistic conditions of use of the plant protection product. This must be followed by a repeat evaluation, taking account of potential uncertainties in the critical data and of a range of use conditions that are likely to occur and resulting in a realistic worst-case approach, to determine whether it is possible that the initial evaluation could have been significantly different. 1.4. The director shall evaluate each microbial plant protection product for which an application for authorisation is made in that Member State—the information evaluated for the micro organism can be taken into account. The director must take into account the fact that any co-formulants might have an impact on the characteristics of the plant protection product compared to the micro-organism. 1.5. In evaluating applications and granting authorisations Member States shall consider the proposed practical conditions of use and in particular the purpose of use, the dose, the manner, frequency and timing of applications, and the nature and compo-sition of the plant protection product. Whenever possible The director shall also take into account the principles of integrated pest control. 1.6. In the evaluation, The director shall consider the agricultural, plant health or environmental (including climatic) conditions in the areas of use. 1.7. Where specific principles in Section 2 provide for the use of calculation models in the evaluation of a plant protection product, those models shall: (a) make a best possible estimation of all relevant processes involved taking into account realistic parameters and assumptions, (b) be submitted to an evaluation as referred to in point 1.3., (c) be reliably validated with measurements carried out under circumstances relevant for the use of the model, (d) be relevant to the conditions in the area of use, (e) be supported with details indicating how the model calculates estimates provided, and explanations of all the inputs to the model and details of how they have been derived. 1.8. The data requirements, specified in Schedule IIB and IIIB, contain guidance as to when and how certain information must be submitted and as to procedures that must be followed when preparing and evaluating a dossier. That guidance must be respected. 2. Specific principles The director shall implement the following principles in the evaluation of the data and information submitted in support of applications, without prejudice to the general principles prescribed in Section 1: 2.1. Identity 2.1.1. I d e n t i t y o f t h e m i c r o - o r g a n i s m i n t h e p l a n t protection product The identity of the micro-organism should be clearly established. It must be ensured that the appropriate data are provided to allow for checking the identity of the micro-organism at strain level in the plant protection product. The identity of the micro-organism shall be evaluated on the strain level. Where the micro-organism is either a mutant or a genetically modified organism (1), the specific differences from other strains within the same species must be recorded. Occurrence of resting stages must be recorded. The deposition of the strain at an internationally recognised culture collection must be checked. (1) See definition of‘genetically modified’in Directive 2001/18/EC. 2.1.2. I d e n t i t y o f t h e p l a n t p r o t e c t i o n p r o d u c t The director shall evaluate the detailed quantitative and quali-tative information provided on the composition of the plant protection product, such as that concerning the micro-organism (see above), relevant metabolites/toxins, residual growth medium, co formulants and microbial contaminants present. 2.2. Biological, physical, chemical, and technical properties 2.2.1. B i o l o g i c a l p r o p e r t i e s o f t h e m i c r o - o r g a n i s m in the plant protection product 2.2.1.1. The origin of the strain, where relevant, its natural habitat including indications on the natural background level, life cycle and the possibilities for survival, colonisation, reproduction and dispersal must be evaluated. Proliferation of indigenous micro organisms should after a short growth period level off and continue as for the background micro-organisms. 2.2.1.2. The ability of micro-organisms to adapt to the environment must be evaluated. In particular, The director must take account of the following principles: (a) depending on the conditions (e.g. availability of substrates for growth and metabolism) micro-organisms can switch on or off the expression of given phenotypic traits; (b) the microbial strains most adapted to the environment can survive and multiply better than the non-adapted strains. Adapted strains have a selective advantage and can form the majority within a population after a number of generations; (c) the relatively rapid multiplication of micro-organisms leads to a higher frequency of mutations. If a mutation is promoting survival in the environment, the mutant strain can become dominant; (d) the properties of viruses, in particular, can change rapidly, including their virulence. Therefore, where appropriate, information on the genetic stability of the micro-organism under the environmental conditions of proposed use must be evaluated, as well as information on the micro-organism's capacity to transfer genetic material to other organisms and information on the stability of encoded traits. 2.2.1.3. The mode of action of the micro-organism should be evaluated in as much detail as appropriate. The possible role of metabolites/ toxins for the mode of action should be evaluated and when identified, the minimal effective concentration for each active metabolite/toxin should be established. Information on mode of action can be a very valuable tool in identifying potential risks. Aspects to be considered in the evaluation, are: (a) antibiosis, (b) induction of plant resistance, (c) interference with the virulence of a pathogenic target organism, (d) endophytic growth, (e) root colonisation, (f) competition of ecological niche (e.g. nutrients, habitats), (g) parasitisation, (h) invertebrate pathogenicity. 2.2.1.4. In order to evaluate possible effects on non-target organisms, information on the micro-organism's host specificity must be evaluated, taking into account the characteristics and properties described in (a) and (b). (a) The ability of a micro-organism to be pathogenic for non target organisms (humans, animals, and other non-target organisms) must be assessed. Any relationship to known plant, animal or human pathogens that are species of the genus of the active and/or contaminating micro-organisms must be assessed. (b) Pathogenicity as well as virulence is strongly related to the host-species (e.g. determined by body temperature, physio logical environment) and to the host conditions (e.g. health condition, immune status). For example, multiplication in humans depends upon the ability of the micro-organism to grow at the body temperature of the host. Some micro organisms can only grow and be metabolically active at temperatures far below or above human body temperature, and therefore can not be pathogenic for humans. However, the route of entry of the micro-organism into the host (oral, inhalation, skin/wound) can also be the critical factor. For example, a microbial species may cause a disease following entry via skin damage, but not via the oral route. 2.2.1.5. Many micro-organisms produce antibiosis substances that cause normal interferences in the microbial community. Resistance to antimicrobial agents of importance for human and veterinary medicine must be assessed. The possibility for transfer of genes that code for resistance to antimicrobial agents must be evaluated. 2.2.2. P h y s i c a l , c h e m i c a l a n d t e c h n i c a l p r o p e r t i e s o f the plant protection product 2.2.2.1. Depending on the nature of the micro-organism and the formu lation type, the technical properties of the plant protection product must be evaluated. 2.2.2.2. Shelf-life and storage stability of the preparation must be evaluated, taking into account possible changes in composition such as growth of the micro-organism or of contaminating micro-organisms, production of metabolites/toxins, etc. 2.2.2.3. The director shall evaluate the physical and chemical prop erties of the plant protection product and the retention of these characteristics after storage and take into consideration: (a) where a suitable Food and Agriculture Organisation of the United Nations (FAO) specification exists, the physical and chemical properties addressed in that specification, (b) where no suitable FAO specification exists, all relevant physical and chemical properties for the formulation referred to in the Manual on the development and use of FAO and World Health Organisation (WHO) specifications for pesticides. 2.2.2.4. Where the proposed label claims include requirements or recom mendations for use of the preparation with other plant protection products or adjuvants as a tank mix, and/or where the proposed label includes indications concerning the compatibility of the preparation with other plant protection products as a tank mix, those plant protection products or adjuvants must be physically and chemically compatible in the tank mix. Biological compati bility must also be demonstrated for tank-mixtures, i.e. it must be shown that each plant protection product in the mixture performs as expected and that no antagonism occurs. 2.3. Further information 2.3.1. Quality control of the production of the micro-organism in the plant protection product The quality assurance criteria proposed for production of the micro-organism must be evaluated. In the evaluation criteria relating to process control, good manufacturing practice, opera tional practices, process flows, cleaning practices, microbial monitoring and hygiene conditions should be taken into account to ensure good quality of the micro-organism. The quality, stability, purity etc., of the micro-organism must be addressed in the quality control system. 2.3.2. Quality control of the plant protection product The quality assurance criteria proposed must be evaluated. If the plant protection product contains metabolites/toxins produced during growth and residues from the growth medium this should be evaluated. The possibility of the occurrence of contam-inating micro-organisms must be evaluated. 2.4. Efficacy 2.4.1. Where the proposed use concerns the control of or protection against an organism, The director shall evaluate the possibility that this organism could be harmful under the agricultural, plant health and environmental (including climatic) conditions in the area of the proposed use. 2.4.2. The director shall evaluate whether significant damage, loss or inconvenience could occur under the agricultural, plant health and environmental (including climatic) conditions in the area of proposed use if the plant protection product were not used. 2.4.3. The director shall evaluate the efficacy data provided for in Schedule IIIB on the plant protection product having regard to the degree of control or the extent of the effect desired and having regard to relevant experimental conditions such as: (a) the choice of the crop or cultivar, (b) the agricultural and environmental (including climatic) conditions (if necessary for acceptable efficacy such data/in formation should also be given for the time before and after application), (c) the presence and density of the harmful organism, (d) the development stage of crop and organism, (e) the amount of the microbial plant protection product used, (f) if required on the label, the amount of adjuvant added, (g) the frequency and timing of the applications, (h) the type of application equipment, (i) the need for any special cleaning measures for the application equipment. 2.4.4. The director shall evaluate the performance of the plant protection product under the range of agricultural, plant health and environmental (including climatic) conditions likely to be encountered in practice in the area of proposed use. The effect on integrated control must be included in the evaluation. In particular, consideration should be paid to: (a) the level, consistency and duration of the effect sought in relation to the dose in comparison with a suitable reference product or products, where they exist, and an untreated control; (b) where relevant, the effect on yield or reduction of loss in storage, in terms of quantity and/or quality, in comparison with a suitable reference product or products, where they exist, and an untreated control. Where no suitable reference product exists, The director shall evaluate the performance of the plant protection product to determine whether there is a consistent and defined benefit under the agricultural, plant health and environmental (including climatic) conditions likely to be encountered in practice in the area of proposed use. 2.4.5. The director shall evaluate the degree of adverse effects on the treated crop after use of the plant protection product according to the proposed conditions of use in comparison, where relevant, with a suitable reference product or products, where they exist, and/or an untreated control. (a) This evaluation will take into consideration the following information: (i) efficacy data; (ii) other relevant information on the plant protection product such as nature of the plant protection product, dose, method of application, number and timing of applications, incompatibility with other crop treatments; (iii) all relevant information on the micro-organism, including biological properties e.g. mode of action, survival, host specificity. (b) This evaluation will include: (i) the nature, frequency, level and duration of observed phytotoxic/ phytopathogenic effects and the agricultural, plant health and environmental (including climatic) conditions that affect them; (ii) differences between main cultivars with regard to their sensitivity to phytotoxic/phytopathogenic effects; (iii) the part of the treated crop or plant products where phytotoxic/phytopathogenic effects are observed; (iv) adverse impact on the yield of the treated crop or plant products in terms of quantity and/or quality; (v) adverse impact on treated plants or plant products to be used for propagation, in terms of viability, germination, sprouting, rooting and establishment; (vi) where micro-organisms are disseminated, the adverse impact on adjacent crops. 2.4.6. Where the plant protection product label includes requirements for use of the plant protection product with other plant protection products and/or with adjuvants as a tank mix, The director shall make the evaluations referred to in points 2.4.3 to 2.4.5 in relation to the information supplied for the tank mix. Where the plant protection product label includes recommen dations for use of the plant protection product with other plant protection products and/or with adjuvants as a tank mix, the director shall evaluate the appropriateness of the mix and of its conditions of use. 2.4.7. Where the available data indicate that the micro-organism or significant relevant metabolites/toxins, degradation and reaction products of the formulants persist in soils and/or in or on plant substances in significant quantities after use of the plant protection product according to the proposed conditions of use, the director shall evaluate the degree of adverse effects on subsequent crops. 2.4.8. Where the proposed use of a plant protection product is intended to have an effect on vertebrates, The director shall evaluate the mechanism by which this effect is obtained and the observed effects on the behaviour and health of the target animals. When the intended effect is to kill the target animal they shall evaluate the time necessary to obtain the death of the animal and the conditions under which death occurs. This evaluation will take into consideration the following infor mation: (a) all relevant information as provided for in Schedule IIB and the results of the evaluation thereof, including the toxicological studies; (b) all relevant information on the plant protection product as provided for in Schedule IIIB, including toxicological studies and efficacy data. 2.5. Identification/detection and quantification methods the director shall evaluate the analytical methods proposed for post registration control and monitoring purposes of the viable and non-viable components both in the formulation and as residues in or on treated crops. Sufficient validation is required for pre authorisation methods and post-authorisation monitoring methods. Methods that are considered suitable for post-authori sation monitoring must be clearly identified. 2.5.1. Analytical methods for the plant protection product 2.5.1.1. Non-viable components The director shall evaluate the analytical methods proposed to identify and quantify the toxicologically, ecotoxicologically or environmentally significant non-viable components resulting from the micro-organism and/or present as impurity or co formulant (including eventually resulting breakdown and/or reaction products thereof). This evaluation will take into consideration the information on analytical methods provided for in Schedule IIB and IIIB and the results of the evaluation thereof. In particular, the following information must be taken into account: (a) the specificity and linearity of the proposed methods, (b) the precision (repeatability) of the proposed methods, (c) the importance of interferences, (d) the accuracy of the proposed methods at appropriate concen trations, (e) the limit of quantification of the proposed methods. 2.5.1.2. Viable components The director shall evaluate the methods proposed to quantify and identify the specific strain concerned and especially methods that discriminate that strain from closely related strains. This evaluation will take into consideration the information on analytical methods provided for in Schedule IIB and IIIB and the results of the evaluation thereof. In particular, the following information must be taken into account: (a) the specificity of the proposed methods, (b) the precision (repeatability) of the proposed methods, (c) the importance of interferences, (d) the quantifiability of the proposed methods. 2.5.2. Analytical methods for the determination of residues 2.5.2.1. N o n - v i a b l e r e s i d u e s The director shall evaluate the analytical methods proposed to identify and quantify the toxicologically, ecotoxicologically or environmentally significant non-viable residues resulting from the micro-organism (including eventually resulting breakdown and/or reaction products thereof). This evaluation will take into consideration the information on analytical methods provided for in Schedule IIB and IIIB and the results of the evaluation thereof. In particular, the following information must be taken into account: (a) the specificity and linearity of the proposed methods, (b) the precision (repeatability) of the proposed methods, (c) the reproducibility (independent laboratory validation) of the proposed methods, (d) the importance of interferences, (e) the accuracy of the proposed methods at appropriate concen trations, (f) the limit of quantification of the proposed methods. 2.5.2.2. Viable residues The director shall evaluate the methods proposed to identify the specific strain concerned and especially methods that discri minate that strain from closely related strains. This evaluation will take into consideration the information on analytical methods provided for in Schedule IIB and IIIB and the results of the evaluation thereof. In particular, the following information must be taken into account: (a) the specificity of the proposed methods, (b) the precision (repeatability) of the proposed methods, (c) the importance of interferences, (d) the quantifiability of the proposed methods. 2.6. Impact on human or animal health The impact on human or animal health must be evaluated. In particular, The director must take account of the following principles: (a) due to the ability of micro-organisms to replicate, there is a clear difference between chemicals and micro-organisms used as plant protection products. Hazards arising are not neces-sarily of the same nature as those presented by chemicals, especially in relation to the capacity of micro organisms to persist and multiply in different environments; (b) the pathogenicity of the micro-organism to humans and non target animals, the infectiveness of the micro-organism, the ability of the micro-organism to colonise, the toxicity of metabolites/toxins as well as the toxicity of the residual growth medium, contaminants and co-formulants, are important endpoints in assessing adverse effects arising from the plant protection product; (c) colonisation, infectiveness and toxicity comprise a complex set of interactions between micro-organisms and hosts and these endpoints may not be resolved easily as independent endpoints; (d) in combining these endpoints, the most important aspects of the micro-organism that must be assessed are: —ability to persist and multiply in a host (indicative of colonisation or infectivity), —ability to produce non-adverse or adverse effects in a host, indicative of infectivity, pathogenicity, and/or toxicity; (e) moreover, the complexity of the biological issues should be taken into account in evaluating the hazards and risks presented by use of these plant protection products for human and animals. An assessment of pathogenicity and infectiveness is necessary even if the potential of exposure is deemed low; (f) for risk assessment purposes the acute toxicity studies used should, where available, include at least two doses (e.g. one very high dose and one corresponding to the expected exposure under practical conditions). 2.6.1. E f f e c t s o n h u m a n o r a n i m a l h e a l t h a r i s i n g from the plant protection product 2.6.1.1. The director shall evaluate operator exposure to the micro organism, and/or to toxicologically relevant compounds in the plant protection product (e.g. their metabolites/toxins, residual growth medium, contaminants and co-formulants), likely to occur under the proposed conditions of use (including in particular dose, application method and climatic conditions). Realistic data on exposure levels must be used and, if such data are not available, a suitable, validated calculation model. When available, a European harmonised generic exposure database for plant protection products should be used. (a) This evaluation will take into consideration the following information: (i) the medical data and the toxicity, infectivity and pathogenicity studies as provided for in Schedule IIB, and the results of the evaluation thereof. Tier 1 tests should permit an evaluation to be made of a micro-organism with respect to its ability to persist or grow in the host and its ability to cause effects/reactions in the host. Parameters that indicate the absence of ability to persist and multiply in the host, and the absence of ability to produce non-adverse or adverse effects in a host, include fast and complete clearance from the body, no activation of the immune system, no histo-pathological changes, and for replication temperatures far below or far above mammalian body temperatures. These parameters can in some cases be assessed using acute studies and existing human data, and sometimes can only be assessed using repeated dose studies. Evaluation based on relevant parameters of Tier 1 tests should lead to an assessment of the possible effects of occupational exposure, taking into account the intensity and duration of exposure including exposure due to repeated use during practical use. The toxicity of certain metabolites/toxins can only be assessed, if it has been demonstrated that the test animals are actually exposed to these metabolites/toxins; (ii) other relevant information on the micro-organism, the metabolites/toxins, residual growth medium, contaminants and co-formulants in the plant protection product, such as their biological, physical and chemical properties (e.g. survival of the micro-organism at the body temperature of humans and animals, ecological niche, behaviour of the micro-organism and/or metabo-lites/toxins during application); (iii) the toxicological studies provided for in Schedule IIIB; (iv) other relevant information provided for in Schedule IIIB such as: — composition of the preparation, — nature of the preparation, — size, design and type of packaging, — field of use and nature of the crop or target, — method of application including handling, loading and mixing of the plant protection product, — exposure reduction measures recommended, — protective clothing recommendations, — maximum application rate, — minimum spray application volume stated on the label, — number and timing of applications. (b) On the basis of the information mentioned in (a) the following overall end-points should be established for single or repeated operator exposure following the intended use: — persistence or growth of the micro-organism in the host, — adverse effects observed, — observed or expected effects of contaminants (including contaminating micro-organisms), — observed or expected effects of relevant metabolites/ toxins. If there are indications of colonisation in the host and/or if any adverse effects, indicative of toxicity/infectivity are observed, taking into account the exposure scenario (i.e. acute or repeated exposure), further testing is indicated. (c) This evaluation shall be made for each type of application method and application equipment proposed for use of the plant protection product as well as for the different types and sizes of containers to be used, taking into account mixing, loading operations, application of the plant protection product and cleaning and routine maintenance of application equipment. Where relevant, other authorised uses of the plant protection product in the area of envisaged use containing the same active substance or which give rise to the same residues may also be taken into account. It should be taken into account that if replication of the micro-organism is expected, exposure assessment could be highly speculative. (d) The absence or presence of the potential for colonisation or the possibility of effects in operators at the tested dose levels as provided for in Schedule IIB and IIIB should be assessed with regard to measured or estimated levels of human exposure. This risk assessment, preferably quantitative, should include consideration of e.g. mode of action, biological, physical and chemical properties of the micro organism and other substances in the formulation. 2.6.1.2. The director shall examine information relating to the nature and characteristics of the packaging proposed with particular reference to the following aspects: (a) the type of packaging, (b) its dimensions and capacity, (c) the size of the opening, (d) the type of closure, (e) its strength, leakproofness and resistance to normal transport and handling, (f) its resistance to and compatibility with the contents. 2.6.1.3. The director shall examine the nature and characteristics of the protective clothing and equipment proposed with particular reference to the following aspects: (a) obtainability and suitability, (b) effectiveness, (c) ease of wearing taking into account physical stress and climatic conditions, (d) resistance to and compatibility with the plant protection product. 2.6.1.4. The director shall evaluate the possibility of exposure of other humans (workers exposed after the application of the plant protection product, such as re-entering workers, or bystanders) or animals to the micro-organism and/or to other toxicologically relevant compounds in the plant protection product under the proposed conditions of use. This evaluation will take into consid eration the following information: (a) the medical data and the toxicity, infectivity and patho genicity studies provided for in Schedule IIB, and the results of the evaluation thereof. Tier 1 tests should permit an evaluation to be made of a micro-organism with respect to its ability to persist or grow in the host and its ability to cause effects/reactions in the host. Parameters that indicate the absence of ability to persist and multiply in the host, and the absence of ability to produce non-adverse or adverse effects in a host, include rapid and complete clearance from the body, no activation of the immune system, no histopathological changes, and inability to replicate at mammalian body temperatures. These parameters can in some cases be assessed using acute studies and existing human data, and sometimes can only be assessed using repeated dose studies. Evaluation based on relevant parameters of Tier 1 tests should lead to an assessment of the possible effects of occu pational exposure, taking into account the intensity and duration of exposure, including exposure due to repeated use during practical use. The toxicity of certain metabolites/toxins can only be assessed, if it has been demonstrated that the test animals are actually exposed to these metabolites/toxins; (b) other relevant information on the micro-organism, the meta bolites/toxins, residual growth medium, contaminants and co formulants in the plant protection product, such as their biological, physical and chemical properties (e.g. survival of the micro-organism at the body temperature of humans and animals, ecological niche, behaviour of the micro-organism and/or metabolites/toxins during application); (c) the toxicological studies provided for in Schedule IIIB; (d) other relevant information on the plant protection product as provided for in Schedule IIIB such as: —re-entry periods, necessary waiting periods or other precautions to protect humans and animals, —method of application, in particular spraying, —maximum application rate, —minimum spray application volume, —composition of the preparation, —excess remaining on plants and plant products after treatment, taking into account the influence of factors such as temperature, UV light, pH and the presence of certain substances, —further activities whereby workers are exposed. 2.6.2. E f f e c t s o n h u m a n o r a n i m a l h e a l t h a r i s i n g from residues In the evaluation, non-viable and viable residues must be addressed separately. Viruses and viroids should be considered as viable residues since they are capable of transferring genetic material, although strictly speaking they are not living. 2.6.2.1. N o n - v i a b l e r e s i d u e s (a) The director shall evaluate the possibility of exposure of humans or animals to non-viable residues and their degra dation products via the food chain due to the possible occurrence of such residues in or on edible parts of treated crops. In particular, the following information should be taken into account: —the stage of development of the micro-organism at which non-viable residues are produced, —the development stages/life cycle of the micro-organism under typical environmental conditions; in particular, attention shall be paid to the assessment of the like lihood of survival and multiplication of the micro organism in or on crops, food or feed, and, as a conse quence, the likelihood of the production of non-viable residues, —the stability of relevant non-viable residues (including the effects of factors such as temperature, UV light, pH and the presence of certain substances), —any experimental study showing whether or not relevant non-viable residues are translocated in plants, —data concerning the proposed good agricultural practice (including number and timing of applications, maximum application rate and minimum spray application volume, proposed pre-harvest intervals for envisaged uses, or with holding periods or storage periods, in the case of post-harvest uses) and additional data on application as provided for in Schedule IIIB, — where relevant, other authorised uses of plant protection products in the area of envisaged use, i.e. containing the same residues, and — the natural occurrence of non-viable residues on edible plant parts as a consequence of naturally occurring micro-organisms. (b) The director shall evaluate the toxicity of non-viable residues and their degradation products having regard in particular to the specific information provided in accordance with Schedule IIB and IIIB. (c) Where non-viable residues or their degradation products are considered toxicologically relevant for humans and/or animals and when exposure is not considered negligible, the actual levels in or on the edible parts of treated crops should be determined, taking into consideration: — analytical methods for the non-viable residues, — the growth curves of the micro-organism under optimal conditions, — the production/formation of non-viable residues at relevant moments (e.g. at the anticipated harvest time). 2.6.2.2. Viable residues (a) The director shall evaluate the possibility of exposure of humans or animals to viable residues via the food chain due to the possible occurrence of such residues in or on edible parts of treated crops. In particular, the following infor-mation should be taken into account: —the likelihood of survival, the persistence and multiplication of the micro-organism in or on crops, food or feed. The various development stages/life cycle of the micro organism should be addressed, —information concerning its ecological niche, —information on fate and behaviour in the various parts of the environment, —the natural occurrence of the micro-organism (and/or a related micro-organism), —data concerning the proposed good agricultural practice (including number and timing of applications, maximum application rate and minimum spray application volume, proposed pre-harvest intervals for envisaged uses, or withholding periods or storage periods in the case of post harvest uses) and additional data on application as provided for in Schedule IIIB, —where relevant, other authorised uses of plant protection products in the area of envisaged use, i.e. containing the same micro-organism or which result in the same residues. (b) The director shall evaluate the specific information concerning the ability of viable residues to persist or grow in the host and the ability of such residues to cause effects/reactions in the host. In particular, the following information should be taken into account: —the medical data and toxicity, infectivity and patho genicity studies provided for in Schedule IIB, and the results of the evaluation thereof, —the development stages/life cycle of the micro-organism under typical environmental conditions (e.g. in or on the treated crop), —the mode of action of the micro-organism, —the biological properties of the micro-organism (e.g. host specificity). The various development stages/life cycle of the micro organism should be addressed. (c) In the event that viable residues are considered to be toxi cologically relevant for humans and/or animals and if exposure is not considered negligible, the actual levels in or on the edible parts of treated crops should be determined, taking into consideration: — analytical methods for the viable residues, — the growth curves of the micro-organism under optimal conditions, — the possibilities of extrapolating data from one crop to another. 2.7. Fate and behaviour in the environment The biocomplexity of the ecosystems and interactions in the microbial communities concerned must be taken into account. Information on the origin and properties (e.g. specificity) of the micro-organism/its residual metabolites/toxins and its intended use forms the basis for an assessment of environmental fate and behaviour. The mode of action of the micro-organism should be taken into consideration. An assessment shall be made of the fate and behaviour of any known relevant metabolite that is produced by the micro organism. The assessment shall be made for each environmental compartment, and shall be triggered on the basis of the criteria specified in section 7 (iv) of Schedule IIB. In the assessment of the environmental fate and behaviour of plant protection products, The director shall have regard to all aspects of the environment, including biota. The potential for persistence and multiplication of micro-organisms has to be assessed in all environmental compartments unless it can be justified that particular micro-organisms will not reach a specific compartment. The mobility of micro-organisms and their residual metabolites/toxins must be considered. 2.7.1. The director shall evaluate the possibility of contamination of ground water, surface water and drinking water under the proposed conditions of use of the plant protection product. In the overall assessment, The director should pay particular attention to potential adverse effects on humans through groundwater contamination, when the active substance is applied in regions with vulnerable conditions, such as drinking water abstraction areas. 2.7.2. The director shall evaluate the risk for the aquatic compartment where the possibility of the exposure of aquatic organisms has been established. A micro-organism may give rise to risks because of its potential through multiplication to establish itself in the environment and can therefore have a long lasting or permanent impact on microbial communities or their predators. This evaluation will take into consideration the following infor mation: (a) the biological properties of the micro-organism, (b) the survival of the micro-organism in the environment, (c) its ecological niche, (d) the natural background level of the micro-organism, where it is indigenous, (e) information on fate and behaviour in the various parts of the environment, (f) where relevant, information on potential interference with analytical systems used for the control of the quality of drinking water as provided for in Council Directive 98/83/EC of 3 November 1998 on the quality of water intended for human consumption, (g) where relevant, other authorised uses of plant protection products in the area of envisaged use, e.g. containing the same active substance or which gives rise to the same residues. 2.7.3. The director shall evaluate the possibility of exposure of organisms in the atmosphere to the plant protection product under the proposed conditions of use; if this possibility exists they shall evaluate the risk for the atmosphere. The transport, short-range and long-range, of the micro-organism in the atmo-sphere should be taken into account. 2.7.4. The director shall evaluate the possibility of exposure of organisms in the terrestrial compartment to the plant protection product under the proposed conditions of use; if this possibility exists they shall evaluate the risks arising for the terrestrial compartment. A micro-organism may give rise to risks because of its potential through multiplication to establish itself in the environment and can therefore have a long-lasting or permanent impact on microbial communities or their predators. This evaluation will take into consideration the following infor mation: (a) the biological properties of the micro-organism, (b) the survival of the micro-organism in the environment, (c) its ecological niche, (d) the natural background level of the micro-organism, where it is indigenous, (e) information on fate and behaviour in the various parts of the environment, (f) where relevant, other authorised uses of plant protection products in the area of envisaged use, e.g. containing the same active substance or which gives rise to the same residues. 2.8. Effects on and exposure of non-target organisms Information on the ecology of the micro-organism and effects on the environment should be assessed as well as possible exposure levels and the effects of its relevant metabolites/toxins. An overall assessment of the environmental risks that the plant protection product may cause, taking into account the normal levels of exposure to micro-organisms both in the environment as well as in the body of organisms, is necessary. The director shall evaluate the possibility of exposure of non target organisms under the proposed conditions of use and if this possibility exists they shall evaluate the risks arising for the non target organisms concerned. Where applicable, an assessment of infectivity and pathogenicity is necessary, unless it can be justified that non-target organisms will not be exposed. To assess the possibility of exposure the following information should also be taken into consideration: (a) the survival of the micro-organism in the respective compartment, (b) its ecological niche, (c) the natural background level of the micro-organism, where it is indigenous, (d) information on fate and behaviour in the various parts of the environment, (e) where relevant, other authorised uses of the plant protection product in the area of envisaged use containing the same active substance or which give rise to the same residues. 2.8.1. M e m b e r S t a t e s s h a l l e v a l u a t e t h e p o s s i bility of exposure of and effects on terrestrial wildlife (non-domestic birds, mammals and other terrestrial vertebrates). 2.8.1.1. A micro-organism may give rise to risks because of its potential to infect and multiply in avian and mammalian host systems. Whether or not identified risks could be changed due to the formulation of the plant protection product shall be assessed, taking into account the following information on the micro organism: (a) its mode of action, (b) other biological properties, (c) studies on mammalian toxicity, pathogenicity and infectivity, (d) studies on avian toxicity, pathogenicity and infectivity. 2.8.1.2. A plant protection product may give rise to toxic effects due to the action of toxins or co-formulants. For the assessment of such effects, the following information should be taken into consid eration: (a) studies on mammalian toxicity, (b) studies on avian toxicity, (c) information on fate and behaviour in the various parts of the environment. If mortality or signs of intoxication are observed in the tests the evaluation must include a calculation of toxicity/exposure ratios based on the quotient of the LD50value and the estimated exposure expressed in mg/kg body weight. 2.8.2. M e m b e r S t a t e s s h a l l e v a l u a t e t h e p o s s i bility of exposure of and effects on aquatic organisms. 2.8.2.1. A micro-organism may give rise to risks because of its potential to infect and multiply in aquatic organisms. Whether or not identified risks could be changed due to the formulation of the plant protection product shall be assessed, taking into account the following information on the micro-organism: (a) its mode of action, (b) other biological properties, (c) studies on toxicity, pathogenicity and infectivity. 2.8.2.2. A plant protection product may give rise to toxic effects due to the action of toxins or co-formulants. For the assessment of such effects the following information should be taken into consid eration: (a) studies on toxicity to aquatic organisms, (b) information on fate and behaviour in the various parts of the environment. If mortality or signs of intoxication are observed in the tests the evaluation must include a calculation of toxicity/exposure ratios based on the quotient of the EC50value and/or the NOEC value and the estimated exposure. 2.8.3. M e m b e r S t a t e s s h a l l e v a l u a t e t h e p o s s i bility of exposure of and effects on bees. 2.8.3.1. A micro-organism may give rise to risks because of its potential to infect and multiply in bees. Whether or not identified risks could be changed due to the formulation of the plant protection product shall be assessed, taking into account the following infor-mation on the micro-organism: (a) its mode of action, (b) other biological properties, (c) studies on toxicity, pathogenicity and infectivity. 2.8.3.2. A plant protection product may give rise to toxic effects due to the action of toxins or co-formulants. For the assessment of such effects the following information should be taken into consid eration: (a) studies on toxicity to bees, (b) information on fate and behaviour in the various parts of the environment. If mortality or signs of intoxication are observed in the tests the evaluation must include a calculation of the hazard quotient, based on the quotient of the dose in g/ha and the LD50value inµg/bee. 2.8.4. M e m b e r S t a t e s s h a l l e v a l u a t e t h e p o s s i bility of exposure of and effects on arthropods other than bees. 2.8.4.1. A micro-organism may give rise to risks because of its potential to infect and multiply in arthropods other than bees. Whether or not identified risks could be changed due to the formulation of the plant protection product shall be assessed, taking into account the following information on the micro-organism: (a) its mode of action, (b) other biological properties, (c) studies on toxicity, pathogenicity and infectivity to honeybees and other arthropods. 2.8.4.2. A plant protection product may give rise to toxic effects due to the action of toxins or co-formulants. For the assessment of such effects the following information should be taken into consid eration: (a) studies on toxicity to arthropods, (b) information on fate and behaviour in the various parts of the environment, (c) available data from biological primary screening. If mortality or signs of intoxication are observed in the tests the evaluation must include a calculation of toxicity/exposure ratios based on the quotient of the ER50value (effective rate) and the estimated exposure. 2.8.5. M e m b e r S t a t e s s h a l l e v a l u a t e t h e p o s s i bility of exposure of and effects on earthworms. 2.8.5.1. A micro-organism may give rise to risks because of its potential to infect and multiply in earthworms. Whether or not identified risks could be changed due to the formulation of the plant protection product shall be assessed, taking into account the following information on the micro-organism: (a) its mode of action, (b) other biological properties, (c) studies on earthworm toxicity, pathogenicity and infectivity. 2.8.5.2. A plant protection product may give rise to toxic effects due to the action of toxins or co-formulants. For the assessment of such effects the following information should be taken into consid eration: (a) studies on earthworm toxicity, (b) information on fate and behaviour in the various parts of the environment. If mortality or signs of intoxication are observed in the tests the evaluation must include a calculation of toxicity/exposure ratios based on the quotient of the LC50value and the estimated exposure expressed in mg/kg dry weight soil. 2.8.6. M e m b e r S t a t e s s h a l l e v a l u a t e t h e p o s s i bility of exposure of and effects on soil micro-organisms. 2.8.6.1. A micro-organism may give rise to risks because of its potential to interfere with nitrogen and carbon mineralisation in the soil. Whether or not identified risks could be changed due to the formulation of the plant protection product shall be assessed, taking into account the following information on the micro organism: (a) its mode of action, (b) other biological properties. Experimental data are not normally required, i.e. where it can be justified that a proper risk assessment can be performed with the available information. 2.8.6.2. The director shall evaluate the impact of exotic/non-indigenous micro-organisms on non-target micro-organisms and on their predators following use of the plant protection product according to the proposed conditions of use. Experimental data are not normally required, i.e. where it can be justified that a proper risk assessment can be performed with the available infor-mation. 2.8.6.3. A plant protection product may give rise to toxic effects due to the action of toxins or co-formulants. For the assessment of such effects the following information should be taken into consid eration: (a) information on fate and behaviour in the various parts of the environment, (b) all available information from biological primary screening. 2.9. Conclusions and proposals The director shall draw conclusions on the need for further information and/or testing and the need for measures to limit the risks arising. The director shall justify proposals for the clas sification and labelling of plant protection products. C. DECISION-MAKING 1. General principles 1.1. Where appropriate, the director shall impose conditions or restrictions on the authorisations they grant. The nature and severity of these conditions or restrictions must be selected on the basis of, and be appropriate to, the nature and extent of the expected advantages and the risks likely to arise. 1.2. The director shall ensure that decisions taken to grant author isations, take account of the agricultural, plant health or environ mental (including climatic) conditions in the areas of envisaged use. Such considerations may result in specific conditions and restrictions on use, and, in authorisation being granted for some but not other areas within the Member State in question. 1.3. The director shall ensure that the authorised amounts, in terms of rates and number of applications, are the minimum necessary to achieve the desired effect even where higher amounts would not result in unacceptable risks to human or animal health or to the environment. The authorised amounts must be differentiated according to, and be appropriate to, the agricultural, plant health or environmental (including climatic) conditions in the various areas for which an authorisation is granted. However, the rates and the number of applications shall not give rise to undesirable effects such as the development of resistance. 1.4. The director shall ensure that decisions respect the principles of integrated pest control if the plant protection product is intended for use in conditions where these principles are relied on. 1.5. Since the evaluation is to be based on data concerning a limited number of representative species, The director shall ensure that use of plant protection products does not have any long-term repercussions for the abundance and diversity of non-target species. 1.6. Before issuing an authorisation, the director shall ensure that the label of the plant protection product: (a) fulfils the requirements of regulation 16 of these regulations, (b) also contains the information on protection of users required by Community legislation on worker protection, (c) specifies in particular the conditions or restrictions under which the plant protection product shall or shall not be used as referred to in points 1.1 to 1.5, (d) The authorisation shall mention the particulars indicated in regulation 16(1)(g) and (h) of these regulations and Article 10(1.2), (2.4), (2.5) and (2.6) of Directive 1999/45/EC of the European Parliament and of the Council of 31 May 1999 concerning the approximation of the laws, regulations and administrative provisions relating to the classification, packaging and labelling of dangerous preparations. 1.7. Before issuing authorisations, The director shall: (a) ensure that the proposed packaging is in accordance with the provisions of Directive 1999/45/EC; (b) ensure that: —the procedures for destruction of the plant protection product, —the procedures for neutralisation of any adverse effects of the plant protection product if it is accidentally dispersed, and —the procedures for the decontamination and destruction of the packaging, are in accordance with the relevant regulatory provisions. 1.8. No authorisation shall be granted unless all the requirements referred to in point 2 are satisfied. However, when one or more of the specific decision-making requirements referred to in point 2.4 are not fully satisfied, authorisations shall be granted only where the advantages of the use of the plant protection product under the proposed conditions of use outweigh the possible adverse effects of its use. Any restrictions on use of the plant protection product relating to non-compliance with some of the requirements referred to in point 2.4 must be mentioned on the label. These advantages can be in terms of: (a) advantages for and compatibility with integrated control measures or organic farming, (b) facilitating strategies to minimise the risk of development of resistance, (c) reduced risk for operators and consumers, (d) reduced contamination of the environment and reduced impact on non-target species. 1.9. Where an authorisation has been granted according to the requirements provided for in this Schedule, the Director may, by virtue of regulation 4(6): (a) define, where possible, preferably in close cooperation with the applicant, measures to improve the performance of the plant protection product, and/or (b) define, where possible, in close cooperation with the applicant, measures to reduce further the exposure that could occur during and after use of the plant protection product. The director shall inform applicants of any measures identified under (a) or (b) and shall invite applicants to provide any supple mentary data and information necessary to demonstrate performance or potential risks arising under the changed conditions. 1.10. The director shall ensure, as far as is practically possible, that for all micro-organisms that are considered for an authorisation, the applicant has taken into account all available relevant knowledge and information in literature at the time of submission. 1.11. Where the micro-organism has been genetically modified, as defined in Directive 2001/18/EC, no authorisation shall be granted unless the evaluation conducted in accordance with Directive 2001/18/EC has been submitted, as required under Article 1(3) of that Directive. The relevant decision taken by the competent authorities in accordance with Directive 2001/18/EC must be provided. 1.12. In accordance with Article 1(3) of Directive 414/1991, no authorisation shall be granted for a plant protection product containing a genetically modified organism unless authorisation is granted according to the provisions in Directive 2001/18/EC, part C, under which that organism can be released into the environment. 1.13. No authorisation shall be granted if relevant metabolites/toxins (i.e. those expected to be of concern for human health and/or the environment) known to be formed by the micro-organism, and/or by microbial contaminants are present in the plant protection product, unless it can be shown that the amount present is at an acceptable level before and after its proposed use. 1.14. The director shall ensure that adequate quality control measures are applied to ensure the identity of the micro-organism and contents of the plant protection product. Such measures must include a Hazard Analysis Critical Control Point (HACCP) system or equivalent system. 2. Specific principles The specific principles shall apply without prejudice to the general principles referred to in Section 1. 2.1. Identity For each authorisation granted the director shall ensure that the micro-organism concerned is deposited at an interna-tionally recognised culture collection and has an accession number. Each micro-organism must be identified and named at the species level and characterised at the strain level. There must also be information as to whether or not the micro-organism is a wild type or a spontaneous or induced mutant, or a genetically modified organism. 2.2. Biological and technical properties 2.2.1. There must be sufficient information to permit assessment of the minimum and maximum content of the micro-organism in the material used for the manufacturing of plant protection products, as well as in the plant protection product. The content of other components and formulants in the plant protection product and contaminating micro-organisms derived from the production process must to the extent possible be defined. The director shall ensure that the level of contaminating organisms is controlled to an acceptable level. In addition: the physical nature and state of the plant protection product must be specified, preferably according to the‘Catalogue of pesticide formulation types and international coding system (CropLife International Technical Monograph No 2, 5th Edition, 2002)’. 2.2.2. No authorisation shall be granted if, at any stage in the devel opment of a microbial plant protection product, it becomes apparent, on the basis of a build-up of resistance, or transfer of resistance, or other mechanism, that there may be interference with the effectiveness of an anti-microbial agent used in human or animal medicine. 2.3. Further information No authorisation shall be granted unless full information is provided on the continuous quality control of the production method, production process and plant protection product. In particular, the occurrence of spontaneous changes in major char acteristics of the micro-organism and the absence/presence of contaminating organisms shall be considered. The quality assurance criteria for production and the techniques used to ensure a uniform plant protection product must to the extent possible be described and specified. 2.4. Efficacy 2.4.1. P e r f o r m a n c e 2.4.1.1. No authorisation shall be granted where the proposed uses include recommendations for the control of or protection against organisms which are not considered to be harmful on the basis of experience acquired or scientific evidence under normal agricultural, plant health and environmental (including climatic) conditions in the areas of proposed use or where the other intended effects are not considered to be beneficial under those conditions. 2.4.1.2. The level, consistency and duration of control or protection or other intended effects must be similar to those resulting from the use of suitable reference products. If no suitable reference product exists, the plant protection product must be shown to give a defined benefit in terms of the level, consistency and duration of control or protection or other intended effects under the agricultural, plant health and environmental (including climatic) conditions in the area of proposed use. 2.4.1.3. Where relevant, yield response when the plant protection product is used and reduction of loss in storage must be quantitatively and/or qualitatively similar to those resulting from the use of suitable reference products. If no suitable reference product exists, the plant protection product must be shown to give a consistent and defined quantitative and/or qualitative benefit in terms of yield response and reduction of loss in storage under the agricultural, plant health and environmental (including climatic) conditions in the area of proposed use. 2.4.1.4. Conclusions as to the performance of the preparation must be valid for all areas of the Member State in which it is to be authorised, and for all conditions under which its use is proposed, except where the proposed label specifies that the preparation is intended for use in certain specified circumstances (e.g. light infestations, particular soil types or particular growing conditions). 2.4.1.5. Where proposed label claims include requirements for use of the preparation with other specified plant protection products or adjuvants as a tank mix, the mixture must achieve the desired effect and comply with the principles referred to in points 2.4.1.1 to 2.4.1.4. Where proposed label claims include recommendations for use of the preparation with specified plant protection products or adjuvants as a tank mix, The director shall not accept the recommendations unless they are justified. 2.4.1.6. If there is evidence of a development of resistance of pathogens towards the plant protection product, the Member State shall decide if the submitted resistance management strategy addresses this adequately and sufficiently. 2.4.1.7. Only plant protection products containing non-viable micro organisms shall be authorised for use to control vertebrate species. The intended effect on vertebrates to be controlled shall be obtained without unnecessary suffering and unnecessary pain for these animals. 2.4.2. A b s e n c e o f u n a c c e p t a b l e e f f e c t s o n p l a n t s a n d plant products 2.4.2.1. There must be no relevant phytotoxic effects on treated plants or plant products except where the proposed label indicates appro priate limitations of use. 2.4.2.2. There must be no reduction of yield at harvest due to phytotoxic effects below that which could be obtained without the use of the plant protection product, unless this reduction is compensated for by other advantages such as an enhancement of the quality of the treated plants or plant products. 2.4.2.3. There must be no unacceptable adverse effects on the quality of treated plants or plant products, except in the case of adverse effects on processing where proposed label claims specify that the preparation should not be applied to crops to be used for processing purposes. 2.4.2.4. There must be no unacceptable adverse effects on treated plants or plant products used for propagation or reproduction, such as effects on viability, germination, sprouting, rooting and estab lishment, except where proposed label claims specify that the preparation should not be applied to plants or plant products to be used for propagation or reproduction. 2.4.2.5. There must be no unacceptable impact on succeeding crops, except where proposed label claims specify that particular crops, which would be affected, should not be grown following the treated crop. 2.4.2.6. There must be no unacceptable impact on adjacent crops, except where proposed label claims specify that the preparation should not be applied when particular sensitive adjacent crops are present. 2.4.2.7. Where proposed label claims include requirements for use of the preparation with other plant protection products or adjuvants, as a tank mix, the mixture must comply with the principles referred to in points 2.4.2.1 to 2.4.2.6. 2.4.2.8. The proposed instructions for cleaning the application equipment must be both practical and effective so that they can be applied with ease so as to ensure the removal of residual traces of the plant protection product which could subsequently cause damage. 2.5. Identification/detection and quantification methods The methods proposed must reflect the latest techniques. Methods for post-authorisation monitoring should involve the use of commonly available reagents and equipment. 2.5.1. No authorisation shall be granted unless there is an adequate method of sufficient quality to identify and quantify the micro organism and non-viable components (e.g. toxins, impurities and co-formulants) in the plant protection product. In the case of a plant protection product containing more than one micro organism, the recommended methods should be capable of iden tifying and determining the content of each one. 2.5.2. No authorisation shall be granted unless there are adequate methods for post-registration control and monitoring of viable and/or non-viable residues. Methods must be available for analysis of: (a) plants, plant products, foodstuffs of plant and animal origin and feedingstuffs if toxicologically relevant residues occur. Residues are considered relevant if a maximum residue level (MRL) or a waiting or re-entry safety period or other such precaution is required, (b) soil, water, air and/or body tissues if toxicologically, ecotox icologically or environmentally relevant residues occur. 2.6. Impact on human and animal health 2.6.1. E f f e c t s o n h u m a n a n d a n i m a l h e a l t h a r i s i n g from the plant protection product 2.6.1.1. No authorisation shall be granted if on the basis of the infor mation provided in the dossier it appears that the micro-organism is pathogenic to humans or non-target animals under the proposed conditions of use. 2.6.1.2. No authorisation shall be granted if the micro-organism and/or the plant protection product containing the micro-organism might, under the recommended conditions of use, including a realistic worst case scenario, colonise or cause adverse effects in humans or animals. When making a decision on the authorisation of the microbial plant protection product, The director shall consider possible effects on all human populations, namely professional users, non-professional users and humans exposed directly or indirectly though the environment and at work, and animals. 2.6.1.3. All micro-organisms should be regarded as potential sensitisers, unless it is established by means of relevant information that there is no risk of sensitisation, taking into account immuno compromised and other sensitive individuals. Authorisations granted shall therefore specify that protective clothing and suitable gloves be worn and that the plant protection product containing the micro-organism should not be inhaled. Moreover, the proposed conditions of use may require use of additional items of protective clothing and equipment. Where the proposed conditions of use require use of items of protective clothing, no authorisation shall be granted unless those items are effective and in accordance with relevant Community provisions, and are readily obtainable by the user and unless it is feasible to use them under the conditions of use of the plant protection product, taking into account climatic conditions in particular. 2.6.1.4. No authorisation shall be granted if it is known that transfer of genetic material from the micro-organism to other organisms may lead to adverse effects on human and animal health, including resistance to known therapeutic substances. 2.6.1.5. Plant protection products which, because of particular properties, or which, if mishandled or misused, could lead to a high degree of risk must be subject to particular restrictions such as restrictions on the size of packaging, formulation type, distri bution, use or manner of use. Moreover, plant protection products which are classified as very toxic shall not be authorised for use by non-professional users. 2.6.1.6. Waiting and re-entry safety periods or other precautions must be established in such a way that no colonisation of or adverse effects on bystanders or workers exposed after application of the plant protection product are expected. 2.6.1.7. Waiting and re-entry safety periods or other precautions must be established in such a way that no colonisation of or adverse effects on animals are expected. 2.6.1.8. Waiting and re-entry periods or other precautions to ensure that no colonisation or adverse effects are expected must be realistic; if necessary, special precautionary measures must be prescribed. 2.6.1.9. The conditions of authorisation shall be in compliance with Council Directive 98/24/EC of 7 April 1998 on the protection of the health and safety of workers from the risks related to chemical agents at work, and Directive 2000/54/EC of the European Parliament and of the Council of 18 September 2000 on the protection of workers from risks related to exposure to biological agents at work. The experimental data and infor mation relevant to the recognition of the symptoms of infection or pathogenicity and on the effectiveness of first aid and thera peutic measures provided shall be considered. The conditions of authorisation shall also be in compliance with Directive 2004/37/EC of the European Parliament and of the Council of 29 April 2004 on the protection of workers from the risks related to exposure to carcinogens or mutagens at work. The conditions of authorisation shall also be in compliance with Council Directive 89/656/EEC of 30 November 1989 on the minimum health and safety requirements for the use by workers of personal protective equipment at the workplace. 2.6.2. E f f e c t s o n h u m a n a n d a n i m a l h e a l t h a r i s i n g from residues 2.6.2.1. No authorisation shall be granted unless there is sufficient infor mation for plant protection products containing the micro organism, to decide that there is no harmful effect on human or animal health arising from exposure to the micro-organism, its residual traces and metabolites/toxins remaining in or on plants or plant products. 2.6.2.2. No authorisation shall be granted unless viable residues and/or non-viable residues occurring reflect the minimum quantities of the plant protection product necessary to achieve adequate control corresponding to good agricultural practice, applied in such a manner (including pre-harvest intervals or withholding periods or storage periods) that the viable residues and/or toxins at harvest, slaughter or after storage are reduced to a minimum. 2.7. Fate and behaviour in the environment 2.7.1. No authorisation shall be granted if the available information indicates that there may be unacceptable adverse environmental effects due to the fate and behaviour of the plant protection product in the environment. 2.7.2. No authorisation shall be granted if contamination of ground water, surface water or drinking water expected as a result of the use of a plant protection product under the proposed conditions of use, may cause interference with the analytical systems for the control of the quality of drinking water provided for in Directive 98/83/EC. 2.7.3. No authorisation shall be granted if the contamination of groundwater expected as a result of the use of a plant protection product under the proposed conditions of use contravenes or exceeds whichever of the following is the lower: (a) the parameters or maximum permissible concentrations laid down by Directive 98/83/EC, or (b) the parameters or maximum permissible concentrations laid down for components in the plant protection product such as relevant metabolites/toxins in accordance with Directive 2000/60/EC of the European Parliament and of the Council of 23 October 2000 establishing a framework for Community action in the field of water policy, or (c) the parameters for the micro-organism or the maximum concentration laid down by the Commission for components in the plant protection product such as relevant metabolites/ toxins when including the micro-organism in Schedule I, on the basis of appropriate data, in particular, toxicological data, or, where that concentration has not been laid down, the concen-tration corresponding to 1/10 of the acceptable daily intake (ADI) laid down when the micro-organism was included in Schedule I, unless it is scientifically demonstrated that under relevant field conditions the lower of the parameters or concentrations is not contravened or exceeded. 2.7.4. No authorisation shall be granted if the contamination of surface water expected as a result of the use of a plant protection product under the proposed conditions of use: (a) exceeds, where the surface water in or from the area of envisaged use is intended for the extraction of drinking water, the parameters or values established in accordance with Directive 2000/60/EC of the European Parliament and of the Council of 23 October 2000 establishing a framework for Community action in the field of water policy, or (b) exceeds the parameters or values for components in the plant protection product, such as relevant metabolites/toxins, established in accordance with Directive 2000/60/EC or (c) has an impact deemed unacceptable on non-target species, including animals, according to the relevant requirements provided for in point 2.8. The proposed instruction for use of the plant protection product, including procedures for cleaning application equipment, must be such that the likelihood of accidental contamination of surface water is reduced to a minimum. 2.7.5. No authorisation shall be granted if it is known that transfer of genetic material from the micro-organism to other organisms, may lead to unacceptable effects on the environment. 2.7.6. No authorisation shall be granted unless there is sufficient infor mation on the possible persistence/competitiveness of the micro organism and relevant secondary metabolites/toxins in or on the crop under the environmental conditions prevailing at and following the intended use. 2.7.7. No authorisation shall be granted if it can be expected that the micro-organism and/or its possible relevant metabolites/toxins will persist in the environment in concentrations considerably higher than the natural background levels, taking into account repeated applications over the years, unless a robust risk assessment indicates that the risks from accumulated plateau concentrations are acceptable. 2.8. Effects on non-target organisms The director shall ensure that the available information is sufficient to permit a decision to be taken as to whether or not there may be unacceptable effects on non-target species (flora and fauna), due to exposure to the plant protection product containing the micro-organism following its intended use. The director shall pay special attention to possible effects on beneficial organisms used for biological control and organisms playing an important role in integrated control. 2.8.1. Where there is a possibility of birds and other non-target terrestrial vertebrates being exposed, no authorisation shall be granted if: (a) the micro-organism is pathogenic to birds and other non target terrestrial vertebrates, (b) in case of toxic effects due to components in the plant protection product, such as relevant metabolites/toxins, the toxicity/exposure ratio is less than 10 on the basis of the acute LD50value or the long-term toxicity/exposure ratio is less than 5, unless it is clearly established through an appro priate risk assessment that under field conditions no unac ceptable effects occur—directly or indirectly—after use of the plant protection product according to the proposed conditions of use. 2.8.2. Where there is a possibility of aquatic organisms being exposed, no authorisation shall be granted if: (a) the micro-organism is pathogenic to aquatic organisms, (b) in case of toxic effects due to components in the plant protection product such as relevant metabolites/toxins, the toxicity/exposure ratio is less than 100 in case of acute toxicity (EC50) to daphnia and fish and 10 for long-term/ chronic toxicity to algae (EC50), daphnia (NOEC) and fish (NOEC), unless it is clearly established through an appro priate risk assessment that under field conditions no unac ceptable impact on the viability of exposed species occurs— directly or indirectly—after use of the plant protection product according to the proposed conditions of use. 2.8.3. Where there is a possibility of bees being exposed, no author isation shall be granted: (a) if the micro-organism is pathogenic to bees, (b) in case of toxic effects due to components in the plant protection product such as relevant metabolites/toxins, the hazard quotients for oral or contact exposure of honeybees are greater than 50, unless it is clearly established through an appropriate risk assessment that under field conditions there are no unacceptable effects on honeybee larvae, honeybee behaviour, or colony survival and development after use of the plant protection product according to the proposed conditions of use. 2.8.4. Where there is a possibility of arthropods other than bees being exposed, no authorisation shall be granted if: (a) the micro-organism is pathogenic to arthropods other than bees, (b) in case of toxic effects due to components in the plant protection product such as relevant metabolites/toxins, unless it is clearly established through an appropriate risk assessment that under field conditions there is no unac ceptable impact on those organisms after use of the plant protection product according to the proposed conditions of use. Any claims for selectivity and proposals for use in inte grated pest management systems shall be substantiated by appropriate data. 2.8.5. Where there is a possibility of earthworms being exposed, no authorisation shall be granted if the micro-organism is pathogenic to earthworms or in the case of toxic effects due to components in the plant protection product such as relevant metabolites/-toxins, the acute toxicity/exposure ratio is less than 10, or the long-term toxicity/exposure ratio is less than 5, unless it is clearly established through an appropriate risk assessment that under field conditions earthworm populations are not at risk after use of the plant protection product according to the proposed conditions of use. 2.8.6. Where there is a possibility of non-target soil micro organisms being exposed, no authorisation shall be granted if the nitrogen or carbon mineralisation processes in laboratory studies are affected by more than 25 % after 100 days, unless it is clearly established through an appropriate risk assessment that under field conditions there is no unacceptable impact on the microbial community after use of the plant protection product according to the proposed conditions of use, taking account of the ability of micro-organisms to multiply. SCHEDULE VII Names of active substances or groups of active substances referred to in Regulation 24. Cases in which placing on the market or use are permitted in accordance with Regulation 25. A. Mercury Compounds Mercuric oxide Mercurous chloride (calomel) Other inorganic mercury compounds Alkyl mercury compounds Alkoxyalkyl and aryl mercury compounds B. Persistent organo-chlorine compounds Camphechlor C. Other compounds Ethylene oxide Nitrofen 1,2-Dibromoethane 1,2-Dichloroethane Dinoseb, its acetate and salts Binapacryl Captafol Dicofol containing less than 78% of p.p. (1) – dicofol or more than 1g/kg DDT and DDT related compounds Maleic hydrazide and its salts, other than its choline, potassium and sodium salts; Choline, potassium and sodium salts of maleic hydrazide containing more than 1 mg/kg of free hydrazine expressed on the basis of the acid equivalent. Quintozene containing more than 1 g/kg of HCB or more than 10 g/kg pentachlorobenzene. (1) (plants and plant products rich in essential oils and aromic principles mainly used as condiments because of their characteristic taste)