Biocides Regulations 2004 (L.N. 294 of 2004)

B 5129 L.N. 294 of 2004 PESTICIDES CONTROL ACT (CAP. 430) Biocides Regulations, 2004 IN exercise of the powers conferred by articles 4 and 5 of the Pesticides Control Act, the Minister of Rural Affairs and the Environment, has made the following regulations: 1. The title of these regulations is the Biocides Regulations, 2004, and they shall come into force as follows: (a) the provisions under Part Two (i) on the expiry of thirty days following the publication of these regulations in the Gazette in relation to biocidal products not listed under Schedule Two to these regulations; (ii) on the 15th May, 2004 in relation to biocidal products listed in Schedule Two to these regulations; and (b) on the expiry of thirty days following the publication of these regulations in the Gazette in relation to all other provisions of these regulations. 2. (1) The scope of these regulations is to provide for the authorisation and control in relation to dealing, advertising and use of any biocidal product or any other active substances intended for use in any biocidal product as specified in the Act. (2) These regulations shall not apply to those products which are regulated within the scope of any other provision made by or under the Act or any other act, in particular : (a) provisions relating to proprietary medicinal products; (b) provisions relating to veterinary medicinal products; (c) provisions relating to veterinary medicinal products and establishing additional provisions for immunological medicinal products; Title and commencement. Scope and applicability. B 5130 (d) provisions relating to medicinal products and establishing additional provisions on homeopathic medicinal products; (e) provisions relating to veterinary medicinal products and establishing additional provisions on homeopathic veterinary medicinal products; (f) provisions relating to authorisation and supervision of medicinal products for human and veterinary use; (g) provisions relating to active implantable medical devices; (h) the provisions concerning medical devices; (i) provisions concerning food additives authorised for use in foodstuffs intended for human consumption, relating to flavourings for use in foodstuffs and to source material for their production and on food additives other than colours and sweeteners; (j) provisions relating to material and articles intended to come into contact with foodstuffs; (k) provisions laying down the health rules for the production and placing on the market of raw milk, heat-treated milk and milk based products; (l) provisions relating to hygiene and health products affecting the production and the placing on the market of egg products; (m) provisions establishing the health conditions for the production and the placing on the market of fishery products; (n) provisions establishing the conditions governing the preparation, placing on the market and use of medicated feedingstuffs; (o) provisions concerning additives in feedingstuffs, on certain products used in animal nutrition and on the marketing of straight feedingstuffs; (p) provisions relating to cosmetic products; B 5131 (q) provisions on certain conditions for granting temporary and limited derogations from specific health rules on the production and the marketing of certain products of animal origin; and (r) provisions concerning the placing of plant protection products on the market. (3) These regulations shall apply, without prejudice to any of the following provisions made by or under any other Act or in relation to measures taken in accordance with the said provisions: (a) provisions relating to restriction on the marketing and use of certain dangerous substances and preparations; (b) provisions prohibiting the placing on the market and use of biocidal products containing certain active substances; (c) provisions concerning the export and import of certain dangerous chemicals; (d) provisions concerning the protection of workers from the risks related to exposure to chemical, physical and biological agents at work and on the introduction of measures to encourage improvements in the safety and health of workers at work; and (e) provisions concerning misleading advertising. (4) The provisions of regulation 35 of these regulations shall not apply to the carriage of biocidal products by road, sea or air. (5) The provisions of Part 2 of these regulations shall not apply in relation to an application for the registration of an active substance listed in Schedule 3 to these regulations or biocidal products listed in Schedule 2 to these regulations as the case may be, which were on the market in Malta on publication of these regulations in the Government Gazette: Provided that an ad hoc application for the registration of such active substances or authorisation of a biocidal product as the case may require, be made to the director in writing as he may establish in the Gazette: Provided further that any such registration of an active substance or authorisation of a biocidal product shall be issued by the Director subject to such terms and conditions as he may deem acceptable and on condition that the provisions under Part 2 of these regulations shall be complied within such time as may be stipulated in the registration or authorisation. B 5132 PART ONE GENERAL PROVISIONS 3. (1) In these regulations, unless the context otherwise requires: “Act” means the Pesticides Control Act; “advertising” in relation to biocidal products includes any form of door-to-door information, canvassing activity or inducement designed to promote the supply, sale or use of biocidal products and without prejudice to the generality of the foregoing in particular includes: (a) the advertising of biocidal 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 of biocidal 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 Part Four of these regulations; (ii) correspondence, even if accompanied by material of a non-promotional nature, which is in reply to a specific question about a particular biocidal product; and (iii) factual, informative, announcement or reference material relating to pack changes, 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; “animal” means an animal belonging to species normally fed and kept or consumed by man or otherwise considered as beneficial; Interpretation. B 5133 “authorised representative” means any person duly authorised by the Director to act on his behalf for any of the purposes referred to in these regulations; “basic substance” also referred to as commodity substance means a substance which is listed in Part IB of the Register of active substances, whose major use is non-pesticidal but which has some minor use as a biocide either directly or in a product consisting of the substance and a simple diluents which itself is not a substance of concern and which is not directly marketed for this biocidal use. Such substances shall inter alia include the following: (a) carbon dioxide; (b) nitrogen; (c) ethanol; (d) 2-propanol; (e) acetic acid; (f) kieselguhr; “dealing” means any activity in the manufacture, import, export, transport, storage, distribution, presenting for sale or sale of any biocidal product; “The Department” means the Department responsible for plant health; “frame formulations” means the specifications for a group of biocidal products having the same use and user type, which group of products must convey the same active substances of the same specifications, and their compositions must present only variations from a previously authorised biocidal products which do not affect the level of risk associated with them and their efficacy and for such purpose a variation is the allowance of a reduction in the percentage of the active substance and, or an alteration in percentage composition of one or more non-active substances and, or the replacement of one or more pigments, dyes, perfumes by others presenting the same or a lower risk, and which do not decrease its efficacy; B 5134 “letter of access” means a document, signed by the owner or owners of relevant data protected under the provisions of these regulations, which states that this data may be used by the Director for the purpose of granting an authorisation or for the registration of a biocidal product in accordance with these regulations; “low-risk biocidal product” means a biocidal product which does not contain as active substance any substance of concern, under the conditions of use, the biocidal product shall pose only a low risk to humans, animals and the environment; “manufacturer” means the holder of a manufacturing process for the manufacturing of a biocidal product; “manufacturing” shall have the same meaning as is assigned to it in the Act; “preparation” means mixtures or solutions composed of two or more substances; “process-oriented research and development” means the further development of a substance in the course of which pilot plant or production trials are used to test the fields of application of the substance; “recognised country” means any Member State of the European Community; “relevant regulations” means The Dangerous Substances (Notification) Regulations, 2001, Legal Notice 318 of 2001, The Dangerous Substances (Risk Assesment) Regulations 2002, Legal Notice 40 of 2002, The Dangerous Substances and Preparation (Restrictions) Regulations 2002, Legal Notice 142 of 2002, The Dangerous Substances and Preparations Regulations, 2002, Legal Notice 221 of 2002, and other regulations as the case may be; “scientific research and development” means scientific experimentation, analysis or chemical research carried out under controlled conditions; it includes the determination of intrinsic B 5135 properties, performance and efficacy as well as scientific investigation related to product development; “substance” means a chemical element and their compounds in the natural state or obtained by any production process, including any additive necessary to preserve the stability of the products and any impurity deriving from the process used, but excluding any solvent which may be separated without affecting the stability of the substance or changing its composition; “substance of concern” means any substance, other than active substance, that has an inherent capacity to cause an adverse effect on humans, animals or the environment and is present or is produced in a biocidal product in sufficient concentration to create such an adverse effect. Such a substance, unless there are other grounds for concern would be normally a substance classified as dangerous according to the relevant provisions of (Legal Notice 318 of 2001) relating to the classification, packaging and labelling of dangerous substances and present in the biocidal product at a concentration leading the product to be regarded as dangerous within the meaning of the relevant provisions of (Legal Notice 221 of 2002) relating to the classification, packaging and labelling of dangerous preparations. PART TWO AUTHORISATION OF BIOCIDAL PRODUCTS 4. (1) Without prejudice to the provisions of sub-regulation (8) of this regulation and regulation 5 of these regulations, the Director shall register any active substance for an initial period not exceeding ten years: (a) if he has received an application for the registration of that active substance in such form and such manner and within such a time as he may from time to time, require by notice in the Gazette; (b) if he has received a dossier for the active substance satisfying the requirements of Annex IVA or the requirements of Annex IIA and, where specified, the relevant parts of Annex IIIA to Council Directive 98/8/EEC of 16 February 1998 concerning the placing of biocidal products on the market (Official Journal of the European Communities, L 123) and as may from time to time be amended; Registration and inclusion of an active substance in The Register of active substances B 5136 (c) if he has received a dossier for at least one biocidal product containing the active substance in accordance with the provisions of regulation 17 of these regulations, other than sub regulation (2) thereof; and (d) if he has verified the dossiers and finds them to be in compliance with the requirements of Annex IVA and Annex IVB or the requirements of Annex IIA and Annex IIB and, where relevant, Annexes IIIA and IIIB to Council Directive 98/8/EEC of 16 February 1998 concerning the placing of biocidal products on the market (Official Journal of the European Communities, L 123) and as may from time to time be amended. (2) Notwithstanding the provisions of sub-regulation (4) of this regulation, the Director shall carry out an evaluation of the above mentioned dossiers and take a decision whether to include or otherwise the active substance under the relevant parts of the Register of active substances, within twelve months of accepting the dossiers: Provided that if, when the dossiers are evaluated, it appears that further information is necessary for full evaluation to be made, the receiving Director shall ask that the applicant to submit such information. The twelve month period shall be suspended from the date of issue of the Director’s request until the date the information is received. (3) An active substance shall, in the light of current scientific and technical knowledge, be included in parts 1, 1A or 1B of the Register of active substances to these regulations if it may be expected that: (a) biocidal products containing the active substance; (b) low-risk biocidal products complying with the definition in regulation 3 of these regulations; (c) basic substances complying with the definition in regulation 3 of these regulations; will fulfil the conditions laid down in paragraphs (b), (c) and (d) of sub-regulation (2) of regulation 9 of these regulations, taking into account, where relevant, cumulative effects from the use of biocidal products containing the same active substances. 4. (a) The Director shall refuse or remove an entry of an active substance from parts I and, where relevant from parts IA or IB of the Register of active substances to these regulations: B 5137 (i) if the evaluation of the active substance in accordance with sub-regulation (2) of regulation 4 of these regulations shows that, under normal conditions of use in any authorised biocidal product, risks to human beings, animals or the environment still give rise to concern, and (ii) if there is another active substance in part I of the Register of active substances to these regulations for the same product type which, in the light of scientific or technical knowledge, presents significantly less risk to health or to the environment. When such a refusal or removal is considered, an assessment of an alternative active substance or substances shall take place to demonstrate that it can be used with similar effect on the target organism without significant economic and practical disadvantages for the user and without an increased risk for health or for the environment. (b) The Director shall carry out the refusal or removal of an active substance from part I and, where from parts IA or IB of the Register of active substances to these regulations under the following conditions: (i) the chemical diversity of the active substances should be adequate to minimise occurrence of resistance in the target organism; (ii) it should be applied only to active substances which, when used under normal conditions in authorised biocidal products, present a significantly different level of risk; (iii) it should be applied only to active substances used in products of the same product type; and (iv) it should be applied only after allowing the possibility, where necessary, of acquiring experience from use in practice, if it is not already available. (5) An active substance shall not be included in part 1A of the Register of active substances to these regulations if it is classified according to relevant regulations as: (a) carcinogenic, (b) mutagenic, B 5138 (c) toxic for reproduction, (d) sensitising, or (e) is bioaccumulative and does not readily degrade. (6) Where appropriate, the active substance shall be registered under part 1A of the Register of active substances to the concentration ranges between which the substance can be used. (7) Inclusion of an active substance in parts 1, 1A or 1B of the Register of active substances, shall where appropriate, be subject to; (a) the requirements on: (i) the minimum degree of purity of the active substance; (ii) the nature and maximum content of certain impurities; (iii) the product type in which it may be used, manner and area of use; (iv) the designation of categories of users (e.g. industrial, commercial or domestic); (v) other particular conditions from the evaluation of the information which has been made available in the context of these regulations; (b) the establishment of the following: (i) acceptable operator exposure level (AOEL), as the case may be required; (ii) where relevant, an acceptable daily intake for human beings (ADI) and a maximum residue limit (MRL); (iii) fate and behaviour in the environment and impact on non-target organisms. (8) The inclusion of an active substance the Register of active substances to these regulations of an active substance shall be restricted to those product types listed in Schedule One to these regulations. B 5139 (9) Following the decision by the competent authority of a recognised country to include or not to include an active substance in Annex I, IA or IB to Council Directive 98/8/EEC of 16 February 1998 concerning the placing of biocidal products on the market (Official Journal of the European Communities, L 123) as may from time to time be amended, the Director shall amend the relevant parts of the Register of active substances whereby Annex 1 shall correspond to Part1 , Annex 1A shall correspond to Part 1A and Annex 1B shall correspond to Part 1B to these regulations to reflect such decisions: 5. (1) The Director shall renew the registration of an active substance in parts I, IA or IB of the Register of active substances to these regulations for periods not exceeding ten years if: (a) he has received an application for renewal in such form and such manner and within such time as the Director may, from time to time require by Notice in the Gazette; and (b) he is satisfied that the conditions detailed in regulation 4 of these regulations are still being complied with: Provided that the Director may request the applicant to provide any additional information as he may deem necessary prior to the renewal or otherwise of the authorisation: Provided further that any renewal of any registration may be subject to any condition as the Director may deem appropriate. (2) Where an application for renewal in accordance with sub-regulation (1) of this regulation has been submitted to the Director, the validity of the registration granted in accordance with regulation 4 of these regulations shall be deemed to continue to have effect until such time as the Director has determined the application for renewal. 6. (1) Where the Director suspects that any of the conditions established by regulation 4 of these regulations for the inclusion or renewal of inclusion of an active substance in part I, IA or IB of the Register of active substances to these regulations is no longer satisfied, he: (a) shall require the applicant to submit any further information necessary to establish compliance with the provisions of regulation 4 of these regulations; (b) may carry out any review or test that he deems necessary; Renewal of registration of an active substance. Review of registration of an active substance. B 5140 (c) may remove an active substance from parts I, IA or IB of the Register of active substances to these regulations in accordance with regulation 4 of these regulations. (2) The Director shall, where necessary, grant renewal of inclusion of an active substance from parts I, IA or IB of the Register of active substances to these regulations in accordance with regulation 4 of these regulations for the minimum period necessary to complete a review. 7. Where in the consideration of an application for renewal in terms of regulation 5 of these regulations or in a review carried out during the currency of a registration in terms of Regulation 6 of these regulations. It is decided that an active substance shall be removed from Part1 and where relevant from Part 1A or 1B because of any of the conditions described in sub-regulation 4 are no longer being complied with. Such a decision shall be notified to the applicant or the Registration holder as the case may be and the removal shall take effect immediately after six months from the date of such notification. 8. (1) Subject to the provisions of Regulation 4 of these regulations the Director shall authorise the placing on the market in Malta of any active substance that is intended for use in biocidal products if: (a) he has received an application submitted in such form and such manner and within such a time as he may from time to time, require by notice in the Gazette: Provided that the applicant shall have a permanent office in Malta or a recognised country, (b) in the case where the active substance is listed in Schedule 3 or was not on the market locally or a recognised country before 14 May 2000, a dossier has been submitted, which is in accordance with the requirements of sub-regulation (1) of regulation 4 of these regulations or in accordance with similar requirements in a recognised country and is accompanied by the declaration that the active substance is intended for inclusion in a biocidal product: Provided that the requirement of this sub-regulation shall not apply to substances for use in accordance with the provisions of regulation 37 of these regulations, and Refusal or revocation of registration of an active substance. Granting of an authorisation to place an active substance on the market. B 5141 (c) he has established that the active substance complies with the provisions of relevant regulations regarding the classification, packaging and labelling of dangerous substances. (2) Provisions of regulation 4 of these regulations mutatis mutandis shall apply to an authorisation under this regulation. 9. (1) The Director shall authorise the placing on the market of any biocidal product if he has: (a) received an application for the issue of an authorisation in accordance with regulation 17 of these regulations; (b) received a product dossier in accordance with regulation 17 of these regulations; and (c) established that the provisions of sub-regulation (2) hereof are complied with. (2) Prior to the issue of an authorisation in accordance with sub-regulation (1) hereof, the Director shall, on the basis of information supplied to him by the applicant, be satisfied that: (a) the active substance is included in Part I or IA of the Register of active substances: Provided that if the active substance is still pending its registration, the Director may issue an authorisation pending a final decision on the registration of the active substance; (b) it is established, in the light of current scientific and technical knowledge, and is shown from appraisal of the biocidal product dossier, according to the common principles for the evaluation of dossiers as laid down in Annex VI to Council Directive 98/8/EEC of 16 February 1998 concerning the placing of biocidal products on the market (Official Journal of the European Communities, L 123) as may from time to time be amended that, when used as authorised and having regard to: all normal conditions under which the biocidal product may be used, how the material treated with it may be used, the consequences from use and disposal, the biocidal product: Granting of an authorisation to place a biocidal product on the market. B 5142 (i) is sufficiently effective; (ii) has no unacceptable effects on the target organisms, such as unacceptable resistance or cross resistance or unnecessary suffering and pain for vertebrates; (iii) has no unacceptable effects itself or as a result of its residues, on human or animal health, directly or indirectly (e.g. thorough drinking water, food or feed, indoor air or consequences in the place of work) or on surface water and groundwater; (iv) has no unacceptable effect itself, or as a result of its residues, on the environment having particular regard to the following considerations: its fate and distribution in the environment; particularly contamination of surface water (including estuarian and seawater), ground water and drinking water, its impact on non-target organisms; (c) the nature and quantity of its active substance and, where appropriate, any toxicologically or ecotoxicologically significant impurities and co-formulants, and its residues of toxicological or environmental significance, which result from authorised uses, can be determined according to the relevant requirements in Annexes IIA, IIB, IIIA, IIIB, IVA, or IVB to Council Directive /EEC of 16 February 1998 concerning the placing of biocidal products on the market (Official Journal of the European Communities, L 123) and as may from time to time be amended; (d) its physical and chemical properties have been determined and deemed acceptable for purposes of the appropriate use, storage and transport of the product; and (e) the packaging and labelling requirements detailed in Part Four of these regulations are complied with: Provided that biocidal product may have different specifications and characteristics for the labelling and packaging of different pack sizes. B 5143 (3) A biocidal product classified under the relevant regulations as toxic, very toxic or as a category 1 or 2 carcinogen, or as a category 1 or 2 mutagen or classified as toxic for reproduction category 1 or 2 shall not be authorised for marketing, or use by the general public. (4) Authorisations under these regulations may be subject to such terms and conditions as the director may deem necessary, in relation to (i) marketing and use of the biocidal product and, (ii) other requirement under any other legislation. (5) The applicant shall, as soon as practicable, notify the Director in writing of any change in the information supplied to the Director in the application or dossier and shall provide him with all the evidence that may be deemed necessary to support any identified change. (6) The Director shall, upon request by the applicant, or on his own initiative, and where relevant, establish a frame-formulation and communicate it to the applicant when issuing an authorisation for a particular biocidal product. (7) Where a frame formulation has been established, an application for the Authorisation of a biocidal product to which the frame formulation refers, a second subsequent application shall be subject to the provisions of Regulation 17 and 46. (8) Any application received by the director under this regulation shall be determined by him within a reasonable time not exceeding 60 working days from the date of receipt of an application: Provided that such time may be suspended until the relevant information is received. (9) The Director may authorise temporarily, for a period not exceeding 120 days, the placing on the market of biocidal products that are not authorised in accordance with these regulations, for a limited and controlled use if such a measure appears necessary because of unforeseen danger which cannot be contained by other means. 10. (1) Any authorisation for a biocidal product issued in accordance with regulation 9 of these regulations shall, as a minimum, specify: (a) the biocidal product trade name; Information found in an authorisation. B 5144 (b) the chemical name and Chemical Abstracts Service registry number of any active substance contained in the product formulation; (c) the approved product formulation; (d) the classification of the biocidal product as a low risk biocidal product or otherwise; (e) the application rates and instructions for use for the biocidal product being authorised; (f) the approved labelling and packaging including any advisory phrases or directions that may be related to the storage or use of the product; (g) any conditions that may be attached to the granting of the authorisation; (h) the name and contact details of the holder of the authorisation; (i) the authorisation number; (j) the term of validity of the authorisation; and (k) any other specification that the Director may deem necessary. 11. Any authorisation issued by the Director in accordance with regulation 9 of these regulations shall be valid for a period not exceeding a period of ten years from the date of first or renewed inclusion of its active substance in Part I or IA of the Register of active substances for the product type. Provided that the Director may extend the validity of any such authorisation upon the submission of an application for the renewal of the authorisation submitted to him in accordance with regulation 14 of these regulations and the Director is satisfied that the conditions established by regulation 9 of these regulations are being complied with. 12. Where the Director suspects that any of the conditions established by regulation 9 of these regulations is no longer satisfied, he: (a) shall require the applicant for authorisation or the holder of the authorisation granted in accordance with regulation 9 of Duration of validity of an authorisation. Review of authorisation. B 5145 these regulations to submit any further information necessary to establish compliance with the provisions of regulation 9 of these regulations; (b) may carry out any review or test that he deems necessary; (c) may suspend or revoke the authorisation in accordance with regulation 13 of these regulations; and (d) if, after having suspended the authorisation and after carrying out the necessary verifications he establishes that the conditions of regulation 9 of these regulations are being complied with, he may extend the validity of an authorisation for the period equivalent to the time needed for the Director to complete its verification. 13. (1) Any authorisation issued in accordance with regulation 9 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-regulation (2) of regulation 9 of these regulations is no longer satisfied; or (c) the applicant for authorisation requests that the Director revokes the authorisation to place on the market, deal or use a biocidal product in Malta; or (d) the biocidal product is no longer satisfactory in the performance of the function or functions for which it was originally intended as detailed in the biocidal product dossier; or (e) new scientific information or data indicates that the introduction into Malta, the marketing or the use of a biocidal product presents a previously unknown risk or unknown risks which are considered to be unacceptable; or the active substance is no longer included in Parts 1 or 1A of the Register of active substances as required by paragraph (a) of sub-regulation (2) of regulation 9 of these regulations. (2) (a) Where the Director suspends or revokes an authorisation, he shall notify the holder of the authorisation in writing of such a decision also providing the holder of the authorisation with detailed reasons on which such a decision was based and shall publish a notice in the Gazette announcing such suspension or revocation. Suspension or revocation of an authorisation. B 5146 (b) In the case of a revocation the Director may specify that the commencement of any such revocation shall take effect within a reasonable time for the disposal or for the storage, marketing and use of existing stocks, and this period shall be of a length that reflects the reason for the revocation. 14. (1) On the expiry of an authorisation, the Director shall renew the authorisation if: (a) he has received an application for renewal in such form and such manner and with such a time as the Director may, from time to time require by Notice in the Gazette; and (b) he is satisfied that the conditions detailed in regulation 9 of these regulations are still being complied with: Provided that the Director may request the applicant to provide any additional information he may deem necessary prior to the renewal or otherwise of the authorisation: Provided further that any renewal of any authorisation may be subject to any condition as the Director may deem appropriate. (2) Where an application for renewal in accordance with sub-regulation (1) of this regulation has been submitted to the Director, the validity of the authorisation granted in accordance with regulation 9 of these regulations shall be deemed to continue to have effect until such time as the Director has determined the application for renewal. 15. (1) Without prejudice to the provisions of regulation 12 of these regulations, the Director may, upon the written request from the holder of the authorisation, modify an authorisation to place a biocidal product on the market in Malta: Provided that the Director is satisfied that such modification is justified, and appropriate, and where relevant, reflects current scientific opinion. (2) Without prejudice to regulation 13 of these regulations, the Director may modify the original authorisation if he considers that any condition on which the authorisation was based in accordance with regulation 9 of these regulations has been substantially changed. (3) Any request for a modification to the authorisation in accordance with sub-regulation (1) of this regulation shall be made by the holder of the authorisation on such form and such manner and within Renewal of an authorisation. Modification of an authorisation. B 5147 such time as the Director may, from time to time require by notice in the Gazette. (4) Where a proposed modification of an authorisation: (a) concerns an extension of uses, the Director shall extend the authorisation subject to the particular conditions placed on the active substance listed in Parts I or IA of the Register of active substances to these regulations; (b) involves changes to the particular conditions placed on the active substance listed in Parts I or IA of the Register of active substances, such changes can be made only after evaluation of the active substance, with regard to the proposed changes, in accordance with the procedures laid down in regulation 17 of these regulations. 16. Without prejudice to any provision made by or under the Act, it shall be the duty of any other person holding an authorisation granted to him in accordance with regulation 9 of these regulations to: (a) keep such records and for such time as the Director may from time to time require by notice in the Gazette; (b) inform the Director in writing, as soon as practicable, of any change to any information supplied to the Director for the granting of the authorisation, in particular: (i) changes in the source or composition of the active substance; (ii) changes in composition of a biocidal product; (iii) development of resistance of the target harmful organisms; (iv) changes of an administrative nature or other aspects, such as the nature of the packaging; (c) inform the Director in writing, as soon as practicable, of any adverse effect on the user through the use or exposure to the product that may have been brought to his attention; (d) 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 biocidal product; Obligations of the holder of an authorisation. B 5148 (e) allow the Director or his authorised representative with access to the land or premises at any reasonable time; and (f) comply with any provision made by or under the Act. 17. (1) An application for the granting of an authorisation for the placing on the market in Malta of a biocidal product shall be submitted to the Director in Maltese or English together with a dossier or a letter of access for the biocidal product satisfying, in the light of current scientific and technical knowledge, the requirements set out in Annex IIB and, where specified, the relevant parts of Annex IIIB to Council Directive 98/8/EEC of 16 February 1998 concerning the placing of biocidal products on the market (Official Journal of the European Communities, L 123) and as may from time to time be amended, and Provided that, the Director may from time to time by Notice in the Gazette establish the organisation and content of the application form that is to be submitted by an applicant. (2) By way of derogation from sub-regulation (1) above, a dossier submitted to the Director in relation to the granting of an authorisation of a low-risk biocidal product shall comprise the following data: (a) applicant: (i) name and address, (ii) manufacturers of the biocidal product and the active substances, (names and addresses including location of manufacturer of the active substances) (iii) where appropriate, a letter of access to any relevant data needed; (b) identity of the biocidal product: (i) trade name, (ii) full composition of the biocidal product, (iii) physical and chemical properties as referred to in paragraph (d) of sub-regulation (2) of regulation 9 of these regulations; (c) intended uses: Application for an authorisation of a Biocidal product B 5149 (i) product type (as listed in Schedule one to these regulations) and field of use, (ii) category of users, (iii) method of use; (d) efficacy data; (e) analytical methods; (f) classification, packaging and labelling, including a draft label, according to Part Four of these regulations; (g) safety data sheet prepared in accordance with the national provisions relating to the classification, packaging and labelling of dangerous substances. (3) Only applications submitted by a person having a permanent office in Malta or a recognised country shall be considered for authorisation. (4) The dossiers under this regulation shall include a detailed and full description of the studies conducted and of the methods used or a literature reference to those methods. The information in the dossiers shall be sufficient for an evaluation to be made of the effects and properties referred to in sub-regulation (2) of regulation 9 of these regulations. It shall be submitted to the Director in the form of technical dossiers, containing the information and results of the studies referred to in Annexes IIB and, where specified, the relevant parts of Annexes IIIB to Council Directive 98/8/EEC of 16 February 1998 concerning the placing of biocidal products on the market (Official Journal of the European Communities, L 123) and as may from time to time be amended. (5) Information which is not necessary owing to the nature of the biocidal product or of its proposed uses need not be supplied. The same applies where it is not scientifically necessary or technically possible to supply the information. In such cases, a justification, acceptable to the Director must be submitted. Such a justification may be the existence of a frame-formulation that the applicant has the right to access. (6) If the evaluation of the dossier shows that further information, including data and results from further testing, is necessary to evaluate the risks of the biocidal product, the Director shall ask the applicant to submit such information. The time period for the evaluation of the dossier shall commence from the provision of such information. B 5150 (7) The name of an active substance must be given as registered in the list contained and provided in the relevant regulations relating to the classification, packaging and labelling of dangerous substances or, if the name is not included therein, the active substance must be given its International Standards Organisation (ISO) common name. If the latter is not available, the substance must be designated by its chemical designation according to International Union of Pure and Applied Chemistry (IUPAC) rules. (8) Tests must be conducted according to the methods described in the relevant regulations relating to the classification, packaging and labelling of dangerous substances. When a method is inappropriate or not described, other methods used should be justified, whenever possible, be internationally recognised. Such tests where appropriate must be conducted in accordance with the relevant provisions of the Animal Welfare Act (Cap 439) regarding the protection of animals used for experimental and other scientific purposes and in any case texts shall comply with the relevant provisions relating to the principles of Good Laboratory Practice (GLP). (9) Without prejudice to the provisions of sub-regulation 8 of this regulation the need to conduct any test shall be decided by the Director on a case-by-case basis, taking into account, among other factors, the need to minimise testing on vertebrate animals. (10) The Director may require that samples of the preparation and of its ingredients shall be provided. In addition to the application for the granting of an authorisation to this regulation an applicant shall submit such samples of the biocidal product, of its ingredients and models or drafts of the packaging, labelling and leaflets as the Director may require 18. (1) The Director shall draw up, keep and maintain a separate product record for each biocidal product for which an application for the granting of an authorisation has been submitted in accordance with these regulations. (2) Each record shall as a minimum contain: (a) a copy of the application submitted to the Director by the applicant; (b) a record of the administrative decisions taken by the Director concerning the application and concerning the dossiers submitted in accordance of sub-regulation (1) of regulation 17 of these regulations, with a summary of the latter; and Biocidal product record. B 5151 (c) any other document or information submitted, considered or used during the course of evaluating the application and the dossier. 19. (1) The Director shall keep and maintain, subject to the provisions of sub-regulation 7 of regulation 4 of these regulations, a register of active and basic substances referred to as ‘The register of active substances’ for biocidal products which shall be divided into 3 parts Part1, Part 1A and Part 1B. Part 1 shall contain a list of active substances which may be contained in biocidal products; Part 1A shall contain a list of active substances which may be contained in low risk biocidal products; Part 1B shall contain a list basic substances. (2) Such register shall, as a minimum, contain the following information: (a) a reference number for the entry in the register; (b) the date of registration; (c) the common name of the active substance/s; (d) the Chemical Abstracts Service (CAS) registry number of each active substance; (e) the classification of the active substance in accordance with the provisions of sub-regulation (1) of regulation 4 of these regulations or whether such classification is still pending; (f) the date on which a decision on the classification was made and a track record of any subsequent change in the classification of the active substance; and (g) any other information the Director may, from time to time, require by Notice in the Gazette. (3) The Director shall also keep a register of biocidal products which shall, as a minimum, contain the following information: (a) the authorisation number of the biocidal product; (b) the date of issue of the current authorisation and a track record of any subsequent issue or otherwise of an authorisation; (c) the date on which the current term of authorisation will expire; Registers to be kept and maintained. B 5152 (d) the name by which the biocidal product is to be placed on the market in Malta; (e) the name, Chemical Abstracts Service registry number and percentage of all active substances contained within the formulation; (f) whether the product is a low risk biocidal product or otherwise; (g) the name and contact details of the authorisation holder; and (h) any other information the Director may, from time to time, establish. 20. (1) The Director shall publish in the Gazette a list of all the active and basic substances contained in the register established under regulation 19 of these regulations and such publication shall: (a) be issued at least once annually and prior to the 1st day of February; (b) contain, as a minimum, the following information: (i) the common name and Chemical Abstracts Service registry number of the active or basic substance; (ii) the classification of the active or basic substance or an indication that the classification of the active substance is still pending. (2) Whenever a new active substance has been entered in the register of active substances or the classification of the active or basic substance has changed, the Director shall, by Notice in the Gazette, publish in relation to such active substance, the information specified in paragraph (b) of the foregoing sub-regulation and such publication shall be deemed to amend the list issued under sub-regulation (1) of this regulation. 21. (1) The Director shall publish in the Gazette a list of all biocidal products authorised for marketing or use in Malta and such publication shall: (a) be issued at least once annually and prior to the 1st day of February; Publication of registered active substances. Publication of authorised biocidal products. B 5153 (b) contain, as a minimum, the following information: (i) the name by which the product is to be placed on the market in Malta; (ii) the active substance and concentration; (iii) the name and postal address of the holder of the authorisation; (iv) whether the product is a low risk biocidal product or otherwise; (v) the authorisation number of the product. (2) Whenever an authorisation has been issued in relation to a biocidal product the Director shall, by notice in the Gazette publish in relation to such biocidal product, the information specified in paragraph (b) of the foregoing sub-regulation and such publication shall be deemed to amend the list of biocidal products issued under subregulation (1) of this regulation. (3) The Director shall by Notice in the Gazette, as soon as practicable, specify the biocidal product for which the authorisation has been suspended or revoked and such publication shall be deemed to amend the list of biocidal products issued under sub-regulation (1) of this regulation. 22. (1) For the purposes of these regulations, and without prejudice to the provisions of regulation 46 of these regulations the Director may deem that a biocidal product or an active substance that is intended for inclusion in a biocidal product satisfies the conditions of these regulations, if in relation to such product, an authorisation has been issued by a recognised country. (2) For the purposes of the issue of an authorisation in accordance with regulation 9 of these regulations the Director shall not require that tests and analysis already carried out by a recognised country be repeated for the purposes of issuing an authorisation provided that: (a) the applicant makes a request for the application to be treated in accordance with this sub-regulation; (b) the applicant provides suitable evidence as to the authenticity of the authorisation issued by a recognised country to the satisfaction of the Director; Recognition of equivalent standards. B 5154 (c) tests and analysis were carried out under circumstances of use, such as climate or breeding period of the target species, relevant to the use of the biocidal product that are comparable to those existent in Malta. (3) Where any test or analysis required for authorisation under these regulations has not been carried out under conditions as are referred to in paragraph (c) of sub-regulation (2) of this regulation, the Director may require that: (a) the applicant carries out such tests or analyses in accordance with conditions existing in Malta; (b) if the applicant so requests, the authorisation shall be issued subject to such conditions that may be required in order to render any non-comparable circumstances of use, such as climate or breeding period of the target species in the regions concerned, irrelevant for the purposes of comparability. Where following any test or analysis carried out as referred in sub-regulation (3) of this regulation, it is established that such tests or analyses establish that the product does not satisfy the conditions established in these regulations in all respects, the Director shall issue the authorisation subject to: (i) adjustment of conditions referred to in paragraphs (e), (f), (h), (j) and (l) of sub-regulation (3) of regulation 35 of these regulations to render irrelevant any non-comparable circumstances for the purposes of comparability; and (ii) any other such restriction as he may deem appropriate. 23. (1) Subject to the provisions relating to the conditions for distribution and use of biocidal products under this or any other legislation, the Director may authorise the use of an abridged authorisation process in relation to a biocidal product that is identical to another product already authorised for placing on the market in Malta or in relation to a biocidal product which is placed on the market in a recognised country: (2) For the purposes of sub-regulation 1 of this regulation, “identical biocidal products” 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 its active substances are the same. Abridged authorisation process and requirements for biocidal products already authorised in Malta and in a recognised country. B 5155 (3) An application for an authorisation for the placing on the market of a biocidal product in accordance with the provisions of this regulation shall contain, as a minimum, the following information: (a) a summary of the dossier as required sub-regulation (1) of regulation 17 of these regulations and Section X of Annex IIB to Council Directive 98/8/EEC of 16 February 1998 concerning the placing of biocidal products on the market (Official Journal of the European Communities, L 123) and as may from time to time be amended, and a certified copy of the first authorisation granted; and in the case of low-risk biocidal products, the data requirements of sub-regulation (2) of regulation 17 of these regulations, except for the efficacy data for which a summary shall suffice; (b) the trade name of the product to be imported; (c) the authorisation number of the imported product; (d) the original label of the imported product and an official translation of it in the Maltese and English languages; (e) the trade name of the reference product; (f) the authorisation number of the reference product; (g) the trade name with which the product will be marketed in Malta; (h) the proposed draft label of the product to be marketed in Malta; (i) a sample of the product as it will be marketed in Malta; (j) a sample of the package as it will be marketed in Malta; and (k) any other additional information as the Director may deem necessary for establishing that the conditions specified in this regulation are satisfied: Provided that the active substance of the biocidal product is included in Parts I or IA of the Register of active substances and conforms to the requirements thereof. (4) In establishing whether the conditions of sub-regulation (1) of this regulation are satisfied, the Director may consult with the B 5156 competent authority of the recognised country in which the biocidal product has been authorised to be placed on the market. (5) 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. (6) Any authorisation issued in accordance with this regulation shall be valid for a maximum period of three (3) years from the date of issue and shall, unless previously revoked, be renewable on application by the holder made at least three (3) months before expiry of the validity period. (7) 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: Provided further that the Director may refuse the granting of an authorisation according to this regulation in the following circumstances: (a) for product types 15, 17 and 23 listed in Schedule One to these regulations if such limitation can be justified and does not jeopardise the purposes of these regulations; (b) in accordance with the provisions of regulation 4 of these regulations, the Director establishes that the target species is not present in harmful quantities; (c) in accordance with the provisions of regulation 4 of these regulations, the Director establishes that there is unacceptable tolerance or resistance of the target organism to the biocidal product. 24. Notwithstanding any of the provisions under this part, the Director shall on application thereof authorise the placing on the market of a basic substance for biocidal purposes provided that such substance is listed under Part 1B in the register of active substances Placing of a basic substance on the market B 5157 PART THREE DEALING IN BIOCIDAL PRODUCTS 25. (1) No person shall deal in any: (a) active substance unless this is authorised in accordance with these regulations; (b) biocidal product unless this is authorised for placing on the market in Malta in accordance with these regulations; (2) No person shall deal in any active substance or biocidal product unless he is in possession of an authorisation to deal in active substances or biocidal products granted to him in accordance with regulation 26 of these regulations. 26. (1) Any application for the granting of an authorisation to deal in biocidal products or active substances shall be made in writing to the Director and shall contain such information, and accompanied by such documents, samples and other material as the director may require. (2) Any application shall contain as a minimum the following requirements: (a) the nature of any activity related to the dealing of active substances and biocidal products the applicant wishes to undertake; (b) the place where such activity is to take place, and 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 the director; (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 the person who will be effectively responsible for carrying out the activity; Authorisation to deal in biocidal products and their active substances. Application for an authorisation to deal. B 5158 (g) in the case of an application for the manufacture of a biocidal product, the name of the biocidal product and any formulation which is to be, or 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. (3) The Director shall determine the application within a reasonable period of time; not exceeding 45 working days from the date of receipt of an application: (4) 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 requisite 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. (5) Any authorisation issued in accordance with this regulation shall be made in writing and be subject to any such condition 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. 27. Any authorisation issued by the Director in accordance with regulation 26 of these regulations shall be valid for such a period not exceeding three (3) years as may be specified in the authorisation: Provided that the Director may extend the validity of any such authorisation upon the submission of an application for its renewal of the authorisation submitted to him in accordance with regulation 30 of these regulations and if he is satisfied that the conditions established by regulation 26 of these regulations are still being complied with. 28. Without prejudice to regulation 29 of these regulations, and if the Director suspects that any of the conditions established by regulation 25 of these regulations is no longer satisfied, the Director: (a) shall require the applicant for authorisation or the holder of the authorisation to submit further information necessary to establish compliance with the provisions of regulation 26 of these regulations or such other information as may be reasonably required; (b) may carry out any inspection, review or test that he deems necessary; Duration of validity of an authorisation. Review of authorisation. B 5159 (c) may suspend the authorisation in accordance with regulation 29 of these regulations. 29. (1) Any authorisation issued in accordance with regulation 26 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 regulation 25 of these regulations is no longer satisfied; or (c) the applicant for authorisation requests that the Director revokes the authorisation to deal in biocidal products or active substances; or (d) if the activity is being carried out in contravention to any provision made by or under the Act. (2) Where the Director suspends or revokes an authorisation, he shall notify the holder of the authorisation in writing of such suspension or revocation also providing reasons on which such a decision was based. 30. On the expiry of an authorisation, the Director shall renew the authorisation 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 regulation 26 of these regulations are still being complied with: Provided that the Director may request the applicant for any additional information he may deem necessary prior to the renewal or otherwise of the authorisation: Provided further that any renewal of any authorisation may be subject to any such as the director may deem appropriate: 31. (1) Without prejudice to the provisions of regulation 28 of these regulations, 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 modification is justified and appropriate, and where relevant, reflects current scientific opinion. Suspension or revocation of an authorisation. Renewal of an authorisation. Modification of an authorisation. B 5160 (2) Without prejudice to regulation 29 of these regulations, the Director may modify the original authorisation if he considers that any condition on which the authorisation was based in accordance with regulation 25 of these regulations has been substantially altered. (3) Any request for a modification to the authorisation in accordance with sub-regulation (1) of this regulation shall be made by the holder of the authorisation in such form and in such manner and within such a time as the Director may, from time to time require by Notice in the Gazette. . 32. (1) 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 regulation 26 of these regulations to: (a) keep such records 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 to be kept for different types of dealing activities; (b) inform the Director, as soon as practicable and in writing, of any change in any information provided to the Director for the granting of the authorisation; (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 authorised representative such records that he may require; and (e) comply with the provisions made by or under the Act. (2) To the extent that may be applicable a person holding an authorisation under regulation 25 of these regulations shall exercise general supervision over his employees and shall, before requiring or permitting any of such employees to handle or to apply any biocidal product: (a) provide such employees with proper training in the safe handling and application of biocides; (b) ensure that any safety precaution set out in the label, or otherwise prescribed, is understood and complied with; and Obligations of the holder of an authorisation. B 5161 (c) ensure that such workers wear suitable protective clothing provided by him. (3) Where a person holding an authorisation of biocidal products has even the slightest suspicion that any biocidal product has caused any poisoning, he shall immediately notify the appropriate health authority. 33. (1) 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. (2) Such list shall contain the following information: (a) the name, surname and postal address of the authorised dealer; (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. 34. (1) Any person authorised to deal in biocidal products shall notify the Director of any consignment of any authorised biocidal product or active substance he brings into Malta. (2) 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. (3) The information supplied in relation to a biocidal product or active substance shall as a minimum include the following information: (a) the name of the product and the batch number; (b) the authorisation number; (c) the country of origin; (d) the quantity of the consignment; and (e) the date and place of bringing into Malta. 35. (1) No person shall advertise or cause to be advertised any biocidal product in any manner whatsoever unless such advertising has been authorised by the Director. Publication of list of authorised dealers Notification of entry into Malta. Advertising of biocidal products. B 5162 (2) 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 biocidal product. (3) The Director shall authorise the advertising of a biocidal product if: (a) he has received an application in accordance with sub regulation (2) of this regulation; (b) he is satisfied that the advertising sufficiently represents the content and conditions of the authorisation; (c) the advertising does not make use of any statement which cannot be technically proven; (d) the advertising does not include any statement that is false or otherwise misleading; (e) the advertising does not encourage the use of the biocidal product for any purpose or circumstance or instruction other than those specified by the authorisation for the biocidal product issued in accordance with regulation 9 of these regulations; (f) the advertising does not contain any wording or statement that claims or implies the absolute safety of the biocidal product and in particular shall not include any of the statements ‘low-risk biocidal product’ or ‘non-toxic’ or ‘harmless’ or any similar statement. (g) the advertising contains the statement ‘Use biocides safely. Always read the label and product information before use’: (4) In any authorised advertising the word biocide may be replaced by an accurate description of the product type referred to in Schedule 1 to these regulations. PART FOUR LABELLING AND PACKAGING OF BIOCIDAL PRODUCTS 36. (1) Biocidal products shall be classified and packaged in accordance with the provisions relating to classification and packaging of relevant regulations. Labelling of a biocidal product. B 5163 (2) Biocidal products shall be classified labelled and packaged in accordance with the provisions relating to packaging and labelling of relevant regulations. Labels shall not be misleading or give an exaggerated impression of the product. Subject to the provisions of these regulations, the label must show clearly and indelibly the following: (a) the identity of every active substance and its concentration in metric units; (b) the authorisation number allocated to the biocidal product by the Director; (c) the type of preparation contained within the product (e.g. liquid concentrates, granules, powders, solids, etc.); (d) the uses for which the biocidal product is authorised (e.g. wood preservation, disinfection, surface biocide, anti-fouling, etc.); (e) directions for use and the dose rate, expressed in metric units, for each use provided for under the terms of the authorisation; (f) particulars of likely direct or indirect adverse side effects and any directions for first aid; (g) if accompanied by a leaflet, the sentence ‘Read attached instructions before use’; (h) directions for safe disposal of the biocidal product and its packaging, including, where relevant, any prohibition on reuse of packaging; (i) the formulation batch number or designation and the expiry date relevant to normal conditions of storage; (j) the period of time needed for the biocidal effect, the interval to be observed between applications of the biocidal product or between application and the next use of the product treated, or the next access by man or animals to the area where the biocidal product has been used, including particulars concerning decontamination means and measures and duration of necessary ventilation of treated areas; particulars for adequate cleaning of equipment; particulars concerning precautionary measures during use, storage and transport (e.g. personal protective clothing and equipment, measures for protection against fire, covering of furniture, removal of food and feedingstuff and directions to prevent animals from being exposed); B 5164 and where applicable: (k) restricitions to the use of biocidal products; (l) information on any specific danger to the environment particularly concerning protection of non-target organisms and avoidance of contamination of water; (3) Information detailed in paragraphs (a), (b), (d) and where applicable (g) and (k) of this sub-regulation shall always be carried on the label of the product. Information detailed in paragraphs (c), (e), (f), (h), (i), (j) and (l) of this sub-regulation may be carried elsewhere on the packaging or on an accompanying leaflet integral to the packaging. Such information shall be regarded as label information for the purposes of these regulations. (4) In the case of microbiological biocidal products, labelling shall also comply with the provisions made by or under the Occupational Health and Safety Act relating to the protection of workers from risks related to exposure to biological agents at work. (5) It is prohibited for a label of a biocidal product to contain the statement ‘low-risk biocidal product’ or ‘non-toxic’ or ‘harmless’ or any similar phrase. (6) Where a biocidal product identified as an insecticide, acaricide, rodenticide, avicide or molluscicide is authorised under these regulations is subject to the provisions of relevant regulations, the Director may permit changes to the packaging and labelling of that product in so far as these do not conflict with the conditions of the authorisation issued under these regulations. (7) The label shall be resistant to exposure to normal conditions of storage, handling and use and shall ensure that its contents shall remain clear and legible throughout the expected product shelf life. 37. The packaging, including any material constituting the immediate container, any outer packaging or any fastening device of any biocidal product, shall as a minimum, satisfy the following requirements: (a) be designed and constructed so that its contents cannot disperse or leak in the environment during storage, transport, handling or otherwise of the container other than for the purpose of use or safe disposal; Packaging of a biocidal product. B 5165 (b) packaging shall be designed in a manner to minimise the likelihood for food, drink or feeding stuff; (c) not be susceptible to degradation through its contact or exposure to its contents and shall be stable under normal conditions of storage, handling or use; (d) shall not be liable to form harmful or dangerous compounds through the chemical interaction with any of its contents; and (e) be sealed in such a way that such a seal is irreparably damaged when the packaging is opened for the first time. (f) In the case of biocidal products which may be mistaken for food, drink or feeding stuff shall contain components to discourage their consumption. PART FIVE RESEARCH AND DEVELOPMENT 38. (1) Without prejudice to the provisions made by or under the Act, the Director may, upon receiving a written request for the issue of an authorisation for a biocidal product or active substance for the purpose of research and development in accordance with this regulation, authorise in writing, for a specific period of time, to keep, use, manipulate, study or otherwise experiment upon any biocidal product or any active substance intended exclusively for use in a biocidal product. (2) An unauthorised biocidal product or an active substance for exclusive use in a biocidal product may not be placed on the market for the purpose of any experiment or test which may involve or result in release to the environment unless the Director has assessed the complete record and issued an authorisation. Such authorisation shall limit the quantities to be used and areas to be treated as the director may deem fit to impose. Provided that such an authorisation shall not be required if the director has granted the pertson concerned the right to undertake such experiments and tests under the conditions of the authorisation issued for such research and development. (3) Such request 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 and shall, as a minimum contain all the necessary information that may be deemed necessary to establish and define: Authorisation for experimentation, research or testing. B 5166 (a) the biocidal product or active substance and the maximum quantities that are to be used or released during the course of such experimentation, research or testing; (b) the chemical, physical and biological properties of the biocidal product or active substance as determined by scientifically acceptable and validated laboratory testing including a dossier containing all the available data to permit an assessment to be made on the possible effects on human or animal health or the possible impact on the environment; (c) the premises, equipment, conditions and procedures to be used for purposes of experimentation, research or testing using the biocidal product or active substance and that these are suitable for use in such purpose; (d) any procedure, precaution and any matter that the Director may consider necessary to be undertaken during such test, research or experiment; (e) the procedures and precautions to be taken when any human being, animal, plant or the environment or any other object is, or may come in contact with or exposed to any biocidal product or active substance; (f) the details of all contingency plans in case of any possible contamination, release or spread of the biocidal product or active substance; (g) the minimum records that are to be kept, maintained and made available upon request to any authorised representative and the minimum period for which these records are to be kept; (h) the name and related qualifications or expertise of the applicant, the person responsible for undertaking the test, research or experiment, and where relevant any person which may be engaged in such undertaking; (i) the contact details of the applicant; (j) the details on how the biocidal product or active substance or any other test material is to be disposed or destroyed after use; (k) any other conditions or additional information as the Director may reasonably require from the applicant in writing. B 5167 (4) In granting an authorisation in accordance with this regulation the Director shall: (a) take into consideration the result of any inspection or any test carried out by an authorised representative in order to verify or establish any of the information outlined in sub-regulation (2) of this regulation; (b) be satisfied that, in the case of scientific research and development, the persons concerned draw up and maintain written records detailing the identity of the biocidal product or active substance, labelling data, quantities supplied and the names and addresses of those persons receiving the biocidal product or active substance and compile a complete record containing all available data on possible effects on human or animal health or impact on the environment. This information shall, if requested, be made available to the Director; (c) be satisfied that, in the case of process-oriented research and development, the complete record referred to in paragraph (b) of this sub-regulation is submitted to him and where the process oriented research & development is carried out in a recognised country such complete record shall also be submitted to the Competent Authority of such recognised country; (d) be satisfied that the test, research or experimentation is appropriate and safe; (e) be satisfied that the test, research or experimentation does not involve, or result in, release into the environment unless he has assessed the available data and issued an authorisation for the purpose which limits the quantities to be used and the areas to be treated: (f) be satisfied that the authorised person has at his disposal the expertise or capability to safely handle the biocidal product or active substance that is being authorised for use in the experimentation, research or testing; (g) be satisfied that all the necessary precautions shall be taken at all times by the authorised person or, where relevant, his employees or representatives; and (h) the premises, equipment, procedures and contingency plans are suitable and appropriate. B 5168 (5) An application submitted under this regulation shall be 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. Provided that the Director may, before determining the application, request the applicant to submit such further information relating to the application as he may consider appropriate. (6) The authorisation under this regulation may be issued in relation to testing or experimentation for any biocidal product or active substance whether such biocidal product or active substance is authorised or otherwise. 39. Any authorisation issued by the Director in accordance with regulation 38 of these regulations shall be valid for such period not exceeding 2 years as may be specified the Director but shall never exceed a maximum validity period of two years: Provided that the Director may extend the validity of any such authorisation upon the submission of an application for the renewal submitted to him in accordance with regulation 43 of these regulations. 40. The holder of an authorisation issued by the Director in accordance with regulation 38 of these regulations shall take all the necessary steps and measures to ensure that the conditions of such an authorisation are complied with at all times. 41. The Director shall not issue an authorisation in accordance with regulation 38 of these regulations if he has: (a) any reasonable doubt to believe that the information contained in the application may be false, inaccurate or of a misleading nature; (b) reason to believe that the risks to human beings, animals or the environment outweigh the potential benefits that will be derived from the experimentation, research or testing. 42. The holder of an authorisation issued by the Director in accordance with regulation 38 of these regulations shall immediately notify the Director of any change in any information submitted for issue of the authorisation under this Part. 43. (1) On the expiry of an authorisation, the Director shall renew the authorisation if: Duration of validity of an authorisation. Obligations of the holder of an authorisation. Refusal of an authorisation. Notification of any change in conditions. Renewal of an authorisation for research & development. B 5169 (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 regulation 38 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 authorisation: Provided further that any renewal of any authorisation may be subject to any such condition, as the Director may deem appropriate. (2) Where an application for renewal in accordance with sub-regulation (1) of this regulation has been submitted to the Director, the validity of the authorisation granted in accordance with regulation 38 of these regulations shall be deemed to continue to have effect until such time as the Director has determined the application for renewal. 44. (1) Any authorisation issued in accordance with regulation 38 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 regulation 38 of these regulations is no longer satisfied; or (c) the holder of the authorisation requests that the Director revokes the authorisation. (2) Where the Director suspends or revokes an authorisation, he shall notify in writing the holder of the authorisation of such suspension or revocation with detailed reasons on which such a decision was based. 45. (1) 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 issued in accordance with regulation 38 of these regulations. (2) Any request for a modification to the authorisation in accordance with sub-regulation (1) of this regulation shall be made by the holder of the authorisation in such form and such manner and within Suspension or revocation of an authorisation for experimentation etc. Modification of an authorisation for experimentation etc. B 5170 such time as the Director may, from time to time require by Notice in the Gazette. PART SIX MISCELLANEOUS 46. (1) In any case where any information has been submitted to the director in relation to any application under these regulations, the applicant may request the director to treat any information so submitted to him to be treated as confidential being of an industrial or commercial nature. In submitting such a request the applicant shall substantiate his demand. (2) The director may, if he deems such a request to be justified allow such information to be treated as confidential. In such a case the holder of an authorisation necessary shall inform the Director of any disclosure by himself or his representative of any such confidential information to any other person. (3) Notwithstanding the provision of sub regulation 1 of these regulations the following information shall after the issue of an authorisation, not be treated as confidential: (a) the name and postal address of the applicant; (b) the name and postal address of the biocidal product manufacturer; (c) the name and postal address of the active substance manufacturer; (d) the names and content of the active substance or substances in the biocidal product and the name of the biocidal product; (e) the names of other substances which are regarded as dangerous within the meaning of the provisions of relevant regulations relating to the classification, packaging and labelling of dangerous substances which contribute to the classification of the product; (f) physical and chemical data concerning the active substance and biocidal product; Confidentiality. B 5171 (g) any ways of rendering the active substance or biocidal product harmless; (h) a summary of the results of the tests required pursuant to regulation 17 of these regulations to establish the substance’s or product’s efficacy and effects on humans, animals and the environment and, where applicable, its ability to promote resistance; (i) recommended methods and precautions to reduce dangers from handling, storage, transport and use as well as from fire or other hazards; (j) safety data sheets; (k) methods of analysis referred to in paragraph (c) of sub regulation (2) of regulation 9 of these regulations; (l) methods of disposal of the product and of its packaging; (m) procedures to be followed and measures to be taken in the case of spillage or leakage; and (n) first aid and medical advice to be given in the case of injury to persons. 47. (1) Where an application has been made for the registration of an active substance, which has already been registered by another applicant in terms of regulation 4 of these regulations. Information in relation to the first applicant should not be disclosed for the benefit of the second or subsequent applicant: (a) unless the second or subsequent applicant has the written agreement in the form of a letter of access of the first applicant that use may be made of such information, or (b) in the case of any information submitted for a registration of an active substance made under paragraph (b) of subregulation 1 of regulation 8 of these regulations, before the lapse of 15 years from the date of first inclusion in part 1 or 1A in the register of active substances, or (c) in the case of an active substance already on the market on May 14, 2000 for a period of 10 years from the date of entry of an active substance into Parts I or IA of the Register of active substances to these regulations for information submitted for the first time in support of the first inclusion in Parts I or IA of the Use of data held by the Director for other applicants. B 5172 Register of active substances of either the active substance or an additional product type for that active substance, (d) in the case of any further information submitted for the first time for any of the following: (i) variation of the requirements of the entry on Parts I or IA of the Register of active substances; (ii) maintenance of the entry of Parts I or IA of the Register of active substances for a period of five years from the date of decision following receipt of further information unless the five-year period expires before the period provided for in paragraphs (b) and (c) of this sub-regulation, in which case the period of five years shall be extended so as to expire on the same date as those periods. (2) Where an application has been made for the authorisation of a biocidal product, which has already been registered by another applicant in terms of regulation 9 of these regulations. Information in relation to the first applicant should not be disclosed for the benefit of the second or subsequent applicant: It shall not be made use of the information referred to in regulation 17 of these regulations, for the benefit of a second or subsequent applicant: (a) unless the second or subsequent applicant has the written agreement in the form of a letter of access of the first applicant that use may be made of such information; or (b) in the case of a biocidal product containing an active substance not on the market on May 14, 2000 for a period of 10 years from the date of first authorisation or; (c) in the case of a biocidal product containing an active substance already on the market on May 14, 2000, for a period of 10 years from the date of entry of an active substance onto Parts I or IA of the Register of active substances, for information which is submitted for the first time in support of the inclusion in Parts I or IA of the Register of active substances either of the active substance or of an additional product type for that active substance; (d) in the case of any data submitted for the first time for either of the following: B 5173 (i) variation of the conditions of authorisation of a biocidal product; (ii) submission of data necessary to maintain entry of an active substance onto Parts I or IA of the Register of active substances for a period of five years from the date of first receipt of further information, unless the five-year period expires before the period in paragraphs (b) and (c) of this sub-regulation, in which case the period of five years shall be extended so as to expire on the same date as those periods. 48. Where any provision of these regulations provides that the Director may issue or grant any authorisation or may carry out any verification, test, analysis or any other activity in relation to the issue, renewal or maintenance of such authorisation, the Director may request the payment of such fees as may be required to cover the costs and expenses of such services as may be prescribed. 49. (1) Every other provision of law made from or under this Act that regulates these regulations in a different manner shall be deleted upon the expiry of thirty days upon the publication of these regulations in the Gazette. (2) Without prejudice, such deletions shall be made to anything made or omitted under the provisions made before that date. Fees. Deletions and Safeguards B 5174 B 5175 B 5176 B 5177 B 5178 B 5179 B 5180 B 5181 B 5182 B 5183 B 5184 B 5185 B 5186 B 5187 B 5188 B 5189 B 5190 B 5191 B 5192 B 5193 B 5194 B 5195