European Communities (Classification, Packaging and Labelling of Pesticides) Regulations, 1985 (S.I. No. 370 of 1985)

European Communities (Classification, Packaging and Labelling of Pesticides) Regulations, 1985 I, AUSTIN DEASY, Minister for Agriculture, in exercise of the powers conferred on me by section 3 of the European Communities Act 1972 (No. 27 of 1972), and for the purpose of giving effect to Council Directive No. 78/631/EEC of 26 June, 19782, Council Directive 81/187/EEC of 26 March 19813, and Commission Directive 84/291/EEC of 18 April, 19844, hereby make the following Regulations: 2O.J. No. L88/29 2/4/1981 3O.J. No. L144/1 30/5/1984 4O.J. No. L196/1 16/8/1967 REG 1 1. (1) These Regulations may be cited as the European Communities (Classification, Packaging and Labelling of Pesticides) Regulations, 1985. (2) These Regulations shall come into operation on the 2nd day of December, 1985. REG 2 2. In these Regulations— "carcinogenic", "corrosive", "dangerous for the environment", "the environment", "explosive", "extremely flammable", "flammable", "highly flammable", "irritant", "oxidising", "preparations", and "substances" have the same meanings as in the Directive of 1967, as amended by the Directive of 1979; "the Directive of 1967" means Council Directive No. 67/548/EEC of 27 June, 19671; "the Directive of 1978 means Council Directive No. 78/631/EEC of 26 June, 19782;; "the Directive of 1979" means Council Directive No. 79/831/EEC of 18 September, 19795; "Annex I" (which is set out in the Schedule hereto) means Annex II to the Directive of 1967, as amended by Commission Directive 83/467/EEC of 29 July 19836; 1O.J. No. L206/13 29/7/1978 2O.J. No. L88/29 2/4/1981 5O.J. No. L259/10 15/1/1979 6O.J. No. L257/1 16/9/1983 "Annex II" (which is set out in the Schedule hereto) means Annex III to the Directive of 1967, as amended by Council Directive 73/146/EEC of 21 May 19737 and Commission Directives 76/907/EEC of 14 July 19768, 79/370/EEC of 30 January 19799 and 83/467/EEC of 29 July 19836; 7O.J. No. L167/1 25/6/1973 8O.J. No. L360/1 30/12/1976 9O.J. No. L88/1 7/4/1979 6O.J. No. L257/1 16/9/1983 "Annex III" (which is set out in the Schedule hereto) means Annex IV to the Directive of 1967, as amended by Commission Directives 76/907/EEC of 14 July 19768, 79/370/EEC of 30 January 19799 and 83/467/EEC of 29 July 19836; 8O.J. No. L360/1 30/12/1976 9O.J. No. L88/1 7/4/1979 6O.J. No. L257/1 16/9/1983 "Annex IV" (which is set out in the Schedule hereto) means Annex V to the Directive of 1978; "Annex V" (which is set out in the Schedule hereto) means Annex I to the Directive of 1978; "Annex VI" (which is set out in the Schedule hereto) means Annex III to the Directive of 1978 as amended by Commission Directive 84/291/EEC of 18 April 198410; 10O.J. No. L144/1 30/5/1984 "Annex VII" means Annex VII set out in the Schedule hereto, which comprises additional safety advice in accordance with Article 6 (5) of the Directive of 1978; "the Minister" means the Minister for Agriculture; "authorised officer" means an officer of the Minister appointed in writing by the Minister to be an authorised officer for the purpose of these Regulations; "placing on the market" has the same meaning as in the Directive of 1967, as amended by the Directive of 1979; "aircraft" includes hovercraft. REG 3 3. (1) Subject to paragraph (2) of this Regulation, these Regulations apply to any pesticide which is a pesticide for the purposes of the Directive of 1978. (2) These regulations shall not apply to— ( a ) any medicine, narcotic or radioactive preparation; ( b ) the carriage of pesticides by rail, road, inland waterway, sea or air; ( c ) any pesticide intended for export to a country other than a Member State of the European Communities; ( d ) pesticides which are in transit subject to customs control and which do not undergo any processing or transformation. REG 4 4. (1) The placing on the market of a pesticide to which these Regulations apply in the form in which it is supplied to the user and intended for use as such is hereby prohibited unless, in relation to it, the requirements of these Regulations regarding classification, packaging and labelling are complied with. (2) The placing on the market of a pesticide to which these Regulations apply is hereby prohibited if the packaging or any label used in relation to it has such indications as "non-toxic", "harmless" or other similar indications. (3) The placing on the market of a pesticide to which these Regulations apply in a package of any class or description is hereby prohibited unless three samples of such package (including any label or container used with the package) have been previously submitted to the Minister for examination by him and the Minister is, as a result of the examination, satisfied that the package, label or container complies with the requirements of these Regulations. (4) Notwithstanding paragraph (3) of this Regulation, in the case of a pesticide which is on the market on or before the commencement of these Regulations, the pesticide shall no longer be placed on the market or used unless the package (including any label or container used with the package) is submitted for approval at a time to be specified by the Minister and is approved by him. REG 5 5. Pesticides to which these Regulations apply shall be classified as being or not being carcinogenic, corrosive, dangerous for the environment, explosive, extremely flammable, highly flammable, irritant, mutagenic, oxidising or teratogenic according to the degree of hazard and the specific nature of the relevant risks, in accordance with Article 4 of the Directive of 1967 (as amended by the Directive of 1979), on the basis of the information specified and the methods mentioned in Article 3 of the Directive of 1967 (as amended by the Directive of 1979). REG 6 6. (1) (a) Subject to subparagraph (b) of this paragraph, in addition to complying with the requirements of Regulation 5 of these Regulations, pesticides to which these Regulations apply shall be classified as to their toxicity, and such classification shall be made in the manner specified in Article 3 of the Directive of 1978, and in making such classification whichever of the reference values specified in subparagraph (a), (b) or (c) of paragraph (1) of the said article 3 is appropriate shall be used, and values shall be determined and tests shall be carried out, in accordance with the requirements of that paragraph. (b) Subject to subparagraph (c) of this paragraph where a pesticide to which these Regulations apply contains not more than one active substance, it may, with the consent of the Minister, be classified as to its toxicity by means of a calculation in accordance with Annexes V and VI, and where Annex VI does not contain LD50 figures for particular pesticides, the LD50 figures specified in the WHO Recommended Classification of Pesticides by Hazard, Guidelines to Classification 1984-85 (World Health Organisation VBC/84.2) shall be used. ( c ) a pesticide to which these Regulations apply shall only be classified in the manner mentioned in subparagraph (b) of this paragraph if— (i) it satisfies the requirement of subparagraph (a) or (b) of Article 3 (2) of the Directive of 1978; and (ii) the assumption specified in the said Article 3 (2) can be made on the grounds so specified. ( d ) If when making a classification pursuant to the requirements of subparagraphs (b) of this Regulation, facts appear which leave the correctness of the classification open to doubt, the Minister may require the calculation to be replaced by toxicological tests referred to in Article 3 (4) of the Directive of 1978. (2) Notwithstanding paragraph (1) of this Regulation, where the conditions specified in Article 3 (5) of the Directive of 1978 apply, additional toxicological data may be taken into account for the purpose of the classification of pesticides to which these Regulations apply. REG 7 7. (1) Where a pesticide is classified in compliance with the requirements of Regulation 6, the person on whose behalf the classification is made shall send to the Minister for consideration by him three copies of an accurate record of the studies conducted and information used to propose a classification or classifications and to establish the nature and extent of foreseeable risks which the handling or use of the pesticide entails, together with relevant supporting documentation and materials, as may be specified from time to time by the Minister, together with the particulars of any safety precautions or other recommendations and the conclusions reached as a result of the studies, information and materials. (2) ( a ) In the case of a pesticide which is on the market on or before the commencement of these regulations, the pesticide shall no longer be placed on the market or used unless the record and the information, documentation and material to which it relates are submitted for approval at a time to be specified by the Minister and are approved by him. ( b ) In the case of a pesticide which is not on the market on or before the commencement of these Regulations, the pesticide shall not be placed on the market or used unless the record and the information, documentation and materials to which it relates have been approved by the Minister. REG 8 8. (1) The packaging of a pesticide to which these regulations apply together with the fastenings or containers used in such packaging and the materials constituting such packaging or fastenings shall comply with the requirements of Article 5 of the Directive of 1978. (2) Where the packaging of a pesticide to which these Regulations apply includes an inner liner, except where the liner is used as a seal to protect rodenticide baits, it shall not be detachable from the rest of the packaging unless it itself complies with the requirements of paragraph (1) of this Regulation. (3) In addition to complying with paragraph (1) of this Regulation— ( a ) packages containing a pesticide to which these regulations apply shall be closed with a distinctive seal in such a way that when the package is opened for the first time the seal is irreparably damaged, and ( b ) containers containing such a pesticide, having a capacity not exceeding three litres and containing a pesticide intended for domestic or garden use shall have fastenings designed (such as by requiring at least three simultaneous actions to open them) to resist their being opened by children. REG 9 9. (1) Subject to paragraphs (2) and (4) of this Regulation, the label on or attached to packaging mentioned in Regulation 8 (1) of these Regulations shall comply with the requirements of paragraphs (1) and (3) of Article 7 of the Directive of 1978 or the requirements specified in Article 7 (5) of that Directive and which, if complied with, are to be regarded as satisfying the labelling requirements of that Directive. (2) Subject to paragraphs (3) and (4) of this Regulation, where a package is either too small or is otherwise unsuitable for labelling in accordance with paragraphs (1) and (3) of Article 7 of the Directive of 1978, a label shall be attached thereto and be as large as practicable. (3) A label shall not be required under this Regulation where the particulars referred to in Article 7 (2) of the Directive of 1978 are shown on the packaging itself in the manner specified in that Article. (4) Where— ( a ) the packaging is either too small or is unsuitable to enable all the information required by paragraph (1) of this Regulation to be shown on the container itself or on a label on or attached thereto, or ( b ) packaging contains a pesticide which has been classified pursuant to these Regulations as being neither very toxic nor toxic and the quantity so contained is small and presents no danger to persons handling the pesticide or who are otherwise concerned, the labelling required by paragraph (1) of this Regulation shall be in a manner which for the time being stands approved of for the purposes of this paragraph by the Minister and which he considers appropriate. (5) Subject to Article 7 (5) of the Directive of 1978, where packaging mentioned in Regulation 8 (1) of these Regulations comprises an outer pack and one or more inner containers, the inner container shall not, or none of such containers shall, as may be appropriate, be sold or offered for sale separately from the outer pack unless it or each of them, as may be appropriate, is also labelled in accordance with this Regulation. (6) The following information shall be stated clearly and in an indelible form on all packaging which is packaging mentioned in Regulation 8 (1) of these Regulations or on a label on or attached to such packaging in the Irish language or in the English language or in both the Irish and English languages: ( a ) the trade or proprietary name (if any) of the relevant pesticide; ( b ) the common name of each of the active substances contained in the pesticide according to the International Standards Organisation, or, if not available, according to the British Standards Institute, or, if a common name is not available, the chemical name according to rules of the International Union of Pure and Applied Chemistry; ( c ) the amount of each active substance so contained expressed:— (i) for pesticides which are solids, aerosols, volatile liquids (maximum boiling point 50°C) or vicious liquids (tower limit I Pa sat 20°C), as a percentage by weight, (ii) for other liquids, as a percentage by weight and in grams per litre at 20°C), (iii) for gases, as a percentage by volume, (iv) for phenoxy alkyl acids, their amides, esters and salts, on an acid equivalent basis; ( d ) in case the pesticide contains either a very toxic, a toxic, a harmful or a corrosive substance, other than an active substance, or in case the pesticide contains a solvent and in relation to such substance or the solvent a concentration limit referred to in Article 6 (2) (d) of the Directive of 1978 is exceeded, the name of the substance or the solvent; ( e ) the net quantity of the pesticide given in the manner specified in Article 6 (2)( e ) of the Directive of 1978; ( f ) the batch number of the formulation; ( g ) an indication of the nature of the formulation; ( h ) the clearance number of the formulation; ( i ) in the case of pesticides which are pesticides first mentioned in Article 6 (2) ( b ) of the Directive of 1978, the name and address of the manufacturer or any other person placing the pesticide on the market; ( j ) (i) the symbols and indications as specified in Annex I. (ii) an indication of the special risks referred to in Article 6 (2) ( b ) of the Directive of 1978, selected from among those contained in Annex II, (iii) safety advice concerning the use of the pesticide and which— (I) is shown and is selected in accordance with the requirements of Article 6 (4) of the Directive of 1978, and (II) complies with the indications referred to in Annexes III and IV, and (III) is additional advice in accordance with article 6 (5) of the Directive of 1978 as set out in Annex VII to these Regulations; and ( k ) in case the package contains a pesticide which is very toxic, toxic or harmful within the meaning of Article 3 of the Directive of 1978, a statement that the packaging must not be re-used for any purpose, except in the case of containers which are specifically designed for re-use, recharging or refilling by the manufacturer or distributor. REG 10 10. The provisions of Regulations 8 arid 9 are in addition to, and not in substitution for, the provisions of the European Communities (Aerosol Dispensers) Regulations, 1977 (S.I. No. 144 of 1977) and the Packaged Goods (Quantity Control) Regulations, 1981 (S.I. No. 39 of 1981). REG 11 11. (1) Where the Minister is satisfied that it is established on the basis mentioned in Article 10 (1) of the Directive of 1978 that a pesticide constitutes a danger to health or safety, he may either prohibit the placing on the market of the pesticide or permit its being so placed only if conditions specified by him are complied with. (2) Where, subsequent to the placing on the market of a pesticide approved by the Minister in accordance with these Regulations, additional toxicological data become available and additional facts become apparent, in accordance with Article 3 (5) of the Directive of 1978, the classification, packaging, labelling and approval of the pesticide may be subject to review by the Minister on the basis of such additional toxicological data and such additional facts. REG 12 12. Where a person proposes to import a pesticide to which these Regulations apply, notice of the intended importation shall be given in writing to the Minister by or on behalf of the importer specifying— ( a ) the brand name of the pesticide, ( b ) the port, airport or other place at which it is expected to land or otherwise bring into the State the pesticide, ( c ) the date on which the pesticide is expected to be so landed or otherwise brought into the State, ( d ) the number of packs which the relevant consignment comprises (if it comprises more than one), ( e ) the pack size (given by reference to volume or weight) of the consignment or, in case the consignment comprises more than one pack, the pack size (so given) of each such pack, and ( f ) the destination to which the pesticide is consigned or, in lieu thereof, an address at which the pesticide may be examined, sampled, tested or inspected pursuant to paragraph (1) of Regulation 13. REG 13 13. (1) Subject to paragraph (5) of this Regulation, an authorised officer may at any reasonable time enter— ( a ) any place or premises in which he has reasonable grounds for believing that a pesticide is being manufactured, placed on the market, stored or used, ( b ) any railway wagon, vehicle, ship, vessel, aircraft, container or other thing in which he has reasonable grounds for believing that a pesticide is being either transported, stored or used and there or at any other place— (i) make such examinations, tests and inspections, and (ii) take samples of any pesticide which he finds in the course of his inspection and which he believes is or may be a pesticide to which these Regulations apply, as he may consider appropriate and provided the quantity which a sample taken pursuant to this Regulation comprises is reasonable. (2) A person who has in any place, on any premises or in any railway wagon, vehicle, ship, vessel, aircraft, container or other thing a pesticide to which these Regulations apply shall at all reasonable times— ( a ) afford to an authorised officer such facilities and assistance as are reasonably necessary for an inspection and taking of samples pursuant to this Regulation, ( b ) give an authorised officer any information which he may reasonably require regarding the purchase, importation, sale or use of any such pesticide and which is within the person's knowledge or procurement, ( c ) produce to an authorised officer any document relating to the raw materials used in the formulation of any pesticide which the authorised officer may reasonably require and when produced permit the officer to inspect and take extracts from the document. (3) In addition to the foregoing any person who carries on the business of manufacturing, formulating, packaging, processing or marketing a pesticide for the purposes of the Directive of 1978 shall— ( a ) keep records of all transactions regarding the pesticide, ( b ) produce at the request of an authorised officer any records, books or other documents relating to such business which are in his possession or under his control, ( c ) permit such an officer to inspect and take extracts from such records, books or other documents and give to the officer any information which is within his knowledge or under his control and which such officer may reasonably require in relation to any entries therein, ( d ) afford to any such an officer such facilities and assistance as are reasonably necessary for inspecting the stock of any pesticide on any premises on which such person carries on such a business, ( e ) give to such an officer any information he may reasonably require in relation to such transactions, including, in particular, information which he may reasonably require regarding any pesticide specified by him. (4) Where a sample is taken pursuant to this Regulation, the authorised officer concerned shall divide the sample into not more than three parts each of which he shall seal and mark. (5) In proceedings for an offence under these Regulations, the result of any test, examination or analysis of, or any report on, a sample taken pursuant to this Regulation shall not be adduced unless before the proceedings were instituted one of the parts into which the sample was divided (as required by paragraph. (4) of this Regulation) was left with, or sent by registered post to, the defendant or his agent. (6) An authorised officer shall be furnished with a certificate of his appointment as an authorised officer and when exercising any power conferred on him by these Regulations, shall, if requested by any person affected, produce the certificate to that person. REG 14 14. (1) An authorised officer may seize and retain, or seize, remove and retain any pesticide which he believes is a pesticide to which these Regulations apply and in relation to which the authorised officer has reasonable grounds for suspecting that there is or has been a failure to comply with any provision of these Regulations. (2) An authorised officer may by a notice in writing given to the owner or to the person in apparent charge or control of a pesticide which has been seized under this Regulation— ( a ) require things specified in the notice to be done in relation to the pesticide before it is released by an authorised officer, ( b ) either— (i) require the disposal of the pesticide by the person to whom the notice is given, in a manner specified in the notice and at the expense of the owner, or (ii) indicate the authorised officer's intentions of disposing of the pesticide at the expense of the owner, such disposal to be, in either case, such as will prevent the said pesticide from being placed on the market or used, and in case a notice given under this paragraph requires specified things to be done in relation to a pesticide, the authorised officer shall retain control of the pesticide to which the notice relates until the requirements of the notice have been complied with. (3) Where a notice is given under this Regulation, a person shall not, without the consent of the authorised officer by whom the notice was given sell, move, dispose of or otherwise interfere with the pesticide in any way pending compliance with the requirements of the notice. (4) Any person who is aggrieved by a notice given under paragraph (2) of this Regulation which requires the pesticide to which it relates to be disposed of or indicates an intention to dispose of such pesticide may, not later than the expiration of the period of seven days beginning on the date of the notice, appeal to the District Court against the notice. (5) ( a ) Where an appeal is made to the District Court under paragraph (4) of this Regulation, that court, if it is satisfied that— (i) the pesticide to which the relevant notice under this Regulation relates is one to which Regulation 3 (1) of these Regulations applies, and (ii) if such pesticide were released, it might be placed on the market or used for purposes not authorised under Regulation 3 (2) of these Regulations, and (iii) there has been a failure to comply with the provisions of these Regulations— shall order that the pesticide be disposed of in the manner specified in the notice, or in such other manner as may be specified in the court's order and which, in the opinion of the court, will prevent the pesticide from being used or placed on the market. ( b ) Where an order made by the District Court under this paragraph requires the pesticide to which it relates to be disposed of by an authorised officer, the cost of such disposal shall be recoverable by the Minister as a simple contract debt in any court of competent jurisdiction from the person who was the owner of the product at the time of its seizure under this Regulation. (6) A notice under this Regulation shall not come into force unless— ( a ) in case an appeal is taken against the notice, the appeal is withdrawn, ( b ) in any other case, the period during which such an appeal may be taken has expired. REG 15 15. (1) A person who contravenes Regulation 4 of these Regulations shall be guilty of an offence and shall be liable on summary conviction to a fine not exceeding £1,000, or, at the discretion of the court, to imprisonment for a term not exceeding six months, or both. (2) A person who fails to comply with the requirements of Regulations 7, 11 (1) or 12 or paragraphs (2) or (3) of Regulation 13 of these Regulations or who obstructs or interferes with an authorised officer in the course of exercising a power conferred on him by the said Regulation 13 or Regulation 14 of these Regulations shall be guilty of an offence and shall be liable on summary conviction to a fine not exceeding £1,000, or, at the discretion of the court, to imprisonment for a term not exceeding six months, or to both. REG 16 16. (1) An offence under these Regulations may be prosecuted by the Minister. (2) In proceedings for an offence under Regulation 15 (1) of these Regulations it shall be a defence for the defendant to prove that the pesticide to which the offence relates was either in stock or purchased by him during the twelve month period following the date of approval of the pesticide by the Minister in accordance with Regulation 7 (2). REG 17 17. The Minister may from time to time make Regulations fixing a scale of fees to be paid in relation to the submission to the Minister of any dossier, declaration, proposal or other document required to be submitted by these Regulations. SCHEDULE ANNEX I (Annex II to Council Directive 67/548/EEC as amended) SYMBOLS AND INDICATIONS EOExplosiveOxidizingFF+Highly flammableExtremely flammableTT+ToxicVery toxicCCorrosiveXnXiHarmfulIrritant ANNEX II (Annex III to Council Directive 67/548/EEC (as amended)) NATURE OF SPECIAL RISKS R1Explosive when dry.R2Risk of explosion by shock, friction, fire or other sources of ignition.R3Extreme risk of explosion by shock, fire or other source of ignition.R4Forms very sensitive explosive metallic compounds.R5Heating may cause an explosion.R6Explosive with or without contact with air.R7May cause fire.R8Contact with combustible material may cause fire.R9Explosive when mixed with combustible material.R10Flammable.R11Highly flammable.R12Extremely flammable.R13Extremely flammable liquefied gas.R14Reacts violently with water.R15Contact with water liberates highly flammable gases.R16Explosive when mixed with oxidising substances.R17Spontaneously flammable in air.R18In use, may form flammable/explosive vapour-air mixture.R19May form explosive peroxides.R20Harmful by inhalation.R21Harmful in contact with skin.R22Harmful if swallowed.R23Toxic by inhalation.R24Toxic in contact with skin.R25Toxic if swallowed.R26Very toxic by inhalation.R27Very toxic in contact with skin.R28Very toxic if swallowed.R29Contact with water liberates toxic gas.R30Can become highly flammable in use.R31Contact with acids liberates toxic gas.R32Contact with acids liberates very toxic gas.R33Danger of cumulative effects.R34Causes burns.R35Causes severe burns.R36Irritating to eyes.R37Irritating to respiratory system.R38Irritating to skin.R39Danger of very serious irreversible effects.R40Possible risks of irreversible effects.R41Risk of serious damage to eyes.R42May cause sensitisation by inhalation.R43May cause sensitisation by skin contact.R44Risk of explosion if heated under confinement.R45May cause cancer.R46May cause heritable genetic damage.R47May cause birth defects.R48Danger of serious damage to health by prolonged exposure.Combination of R-PhasesR14/15Reacts violently with water, liberating highly flammable gases.R15/29Contact with water liberates toxic, highly flammable gas.R20/21Harmful by inhalation and in contact with skin.R21/22Harmful in contact with skin and if swallowed.R20/22Harmful by inhalation and if swallowed.R20/21/22Harmful by inhalation, in contact with skin and if swallowed.R23/24Toxic by inhalation and in contact with skin.R24/25Toxic in contact with skin and if swallowed.R23/25Toxic by inhalation and if swallowed.R23/24/25Toxic by inhalation, in contact with skin and if swallowed.R26/27Very toxic by inhalation and in contact with skin. R27/28Very toxic in contact with skin and if swallowed.R26/27/28Very toxic by inhalation, in contact with skin and if swallowed.R36/37Irritating to eyes and respiratory system.R37/38Irritating to respiratory system and skin.R36/38Irritating to eyes and skin.R36/37/38Irritating to eyes, respiratory system and skin. ANNEX III (Annex IV to Council Directive 67/548/EEC as amended) SAFETY ADVICE S1Keep locked up.S2Keep out of reach of children.S3Keep in a cool place.S4Keep away from living quarters.S5Keep contents under . . . (appropriate liquid to be specified by the manufacturer).S6Keep under . . . (inert gas to be specified by the manufacturer).S7Keep container tightly closed.S8Keep container dry.S9Keep container in a well-ventilated place.S12Do not keep the container sealed.S13Keep away from food, drink and animal feeding stuffs.S14Keep away from . . . (incompatible materials to be indicted by the manufacturer).S15Keep away from heat.S16Keep away from sources of ignition — No smoking.S17Keep away from combustible material.S18Handle and open container with care.S20When using do not eat or drink.S21When using do not smoke.S22Do not breathe dust.S23Do not breathe gas/fumes/vapour/spray (appropriate wording to be specified by the manufacturer).S24Avoid contact with skin.S25Avoid contact with eyes.S26In case of contact with eyes, rinse immediately with plenty of water and seek medical advice.S27Take off immediately all contaminated clothing.S28After contact with skin, wash immediately with plenty of . . . (to be specified by the manufacturer).S29Do not empty into drains.S30Never add water to this product.S33Take precautionary measures against static discharges.S34Avoid shock and friction.S35This material and its container must be disposed of in a safe way.S36Wear suitable protective clothing.S37Wear suitable gloves.S38In case of insufficient ventilation, wear suitable, respiratory equipment.S39Wear eye/face protection.S40To clean the floor and all objects contaminated by this material, use . . . (to be specified by the manufacturer).S41In case of fire and/or explosion, do not breathe fumes.S42During fumigation/spraying, wear suitable respiratory equipment (appropriate wording to be specified by the manufacturer).S43In the case of fire, use . . . (indicate in the space the precise type of fire-fighting equipment. If water increases the risk, add — Never use water).S44If you feel unwell, seek medical advice (show the label where possible). S45In case of accident or if you feel unwell, seek medical advice immediately (show the lavel where possible.S46If swallowed, seek medical advice immediately and show the container or label.S47Keep at temperature not exceeding ... °C (to be specified by the manufacturer).S48Keep wetted with . . . (appropriate material to be specified by the manufacturer).S49Keep only in the original container. S50Do not mix with ... (to be specified by the manufacturer).S51Use only in well-ventilated areas. not recommended for interior use on large surface areas.S52Not recommended for interior use on large surfaces areas.COMBINATION OF S-PHRASESS1/2Keep locked up and out of reach of children.S3/9Keep in a cool, well-ventilated place.S3/7/9Keep container tightly closed in a cool, well-ventilated place.S3/14Keep in a cool place away from . . . (incompatible materials to be indicated by manufacturer).S3/9/14Keep in a cool, well-ventilated place away from . . . (incompatible materials to be indicated by the manufacturer).S3/9/49Keep only in the original container in a cool, well-ventilated place.S3/9/14/49Keep only in the original container in a cool, well-ventilated place away from . . .(incompatible materials to be indicated by the manufacturer).S7/9Keep container tightly closed and in a well-ventilated place.S7/8Keep container tightly closed and dry.S20/21When using do not eat, drink or smoke.S24/25Avoid contact with skin and eyes.S36/37Wear suitable protective clothing and gloves.S36/39Wear suitable protective clothing and eye/face protection.S36/37/39Wear suitable protective clothing, gloves and eye/face protection.S37/39Wear suitable gloves and eye/face protection.S47/49Keep only in the original container at temperature not exceeding . . .°C (to be specified by the manufacturer). ANNEX IV (Annex V to Council Directive 78/631) SAFETY ADVICE For pesticides classified as very toxic, toxic, harmful, corrosive or irritant, the following safety advice is compulsory: No. in Annex IV to Directive 67/548/EEC.Standard PhrasesS2Keep out of reach of childrenS20/21When using do not eat, drink or smokeS13Keep away from food, drink and animal feedingstuffsFor harmful pesticides:S44If you feel unwell, seek medical advice (show the label where possible)For every toxic and toxic pesticides:S45In case of accident or if you feel unwell, seek medical advice immediately (show the label where possible)Depending on the particular nature of the risks of the pesticide, the following safety advice must also be given:S22Do not breathe dustS23Do not breathe gas/fumes/vapour/sprayS27Take off immediately all contaminated clothingS36Wear suitable protective clothingS37Wear suitable glovesS42During fumigation/spraying wear suitable respiratory equipmentWhen a pesticide is classified as corrosive, the following safety advice must also be given:S28After contact with skin, wash immediately with plenty of ......(to be specified by the manufacturer)S37Wear suitable glovesS39Wear eye/face protectionWhen pesticide contains phosphoric acid esters, the following advice must also be given:S28After contact with skin, wash immediately with plenty of . . . (to be specified by the manufacturer)If two or more phrases are required, they can be combined in accordance with Annex IV. ANNEX V (Annex I to Council Directive 78/631/EEC) CLASSIFICATION BY CALCULATION OF PESTICIDES CONTAINING ONE ACTIVE SUBSTANCE Pesticides containing one active substance and one or more inert vehicles and/or adjuvants shall be classified by means of the following formula: where: L = oral LD50 of the active substance in the rat, C= concentration of active substance in percentage by weight, A = value determining the classification of the pesticide in accordance with Article 3 (1) (a). ANNEX VI (Annex III to Council Directive 78/631/EEC) LIST OF ACTIVE SUBSTANCES WITH INDICATIONS OF THEIR CONVENTIONAL LD50 AND LD50 VALUES Explanatory notes 1. The values in italics are those that are to be taken into consideration for the purpose of applying the formula. The other values are given for information in order to assign additional appropriate phrases indicating the nature of the special risk (R phrases) and safety advice (S phrases) that must appear on the label. 2. NR (not relevant). This indication means that the values are available but of no relevance for either the classification or the labelling of preparations: for example, percutaneous LD50 values exceeding the maximum limits laid down. EEC numberSubstanceConventional values ofOral I.D50 mg/kgCut. LD50 mg/kgIhl LC50 mg/1/4h015-079-00-7Acephate945NR605-008-00-32-Propenal (Acrolein)46562AlachlorI 200NR602-048-00-3Aldrin4698006-025-00-3Allethrin920NR616-004-00 6Allidochlor700360603-015-00-62-Propen-1-ol6490613-011-00-6Aminotriazole2 000613-010-00-0Ametryne1 405NRNR015-080-00-2Amidithion600612-052-00-72-Aminobutane3802 500006-018-00-5Aminocarb50275006-008-00-0Antu2015-056-00-1Azinphos ethyl12250015-039-00-9Azinphos-methyl16250006-020-00-6Barban1 300NRNRBarium carbonate650015-083-00-9Bensulide7703 950613-012-00-1Bentazone1 100NR006-036-00-3Benzthiazuron1 280609-024-00-1Binapacryl421720609-032-00-5Bromofenoxim1 217NRBromophos1 6002 181015-064-00-5Bromophos-ethyl711 000608-006-00-0Bromoxynil190602-044-00-1Camphechlor801 075006-011-00-7Carbaryl300NR006-026-00-9Carbofuran8120015-044-00 6Carbophenothion3227602-047-00-8Chlordane460700606-019-00-6Chlordecone114475650 007-00-3Chlordimeform340640607-074-00-9Chlorfenac5753 160603-049-00-1Chlorfenethol930607-075-00-4Chlorfenprop-methyl1 190015-071-00-3Chlorfenvinphos10108606-014-00-9Chlorophacinone2200015-085-00 XChlorphonium178750015-084-00-4Chlorpyrifos135202616-005-00-1Chlorthiamid757607 057-00-6Coumachlor900015-038-00-3Coumaphos16860607-059-00-7Coumatetralyl17015 086-00-5Coumithoate67Crotoxyphos74202613-004-00-8Crimidine1,25015-074-00 XCrufomate7702 000613-013-00-7Cyanazine182NR015-087-00-0Cyanophos610800Cycloheximide2015-070 00-8Cyanthoate3,2105050-002-00-0Cyhexatin5402 200607-039-00-82,4-D3751 500613-008-00-XDazomet640607-083-00-82,4-DB700800602-045-00-7DDT1132 510015-028-00-9Demeton-O1,7015-030-00-XDemeton-O-methyl180015-029-00-4Demeton S1,7015-031-00-5Demeton-S-methyl40302015-078-00-1Demeton-S-methyl sulphone37613-007-00-4Desmetryne1 3901 000015-088-00-6Dialifos5145006-019-00-0Diallate395015-040-00-4Diazinon300900602 021-00-61,2-Dibromo-3-chloropropane1701 420015-068-00-7Dichlofenthion270NR606-018-00-0Dichlone1 300602-012-00-71,2-Dichloroethane6702 800607-045-00-0Dichlorprop8001 400015-019-00-XDichlorvos56107603-044-00-4Dicofol6901 870015-073-00-4Dicrotophos22181602-049-00-9Dieldrin3810015-061-00-9Dimefox15006 010-00-1Dimetan120015-051-00-4Dimethoate425006-040-00-5Dimetilan47600006-028-00 XDinobuton140NR609-025-00-7Dinoseb58200609-023-00-6Dinocap980NR609-026-00 2Salts and esters of dinoseb60609-030-00-4Dinoterb25609-031-00-XSalts and esters of dinoterb25006-029-00-5Dioxacarb903 000015-063-00-XDioxathion2363616-007-00-2Diphenamid970015-060-00 3Disulfoton2,620613-021-00-0Dithianon640609-020-00-XDNOC25200607-076-00 XDodine1 000NR650-008-00-9Drazoxolon126602-052-00-5Endosulfan80359607-055-00-5Endothal sodium51750015-049-00-3Endothion30400602-051-00-XEndrin760015-036-00 2EPN1425006-030-00-0EPTC1 6523 200607-077-00-5Erbon1 120015-047-00-2Ethion161915015-089-00-1Ethoate-methyl3401 000Ethoprophos6226611-003-00-7Fenaminosulf601 000613-015-00-8Fenazaflor283700015-052-00-XFenchlorphos1 7402 000015-054-00-0Fenitrothion503607-047-00-1Fenoprop650015-090-00 7Fensulfothion3,53,5015-048-00-8Fenthion1901 680050-003-00-6Fentin acetate125500050-004-00-1Fentin hydroxide108607-078-00-1Fluenetil64616-002-00-5Fluoroacetamide1380015-091-00 2Fonofos825015-057-00-7Formothion365Hexachloroacetone1 5502 980Heptachlor epoxide34602-046-00-2Heptachlor100159613-017-00-98-Hydroxyquinoline sulphate200608-007-00-6loxynil110809loxynil.octanoate390602-053-00-0Isobenzan4,84006 009-00-6Isolan115,6607-079-00-6Kelevan240314602-043-00-6Lindane88900Malathion containing more than 1,8% isomalathion885Malathion containing 1,8% isomalathion or less2 000607-051-00-3MCPA700607-052-00-9Salts and esters of MCPA700607-053-00-4MCPB680607-054-00-XSalts and esters of MCPB680015-045-00-1Mecarbam36607-049-00-2Mecoprop930900015-094-00 9Mephosfolan99.7006-023-00-2Methiocarb35400080-003-00-1Mercurous chloride210605-005-00-7Metaldehyde630015-095-00-4Methamidophos7,5110015-069-00 2Methidathion251 546615-002-00-2Methyl isothiocyanate1752 780Methomyl17NRMevinphos44Molinate720Monuron1 480015-072-00-9Monocrotophos14112006-032-00-1Monolinuron1 800613-018-00-4Morfamguat325006-014-00-3Nabam395015-055-00-6Naled430800614 001-00-4Nicotine5050650-004-00-7Norbormide4,4015-066-00-6Omethoate50700015-034 00-1Parathion26,8015-035-00-7Parathion-methyl667006-034-00-2Pebulate1 120604-002-00-8Pentachlorophenol27105015-097-00-5Phenthoate400700015-033-00 6Phorate22,5015-101-00-5Phosmet2301 150015-022-00-6Phosphamidon17374Phospholan923015-100-00-XPhoxim1 845NR015-099-00-6Pirimiphos-ethyl1401 000006-037-00-9Promecarb74616-009-00-3Propanil1 400NRPropargite1 500Promurit0,28006-016-00-4Propoxur95NR015-032-00-0Prothoate814015-026-00 8Schradan915614-003-00-5Strychnine5006-038-00-4Sulfallate850015-027-00 3Sulfotep520607-041-00-92,4,5-T500607-042-00-4Salts and esters of 2,4,5-T500NR015-025-00-2TEPP1,12,4015-050-00-9Thiometon120700Thionazin1211006 039-00-XTriallate1 700015-098-00-0Trichloronate16135613-020-00-5Tridemorph6501 350Trifenmorph1 4002,3,6-TBA1 500006-005-00-4Thiaram5602 000015-024-00-7Triamiphos2048015-021-00-0Trichlorphon560NR015-059-00 8Vamidothion1031 160607-056-00-0Warfarin3006-012-00-2Ziram1 400602-008-00-5Tetrachloromethane(1)0.4602-002-00-3Bromomethane(1)0.40,004006-003 00-3Carbon disulphide(1)0,4015-004-00-8Aluminium phosphide(1)0,40,004015-006-00-9Zinc phosphide(1)0.40.004602-010-00-61.2-Dibromoethane(1)0.4603-023-00-XEthylene oxide(1)0,004016-010-00-3Sodium polysulphides(2)016-007-00-7Potassium polysulphides(2)016-008-00-2Ammonium polysulphides(2)016-005-00-6Calcium polysulphides(2)016-003-00-5Barium polysulphides(2)616-006-00-7Dichlofluanid(2)1 Not determined experimentally.2 Conventional LD50 and LC50 values have not been given to these substances because of their corrosive/irritant properties. ANNEX VII ADDITIONAL SAFETY ADVICE FS 1Store/keep in a safe place/under lock and key.FS 2Store/keep/away from/install out of reach of pets.FS 3Store unused sachets in a safe place. Do not store half-used sachets.FS 4Not to be used on food crops.FS 5For use only on crop/foodstuff/surface/situation/for control of/process.FS 6To be used only by operators instructed or trained in the use of chemical/product/type of product/and familiar with the precautionary measures to be observed.FS 7Do not apply directly to livestock/poultry/pets.FS 8Do not apply to clothing/fabric/bedding.FS 9Do not apply to surfaces on which food/feed is stored, prepared or eaten.FS 10Do not prepare/use/place bait/dust in larders/food cupboards where human or animal food or water could become contaminated.FS 11Do not use in wet weather/strong winds.FS 12Avoid all contact by mouth.FS 13Install out of reach of children.FS 14Wear respiratory equipment*/protective gloves/synthetic rubber gloves/PVC gloves/goggles/face shield/sou'wester/ overalls/apron/impervious apron/mackintosh/boots/ impervious boots/spray mask/dust mask when handling/diluting/ applying/spraying the concentrate/ liquid/dust/fumigant/bait/ product/treated seed/freshly treated timber/solution.*a suitable type of respirator and canister should be specified.FS 15Do not breathe dust/mist/smoke/fog.FS 16Wash off splashes (immediately).FS 17Wash hands and exposed skin/before eating, drinking or smoking and after work/before meals and after work/after use/handlingorWash hands before meals and after work.FS 18Extinguish all naked flames/including pilot lights/when applying the fumigant/dust/liquid/product.FS 19Do not apply in the presence of naked flames, hot surfaces or unprotected electrical equipment.FS 20Do not work in confined spaces or enter spaces in which high concentrations of vapour are present. Where this precaution cannot be observed distance breathing or self contained breathing apparatus must be worn, and the work should be done by trained operators.FS 21Ensure adequate ventilation when handling/applying (in confined spaces).FS 22Wash all protective clothing thoroughly after use, especially the insides of gloves.FS 23Do not handle seed unnecessarily.FS 24Not to be used as food or feedFS 25Do not re-use sack for food or feed.FS 26Do not allow ....... (product) ......... to come into contact with food or cooking utensils.FS 27Protect food preparing equipment and eating utensils from contamination during application.FS 28Do not exceed use of one unit/strip per.......cu m(cu f).FS 29Do not apply more than ........ per (state amount).FS 30Do not apply more than........ times per crop/season/time period.FS 31Keep children/pets/animals away from treated areas/baits for ...... hours/days.FS 32Remove/cover all foodstuffs/fish bowls/fish tanks/caged birds/pets/water storage tanks/before spraying/application/ dusting/treatment.FS 33Protect exposed water/feed/milk machinery/milk containers from contamination.FS 34Do not prepare/use/laybaits/dust/spray where food/feed/water could become contaminated.FS 35Remove exposed milk/collect eggs before application.orRemove pets/livestock/feed/exposed water/milk/collect eggs before application.FS 36Fumigate only under conditions which allow no leakage of gas to adjacent occupied premises.FS 37Do not harvest for at least (....days/weeks) after last application.FS 38For use on the following crops only with stated minimum interval between last application and harvesting. Any table prepared should be based on cleared uses for the product in question. This safety information may be combined on the label with that on the efficient use of the product.FS 39Keep unprotected persons/livestock/pets out of treated areas for at least . . . (interval)/until walls/surfaces are dry/until smoke has cleared.FS 40Dangerous/Harmful to livestock. Keep all livestock/out of treated areas/away from treated water/for at least ........ (interval). Bury or remove spillages,orKeep livestock out of treated areas for at least ........ (interval)/if poisonous weeds such as ragworth are present.FS 41Ventilate treated areas/rooms/confined spaces thoroughly/ before occupying/after application when gas/smoke has cleared.FS 42Prevent access to baits by children, domesticated animals and pets.FS 43Use bait containers clearly marked "Poison" at all/surface baiting points.FS 44Remove all remains of bait/and bait containers/and dead rodents/after treatment and burn/bury.FS 45Do not sow/plant/transplant, .......... (specify crops) ........ for at least ....... (interval).FS 46Do not use outdoors.FS 47Do not use in occupied dwelling-houses.FS 48Do not apply from the air.FS 49Dangerous/Harmful to game/wild birds/butterflies/animals. Bury spillages.FS 50Dangerous/Harmful to bees. Do not apply at flowering stage. Keep down flowering weeds.FS 51Dangerous/Harmful to fish. Do not contaminate ponds, waterways or ditches with chemical or used container.orDo not contaminate ponds, waterways or ditches with chemical or used container.FS 52Prevent any surface run off to drains.FS 53This material and its container must be disposed of in a safe way.FS 54All washable containers should be labelled: Wash out container thoroughly/empty washings into spraytank/and dispose of safely/dispose of as follows: ....... (specify).FS 55All non-washable containers should be labelled: Empty container completely and dispose of safely/dispose of as follows: ...... (specify).orReturn empty container as instructed by supplier.4.Medical Advice.Situations will arise where it is either desirable or necessary that medical advice additional to that provided in the context of safety phrases S 26, S 44, S 45 and S 46 be provided on labels. In such cases the following criteria apply:4.1 Organophosphorus Pesticides Symptoms These may include sweating, headache, weakness, faintness and giddiness, nausea, stomach pains, vomiting, small pupils, blurred vision, muscle twitching.First Aid If any of the above symptoms occur, particularly if there is known contamination; stop work; remove contaminated clothing; wash exposed skin and hair; prevent all exertion; and call doctor at once and show him the label.Guide to Doctor Specific treatment. 1. Where signs and symptoms are present and as early as possible, inject atropine sulphate 2 mg or pro rata for children and repeat (if necessary) until fully atropinised. 2. If available administer pralidoxime 1g by intra-muscular injection. Repeat after 3-4 hours.Other measures 1. Keep airway clear. 2. Watch respiration — intubation with endotracheal tube, or tracheotomy may be necessary in conjunction with artificial ventilation. 3. Put patient at complete rest in hospital for 24 hours at least.Confirmation of Diagnosis Estimate chlolinesterase activity (5 ml blood unhaemolysed, collected in an anticoagulant).Further Advice. Poisons Information Centre, Jervis Street Hospital, Dublin 1. Telephone 01:745588.4.2Dinitro pesticides Symptoms These may include fatigue, excessive and unusual sweating and thirst, with sleeplessness and loss of weight in protracted cases. In severe cases there may be rapidly increasing anxiety and restlessness with an increase in respiration and heart rate.First Aid If any of the symptoms occur, particularly if there is known contamination; stop work; remove contaminated clothing; wash thoroughly; keep person at rest in the coolest available place; sponge skin with cold water and give cold water to drink; and call doctor at once and show him the label.Guide to DoctorTreatment 1. Treat suspected cases of poisoning by vigorous cooling, giving abundant fluids and oxygen for dyspnoea. 2. Do not give morphine or barbiturates. 3. If swallowed, wash out stomach and give activated charcoal.Diagnosis Estimate blood DNOC/Dinoseb (DNBP) concentration. (5 ml blood collected in an anticoagulant).Further Advice Poisons Information Centre Jervis Street Hospital Dublin 1 Telephone 01:745588.4.3Carbamate pesticidesSymptoms These include excessive sweating, headache, weakness, faintness and giddiness, nausea, stomach pains, vomiting, small pupils, blurred vision, muscle twitching.First Aid If any of the above symptoms occur, particularly if there is known contamination; stop work; remove contaminated clothing; wash exposed skin and hair; prevent all exertion; call doctor at once and show him the label.Guide to Doctor Specific Treatment 1. Where signs and symptoms are present and as early as possible inject atropine sulphate 2 mg or pro rata for children and repeat if necessary until fully atropinised. 2. Do not use pralidoxine.Other Measures 1. Keep airway clear. 2. Watch respiration intubation with endotracheal tube or tracheotomy may be necessary in conjunction with artificial ventilation. 3. Put patient at complete rest in hospital for 24 hours at least.Further Advice Poisons Information Centre Jervis Street Hospital Dublin 1 Tel. 01: 745588.4.4Bipyridyl pesticidesSymptoms Following injestion, nausea, vomiting, abdominal pain and diarrhoea (often bloody) may occur within a few hours and result in severe fluid and electrolyte disturbance. In severe cases, circulatory collapse and coma may occur. The concentrate may cause irritation to skin and eyes.First Aid Wash concentrate or spray from skin immediately; wash eye splashes with water for 10 to 15 minutes and seek medical attention; if swallowed, induce vomiting, if not already occurring and take patient to hospital immediately.Guide to Doctor 1. Give stomach washout and at the same time test urine and gastric aspirate for the presence of paraquat or diquat. 2. If the test is positive, purge the gastrointestinal tract immediately with up to one litre of a 15% suspension of Fuller's Earth and 200 ml of 20% mannitol in water. 3. Give a sodium or magnesium sulphate purgative separately. 4. Contact the Poisons Information Centre for further advice on treatment.Quick Qualitative Test Paraquat and diquat can be detected by reduction to blue or green radical ion with sodium dithionite under alkaline conditions. Quick test capsules can be prepared by mixing the following materials: Sodium dithionite (hydrosulphite) 10g pH buffer powder 6g Sodium bicarbonate 25g The reagents, thoroughly mixed, and packed in 1g amounts in gelatin capsules (gauge 0) can be stored at room temperature in a screw-capped container for at least six months. The test is performed by breaking open the capsule and tipping the contents into 10ml of urine, and shaking gently until dissolved. A green or blue colour indicates the presence of paraquat or diquat.Further Advice Poisons Information Centre Jervis Street Hospital Dublin 1. Tel. 01: 745588 GIVEN under my Official Seal, this 22nd day of November, 1985. AUSTIN DEASY, Minister for Agriculture. EXPLANATORY NOTE. These Regulations prescribe classification, packaging and labelling conditions which must be complied with in relation to the placing on the market of pesticides, in accordance with Council Directive 78/631/EEC and amending Directives.