S.I. No. 138/1994 - European Communities (Classification, Packaging and Labelling of Pesticides) Regulations, 1994.

I, JOE WALSH, Minister for Agriculture, Food and Forestry, 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 1978 ¹ Council Directive 81/187/EEC of 26 March 1981 ², and Commission Directive 84/291/EEC of 18 April 1984 ³, taking account of Council Directive 67/548/EEC of 27 June 1967 ⁴as amended by Council Directive 92/32/EEC of 30 April ⁵ 1992 hereby make the following Regulations:

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1. (1) These Regulations may be cited as the European Communities (Classification, Packaging and Labelling of Pesticides) Regulations, 1994.

(2) These Regulations shall come into operation on the first day of June, 1994.

2 Interpretation.

2. (1) In these Regulations—

"Annex I" (which is set out in the First Schedule) means Annex II to the Directive of 1967, as amended by the Directive of 1992 and Commission Directive No. 93/21/EEC of 27 April 1993⁶;

"Annex II" (which is set out in the First Schedule) means Annex III to the Directive of 1967, as amended by the Directive of 1992 and Commission Directive No. 93/21/EEC of 27 April 1993⁶;

"Annex III" (which is set out in the First Schedule) means Annex IV to the Directive of 1967, as amended by the Directive of 1992 and Commission Directive No. 93/21/EEC of 27 April 1993⁶;

¹O.J. No. L206/13 29/7/1978.

²O.J. No. L88/29 2/4/1981.

³O.J. No. L144/1 30/5/1984.

⁴O.J. No. L196/1 16/8/1967.

⁵O.J. No. L154/1 5/6/1992.

⁶O.J. No. L110/2 4/5/1993.

"Annex IV" (which is set out in the First Schedule) means Annex V to the Directive of 1978;

"Annex V" (which is set out in the First Schedule) means Annex I to the Directive of 1978;

"Annex VI" (which is set out in the First Schedule) means Annex III to the Directive of 1978 as amended by Commission Directive 84/291/EEC of 18 April 1984³;

"Annex VII" means Annex VII set out in the First Schedule, comprises additional safety advice in accordance with Article 6 (5) of the Directive of 1978;

"Annex VIII" (which is set out in the First Schedule) means Annex II to the Directive of 1978 as amended by Council Directive 81/187/EEC of 26 March 1981 ² and Commission Directive 84/291/EEC of 18 April 1984³;

"Annex IX" (which is set out in the First Schedule) means Annex IX to the Directive of 1967 as amended by the Directive of 1992 and Commission Directive No. 91/410/EEC of 22 July 1991⁷;

"aircraft" includes hovercraft;

"approval" means acceptance by the Minister that, following examination, the record of studies conducted and the information, documentation, materials, labelling and packaging submitted in relation to a pesticide, are in compliance with the requirements of these Regulations and cognate words shall be construed accordingly;

"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;

"clearance" means clearance to market or use a pesticide for which the record of studies conducted, and the information, documentation, materials, labelling and packaging submitted in relation to the pesticide have been approved by the Minister in accordance with the requirements of these Regulations and cognate words shall be construed accordingly;

⁶O.J. No. L110/2 4/5/1993.

³O.J. No. L144/1 30/5/1984.

²O.J. No. L88/29 2/4/1981.

⁷O.J. No. L228/67 17/8/1991.

"designated chemist" means an officer of the Minister holding the position of a chemist authorised in writing by the Minister for the purposes of these Regulations;

"the Directive of 1967" means Council Directive No. 67/548/EEC of 27 June 1967⁴;

"the Directive of 1978" means Council Directive No. 78/631/EEC of 26 June 1978¹;

"the Directive of 1992" means Council Directive No. 92/32/EEC of 30 April 1992⁵;

"the Minister" means the Minister for Agriculture, Food and Forestry;

"notified" means the packaging, including any label or container used with the package, giving basic information as to the nature and composition of a pesticide on the market on or before the second day of December 1985, and as to the manufacturer or manufacturers, has been submitted and approved by the Minister and cognate words shall be construed accordingly;

"the State Chemist" means the Head of the State Laboratory or a member of the staff of the State Laboratory holding the position of a chemist authorised by the State Chemist in writing to perform functions assigned to the State Chemist under Regulation 16.

(2) In these Regulations, unless otherwise indicated—

( a ) a reference to a Regulation is a reference to a Regulation of these Regulations,

( b ) a reference to a paragraph or subparagraph is a reference to a paragraph or subparagraph of the provision in which the reference occurs,

⁴O.J. No. L196/1 16/8/1967.

¹O.J. No. L206/13 29/7/1978.

⁵O.J. No. L154/1 5/6/1992.

( c ) a reference to a Schedule is a reference to a Schedule to these Regulations.

(3) A word or expression that is used in any Council Directive of the European Communities mentioned in these Regulations has, unless the contrary intention appears, the meaning in these Regulations that it has in the Directive concerned.

3 Application.

3. (1) Subject to paragraph (2), these Regulations apply to any pesticide which is a pesticide for the purposes of the Directive of 1978, being:

( a ) a pesticide, which is mentioned in subparagraphs 1 to 5 of Article 2 of the Directive of 1978; or

( b ) a pesticide, which is mentioned in subparagraph 6 of Article 2 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, or

( d ) any pesticide which is in transit subject to customs control and which does not undergo any processing or transformation.

4 General Requirements for Placing on the Market.

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), in the case of a pesticide on the market on or before the second of December, 1985, the pesticide shall no longer be placed on the market or used unless the package (including any label or container used with the package), and basic information as to the nature and composition of the pesticide and as to the manufacturer or manufacturers, have been submitted for approval at a time specified by the Minister and have been approved by him, that is, the pesticide has been duly notified.

(5) 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 if—

( a ) the net quantity in any container of such pesticide is less than the quantity stated thereon in the manner specified in Article 6 (2) (e) of the Directive of 1978, or

( b ) the fastenings or containers used to package such pesticide have been tampered with.

5 Classification as to Toxicity.

5. (1) ( a ) Subject to subparagraph (b) and (c) 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, using methods specified in the Directive of 1967, as amended by the Directive of 1992, Commission Directive No. 88/302/EEC of 18 November 1987 ⁸ and Commission Directive No. 92/69/EEC of 31 July 1992 ⁹.

⁸O.J. No. L133/1 30/5/1988 and O.J. No. L136/20 2/6/1988.

⁹O.J. No. L383/113 29/12/1992.

( b ) Subject to subparagraph (d) 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 and Guidelines to Classification 1994-1995 (World Health Organisation WHO/PCS/94.2) shall be used.

( c ) Subject to subparagraph (d) where a pesticide to which these Regulations apply contains 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 Annex VIII and where Annex VIII does not include a class and subclass for particular pesticides, the equivalent class and subclass specified in the WHO Recommended Classification of Pesticides by Hazard and Guidelines to Classification 1994-95 (World Health Organisation WHO/PCS/94.2) shall be used.

( d ) A pesticide to which these Regulations apply shall be classified in the manner mentioned in subparagraph (b) or (c) only if—

(i) it satisfies the requirements 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.

( e ) If when making a classification pursuant to the requirements of subparagraphs (b) or (c) 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) where the conditions specified in Article 3 (5) of the Directive of 1978 apply, additional toxicological data may be taken into account for the purposes of the classification of pesticides to which these Regulations apply, in particular toxicological data relating to carcinogenic, corrosive, irritant, mutagenic, toxic for reproduction or sensitizing properties shall be taken into account. Relevant testing shall be carried out in accordance with the requirements of Article 3 (1) of the Directive of 1978, using methods specified in the Directive of 1967, as amended by the Directive of 1992, Commission Directive No. 88/302/EEC of 18 November 1987⁸ and Commission Directive No. 92/69/EEC of 31 July 1992⁹

6 Studies, Information, Supporting Documentation and Materials.

6. (1) Where a pesticide is classified in compliance with the requirements of Regulation 5 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 placed on the market on or before the 2nd day of December 1985, the pesticide shall no longer be placed on the market or used unless the record of the studies conducted and the information, documentation and materials 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 not placed on the market on or before the 2nd day of December 1985, the pesticide shall not be cleared and placed on the market or used unless the record of the studies conducted and the information, documentation and materials to which it relates have been approved by the Minister.

( c ) In the case of a pesticide referred to in subparagraph (b) and notwithstanding the provisions of that subparagraph or of paragraph (1), where the pesticide is similar to and considered by the Minister to involve no greater risk for man or for the environment than a pesticide referred to in subparagraph (a) and the record of the studies conducted and the supporting information, documentation and materials referred to in subparagraph (a) have not been approved permission may be granted by the Minister on approval of an accurate record of a limited number of studies, information, supporting documentation and materials, as specified from time to time by the Minister, to market such a pesticide.

⁸O.J. No. L133/1 30/5/1988 and O.J. No. L136/20 2/6/1988.

⁹O.J. No. L383/113 29/12/1992.

( d ) In the case of a pesticide in relation to which the record of the studies conducted and the information, documentation and materials have neither been approved nor submitted for approval by the Minister under subparagraph (a), (b) or (c) notwithstanding non-compliance with the provisions of this Regulation, an authorised officer acting on behalf of the Minister, where there is no apparent risk to man or to the environment through the placing on the market or use of such a pesticide, may, by a notice in writing given to the owner or person in apparent charge or control, permit the controlled placing on the market or use of existing stocks of the pesticide subject to specified conditions.

( e ) The Minister may, on a request being made to him in that behalf by a person who had been granted clearance in respect of a pesticide under this paragraph, withdraw his approval in respect of that pesticide.

7 Packaging and Labelling.

7. (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 (1) 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).

(3) In addition to complying with paragraph (1)—

( 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 childproof fastenings designed in accordance with Annex IX.

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8. (1) Subject to paragraphs (2) and (4) the label on or attached to packaging mentioned in Regulation 7(1) 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) 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) 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) 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 7 (1) 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 7 (1) 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 viscous liquids (lower limit 1 Pas at 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 acids, their amides, esters and salts, on an acid equivalent basis;

( d ) in case the pesticide contains either a very toxic, a toxic harmful or a corrosive substance, other than an active substance, the name as given in the list contained in Annex I to the Directive of 1967, of each very toxic, toxic harmful or corrosive substance contained in the pesticide, in concentrations of more than 0.2 per cent in the case of very toxic and toxic substances, 5 per cent in the case of harmful substances and 5 per cent in the case of corrosive substances.

( 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) (h) 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; 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.

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9. The Provisions of Regulations 7 and 8 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 ).

10 Emergency Measures.

10. (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 which has been cleared 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.

11 Notification of Imports.

11. Where a person proposes to import into the State a pesticide to which these Regulations apply, three days notice of the intended importation shall be given in writing to the Minister 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 that the pesticide shall be landed or otherwise brought into the State,

( c ) the date on which the pesticide is expected to be so transferred 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 ) in the case of a pesticide being imported into the State, 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 12.

12 Inspections, Sampling, Tests and Examinations.

12. (1) Subject to paragraph (5) 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,

( c ) any premises in which he has reasonable grounds for believing that there are any books, documents or records relating to any business whose activities consist of or include the manufacture, placing on the market, storage, transport or use of a pesticide,

and there or at any other place—

(i) make such examinations, tests and inspections, and

(ii) take samples in accordance with the methods described in the manual on the development and use of FAO specifications for plant protection products (Food and Agriculture Organization of the United Nations, FAO Plant Production and Protection Paper 85, Fourth Revised Edition), 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, and

(iii) take samples in accordance with Commission Directive 79/700/EEC of 24th July 1979 ¹⁰, or the Joint FAO/WHO Food Standards Programme, Codex Alimentarius Commission, recommended method of sampling for the determination of Pesticide Residues (Food and Agriculture Organisation of the United Nations CAC/PR5 - 1984), where relevant, and in accordance with other internationally accepted procedures in other cases, of any plant, plant product, soil, compost, or take samples from or of any other thing, which he finds in the course of his inspections and which he believes may have been treated or contaminated with 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, and

( 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—

¹⁰O.J. No. L207/26 15/8/1979

( 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, and

( 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—

( a ) divide the sample into three parts, each of which he shall seal and mark,

( b ) give one part thereof to a designated chemist for analysis in accordance with paragraph (5),

( c ) leave with, or send by registered post to, the defendant or his agent, a second part thereof, and

( d ) retain the remaining part thereof for possible analysis by the State Chemist in accordance with Regulation 16.

(5) Where a designated chemist receives a sample from an authorized officer in pursuance of these Regulations he shall make analyses thereof in accordance with the relevant CIPAC method (Collaborative International Pesticides Analytical Council Limited, Handbook Volume 1, IA, IB, IC, and D), or the method included as part of the documentation approved in accordance with Regulation 6, as appropriate.

(6) ( a ) In any 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)) was left with, or sent by registered post to, the defendant or his agent.

( b ) In any proceedings for an offence under these Regulations, evidence of the presence of a pesticide to which the Regulations apply, in or on equipment capable of use for application of the pesticide, shall be evidence, until the contrary is proved, of the use of the pesticide by the owner or person in possession of the equipment.

( c ) In any proceedings for an offence under these Regulations, evidence of the presence of a residue of a pesticide to which the Regulations apply, in or on agricultural produce, in soil or compost or in or on surfaces or other materials which may have been treated with or exposed to the pesticide, shall be evidence, until the contrary is proved, of the use of the pesticide by the owner, occupier or person in possession, as the case may be.

( d ) In any proceedings for an offence under these Regulations, a certificate in the form set out in the Second or Third Schedule showing the results of an analysis shall, until the contrary is shown, be sufficient evidence of the facts certified to therein in relation to the presence in a pesticide of any pesticidal substance, impurity or formulating ingredient, and the level such presence and a document purporting to be such a certificate shall be deemed, until the contrary is shown, to be such a certificate.

( e ) In any proceedings for an offence under these Regulations, each of the documents referred to in subparagraphs (1) (ii) and (iii) and paragraph (5) and Regulation 5 (1) (b) may be proved by a production of a copy thereof purporting to have been published in the Official Journal of European Communities, by the Food and Agriculture Organization of the United Nations, by the World Health Organization, by the Collaborative International Pesticides Analytical Council Limited, or by the production of the document describing the method, certified by the officer-in-charge of the Pesticide Control Service as being part of the documentation approved in accordance with Regulation 6, as appropriate.

( f ) For the purpose of these Regulations, the presence of a pesticide, to which these Regulations apply, on any premises (including any stores) where the business of marketing such pesticide is carried on, shall, until the contrary is shown, be sufficient evidence that the pesticide in question is or was being placed on the market by the owner and by the occupier of such premises.

(7) 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.

(8) A designated chemist shall be furnished with a warrant of his appointment by the Minister to carry out analyses as required by these Regulations.

13 Seizure, Retention, Removal and Disposal.

13. (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) which either 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 a period of seven days beginning on the date of the notice, appeal against the notice to the District Court in the District Court District in which the notice has been served.

(5) Disposal of a pesticide pursuant to a notice given under paragraph (2) shall not take place until—

( a ) the period during which an appeal under paragraph (4) may be taken against the notice has expired, or

( b ) an appeal under that paragraph is determined or withdrawn.

(6) ( a ) Where an appeal is made to the District Court under paragraph (4) 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) 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), 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.

(7) Notwithstanding paragraph (2) and the requirements of these Regulations in relation to classification, packaging and labelling, the method of disposal specified in a notice given under paragraph (2) may include its use subject to such conditions as the authorised officer may specify in the notice, provided that the officer is not aware of any apparent risk to man or the environment by such use.

(8) In the case of a notice given under paragraph (2) which indicates an intention to dispose of a pesticide, the ownership of such pesticide shall, in the absence of an appeal by the owner against the notice to the District Court, vest in the Minister on the expiration of a period of seven days beginning on the date of the notice, In the event of an appeal by the owner against the notice to the District Court, ownership of the pesticide shall vest in the Minister if the court makes an order under paragraph (5) which requires the pesticide to be disposed of by an authorised officer.

(9) In the case of a notice under paragraph (2) which requires the disposal at the expense of the owner of a pesticide which has been seized under this Regulation and where there has been a failure to pay, 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 pesticide at the time of its seizure under this Regulation.

14 General Offences.

14. (1) A person who contravenes Regulation 4 shall be guilty of an offence and shall be liable on summary conviction to a fine not exceeding £1,000, or to imprisonment for a term not exceeding six months, or to both.

(2) If any person—

( a ) tampers with any pesticide so as to procure that any sample of it taken pursuant to Regulation 12 does not correctly represent the pesticide, or

( b ) tampers or interferes with any sample taken pursuant to Regulation 12,

he shall be guilty of an offence and shall be liable on summary conviction to a fine not exceeding £1,000 or to imprisonment for a term not exceeding six months or to both.

(3) A person who—

( a ) fails to comply with the requirements of Regulations 6, 10 (1) or 11, paragraphs (2) and (3) of Regulation 12 or paragraph (3) of Regulation 13, or

( b ) obstructs or interferes with an authorised officer in the course of exercising a power conferred on him by Regulation 12, 13 or 19, or

( c ) gives false information when requested to provide information under Regulation 19, shall be guilty of an offence and shall be liable on summary conviction to a fine not exceeding £1,000, or to imprisonment for a term not exceeding six months, or to both.

15 Prosecutions and Specific Rules of Evidence.

15. (1) An offence under these Regulations may be prosecuted by the Minister.

(2) In proceedings for an offence under Regulation 14 (1) 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 clearance of the pesticide by the Minister in accordance with these Regulations.

16 Referee Analysis.

16. (1) Where an appeal is made to the District Court concerning the results of any analysis made under Regulation 12 (5) the third part of the sample shall if the defendant so requests be analyzed by the State Chemist.

(2) The State Chemist shall in making an analysis under this Regulation comply with the methods of analysis that apply in the particular case as specified in Regulation 12 (5) and issue a certificate in the form set out in the Third Schedule to the defendant and to the designated chemist concerned.

17 ..

17. The defendant shall be liable for the cost of the analysis carried out by the State Chemist under Regulation 16 in the event that the results of that analysis confirm that there has been a breach of these Regulations.

18 Fees.

18. (1) Every application for approval of documentation and materials and for clearance of a pesticide shall be subject to the payment of the following fees, that is to say—

( a ) for each active substance contained in the pesticide, the fee set out in column (2) of Part 1A of the Fourth Schedule payable to the Minister in respect of the appropriate type of clearance in relation to a category set out in column (1) of the said Part 1A;

( b ) in relation to each preparation, the fee set out in column (2) of Part 1B of the Fourth Schedule payable to the Minister in respect of the appropriate type of clearance in relation to a category set out in column (1) of the said Part 1B;

( c ) an initial fee of £100 shall accompany each application in relation to a pesticide which payment shall be offset against the fees mentioned in sub-paragraphs (a) and (b) (evaluation of each application shall not be undertaken until the balance of the relevant fee is paid);

( d ) a fee of £150 shall be payable in each case where an application is made for minor amendments to the packaging and labelling or to the documentation and materials submitted in accordance with Regulation 6 (2) (a) or 6 (2) (b) and where it is considered no hazard evaluation is involved or required. This fee shall not be offset against the fees mentioned in sub-paragraphs (a) and (b).

( e ) a fee of £500 shall be payable in each case where an application is made for permission to market under Regulation 6 (2) (c). This fee shall not be offset against the fees mentioned in sub-paragraphs (a) and (b) of this paragraph.

(2) ( a ) Every grant of an approval of documentation and materials and for clearance of pesticides shall be for 12 months from the date of such grant and shall be renewable at the discretion of the Minister for a maximum of 9 further periods of 12 months on an application being made in that behalf to the Minister and shall be accompanied by the appropriate fee set out in Part 2 of the Fourth Schedule and on a request being made to him in that behalf.

( b ) The Minister may reduce the fee payable under this paragraph where he is satisfied that the wholesale sales of a pesticide during the previous 12 month period did not exceed 50 times the fee payable under this paragraph to the Minister.

(3) In the case of a pesticide already on the market the Minister may reduce the fee, or fees, payable under paragraph (1) on a request being made to him in that behalf, where he is satisfied that the wholesale sales of the pesticide during the previous 12 month period did not exceed 50 times the fee, or fees, payable to the Minister in accordance with paragraph (1). In the case of an application for trials clearance of a pesticide the fee, or fees, payable under paragraph (1) may be reduced by the Minister on a request being made to him in that behalf where the potential area of use is limited to a specialised area or specialised areas of use.

(4) In the case of a pesticide which is being placed on the market for the first time, the Minister may refund part of the fee, or fees, payable in accordance with paragraph (1) on a request being made to him in that behalf, where he is satisfied that the wholesale sales of the pesticide during the twelve month period from the date of clearance of the pesticide in accordance with paragraph 2 (b) of Regulation 6 did not exceed 50 times the fee, or fees, payable to the Minister in accordance with paragraph (1). In the case of an application for trials clearance of a pesticide the fee, or fees, payable under paragraph (1) may be reduced by the Minister on a request being made to him in that behalf where the potential area of use is limited to a specialised area or specialised areas of use.

(5) Clearance of a pesticide in accordance with the requirements of these Regulations shall be withdrawn if, in the case such a pesticide continues to be placed on the market, there is a failure to pay the annual renewal fee set out in Part 2 of the Fourth Schedule within 30 days of the fee falling due but an application for a renewal of clearance of a pesticide may be made more than 30 but not more than 60 days after the renewal fee fell due on payment to the Minister of the late annual renewal fee set out in Part 3 of the Fourth Schedule.

(6) In the case of an application to alter the type of clearance where a clearance has been approved, the fee, or fees, payable in respect of any subsequent clearance shall be reduced by the amount already paid in accordance with paragraph (1) (a), (b) and (c).

(7) A fee payable under these Regulations may be recovered by the Minister as a simple contract debt in any court of competent jurisdiction.

19 ..

19. A person who makes a claim for a reduction or a refund of fees in accordance with Regulation 18 (2), 18 (3) or 18 (4) shall, at all reasonable times—

( a ) produce, at the request of an authorised officer, any records, books or other documents which are in his possession or under his control which substantiate such a claim,

( b ) permit the 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 for the purpose of verifying the claim,

( c ) afford to such an officer such facilities and assistance as are reasonably necessary for inspecting the stock of the relevant pesticide if the officer considers such inspection is necessary for the purpose of verifying the claim.

20 Statutory Instruments Revoked.

20. The following are hereby revoked—

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

( b ) the European Communities (Classification, Packaging and Labelling of Pesticides) (Amendment) Regulations, 1987 ( S.I. No. 207 of 1987 ),

( c ) the European Communities (Classification, Packaging and Labelling of Pesticides) (Amendment) Regulations, 1989 ( S.I. No. 149 of 1989 ),

( d ) the European Communities (Classification, Packaging and Labelling of Pesticides) (Amendment) Regulations, 1991 ( S.I. No. 88 of 1991 ), and

( e ) the European Communities (Classification, Packaging and Labelling of Pesticides) (Amendment) Regulations, 1992 ( S.I. No. 416 of 1992 ).

FIRST SCHEDULE.

ANNEX I.

(Annex II to Council Directive 67/548/EEC as amended by the Directive of 1992 and adapted by Commission Directive 93/21/EEC).

SYMBOLS AND INDICATIONS.

E		O
	Explosive		Oxidizing
F		F+
	Highly flammable		Extremely flammable
F		T+
	Toxic		Very toxic
C		Xn
	Corrosive		Harmful
Xi		N
	Irritant		Dangerous for the environment

ANNEX II.

(Annex III to Council Directive 67/548/EEC as amended by the Directive of 1992 and adapted by Commission Directive 93/21/EEC).

NATURE OF SPECIAL RISKS.

R1	Explosive when dry.
R2	Risk of explosion by shock, friction, fire or other sources of ignition.
R3	Extreme risk of explosion by shock, friction, fire or other sources of ignition.
R4	Forms very sensitive explosive metallic compounds.
R5	Heating may cause an explosion.
R6	Explosive with or without contact with air.
R7	May cause fire.
R8	Contact with combustible material may cause fire.
R9	Explosive when mixed with combustible material.
R10	Flammable.
R11	Highly flammable.
R12	Extremely flammable.
R14	Reacts violently with water.
R15	Contact with water liberates extremely flammable gases.
R16	Explosive when mixed with oxidising substances.
R17	Spontaneously flammable in air.
R18	In use, may form flammable/explosive vapour-air mixture.
R19	May form explosive peroxides.
R20	Harmful by inhalation.
R21	Harmful in contact with skin.
R22	Harmful if swallowed.
R23	Toxic by inhalation.
R24	Toxic in contact with skin.
R25	Toxic if swallowed.
R26	Very toxic by inhalation.
R27	Very toxic in contact with skin.
R28	Very toxic if swallowed.
R29	Contact with water liberates toxic gas.
R30	Can become highly flammable in use.
R31	Contact with acids liberates toxic gas.
R32	Contact with acids liberates very toxic gas.
R33	Danger of cumulative effects.
R34	Causes burns.
R35	Causes severe burns.
R36	Irritating to eyes.
R37	Irritating to respiratory system.
R38	Irritating to skin.
R39	Danger of very serious irreversible effects.
R40	Possible risks of irreversible effects.
R41	Risk of serious damage to eyes.
R42	May cause sensitization by inhalation.
R43	May cause sensitization by skin contact.
R44	Risk of explosion if heated under confinement.
R45	May cause cancer.
R46	May cause heritable genetic damage.
R48	Danger of serious damage to health by prolonged exposure.
R49	May cause cancer by inhalation.
R50	Very toxic to aquatic organisms.
R51	Toxic to aquatic organisms.
R52	Harmful to aquatic organisms.
R53	May cause long-term adverse effects in the aquatic environment.
R54	Toxic to flora.
R55	Toxic to fauna.
R56	Toxic to soil organisms.
R57	Toxic to bees.
R58	May cause long-term adverse effects in the environment.
R59	Dangerous for the ozone layer.
R60	May impair fertility.
R61	May cause harm to the unborn child.
R62	Possible risk of impaired fertility.
R63	Possible risk of harm to the unborn child.
R64	May cause harm to breastfed babies.
Combination of R-Phases.
R14/15	Reacts violently with water, liberating extremely flammable gases.
R15/29	Contact with water liberates toxic, extremely flammable gas.
R20/21	Harmful by inhalation and in contact with skin.
R20/22	Harmful by inhalation and if swallowed.
R20/21/22	Harmful by inhalation, in contact with skin and if swallowed.
R21/22	Harmful in contact with skin and if swallowed.
R23/24	Toxic by inhalation and in contact with skin.
R23/25	Toxic by inhalation and if swallowed.
R23/24/25	Toxic by inhalation, in contact with skin and if swallowed.
R24/25	Toxic in contact with skin and if swallowed.
R26/27	Very toxic by inhalation and in contact with skin.
R26/28	Very toxic by inhalation and if swallowed.
R26/27/28	Very toxic by inhalation, in contact with skin and if swallowed.
R27/28	Very toxic in contact with skin and if swallowed.
R36/37	Irritating to eyes and respiratory system.
R36/38	Irritating to eyes and skin.
R36/37/38	Irritating to eyes, respiratory system and skin.
R37/38	Irritating to respiratory system and skin.
R39/23	Toxic: danger of very serious irreversible effects through inhalation.
R39/24	Toxic: danger of very serious irreversible effects in contact with skin.
R39/25	Toxic: danger of very serious irreversible effects if swallowed.
R39/23/24	Toxic: danger of very serious irreversible effects through inhalation and in contact with skin.
R39/23/25	Toxic: danger of very serious irreversible effects through inhalation and if swallowed.
R39/24/25	Toxic: danger of very serious irreversible effects in contact with skin and if swallowed.
R39/23/24/25	Toxic: danger of very serious irreversible effects through inhalation, in contact with skin and if swallowed.
R39/26	Very toxic: danger of very serious irreversible effects through inhalation.
R39/27	Very toxic: danger of very serious irreversible effects in contact with skin.
R39/28	Very toxic: danger of very serious irreversible effects if swallowed.
R39/26/27	Very toxic: danger of very serious irreversible effects through inhalation and in contact with skin.
R39/26/28	Very toxic: danger of very serious irreversible effects through inhalation and if swallowed.
R39/27/28	Very toxic: danger of very serious irreversible effects in contact with skin and if swallowed.
R39/26/27/28	Very toxic: danger of very serious irreversible effects through inhalation, in contact with skin and if swallowed.
R40/20	Harmful: possible risk of irreversible effects through inhalation.
R40/21	Harmful: possible risk of irreversible effects in contact with skin.
R40/22	Harmful: possible risk of irreversible effects if swallowed.
R40/20/21	Harmful: possible risk of irreversible effects through inhalation and in contact with skin.
R40/20/22	Harmful: possible risk of irreversible effects through inhalation and if swallowed.
R40/21/22	Harmful: possible risk of irreversible effects in contact with skin and if swallowed.
R40/20/21/22	Harmful: possible risk of irreversible effects through inhalation, in contact with skin and if swallowed.
R42/43	May cause sensitization by inhalation and skin contact.
R48/20	Harmful: danger of serious damage to health by prolonged exposure through inhalation.
R48/21	Harmful: danger of serious damage to health by prolonged exposure in contact with skin.
R48/22	Harmful: danger of serious damage to health by prolonged exposure if swallowed.
R48/20/21	Harmful: danger of serious damage to health by prolonged exposure through inhalation and in contact with skin.
R48/20/22	Harmful: danger of serious damage to health by prolonged exposure through inhalation and if swallowed.
R48/21/22	Harmful: danger of serious damage to health by prolonged exposure in contact with skin and if swallowed.
R48/20/21/22	Harmful: danger of serious damage to health by prolonged exposure through inhalation, in contact with skin and if swallowed.
R48/23	Toxic: danger of serious damage to health by prolonged exposure through inhalation.
R48/24	Toxic: danger of serious damage to health by prolonged exposure in contact with skin.
R48/25	Toxic: danger of serious damage to health by prolonged exposure if swallowed.
R48/23/24	Toxic: danger of serious damage to health by prolonged exposure through inhalation and in contact with skin.
R48/23/25	Toxic: danger of serious damage to health by prolonged exposure through inhalation and if swallowed.
R48/24/25	Toxic: danger of serious damage to health by prolonged exposure in contact with skin and if swallowed.
R48/23/24/25	Toxic: danger of serious damage to health by prolonged exposure through inhalation, in contact with skin and if swallowed.
R50/53	Very toxic to aquatic organisms, may cause long-term adverse effects in the aquatic environment.
R51/53	Toxic to aquatic organisms, may cause long-term adverse effects in the aquatic environment.
R52/53	Harmful to aquatic organisms, may cause long-term adverse effects in the aquatic environment.

ANNEX III.

(Annex IV to Council Directive 67/548/EEC as amended by the Directive of 1992 and adapted by Commission Directive 93/21/EEC).

SAFETY ADVICE.

S1	Keep locked up.
S2	Keep out of the reach of children.
S3	Keep in a cool place.
S4	Keep away from living quarters.
S5	Keep contents under . . . (appropriate liquid to be proposed by the manufacturer).
S6	Keep under. . . (inert gas to be proposed by the manufacturer).
S7	Keep container tightly closed.
S8	Keep container dry.
S9	Keep container in a well-ventilated place.
S12	Do not keep the container sealed.
S13	Keep away from food, drink and animal feeding stuffs.
S14	Keep away from .... (incompatible materials to be indicated by the manufacturer).
S15	Keep away from heat.
S16	Keep away from sources of ignition — No smoking.
S17	Keep away from combustible material.
S18	Handle and open container with care.
S20	When using do not eat or drink.
S21	When using do not smoke.
S22	Do not breathe dust.
S23	Do not breathe gas/fumes/vapour/spray (appropriate wording to be proposed by the manufacturer).
S24	Avoid contact with skin.
S25	Avoid contact with eyes.
S26	In case of contact with eyes, rinse immediately with plenty of water and seek medical advice.
S27	Take off immediately all contaminated clothing.
S28	After contact with skin, wash immediately with plenty of . . . (to be proposed by the manufacturer).
S29	Do not empty into drains.
S30	Never add water to this product.
S33	Take precautionary measures against static discharges.
S35	This material and its container must be disposed of in a safe way.
S36	Wear suitable protective clothing.
S37	Wear suitable gloves.
S38	In case of insufficient ventilation, wear suitable respiratory equipment.
S39	Wear eye/face protection.
S40	To clean the floor and all objects contaminated by this material, use ... (to be proposed by the manufacturer).
S41	In case of fire and/or explosion do not breathe fumes.
S42	During fumigation/spraying wear suitable respiratory equipment (appropriate working to be proposed by the manufacturer).
S43	In case of fire, use . . . (indicate in the space the precise type of fire-fighting equipment. If water increases risk, add—Never use water).
S45	In case of accident or if you feel unwell, seek medical advice immediately (show the label where possible).
S46	If swallowed, seek medical advice immediately and show this container or label.
S47	Keep at temperature not exceeding . . . °C (to be proposed by the manufacturer).
S48	Keep wetted with . . . (appropriate material to be proposed by the manufacturer).
S49	Keep only in the original container.
S50	Do not mix with . . . (to be proposed by the manufacturer).
S51	Use only in well ventilated areas.
S52	Not recommended for interior use on large surface areas.
S53	Avoid exposure - obtain special instructions before use.
S56	Dispose of this material and its container to hazardous or special waste collection point.
S57	Use appropriate containment to avoid environmental contamination.
S59	Refer to manufacturer/supplier for information on recovery/recycling.
S60	This material and its container must be disposed of as hazardous waste.
S61	avoid release to the environment. Refer to special instructions / Safety data sheets.
S62	If swallowed, do not induce vomiting: seek medical advice immediately and show this container or label.
Combination of S-Phrases.
S1/2	Keep locked up and out of the reach of children.
S3/7	Keep container tightly closed in a cool place.
S3/9/14	Keep in a cool, well ventilated place away from . . . (incompatible materials to be indicated by the manufacturer).
S/3/14/49	Keep only in the original container in a cool, well ventilated place away from . . . (incompatible materials to be indicated by the manufacturer).
S3/9/49	Keep only in the original container in a cool, well ventilated place.
S3/14	Keep in a cool place away from . . . (incompatible materials to be indicated by the manufacturer).
S7/8	Keep container tightly closed and dry.
S7/9	Keep container tightly closed and in a well ventilated place.
S7/47	Keep container tightly closed and at temperature not exceeding . . . øC (to be proposed by the manufacturer).
S20/21	When using do not eat, drink or smoke.
S24/25	Avoid contact with skin and eyes.
S29/56	Do not empty into drains, dispose of this material and its container to hazardous or special waste collection point.
S36/37	Wear suitable protective clothing and gloves.
S36/37/39	Wear suitable protective clothing, gloves and eye/face protection.
S36/39	Wear suitable protective clothing and eye/face protection.
S37/39	Wear suitable gloves and eye/face protection.
S47/49	Keep only in the original container at temperature not exceeding . . . °C (to be proposed by the manufacturer).

ANNEX IV.

(Annex V to Council Directive 78/631/EEC).

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 Phrases
S2	Keep out of reach of children.
S20/21	When using do not eat, drink or smoke.
S13	Keep away from food, drink and animal feeding stuffs.
For harmful pesticides:
S44	If you feel unwell, seek medical advice (show the label where possible).
For very toxic and toxic pesticides:
S45	In 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:
S22	Do not breathe dust.
S23	Do not breathe gas/fumes/vapour/spray (apparopriate wording to be proposed by the manufacturer).
S27	Take off immediately all contaminated clothing.
S36	Wear suitable protective clothing.
S37	Wear suitable gloves.
S42	During fumigation/spraying wear suitable respiratory equipment (appropriate wording to be proposed by the manufacturer).
When a pesticide is classified as corrosive, the following safety advice must also be given:
S28	After contact with skin, wash immediately with plenty of . . . (to be proposed by the manufacturer).
S37	Wear suitable gloves.
S39	Wear eye/face protection.
When a pesticide contains phosphoric acid esters, the following advice must also be given:
S28	After contact with skin, wash immediately with plenty of . . . (to be proposed by the manufacturer).
If two or more phrases are required, they can be combined in accordance with Annex XI.

ANNEX V.

(Annex I to Council Directive 78/631/EEC).

CLASSIFICATION BY CALCULATION OF PESTICIDES CONTAINING ONE ACTIVE SUBSTANCE.

Pesticides containing onae active substance and one or more inert vehicles and/or adjuvants shall be classified by means of the following formula:

Lx100 = A

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 LC₅₀ 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 Number Substance		Conventional values of
		Oral LD₅₀ mg/kg	Cut LD₅₀ mg/kg	Inh LC₅₀ Mg/¼h
015-079-00-7	Acephate	945	NR
605-008-00-3	2-Propenal (Acrolein)	46	562
	Alachlor	1,200	NR
602-048-00-3	Aldrin	46	98
006-025-00-3	Allethrin	920	NR
616-004-00-6	Allidochlor	700	360
603-015-00-6	2-Propen-l-ol	64	90
613-011-00-6	Aminotriazole	2,000
613-010-00-0	Ametryne	1,405	NR	NR
015-080-00-2	Amidithion	600
612-052-00-7	2-Aminobutane	380	2500
006-018-00-5	Aminocarb	50	275
006-008-00-0	Antu	2
015-056-00-1	Axinphos-ethyl	12	250
015-039-00-9	Azinphos-methyl	16	250
006-020-00-6	Barban	1,300	NR	NR
	Barium carbonate	650
015-083-00-9	Bensulide	770	3,950
613-012-00-1	Bentazone	1,100	NR
006-036-00-3	Benzthiazuron	1,280
609-024-00-1	Binapacryl	421	720
609-032-00-5	Bromofenoxim	1,217	NR
	Bromophos	1,600	2,181
015-064-00-5	Bromophos-ethyl	71	1,000
608-006-00-0	Bromoxynil	190
602-044-00-1	Camphechlor	80	1,075
006-011-00-7	Carbaryl	300	NR
006-026-00-9	Carbofuran	8	120
015-044-00-6	Carbophenothion	32	27
602-047-00-8	Chlordane	460	700
606-019-00-6	Chlordecone	114	475
650-007-00-3	Chlordimeform	340	640
607-074-00-9	Chlorfenac	575	3,160
603-049-00-1	Chlorfenethol	930
607-075-00-4	Chlorfenpropmethyl	1,190
015-071-00-3	Chlorfenvinphos	10	108
606-014-00-9	Chlorophacinone	2	200
015-085-00-X	Chlorphonium	178	750
015-084-00-4	Chlorpyrifos	135	202
616-005-00-1	Chlorthiamid	757
607-057-00-6	Coumachlor	900
015-038-00-3	Coumaphos	16	860
607-059-00-7	Coumatetralyl	17
015-086-00-5	Coumithoate	67
	Crotoxyphos	74	202
613-004-00-8	Crimidine	1.25
015-074-00-X	Crufomate	770	2,000
613-013-00-7	Cyanazine	182	NR
015-087-00-0	Cyanophos	610	800
	Cycloheximide	2
015-070-00-8	Cyanthoate	3.2	105
050-002-00-0	Cyhexatin	540	2,200
607-039-00-8	2, 4-D	375	1,500
613-008-00-X	Dazomet	640
607-083-00-8	2, 4-DB	700	800
602-045-00-7	DDT	113	2,510
015-028-00-9	Demeton-O	1.7
015-030-00-X	Demeton-O-methyl	180
015-029-00-4	Demeton-S	1.7
015-031-00-5	Demeton-S-methyl	40	302
015-078-00-1	Demeton-S-methyl sulphone	37
613-007-00-4	Desmetryne	1,390	1,000
015-088-00-6	Dialifos	5	145
006-019-00-0	Di-allate	395
015-040-00-4	Diazinon	300	900
602-021-00-6	1, 2-Dibromo-3-chloropropane	170	1,420
015-068-00-7	Dichlofenthion	270	NR
606-018-00-0	Dichlone	1,300
602-012-00-7	1, 2-Dichloroethane	670	2,800
607-045-00-0	Dichlorprop	800	1,400
015-019-00-X	Dichlorvos	56	107
603-044-00-4	Dicofol	690	1,870
015-073-00-4	Dicrotophos	22	181
602-049-00-9	Dieldrin	38	10
015-061-00-9	Dimefox	1	5
006-010-00-1	Dimetan	120
015-051-00-4	Dimethoate	425
006-040-00-5	Dimetilan	47	600
006-028-00-X	Dinobuton	140	NR
609-025-00-7	Dinoseb	58	200
609-023-00-6	Dinocap	980	NR
609-026-00-2	Salts and esters of dinoseb	60
609-030-00-4	Dinoterb	25
609-031-00-X	Salts and esters of dinoterb	25
006-029-00-5	Dioxacarb	90	3,000
015-063-00-X	Dioxathion	23	63
616-007-00-2	Diphenamid	970
015-060-00-3	Disulfoton	2.6	20
613-021-00-0	Dithianon	640
609-020-00-X	DNOC	25	200
607-076-00-X	Dodine	1,000	NR
650-008-00-9	Drazoxolon	126
602-052-00-5	Endosulfan	80	359
607-055-00-5	Endothal-sodium	51	750
015-049-00-3	Endothion	30	400
602-051-00-X	Endrin	7	60
015-036-00-2	EPN	14	25
006-030-00-0	EPTC	1,652	3,200
607-077-00-5	Erbon	1,120
015-047-00-2	Ethion	161	915
015-089-00-1	Ethoate-methyl	340	1,000
	Ethoprophos	62	26
611-003-00-7	Fenaminosulf	60	1,000
613-015-00-8	Fenazaflor	283	700
015-052-00-X	Fenchlorphos	1,740	2,000
015-054-00-0	Fenitrothion	503
607-047-00-1	Fenoprop	650
015-090-00-7	Fensulfothion	3.5	3.5
015-048-00-8	Fenthion	190
050-003-00-6	Fentin acetate	125	1,680
050-004-00-1	Fentin hydroxide	108	500
607-078-00-0	Fluenetil	6	4
616-002-00-5	Fluoroacetamide	13	80
015-091-00-2	Fonofos	8	25
015-057-00-7	Formothion	365
	Hexachloroacetone	1,550	2,980
	Heptachlor epoxide	34
602-046-00-2	Heptachlor	100	159
613-017-00-9	8-Hydroxyquinoline sulphate	1,200
608-007-00-6	loxynil	110	809
	loxynil-octanoate	390
602-053-00-0	Isobenzan	4.8	4
006-009-00-6	Isolan	11	5.6
607-079-00-6	Kelevan	240	314
602-043-00-6	Lindane	80	900
	Malathion containing more than 1.8% isomalathion	885
	Malathion containing 1.8% isomalathion or less	2,000
607-051-00-3	MCPA	700
607-052-00-9	Salts and esters of MCPA	700
607-053-00-4	NCPB	680
607-054-00-X	Salts and esters of MCPB	680
015-045-00-1	Mecarbam	36
607-049-00-2	Mecoprop	930	900
015-094-00-9	Mephosfolan	9	9-7
006-023-00-2	Methiocarb	35	400
080-003-00-1	Mercurous chloride	210
605-005-00-7	Metaldehyde	630
015-095-00-4	Methamidophos	7.5	110
015-069-00-2	Methidathion	25	1,546
615-002-00-2	Methyl isothiocyanate	175	2,780
	Methomyl	17	NR
	Mevinphos	4	4
	Molinate	720
	Monuron	1,480
015-072-00-9	Monocrotophos	14	112
006-032-00-1	Monolinuron	1,800
613-018-00-4	Morfamquat	325
006-014-00-2	Nabam	395
015-055-00-6	Naled	430	800
614-001-00-4	Nicotine	50	50
650-004-00-7	Norbormide	4.4
015-066-00-6	Omethoate	50	700
015-034-00-1	Parathion	2	6.8
015-035-00-7	Parathion-methyl	6	67
006-034-00-2	Pebulate	1,120
604-002-00-8	Pentachlorophenol	27	105
015-097-00-5	Phenthoate	400	700
015-033-00-6	Phorate	2	2.5
015-101-00-5	Phosmet	230	1,150
015-022-00-6	Phosphamidon	17	374
	Phospholan	9	23
015-100-00-X	Phoxim	1,845	NR
015-099-00-6	Pirimiphos-ethyl	140	1,000
006-037-00-9	Promecarb	74
616-009-00-3	Propanil	1,400	NR
	Propargite	1,500
	Promurit	0.28
006-016-00-4	Propoxur	95	NR
015-032-00-0	Prothoate	8	14
015-026-00-8	Schradan	9	15
614-003-00-5	Strychnine	5
006-038-00-4	Sulfallate	850
015-027-00-3	Sulfotep	5	20
607-041-00-9	2, 4, 5-T	500
607-042-00-4	Salts and esters of 2, 4, 5-T	500	NR
015-025-00-2	TEPP	1.1	2.4
015-050-00-9	Thiometon	120	700
	Thionazin	12	11
006-039-00-X	Triallate	1,700
015-098-00-0	Trichloronate	16	135
613-020-00-5	Tridemorph	650	1,350
	Trifenmorph	1,400
	2, 3, 6-TBA	1,500
006-005-00-4	Thiram	560	2,000
015-024-00-7	Triamiphos	20	48
015-021-00-0	Trichlorphon	560	NR
015-059-00-8	Vamidothion	103	1,160
607-056-00-0	Warfarin	3
006-012-00-2	Ziram	1,400
602-008-00-5	Tetrachloromethane⁽¹⁾	0.4
602-002-00-3	Bromomethane⁽¹⁾	0.4		0.004
006-003-00-3	Carbon disulphide⁽¹⁾	0.4
015-004-00-8	Aluminium phosphide⁽¹⁾	0.4		0.004
015-006-00-9	Zinc phosphide⁽¹⁾	0.4		0.004
602-010-00-6	1, 2-Dibromoethane⁽¹⁾	0.4
603-023-00-X	Ethylene oxide⁽¹⁾			0.004
016-010-00-3	Sodium polysulphides⁽²⁾
016-007-00-7	Potassium polysulphides⁽²⁾
016-008-00-2	Ammonium polysulphides⁽²⁾
016-005-00-6	Calcium polysulphides⁽²⁾
016-003-00-5	Barium polysulphides⁽²⁾
616-006-00-7	Dichloflaunid⁽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 1	Store/keep in original container, tightly closed, in a safe place/under lock and key/away from damp/sources of heat.
FS 2	Store/keep/apply/away from/install out of reach of pets/birds/bees/fish/(young) children.
FS 3	Store unused sachets in a safe place. Do not store half-used sachets.
FS 4	Not to be used on food crops.
FS 5	For use only on/crop/foodstuff/surface/situation/for control of process.
FS 6	To be used only by (professional) operators (instructed/or trained/in the use of chemical/product/type of product/ and familiar with the precautionary measures to be observed).
FS 7	Do not spray/apply directly to livestock/poultry/pets food/food crops.
FS 8	Do not apply to clothing/fabric/bedding.
FS 9	Do not apply to those surfaces/on which food/feed is stored, prepared/or/eaten/which children are likely to touch.
FS 10	Do not prepare/use/place bait/dust in/domestic kitchens/ larders/food cupboards/ where human or animal food or water could become contaminated.
FS 11	Do not use in wet weather/strong winds.
FS 12	Avoid all contact by mouth/with skin/eyes.
FS 13	Avoid contact during pregnancy.
FS 14	Wear 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 15	Do not breathe dust/mist/smoke/fog. (If necessary for personal comfort, wear a mask.)
	or
	Avoid working in spray mist/smoke/fog.
FS 16	Wash off splashes immediately.
	or
	Wash splashes/dust/powder/concentrate/any contamination/ from skin and eyes immediately.
FS 17	Wash hands and exposed skin/before eating, drinking or smoking and after work/before meals and after work/after use/handling.
	or
	Wash hands before meals and after work.
FS 18	Extinguish all naked flames/including pilot lights/ when applying the fumigant/dust/liquid/product.
FS 19	Do not apply in the presence of/avoid/naked flames, hot surfaces/or/unprotected electrical equipment.
FS 20	Do not work in confined spaces or enter spaces in which high concentrations of vapouar 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 21	Ensure adequate ventilation when handling/applying (in confined spaces).
FS 22	Wash all protective clothing thoroughly after use, especially the insides of gloves.
	or
	Avoid excessive contamination of overalls/clothing and launder regularly.
FS 23	Do not handle seed unnecessarily.
FS 24	Not to be used as food or feed.
FS 25	Do not re-use sack for food or feed.
FS 26	Do not allow . . . (product) . . . to come into contact with food or cooking utensils.
FS 27	Protect/cover food preparing equipment and eating utensils from contamination during application/before spraying.
FS 28	Do not exceed use of one unit/strip per . . . cu m (cu f).
FS 29	Do not apply more than . . . per (state amount).
FS 30	Do not apply more than . . . times per crop/season/time period.
FS 31	Keep children/pets/animals away from treated areas/baits for . . . hours/days.
FS 32	Remove/cover all/food/food processing equipment/eating utensils/foodstuffs/fish bowls/fish tanks/caged birds/pets/water storage tanks/before spraying/application/dusting/treatment.
FS 33	Protect exposed water/feed/milk machinery/milk containers from contamination.
FS 34	Do not prepare/use/lay baits/dust/spray where food/feed water could become contaminated.
FS 35	Remove exposed milk/collect eggs before application.
	or
	Remove/all animals/pets/livestock/feed/exposed water/milk/ collect eggs before application/spraying.
FS 36	Fumigate only under conditions which allow no leakage of gas to adjacent occupied premises.
FS 37	Do not harvest/crops for human/animal consumption/for at least ( . . . days/weeks) after last application.
	or
	Do not pick/gather/food crops within . . . hours/days/weeks of treatment.
FS 38	For use on the following crops 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 39	Keep unprotected persons/livestock/pets out of treated areas for at least . . . (interval)/until walls/surfaces are dry/until smoke has cleared.
FS 40	Dangerous/Harmful to livestock. Keep all livestock/out of treated areas/away from treated water/for at least . . . (interval). Bury or remove spillages.
	or
	Keep livestock out of treated areas for at least . . . (interval)/if poisonous weeks such as ragwort are present.
FS 41	Ventilate treated areas/rooms/confined spaces thoroughly/ before occupying/after application when gas/smoke has cleared.
FS 42	Prevent access to baits by children, domesticated animals and pets, (particularly cats, dogs and pigs).
	or
	Keep/apply/suspend only in positions inaccessible to children and pets.
FS 43	Use bait containers clearly marked "Poison" at all/ surface baiting points.
FS 44	Remove all remains of dust/bait/and bait containers/and dead rodents/after/at end of/treatment and burn/bury/destroy/ dispose of safely.
	or
	Remove exposed dust thoroughly after use and bury/burn.
FS 45	Do not sow/plant/transplant . . . (specify crops) . . . for at least . . . (interval).
FS 46	Do not use outdoors.
FS 47	Do not use in occupied dwelling-houses.
FS 48	Do not apply from aircraft/the air.
FS 49	Dangerous/Harmful to game/wild/caged/birds/butterflies/ animals/fish/bees/pets. Bury spillages/Do not apply within reach of domestic animals/where animals may lick/come in contact with freshly treated surfaces.
	or
	FS 2
FS 50	Dangerous/Harmful to bees. Do not apply/dust/spray/at flowering stage/crops in open flower/during bee activity. Keep down flowering weeds.
FS 51	Dangerous/Harmful to fish. Do not contaminate ponds, waterways or ditches with the chemical or used container.
	or
	Do not contaminate ponds, waterways or ditches with chemical or used container.
FS 52	Prevent any surface run off to/from entering storm/drains.
	or
	Avoid contamination of watercourses/ground.
FS 53	This material and its container must be disposed of in a safe way.
	or
	Dispose of used generator/packaging safely.
FS 54	All washable containers should be labelled: Wash out container thoroughly/empty washings into spray tank/and dispose of safely/dispose of as follows: . . . (specify).
FS 55	All non-washable containers should be labelled: Empty/and return used/ container (completely) and dispose of safely/dispose of as follows: . . . (specify)/in a safe way.
	or
	Return empty container as instructed by supplier.
FS 56	Handle with care and mix only in closed container.
FS 57	Keep off skin/away from eyes.
FS 58	Avoid contaminating food.
FS 59	Open containers outdoors. (Protect from contact with moisture and keep away from burning or glowing material.
FS 60	Apply solutions from unbreakable containers carrying a pouring tube or similar device.
FS 61	Air/ventilate animal feed for at least . . . hours following fumigation.
FS 62	Keep animals/birds/out of premises where grain is under fumigation or being aired/ ventilated following fumigation.
FS 63	Remove excess dust and air treated fabrics thoroughly before use.
FS 64	Search for and burn/bury all rodent bodies. Do not place in refuse bins or on rubbish tips.
FS 65	Spray only into the air/onto surfaces.
FS 66	Do not handle treated fabrics until dry and air thoroughly before use.
FS 67	Avoid skin contact with/do not wear/freshly treated clothing.
FS 68	Do not use on beehives/beekeeping equipment.
FS 69	Avoid (direct) contact with plant life/leaves of growing plants (until solvent has evaporated).
FS 70	Dispose of contaminated material safely by a method approved by the Waste Disposal Authority.
FS 71	Sawdust from treated timber should be treated as contaminated waste and disposed of safely.
FS 72	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:

Further Advice	Poisons Information Centre, Beaumont Hospital, Dublin 9. Telephone: 01-8379964 and 01-8379966.
Organophosphorous 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 treatment atropine sulphate 2 mg or pro rata for children and repeat (if necessary) until fully atropinised.
	2. If available administer pralidoxine 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 Estimate cholinesterase activity (5 ml blood unhaemolysed, of Diagnosis collected in an anticoagulant).
Dinitro 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 above 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 Doctor.
Treatment	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).
Carbamate pesticides.
Symptoms	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 3 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.
Bipyridyl pesticides.
Symptoms	Following ingestion, 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.
Specific treatment	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 per cent suspension of Fuller's Earth and 200 ml of 20 per cent mannitol in water.
	3. Give a sodium or magnesium sulphate purgative separately.
	4. Contact the Poisons Information Centre for further advice on treatment.
Test-quick qualitative	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.

ANNEX VIII.

(Annex II to Council Directive 78/631/EEC as amended by Council Directive 81/187/EEC and adapted by Commission Directive 84/291/EEC).

CLASSIFICATION BY CALCULATION OF PESTICIDES CONTAINING MORE THAN ONE ACTIVE SUBSTANCE.

1. For the purpose of applying the method of calculation for the classification of pesticides which contain more than one active substance, the dangerous substances used in their preparation are divided into categories and sub-categories in accordance with the list in point 5.

2. The following formula shall be used for the classification of a pesticide:

/images/si138y94p0049a.gif

Where:

P = the percentage by weight of each dangerous substance present in the pesticide;

I = the distinguishing index of the sub-category to which each substance belongs. It is assigned for every percentage unit of the substance in question present in the pesticide.

In particular, I breaks down into the following:

I₁: for classifying solid pesticides as toxic or harmful;

I₂: for classifying liquid or gaseous pesticides as toxic or harmful.

The values of the indices I₁ and I₂ are given in the table below:

Table of Classification Indices.

Category to which the substance belongs	Pesticide classification indices
	Solid	Liquid or gaseous
	I₁ (= conc.%)	I₂ (= conc.%)
Category I
I/a	500 (= 1%)	500 (= 1%)
I/b	100 (= 5%)	125 (=4%)
I/c	15 =( 33%)	25 (= 20%)
Category II
11/a	5 (= 100%)	10 (= 50%)
II/b	2 (= 100%)	4 (= 100%)
II/c	1 (= 100%)	2 (= 100%)
II/d	0.5 (= 100%)	1 (= 100%)

3. Pesticides containing one or more of the substances listed in point 5 are regarded as toxic if the sum of the products obtained by multiplying the percentage by weight P of the various substances present in the pesticide by the respective indices I₁ of I₂ is greater than 500, i.e.:

—for solid pesticides: /images/si138y94p0049b.gif

—for liquid or gaseous pesticides: /images/si138y94p0049c.gif

4. Pesticides containing one or more of the substances listed in point 5 are regarded as harmful if the sum of the products referred to in point 3 is 500 or less, but greater than 25 for solid pesticides, or 500 or less, but greater than 40 for liquid or gaseous pesticides, i.e.:

—for solid pesticides: /images/si138y94p0050a.gif

—for liquid or gaseous pesticides: /images/si138y94p0050b.gif

When the result of this calculation is 25 or less for a solid pesticide, or 40 or less for a liquid or gaseous one, the pesticide is not classified.

5. List of active substances, divided into classes and subclasses.

The substances bearing the indication (NT) cannot be transferred into other classes.

CLASS I/a.

No. in Directive 67/548/EEC	Nomenclature according to Directive 67/548/EEC
006-008-00-0	Antu	(NT)
015-056-00-1	Azinphos-ethyl
015-039-00-9	Azinphos-methyl
006-029-00-5	Dioxacarb
006-026-00-9	Carbofuran
015-071-00-3	Chlorfenvinphos
606-014-00-9	Chlorophacinone	(NT)
015-038-00-3	Coumaphos
607-059-00-7	Coumatetralyl
613-004-00-8	Crimidine	(NT)
015-070-00-8	Cyanthoate	(NT)
	Cycloheximide	(NT)
015-028-00-9	Demeton-O	(NT)
015-029-00-4	Demeton-S	(NT)
015-088-00-6	Dialifos	(NT)
015-073-00-4	Dicrotophos
015-061-00-9	Dimefox	(NT)
015-063-00-X	Dioxathion
609-020-00-X	DNOC
015-060-00-3	Disulfoton	(NT)
602-051-00-X	Endrin
015-036-00-2	EPN
	Ethoprophos
015-090-00-7	Fensulfothion	(NT)
607-078-00-0	Fluenetil	(NT)
616-002-00-5	Fluoroacetamide
015-091-00-2	Fonofos
602-053-00-0	Isobenzan	(NT)
006-009-00-6	Isolan
015-094-00-9	Mephosfolan
015-095-00-4	Methamidophos
015-069-00-2	Methidathion
	Methomyl
	Mevinphos	(NT)
015-072-00-9	Monocrotophos
614-001-00-4	Nicotine
650-004-00-7	Norbormide	(NT)
015-034-00-1	Parathion	(NT)
015-035-00-7	Parathion-methyl	(NT)
015-033-00-6	Phorate	(NT)
	Phospholan
015-022-00-6	Phosphamidon
	Promurit	(NT)
015-032-00-0	Prothoate
015-026-00-8	Schradan
614-003-00-5	Strychnine
015-027-00-3	Sulfotep	(NT)
015-025-00-2	TEPP	(NT)
	Thionazin	(NT)
015-024-00-7	Triamiphos
015-098-00-0	Trichloronate
607-056-00-0	Warfarin	(NT)
602-049-00-9	Dieldrin
604-002-00-8	Pentachlorophenol
602-008-00-5	Tetrachloromethane	(NT)
602-002-00-3	Bromomethane	(NT)
006-003-00-3	Carbon disulphide	(NT)
015-004-00-8	Aluminium phosphide	(NT)
015-006-00-9	Zinc phosphide	(NT)
602-010-00-6	1,2-Dibromoethane	(NT)
603-023-00-X	Ethylene oxide	(NT)

CLASS I/b.

No. in Directive 67/548/EEC	Nomenclature according to Directive 67/548/EEC
605-008-00-3	2-Propenal (Acrolein)
602-048-00-3	Aldrin
603-015-00-6	2-Propen-l-ol
006-018-00-5	Aminocarb
015-064-00-5	Bromophos-ethyl
	Crotoxyphos
015-044-00-6	Carbophenothion
015-086-00-5	Coumithoate
015-031-00-5	Demeton-S-methyl
015-078-00-1	Demeton-S-methyl sulphone
015-019-00-X	Dichlorvos
006-040-00-5	Dimetilan
609-025-00-7	Dinoseb
609-026-00-2	Salts and esters of dinoseb
609-030-00-4	Dinoterb
609-031-00-X	Salts and esters of dinoterb
607-055-00-5	Endothal-sodium
015-049-00-3	Endothion
611-003-00-7	Fenaminosulf
015-045-00-1	Mecarbam
015-066-00-6	Omethoate
	Heptachlor epoxide
006-023-00-2	Methiocarb
006-037-00-9	Promecarb

CLASS I/c.

No. in Directive 67/548/EEC	Nomenclature according to Directive 67/548/EEC
608-006-00-0	Bromoxynil
602-044-00-1	Camphechlor
606-019-00-6	Chlordecone
015-085-00-X	Chlorphonium
015-084-00-4	Chlorpyrifos
613-013-00-7	Cyanazine
602-045-00-7	DDT
015-030-00-X	Demeton-O-methyl
602-021-00-6	1,2-Dibromo-3-chloropropane
006-010-00-1	Dimetan
006-028-00-X	Dinobuton
006-029-00-5	Dioxacarb
650-008-00-9	Drazoxolon
602-052-00-5	Endosulfan
015-047-00-2	Ethion
015-048-00-8	Fenthion
050-003-00-6	Fentin acetate
050-004-00-1	Fentin hydroxide
602-046-00-2	Heptachlor
608-007-00-6	Ioxynil
602-043-00-6	Lindane
615-002-00-2	Methyl isothiocyanate
015-099-00-6	Pirimiphos-ethyl
006-016-00-4	Propoxur
015-050-00-9	Thiometon
015-059-00-8	Vamidothion

CLASS II/a.

No. in Directive 67/548/EEC	Nomenclature according to Directive 67/548/EEC
612-052-00-7	2-Aminobutane
006-011-00-7	Carbaryl
650-007-00-3	Chlordimeform
607-039-00-8	2, 4-D
006-019-00-0	Di-allate
015-068-00-7	Dichlofenthion
015-089-00-1	Ethoate-methyl
613-015-00-8	Fenazaflor
015-057-00-7	Formothion
607-079-00-6	Kelevan
080-003-00-1	Mercurous chloride
613-018-00-4	Morfamquat, and salts
006-014-00-3	Nabam
015-097-00-5	Phenthoate
015-101-00-5	Phosmet
015-040-00-4	Diazinon
	loxynil octanoate

CLASS II/b.

No. in Directive 67/548/EEC	Nomenclature according to Directive 67/548/EEC
015-080-00-2	Amidithion
602-047-00-8	Chlordane
607-074-00-9	Chlorfenac
015-087-00-0	Cyanophos
050-002-00-0	Cyhexatin
613-008-00-X	Dazomet
613-021-00-0	Dithianon
015-054-00-0	Fenitrothion
605-005-00-7	Metaldehyde
015-055-00-6	Naled
607-041-00-9	2, 4, 5-T
607-042-00-4	Salts and esters of 2, 4, 5-T
006-005-00-4	Thiram
015-021-00-0	Trichlorphon
609-024-00-1	Binapacryl
015-051-00-4	Dimethoate

CLASS II/c.

No. in Directive 67/548/EEC	Nomenclature according to Directive 67/548/EEC
015-079-00-7	Acephate
006-025-00-3	Allethrin
616-004-00-6	Allidochlor
	Barium carbonate
015-083-00-9	Bensulide
603-049-00-1	Chlorfenethol
616-005-00-1	Chlorthiamid
607-057-00-6	Coumachlor
015-074-00-X	Crufomate
607-083-00-8	2, 4-DB
602-012-00-7	1, 2-Dichloroethane
607-045-00-0	Dichlorprop
603-044-00-4	Dicofol
607-047-00-1	Fenoprop
	Malathion containing more than 1.8 per cent isomalathion
607-051-00-3	MCPA
706-052-00-9	Salts and esters of MCPA
607-053-00-4	MCPB
607-054-00-X	Salts and esters of MCPB
607-049-00-2	Mecoprop
006-038-00-4	Sulfallate
	Molinate
613-020-00-5	Tridemorph

CLASS II/d.

No. in Directive 67/548/EEC	Nomenclature according to Directive 67/548/EEC
	Alachlor
613-010-00-0	Ametryne
006-020-00-6	Barban
613-012-00-1	Bentazone
006-036-00-3	Benzthiazuron
609-032-00-5	Bromofenoxim
	Bromophos
607-075-00-4	Chlorfenprop-methyl
613-007-00-4	Desmetryne
606-018-00-0	Dichlone
609-023-00-6	Dinocap
616-007-00-2	Diphenamid
607-076-00-X	Dodine
006-030-00-0	EPTC
607-077-00-5	Erbon
015-052-00-X	Fenchlorphos
613-017-00-9	8-Hydroxyquinoline sulphate
	Hexachloroacetone
006-032-00-1	Monolinuron
	Monuron
006-034-00-2	Pebulate
616-009-00-3	Propanil
	Propargite
	2, 3, 6-TBA
	Trifenmorph
006-039-00-X	Triallate
	Malathion containing 1.8% iso-malathion or less
006-012-00-2	Ziram
613-011-00-6	Aminotriazole
015-100-00-X	Phoxim
016-010-00-3	Sodium polysulphides⁽¹⁾
016-007-00-7	Patassium polysulphides⁽¹⁾
016-008-00-2	Ammonium polysulphides⁽¹⁾
016-005-00-6	Calcium polysulphides⁽¹⁾
016-003-00-5	Barium polysulphides⁽¹⁾
616-006-00-7	Dichlofluanid⁽¹⁾

⁽¹⁾Conventional LD₅₀ and LC₅₀ values have not been given to these substances because of their corrosive/irritant properties.

ANNEX IX.

(Annex IX to Council Directive 67/548/EEC as amended by the Directive of 1992 and adapted by Commission Directive No. 91/410/EEC).

PROVISIONS RELATING TO CHILD-PROOF FASTENINGS.

1. Reclosable packages.

Child-proof fastenings used on reclosable packages shall comply with ISO Standard 8317 (1 July 1989 edition) relating to 'Child-resistant packages — Requirements and methods of testing for reclosable packages' adopted by the International Standard Organization (ISO).

2. Non-reclosable packages.

(pro memoria).

3. Notes.

1. Evidence of conformity with the above standard may be certified only by laboratories which conform with European Standards Series EN 45000.

2. Specific cases.

If it seems obvious that packaging is sufficiently safe for children because they cannot get access to the contents without the help of a tool, the test doesn't need to be performed.

In all other cases and when there are sufficient grounds for doubting the security of the closure for a child, the national authority may ask the person responsible for putting the product on the market to give him a certificate from a test house described below, that either:

—the type of closure is such that it is not necessary to test to the ISO standard referred to above, or

—the closure has been tested and has been found to conform with the standard referred to above.

SECOND SCHEDULE.

Regulation 12 (6) (d)

CERTIFICATE OF RESULT OF ANALYSIS.

				Laboratory Reference Number........................................
Sample of		............................................................ ............................................................ ........
received by the designated chemist on					............................................................ .....................
from	............................................................ ............................................................ ..................
Methods of analysis used			............................................................ ..........................................
............................................................ ............................................................ ...............................
............................................................ ............................................................ ...............................

This is to certify that the above mentioned sample, which was duly fastened and sealed, has been analyzed under the provisions of the European Communities (Classification, Packaging and Labelling of Pesticides) Regulations, 1994 ( S.I. No. 138 of 1994 ) and that the results of the analysis are as follows:— ............................................................ ............................................................ .....................................

............................................................ ............................................................ .....................................

This certificate is issued under the European Communities (Classification, Packaging and Labellingof Pesticides) Regulations, 1994 ( S.I. No. 138 of 1994 ).

Date.....................................................

Signed..........................................................

Designated Chemist.

THIRD SCHEDULE.

Regulation 12 (6) (d)

CERTIFICATE OF RESULT OF ANALYSIS.

				Laboratory Reference Number..............................................
Sample of		............................................................ ............................................................ ...............
taken at the premises of.......................................................						on.....................................................
temperature and place of storage				............................................................ ...................................
Date............................................................ .					Signed............................................................ .. Authorized Officer
received by the State Chemist on				............................................................ ...................................
from	............................................................ ............................................................ .........................
Methods of analysis used			............................................................ .................................................
............................................................ ............................................................ .......................................
............................................................ ............................................................ .......................................

............................................................ ............................................................ ......................................

This certificate is issued under the European Communities (Classification, Packaging and Labelling of Pesticides) Regulations, 1994 ( S.I. No. 138 of 1994 ).

Date............................................................ ...

Signed............................................................ ..........State ............................................................ .

State Chemist.

FOURTH SCHEDULE.

Regulation 18

PART I.

Fees for clearance of pesticides.

A. Each active substance contained in the pesticide.

Column (1)	Column (2)
	Type of clearance and fee payable.
Category	Trial	Limited	Provisional	Restricted or Commercial
	£	£	£	£
I	150	1,500	3,000	3,500

B. Each preparation.

Column (1)	Column (2)
	Type of clearance and fee payable.
Category	Trial	Limited	Provisional	Restricted or Commercial
	£	£	£	£
I	100	300	750	1,250
II	100	300	750	1,250
III	75	150	300	500

In this Schedule—

"Category I"	means a pesticide containing one or more active ingredients of particular specification not previously cleared and for which approval of classification, packaging and labelling in accordance with Regulation 4 is sought;
"Category II"	means a pesticide for which clearance and approval of classification, packaging and labelling in accordance with Regulation 4, for a major new area of use or a major formulation change, is sought;
"Category III"	means a pesticide for which clearance and approval of classification, packaging and labelling in accordance with Regulation 4, for a minor extension in use or a minor formulation changes, is sought;
"Commercial clearance"	means clearance for commercial sale and use of a pesticide;
"Limited clearance"	means clearance for commercial sale and use of a pesticide, in limited quantities or for a limited period or both, subject to specified restrictions or conditions;
"Provisional clearance"	means clearance for commercial sale and use of a pesticide, sometimes for a limited period, subject to specified restrictions or conditions;
"Restricted clearance"	means clearance for commercial sale and use of a pesticide subject to restriction(s) imposed by other statutory provisions or subject to special restrictions;
"Trial clearance"	means clearance for experimental use of a pesticide subject to specified restrictions or conditions.

PART 2.

Type of Clearance	Amount
Annual Fee for a Limited, Provisional, Commercial, or Restricted Clearance	£100
Trial Clearance	£50

PART 3.

Type of Clearance	Amount
Late Annual Renewal fee for a Limited, Provisional, Commercial, or Restricted Clearance	£150

GIVEN under my Official Seal, this 12th day of May, 1994.

JOE WALSH,

Minister for Agriculture, Food and

Forestry.

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, and specify the terms under which clearance for placing on the market is granted, in accordance with Council Directive 78/631/EEC and amending Directives.

In particular, these Regulations serve to consolidate the provisions of European Communities (Classification, Packaging and Labelling of Pesticides) Regulations, 1985 to 1992 ( S.I. No. 370 of 1985 ; S.I. No. 207 of 1987; S.I. No. 149 of 1989 ; S.I. No. 88 of 1991; and S.I. No. 416 of 1992 ), which are revoked. They expand the definition of the term "pesticides" as prescribed in the Directives; and introduce a revised scale of fees for the approval of documentation submitted in support of applications for clearance to market pesticides.