Source: http://www.irishstatutebook.ie/eli/1994/si/138/made/en/print
Timestamp: 2020-01-24 01:42:45
Document Index: 146893229

Matched Legal Cases: ['art 1', 'art 1', 'art 1', 'art 1', 'art 2', 'art 2', 'art 3']

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 4 as amended by Council Directive 92/32/EEC of 30 April 5 1992 hereby make the following Regulations:
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.
"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;
1 O.J. No. L206/13 29/7/1978.
2 O.J. No. L88/29 2/4/1981.
3 O.J. No. L144/1 30/5/1984.
4 O.J. No. L196/1 16/8/1967.
5 O.J. No. L154/1 5/6/1992.
6 O.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;
"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;
"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;
7 O.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;
"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.
(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. (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.
( 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) 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.
8 O.J. No. L133/1 30/5/1988 and O.J. No. L136/20 2/6/1988.
9 O.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
( 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)—
( 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.
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.
( 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:
(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,
(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;
( 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) is additional advice in accordance with Article 6 (5) of the Directive of 1978 as set out in Annex VII; and
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—
( 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,
( 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—
( 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,
(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,
( 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
10 O.J. No. L207/26 15/8/1979
( 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
( 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.
( 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.
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.
(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
(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.
( 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,
( 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. 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. (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. 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 ).
(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.
(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.
Combination of R-Phases.
(Annex IV to Council Directive 67/548/EEC as amended by the Directive of 1992 and adapted by Commission Directive 93/21/EEC).
Keep contents under . . . (appropriate liquid to be proposed by the manufacturer).
Keep under. . . (inert gas to be proposed by the manufacturer).
Keep away from .... (incompatible materials to be indicated by the manufacturer).
Do not breathe gas/fumes/vapour/spray (appropriate wording to be proposed by the manufacturer).
After contact with skin, wash immediately with plenty of . . . (to be proposed by the manufacturer).
To clean the floor and all objects contaminated by this material, use ... (to be proposed by the manufacturer).
During fumigation/spraying wear suitable respiratory equipment (appropriate working to be proposed by the manufacturer).
In case of fire, use . . . (indicate in the space the precise type of fire-fighting equipment. If water increases risk, add—Never use water).
Keep at temperature not exceeding . . . °C (to be proposed by the manufacturer).
Keep wetted with . . . (appropriate material to be proposed by the manufacturer).
Do not mix with . . . (to be proposed by the manufacturer).
Combination of S-Phrases.
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).
Keep in a cool place away from . . . (incompatible materials to be indicated by the manufacturer).
Keep container tightly closed and at temperature not exceeding . . . øC (to be proposed by the manufacturer).
Keep only in the original container at temperature not exceeding . . . °C (to be proposed by the manufacturer).
(Annex V to Council Directive 78/631/EEC).
No. in Annex IV to Directive 67/548/EEC
For very toxic and toxic pesticides:
Do not breathe gas/fumes/vapour/spray (apparopriate wording to be proposed by the manufacturer).
During fumigation/spraying wear suitable respiratory equipment (appropriate wording to be proposed by the manufacturer).
When a pesticide contains phosphoric acid esters, the following advice must also be given:
If two or more phrases are required, they can be combined in accordance with Annex XI.
(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
(Annex III to Council Directive 78/631/EEC).
LIST OF ACTIVE SUBSTANCES WITH INDICATIONS OF THEIR CONVENTIONAL LD50 AND LC50 VALUES.
EEC Number Substance
Cut LD50 mg/kg
Inh LC50 Mg/¼h
Axinphos-ethyl
loxynil-octanoate
Malathion containing more than 1.8% isomalathion
Malathion containing 1.8% isomalathion or less
006-014-00-2
Salts and esters of 2, 4, 5-T
2, 3, 6-TBA
1, 2-Dibromoethane(1)
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.
Additional safety advice.
Store/keep in original container, tightly closed, in a safe place/under lock and key/away from damp/sources of heat.
Store/keep/apply/away from/install out of reach of pets/birds/bees/fish/(young) children.
For use only on/crop/foodstuff/surface/situation/for control of process.
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).
Do not spray/apply directly to livestock/poultry/pets food/food crops.
Do not apply to those surfaces/on which food/feed is stored, prepared/or/eaten/which children are likely to touch.
Do not prepare/use/place bait/dust in/domestic kitchens/ larders/food cupboards/ where human or animal food or water could become contaminated.
Avoid all contact by mouth/with skin/eyes.
Avoid contact during pregnancy.
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.
Do not breathe dust/mist/smoke/fog. (If necessary for personal comfort, wear a mask.)
Avoid working in spray mist/smoke/fog.
Wash splashes/dust/powder/concentrate/any contamination/ from skin and eyes immediately.
Wash hands and exposed skin/before eating, drinking or smoking and after work/before meals and after work/after use/handling.
Extinguish all naked flames/including pilot lights/ when applying the fumigant/dust/liquid/product.
Do not apply in the presence of/avoid/naked flames, hot surfaces/or/unprotected electrical equipment.
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.
Avoid excessive contamination of overalls/clothing and launder regularly.
Not to be used as food or feed.
Do not allow . . . (product) . . . to come into contact with food or cooking utensils.
Protect/cover food preparing equipment and eating utensils from contamination during application/before spraying.
Do not exceed use of one unit/strip per . . . cu m (cu f).
Do not apply more than . . . per (state amount).
Do not apply more than . . . times per crop/season/time period.
Keep children/pets/animals away from treated areas/baits for . . . hours/days.
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.
Do not prepare/use/lay baits/dust/spray where food/feed water could become contaminated.
Remove/all animals/pets/livestock/feed/exposed water/milk/ collect eggs before application/spraying.
Do not harvest/crops for human/animal consumption/for at least ( . . . days/weeks) after last application.
Do not pick/gather/food crops within . . . hours/days/weeks of treatment.
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.
Dangerous/Harmful to livestock. Keep all livestock/out of treated areas/away from treated water/for at least . . . (interval). Bury or remove spillages.
Keep livestock out of treated areas for at least . . . (interval)/if poisonous weeks such as ragwort are present.
Prevent access to baits by children, domesticated animals and pets, (particularly cats, dogs and pigs).
Keep/apply/suspend only in positions inaccessible to children and pets.
Use bait containers clearly marked "Poison" at all/ surface baiting points.
Remove all remains of dust/bait/and bait containers/and dead rodents/after/at end of/treatment and burn/bury/destroy/ dispose of safely.
Remove exposed dust thoroughly after use and bury/burn.
Do not sow/plant/transplant . . . (specify crops) . . . for at least . . . (interval).
Do not apply from aircraft/the air.
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.
Dangerous/Harmful to bees. Do not apply/dust/spray/at flowering stage/crops in open flower/during bee activity. Keep down flowering weeds.
Dangerous/Harmful to fish. Do not contaminate ponds, waterways or ditches with the chemical or used container.
Prevent any surface run off to/from entering storm/drains.
Avoid contamination of watercourses/ground.
Dispose of used generator/packaging safely.
All washable containers should be labelled: Wash out container thoroughly/empty washings into spray tank/and dispose of safely/dispose of as follows: . . . (specify).
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.
Handle with care and mix only in closed container.
Keep off skin/away from eyes.
Avoid contaminating food.
Open containers outdoors. (Protect from contact with moisture and keep away from burning or glowing material.
Apply solutions from unbreakable containers carrying a pouring tube or similar device.
Air/ventilate animal feed for at least . . . hours following fumigation.
Keep animals/birds/out of premises where grain is under fumigation or being aired/ ventilated following fumigation.
Remove excess dust and air treated fabrics thoroughly before use.
Search for and burn/bury all rodent bodies. Do not place in refuse bins or on rubbish tips.
Spray only into the air/onto surfaces.
Avoid skin contact with/do not wear/freshly treated clothing.
Do not use on beehives/beekeeping equipment.
Avoid (direct) contact with plant life/leaves of growing plants (until solvent has evaporated).
Dispose of contaminated material safely by a method approved by the Waste Disposal Authority.
Sawdust from treated timber should be treated as contaminated waste and disposed of safely.
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:
Poisons Information Centre, Beaumont Hospital, Dublin 9. Telephone: 01-8379964 and 01-8379966.
Organophosphorous pesticides.
Guide to Doctor.
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.
Confirmation Estimate cholinesterase activity (5 ml blood unhaemolysed, of Diagnosis collected in an anticoagulant).
Dinitro pesticides.
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.
Estimate blood DNOC/Dinoseb (DNBP) concentration (5 ml blood collected in an anticoagulant).
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. Watch respiration — intubation with endotracheal tube or tracheotomy may be necessary in conjunction with artificial ventilation.
Bipyridyl pesticides.
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.
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.
Test-quick qualitative
Sodium dithionite (hydrosulphite)
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 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.
2. The following formula shall be used for the classification of a pesticide:
I1: for classifying solid pesticides as toxic or harmful;
I2: for classifying liquid or gaseous pesticides as toxic or harmful.
Table of Classification Indices.
Category to which the substance belongs
Pesticide classification indices
I1 (= conc.%)
I2 (= conc.%)
500 (= 1%)
100 (= 5%)
125 (=4%)
15 =( 33%)
25 (= 20%)
5 (= 100%)
10 (= 50%)
2 (= 100%)
4 (= 100%)
1 (= 100%)
0.5 (= 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:
—for liquid or gaseous pesticides:
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.:
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
CLASS I/b.
CLASS I/c.
CLASS II/a.
Morfamquat, and salts
CLASS II/b.
CLASS II/c.
Malathion containing more than 1.8 per cent isomalathion
706-052-00-9
CLASS II/d.
Malathion containing 1.8% iso-malathion or less
Sodium polysulphides(1)
Patassium polysulphides(1)
Ammonium polysulphides(1)
Calcium polysulphides(1)
Barium polysulphides(1)
Dichlofluanid(1)
(1)Conventional LD50 and LC50 values have not been given to these substances because of their corrosive/irritant properties.
(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.
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.
1. Evidence of conformity with the above standard may be certified only by laboratories which conform with European Standards Series EN 45000.
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.
Regulation 12 (6) (d)
Laboratory Reference Number........................................
received by the designated chemist on
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 ).
Designated Chemist.
Laboratory Reference Number..............................................
taken at the premises of.......................................................
temperature and place of storage
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 Labelling of Pesticides) Regulations, 1994 ( S.I. No. 138 of 1994 ).
Signed............................................................ ..........State ............................................................ .
Fees for clearance of pesticides.
A. Each active substance contained in the pesticide.
Type of clearance and fee payable.
Restricted or Commercial
B. Each preparation.
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;
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;
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.
Annual Fee for a Limited, Provisional, Commercial, or Restricted Clearance
Trial Clearance
Late Annual Renewal fee for a Limited, Provisional, Commercial, or Restricted Clearance
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.