European Communities (Classification, Packaging and Labelling of Plant Protection Products and Biocide Products) Regulations, 2001

• Jurisdiction: Ireland
• Citation: IR SI 624/2001
• Year: 2001

ARRANGEMENT OF REGULATIONS
1 Citation 2 Interpretation 3 Application 4 National Authorities 5 General requirements for placing on the market 6 Dangerous properties to be assessed and dangerous substances to be considered in the evaluation of hazards 7 General principles of classification and labelling 8 Evaluation of hazards deriving from physico-chemical properties 9 Evaluation of health hazards 10 Evaluation of environmental hazards 11 Data, information, supporting documentation and materials 12 Packaging 13 Labelling 14 Distance selling 15 Safety data sheets 16 Confidentiality of chemical names 17 Emergency measures 18 Notification of imports and exports 19 Inspections, sampling, tests and examinations 20 Seizure, retention, removal and disposal 21 General offences 22 Prosecution and specific rules of evidence 23 & 24 Referee analysis 25 & 26 Fees 27 Statutory instruments revoked
Schedule 1 Annex I List of the dangerous substances for which classification and labelling have been agreed Annex II Symbols and indications Annex III Nature of special risks Annex IV Safety advice (phrases) Annex V Test methods Annex VI Classification and labelling requirements for dangerous substances and preparations Schedule 2 Annex VII Additional safety advice Schedule 3 Annex VIII Methods for the evaluation of physico-chemical properties of preparations in accordance with Regulation 8 Annex IX Methods for the evaluation of health hazards of preparations in accordance with Regulation 9 Annex X Methods for the evaluation of environmental hazards of preparations in accordance with Regulation 10 Annex XI Special provisions for containers containing preparations offered or sold to the general public Annex XII Special provisions for labelling certain preparations Annex XIII Confidentiality for the chemical identity of a substance Schedule 4 Annex XIV Preparation (formulation) types and codes Schedule 5 Information and documentation to support a notification for a biocide product in accordance with subparagraph (3) (b) of Regulation 5 or paragraph (3) of Regulation 11 Schedule 6 Certificate of result of analysis carried out by a designated analyst Schedule 7 Certificate of result of analysis carried out by the State Chemist Schedule 8 Application and annual fees for clearance and notification of plant protection products and biocide products
S.I. No. 624 of 2001
EUROPEAN COMMUNITIES (CLASSIFICATION, PACKAGING AND LABELLING OF PLANT PROTECTION PRODUCTS AND BIOCIDE PRODUCTS) REGULATIONS, 2001
I, Joe Walsh, Minister for Agriculture, Food and Rural Development, 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 Directive 1999/45/EC of the European Parliament and of the Council of 31 May 19991 and Commission Directive 2001/60/EC of 7 August 20012 ,
taking account of Council Directive 67/548/EEC of 27 June 19673 , Council Directive 92/32/EEC of 30 April 19924 , Council Directive 96/56/EEC of 3 September 19965 , Commission Directive 88/302/EEC of 18 November 19876 , the corrigendum to Commission Directive 88/302/EEC of 18 November 19877 , Commission Directive 91/410/EEC of 22 July 19918 , Commission Directive 92/69/EEC of 31 July 19929 , Commission Directive 93/21/EEC of 27 April 199310 , Commission Directive 93/72/EEC of 1 September 199311 , Commission Directive 93/105/EC of 25 November 199312 , Commission Directive 93/101/EC of 11 November 199313 , Commission Directive 94/69/EC of 19 December 199414 , Commission Directive 96/54/EC of 30 July 199615 , Commission Directive 97/69/EC of 5 December 199716 , Commission Directive 98/73/EC of 18 September 199817 , the corrigendum to Commission Directive 98/73/EC of 18 September 199818 , Commission Directive 98/98/EC of 15 December 199819 , the corrigendum to Commission Directive 98/98/EC of 15 December 199820 , Commission Decision of 19 May 2000 correcting Commission Directive 98/98/EC of 15 December 199821 , Commission Directive 2000/32/EC of 19 May 200022 , Commission Directive 2000/33/EC of 25 April 200023 , Commission Directive 2001/59/EC of 6 August 200124 ,
taking account of Council Directive 91/414/EEC of 15 July 199125 ,
and further taking account of Directive 98/8/EC of the European Parliament and of the Council of 16 February 199826 , hereby make the following Regulations:
	Citation	1 (1) These Regulations may be cited as the European Communities (Classification, Packaging and Labelling of Plant Protection Products and Biocide Products) Regulations, 2001.
(2) These Regulations shall come into operation on the 28th day of December 2001.
	Interpretation	2 (1) In these Regulations -
“Annex I” means Annex I to the Directive of 1967, as last amended by Commission Directive 2001/59/EC of 6 August 200124 ;
“Annex II” (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 2001/59/EC of 6 August 200124 ;
“Annex III” (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 2001/59/EC of 6 August 200124 ;
“Annex IV” (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 2001/59/EC of 6 August 200124 ;
“Annex V” means Annex V to the Directive of 1967, as amended by the Directive of 1992, Commission Directive 88/302/EEC of 18 November 19876 , Commission Directive 92/69/EEC of 31 July 199224 , Commission Directive 93/21/EEC of 27 April 199310 , Commission Directive 96/54/EC of 30 July 199615 , Commission Directive 98/73/EC of 18 September 199817 , the corrigendum to Commission Directive 98/73/EC of 18 September 199818 , Commission Directive 2000/32/EC of 19 May 2000 22 , Commission Directive 2000/33/EC of 25 April 200023 and Commission Directive 2001/59/EC of 6 August 200124 ;
“Annex VI” (which is set out in the First Schedule) means Annex VI to the Directive of 1967, as amended by the Directive of 1992 and Commission Directive 2001/59/EC of 6 August 200124 ;
“Annex VII” means Annex VII set out in the Second Schedule, comprising additional safety advice in accordance with Article 16 (5) of the Directive of 1991;
“Annex VIII” (which is set out in the Third Schedule) means Annex I to the Directive of 1999;
“Annex IX” (which is set out in the Third Schedule) means Annex II to the Directive of 1999 as amended by Commission Directive 2001/60/EC of 7 August 20012 ;
“Annex X” (which is set out in the Third Schedule) means Annex III to the Directive of 1999;
“Annex XI” (which is set out in the Third Schedule) means Annex IV to the Directive of 1999, supplemented by the technical specifications comprising Annex IX to the Directive of 1967 as amended by the Directive of 1992, Commission Directive No. 91/410/EEC of 22 July 19917 , and Commission Directive 2000/32/EC of 19 May 2000 21 ;
“Annex XII” (which is set out in the Third Schedule) means Annex V to the Directive of 1999 as amended by Commission Directive 2001/60/EC of 7 August 20012 ;
“Annex XIII” (which is set out in the Third Schedule) means Annex VI to the Directive of 1999;
“Annex XIV” means Annex XIV set out in the Fourth Schedule, comprising a list of preparation (formulation) types and codes;
“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 plant protection product or biocide product, 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;
“carcinogenic substances and preparations” means substances or preparations which, if they are inhaled or ingested or if they penetrate the skin, may induce cancer or increase its incidence;
“clearance” means clearance to market or use a plant protection product or biocide product for which the record of studies conducted, and the information, documentation, materials, labelling and packaging submitted have been approved by the Minister in accordance with the requirements of these Regulations and cognate words shall be construed accordingly;
“corrosive substances and preparations” means substances and preparations which may on contact with living tissues, destroy them;
“dangerous for the environment” means substances and preparations which, were they to enter the environment, would or could present an immediate or delayed danger for one or more components of the environment;
“dangerous substances and preparations” means substances and preparations which are flammable, highly flammable, extremely flammable, explosive, oxidising, very toxic, toxic, harmful, corrosive, irritant, sensitising, carcinogenic, mutagenic, toxic for reproduction and / or dangerous for the environment;
“designated analyst” means any appropriately qualified officer of the Minister who is authorized in writing by the Minister for the purposes of these Regulations;
“Directive of 1967” means Council Directive 67/548/EEC of 27 June 19673 ;
“Directive of 1978” means Council Directive 78/631/EEC of 26 June 197827 ;
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