European Communities (Authorization, Placing on the Market, Use and Control of Plant Protection Products) Regulations, 2003

• Jurisdiction: Ireland
• Citation: IR SI 83/2003

Arrangement of Regulations
1 Citation 2 Interpretation 3 Application 4 Placing on the market 5 Exemptions from certain provisions 6 Use of plant protection products 7 Marketing of active substances 8 Application for authorization 9 Limiting of testing involving vertebrate species 10 Proprietary rights to data 11 Confidentiality 12 Consideration of applications 13 Granting of authorizations 14 Refusal to recognize comparability 15 Authorization for provisional periods 16 Extension of the field of application of a plant protection product 17 Information on potentially harmful effects 18 Authorization of certain plant protection products on the market before 25 July 1993 19 Renewal, alteration and cancellation of authorizations 20 Emergency authorization 21 Information exchange 22 Packaging 23 Labelling 24 Trials authorizations 25 Trials permits 26 Notification of imports and exports 27 Provisional maximum residue levels 28 Products containing residues 29 Appointment of authorized officer 30 Appointment of designated analyst 31 Search and inspections 32 Sampling 33 Seizure, retention, removal and disposal 34 General offences 35 Prosecution and specific rules of evidence 36 Fees 37 Reduction in fees 38 Revocations 39 Savers
S.I. No. 83 of 2003
EUROPEAN COMMUNITIES (AUTHORIZATION, PLACING ON THE MARKET, USE AND CONTROL OF PLANT PROTECTION PRODUCTS) REGULATIONS 2003
I, Joe Walsh, Minister for Agriculture and Food, in exercise of the powers conferred on me by section 3 of the European Communities Act, 1972 (No. 27 of 1972), for the purpose of giving effect to Council Directive 91/414/EEC of 15 July 1991 1 , the Corrigendum to Council Directive 91/414/EEC 2 , Council Directive 97/57/EC of 22 September 1997 3 , Commission Directive 93/71/EEC of 27 July 19934 , the Corrigendum to Commission Directive 93/71/EEC 5 Commission Directive 94/37/EC of 22 July 1994 6 , Commission Directive 94/79/EC of 21 December 1994 7 , the Corrigendum to Commission Directive 94/79/EEC 8 , Commission Directive 95/35/EC of 14 July 1995 9 , Commission Directive 95/36/EC of 14 July 1995 10 Commission Directive 96/12/EC of 8 March 1996 11 , Commission Directive 96/46/EC of 16 July 1996 12 . Commission Directive 96/68/EC of 21 October 1996 13 , Commission Directive 2000/80/EC of 4 December 2000 14 , Commission Directive 2001/21/EC of 5 March 2001 15 Commission Directive 2001/28/EC of 20 April 2001 16 , Commission Directive 2001/47/EC of 25 June 2001 17 , Commission Directive 2001/49/EC of 28 June 2001 18 , Commission Directive 2001/87/EC of 12 October 2001 19 , Commission Directive 2001/99/EC of 20 November 200120 Commission Directive 2001/36/EC of 16 May 2001 21 , Commission Directive 2001/103/EC of 28 November 2001 22 , Commission Directive 2002/18/EC of 22 February 2002 23 , Commission Directive 2002/37/EC of 3 May 2002 24 , Commission Directive 2002/48/EC of 30 May 2002 25 Commission Directive 2002/64/EC of 15 July 2002 26 , and Commission Directive 2002/81/EC of 10 October 200227 hereby make the following regulations:
	Citation	1 These Regulations may be cited as the European Communities (Authorization Placing on the Market, Use and Control of Plant Protection Products) Regulations 2003.
	Interpretation	2 (1) In these Regulations —
“actual conditions of use” in relation to good agriculture practice includes any stage in the production, storage, transport and distribution of plants and plant products;
“aircraft” includes hovercraft;
“authorized officer” means a person appointed in writing under Regulation 29;
“Commission” means the Commission of the European Communities;
“designated analyst” means any appropriately qualified person who is authorized in writing under Regulation 30;
“Directive of 1967” means Council Directive 67/548/EEC of 27 June, 1967 29 , as amended and adapted;
“Directive of 1991” means Council Directive No. 91/414/EEC of 15 July 1991;
“Directive of 1992” means Council Directive 92/32/EC of 30 April 1992 30 ;.
“Directive of 1999” means Directive 1999/45/EC of the European Parliament and of the Council of 31 May 1999 31 and the corrigendum to Directive 1999/45/EC 32 ;
“essential use” means a use of a plant protection product for which there is no practical alternative available or for which there are an insufficient number of suitable alternatives available;
“good agricultural practice” in the use of a plant protection product, means safe use of the plant protection product under actual conditions necessary for its effective action, in accordance with an authorization granted pursuant to these Regulations encompassing a range of levels of application up to the highest level of use for which an authorization has been granted, applied in a manner which leaves a residue which is the smallest practicable;
“good plant protection practice” in the use of plant protection products, means their responsible use in accordance with the guidelines issued from time to time by the Minister,
“insufficient number of suitable alternatives”, in relation to essential use means insufficient to avoid the imposition of selective pressure for the development of resistant populations of harmful organisms;
‘ISO.’ means the International Organisation for Standardisation;
‘IUPAC Rules’ means the chemical nomenclature rules adopted by the International Union of Pure and Applied Chemistry;
“maximum residue level” is the maximum content of residual traces of a plant protection product contained in a product to which a plant protection product has been applied;
“Member State” means a Member State of European Communities;
“Minister” means the Minister for Agriculture and Food;
“notified” means the packaging, including any label or container used with the package, and basic information as to the nature and composition of any such plant protection product on the market on or before the 2nd December 1985 and the manufacturer of each plant protection product which has been submitted and approved by the Minister under the Regulations of 2001, and cognate words shall be construed accordingly,
“notified” in the case of an adjuvant for use with a plant protection product or a plant protection product containing a macro-organism means
a) the packaging, including any label or container used with the package,
b) basic documentation,
c) information as to the nature and composition of any such adjuvant or plant protection product,
and as to the producer or manufacturer of each such adjuvant or plant protection product, has been submitted to and been approved by the Minister and cognate words shall be construed accordingly,
“officially recognized testing facilities and organizations” for the purposes of these Regulations, means testing facilities and organizations which carry out officially recognised tests and analyses,
“officially recognized tests and analyses” for the purposes of these Regulations means experiments, studies, tests and analyses carried out in accordance with methodologies and to a standard accepted from time to time by the Minister and issued as guideline documentation,
“parallel import approval” means an approval granted by the Minister for the importation, distribution, sale and use of a plant protection product deemed identical to a product on the register of plant protection products that may be placed on the market and used in accordance with these regulations,
“permission to market” means a permission granted by the Minister to place on the market and use a plant protection product;
“register of plant protection products” means a list established under Regulation 21;
“Regulations of 2001” means the European Communities (Classification, Packaging and Labelling of Plant Protection Products and Biocide Products) Regulations, 2001 ( S.I. No. 624 of 2001 );
“safe use, in relation to good agricultural practice”, means taking into account public and occupational health and environmental considerations;
“trials authorization” means an authorization granted in accordance with Regulation 24
“trials permit” means a permit granted in accordance with Regulation 25
(2) A word or expression that is used in the Directive of 1991 or in or Commission Directive or Regulation 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 or Regulation concerned
(3) 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,
(c) a reference to a Schedule is a reference to the Schedule to these Regulations.
(4) A reference to a Directive is to the Directive as amended or extended.
	Application	3. (1) Subject to paragraph (2), these Regulations apply to the production, storage or movement of a plant protection product
(2) These Regulations do not apply to a plant protection product intended for use in another Member State and Regulations 32 and 33 are complied with.
	Placing on the market	4. (1) A person shall not place a plant protection product on the market, cause or permit another person to place a plant protection product on the market, use the product or cause or permit another person to use the product unless these Regulations are complied with.
(2) A person shall not place a plant protection product on the market if -
(a) the net quantity of a plant...