The Plant Protection Products Regulations 2003
| Year | 2003 |
2003 No. 3241
PESTICIDES, ENGLAND AND WALES
The Plant Protection Products Regulations 2003
10thDecember 2003
10thDecember 2003
31stDecember 2003
ARRANGEMENT OF REGULATIONS
1. |
Title, extent and commencement |
2. |
Interpretation |
3. |
Prohibitions |
4. |
Applications concerning active substances |
5. |
Standard approvals |
6. |
General requirements for granting standard approvals |
7. |
Provisional approvals |
8. |
Emergency approvals |
9. |
Approvals for research and development |
10. |
Extensions of approved use |
11. |
Mutual recognition of approvals |
12. |
Provisional restrictions and prohibitions |
13. |
Applications, reviews, revocations and modifications |
14. |
Notification of information on potentially dangerous effects |
15. |
Data protection |
16. |
Duplication of experiments |
17. |
Confidentiality |
18. |
Packaging |
19. |
Labelling |
20. |
Seizure and disposal of plant protection products |
21. |
General offences |
22. |
Penalties |
23. |
General defence of due diligence |
24. |
Enforcement |
25. |
Service of documents |
26. |
Transitional provisions |
27. |
Disapplication |
28. |
Revocations |
1. |
Instruments amending Council Directive 91/414/EEC |
2. |
Non-confidential information |
3. |
Labelling |
4. |
Transitional provisions |
5. |
Revocations |
The Secretary of State for Environment, Food and Rural Affairs and the National Assembly for Wales being designated(1) for the purposes of section 2(2) of the European Communities Act 1972(2) in relation to the common agricultural policy of the European Community, acting jointly (the National Assembly for Wales acting in relation to Wales only), in exercise of the powers conferred upon them by that section, hereby make the following Regulations:
Title, extent and commencement
1. These Regulations may be cited as the Plant Protection Products Regulations 2003, extend to England and Wales, and come into force on 31st December 2003.
Interpretation
2. - (1) In these Regulations -
"the 1985 Act" means the Food and Environment Protection Act 1985(3);
"active substance" means any substance or micro-organism, including a virus, having general or specific action against harmful organisms or on plants, parts of plants or plant products;
"animals" means animals belonging to species normally fed and kept or consumed by man;
"approval" in relation to a plant protection product means an administrative act under these Regulations by which the Secretary of State, following an application submitted by an applicant, approves the placing on the market or use of that plant protection product in the whole or any part of England and Wales and "approved" shall be construed accordingly;
"the Commission" means the Commission of the European Communities;
"contravenes" includes "fails to comply with";
"the Directive" means Council Directive 91/414/EEC concerning the placing of plant protection products on the market(4), as amended by the instruments listed in Schedule 1;
"the EEA" means the European Economic Area established under the EEA Agreement;
"the EEA Agreement" means the Agreement on the EEA signed at Oporto on 2nd May 1992 as adjusted by the Protocol signed at Brussels on 17th March 1993;
"EEA State" means a State which is a Contracting Party to the EEA Agreement;
"the environment" means water, air, land, wild species of fauna and flora, and any interrelationship between them, as well as any relationship with living organisms;
"equivalent provision" means any provision in any other Regulations made for the purposes of implementing the Directive, extending to any part of the United Kingdom, which has equivalent effect to a specified provision in these Regulations;
"harmful organisms" means pests of plants or plant products belonging to the animal or plant kingdom, viruses, bacteria and mycoplasmas and other pathogens;
"integrated control" means the rational application of a combination of biological, biotechnological, chemical, cultural or plant-breeding measures whereby the use of chemical plant protection products is limited to the minimum strictly necessary to maintain harmful organisms below levels above which economically unacceptable damage or loss would occur;
"International Organisation for Standardization" means the institution of that name founded in 1947 and currently having its headquarters at 1 Rue de Varembé, CP 56, 1211 Geneva 20, Switzerland;
"International Union of Pure and Applied Chemistry" means the institution of that name founded in 1919 and currently having its headquarters at 104 T.W. Alexander Drive, Building 19, Research Triangle Park, NC 27709, USA;
"new active substance" means any active substance which is not an old active substance;
"old active substance" means any active substance which was on the market -
(a) in Austria, Finland, Iceland, Liechtenstein, Norway or Sweden, on or before 1st July 1994; or(b) in any other state within the EEA, on or before 26th July 1993;"placing on the market" means any supply, whether in return for payment or not, within England and Wales, including importation into England and Wales from outside the EEA, other than a supply for storage followed by consignment from the EEA or disposal, and "place on the market" shall be construed accordingly;
"plants" means live plants and live parts of plants including fresh fruit and seeds;
"plant products" means products derived from plants in the unprocessed state or having undergone only simple preparation such as milling, drying or pressing, but excluding plants themselves;
"plant protection product" means an active substance or a preparation containing one or more active substances, put up in the form in which it is supplied to the user, intended to -
(a) protect plants or plant products against all harmful organisms or prevent the action of such organisms;(b) influence (for example, as a growth regulator) the life processes of plants, otherwise than as a nutrient;(c) preserve plant products, in so far as such substances or products are not subject to provisions of Community law on preservatives;(d) destroy undesired plants; or(e) destroy parts of plants or check or prevent the undesired growth of plants;"preparation" means a mixture or solution composed of two or more substances, of which at least one is an active substance, and which is intended for use as a plant protection product;
"the 1986 Regulations" means the Control of Pesticides Regulations 1986(5);
"the relevant competent authorities" means the authorities appointed in the member States, other than the United Kingdom, for the purpose of carrying out the duties of a competent authority under the Directive;
"residue" in relation to a plant protection product means one or more substances present in or on plants or products of plant origin, edible animal products or elsewhere in the environment and resulting from the use of that plant protection product, and includes its metabolites and products resulting from its degradation or reaction;
"substance" means any chemical element and its compounds, as they occur naturally or by manufacture, and includes any impurity inevitably resulting from the manufacturing process;
and other terms used in Regulations have the same meaning as in the Directive.
(2) In these Regulations -
(a) any reference to a numbered Article shall be construed as a reference to the Article so numbered in the Directive; and(b) any reference to a numbered Annex shall be construed as a reference to the Annex so numbered of the Directive.Prohibitions
3. - (1) No person shall place on the market any plant protection product unless -
(a) it has been approved under regulation 5, 7, 8 or 11 or an equivalent provision; and(b) it is placed on the market in accordance with any requirement or condition which is specified in the approval.(2) No person shall use any plant protection product unless -
(a) it has been approved under regulation 5, 7, 8 or 11 or an equivalent provision;(b) it is used in accordance with any requirement or condition which is - (i) specified in the approval or in any extension of use granted under regulation 10 or an equivalent provision; or(ii) required by the approval or extension of use to be on the labelling;(c) it is used in accordance with the principles of good plant protection practice; and(d) whenever possible, it is used in accordance with the principles of integrated control.(3) No person shall place on the market any new active substance unless -
(a) that active substance is included in Annex I; or(b) an application (which has not yet been decided in accordance with the procedure in Article 19) has been made for the inclusion of that active substance in Annex I.(4) Paragraphs (1), (2) and (3) above shall not apply to any plant protection product or active substance which is approved under regulation 9 or an equivalent provision.
(5) Nothing in this regulation shall impede the production, storage or movement within England and Wales of a plant protection product intended for use in another EEA State, provided that -
(a) the product is authorised by the competent authority of that EEA State for use in that EEA State; and(b) the inspection requirements laid down by that EEA State in order to ensure compliance with Article 3(1) are satisfied.(6) Any person who contravenes or causes or permits any person to contravene paragraph (1), (2)(a) or (b) or (3) above shall be guilty of an offence.
Applications concerning active substances
4. - (1) Any person who applies for the inclusion of a new active substance in Annex I shall submit to the Secretary of State, the relevant competent authorities and the Commission a dossier which satisfies the requirements of Annex II, a declaration that the active substance is intended for use in a plant protection product, and a dossier complying with Annex III on at least one preparation containing that active substance.
(2) Where any active substance has been included in Annex I, any person may make an application for variation of the conditions subject to which the active...
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