Legal provisions of COM(2006)908 - Amendment of Regulation (EC) No 396/2005 on maximum residue levels of pesticides in or on food and feed as regards the implementing powers conferred on the Commission - Main contents
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dossier | COM(2006)908 - Amendment of Regulation (EC) No 396/2005 on maximum residue levels of pesticides in or on food and feed as regards the ... |
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document | COM(2006)908 ![]() |
date | March 11, 2008 |
Article 1
Amendments
Regulation (EC) No 396/2005 is hereby amended as follows:
1. | Article 4(1) shall be replaced by the following: ‘1. The products, product groups and/or parts of products referred to in Article 2(1) to which harmonised MRLs shall apply shall be defined in and covered by Annex I. That measure, designed to amend non-essential elements of this Regulation, shall be adopted in accordance with the regulatory procedure with scrutiny referred to in Article 45(3). Annex I shall include all products for which MRLs are set, as well as the other products for which it is appropriate to apply harmonised MRLs, in particular in view of their relevance in the diet of consumers or in trade. Products shall be grouped in such a way that MRLs may as far as possible be set for a group of similar or related products.’; |
2. | Article 5(1) shall be replaced by the following: ‘1. Active substances of plant protection products evaluated under Directive 91/414/EEC for which no MRLs are required shall be defined and listed in Annex IV to this Regulation, taking into account the uses of those active substances and the matters referred to in points (a), (c) and (d) of Article 14(2). Those measures, designed to amend non-essential elements of this Regulation, shall be adopted in accordance with the regulatory procedure with scrutiny referred to in Article 45(4).’; |
3. | Article 8(2) shall be replaced by the following: ‘2. Applications shall be evaluated in accordance with the relevant provisions of the Uniform Principles for the Evaluation and Authorisation of Plant Protection Products set out in Annex VI to Directive 91/414/EEC or specific evaluation principles to be laid down in a Commission regulation. That regulation, designed to amend non-essential elements of this Regulation by supplementing it, shall be adopted in accordance with the regulatory procedure with scrutiny referred to in Article 45(3).’; |
4. | Article 14(1) shall be replaced by the following: ‘1. Upon receipt of the opinion of the Authority and taking account of that opinion, one of the following shall be prepared by the Commission without delay and at the latest within three months:
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5. | Article 15(2) shall be replaced by the following: ‘2. Where a temporary MRL is set as provided for in paragraph 1(b), it shall be deleted from Annex III by a regulation one year after the date of the inclusion or non-inclusion in Annex I to Directive 91/414/EEC of the active substance concerned. That regulation, designed to amend non-essential elements of this Regulation, shall be adopted in accordance with the regulatory procedure with scrutiny referred to in Article 45(4). On imperative grounds of urgency, the Commission may have recourse to the urgency procedure referred to in Article 45(5) in order to ensure a high level of consumer protection. However, where one or more Member States so request, the temporary MRL may be maintained for an additional year pending confirmation that any scientific studies necessary for supporting an application for setting a MRL have been undertaken. In cases where such confirmation is provided, the temporary MRL shall be maintained for a further two years, provided that no unacceptable safety concerns for consumers have been identified.’; |
6. | Article 18 shall be replaced by the following: ‘Article 18 Compliance with MRLs 1. The products covered by Annex I shall not contain, from the time they are placed on the market as food or feed, or fed to animals, any pesticide residue exceeding:
2. Member States may not prohibit or impede the placing on the market or the feeding to food-producing animals within their territories of the products covered by Annex I on the grounds that they contain pesticide residues provided that:
3. By way of derogation from paragraph 1, Member States may authorise, further to a post-harvest treatment with a fumigant on their own territory, residue levels for an active substance which exceed the limits specified in Annexes II and III for a product covered by Annex I where the active substance/product combinations are listed in Annex VII provided that:
Measures designed to amend non-essential elements of this Regulation and defining the active substance/product combinations listed in Annex VII shall be adopted in accordance with the regulatory procedure with scrutiny referred to in Article 45(3). 4. In exceptional circumstances, and in particular further to the use of plant protection products in accordance with Article 8(4) of Directive 91/414/EEC or pursuant to obligations set out in Directive 2000/29/EC (6), a Member State may authorise the placing on the market and/or the feeding to animals within its territory of treated food or feed not complying with paragraph 1, provided that such food or feed does not constitute an unacceptable risk. Such authorisations shall immediately be notified to the other Member States, the Commission and the Authority, together with an appropriate risk assessment for consideration without undue delay with a view to setting a temporary MRL for a specified period or taking any other necessary measure in relation to such products. Those measures, designed to amend non-essential elements of this Regulation by supplementing it, shall be adopted in accordance with the regulatory procedure with scrutiny referred to in Article 45(4). On imperative grounds of urgency, the Commission may have recourse to the urgency procedure referred to in Article 45(5) in order to ensure a high level of consumer protection. |
7. | Article 20(2) shall be replaced by the following: ‘2. Specific concentration or dilution factors for certain processing and/or mixing operations or for certain processed and/or composite products may be included in the list in Annex VI. That measure, designed to amend non-essential elements of this Regulation, shall be adopted in accordance with the regulatory procedure with scrutiny referred to in Article 45(3).’; |
8. | Article 21(1) shall be replaced by the following: ‘1. MRLs for products covered by Annex I shall be first established and listed in Annex II, incorporating the MRLs provided for under Directives 86/362/EEC, 86/363/EEC and 90/642/EEC, taking into account the criteria listed in Article 14(2) of this Regulation. Those measures, designed to amend non-essential elements of this Regulation, shall be adopted in accordance with the regulatory procedure with scrutiny referred to in Article 45(3).’; |
9. | Article 22(1) shall be replaced by the following: ‘1. Temporary MRLs for active substances for which a decision on inclusion or non-inclusion in Annex I to Directive 91/414/EEC has not yet been taken shall be first established and listed in Annex III to this Regulation, unless already listed in Annex II, taking into account the information provided by the Member States, where relevant the reasoned opinion referred to in Article 24, the factors referred to in Article 14(2) and the following MRLs:
Those measures, designed to amend non-essential elements of this Regulation, shall be adopted in accordance with the regulatory procedure with scrutiny referred to in Article 45(3).’; |
10. | Article 27(2) shall be replaced by the following: ‘2. Measures designed to amend non-essential elements of this Regulation by supplementing it and determining the sampling methods necessary for carrying out such controls of pesticide residues in products other than those provided for in Directive 2002/63/EC (7) shall be adopted in accordance with the regulatory procedure with scrutiny referred to in Article 45(3) of this Regulation. |
11. | Article 45 shall be replaced by the following: ‘Article 45 Committee procedure 1. The Commission shall be assisted by the Standing Committee on the Food Chain and Animal Health established by Article 58 of Regulation (EC) No 178/2002. 2. Where reference is made to this paragraph, Articles 5 and 7 of Decision 1999/468/EC shall apply, having regard to the provisions of Article 8 thereof. The period laid down in Article 5(6) of Decision 1999/468/EC shall be set at three months. 3. Where reference is made to this paragraph, Article 5a(1) to (4) and Article 7 of Decision 1999/468/EC shall apply, having regard to the provisions of Article 8 thereof. 4. Where reference is made to this paragraph, Article 5a(1) to (4) and (5)(b), and Article 7 of Decision 1999/468/EC shall apply, having regard to the provisions of Article 8 thereof. The time limits laid down in Article 5a(3)(c) and (4)(b) and (e) of Decision 1999/468/EC shall be set at two months, one month and two months respectively. 5. Where reference is made to this paragraph, Article 5a(1), (2), (4) and (6) and Article 7 of Decision 1999/468/EC shall apply, having regard to the provisions of Article 8 thereof.’; |
12. | Article 46 shall be replaced by the following: ‘Article 46 Implementing measures 1. Implementing measures to ensure the uniform application of this Regulation, technical guidance documents to assist in its application and detailed rules concerning the scientific data required for the setting of MRLs shall be established or may be amended in accordance with the regulatory procedure referred to in Article 45(2), taking into account, where appropriate, the opinion of the Authority. 2. Measures designed to amend non-essential elements of this Regulation and relating to the establishment or amendment of the dates referred to in Article 23, Article 29(2), Article 30(2), Article 31(1) and Article 32(5) shall be adopted in accordance with the regulatory procedure with scrutiny referred to in Article 45(3), taking into account, where appropriate, the opinion of the Authority.’; |
13. | Article 49 shall be replaced by the following: ‘Article 49 Transitional measures 1. The requirements of Chapter III shall not apply to products lawfully produced or imported into the Community before the date referred to in the second paragraph of Article 50. However, in order to ensure a high level of consumer protection, appropriate measures concerning those products may be taken. Those measures, designed to amend non-essential elements of this Regulation by supplementing it, shall be adopted in accordance with the regulatory procedure with scrutiny referred to in Article 45(5). 2. Where necessary to allow for the normal marketing, processing and consumption of products, further transitional measures may be laid down for the implementation of certain MRLs provided for in Articles 15, 16, 21, 22, and 25. Those measures, designed to amend non-essential elements of this Regulation by supplementing it, and without prejudice to the obligation to ensure a high level of consumer protection, shall be adopted in accordance with the regulatory procedure with scrutiny referred to in Article 45(4).’ |
Article 2
Entry into force
This Regulation shall enter into force on the day following that of its publication in the Official Journal of the European Union.
This Regulation shall be binding in its entirety and directly applicable in all Member States.