Regulation (EC) No 299/2008 of the European Parliament and of the Council of 11 March 2008 amending Regulation (EC) No 396/2005 on maximum residue levels of pesticides in or on food and feed of plant and animal origin, as regards the implementing powers conferred on the Commission

THE EUROPEAN PARLIAMENT AND THE COUNCIL OF THE EUROPEAN UNION,

Having regard to the Treaty establishing the European Community, and in particular Articles 37 and 152(4)(b) thereof,

Having regard to the proposal from the Commission,

Having regard to the opinion of the European Economic and Social Committee (1),

After consulting the Committee of the Regions,

Acting in accordance with the procedure laid down in Article 251 of the Treaty (2),

Whereas:

(1) Regulation (EC) No 396/2005 of the European Parliament and of the Council (3) provides that certain measures are to be adopted in accordance with Council Decision 1999/468/EC of 28 June 1999 laying down the procedures for the exercise of implementing powers conferred on the Commission (4).

(2) Decision 1999/468/EC has been amended by Decision 2006/512/EC, which introduced the regulatory procedure with scrutiny for the adoption of measures of general scope and designed to amend non-essential elements of a basic instrument adopted in accordance with the procedure referred to in Article 251 of the Treaty, inter alia by deleting some of those elements or by supplementing the instrument with new non-essential elements.

(3) In accordance with the statement by the European Parliament, the Council and the Commission (5) concerning Decision 2006/512/EC, for the regulatory procedure with scrutiny to be applicable to instruments adopted in accordance with the procedure referred to in Article 251 of the Treaty which are already in force, those instruments must be adjusted in accordance with the applicable procedures.

(4) The Commission should be empowered to define the scope of Regulation (EC) No 396/2005 and the criteria necessary for the establishment of certain maximum residue levels (MRLs) of pesticides in or on food and feed of plant and animal origin listed in its relevant annexes. Since those measures are of general scope and are designed to amend non-essential elements of Regulation (EC) No 396/2005, inter alia by supplementing it with new non-essential elements, they must be adopted in accordance with the regulatory procedure with scrutiny provided for in Article 5a of Decision 1999/468/EC.

(5) On grounds of efficiency and in order to guarantee economic operators a rapid decision-making process, whilst ensuring a high level of consumer protection, the normal time limits for the regulatory procedure with scrutiny should be curtailed for the adoption of measures setting, including, implementing, modifying or deleting MRLs and establishing a list of active substances for which no MRLs are required, as well as a list of active substance/product combinations where active substances are used as fumigant for post-harvest treatment.

(6) When, on imperative grounds of urgency, and in particular where a risk to human or animal health exists, the normal time limits for the regulatory procedure with scrutiny cannot be complied with, the Commission should be able to apply the urgency procedure provided for in Article 5a(6) of Decision 1999/468/EC for the adoption of measures setting, including, implementing, modifying or deleting MRLs.

(7) Regulation (EC) No 396/2005 should therefore be amended accordingly,

HAVE ADOPTED THIS REGULATION:

Article 1

Amendments

Regulation (EC) No 396/2005 is hereby amended as follows:

‘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.’;

‘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).’;

‘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).’;

‘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.’;

‘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).’;

‘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).’;

‘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(2) shall be adopted in accordance with the regulatory procedure with scrutiny referred to in Article 45(3) of this Regulation. (2)  Commission Directive 2002/63/EC of 11 July 2002 establishing Community methods of sampling for the official control of pesticide residues in and on products of plant and animal origin and repealing Directive 79/700/EEC (OJ L 187, 16.7.2002, p. 30).’;"

‘Article 45 Committee procedure

‘Article 46 Implementing measures

‘Article 49 Transitional measures

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.

Done at Strasbourg, 11 March 2008.

For the European Parliament The President H.-G. PÖTTERING

For the Council The President J. LENARČIČ

(1) OJ C 161, 13.7.2007, p. 45.

(2) Opinion of the European Parliament of 29 November 2007 (not yet published in the Official Journal) and Council Decision of 3 March 2008.

(3) OJ L 70, 16.3.2005, p. 1. Regulation as amended by Commission Regulation (EC) No 178/2006 (OJ L 29, 2.2.2006, p. 3).

(4) OJ L 184, 17.7.1999, p. 23. Decision as amended by Decision 2006/512/EC (OJ L 200, 22.7.2006, p. 11).

(5) OJ C 255, 21.10.2006, p. 1.