9.4.2008 EN Official Journal of the European Union L 97/67
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,
Amendments
Regulation (EC) No 396/2005 is hereby amended as follows:
1. Article 4(1) shall be replaced by the following:
2. Article 5(1) shall be replaced by the following:
3. Article 8(2) shall be replaced by the following:
4. Article 14(1) shall be replaced by the following:
(a) a regulation on the setting, modification or deletion of an MRL. 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;
(b) a decision rejecting the application, which shall be adopted in accordance with the regulatory procedure referred to in Article 45(2).’;
5. Article 15(2) shall be replaced by the following:
6. Article 18 shall be replaced by the following:
(a) the MRLs for those products set out in Annexes II and III;
(b) 0,01 mg/kg for those products for which no specific MRL is set out in Annexes II or III, or for active substances not listed in Annex IV unless different default values are fixed for an active substance while taking into account the routine analytical methods available. Such default values shall be listed in Annex V. 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(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.
(a) such products comply with paragraph 1 and Article 20; or
(b) the active substance is listed in Annex IV.
(a) such products are not intended for immediate consumption;
(b) appropriate controls are in place to ensure that such products cannot be made available to the end user or consumer, if they are supplied directly to the latter, until the residues no longer exceed the maximum levels specified in Annexes II or III;
(c) the other Member States and the Commission have been informed of the measures taken.
7. Article 20(2) shall be replaced by the following:
8. Article 21(1) shall be replaced by the following:
9. Article 22(1) shall be replaced by the following:
(a) remaining MRLs in the Annex to Directive 76/895/EEC; and
(b) hitherto unharmonised national MRLs.
10. Article 27(2) shall be replaced by the following:
11. Article 45 shall be replaced by the following:
12. Article 46 shall be replaced by the following:
13. Article 49 shall be replaced by the following:
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.