Regulation (EC) No 396/2005 of the European Parliament and of the CouncilShow full title

SECTION 2 Consideration of applications concerning MRLs by the authority

Article 10 The Authority's opinion on applications concerning MRLs

1. The Authority shall assess the applications and the evaluation reports and give a reasoned opinion on, in particular, the risks to the consumer and where relevant to animals associated with the setting, modification or deletion of an MRL. That opinion shall include:

(a) an assessment of whether the analytical method for routine monitoring proposed in the application is appropriate for the intended control purposes;

(b) the anticipated LOD for the pesticide/product combination;

(c) an assessment of the risks of the acceptable daily intake or acute reference dose being exceeded as a result of the modification of the MRL; the contribution to the intake due to the residues in the product for which the MRLs was requested;

(d) any other element relevant to the risk assessment.

2. The Authority shall forward its reasoned opinion to the applicant, the Commission and the Member States. The reasoned opinion shall clearly define the basis for each conclusion reached.

3. Without prejudice to Article 39 of Regulation (EC) No 178/2002, the Authority shall make its reasoned opinion public.

Article 11 Time limits for the Authority's opinion on applications concerning MRLs

1. The Authority shall give its reasoned opinion as provided for in Article 10 as soon as possible and at the latest within three months from the date of receipt of the application.

In exceptional cases where more detailed evaluations need to be carried out, the time limit laid down in the first subparagraph may be extended to six months from the date of receipt of the valid application.

2. Where the Authority requests supplementary information, the time limit laid down in paragraph 1 shall be suspended until that information has been provided. Such suspensions are subject to Article 13.

Article 12 Assessment of existing MRLs by the Authority

1. The Authority shall, within a period of 12 months from the date of the inclusion or non-inclusion of an active substance in Annex I to Directive 91/414/EEC after the entry into force of this Regulation, submit a reasoned opinion based in particular on the relevant assessment report prepared under Directive 91/414/EEC to the Commission and the Member States on:

(a) existing MRLs for that active substance set out in Annex II or III to this Regulation;

(b) the necessity of setting new MRLs for that active substance, or its inclusion in Annex IV to this Regulation;

(c) specific processing factors as referred to in Article 20(2) of this Regulation that may be needed for that active substance;

(d) MRLs which the Commission may consider including in Annex II and/or Annex III to this Regulation and on those MRLs which may be deleted related to that active substance.

2. For substances included in Annex I to Directive 91/414/EEC before the entry into force of this Regulation, the reasoned opinion referred to in paragraph 1 of this Article shall be delivered within 12 months of the entry into force of this Regulation.

Article 13 Administrative review

Any decision taken under, or failure to exercise, the powers vested in the Authority by this Regulation may be reviewed by the Commission on its own initiative or in response to a request from a Member State or from any person directly and individually concerned.

For that purpose, a request shall be submitted to the Commission within two months after the day on which the party concerned became aware of the act or omission in question.

The Commission shall take a decision within two months requiring, if appropriate, the Authority to withdraw its decision or to remedy its failure to act within a set time-limit.