CHAPTER IIAUTHORISATION, USE, MONITORING AND TRANSITIONAL MEASURES APPLICABLE FOR FEED ADDITIVES

Article 8Opinion of the Authority

1.

The Authority shall give an opinion within six months of receipt of a valid application. This time limit shall be extended whenever the Authority seeks supplementary information from the applicant under paragraph 2.

2.

The Authority may, where appropriate, request the applicant to supplement the particulars accompanying the application within a time limit specified by the Authority after consultation with the applicant.

3.

In order to prepare its opinion, the Authority:

(a)

shall verify that the particulars and documents submitted by the applicant are in accordance with Article 7 and undertake an assessment in order to determine whether the feed additive complies with the conditions laid down in Article 5;

(b)

shall verify the report of the Community Reference Laboratory.

4.

In the event of an opinion in favour of authorising the feed additive, the opinion shall also include the following elements:

(a)

the name and address of the applicant;

(b)

the designation of the feed additive including its categorisation and allocation within functional groups provided for in Article 6, its specification, including, where applicable, purity criteria and method of analysis;

(c)

depending on the outcome of the assessment, specific conditions or restrictions in relation to handling, post-market monitoring requirements and use, including animal species and categories of animal species for which the additive is to be used;

(d)

specific additional requirements for the labelling of the feed additive necessary as a result of conditions and restrictions imposed under (c);

(e)

a proposal for the establishment of Maximum Residues Limits (MRLs) in the relevant foodstuffs of animal origin, unless the opinion of the Authority concludes that the establishment of MRLs is not necessary for the protection of consumers or MRLs have already been established in Annex I or III to Council Regulation (EEC) No 2377/90 of 26 June 1990 laying down a Community procedure for the establishment of maximum residue limits of veterinary medicinal products in foodstuffs of animal origin17.

5.

The Authority shall without delay forward its opinion to the Commission, the Member States and the applicant, including a report describing its assessment of the feed additive and stating the reasons for its conclusion.

6.

The Authority shall make its opinion public, after deletion of any information identified as confidential in accordance with Article 18(2).