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

Article 8Opinion of the F1Food Safety Authority

1.

The F1Food Safety Authority shall give an opinion within six months of receipt of a valid application. This time limit shall be extended whenever the F1Food Safety Authority seeks supplementary information from the applicant under paragraph 2.

2.

The F1Food Safety Authority may, where appropriate, request the applicant to supplement the particulars accompanying the application within a time limit specified by the F1Food Safety Authority after consultation with the applicant.

3.

In order to prepare its opinion, the F1Food Safety 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 F2reference 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 F1Food Safety Authority concludes that the establishment of MRLs is not necessary for the protection of consumers or MRLs have already been established in F3Regulation (EC) No 470/2009.

F45.

The Food Safety Authority must without delay forward its opinion to the appropriate authority including a report describing its assessment of the feed additive and stating the reasons for its conclusion.

6.

The F1Food Safety Authority shall make its opinion public, after deletion of any information identified as confidential in accordance with Article 18(2).