CHAPTER IU.K.GENERAL PROVISIONS

Article 5U.K.Evaluation reports by the [F1reference laboratory]

[F21.The [F1reference laboratory] shall submit a full evaluation report to the [F3Food Safety Authority] for each application, or for each group of applications, within three months from the date of receipt of a valid application as referred to in Article 8(1) of Regulation (EC) No 1831/2003 and the payment of the fee.

However, if the [F1reference laboratory] considers the application to be very complex, it may extend that period by an additional month. The [F1reference laboratory] shall inform the [F4appropriate authority], the [F5Food Safety Authority], and the applicant when the period is extended.

The time limits provided for in this paragraph may be further extended with the agreement of the [F5Food Safety Authority], whenever the [F1reference laboratory] requests supplementary information which cannot be provided by the applicant and/or cannot be evaluated by the [F1reference laboratory] within those time limits.

However, the time limit for the [F1reference laboratory] to submit the evaluation report to the [F5Food Safety Authority] shall not exceed the time limit for [F5Food Safety Authority] to provide its opinion, as provided for in Article 8(1) of Regulation (EC) No 1831/2003.]

2.The evaluation report provided for in paragraph 1 shall include in particular:

(a)an evaluation indicating if the methods of analysis in the data submitted in the application are suitable to be used for official controls;

(b)an indication if testing of a method of analysis is considered necessary;

(c)an indication if a validation of a method of analysis by an intercomparison study is considered necessary.

[F63.The evaluation report provided for in paragraph 1 may be amended by the [F1reference laboratory] at the request of the [F4appropriate authority] or the [F5Food Safety Authority] where:

(a)the conditions for placing the feed additive on the market resulting from the Authority's opinion in accordance with Article 8(3)(a) of Regulation (EC) No 1831/2003 differ from those originally proposed by the applicant;

(b)supplementary information relevant to the method of analysis have been provided by the applicant to the [F5Food Safety Authority].

[F74.An evaluation report shall not be required for:

(a)applications for a new use of a feed additive submitted in accordance with Article 4(1) of Regulation (EC) No 1831/2003, when the proposed conditions for placing the feed additive on the market for the new use fall within the scope of the method of analysis previously submitted in accordance with paragraph 2.6 of Annex II to Regulation (EC) No 429/2008 and already evaluated by the [F1reference laboratory];

(b)applications for changing the terms of an existing authorisation submitted in accordance with Article 13(3) of Regulation (EC) No 1831/2003, when the proposed change or the new conditions for placing the feed additive on the market fall within the scope of the method of analysis previously submitted in accordance with paragraph 2.6 of Annex II to Regulation (EC) No 429/2008 and already evaluated by the [F1reference laboratory];

F8(c). . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

Notwithstanding paragraph 4, the [F4appropriate authority], the [F1reference laboratory] or the [F5Food Safety Authority] may, on the basis of legitimate factors relevant to the application, consider that a new evaluation of the methods of analysis is necessary. In such cases the applicant shall be informed by the [F1reference laboratory].]]

Textual Amendments