Article 1

Regulation (EC) No 378/2005 is amended as follows:

1. 1..

   Article 1 is replaced by the following:

   ‘Subject matter and scope

   Article 1

   This Regulation lays down detailed rules for the implementation of Regulation (EC) No 1831/2003 as regards the duties and tasks of the Community Reference Laboratory (the CRL).’

2. 2..

   In Article 2, the following points (h) and (i) are added:

   1. (h)

      ‘“multi-analyte methods” are methods based on a defined principle applicable for the single or simultaneous determination of one or more substance(s)/agent(s) in the specific matrices defined in the scope of the method.

   2. (i)

      “reference standard” is a sample of a pure active agent used for calibration purposes.’

3. 3..

   Article 3 is replaced by the following:

   ‘Reference samples

   Article 3

   1.

   Any person submitting an application for an authorisation for a feed additive or for a new use of a feed additive, as provided for in Article 4(1) of Regulation (EC) No 1831/2003, shall send three reference samples in a form in which the feed additive is intended to be placed on the market by the applicant.

   In addition, the applicant shall provide to the CRL:

   (a)

   reference standards of the pure active agents in the case of feed additives:

   • belonging to the category zootechnical additives referred to in Article 6(1)(d) of Regulation (EC) No 1831/2003, except feed additives consisting of or containing micro-organisms;

   • belonging to the category coccidiostats and histomonostats referred to in Article 6(1)(e) of Regulation (EC) No 1831/2003;

   • falling within the scope of Community legislation relating to the marketing of products consisting of, containing or produced from genetically modified organisms (GMOs);

   • for which Maximum Residue Limits have been established in Annex I or III of Council Regulation (EEC) No 2377/90^f1 or following Regulation (EC) No 1831/2003.

   (b)

   where the application concerns a feed additive consisting of or containing micro-organisms, an authorisation to the CRL to access the microbial strain deposited at the internationally recognised culture collection mentioned in point 2.2.1.2. of Annex II of Commission Regulation (EC) No 429/2008^f2, if requested by the CRL.

   Where the application concerns a feed additive belonging to the category sensory additives and allocated within the functional group flavouring compounds referred to at point 2(b) of Annex I to Regulation (EC) No 1831/2003, subject to Article 10(2) of that Regulation, which forms part of a group of applications, the reference samples must be representative of all the compounds/substances in the group.

   2.

   The three reference samples of the feed additive shall be accompanied by a written statement by the applicant that the fee provided for in Article 4(1) has been paid.

   3.

   The applicant shall maintain the reference samples valid for the entire period of the authorisation of the feed additive by supplying new reference samples to the CRL to replace those expired.

   The applicant shall supply additional reference samples, reference standards, feed and/or food test materials, as defined in Article 2, if requested by the CRL. Upon justified request of the national reference laboratories of the consortium and without prejudice of Articles 11, 32 and 33 of Regulation (EC) No 882/2004, the CRL may request to the applicant additional reference samples, reference standards, feed and/or food test materials.

   4.

   Reference samples shall not be required for:

   (a)

   an application for a new use of a feed additive, already authorised for another use, submitted in accordance with Article 4(1) of Regulation (EC) No 1831/2003, when reference samples have been previously sent to the CRL for that other use;

   (b)

   an application 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 is not related to the characteristics of the feed additive previously sent to the CRL as reference sample of the feed additive concerned.’

4. 4..

   In Article 4, paragraph 1 is replaced by the following:

   ‘1.

   The CRL shall charge the applicant a fee in accordance with the rates set out in Annex IV (“the fee”).’

5. 5..

   Article 5 is amended as follows:

   1. (a)

      Paragraph 1 is replaced by the following:

      ‘1.

      The CRL shall submit a full evaluation report to the European Food Safety Authority (the 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 CRL considers the application to be very complex, it may extend that period by an additional month. The CRL shall inform the Commission, the 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 Authority, whenever the CRL requests supplementary information which cannot be provided by the applicant and/or cannot be evaluated by the CRL within those time limits.

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

   2. (b)

      The following paragraphs 3 and 4 are added:

      ‘3.

      The evaluation report provided for in paragraph 1 may be amended by the CRL at the request of the Commission or the 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 Authority.

      4.

      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 CRL;

      (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 CRL.

      Notwithstanding paragraph 4, the Commission, the CRL or the 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 CRL.’

6. 6..

   In Article 8, the following point (d) is added:

   1. (d)

      ‘if requested by the CRL, submitting an amendment to the evaluation report concerning the supplementary data submitted by the applicant to the CRL or to the Authority.’

7. 7..

   In Article 12, paragraph 1, the following point (d) is added:

   1. (d)

      ‘requirements concerning methods of analysis submitted in accordance with paragraph 2.6. of Annex II to Regulation (EC) No 429/2008;’

8. 8..

   Annex II is replaced by the text in Annex I to this Regulation.

9. 9..

   A new Annex IV, the text of which is set out in Annex II to the present Regulation, is added.