Commission Regulation (EC) No 885/2009 of 25 September 2009 amending Regulation (EC) No 378/2005 as regards reference samples, fees and the laboratories listed in Annex II (Text with EEA relevance)

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).’

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 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 , 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.

This Regulation shall enter into force on the twentieth day following its publication in the Official Journal of the European Union.