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Subject matter and scope
This Regulation lays down detailed rules for the implementation of Regulation (EC) No 1831/2003 as regards: (a) applications for authorisation of a feed additive or for a new use of a feed additive as provided for in Article 4(1) of that Regulation (the application); and (b) the duties and tasks of the Community Reference Laboratory (the CRL).
Definitions
For the purposes of this Regulation, the following definitions shall apply: (a) ‘reference sample’ means a representative sample of the feed additive, as referred to in Article 7(3)(f) of Regulation (EC) No 1831/2003, which is the object of an application; (b) ‘method of analysis’ means the procedure for the determination of the active substance(s) of the feed additive in feedingstuffs, and where appropriate, of its residue(s) or metabolite(s) in food, as referred to in Article 7(3)(c) of the Regulation (EC) No 1831/2003; (c) ‘evaluation of the method of analysis’ means the thorough assessment of the protocol of the method of analysis as described in the application, including, if appropriate, literature research but not necessarily any experimental work; (d) ‘testing of a method of analysis’ means the application of the method of analysis in a laboratory and comparison of results with those described in the application; (e) ‘validation of a method of analysis’ means the process of proving that a method of analysis is fit for the intended purpose, by an intercomparison study according to ISO 5725-1 to 6 or other internationally harmonised guidelines for validation of methods by intercomparison study; (f) ‘feed test material’ means a feedingstuff sample or premixture sample with or without the inclusion of the feed additive which is the object of the application, to be used for experimental studies on the method of analysis for the determination of the feed additive in feedingstuffs and/or premixtures; (g) ‘food test material’ means a food sample derived from an animal that has been fed with feedingstuffs with or without the inclusion of the feed additive which is the object of the application, to be used for experimental studies on the method of analysis for the determination of the feed additive in the residue(s) or metabolite(s).
Reference samples
1. Any person making an application shall send reference samples: (a) in a form in which the feed additive is intended to be placed on the market by the applicant; or (b) that are suitable to be converted easily in a form in which the feed additive is intended to be placed on the market by the applicant. 2. The three reference samples 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 supply feed and/or food test materials related to the samples if requested by the CRL.
Fees
1. The CRL shall charge the applicant a fee of EUR 3 000 for each application (the fee). 2. The CRL shall use the fees towards supporting the costs of the duties and tasks as set out in Annex II to Regulation (EC) No 1831/2003, and in particular those referred to in 2.1, 2.2 and 2.3 of that Annex. 3. The amount of the fee mentioned in paragraph 1 may be adapted once a year in accordance with the procedure referred to in Article 22(2) of Regulation (EC) No 1831/2003. The adaptation shall take into account the experience gained during the operation of this Regulation and in particular the possibility of fixing different fees for different types of applications.
Evaluation reports by the CRL
1. The CRL shall submit a full evaluation report to the European Food Safety Authority (the Authority) for each application 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 that the application is very complex, it may extend that period by an additional month. The CRL shall inform the Commission, the Authority and the applicant where the period is extended. 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.
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