THE COMMISSION OF THE EUROPEAN COMMUNITIES,
Having regard to the Treaty establishing the European Community,
Having regard to Regulation (EC) No 1831/2003 of the European Parliament and of the Council of 22 September 2003 on additives for use in animal nutrition(1), and in particular the first subparagraph of Article 7(4) and the third subparagraph of Article 21 thereof,
Whereas:
Regulation (EC) No 1831/2003 lays down rules for the placing on the market and use of feed additives in animal nutrition. It provides that any person seeking an authorisation for a feed additive or a new use of a feed additive is to submit an application for authorisation to the Commission in accordance with that Regulation (the application).
Regulation (EC) No 1831/2003 provides for a Community reference laboratory (the CRL) to carry out certain duties and tasks set out in Annex II to that Regulation. It also provides that the Joint Research Centre of the Commission is to be the CRL and that it may be assisted by a consortium of national reference laboratories to perform the duties and tasks set out in that Annex.
In accordance with Regulation (EC) No 1831/2003, it is necessary to adopt detailed rules for implementing Annex II to that Regulation, including practical conditions for the duties and tasks of the CRL and to amend that Annex accordingly.
In addition, the samples to be provided in the application, in accordance with Regulation (EC) No 1831/2003, should meet specific requirements in view of the duties and tasks of the CRL.
It is necessary to establish a precise timing for the delivery of the evaluation report from the CRL to the European Food Safety Authority (the Authority) in order to ensure that the procedures provided for in Regulation (EC) No 1831/2003 can be met.
The CRL should be authorised to charge a fee to applicants towards the costs of supporting the duties and tasks of the CRL and the consortium of national reference laboratories.
National reference laboratories should be part of the consortium of laboratories assisting the CRL only if they meet specific requirements in order to properly perform the duties and tasks laid down in Regulation (EC) No 1831/2003. Member States should be permitted to apply to the Commission for the designation of such laboratories.
In order to ensure the effective functioning of the consortium, it is necessary to appoint a rapporteur laboratory to carry out an initial assessment of the method(s) of analysis of each individual application and to establish clearly the duties and tasks of the rapporteur laboratories and the other laboratories participating in the consortium.
It is necessary to establish special procedures for the cases where the data in the application are insufficient concerning testing or validation of the method(s) of analysis.
In the interests of stability and efficacy and also in order to make the consortium operational, it is necessary to appoint the national reference laboratories participating in the consortium.
The relations between the members of the consortium should be defined by contract between them. In this context the CRL may develop guidance for applicants and for the laboratories participating in the consortium.
The measures provided for in this Regulation are in accordance with the opinion of the Standing Committee on the Food Chain and Animal Health,
HAS ADOPTED THIS REGULATION:
This Regulation lays down detailed rules for the implementation of Regulation (EC) No 1831/2003 as regards:
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
the duties and tasks of the Community Reference Laboratory (the CRL).
For the purposes of this Regulation, the following definitions shall apply:
‘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;
‘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;
‘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;
‘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;
‘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;
‘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;
‘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).
Any person making an application shall send reference samples:
in a form in which the feed additive is intended to be placed on the market by the applicant; or
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.
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.
The applicant shall supply feed and/or food test materials related to the samples if requested by the CRL.