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EURL-FA - Authorisation

The scientific assessment of applicants’ dossiers requires an evaluation of the analytical methods proposed by the applicant to determine the active substance(s)/agent(s) in the feed additive (as finished product), in premixtures, in feed, and in water (if applicable). In some cases, when maximum limits are established, the method(s) to determine the residues and/or metabolites in food shall also be evaluated. Evaluation of the analytical method is the task of the EURL.

 

The method is evaluated in a stepwise manner in which the EURL first assesses the documents provided by the applicants. The documentation submitted by the applicant must be in compliance with chapter 2.6 of Annex II to Regulation (EC) No 429/2008. On the basis of the documentation submitted by the applicant, the EURL is generally able to give a favourable opinion to EFSA without performing experiments. However, in some cases the EURL may conclude that it is necessary to test the method in its laboratory or organise an inter-laboratory comparison study to validate it in order to complete the assessment. The EURL also maintains a bank of reference samples of all authorised additives.

Given the high number of different feed additives ranging from trace elements to probiotics, expertise in many fields of analytical chemistry is needed. Therefore the EURL is supported by a consortium of European national reference laboratories. The administrative and technical guidance documents prepared by the EURL for applicants seeking authorisation for feed additives are provided in the page Guidance for applicants.

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