L-valine produced by fermentation with Corynebacterium glutamicum KCCM 80365

In the current application an authorisation is sought under Article 4(1) for L-valine produced by fermentation with Corynebacterium glutamicum KCCM 80365 under the category/functional groups 3(c) 'nutritional additives'/'amino acids, their salts and analogues', according to Annex I of Regulation (EC) No 1831/2003. Specifically, the authorisation is sought for all animal species. According to the Applicant, L-valine has a minimum purity (mass fraction) of 72 %. The feed additive is intended to be mixed either into premixtures, incorporated through complementary feed or added directly to compound feed. However, the Applicant did not propose any minimum or maximum content of L-valine in compound feed. For the quantification of valine in the feed additive, premixtures, compound feed the Applicant submitted the ring-trial validated European Union (EU) method based on ion exchange chromatography coupled to post-column derivatisation and photometric detection (IEC-VIS). The method does not distinguish between the salts of amino acids and cannot differentiate between enantiomers. The following performance characteristics were reported for the quantification of total valine in feed: a relative standard deviation for repeatability (RSD_r) ranging from 1.7 to 3.8 % and a relative standard deviation for reproducibility (RSD_R) ranging from 8.8 to 16.1 %. In addition, in the frame of the batch-to-batch analysis and for the stability studies of valine in the feed additive, the Applicant presented acceptable experimental data when applying the above mentioned EU method. In the frame of this authorisation the EURL recommends for official control the ring-trial validated European Union method based on IEC-VIS for the quantification of valine in the feed additive, premixtures, compound feed. Further testing or validation of the methods to be performed through the consortium of National Reference Laboratories as specified by Article 10 (Commission Regulation (EC) No 378/2005, as last amended by Regulation (EU) 2015/1761) is not considered necessary.