L-valine produced by fermentation with Corynebacterium glutamicum CCTCC 20232578

In the current application an authorisation is sought under Article 4 for L-valine produced by fermentation with Corynebacterium glutamicum CCTCC 20232578, 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 [1,2]. Specifically, the authorisation is sought for all animal species. According to the Applicant, L-valine has a minimum purity (mass fraction) of 94 %. The feed additive is intended to be mixed either into premixtures, incorporated through complementary feed, added directly to compound feed or water for drinking. However, the Applicant did not propose any minimum or maximum content of L-valine in compound feed or water. The EURL recommends for official control the “L-valine monograph” of Food Chemical Codex monograph for the identification of L-valine in the feed additive. For the determination of valine in the feed additive, premixtures and compound feed, the Applicant proposed the ring-trial validated European Union (EU) method based on ionexchange chromatography coupled to post-column derivatisation and optical 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 determination of total valine in feedingstuffs: a relative standard deviation for repeatability (RSDr) ranging from 1.7 to 3.8 % and a relative standard deviation for reproducibility (RSDR) ranging from 8.8 to 16.1 %. Additionally, in the frame of the stability studies, the Applicant provided experimental data applying the European Union (EU) for the determination of valine in compound feed and the EN ISO 17180 method for the determination of valine in the feed additive, premixtures, and water.
Furthermore, the EURL is aware on the suitability of the European Union (EU) method for the determination of other various amino acids (valine included) in the feed additive, premixtures and water considering it also suitable in the frame of the current application. Based on the performance characteristics available, the EURL recommends for official control: (i) the EN ISO 17180 method based on ion exchange chromatography coupled to optical detection (IEC-VIS/FLD) to determine valine in the feed additive, premixtures and water (ii) and the European Union (EU) method (or equivalent EN ISO 13903 method), based on IEC-VIS to determine valine in the feed additive, premixtures, compound feed and water. 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.