L-valine produced by fermentation with Escherichia coli CCTCC M 2022134

In the current application an authorisation is sought under Article 4 for L-valine produced by fermentation with Escherichia coli CCTCC M 2022134 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 98 %. The feed additive is intended to be mixed either into premixtures, incorporated through complementary feed or added directly to compound feed or water. However, the Applicant did not propose
any minimum or maximum content of L-valine in compound feed or water. For the determination of valine in the feed additive, the Applicant proposed the ring-trial validated method EN ISO 17180, dedicated for the determination of free lysine, methionine and threonine in commercial amino acid products and premixtures. The EURL is aware on the suitability of the above-mentioned method for the determination of various amino acids (valine included) in feed additives and thus considers it fit-for-purpose for the official control of the current product. For the determination of valine in 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 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 to16.1 %. In addition, the experimental data provided in the frame of the batch-to-batch variation analysis and in the frame of stability studies of the feed additive, and water demonstrated the applicability of the above-mentioned EU method for the determination of valine in these matrices. Furthermore, the EURL is aware on the suitability of the abovementioned method for the determination valine included in premixtures. Based on the performance characteristics available, the EURL recommends for official control the ring-trial validated 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. For identification purposes the EURL recommends the “L-valine monograph” of the Food Chemical Codex (FCC) where different tests (including the test based on optical rotation) are used for the identification of L-valine in the feed additive. 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.