L-valine produced by fermentation with Corynebacterium glutamicum KCCM 80366

In the current application an authorisation is sought under Article 4(1) for L-valine produced by fermentation with Corynebacterium glutamicum KCCM 80366, under the category/functional group 3(c) “nutritional additives”/“amino acids, their salts and analogues” according to Annex I of Regulation (EC) No 1831/2003. 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 added to feed through premixtures, complementary feed or directly into compound feed. However, the Applicant did not propose any minimum or maximum content of L-valine in compound feed.
For the determination of valine in the feed additive, premixtures and compound feed the Applicant submitted the ring-trial validated European Union (EU) method, based on ion-exchange chromatography (IEC) coupled to post-column derivatisation and optical (VIS) detection, which is described in Commission Regulation (EC) No 152/2009. The method does not distinguish between the salts of amino acids and cannot differentiate between enantiomers. This method was further ring-trial validated resulting in the equivalent EN ISO 13903 leading to the following performance characteristics for the determination of total valine in animal feedingstuffs: 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, the experimental data provided in the frame of the batch-to-batch analysis demonstrated the applicability of the EU method for the determination of valine in the feed additive.
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 and 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.