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 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, the feed additive contains a minimum L-valine content of 98.0 % (w/w, based on dry matter).
L-valine is intended to be added to feed through premixtures or directly into compound feed and water. However, the Applicant did not propose a minimum or maximum L-valine content in compound feed or water.
The EURL recommends for official control “L-valine monograph” of the Food Chemical Codex (FCC), where different tests (including the test based on an optical rotation) are used 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 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 Commission Regulation (EC) No 152/2009. The method is designed for the determination of free (synthetic and natural) and of total (peptide-bound and free) amino acids in premixtures and compound feed and it does not distinguish between the salts of amino acids and cannot differentiate between enantiomers. The EU method was initially ring-trial validated using four different matrices for threonine, cyst(e)ine, methionine and lysine only. This method was further ring-trial validated for amino acids (valine included), resulting in the equivalent EN ISO 13903 method, which is listed in the Regulation (EC) No 152/2009.
The following performance characteristics were reported in the frame of the ring-trial validation studies 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.
While the Applicant did not propose any method for the determination of valine in water, the EURL previously recommended the EU method for the determination of valine in water in the frame of dossiers for very similar feed additives. Moreover, in the frame of some L-valine dossiers, the EURL recommended VDLUFA official method (4.11.6) or equivalent method based on ion-exchange chromatography coupled with post-column derivatisation and optical (visible or fluorescence) detection (IEC-VIS/FLD) for the determination of valine in water. The EURL considers all these recommendations are also valid in the frame of the current application.
Based on the performance characteristics available, the EURL recommends for official control: (i) 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; and (ii) the analytical method described by VDLUFA (4.11.6) or equivalent method based on IEC-VIS/FLD to determine valine in 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.