- Fecha de publicación
- 26 septiembre 2022 (Última actualización el: 28 febrero 2023)
- Centro Común de Investigación
In the current application an authorisation is sought under Article 4 for L-valine produced by fermentation with Corynebacterium glutamicum CGMCC 18932, 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 98.5 %. The feed additive is produced by fermentation with Corynebacterium glutamicum CGMCC 18932.
The feed additive is intended to be mixed either in premixtures or added directly to feedingstuffs or water for drinking. However, the Applicant did not propose any minimum or maximum content of L-valine in feedingstuffs.
For the characterisation of the feed additive, the EURL found the "L-valine monograph" of Food Chemical Codex (FCC), where different tests (including the test based on an optical rotation) are used for the identification of L-valine.
For the quantification of valine in the feed additive, premixtures, feedingstuffs and water the Applicant proposed two equivalent ring-trial validated methods, namely EN ISO 13903 method (only for the feed additive) and the European Union (EU) method for all the matrices.
The EU method is applicable for the determination of free (synthetic and natural) and total (peptide-bound and free) amino acids, using an amino acid analyser or High Performance Liquid Chromatography equipment provided with an ion-exchange column (IEC). The method is intended for premixtures and feedingstuffs, it does not distinguish between the amino acids and their salts, or between different salts of the same amino acids, and it cannot differentiate between enantiomers. The following performance characteristics were reported in the frame of the ring-trial validation studies for the quantification 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 %.
In addition, the Applicant performed the analysis of valine in the feed additive, premixtures, feedingstuffs and water in the frame of stability and homogeneity studies by using the above mentioned EU method and demonstrating the applicability of the method for all the mentioned matrices.
Furthermore, the EURL recently recommended in the frame of several dossiers (FAD-2019-0072, FAD-2020-0033 and FAD-2021-0032) the EU method for the determination of valine in very similar feed additives and water. Moreover, in the frame of L-valine dossiers (FAD-2017-0032 and FAD-2021-0032) the EURL previously 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 quantification of valine in water. The EURL considers that these recommendations are also valid in the frame of the current application.
Based on the available data, the EURL recommends for official control (i) the ring-trial validated European Union method based on IEC-VIS to quantify valine in the feed additive, premixtures, feedingstuffs and water; and (ii) the analytical method described by VDLUFA (4.11.6) or equivalent method based on IEC-VIS/FLD to quantify 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.