L-valine - 3c371ii

In the current application an authorisation is sought under Article 4(1) for L-valine produced by fermentation with Escherichia coli CCTCC M2020321, 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 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 feedingstuffs the Applicant submitted the ring-trial validated European Union (EU) method based on ion-exchange chromatography (IEC) coupled with post-column derivatisation and optical (visible – VIS) detection. This method applies for the determination of free (synthetic and natural) and total (peptide-bound and free) amino acids. The EU 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 for the quantification of total valine in 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 EURL recently evaluated and recommended in the frame of two dossiers (FAD-2019-0072 and FAD-2020-0033) the EU method for the determination of valine in very similar feed additives and water. Furthermore, in the frame of another L-valine dossier (FAD-2017-0032), the EURL previously evaluated and 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. 

In the frame of this authorisation the EURL recommends for official control (i) the "L-valine monograph" of the Food Chemical Codex (FCC) for the identification of L-valine in the feed additive; (ii) the ring-trial validated European Union method based on IEC-VIS for the quantification of valine in the feed additive, premixtures, feedingstuffs and water; and (iii) 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.

Recommended Method

as of:

- Commission Implementing Regulation (EU) 2022/1492

For the identification of L-valine in the feed additive:

Food Chemical Codex ‘L-valine monograph’

For the quantification of valine in the feed additive:

ion exchange chromatography coupled with post-column derivatisation and optical detection (IEC-VIS) 

For the quantification of valine in premixtures, feed materials and compound feed:

ion exchange chromatography coupled with post-column derivatisation and optical detection (IEC-VIS) – Commission Regulation (EC) No 152/2009 (Annex III, F)

For the quantification of valine in water:

ion exchange chromatography coupled with post-column derivatisation and optical detection (IEC-VIS or IEC-VIS/FLD)