L-valine - 3c371i

In the current application an authorisation is sought under Article 4(1) for L-valine produced by fermentation with Corynebacterium glutamicum CGMCC 7.358, 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 the Food Chemical Codex (FCC), where identification is based on infrared absorption. 

For the quantification of L-valine in the feed additive, premixtures, feedingstuffs and water the Applicant submitted the ring-trial validated European Union method based on ion exchange chromatography coupled with post-column derivatisation and photometric detection (IEC-VIS). The method does not distinguish between the salts of amino acids and it cannot differentiate between enantiomers. The following performance characteristics were reported for the quantification of total valine in feed: 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, in the frame of the batch-to-batch analysis and for the stability studies of L-valine in the feed additive and water, the Applicant presented acceptable experimental data when applying the above mentioned European Union method. 

In the frame of this authorisation the EURL recommends for official control (i) the "L-valine monograph" of the Food Chemical Codex (FCC) based on infrared absorption for the identification of L-valine in the feed additive, and (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. 

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) 2021/719

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 photometric detection (IEC-VIS)

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

— ion exchange chromatography coupled with post- column derivatisation and photometric 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/FD)