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L-Valine - 3c371i

L-valine ((2S)-2-amino- 3-methylbutanoic acid) produced by Corynebacterium glutamicum CGMCC 7.366

Details

Publication date
4 September 2020 (Last updated on: 16 October 2020)

Description

In the current application an authorisation is sought under Article 4(1) for L-valine produced by fermentation with Corynebacterium glutamicum CGMCC 7.366, 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 into premixtures, incorporated through complementary feed 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 different tests (including 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 submitted the ring-trial validated European Union (EU) method based on ion-exchange chromatography coupled to post-column derivatisation and photometric detection (IEC-VIS). The method does not distinguish between the salts of amino acids and cannot differentiate between enantiomers. The following performance characteristics were reported for the quantification of total valine in feed: 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, in the frame of the batch-to-batch analysis and for the stability studies of valine in the feed additive and water, the Applicant presented acceptable experimental data when applying the above mentioned EU method. 

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, 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) 2021/2077

 

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)

Files

  • 16 OCTOBER 2020
finrep_fad-2020-0033_l-valine.pdf