COMMISSION IMPLEMENTING REGUL ATION (EU) 2021/2077 
of 26 November 2021
concer ning the author isation of L-valine produced by Cor ynebacter ium glutamicum CGMCC 7.366 as 
a feed additiv e for all animal species 
(Text with EEA relevance) 
THE EUR OPEAN COMMISSION,
Havi ng regar d to the Treaty on the Functioning of the European Union,
Havi ng rega rd to Regulation (EC) No 1831/2003 of the European Parliament and of the Council of 22 Sept ember 2003 on 
additives for use in animal nutr ition (1), and in particular Article 9(2) thereof,
Whereas:
(1) Regulation (EC) No 1831/2003 provid es for the author isation of additives for use in animal nutr ition and for the 
grounds and procedures for granting such an author isation.
(2) In accordance with Article 7 of Regulation (EC) No 1831/2003, an application was submitted for the author isation 
of L-valine. The application was accompan ied by the particulars and documents required under Article 7(3) of that 
Regulation.
(3) The application concer ns the author isation of L-valine produced by Corynebacter ium glutamicum CGMCC 7.366 as a 
feed additive for all animal species, to be classified in the additive catego ry ‘nutr itional additives ’, functional group 
‘amino acids, their salts and analogues’.
(4) The European Food Safety Author ity (‘the Author ity’) concluded in its opinion of 17 March 2021 (2)that, under the 
proposed conditions of use, L-valine produced by Corynebacter ium glutamicum CGMCC 7.366, when supplement ed to 
diets in appropr iate amounts, does not have an adverse effect on animal health, consumer safety or the envi ronment. 
With respect to the safety of the user of that additive, the Author ity could neither excl ude a risk by inhalation, nor 
that L-valine might be irritant to skin or eyes, or a dermal sensitiser . Theref ore, the Commission considers that 
appropr iate prote ctive measures should be taken to prevent adverse effects on human health, in particular as 
regards the users of the additive. Further , the Author ity concluded that it is considered an efficacious source of the 
essential amino acid L-valine for animal nutr ition and that in order to be efficacious in ruminants, the additive 
should be protect ed against degradation in the rumen. The Author ity does not consider that there is a need for 
specifi c requirements of post-marke t monitori ng. It also verified the repor ts on the method of analysis of the feed 
additive in feed submitted by the Reference Laboratory set up by Regulation (EC) No 1831/2003.
(5) The assessment of L-valine produced by Corynebacter ium glutamicum CGMCC 7.366 shows that the conditions for 
author isation, as provided for in Article 5 of Regulation (EC) No 1831/2003, are satisfied. According ly, the use of 
this substance should be author ised as specified in the Annex to this Regulation.
(6) The measures provid ed for in this Regulation are in accordance with the opinion of the Standing Committ ee on 
Plants, Animals, Food and Feed,
HAS ADOPTED THIS REGUL ATION:
Article 1
The substance specifi ed in the Annex, belonging to the additive categor y ‘nutr itional additives ’ and to the functional group 
‘amino acids, their salts and analogues’, is author ised as a feed additive in animal nutr ition subject to the conditions laid 
down in that Annex.
(1)OJ L 268, 18.10.2003, p. 29.
(2)EFSA Journal 2021;19(4):6521.EN Offi cial Jour nal of the European Union 29.11.2021 L 426/5  Article 2
This Regulation shall enter into force on the twentieth day followi ng that of its publication in the Official Journal of the 
European Union.
This Regulation shall be binding in its entirety and directly applicable in all Member States.
Done at Brussels, 26 November 2021 .
For the Commission
The President
Ursula VON DER LEYENEN Offi cial Jour nal of the European Union L 426/6 29.11.2021  ANNEX 
Identification 
number of the 
additiveName of the 
holder of 
author isationAdditiveComposition, chemical formula, descr iption, 
analytical methodSpecies or 
categor y of 
animalMaximum 
ageMinimum 
conten tMaximum 
conten t
Other provisionsEnd of period of 
author isation mg/kg of complet e feed 
with a moisture content 
of 12 %
Categor y of nutr itional additiv es
Functional group: amino acids, their salts and analogues
3c371i - L-valine Additive composition
Powder with a minimum content of 
L-valine of 98 % (on a dry matt er basis) 
and a maximum cont ent of 1,5 % water .All 
species- 1.The additive may be used via 
water for drinking.
2.In the directions for use of the 
additive and premixture, the 
storag e conditions, the stability 
to heat treatment and the stabi ­
lity in water for drinking shall be 
indicated.
3.The label of the additive and 
premixture shall indicate the 
followi ng: ‘The supplementa ­
tion with L-valine, in particular 
via water for drinking, should 
take into account all essential 
and conditional essential amino 
acids in order to avoid imbal ­
ances.’
4.For users of the additive and 
premixtures, feed business op­
erators shall establish opera ­
tional procedures and organisa ­
tional measures to address the 
potential risks by inhalation, 
eye or dermal contact. Where 
those risks cannot be eliminated 
or reduced to a minimum by 
such procedures and measures, 
the additive and premixtures 
shall be used with appropr iate 
personal protective equipment, 
including eyes, skin and breath ­
ing protection.19 December 
2031
Char acter isation of the active substance
L-valine ((2S)-2-amino- 
3-methyl butanoic acid) produced by 
Corynebacter ium glutamicum CGMCC 
7.366
Chemical formula: C5H11NO 2
CAS number: 72-18-4
Analytical method (1)
For the identification of L-valine in the 
feed additive:
— Food Chemical Codex ‘L-valine 
monograph’
— For the quantifi cation of valine in the 
feed additive:
— ion exchange chromatograph y 
coupled with post-column derivati ­
sation and photometr ic detection 
(IEC- VIS)
For the quantification of valine in 
premixtures, feed mater ials and 
compo und feed:
— ion exchange chromatograph y 
coupled with post-column derivati ­
sation and photometr ic detection 
(IEC- VIS) – Commission Regulation 
(EC) No 152/2009 (Annex III, F)EN Offi cial Jour nal of the European Union 29.11.2021 L 426/7  For the quantifi cation of valine in water:
— ion exchange chromatograph y 
coupled with post-column derivati ­
sation and optical detection 
(IEC- VIS/FD)
(1)Details of the analytical methods are avail able at the follo wing address of the Reference Laboratory : https://ec.europa.eu/jrc/en/eurl/feed-additives/evaluation-repor tsEN Offi cial Jour nal of the European Union L 426/8 29.11.2021