COMMISSION IMPLEMENTING REGUL ATION (EU) 2021/719 
of 30 Apr il 2021
concer ning the author isation of L-valine produced by Cor ynebacter ium glutamicum CGMCC 7.358 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 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 7.358 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 Auth ority’) concluded in its opinion of 30 September 2020 (2)that, under 
the proposed conditions of use, L-valine produced by Corynebacter ium glutamicum CGMCC 7.358, when 
supplemente d to diets in appropr iate amounts, does not have an adverse effect on animal health, consumer health 
or the environment. With respect to the safety of the user of L-valine produced by Corynebacter ium glutamicum 
CGMCC 7.358, the Author ity could neither exclude a risk by inhalation, nor that the substance it is irritant to skin 
or eyes, or a dermal sensitiser . Theref ore, appropr iate prot ective measures should be taken for this additive to 
prevent adverse effects on human health, in particular as regar ds the users of the additive. Further more, the 
Authority concluded that the substance 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, it should be protect ed again st degradation in the 
rumen. The Author ity does not consider that there is a need for specif ic requirements of post-market monitoring. It 
also verified the repor ts on the method of analysis of the feed additive in feed submitted by the Reference Laborat ory 
set up by Regulation (EC) No 1831/2003.
(5) The assessment of L-valine produced by Corynebacter ium glutamicum CGMCC 7.358 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, subject to the conditions laid down in that Annex.
(1)OJ L 268, 18.10.2003, p. 29.
(2)EFSA Jour nal 2020; 18(11):6286.EN Offi cial Jour nal of the European Union L 151/12                                                                                                                                           3.5.2021  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, 30 Apr il 2021 .
For the Commission
The President
Ursula VON DER LEYENEN Offi cial Jour nal of the European Union 3.5.2021                                                                                                                                          L 151/13  ANNEX 
Identification 
number of the 
additiveName of the 
holder of 
author isationAdditiveCompo sition, chem ical formula, 
descr iption, analytical method.Species or category 
of animalMaximum ageMinimum 
conten tMaximum 
conten t
Other provisi onsEnd of period of 
author isationmg additive/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 Additiv e composition:
Powder with a minimum 
conte nt of L-valine of 98 % (on 
a dry matter basis) and a 
maximum cont ent of 1,5 % 
waterAll species - - - 1.L-valine may be placed on 
the mark et and used as an 
additive consisting of a 
preparation.
2.The additive may be used 
via water for drinking.
3.In the directions for use of 
the additive and premix ­
ture, the storag e condi ­
tions, the stability to heat 
treatment and the stability 
in water for drinking shall 
be indicated .
4.The label of the additive 
and premixture shall indi ­
cate the following: ‘The 
supplementation with 
L-valine, in particular via 
water for drinking, should 
take into account all essen ­
tial and conditionally es­
sential amino acids in or­
der to avoid imbalances. ’
5.For users of the additive 
and premixtures, feed 
business operators shall 
establish operational pro­
cedures and organisati onal 
measures to address the 23.5.2031
Character isation of the 
activ e subst ance:
L-valine ((2S)-2-amino-3- 
meth ylbutanoic acid) 
produced by Corynebacter ium 
glutamicum CGMCC 7.358
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 "EN Offi cial Jour nal of the European Union L 151/14                                                                                                                                           3.5.2021  potential risks by inhala ­
tion, eye or dermal con­
tact. Where those risks 
cannot be eliminated or re­
duced to a minimum by 
such procedures and mea ­
sures, the additive and pre­
mixtures shall be used with 
appropr iate personal pro­
tective equipment, includ ­
ing breathing prote ction, 
safety glasses and gloves.For the quantifi cation of valine 
in the feed additive:
—ion exchange chromat o­
graphy coupled with post- 
column derivatisation and 
photomet ric detection 
(IEC- VIS)
For the quantifi cation of valine 
in premixtures, feed mater ials 
and compo und feed:
—ion exchange chromat o­
graphy coupled with post- 
column derivatisation and 
photomet ric detection 
(IEC- VIS) – Commission 
Regulation (EC)  
No 152/2009 (Annex III, F)
For the quantifi cation of valine 
in water:
—ion exchange chromat o­
graphy coupled with post- 
column derivatisation 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 3.5.2021                                                                                                                                          L 151/15