COMMISSION IMPLEMENTING REGUL ATION (EU) 2022/1492 
of 8 September 2022
concer ning the author isation of L-valine produced by Escherichia coli CCTCC M2020321 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 produced by Escher ichia coli CCTCC M2020321 as a feed additive for all animal species. The application 
was accompanied 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 Escher ichia coli CCTCC M2020321 as a feed 
additive for all animal species, to be classified in the additive categor y ‘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 27 Januar y 2022 (2)that, under the 
proposed conditions of use, L-valine produced by Escher ichia coli CCTCC M2020321, when supplemented to diets in 
appropr iate amounts, does not have an adverse effect on animal health, consumer safety or the environment. As 
regards the safety of the additive for the user , the Auth ority could not conclude on the potential of the additive to 
be toxic by inhalation, irritant to skin or eyes, or on its poten tial to be a dermal or a respirato ry sensitiser , and note d 
that the endoto xin activity of the additive does not represent a hazard for users handling the additive. Further more, 
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 effic acious in ruminants, the additive should be protect ed against degradation in 
the rumen. The Auth ority did not consider that there is a need for specific 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 
Laboratory set up by Regulation (EC) No 1831/2003.
(5) In view of the Author ity’s opinion, the Commission theref ore considers that appropr iate prote ctive measures should 
be taken to prevent adverse effects on human health, in particular as regar ds the users of the additive.
(6) The assessment of L-valine produced by Escher ichia coli CCTCC M2020321 shows that the conditions for 
author isation set out in Article 5 of Regulation (EC) No 1831/2003, are fulfilled.
(7) The use of this substance should theref ore be author ised as specifi ed in the Annex to this Regulation.
(8) 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,
(1)OJ L 268, 18.10.2003, p. 29.
(2)EFSA Jour nal 2022;20(2):7163.EN Offi cial Jour nal of the European Union L 234/14 9.9.2022  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.
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, 8 Sept ember 2022 .
For the Commission
The President
Ursula VON DER LEYENEN Offi cial Jour nal of the European Union 9.9.2022 L 234/15  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 
contentMaximum 
content
Other provisionsEnd of period 
of 
author isationmg/kg of complet e feed 
with a moisture conten t 
of 12 %
Categor y of nutr itional additiv es. Functional group: amino acids, their salts and analogues.
3c371ii - L-valine Additive composition
L-valine with a minimum content of 98 % 
(on a dry matt er basis) and a maximum 
conte nt of 1,5 % water .
Powder formAll 
species- 1.The additive may be used via water 
for drinking.
2.The directions for use of the additive 
and premixture shall indicate the 
stora ge conditions, the stability to 
heat treatment and the stability in 
water for drinking.
3.The label of the additive and pre­
mixture shall indicate the followi ng: 
‘The supplementation with L-valine, 
in particular via water for drinking, 
should take into account all essen ­
tial and conditional essential amino 
acids in order to avoid imbalances.’
4.For users of the additive and pre­
mixtures, feed business operat ors 
shall establish operational proce ­
dures and appropr iate organisa ­
tional measures to address the po­
tential risks. Where risks cannot be 
reduced to an acceptable level by 
these procedures and measures, 
the additive and premixtures shall 
be used with appropr iate personal 
prote ctive equipment, including 
breathing, skin and eye protect ion.29 Sept ember 
2032
Char acter isation of the active substance
L-valine ((2S)-2-amino- 
3-methyl butanoic acid) produced by 
Escher ichia coli CCTCC M2020321
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 chromat ography 
coupled with post-column derivatisa ­
tion and optical detection (IEC- VIS)EN Offi cial Jour nal of the European Union L 234/16 9.9.2022  For the quantification of valine in 
premixtures, feed mater ials and 
compo und feed:
— ion exchange chromat ography 
coupled with post-column derivatisa ­
tion and optical detection (IEC- VIS) – 
Commission Regulation (EC) 
No 152/2009 (Annex III, F)
For the quantification of valine in water:
— ion exchange chromat ography 
coupled with post-column derivatisa ­
tion and optical detection (IEC- VIS or 
IEC- VIS/FLD)
(1)Details of the analytical methods are available at the follo wing address of the Reference Laboratory : https://joint-research-centre.ec.europa.eu/eurl-f a-eurl-f eed-additives/eurl-fa-author isation/eurl-f a-evaluation- 
repor ts_enEN Offi cial Jour nal of the European Union 9.9.2022 L 234/17