ELI: http://data.europa.eu/eli/reg_impl/2024/997/oj 1/4COMMISSION IMPLEMENTING REGUL ATION (EU) 2024/997 
of 3 Apr il 2024
concer ning the author isation of L-valine produced by Cor ynebacter ium glutamicum CGMCC 18932 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 Corynebacter ium glutamicum CGMCC 18932. That application was accompan ied by the 
particulars and documents required under Article 7(3) of Regulation (EC) No 1831/2003.
(3) The application concer ns the author isation of L-valine produced by Corynebacter ium glutamicum CGMCC 18932 as a 
feed additive for use in feed and in water for drinking for all animal species, requesting that additive to be classifie d in 
the catego ry ‘nutr itional additives ’ and in the functional group ‘amino acids, their salts and analogues’.
(4) The European Food Safet y Author ity (‘the Author ity’) concluded in its opinion of 5 June 2023 (2)that, under the 
proposed conditions of use, L-valine produced by Corynebacter ium glutamicum CGMCC 18932 is safe for the target 
species, when supplemented to the diet in appropr iate amounts according to the nutr itional needs of the target 
species, and that it is safe for consumers and the environment. The Auth ority could not conclude on the potential of 
L-valine produced by Corynebacter ium glutamicum CGMCC 18932 to be irritant to the skin or eyes or to be a dermal 
sensitiser but it concluded that exposure through inhalation is likely . The Auth ority further concluded that the 
substance is regarded as an effic acious source of the essential amino acid L-valine for non-r uminant animals and 
that for the substance to be fully efficacious in ruminants, it should be prot ected against degradation in the rumen. 
The Author ity did not consider that there is a need for specific requirements of post-market monitori ng. It also 
verified the repor t on the method of analysis of the feed additive in feed submitte d by the Reference Laboratory set 
up by Regulation (EC) No 1831/2003.
(5) In view of the abov e, the Commission considers that L-valine produced by Corynebacter ium glutamicum CGMCC 
18932 satisfies the conditions provi ded for in Article 5 of Regulation (EC) No 1831/2003. According ly, the use of 
that substance as a feed additive should be author ised. It is appropr iate to alert the user to take into account the 
dietar y supply with all the essential and conditionally essential amino acids, in particular in the case of 
supplementation with L-valine via water for drinking. In addition, the Commission considers that appropr iate 
prote ctive measures should be taken to prevent adverse effects on the health of the users of the additive.
(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,
(1)OJ L 268, 18.10.2003, p. 29.
(2)EFSA Journal 2023;21(7):8104.
Offi cial Jour nal  
of the European Union EN 
L series    
2024/997  4.4.2024ELI: http://data.europa.eu/eli/reg_im pl/2024/997/oj 2/4HAS ADOPTED THIS REGUL ATION:
Article 1
Author isation
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 an additive in animal nutr ition, subject to the conditions laid down 
in that Annex.
Article 2
Entr y into force
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, 3 Apr il 2024 .
For the Commission
The President
Ursula VON DER LEYENOJ L, 4.4.2024 EN  ELI: http://data.europa.eu/eli/reg_impl/2024/997/oj 3/4ANNEX 
Identification 
number of 
the feed 
additiveAdditiveComposition, chemical formula, descr iption, analytical 
methodSpecies or 
categor y of 
animalMaximum 
ageMinimum 
contentMaximum 
content
Other provisionsEnd of period of 
author isation mg/kg of complet e feed 
with 12 % moisture 
content
Categor y: nutr itional additiv es. Functional group: amino acids, their salts and analogues
3c373 L-valine Additive composition
L-valine with a minimum content of 98 % (on a dry 
matte r basis) and a maximum conte nt of 0,5 % 
water .
Solid form
Char acter isation of the active substance
L-valine ((2S)-2-amino-3-methylb utanoic acid) 
produced by Corynebacter ium glutamicum CGMCC 
18932
Chemical formula: C5H11NO 2
CAS number: 72-18-4
Analytical method (1)
For the identif ication of L-valine in the feed additive:
— Food Chemical Codex ‘L-valine monograph’
For the quantifi cation of valine in the feed additive:
— ion exchang e chromatograph y coupled with 
post-column derivatisation and optical detec­
tion (IEC- VIS)
For the quantific ation of valine in premixtures and 
compo und feed:
— ion exchang e chromatograph y coupled with 
post-column derivatisation and optical detec­
tion (IEC- VIS) – Commission Regulation (EC) 
No 152/2009 (2)(Annex III, F)All animal 
species— — — 1. In the directions for use of the additive 
and premixtures, the storage condi ­
tions, the stability to heat treatment 
and in water shall be indicated .
2. The additive may be used via water for 
drinking.
3. Declaration to be made on the label of 
the additive and premixtures:
‘The supplementation with L-valine, in 
particular via water for drinking, shall 
take into account all essential and 
conditionally essential amino acids in 
order to avoid imbalances.’
4. For users of the additive and premix ­
tures, feed business operat ors shall es­
tablish operational procedures and or­
gani sational measures to address 
poten tial risks resulting from their 
use. Where those risks cannot be 
eliminated by such procedures and 
measures, the additive and premix ­
tures shall be used with personal skin, 
eye and breathing prot ective equip ­
ment.24 Apr il 2034OJ L, 4.4.2024 EN  ELI: http://data.europa.eu/eli/reg_im pl/2024/997/oj 4/4
For the quantification of valine in water: 
— ion exchang e chromatograph y coupled with 
post-column derivatisation and optical detec­
tion (IEC- VIS or IEC- VIS/FLD)
(1)Details of the analytical methods are available at the following address of the Reference Laborato ry: https://joint-research-c entre.ec.europa.eu/eurl-fa-eurl-f eed-additives/eurl-fa-author isation/eurl-f a-evaluation- 
repor ts_en
(2)Commission Regulation (EC) No 152/2009 of 27 Januar y 2009 laying down the methods of sampling and analysis for the official control of feed (OJ L 54, 26.2.2009, p. 1).OJ L, 4.4.2024 EN