Commission Implementing Regulation (EU) 2025/2590of 18 December 2025concerning the authorisation of L-valine produced with Corynebacterium glutamicum KCCM 80365 as a feed additive for all animal species(Text with EEA relevance)

Commission Implementing Regulation (EU) 2025/2590 of 18 December 2025 concerning the authorisation of L-valine produced with Corynebacterium glutamicum KCCM 80365 as a feed additive for all animal species (Text with EEA relevance) THE EUROPEAN COMMISSION, Having regard to the Treaty on the Functioning of the European Union, Having regard to Regulation (EC) No 1831/2003 of the European Parliament and of the Council of 22 September 2003 on additives for use in animal nutrition OJ L 268, 18.10.2003, p. 29, ELI: http://data.europa.eu/eli/reg/2003/1831/oj. , and in particular Article 9(2) thereof, Whereas: (1) Regulation (EC) No 1831/2003 provides for the authorisation of additives for use in animal nutrition and for the grounds and procedures for granting such an authorisation. (2) In accordance with Article 7 of Regulation (EC) No 1831/2003, an application was submitted for the authorisation of L-valine produced with Corynebacterium glutamicum KCCM 80365. That application was accompanied by the particulars and documents required under Article 7(3) of Regulation (EC) No 1831/2003. (3) The application concerns the authorisation of L-valine produced with Corynebacterium glutamicum KCCM 80365 as a feed additive for use in feed and in water for drinking for all animal species, requesting that additive to be classified in the additive category nutritional additives and in the functional group amino acids, their salts and analogues. (4) The European Food Safety Authority (the Authority) concluded in its opinion of 18 March 2025 EFSA Journal, 23(4), e9348, https://doi.org/10.2903/j.efsa.2025.9348. that L-valine produced with Corynebacterium glutamicum KCCM 80365 is safe for the target species when supplemented in appropriate amounts to the diet according to their nutritional needs. However, due to the risk of nutritional imbalances and hygienic reasons the Authority has concerns on the of use l-valine in water for drinking. The Authority concluded that the use of L-valine produced with Corynebacterium glutamicum KCCM 80365 in animal nutrition is safe for the consumers and the environment. It also concluded that the additive is not irritant to the eyes and skin and is not considered a skin sensitiser. The Authority further concluded that the substance is regarded as an efficacious source of the essential amino acid L-valine for non-ruminant species and that for the substance to be fully efficacious in ruminants, it should be protected against ruminal degradation. The Authority did not consider that there is a need for specific requirements of post-market monitoring. It also verified the report 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 above, the Commission considers that L-valine produced with Corynebacterium glutamicum KCCM 80365 satisfies the conditions provided for in Article 5 of Regulation (EC) No 1831/2003. Accordingly, the use of that substance as a feed additive should be authorised. The Commission considers that the safe use of this amino acid in water for drinking, with regard to possible hygiene risks, is to be considered within the scope of Regulation (EC) No 183/2005 laying down requirements for feed hygiene

Regulation (EC) No 183/2005 of the European Parliament and of the Council of 12 January 2005 laying down requirements for feed hygiene (OJ L 35, 8.2.2005, p. 1, ELI: https://data.europa.eu/eli/reg/2005/183/oj). . When fed to ruminants, L-valine produced with Corynebacterium glutamicum KCCM 80365 should be protected against degradation in the rumen. It is appropriate to alert the user to take into account the dietary supply with all the essential and conditionally essential amino acids, in particular in the case of supplementation with L-valine via water for drinking. (6) The measures provided for in this Regulation are in accordance with the opinion of the Standing Committee on Plants, Animals, Food and Feed, HAS ADOPTED THIS REGULATION:

Article 1

Authorisation The substance specified in the Annex, belonging to the additive category nutritional additives and to the functional group amino acids, their salts and analogues, is authorised as an additive in animal nutrition, subject to the conditions laid down in that Annex.

Article 2

Entry into force This Regulation shall enter into force on the twentieth day following 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, 18 December 2025. For the Commission The President Ursula von der Leyen

Annex

ANNEX Details of the analytical methods are available at the following address of the Reference Laboratory: https://joint-research-centre.ec.europa.eu/eurl-fa-eurl-feed-additives/eurl-fa-authorisation/eurl-fa-evaluation-reports_en. Commission Regulation (EC) No 152/2009 of 27 January 2009 laying down the methods of sampling and analysis for the official control of feed (OJ L 54, 26.2.2009, p. 1, ELI: http://data.europa.eu/eli/reg/2009/152/oj). Identification number of the feed additiveName of the additiveComposition, chemical formula, description, analytical methodSpecies or category of animalMaximum ageMinimum contentMaximum contentOther provisionsEnd of period of authorisationmg/kg of complete feed with 12 % moisture contentCategory: nutritional additives. Functional group: amino acids, their salts and analogues3c374iL-valine Additive composition L-valine with a minimum content of 98 % (on a dry matter basis). Solid form. Characterisation of the active substance L-valine produced with Corynebacterium glutamicum KCCM 80365 IUPAC name: ((2S)-2-amino-3-methylbutanoic acid) Chemical formula: C5H11NO2 CAS number: 72-18-4 Analytical method For the identification of L-valine in the feed additive: Food Chemical Codex L-valine monograph For the determination of valine in the feed additive: Ion-exchange chromatography coupled with post-column derivatisation and optical detection (IEC-VIS) For the determination of valine in premixtures and compound feed: Ion-exchange chromatography coupled with post-column derivatisation and optical detection (IEC-VIS), Commission Regulation (EC) No 152/2009

For the determination of valine in water for drinking: Ion-exchange chromatography coupled with post-column derivatisation and optical detection (IEC-VIS or IEC-VIS/FLD) All animal species---

1. In the directions for use of the additive and premixtures, the storage conditions, the stability to heat treatment and the stability in water for drinking shall be indicated.
2. The additive may be used via water for drinking.
3. Feed business operators shall ensure that L-valine is rumen protected, when fed to ruminants.
4. The moisture content shall be indicated on the label of the additive.
5. The label of the additive and premixtures shall indicate the following: 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 nutritional imbalances. 8 January 2036