Commission Implementing Regulation (EU) 2025/756 of 16 April 2025 concerning the authorisation of L-valine produced with Escherichia coli CGMCC 22721 as a feed additive for all animal species

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 (1), 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 Escherichia coli CGMCC 22721. 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 Escherichia coli CGMCC 22721 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 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 September 2024 (2) that, under the proposed conditions of use, L-valine produced with Escherichia coli CGMCC 22721 is safe for the target species when supplemented in appropriate amounts to the diet according to their nutritional needs. However, the Authority has concerns on the safety of the substance for the target species resulting from the simultaneous administration of L-valine via water for drinking and feed due to possible amino acid imbalances and hygienic reasons. The Authority concluded that the use of L-valine produced with Escherichia coli CGMCC 22721 in animal nutrition is considered safe for the consumers and for the environment. In the absence of data, the Authority could not conclude on the potential of the additive to be irritant to skin or eyes, or on its potential to be a dermal or respiratory 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 degradation in the rumen. 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 Escherichia coli CGMCC 22721 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. When fed to ruminants, L-valine produced with Escherichia coli CGMCC 22721 needs to 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. In addition, the Commission considers that appropriate protective measures should be taken to prevent adverse effects on the health of the users of the additive.

(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, 16 April 2025.

For the Commission The President Ursula VON DER LEYEN

(1) OJ L 268, 18.10.2003, p. 29, ELI: http://data.europa.eu/eli/reg/2003/1831/oj.

(2) EFSA Journal 2024; 22(10); e9024.