BAKGRUNN (fra kommisjonsforordningen)

(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 by Corynebacterium glutamicum CGMCC 18932. 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 by Corynebacterium 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 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 5 June 2023 (2) that, under the proposed conditions of use, L-valine produced by Corynebacterium glutamicum CGMCC 18932 is safe for the target species, when supplemented to the diet in appropriate amounts according to the nutritional needs of the target species, and that it is safe for consumers and the environment. The Authority could not conclude on the potential of L-valine produced by Corynebacterium 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 Authority further concluded that the substance is regarded as an efficacious source of the essential amino acid L-valine for non-ruminant animals 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 by Corynebacterium glutamicum CGMCC 18932 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. 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,