(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-arginine produced with Escherichia coli CCTCC M 20231961. 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-arginine produced with Escherichia coli CCTCC M 20231961 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 21 July 2025 (2) that, under the proposed conditions of use, L-arginine produced with Escherichia coli CCTCC M 20231961 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-arginine in water for drinking. The Authority also concluded that the use of L-arginine produced with Escherichia coli CCTCC M 20231961 in animal nutrition is safe for the consumers and the environment. In the absence of data, it could not conclude on the potential of the substance to be an irritant to skin and/or eyes, or to be a dermal or respiratory sensitiser. The Authority further concluded that the substance is regarded as an efficacious source of the amino acid L-arginine for non-ruminant nutrition. For the supplemental L-arginine to be as efficacious in ruminants as in non-ruminant species, it requires protection 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-arginine produced with Escherichia coli CCTCC M 20231961 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 of the European Parliament and of the Council (3) laying down requirements for feed hygiene. When fed to ruminants, L-arginine produced with Escherichia coli CCTCC M 20231961 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-arginine 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,