(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-isoleucine produced with Corynebacterium glutamicum CGMCC 20437. 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-isoleucine produced with Corynebacterium glutamicum CGMCC 20437 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 12 March 2024 that, under the proposed conditions of use, L-isoleucine produced with Corynebacterium glutamicum CGMCC 20437 is safe for the target species, for the consumer and for the environment. Regarding the use in water, the Authority has concerns on the safety for the target species of L-isoleucine resulting from the simultaneous oral administration of L-isoleucine via water for drinking and feed, due to the risk of nutritional imbalances and hygienic reasons. In the absence of data, the Authority was not in a position to conclude on the potential of L-isoleucine produced with Corynebacterium glutamicum CGMCC 20437 to be irritant to skin and/or eyes, or as a dermal sensitiser. Due to the high dusting potential, exposure by inhalation was considered likely. The Authority further concluded that the substance is considered an efficacious source of the essential amino acid L-isoleucine 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-isoleucine produced with Corynebacterium glutamicum CGMCC 20437 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-isoleucine 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-isoleucine 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,