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 authorisation.

(2) In accordance with Article 7 of Regulation (EC) No 1831/2003, an application was submitted for the authorisation of cyanocobalamin (vitamin B12) produced with Ensifer adhaerens CGMCC 19596. The application was accompanied by the particulars and documents required under Article 7(3) of Regulation (EC) No 1831/2003.

(3) That application concerns the authorisation of cyanocobalamin produced with Ensifer adhaerens CGMCC 19596 as a feed additive for all animal species, to be classified in the additive category ‘nutritional additives’ and in the functional group ‘vitamins, pro-vitamins and chemically well-defined substances having similar effect’.

(4) The European Food Safety Authority (‘the Authority’) concluded in its opinions of 23 March 2023 (2) and of 4 June 2024 (3) that, under the proposed conditions of use, cyanocobalamin produced with Ensifer adhaerens CGMCC 19596 is safe for all animal species, consumers and the environment. The Authority further concluded that cyanocobalamin (vitamin B12) produced with Ensifer adhaerens CGMCC 19596, is not irritant to skin and eyes. No conclusion on the potential of the additive to be a skin sensitiser could be drawn. The potential endotoxin activity of the additive does not represent a hazard for users handling the additive when exposed by inhalation. The Authority concluded that cyanocobalamin produced with Ensifer adhaerens CGMCC 19596 is efficacious in meeting animals’ nutritional requirements when administered via feed. The Authority does 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 cyanocobalamin (vitamin B12) produced with Ensifer adhaerens CGMCC 19596 satisfies the conditions provided for in Article 5 of Regulation (EC) No 1831/2003. Accordingly, the use of that substance should be authorised. The Commission consider that a maximum endotoxin content of the additive should be set up to minimise the potential hazard for the users. 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,