(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 a preparation of cyanocobalamin (vitamin B12) produced with Ensifer adhaerens CGMCC 21299. 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 a preparation of cyanocobalamin (vitamin B12) produced with Ensifer adhaerens CGMCC 21299 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 opinion of 22 March 2024 (2) that, under the proposed conditions of use, the preparation of cyanocobalamin (vitamin B12) produced with Ensifer adhaerens CGMCC 21299 is safe for all animal species, consumers and the environment. The Authority further concluded that the preparation of cyanocobalamin (vitamin B12) produced with Ensifer adhaerens CGMCC 21299, due to the presence of nickel, is considered a skin and respiratory sensitiser. Inhalation and dermal exposure are considered a risk. Due to the lack of data, the Authority could not conclude on the potential of the preparation to be an eye irritant. The Authority concluded that the preparation 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 the preparation cyanocobalamin (vitamin B12) produced with Ensifer adhaerens CGMCC 21299 satisfies the conditions provided for in Article 5 of Regulation (EC) No 1831/2003. Accordingly, the use of that substance should be authorised. 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,