(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 a preparation of Bacillus velezensis NRRL B-67647, Bacillus pumilus NRRL B-67648 and Bacillus licheniformis NRRL B-67649. 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 the preparation of Bacillus velezensis NRRL B-67647, Bacillus pumilus NRRL B-67648 and Bacillus licheniformis NRRL B-67649 as a feed additive for chickens for fattening, other poultry for fattening and ornamental birds, requesting that additive to be classified in the category ‘zootechnical additives’ and in the functional group ‘gut flora stabilisers’. 

(4) The European Food Safety Authority (‘the Authority’) concluded in its opinion of 6 May 2025 that, under the proposed conditions of use, the preparation of Bacillus velezensis NRRL B-67647, Bacillus pumilus NRRL B-67648 and Bacillus licheniformis NRRL B-67649 is safe for the target species, consumers and the environment. The Authority also concluded that the preparation of Bacillus velezensis NRRL B-67647, Bacillus pumilus NRRL B-67648 and Bacillus licheniformis NRRL B-67649, in concentrated form is not irritant to the skin or eyes. Considering the similarity in composition, this conclusion can be extended to diluted form provided it is formulated with only calcium carbonate. Both forms of the additive are considered skin and respiratory sensitisers, and any exposure via skin or respiratory tract is considered a risk. The Authority further concluded that the preparation of Bacillus velezensis NRRL B-67647, Bacillus pumilus NRRL B-67648 and Bacillus licheniformis NRRL B-67649 has the potential to be efficacious in chickens for fattening, other poultry for fattening and ornamental birds at a proposed minimum inclusion level of 3 × 107 total CFU/kg of complete feedingstuffs. It did not consider that there is a need for specific requirements of post-market monitoring. The Authority also verified the report on the methods 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 of Bacillus velezensis NRRL B-67647, Bacillus pumilus NRRL B-67648 and Bacillus licheniformis NRRL B-67649 satisfies the conditions for authorisation provided for in Article 5 of Regulation (EC) No 1831/2003. Accordingly, the use of that preparation should be authorised for poultry for fattening and ornamental birds. 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,