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 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 protease (also known as ‘subtilisin’) produced by Bacillus licheniformis DSM 33099. 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 a preparation of protease produced by Bacillus licheniformis DSM 33099 as a feed additive for all growing poultry species, requesting that additive to be classified in the category ‘zootechnical additives’ and in the functional group ‘digestibility enhancers’.

(4) The European Food Safety Authority (‘the Authority’) concluded in its opinion of 5 July 2023 (2) that, under the proposed conditions of use, the preparation of protease produced by Bacillus licheniformis DSM 33099 is safe for all poultry species for fattening and reared for laying/breeding, consumers and the environment. The Authority also concluded that the preparation of protease produced by Bacillus licheniformis DSM 33099 is not an eye or a dermal irritant but should be considered a respiratory sensitiser, while, in the absence of data, no conclusions could be reached on its skin sensitisation potential. The Authority further concluded that the preparation of protease produced by Bacillus licheniformis DSM 33099 has the potential to be efficacious at the level of inclusion of 30 000 NFP protease/kg complete feed for all poultry species for fattening and reared for laying/breeding. 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 protease produced by Bacillus licheniformis DSM 33099 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 all poultry species for fattening, reared for laying and reared for breeding. 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,