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 Bacillus subtilis CNCM I-4606, CNCM I-5043 and CNCM I-4607 and Lactococcus lactis CNCM I-4609. 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 subtilis CNCM I-4606, CNCM I-5043 and CNCM I-4607 and Lactococcus lactis CNCM I-4609 as a feed additive for all animal species, requesting that additive to be classified in the category ‘technological additives’ and in the functional group ‘hygiene condition enhancers’.

(4) The European Food Safety Authority (‘the Authority’) concluded in its opinions of 30 September 2021 (2) and of 1 February 2023 (3) that, under the proposed conditions of use, which exclude the use of the additive in commercial premixtures containing trace elements or preservatives, the preparation of Bacillus subtilis CNCM I-4606, CNCM I-5043 and CNCM I-4607 and Lactococcus lactis CNCM I-4609 is safe for the target species, consumers and the environment. It also concluded that the preparation is not irritant to skin or eyes or a skin sensitiser but that, given the proteinaceous nature of the active agent, it should be considered a respiratory sensitiser. The Authority further concluded that the additive at the minimum proposed inclusion level showed potential to reduce Salmonella Typhimurium growth in feed with high moisture content (60–90 % moisture) and noted that the use of this additive cannot be considered as a replacement for the standard hygiene farming conditions. The Authority 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 of Bacillus subtilis CNCM I-4606, CNCM I-5043 and CNCM I-4607 and Lactococcus lactis CNCM I-4609 satisfies the conditions provided for in Article 5 of Regulation (EC) No 1831/2003. Accordingly, the use of that preparation 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 that 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,