(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 Saccharomyces cerevisiae DBVPG 48 SF as a feed additive. 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 Saccharomyces cerevisiae DBVPG 48 SF as a feed additive for horses, ruminants and all pigs, requesting that additive to be classified in the category ‘zootechnical additives’ and in the functional group ‘digestibility enhancers’ as regards horses, and in the functional group ‘other zootechnical additives’ as regards ruminants and pigs.

(4)

The European Food Safety Authority (‘the Authority’) concluded in its opinion of 23 March 2023 (2) that, under the proposed conditions of use, the preparation of Saccharomyces cerevisiae DBVPG 48 SF is safe for horses, ruminants and all pigs, consumers and the environment. It also concluded that the preparation of Saccharomyces cerevisiae DBVPG 48 SF is not irritant to the eyes and skin but should be considered a respiratory sensitiser, while it could not conclude on the skin sensitisation potential of that preparation. The Authority further concluded that the preparation of Saccharomyces cerevisiae DBVPG 48 SF has the potential to be efficacious at the proposed conditions of use for horses, dairy ruminants and all pigs, but was not in the position to conclude on the efficacy of that preparation for ruminants other than dairy ruminants. 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)

The applicant committed on 13 June 2023 to submit supplementary information with a view to demonstrate the efficacy of the preparation of Saccharomyces cerevisiae DBVPG 48 SF for ruminants other than dairy ruminants.

(6)

In view of the above, the Commission considers that the preparation of Saccharomyces cerevisiae DBVPG 48 SF satisfies the conditions for authorisation provided for in Article 5 of Regulation (EC) No 1831/2003 for horses, dairy ruminants and all pigs. Accordingly, the use of that preparation should be authorised for horses, dairy ruminants and all pigs. 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.

(7)

The measures provided for in this Regulation are in accordance with the opinion of the Standing Committee on Plants, Animals, Food and Feed,