(fra kommisjonsforodningen)

(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 preparation of Saccharomyces cerevisiae DBVPG 48 SF was authorised for 10 years as a feed additive for horses, dairy ruminants and pigs by Commission Implementing Regulation (EU) 2023/2734. 

(5) The European Food Safety Authority (‘the Authority’) concluded in its opinions of 23 March 2023 and 13 March 2024 that, under the proposed conditions of use, the preparation of Saccharomyces cerevisiae DBVPG 48 SF is safe for the target species, 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 the preparation. The Authority further concluded that the preparation of Saccharomyces cerevisiae DBVPG 48 SF has the potential to be efficacious for all ruminants at the proposed condition of use. 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. 

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