(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 paralicheniformis DSM 33902 and Bacillus subtilis DSM 33903. 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 paralicheniformis DSM 33902 and Bacillus subtilis DSM 33903 as a feed additive for dairy cows and other dairy ruminants, 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 9 April 2025 that, under the proposed conditions of use, the preparation of Bacillus paralicheniformis DSM 33902 and Bacillus subtilis DSM 33903 is safe for the target species, consumers and the environment. The Authority also concluded that the preparation of Bacillus paralicheniformis DSM 33902 and Bacillus subtilis DSM 33903 in its both forms is considered non-irritant to the skin and eyes, but skin and respiratory sensitiser, and any exposure through the skin and respiratory tract are considered a risk. The Authority further concluded that the preparation of Bacillus paralicheniformis DSM 33902 and Bacillus subtilis DSM 33903 has the potential to be efficacious as a zootechnical additive in dairy cows and other dairy ruminants when used in feed and water. It also concluded that the minimum use level of the preparation in feed can be established at 3.8 × 108 CFU/kg complete feed while the minimum use level in water can be established based on the daily dose per animal (9.6 × 109 CFU per animal) and the daily water intake. The Authority did not consider that there is a need for specific requirements of post-market monitoring. It 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 paralicheniformis DSM 33902 and Bacillus subtilis DSM 33903 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 ruminants for milk production/reproduction. 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,