Commission Implementing Regulation (EU) 2025/2511 of 11 December 2025 concerning the authorisation of a preparation of Bacillus paralicheniformis DSM 33902 and Bacillus subtilis DSM 33903 as a feed additive for ruminants for milk production/reproduction (holder of authorisation: Chr. Hansen A/S)

Official Journal EN of the European Union L series 2025/2511 12.12.2025 COMMISSION IMPLEMENTING REGULATION(EU) 2025/2511 of 11 December 2025 concerning the authorisation of a preparation of Bacillus paralicheniformisDSM 33902 and Bacillus subtilisDSM 33903 as a feed additive for ruminants for milk production/reproduction (holder of authorisation: Chr. Hansen A/S) (Text with EEA relevance) THE EUROPEAN COMMISSION, Having regard to the Treaty on the Functioning of the European Union, Having regard to Regulation (EC) No 1831/2003 of the European Parliament and of the Council of 22 September 2003 on additives for use in animal nutrition(1), and in particular Article 9(2) thereof, Whereas: (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(2) that, under the proposed conditions of use, the preparation of Bacillus paralicheniformisDSM 33902 and Bacillus subtilisDSM 33903 is safe for the target species, consumers and the environment. The Authority also concluded that the preparation of Bacillus paralicheniformisDSM 33902 and Bacillus subtilisDSM 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 paralicheniformisDSM 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 × 108CFU/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, (1) OJ L 268, 18.10.2003, p. 29, ELI: http://data.europa.eu/eli/reg/2003/1831/oj. (2) EFSA Journal2025; 23:e9426. https://doi.org/10.2903/j.efsa.2025.9426. ELI: http://data.europa.eu/eli/reg_impl/2025/2511/oj 1/4EN OJ L, 12.12.2025 HAS ADOPTED THIS REGULATION: Article 1 Authorisation The preparation specified in the Annex, belonging to the additive category ‘zootechnical additives’ and to the functional group ‘gut flora stabilisers’, is authorised as an additive in animal nutrition, subject to the conditions laid down in that Annex. Article 2 Entry into force This Regulation shall enter into force on the twentieth day following that of its publication in the Official Journal of the European Union. This Regulation shall be binding in its entirety and directly applicable in all Member States. Done at Brussels, 11 December 2025. For the Commission The President Ursula VON DER LEYEN 2/4 ELI: http://data.europa.eu/eli/reg_impl/2025/2511/ojANNEX Minimum Maximum Minimum Maximum content content content content Identification Name of the Composition, chemical Species or End of period Name of the Maximum number of the holder of formula, description, category of Other provisions of additive age CFU/kg of complete feed feed additive authorisation analytical method animal authorisation with a moisture content of CFU/l of water for drinking 12 % Category: zootechnical additives. Functional group: gut flora stabilisers. 4b1896 Chr. Bacillus Additive composition Ruminants - 3,8 × 108 - 7,4 × 107 - 1. The additive may 1 January Hansen A/S paralichenifor­ Preparation of Bacillus for milk be used via water 2036 misDSM paralicheniformisDSM production/ for drinking. 33902 and 33902 and Bacillus reproduc­ Bacillus subtilis subtilisDSM 33903 tion 2. In the directions DSM 33903 containing a minimum for use of the total of Bacillus spp. additive and 3,2 × 1010CFU/g premixtures, the additive (1:1 ratio) storage Solid form conditions, the stability to heat Characterisation of the treatment and the active substance stability in water Viable spores of for drinking shall Bacillus be indicated. paralicheniformisDSM 33902 and Bacillus 3. When it is used via subtilisDSM 33903. water for drinking, the additive shall be used ensuring a minimum dose of: 9,6 × 109CFU/ animal/day. ELI: http://data.europa.eu/eli/reg_impl/2025/2511/oj 3/4 OJ L, 12.12.2025 ENMinimum Maximum Minimum Maximum content content content content Identification Name of the Composition, chemical Species or End of period Name of the Maximum number of the holder of formula, description, category of Other provisions of additive age CFU/kg of complete feed feed additive authorisation analytical method animal authorisation with a moisture content of CFU/l of water for drinking 12 % Analytical method(1) 4. For users of the For enumeration in additive and the feed additive, premixtures, feed compound feed and business water for drinking: operators shall Spread-plate method establish on tryptone soya agar operational (EN 15784) procedures and organisational For identification: measures to DNA sequencing address potential methods or Pulsed- risks resulting Field Gel from their use. Electrophoresis (PFGE) Where those risks (CEN/TS 17697) cannot be eliminated by such procedures and measures, the additive and premixtures shall be used with personal breathing and skin protective equipment. (1) Details of the analytical methods are available at the following address of the Reference Laboratory: https://joint-research-centre.ec.europa.eu/eurl-fa-eurl-feed-additives/eurl-fa-authorisation/eurl-fa- evaluation-reports_en. 4/4 ELI: http://data.europa.eu/eli/reg_impl/2025/2511/oj EN OJ L, 12.12.2025