Commission Implementing Regulation (EU) 2025/2500 of 11 December 2025 concerning the authorisation of a preparation of Bacillus velezensis NRRL B-67647, Bacillus pumilus NRRL B-67648 and Bacillus licheniformis NRRL B-67649 as a feed additive for poultry for fattening and ornamental birds (holder of authorisation: S.I.Lesaffre)

Official Journal EN of the European Union L series 2025/2500 12.12.2025 COMMISSION IMPLEMENTING REGULATION(EU) 2025/2500 of 11 December 2025 concerning the authorisation of a preparation of Bacillus velezensisNRRL B-67647, Bacillus pumilus NRRL B-67648 and Bacillus licheniformisNRRL B-67649 as a feed additive for poultry for fattening and ornamental birds (holder of authorisation: S.I.Lesaffre) (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 velezensis NRRL B-67647, Bacillus pumilus NRRL B-67648 and Bacillus licheniformis NRRL B-67649. 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 velezensis NRRL B-67647, Bacillus pumilus NRRL B-67648 and Bacillus licheniformisNRRL B-67649 as a feed additive for chickens for fattening, other poultry for fattening and ornamental birds, 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 6 May 2025(2) that, under the proposed conditions of use, the preparation of Bacillus velezensisNRRL B-67647, Bacillus pumilusNRRL B-67648 and Bacillus licheniformisNRRL B-67649 is safe for the target species, consumers and the environment. The Authority also concluded that the preparation of Bacillus velezensis NRRL B-67647, Bacillus pumilus NRRL B-67648 and Bacillus licheniformis NRRL B-67649, in concentrated form is not irritant to the skin or eyes. Considering the similarity in composition, this conclusion can be extended to diluted form provided it is formulated with only calcium carbonate. Both forms of the additive are considered skin and respiratory sensitisers, and any exposure via skin or respiratory tract is considered a risk. The Authority further concluded that the preparation of Bacillus velezensisNRRL B-67647, Bacillus pumilus NRRL B-67648 and Bacillus licheniformis NRRL B-67649 has the potential to be efficacious in chickens for fattening, other poultry for fattening and ornamental birds at a proposed minimum inclusion level of 3 × 107 total CFU/kg of complete feedingstuffs. 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) In view of the above, the Commission considers that the preparation of Bacillus velezensis NRRL B-67647, Bacillus pumilus NRRL B-67648 and Bacillus licheniformis NRRL B-67649 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 poultry for fattening and ornamental birds. 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 Journal. 2025;23:e9465. https://doi.org/10.2903/j.efsa.2025.9465. ELI: http://data.europa.eu/eli/reg_impl/2025/2500/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/2025/2500/ojANNEX Minimum Maximum content content Identification Name of the Species or End of period Name of the Composition, chemical formula, Maximum number of the holder of category of Other provisions of additive description, analytical method age CFU/kg of complete feed feed additive authorisation animal authorisation with a moisture content of 12 % Category: zootechnical additives. Functional group: gut flora stabilisers. 4b1898 S.I.Lesaffre Preparation of Additive composition Poultry for - 3 × 107 - 1. In the directions for use of 1 January Bacillus Preparation of Bacillus fattening the additive and 2036 velezensisNRRL velezensisNRRL B-67647, premixture, the storage B-67647, Bacillus pumilusNRRL Ornamen­ conditions and stability to Bacillus pumilus B-67648 and tal birds heat treatment shall be NRRL B-67648 Bacillus licheniformisNRRL indicated. and Bacillus B-67649 containing a 2. The additive may be used licheniformis minimum total of Bacillusspp. simultaneously with the NRRL B-67649 (ratio 1:1:1): following coccidiostats, in 2 × 108CFU/g additive. accordance with their Solid forms respective conditions of Characterisation of the active authorisation as feed substance additives: diclazuril, Viable cells of Bacillus velezensis narasin, maduramicin NRRL B-67647, Bacillus ammonium, salinomycin pumilusNRRL B-67648 and sodium, monensin Bacillus licheniformisNRRL sodium, robenidine B-67649. hydrochloride, the combination narasin with nicarbazin, lasalocid or halofuginone. ELI: http://data.europa.eu/eli/reg_impl/2025/2500/oj 3/4 OJ L, 12.12.2025 ENMinimum Maximum content content Identification Name of the Species or End of period Name of the Composition, chemical formula, Maximum number of the holder of category of Other provisions of additive description, analytical method age CFU/kg of complete feed feed additive authorisation animal authorisation with a moisture content of 12 % Analytical method(1) 3. For users of the additive — Identification: DNA and premixtures, feed sequencing methods or business operators shall Pulsed Field Gel establish operational Electrophoresis (PFGE) procedures and (CEN/TS 17697) organisational measures — Enumeration in the feed to address potential risks additive, premixtures, resulting from their use. compound feed: Spread- Where those risks cannot plate method on tryptone be eliminated by such soya agar (EN 15784) 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/2025/2500/oj EN OJ L, 12.12.2025