Commission Implementing Regulation (EU) 2025/2502 of 11 December 2025 concerning the authorisation of a preparation of protease produced with Bacillus subtilis CBS 148232 and viable spores of Bacillus velezensis NRRL B-50508, Bacillus velezensis NRRL B-50509 and Bacillus subtilis NRRL B-50510 as a feed additive for pigs for fattening of all Suidae species and weaned piglets of minor Suidae species (holder of authorisation: Genencor International B.V.)

Official Journal EN of the European Union L series 2025/2502 12.12.2025 COMMISSION IMPLEMENTING REGULATION(EU) 2025/2502 of 11 December 2025 concerning the authorisation of a preparation of protease produced with Bacillus subtilisCBS 148232 and viable spores of Bacillus velezensisNRRL B-50508, Bacillus velezensisNRRL B-50509 and Bacillus subtilisNRRL B-50510 as a feed additive for pigs for fattening of all Suidae species and weaned piglets of minor Suidae species (holder of authorisation: Genencor International B.V.) (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 protease produced with Bacillus subtilis CBS 148232 and viable spores of Bacillus velezensis NRRL B-50508, Bacillus velezensis NRRL B-50509 and Bacillus subtilis NRRL B-50510. 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 protease produced with Bacillus subtilisCBS 148232 and viable spores of Bacillus velezensis NRRL B-50508, Bacillus velezensis NRRL B-50509 and Bacillus subtilis NRRL B-50510 as a feed additive for pigs for fattening and other growing Suidae, requesting that additive to be classified in the category ‘zootechnical additives’ and in the functional group ‘digestibility enhancers’.

(4) The European Food Safety Authority (‘the Authority’) concluded in its opinion of 29 January 2025(2) that the preparation of protease produced with Bacillus subtilis CBS 148232 and viable spores of Bacillus velezensis NRRL B-50508, Bacillus velezensis NRRL B-50509 and Bacillus subtilis NRRL B-50510 is safe for the target species, consumers and the environment. The Authority also concluded that the preparation of protease produced with Bacillus subtilisCBS 148232 and viable spores of Bacillus velezensisNRRL B-50508, Bacillus velezensisNRRL B-50509 and Bacillus subtilis NRRL B-50510 is not irritant to eyes or skin but should be considered a skin and respiratory sensitiser and any exposure through skin and respiratory tract is considered a risk. The Authority further concluded that the preparation of protease produced with Bacillus subtilis CBS 148232 and viable spores of Bacillus velezensis NRRL B-50508, Bacillus velezensis NRRL B-50509 and Bacillus subtilis NRRL B-50510 has the potential to be efficacious in pigs for fattening and other minor porcine species at the same physiological stage at 5 000 U protease/ kg and 1,5 × 108CFU/kg of complete feed. 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 additives in feed submitted by the Reference Laboratory set up by Regulation (EC) No 1831/2003.

(5) Following a request from the Commission, the Authority, in its reply dated May 5, 2025, confirmed that in this specific case the phrase ‘other minor porcine species at the same physiological stage’ includes weaned piglets of minor porcine species or pigs for fattening of minor porcine species.

(1) OJ L 268, 18.10.2003, p. 29, ELI: http://data.europa.eu/eli/reg/2003/1831/oj.

(2) EFSA Journal. 2025;23:e9265, https://doi.org/10.2903/j.efsa.2025.9265.

ELI: http://data.europa.eu/eli/reg_impl/2025/2502/oj 1/4EN OJ L, 12.12.2025

(6) On 27 June 2025, the applicant withdrew the application for use in suckling piglets of minor Suidae species.

(7) In view of the above, the Commission considers that the preparation of protease produced with Bacillus subtilisCBS 148232 and viable spores of Bacillus velezensisNRRL B-50508, Bacillus velezensisNRRL B-50509 and Bacillus subtilis NRRL B-50510 satisfies the conditions provided for in Article 5 of Regulation (EC) No 1831/2003. Accordingly, the use of that preparation should be authorised for pigs for fattening of all Suidae species and weaned piglets of minor Suidae species. 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.

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

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 ‘digestibility enhancers’, 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/2025/2502/ojANNEX Minimum Maximum content content Identification Name of the Species or End of period Composition, chemical formula, Maximum number of the holder of Name of the additive category of Other provisions of description, analytical method age Units of activity and CFU/kg feed additive authorisation animal authorisation of complete feed with a moisture content of 12 %

Category: zootechnical additives. Functional group: digestibility enhancers.

4a63 Genencor Protease (EC Additive composition Pigs for — 5 000 U — 1. In the directions for 1 January Interna­ 3.4.21.62), Bacillus Preparation of: fattening of Protease use of the additive 2036 tional B.V. velezensisNRRL — protease (EC 3.4.21.62) all Suidae And 1,5 × and premixtures, B-50508, Bacillus produced with Bacillus subtilis species 108CFU the storage velezensisNRRL CBS 148232 with a minimum Bacillus conditions and B-50509 and Bacillus activity of: 50 000 U(1)/g Weaned spp. stability to heat subtilisNRRL — Bacillus velezensisNRRL B-50508, piglets of treatment shall be B-50510 Bacillus velezensisNRRL B-50509 minor indicated.

and Bacillus subtilisNRRL Suidae B-50510 containing a minimum species 2. For users of the additive and

total of: premixtures, feed Bacillusspp. 1,5 × 109CFU/g (ratio business operators 1:1:1) shall establish — Food- grade mineral oil: ≤ 0,4 % operational — Food- grade polyvinyl procedures and

alcohol: ≤ 3,5 % organisational Solid form. measures to address Characterisation of the active substance the potential risks Protease (EC 3.4.21.62) produced resulting from their with Bacillus subtilisCBS 148232, use. Where those and risks cannot be viable spores of Bacillus velezensis eliminated by such NRRL B-50508, Bacillus velezensis procedures and NRRL B-50509 and Bacillus subtilis measures, the NRRL B-50510 additive and premixtures shall be used with personal skin and breathing protective equipment.

ELI:

http://data.europa.eu/eli/reg_impl/2025/2502/oj 3/4 OJ L,

12.12.2025 ENMinimum Maximum content content Identification Name of the Species or End of period Composition, chemical formula, Maximum number of the holder of Name of the additive category of Other provisions of description, analytical method age Units of activity and CFU/kg feed additive authorisation animal authorisation of complete feed with a moisture content of 12 % Analytical method(2) For the quantification of protease in the feed additive, premixtures and

compound feed:

Colorimetric method based on the enzymatic hydrolysis by protease of a dyed cross-linked casein substrate at pH 10,0 and 50 °C.

For the identification of Bacillus velezensisNRRL B-50508, Bacillus velezensisNRRL B-50509 and Bacillus subtilisNRRL B-50510:

Pulsed Field Gel Electrophoresis

(PFGE) - CEN/TS 17697 or DNA sequencing methods.

For the enumeration of the overall Bacillusspp. (NRRL B-50508, NRRL B-50509 and NRRL B-50510) in the feed additive, premixture and

compound feed: Spread plate method on tryptone soya agar (EN

15784).

(1) 1 unit of protease activity is defined as the amount of enzyme that liberates, under defined assay conditions, 2,3 μg of phenolic compounds (expressed as tyrosine equivalents) from a casein substrate per minute at pH 10,0 and 50 °C.

(2) 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/2025/2502/oj EN OJ L,

12.12.2025