Commission Implementing Regulation (EU) 2025/2503 of 11 December 2025 concerning the authorisation of a preparation of endo-1,4-beta-xylanase, endo-1,4-beta-glucanase and xyloglucan-specific-endo-beta-1,4-glucanase produced with Trichoderma citrinoviride DSM 33578 as a feed additive for poultry other than poultry for fattening, poultry reared for laying and reared for breeding and porcine species other than sows of all Suidae species (holder of authorisation: Huvepharma EOOD)

Official Journal EN of the European Union L series 2025/2503 12.12.2025 COMMISSION IMPLEMENTING REGULATION(EU) 2025/2503 of 11 December 2025 concerning the authorisation of a preparation of endo-1,4-beta-xylanase, endo-1,4-beta-glucanase and xyloglucan-specific-endo-beta-1,4-glucanase produced with Trichoderma citrinovirideDSM 33578 as a feed additive for poultry other than poultry for fattening, poultry reared for laying and reared for breeding and porcine species other than sows of all Suidae species (holder of authorisation: Huvepharma EOOD) (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 endo-1,4-beta-xylanase, endo-1,4-beta-glucanase and xyloglucan-specific-endo-beta-1,4-glucanase produced with Trichoderma citrinoviride DSM 33578. 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 endo-1,4-beta-xylanase, endo-1,4-beta-glucanase and xyloglucan-specific-endo-beta-1,4-glucanase produced with Trichoderma citrinovirideDSM 33578 as a feed additive for laying or breeding hens, piglets (weaned and suckling) and Suidae for fattening, 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 opinions of 23 November 2022(2) and 1 February 2024(3) that, under the proposed conditions of use, the preparation of endo-1,4-beta-xylanase, endo-1,4-beta-glucanase and xyloglucan-specific-endo-beta-1,4-glucanase produced with Trichoderma citrinoviride DSM 33578 is safe for the target species, consumers and the environment. The Authority also concluded that the preparation in granulated formulation is not an irritant to the skin and eyes but should be considered a skin sensitiser. It further concluded that the liquid formulation of the preparation is considered not to be an irritant to the skin and eyes, and not a skin sensitiser. However, both formulations of the preparation are considered respiratory sensitisers. After the assessment of newly submitted data by the applicant, the Authority concluded in its opinion of 6 May 2025(4) that the preparation has the potential to be efficacious in all poultry and all porcine species at the proposed use level of 1 500 EPU, 100 CU and 100 XGU/kg feed. It did not consider that there is a need for specific requirements of post-market monitoring. (1) OJ L 268, 18.10.2003, p. 29. ELI: http://data.europa.eu/eli/reg/2003/1831/oj. (2) EFSA Journal.2022;20(12):7702. https://doi.org/10.2903/j.efsa.2022.7702. (3) EFSA Journal. 2024;22:e8643. https://doi.org/10.2903/j.efsa.2024.8643. (4) EFSA Journal. 2025;23:e9460. https://doi.org/10.2903/j.efsa.2025.9460. ELI: http://data.europa.eu/eli/reg_impl/2025/2503/oj 1/5EN OJ L, 12.12.2025 (5) The Reference Laboratory set up by Regulation (EC) No 1831/2003 considered that the conclusions and recommendations reached in a previous assessment concerning another application for the authorisation of the same additive and verified by the Authority in its opinion of 23 November 2022 are valid and applicable for the current application In accordance with Article 5(4), point (a), of Commission Regulation (EC) No 378/2005(5), an evaluation report of the Reference Laboratory was therefore not required. (6) In view of the above, the Commission considers that the preparation of endo-1,4-beta-xylanase, endo-1,4-beta- glucanase and xyloglucan-specific-endo-beta-1,4-glucanase produced with Trichoderma citrinoviride DSM 33578 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 other than poultry for fattening, poultry reared for laying and reared for breeding and porcine species other than sows of all 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. (7) 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 (5) Commission Regulation (EC) No 378/2005 of 4 March 2005 on detailed rules for the implementation of Regulation (EC) No 1831/2003 of the European Parliament and of the Council as regards the duties and tasks of the Community Reference Laboratory concerning applications for authorisations of feed additives (OJ L 59, 5.3.2005, p. 8. ELI: http://data.europa.eu/eli/reg/ 2005/378/oj). 2/5 ELI: http://data.europa.eu/eli/reg_impl/2025/2503/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/kg of feed additive authorisation animal authorisation complete feed with a moisture content of 12 % Category: zootechnical additives. Functional group: digestibility enhancers. 4a39 Huvepharma Endo-1,4-beta- Additive composition Poultry other - Endo-1,4-be­ - 1. In the directions for 1 January EOOD xylanase (EC 3.2.1.8) Preparation of endo-1,4-beta- than poultry ta-xylanase use of the additive 2036 Endo-1,4-beta- xylanase, endo-1,4-beta- for fattening, 1 500 EPU and premixtures, the glucanase (EC glucanase and xyloglucan- poultry storage conditions 3.2.1.4) Xyloglucan- specific-endo- reared for Endo-1, and stability to heat specific-endo- beta-1,4-glucanase produced laying and 4-beta- treatment shall be beta-1,4-glucanase with Trichoderma citrinoviride reared for glucanase indicated. (EC 3.2.1.151) DSM 33578 having a breeding 100 CU 2. For users of the minimum activity of: Endo-1,4-beta-xylanase: Porcine Xyloglucan- additive and 15 000 EPU(1)/g, species other specific premixtures, feed Endo-1, 4-beta-glucanase: than sows of endo- business operators 1 000 CU(2)/g, all Suidae beta-1,4-glu­ shall establish Xyloglucan-specific endo- species canase 100 operational XGU procedures and beta-1,4-glucanase: 1 000 organisational XGU(3)/g. measures to address Granulated or liquid form. the potential risks Characterisation of the active resulting from their substance use. Where those Endo-1,4-beta-xylanase (EC risks cannot be 3.2.1.8), endo-1,4-beta- eliminated by such glucanase (EC 3.2.1.4) and procedures and xyloglucan-specific-endo- measures, the beta-1,4-glucanase (EC additive and 3.2.1.151) produced with premixtures shall be Trichoderma citrinovirideDSM used with personal 33578 breathing and skin protective equipment. ELI: http://data.europa.eu/eli/reg_impl/2025/2503/oj 3/5 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/kg of feed additive authorisation animal authorisation complete feed with a moisture content of 12 % Analytical method(4) For the determination of endo-1,4-beta-xylanase activity in the feed additive, premixtures and compound feed: — colorimetric method measuring water soluble dye released by action of endo-1,4-beta-xylanase from azurine cross-linked wheat arabinoxylan substrate. For the determination of endo-1,4-beta-glucanase activity in the feed additive, premixtures and compound feed: — colorimetric method based on the quantification of water soluble dyed fragments (azurine) produced by the action of endo-1,4-beta-glucanase on azurine-crosslinked cellulose. 4/5 ELI: http://data.europa.eu/eli/reg_impl/2025/2503/oj EN OJ L, 12.12.2025Minimum 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/kg of feed additive authorisation animal authorisation complete feed with a moisture content of 12 % For the determination of xyloglucan-specific-endo- beta-1,4-glucanase activity in the feed additive, premixtures and compound feed: — colorimetric method based on the quantification of soluble dyed labelled fragments produced by the action of xyloglucan- specific-endo- beta-1,4-glucanase on xyloglucan substrate. (1) One EPU unit is the amount of enzyme which liberates 0,0083 micromoles of reducing sugars (xylose equivalents) from oat spelt xylan per minute at pH 4,7 and 50 °C. (2) One CU unit is the amount of enzyme that liberates 0,128 micromoles of reducing sugars (glucose equivalents) from barley beta-glucan per minute at pH 4,5 and 30 °C. (3) One XGU unit is the amount of enzyme that releases low-molecular fragments from dyed xyloglucan in amount equal to the amount of such fragments liberated from 1 unit enzyme standard under the conditions of the assay (50 °C and pH 4,5). (4) 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. ELI: http://data.europa.eu/eli/reg_impl/2025/2503/oj 5/5 OJ L, 12.12.2025 EN