COMMISSION IMPLEMENTING REGULATION (EU) 2025/2556

| Official Journal of the European Union | EN L series ---|---|--- * * * | 2025/2556 | 18.12.2025 ---|---|--- COMMISSION IMPLEMENTING REGULATION (EU) 2025/2556 of 17 December 2025 concerning the authorisation of a preparation of endo-1,4-beta-xylanase produced with Komagataella phaffii DSM 25376 and endo-1,3(4)-beta-glucanase produced with Komagataella phaffii DSM 26469 as a feed additive for chickens for laying or breeding, turkeys for breeding, minor poultry species for fattening and minor poultry species for laying or breeding (holder of authorisation: Kaesler Nutrition GmbH) and amending Implementing Regulation (EU) 2018/1090 as regards the terms of the authorisation of the preparation of endo-1,4-beta-xylanase produced with Komagataella phaffii DSM 25376 and endo-1,3(4)-beta-glucanase produced with Komagataella phaffii DSM 26469 as a feed additive for chickens for fattening and chickens reared for laying (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) and Article 13(3) 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) | A preparation of endo-1,4-beta-xylanase produced with Komagataella phaffii (previously allocated to the species Komagataella pastoris) DSM 25376 and endo-1,3(4)-beta-glucanase produced with Komagataella phaffii (previously allocated to the species Komagataella pastoris) DSM 26469 was authorised for a period of 10 years as a feed additive for chickens for fattening, chickens reared for laying, turkeys for fattening, all avian species reared for laying or for breeding purposes, weaned piglets and minor porcine species (weaned) by Commission Implementing Regulation (EU) 2018/1090 (2). ---|--- (3) | 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 produced with Komagataella phaffii DSM 25376 and endo-1,3(4)-beta-glucanase produced with Komagataella phaffii DSM 26469. That application was accompanied by the particulars and documents required under Article 7(3) of Regulation (EC) No 1831/2003. ---|--- (4) | The application concerns the authorisation of the preparation of endo-1,4-beta-xylanase produced with Komagataella phaffii DSM 25376 and endo-1,3(4)-beta-glucanase produced with Komagataella phaffii DSM 26469 as a feed additive for chickens for laying or breeding, turkeys for breeding, minor poultry species for fattening and minor poultry species for laying or breeding, requesting that additive to be classified in the additive category ‘zootechnical additives’ and in the functional group ‘digestibility enhancers’. ---|--- (5) | In accordance with Article 13(3) of Regulation (EC) No 1831/2003, an application was submitted for the modification of the terms of the authorisation of the preparation of endo-1,4-beta-xylanase produced with Komagataella phaffii DSM 25376 and endo-1,3(4)-beta-glucanase produced with Komagataella phaffii DSM 26469 as regards the use for chickens for fattening and chickens reared for laying. That application concerns the modification of the terms of the existing authorisation by reduction of the minimum use level from 4 250 xylanase enzyme activity (LXU) and 375 glucanase enzyme activity (LGU)/kg complete feed to 1 400 LXU and 120 LGU/kg complete feed. ---|--- (6) | The European Food Safety Authority (‘the Authority’) concluded in its opinion of 18 March 2025 (3) that, under the proposed conditions of use, the preparation of endo-1,4-beta-xylanase produced with Komagataella phaffii DSM 25376 and endo-1,3(4)-beta-glucanase produced with Komagataella phaffii DSM 26469 is safe for all poultry, as well as for consumers and the environment. The Authority also concluded that the preparation of endo-1,4-beta-xylanase produced with Komagataella phaffii DSM 25376 and endo-1,3(4)-beta-glucanase produced with Komagataella phaffii DSM 26469, in either formulation is not a skin or eye irritant or a dermal sensitiser but is considered a respiratory sensitiser. The Authority further concluded that the preparation of endo-1,4-beta-xylanase produced with Komagataella phaffii DSM 25376 and endo-1,3(4)-beta-glucanase produced with Komagataella phaffii DSM 26469 has the potential to be efficacious in all poultry at 1 400/120 LXU/LGU per kg complete feed. It did not consider that there is a need for specific requirements of post-market monitoring. ---|--- (7) | 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 30 November 2017 (4) 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. ---|--- (8) | In view of the above, the Commission considers that the preparation of endo-1,4-beta-xylanase produced with Komagataella phaffii DSM 25376 and endo-1,3(4)-beta-glucanase produced with Komagataella phaffii DSM 26469 satisfies the conditions provided for in Article 5 of Regulation (EC) No 1831/2003. Accordingly, the use of that preparation should be authorised for chickens for laying or breeding, turkeys for breeding, minor poultry species for fattening and minor poultry species for laying or breeding. 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. ---|--- (9) | In addition, in view of the above, the Commission considers that the authorisation of the preparation of endo-1,4-beta-xylanase produced with Komagataella phaffii DSM 25376 and endo-1,3(4)-beta-glucanase produced with Komagataella phaffii DSM 26469 still meets the conditions provided for in Article 5 of Regulation (EC) No 1831/2003 when modifying the terms thereof as regards the use for chickens for fattening and chickens reared for laying, by reduction of the minimum use level from 4 250 xylanase enzyme activity (LXU) and 375 glucanase enzyme activity (LGU)/kg complete feed to 1 400 LXU and 120 LGU/kg complete feed. Implementing Regulation (EU) 2018/1090 should therefore be amended accordingly. ---|--- (10) | Since safety reasons do not require the immediate application of the modifications to the conditions of authorisation of the preparation of endo-1,4-beta-xylanase produced with Komagataella phaffii DSM 25376 and endo-1,3(4)-beta-glucanase produced with Komagataella phaffii DSM 26469 for chickens for fattening and chickens reared for laying, it is appropriate to provide for a transitional period for interested parties to prepare themselves to meet the new requirements resulting from the modification of the authorisation concerned. ---|--- (11) | 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 Annex I, 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 Amendment to Implementing Regulation (EU) 2018/1090 The Annex to Implementing Regulation (EU) 2018/1090 is replaced by the Annex II to this Regulation. Article 3 Transitional measures 1\. The feed additive endo-1,4-beta-xylanase produced with Komagataella phaffii DSM 25376 and endo-1,3(4)-beta-glucanase produced with Komagataella phaffii DSM 26469, as authorised by Implementing Regulation (EU) 2018/1090 and premixtures containing that additive, which are intended for chickens for fattening and chickens reared for laying, and which are produced and labelled before 7 July 2026 in accordance with the rules applicable before 7 January 2026 may continue to be placed on the market and used until the stocks concerned are exhausted. 2\. Compound feed and feed materials containing the feed additive referred to in paragraph 1, which are intended for chickens for fattening and chickens reared for laying, and which are produced and labelled before 7 January 2027 in accordance with the rules applicable before 7 January 2026 may continue to be placed on the market and used until the stocks concerned are exhausted. Article 4 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, 17 December 2025. For the Commission The President Ursula VON DER LEYEN * * * (1) OJ L 268, 18.10.2003, p. 29, ELI: http://data.europa.eu/eli/reg/2003/1831/oj. (2) Commission Implementing Regulation (EU) 2018/1090 of 31 July 2018 concerning the authorisation of a preparation of endo-1,4-beta-xylanase and endo-1,3(4)-beta-glucanase produced by Komagataella pastoris (CBS 25376) and Komagataella pastoris (CBS 26469) as a feed additive for chickens for fattening, chickens reared for laying, turkeys for fattening, all avian species reared for laying or for breeding purposes, weaned piglets and minor porcine species (weaned) (holder of the authorisation Kaesler Nutrition GmbH) (OJ L 195, 1.8.2018, p. 23, ELI: http://data.europa.eu/eli/reg_impl/2018/1090/oj). (3) EFSA Journal. 2025;23:e9344. https://doi.org/10.2903/j.efsa.2025.9344. (4) EFSA Journal. 2017;15(12):5097. https://doi.org/10.2903/j.efsa.2017.5097. (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). * * * ANNEX I Identification number of the feed additive | Name of the holder of authorisation | Name of the additive | Composition, chemical formula, description, analytical method | Species or category of animal | Maximum age | Minimum content | Maximum content | Other provisions | End of period of authorisation ---|---|---|---|---|---|---|---|---|--- Units of activity/kg of complete feed with a moisture content of 12 % Category of zootechnical additives. Functional group: digestibility enhancers 4a28 | Kaesler Nutrition GmbH | Endo-1,4- beta-xylanase (EC 3.2.1.8) Endo-1,3(4)- beta-glucanase (EC 3.2.1.6) | Additive composition Preparation of endo-1,4-beta-xylanase produced with Komagataella phaffii DSM 25376 and endo-1,3(4)-beta-glucanase produced with Komagataella phaffii DSM 26469 having a minimum activity of: 25 000 LXU (1) and 2 200 LGU (2)/g. Solid and liquid form. Characterisation of the active substance Endo-1,4- beta-xylanase (EC 3.2.1.8) produced with Komagataella phaffii DSM 25376 and endo-1,3(4)- beta-glucanase (EC 3.2.1.6) produced with Komagataella phaffii DSM 26469 Analytical method (3) For the determination of xylanase in the feed additive, premixtures and compound feed: | — | colorimetric method based on the quantification of water soluble dyed fragments produced by the action of endo-1,4-β-xylanase on cross-linked wheat arabinoxylan. ---|--- For the determination of β-glucanase in the feed additive, premixtures and compound feed: — | colorimetric method based on the quantification of water soluble dyed fragments produced by the action of 1,4-β-β-gluconases on cross-linked azo-barley-glucan. ---|--- Hens Turkeys for breeding Minor poultry species for fattening Minor poultry species for laying or breeding | - | 1 400 LXU 120 LGU | - | | 1. | In the directions for use of the additive and premixtures, the storage conditions and stability to heat treatment shall be indicated. ---|--- 2. | For users of the additive and premixtures, feed business operators shall establish operational procedures and organisational measures to address potential risks resulting from their use. Where those risks cannot be eliminated by such procedures and measures, the additive and premixtures shall be used with personal breathing protective equipment. ---|--- 7 January 2036 * * * (1) 1 LXU is the amount of enzyme that releases one μmole of reducing sugar equivalents per minute (as xylose from birch xylan) at pH 5,5 and 50 °C. (2) 1 LGU is the amount of enzyme which liberates one μmole of reducing sugar equivalents per minute (as glucose from barley glucan) at pH 5,5 and 50 °C. (3) 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 * * * ANNEX II Identification number of the feed additive | Name of the holder of authorisation | Name of the additive | Composition, chemical formula, description, analytical method | Species or category of animal | Maximum age | Minimum content | Maximum content | Other provisions | End of period of authorisation ---|---|---|---|---|---|---|---|---|--- Units of activity/kg of complete feed with a moisture content of 12 % Category of zootechnical additives. Functional group: digestibility enhancers 4a28 | Kaesler Nutrition GmbH | Endo-1,4- beta-xylanase (EC 3.2.1.8) Endo-1,3(4)- beta-glucanase (EC 3.2.1.6) | Additive composition Preparation of endo-1,4-beta-xylanase produced with Komagataella phaffii DSM 25376 and endo-1,3(4)-beta-glucanase produced with Komagataella phaffii DSM 26469 having a minimum activity of: 25 000 LXU (1) and 2 200 LGU (2)/g. Solid and liquid form. Characterisation of the active substance Endo-1,4- beta-xylanase (EC 3.2.1.8) produced with Komagataella phaffii DSM 25376 and endo-1,3(4)- beta-glucanase (EC 3.2.1.6) produced with Komagataella phaffii DSM 26469 Analytical method (3) For the determination of xylanase in the feed additive, premixtures and compound feed: | — | colorimetric method based on the quantification of water soluble dyed fragments produced by the action of endo-1,4-β-xylanase on cross-linked wheat arabinoxylan. ---|--- For the determination of β-glucanase in the feed additive, premixtures and compound feed: — | colorimetric method based on the quantification of water soluble dyed fragments produced by the action of 1,4-β-β-gluconases on cross-linked azo-barley-glucan. ---|--- Chickens for fattening Turkeys for fattening All avian species reared for laying or for breeding purposes | - | 1 400 LXU 120 LGU | - | | 1. | In the directions for use of the additive and premixture, the storage conditions and stability to heat treatment shall be indicated. ---|--- 2. | For users of the additive and premixtures, feed business operators shall establish operational procedures and organisational measures to address potential risks from their use. Where those risks cannot be eliminated or reduced to a minimum by such procedures and measures, the additive and premixtures shall be used with personal protective equipment. ---|--- 21.8.2028 Piglets (weaned) Minor porcine species (weaned) | 700 LXU 60 LGU * * * (1) 1 LXU is the amount of enzyme that releases one μmole of reducing sugar equivalents per minute (as xylose from birch xylan) at pH 5,5 and 50 °C. (2) 1 LGU is the amount of enzyme which liberates one μmole of reducing sugar equivalents per minute (as glucose from barley glucan) at pH 5,5 and 50 °C. (3) 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/2025/2556/oj ISSN 1977-0677 (electronic edition) * * *