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

Official Journal EN of the European Union 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 phaffiiDSM 25376 and endo-1,3(4)-beta-glucanase produced with Komagataella phaffiiDSM 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 phaffiiDSM 25376 and endo-1,3(4)-beta-glucanase produced with Komagataella phaffiiDSM 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 phaffiiDSM 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 phaffiiDSM 25376 and endo-1,3(4)-beta-glucanase produced with Komagataella phaffiiDSM 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 phaffiiDSM 25376 and endo-1,3(4)-beta-glucanase produced with Komagataella phaffiiDSM 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.

(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).

ELI: http://data.europa.eu/eli/reg_impl/2025/2556/oj 1/7EN OJ L, 18.12.2025

(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 phaffiiDSM 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 phaffiiDSM 25376 and endo-1,3(4)-beta-glucanase produced with Komagataella phaffiiDSM 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 phaffiiDSM 25376 and endo-1,3(4)-beta- glucanase produced with Komagataella phaffiiDSM 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,

(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).

2/7 ELI: http://data.europa.eu/eli/reg_impl/2025/2556/ojEN OJ L, 18.12.2025

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 phaffiiDSM 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

ELI: http://data.europa.eu/eli/reg_impl/2025/2556/oj 3/7ANNEX I Minimum Maximum Identification content content Name of the Species or End of period number of Name of the Composition, chemical formula, Maximum holder of category of Other provisions of the feed additive description, analytical method age Units of activity/kg of authorisation animal authorisation additive complete feed with a moisture content of 12 % Category of zootechnical additives. Functional group: digestibility enhancers 4a28 Kaesler Endo-1,4- beta- Additive composition Hens - 1 400 LXU - 1. In the directions for use 7 January Nutrition xylanase Preparation of endo-1,4-beta- of the additive and 2036 GmbH (EC 3.2.1.8) xylanase produced with Turkeys for 120 LGU premixtures, the storage Endo-1,3(4)- Komagataella phaffiiDSM breeding conditions and stability beta-glucanase 25376 and endo-1,3(4)-beta- to heat treatment shall Minor poultry (EC 3.2.1.6) glucanase produced with be indicated.

species for Komagataella phaffiiDSM 26469 having a minimum fattening 2. For users of the additive

activity of: and premixtures, feed Minor poultry 25 000 LXU(1)and 2 200 business operators shall species for LGU(2)/g. establish operational laying or Solid and liquid form. procedures and breeding organisational Characterisation of the active measures to address substance potential risks resulting Endo-1,4- beta-xylanase (EC from their use. Where

3.2.1.8) produced with those risks cannot be Komagataella phaffiiDSM eliminated by such 25376 and endo-1,3(4)- beta- procedures and glucanase (EC 3.2.1.6) measures, the additive produced with Komagataella and premixtures shall be phaffiiDSM 26469 used with personal breathing protective Analytical method(3) equipment.

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.

4/7

ELI:

http://data.europa.eu/eli/reg_impl/2025/2556/oj EN OJ L,

18.12.2025Minimum Maximum Identification content content Name of the Species or End of period number of Name of the Composition, chemical formula, Maximum holder of category of Other provisions of the feed additive description, analytical method age Units of activity/kg of authorisation animal authorisation additive complete feed with a moisture content of 12 % 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.

(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 5/7 OJ L,

18.12.2025 ENANNEX II Minimum Maximum Identification content content Name of the Species or End of period number of Name of the Composition, chemical formula, Maximum holder of category of Other provisions of the feed additive description, analytical method age Units of activity/kg of authorisation animal authorisation additive complete feed with a moisture content of 12 % Category of zootechnical additives. Functional group: digestibility enhancers 4a28 Kaesler Endo-1,4- beta- Additive composition Chickens for - 1 400 LXU - 1. In the directions for use 21.8.2028 Nutrition xylanase Preparation of endo-1,4-beta- fattening of the additive and GmbH (EC 3.2.1.8) xylanase produced with 120 LGU premixture, the storage Endo-1,3(4)- Komagataella phaffiiDSM Turkeys for conditions and stability beta-glucanase 25376 and endo-1,3(4)-beta- fattening to heat treatment shall (EC 3.2.1.6) glucanase produced with be indicated.

All avian Komagataella phaffiiDSM 26469 having a minimum species reared 2. For users of the additive

activity of: for laying or and premixtures, feed 25 000 LXU(1)and 2 200 for breeding business operators shall LGU(2)/g. purposes establish operational Solid and liquid form. procedures and organisational Characterisation of the active measures to address substance potential risks from Endo-1,4- beta-xylanase (EC their use. Where those

3.2.1.8) produced with risks cannot be Komagataella phaffiiDSM eliminated or reduced to 25376 and endo-1,3(4)- beta- a minimum by such glucanase (EC 3.2.1.6) procedures and produced with Komagataella measures, the additive phaffiiDSM 26469 and premixtures shall be used with personal Analytical method(3) protective equipment.

For the determination of Piglets 700 LXU xylanase in the feed additive,

(weaned) premixtures and compound 60 LGU

feed: Minor — colorimetric method based porcine on the quantification of species water soluble dyed (weaned) fragments produced by the action of endo-1,4-β- xylanase on cross-linked wheat arabinoxylan.

6/7

ELI:

http://data.europa.eu/eli/reg_impl/2025/2556/oj EN OJ L,

18.12.2025Minimum Maximum Identification content content Name of the Species or End of period number of Name of the Composition, chemical formula, Maximum holder of category of Other provisions of the feed additive description, analytical method age Units of activity/kg of authorisation animal authorisation additive complete feed with a moisture content of 12 % 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.

(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 7/7 OJ L,

18.12.2025 EN