Commission Implementing Regulation (EU) 2026/356 of 18 February 2026 concerning the authorisation of a preparation of endo-1,4-beta-xylanase produced with Bacillus subtilis LMG S-15136 as a feed additive for gestating sows (holder of authorisation: Puratos NV)

Official Journal EN of the European Union L series 2026/356 19.2.2026 COMMISSION IMPLEMENTING REGULATION(EU) 2026/356 of 18 February 2026 concerning the authorisation of a preparation of endo-1,4-beta-xylanase produced with Bacillus subtilisLMG S-15136 as a feed additive for gestating sows (holder of authorisation: Puratos NV) (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 produced with Bacillus subtilis LMG S-15136. 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 endo-1,4-beta-xylanase produced with Bacillus subtilis LMG S-15136 as a feed additive for gestating sows, requesting that additive to be classified in the additive category ‘zootechnical additives’ and in the functional group ‘digestibility enhancers’.

(4) The European Food Safety Authority (‘the Authority’) concluded in its opinion of 25 June 2025(2) that, under the proposed conditions of use, the preparation of endo-1,4-beta-xylanase produced with Bacillus subtilisLMG S-15136 is safe for gestating sows, as well as for consumers and the environment. The Authority also concluded that the preparation of endo-1,4-beta-xylanase produced with Bacillus subtilisLMG S-15136 in both formulations, solid and liquid, is considered a skin and eye irritant and respiratory sensitiser, and any exposure to this preparation is considered a risk. The Authority further concluded that the preparation of endo-1,4-beta-xylanase produced with Bacillus subtilis LMG S-15136 has the potential to be efficacious as a zootechnical additive in sows during the gestation period at 10 IU/kg complete feed. The Authority did not consider that there is a need for specific requirements of post-market monitoring.

(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 13 July 2016(3)are valid and applicable for the current application. In accordance with Article 5(4), point (a), of Commission Regulation (EC) No 378/2005(4), an evaluation report of the Reference Laboratory was therefore not required.

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

(2) EFSA Journal2025;23:e9552, https://doi.org/10.2903/j.efsa.2025.9552.

(3) EFSA Journal2016;14(9):4562, https://doi.org/10.2903/j.efsa.2016.4562.

(4) 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).

ELI: http://data.europa.eu/eli/reg_impl/2026/356/oj 1/4EN OJ L, 19.2.2026

(6) In view of the above, the Commission considers that the preparation of endo-1,4-beta-xylanase produced with Bacillus subtilis LMG S-15136 satisfies the conditions provided for in Article 5 of Regulation (EC) No 1831/2003.

Accordingly, the use of that preparation should be authorised for gestating sows. 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, 18 February 2026.

For the Commission The President Ursula VON DER LEYEN 2/4 ELI: http://data.europa.eu/eli/reg_impl/2026/356/ojANNEX Minimum Maximum content content Identification Name of the Species or End of period Name of the Composition, chemical formula, Maximum number of holder of category of Other provisions of additive description, analytical method age Units of activity/kg of the additive authorisation animal authorisation complete feed with a moisture content of 12 %

Category: zootechnical additives. Functional group: digestibility enhancers.

4a1606i Puratos NV Endo-1,4-beta- Additive composition Gestating — 10 IU — 1. In the directions for use 11 March xylanase (EC sows of the additive and 2036 Preparation of endo-1,4-beta-

3.2.1.8) premixtures, the storage xylanase (EC 3.2.1.8) produced conditions and stability with Bacillus subtilisLMG to heat treatment shall be S-15136 having a minimum indicated.

activity of: 400 IU(1)/g.

Solid form and liquid form 2. For users of the additive and premixtures, feed Characterisation of the active business operators shall substance establish operational Endo-1,4-beta-xylanase (EC procedures and

3.2.1.8) produced with Bacillus organisational measures subtilisLMG S-15136 to address the potential risks resulting from their Analytical method(2) use. Where those risks cannot be eliminated by For the quantification of such procedures and xylanase activity in the feed measures, the additive

additive: and premixtures shall be — colorimetric method used with personal measuring reducing sugars breathing, skin and eye released by action of protective equipment. xylanase on birchwood xylan substrate in the presence of 3,5-dinitrosalicylic acid (DNS).

ELI:

http://data.europa.eu/eli/reg_impl/2026/356/oj 3/4 OJ L,

19.2.2026 ENMinimum Maximum content content Identification Name of the Species or End of period Name of the Composition, chemical formula, Maximum number of holder of category of Other provisions of additive description, analytical method age Units of activity/kg of the additive authorisation animal authorisation complete feed with a moisture content of 12 % For the quantification of xylanase activity in premixtures, compound feed:

— colorimetric method measuring water soluble dye released by action of xylanase from azurine cross-linked wheat arabinoxylan substrates.

(1) 1 IU is defined as the amount of enzyme which liberates one micromole of reducing sugars (xylose equivalents) from birchwood xylan per minute at pH 4,5 and 30 °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/2026/356/oj EN OJ L,

19.2.2026