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)
Date: 2026-02-18
Institutions: Directorate-General for Health and Food Safety, European Commission
Subjects: animal feedingstuffs, food additive, market approval, microorganism, swine








L_202600356EN.000101.fmx.xml












Official Journal of the European Union


EN
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 subtilis LMG 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 subtilis LMG 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 subtilis LMG 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.












(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
            





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

(2)  
            EFSA Journal 2025;23:e9552, https://doi.org/10.2903/j.efsa.2025.9552.

(3)  
            EFSA Journal 2016;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).




ANNEX














Identification number of the 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: zootechnical additives. Functional group: digestibility enhancers.





4a1606i


Puratos NV


Endo-1,4-beta-xylanase (EC 3.2.1.8)



Additive composition

Preparation of endo-1,4-beta-xylanase (EC 3.2.1.8) produced with Bacillus subtilis LMG S-15136 having a minimum activity of: 400 IU (1)/g.
Solid form and liquid form

Characterisation of the active substance

Endo-1,4-beta-xylanase (EC 3.2.1.8) produced with Bacillus subtilis LMG S-15136

Analytical method
 (2)

For the quantification of xylanase activity in the feed additive:






—


colorimetric method measuring reducing sugars released by action of xylanase on birchwood xylan substrate in the presence of 3,5-dinitrosalicylic acid (DNS).




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.






Gestating sows


—


10 IU


—








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 the 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, skin and eye protective equipment.






11 March 2036






(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.



ELI: http://data.europa.eu/eli/reg_impl/2026/356/oj
ISSN 1977-0677 (electronic edition)