Address https://gelex.eu/eli/EU/regulation/2026/2130@2026-09-18/en

Contents

1. Preamble
2. 1. Article 1 Renewal of the authorisation
   2. Article 2 Authorisation
   3. Article 3 Repeal
   4. Article 4 Transitional measures
   5. Article 5 Entry into force
3. ANNEX
4. ANNEX

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, 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 and renewing such an authorisation.

(2) A preparation of endo-1,4-beta-xylanase produced with Bacillus subtilis LMG S-15136 was authorised for a period of 10 years as a feed additive for poultry, weaned piglets and pigs for fattening by Commission Implementing Regulation (EU) 2017/211, for suckling piglets, all minor porcine species other than reproductive animals by Commission Implementing Regulation (EU) 2020/1377, for lactating sows by Commission Implementing Regulation (EU) 2021/1413 and for gestating sows by Commission Implementing Regulation (EU) 2026/356.

(3) In accordance with Article 14(1) of Regulation (EC) No 1831/2003, an application was submitted for the renewal of the authorisation of the preparation of endo-1,4-beta-xylanase produced with Bacillus subtilis LMG S-15136 as a feed additive for all poultry species, suckling and weaned piglets, pigs for fattening, lactating sows, gestating sows and all minor porcine species other than reproductive animals, requesting that additive to be classified in the additive category zootechnical additives and in the functional group digestibility enhancers. In accordance with Article 7 of Regulation (EC) No 1831/2003, that application also concerned the extension of the authorisation as a new use of the same preparation as a feed additive to all porcine species, requesting that additive to be classified in the additive category zootechnical additives and in the functional group digestibility enhancers. That application was accompanied by the particulars and documents required under Article 14(2) and Article 7(3) of Regulation (EC) No 1831/2003.

(4) The European Food Safety Authority (the Authority) concluded in its opinion of 27 January 2026 that, under the current authorised conditions of use and considering the fact that the manufacturing and composition of the additive have not been modified, the preparation of endo-1,4-beta-xylanase produced with Bacillus subtilis LMG S-15136 remains safe for the target species, consumers and the environment. In addition, the Authority concluded that, regarding the extension of use to all porcine species, the additive is safe for the target species, consumers, and the environment. It further concluded that the two formulations of the preparation are considered skin and eye irritants, and respiratory sensitisers. Any exposure is considered a risk. The Authority stated that the application for renewal of the authorisation does not include a proposal for amending or supplementing the conditions of the original authorisation that would have an impact on the efficacy of the additive. Therefore, it concluded that there is no need for assessing the efficacy of the additive in the context of the renewal of the authorisation. It also considered that the conclusions reached in the original authorisation can be extended to other species and therefore concluded that the additive, in both forms, has the potential to be efficacious in all porcine species/categories at the minimum use level of 10 IU endo-1,4-beta-xylanase/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 are valid and applicable for the current application. In accordance with Article 5(4), points (a) and (c), of Commission Regulation (EC) No 378/2005, an evaluation report of the Reference Laboratory is 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 authorisation of that additive should be renewed for all poultry species, suckling and weaned piglets, pigs for fattening, lactating sows, gestating sows and all minor porcine species other than reproductive animals. Furthermore, the extension of use of that preparation should be authorised for all porcine 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. Those protective measures should be without prejudice to other workers’ safety requirements under Union law.

(7) As a consequence of the renewal of the authorisation of the preparation of endo-1,4-beta-xylanase produced with Bacillus subtilis LMG S-15136 as a feed additive for all poultry species, suckling and weaned piglets, pigs for fattening, lactating sows, gestating sows and all minor porcine species other than reproductive animals, Implementing Regulations (EU) 2017/211, (EU) 2020/1377, (EU) 2021/1413 and (EU) 2026/356 should be repealed.

(8) 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 Bacillus subtilis LMG S-15136 for all poultry species, suckling and weaned piglets, pigs for fattening, lactating sows, gestating sows and all minor porcine species other than reproductive animals, it is appropriate to provide for a transitional period for interested parties to prepare themselves to meet the new requirements resulting from the renewal of the authorisation.

(9) 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 Renewal of the authorisation

The authorisation of the preparation specified in the Annex, belonging to the additive category zootechnical additives and to the functional group digestibility enhancers, is renewed for all poultry species, suckling and weaned piglets, pigs for fattening, lactating sows, gestating sows and all minor porcine species other than reproductive animals, subject to the conditions laid down in that Annex.

Article 2 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 for all porcine species, subject to the conditions laid down in that Annex.

Article 3 Repeal

Implementing Regulations (EU) 2017/211, (EU) 2020/1377, (EU) 2021/1413 and (EU) 2026/356 are repealed.

Article 4 Transitional measures

1. The feed additive of endo-1,4-beta-xylanase produced with Bacillus subtilis LMG S-15136, as authorised by Implementing Regulations (EU) 2017/211, (EU) 2020/1377, (EU) 2021/1413 and (EU) 2026/356, and premixtures containing that additive, which are intended for all poultry species, suckling and weaned piglets, pigs for fattening, lactating sows, gestating sows and all minor porcine species other than reproductive animals and which are produced and labelled before 11 April 2027 in accordance with the rules applicable before 11 October 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 all poultry species, suckling and weaned piglets, pigs for fattening, lactating sows, gestating sows and all minor porcine species other than reproductive animals, and which are produced and labelled before 11 October 2027 in accordance with the rules applicable before 11 October 2026 may continue to be placed on the market and used until the stocks concerned are exhausted.

Article 5 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 September 2026. For the Commission The President Ursula von der Leyen

ANNEX

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/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 For the quantification of endo-1,4-beta-xylanase activity in the feed additive: For the quantification of endo-1,4-beta-xylanase activity in premixtures and compound feed: Poultry Porcine species - 10 IU - 11 October 2036

colorimetric method measuring reducing sugars released by action of endo-1,4-beta-xylanase on birchwood xylan substrate in the presence of 3,5-dinitrosalicylic acid (DNS).

colorimetric method measuring water soluble dye released by action of endo-1,4-beta-xylanase from azurine cross-linked wheat arabinoxylan substrates.

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.

Versions

1. 2026-09-18