LegalizeCommission Implementing Regulation (EU) 2025/1386 of 15 July 2025 concerning the authorisation of a preparation of endo-1,4-beta-xylanase produced with Trichoderma reesei CBS 114044 as a feed additive for pigs for fattening, laying hens and minor poultry species (holder of authorisation: AB Enzymes Finland Oy)
This is the act as published. Later amendments are not folded into the text below: each one is a separate act in this repository and an entry in this law's history.
| Image omitted; see official source | Official Journal of the European Union | EN L series |
| --- | --- | --- |
| 2025/1386 | 16.7.2025 |
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 [^ntr1-L_202501386EN.000101-E0001], 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 Trichoderma reesei CBS 114044. 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 Trichoderma reesei CBS 114044 as a feed additive for pigs for fattening, laying hens and minor poultry species, requesting that additive to be classified in the category ‘zootechnical additives’ and in the functional group ‘digestibility enhancers’.
- (4) The European Food Safety Authority (‘the Authority’) concluded in its opinion of 18 September 2024 [^ntr2-L_202501386EN.000101-E0002] that, under the proposed conditions of use, the preparation of endo-1,4-beta-xylanase produced with Trichoderma reesei CBS 114044 is safe for the target species, consumers and the environment. The Authority also concluded that the preparation of endo-1,4-beta-xylanase produced with Trichoderma reesei CBS 114044, in all the forms is non-irritant to the skin but is considered to be respiratory sensitiser. All liquid forms of that preparation are non-irritant to the eyes and are not dermal sensitisers. The Authority could not conclude on the potential of the solid forms to be eye irritants and dermal sensitisers. The Authority further concluded that the preparation of endo-1,4-beta-xylanase produced with Trichoderma reesei CBS 114044 has the potential to be efficacious in pigs for fattening at 20 000 BXU/kg of complete feed, in laying hens and laying minor poultry species at 12 000 BXU/kg of complete feed and in minor poultry species other than laying birds at 8 000 BXU/kg of complete feed. It did not consider that there is a need for specific requirements of post-market monitoring.
- (5) In accordance with Article 5(4), point (a), of Commission Regulation (EC) No 378/2005 [^ntr3-L_202501386EN.000101-E0003], the Reference Laboratory set up by Regulation (EC) No 1831/2003 considered that the conclusions and recommendations reached in a previous assessment concerning the same additive are valid and applicable for the current application.
- (6) In view of the above, the Commission considers that the preparation of endo-1,4-beta-xylanase produced with Trichoderma reesei CBS 114044 satisfies the conditions for authorisation provided for in Article 5 of Regulation (EC) No 1831/2003. Accordingly, the use of that preparation should be authorised for pigs for fattening, laying hens and minor poultry 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.
- (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, 15 July 2025.
For the Commission
The President
Ursula VON DER LEYEN
[^ntr1-L_202501386EN.000101-E0001]: OJ L 268, 18.10.2003, p. 29, ELI: http://data.europa.eu/eli/reg/2003/1831/oj.
[^ntr2-L_202501386EN.000101-E0002]: EFSA Journal 2024;22:e9025, https://doi.org/10.2903/j.efsa.2024.9025.
[^ntr3-L_202501386EN.000101-E0003]: 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 feed additive | Name of the holder of authorisation | 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 |
|---|---|---|---|---|---|---|---|---|---|
| Identification number of the feed additive | Name of the holder of authorisation | Additive | Composition, chemical formula, description, analytical method | Species or category of animal | Maximum age | Units of activity/kg of complete feedingstuff with a moisture content of 12 % | Units of activity/kg of complete feedingstuff with a moisture content of 12 % | Other provisions | End of period of authorisation |
| Category: zootechnical additives. Functional group: digestibility enhancers | Category: zootechnical additives. Functional group: digestibility enhancers | Category: zootechnical additives. Functional group: digestibility enhancers | Category: zootechnical additives. Functional group: digestibility enhancers | Category: zootechnical additives. Functional group: digestibility enhancers | Category: zootechnical additives. Functional group: digestibility enhancers | Category: zootechnical additives. Functional group: digestibility enhancers | Category: zootechnical additives. Functional group: digestibility enhancers | Category: zootechnical additives. Functional group: digestibility enhancers | Category: zootechnical additives. Functional group: digestibility enhancers |
| 4a8i | AB Enzymes Finland Oy | Endo-1,4-beta-xylanase (EC 3.2.1.8) | Additive composition Preparation of endo-1,4-beta-xylanase produced with Trichoderma reesei CBS 114044 having a minimum activity of: Solid form: 160 000 BXU[^ntr1-L_202501386EN.000301-E0001]/g Liquid form: 160 000 BXU/g Characterisation of the active substance Endo-1,4-beta-xylanase (EC 3.2.1.8) produced with Trichoderma reesei CBS 114044 Analytical method [^ntr2-L_202501386EN.000301-E0002] For the quantification of endo-1,4-beta-xylanase in the feed additive and premixtures: — colorimetric method based on the enzymatic reaction of endo-1,4-beta-xylanase on the birch xylan substrate at pH 5,3 and 50 oC For the quantification of endo-1,4-beta-xylanase in compound feed: — colorimetric method based the enzymatic reaction of endo-1,4-beta-xylanase on the azurine cross-linked wheat arabinoxylan substrate at pH 5,3 and 50 oC | Pigs for fattening | — | 20 000 BXU | — | 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 protective equipment, including breathing, skin and eye protection for solid forms, and breathing protection for liquid forms. | 5 August 2035 |
| 4a8i | AB Enzymes Finland Oy | Endo-1,4-beta-xylanase (EC 3.2.1.8) | Additive composition Preparation of endo-1,4-beta-xylanase produced with Trichoderma reesei CBS 114044 having a minimum activity of: Solid form: 160 000 BXU[^ntr1-L_202501386EN.000301-E0001]/g Liquid form: 160 000 BXU/g Characterisation of the active substance Endo-1,4-beta-xylanase (EC 3.2.1.8) produced with Trichoderma reesei CBS 114044 Analytical method [^ntr2-L_202501386EN.000301-E0002] For the quantification of endo-1,4-beta-xylanase in the feed additive and premixtures: — colorimetric method based on the enzymatic reaction of endo-1,4-beta-xylanase on the birch xylan substrate at pH 5,3 and 50 oC For the quantification of endo-1,4-beta-xylanase in compound feed: — colorimetric method based the enzymatic reaction of endo-1,4-beta-xylanase on the azurine cross-linked wheat arabinoxylan substrate at pH 5,3 and 50 oC | Laying hens Minor poultry species for laying | — | 12 000 BXU | — | 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 protective equipment, including breathing, skin and eye protection for solid forms, and breathing protection for liquid forms. | 5 August 2035 |
| 4a8i | AB Enzymes Finland Oy | Endo-1,4-beta-xylanase (EC 3.2.1.8) | Additive composition Preparation of endo-1,4-beta-xylanase produced with Trichoderma reesei CBS 114044 having a minimum activity of: Solid form: 160 000 BXU[^ntr1-L_202501386EN.000301-E0001]/g Liquid form: 160 000 BXU/g Characterisation of the active substance Endo-1,4-beta-xylanase (EC 3.2.1.8) produced with Trichoderma reesei CBS 114044 Analytical method [^ntr2-L_202501386EN.000301-E0002] For the quantification of endo-1,4-beta-xylanase in the feed additive and premixtures: — colorimetric method based on the enzymatic reaction of endo-1,4-beta-xylanase on the birch xylan substrate at pH 5,3 and 50 oC For the quantification of endo-1,4-beta-xylanase in compound feed: — colorimetric method based the enzymatic reaction of endo-1,4-beta-xylanase on the azurine cross-linked wheat arabinoxylan substrate at pH 5,3 and 50 oC | Minor poultry species other than for laying | — | 8 000 BXU | — | 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 protective equipment, including breathing, skin and eye protection for solid forms, and breathing protection for liquid forms. | 5 August 2035 |
| 4a8i | AB Enzymes Finland Oy | Endo-1,4-beta-xylanase (EC 3.2.1.8) | Additive composition Preparation of endo-1,4-beta-xylanase produced with Trichoderma reesei CBS 114044 having a minimum activity of: Solid form: 160 000 BXU[^ntr1-L_202501386EN.000301-E0001]/g Liquid form: 160 000 BXU/g Characterisation of the active substance Endo-1,4-beta-xylanase (EC 3.2.1.8) produced with Trichoderma reesei CBS 114044 Analytical method [^ntr2-L_202501386EN.000301-E0002] For the quantification of endo-1,4-beta-xylanase in the feed additive and premixtures: — colorimetric method based on the enzymatic reaction of endo-1,4-beta-xylanase on the birch xylan substrate at pH 5,3 and 50 oC For the quantification of endo-1,4-beta-xylanase in compound feed: — colorimetric method based the enzymatic reaction of endo-1,4-beta-xylanase on the azurine cross-linked wheat arabinoxylan substrate at pH 5,3 and 50 oC | — | — | 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 protective equipment, including breathing, skin and eye protection for solid forms, and breathing protection for liquid forms. | 5 August 2035 |
[^ntr1-L_202501386EN.000301-E0001]: 1 BXU is the amount of enzyme which liberates 1 nmol reducing sugars as xylose from birch xylan per second at pH 5,3 and 50 °C.
[^ntr2-L_202501386EN.000301-E0002]: 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/2025/1386/oj
ISSN 1977-0677 (electronic edition)
Reading this document does not replace reading the official text published in the Official Journal of the European Union. We assume no responsibility for any inaccuracies arising from the conversion of the original to this format.
This text is published under EUR-Lex's own terms of reuse, not a Legalize or public-domain licence.
EUR-Lex
Creative Commons Attribution 4.0 International (CC BY 4.0)
© European Union, https://eur-lex.europa.eu — Source: EUR-Lex (Publications Office of the European Union). Reused under the Creative Commons Attribution 4.0 International (CC BY 4.0) licence. Only EU legislation published in the printed Official Journal of the European Union is deemed authentic; consolidated texts are reproduced here for documentation purposes and have been reformatted to Markdown.