LegalizeCommission Implementing Regulation (EU) 2025/1418 of 17 July 2025 concerning the renewal of the authorisation of a preparation of endo-1,3(4)-beta-glucan’s and endo-1,4-beta-xylanase produced with Talaromyces versatilis IMI CC 378536 as a feed additive for all poultry species, weaned piglets, pigs for fattening and sows (holder of authorisation: Adisseo France S.A.S.) and repealing Implementing Regulations (EU) No 290/2014 and (EU) No 1138/2014
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| Image omitted; see official source | Official Journal of the European Union | EN L series |
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| 2025/1418 | 18.7.2025 |
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 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 and renewing such an authorisation.
- (2) A preparation of endo-1,3(4)-beta-glucanase and endo-1,4-beta-xylanase produced with Talaromyces versatilis IMI CC 378536, was authorised for 10 years as a feed additive for poultry, weaned piglets and pigs for fattening by Commission Implementing Regulation (EU) No 290/2014 2, and for sows by Commission Implementing Regulation (EU) No 1138/2014 3.
- (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-1,3(4)-beta-glucanase and endo-1,4-beta-xylanase produced with Talaromyces versatilis IMI CC 378536 as a feed additive for all poultry species, weaned piglets, pigs for fattening and sows, requesting the 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) of Regulation (EC) No 1831/2003.
- (4) The European Food Safety Authority (‘the Authority’) concluded in its opinion of 26 November 2024 4 that the preparation of endo-1,3(4)-beta-glucanase and endo-1,4-beta-xylanase produced with Talaromyces versatilis IMI CC 378536 in all its formulations remains safe for all poultry species, weaned piglets, pigs for fattening and sows, the consumers and the environment under the conditions of use currently authorised. It also concluded that the preparation of endo-1,3(4)-beta-glucanase and endo-1,4-beta-xylanase produced with Talaromyces versatilis IMI CC 378536, in all its formulations, is non-irritant to the eyes and skin but should be considered a respiratory sensitiser, and all solid formulations should also be considered dermal sensitisers. It also indicated that there is no need for assessing the efficacy of the preparation of endo-1,3(4)-beta-glucanase and endo-1,4-beta-xylanase produced with Talaromyces versatilis IMI CC 378536, as the application for renewal of the authorisation does not include a proposal for amending or supplementing the conditions of the original authorisations which would have an impact on the efficacy of the additive. 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 the assessment carried out regarding the method of analysis of the preparation of endo-1,3(4)-beta-glucanase and endo-1,4-beta-xylanase produced with Talaromyces versatilis IMI CC 378536 as a feed additive in the context of the previous authorisations are valid and applicable for the current application. In accordance with Article 5(4), point (c), of Commission Regulation (EC) No 378/2005 5, 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-1,3(4)-beta-glucanase and endo-1,4-beta-xylanase produced with Talaromyces versatilis IMI CC 378536 satisfies the conditions provided for in Article 5 of Regulation (EC) No 1831/2003. Accordingly, the authorisation of that additive should be renewed. 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-1,3(4)-beta-glucanase and endo-1,4-beta-xylanase produced with Talaromyces versatilis IMI CC 378536 as a feed additive, Implementing Regulations (EU) No 290/2014 and (EU) No 1138/2014 should be repealed.
- (8) 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 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 subject to the conditions laid down in that Annex.
Article 2
Repeals
Implementing Regulations (EU) No 290/2014 and (EU) No 1138/2014 are repealed.
Article 3
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 July 2025.
For the Commission
The President
Ursula VON DER LEYEN
Commission Implementing Regulation (EU) No 290/2014 of 21 March 2014 concerning the authorisation of a preparation of endo-1,4-beta-xylanase and endo-1,3(4)-beta-glucanase produced by Talaromyces versatilis sp. nov. IMI CC 378536 as a feed additive for poultry, weaned piglets and pigs for fattening and amending Regulations (EC) No 1259/2004, (EC) No 943/2005, (EC) No 1206/2005 and (EC) No 322/2009 (holder of the authorisation Adisseo France S.A.S.) (OJ L 87, 22.3.2014, p. 84, ELI: http://data.europa.eu/eli/reg_impl/2014/290/oj).
Commission Implementing Regulation (EU) No 1138/2014 of 27 October 2014 concerning the authorisation of a preparation of endo-1,4-beta-xylanase and endo-1,3(4)-beta-glucanase produced by Talaromyces versatilis sp. nov. IMI CC 378536 as a feed additive for sows (holder of the authorisation Adisseo France S.A.S.) (OJ L 307, 28.10.2014, p. 30, ELI: http://data.europa.eu/eli/reg_impl/2014/1138/oj).
EFSA Journal 2025;23:e9131, https://doi.org/10.2903/j.efsa.2025.9131.
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. |
| 4a1604i | Adisseo France S.A.S. | Endo-1,3(4)- beta-glucanase (EC 3.2.1.6) Endo-1,4- beta-xylanase (EC 3.2.1.8) | Additive composition Preparation of endo-1,3(4)-beta-glucanase (EC 3.2.1.6) and endo-1,4-beta-xylanase (EC 3.2.1.8) produced with Talaromyces versatilis IMI CC 378536 having a minimum activity of: — solid form: endo-1,3(4)-beta-glucanase 30 000 VU6/g and endo-1,4-beta- xylanase 22 000 VU/g; — liquid form: endo-1,3(4)-beta-glucanase 7 500 VU/ml and endo-1,4- beta-xylanase 5 500 VU/ml. Characterisation of the active substance Endo-1,3(4)-beta-glucanase (EC 3.2.1.6) and endo-1,4-beta-xylanase (EC 3.2.1.8) produced with Talaromyces versatilis IMI CC 378536 Analytical method 7 For the quantification of endo-1,3(4)- beta-glucanase activity in the feed additive, premixture and compound feed: — viscosimetric method based on decrease in viscosity produced by action of endo-1,3(4)-beta-glucanase on the glucan substrate barley betaglucan at pH = 5,5 and 30 °C. For the quantification of endo-1,4-beta- xylanase activity in the feed additive, premixture and compound feed: — viscosimetric method based on decrease in viscosity produced by action of endo-1,4-beta-xylanase on the xylan containing substrate wheat arabinoxylan at pH = 5,5 and 30 °C. | All poultry species Piglets (weaned) Pigs for fattening Sows | — | Endo-1,3(4)-beta-glucanase 1 500 VU Endo-1,4-beta- xylanase 1 100 VU | — | 1. In the directions for use of the additive and premixture, the storage conditions and stability to heat treatment shall be indicated. 2. For use in sows from one week before farrowing until the end of the lactation period. 3. 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 and skin (only for the solid formulations of the additive) protective equipment. | 7 August 2035 |
1 VU of glucanase or xylanase activity is the amount of enzyme which hydrolyzes the substrate (barley betaglucan and wheat arabinoxylan, respectively), reducing the viscosity of the solution, to give a change in relative fluidity of 1 (dimensionless unit)/min at 30 °C and pH 5,5.
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/2025/1418/oj
ISSN 1977-0677 (electronic edition)
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