Date: 2025-07-18Category: Not ApplicableState: Union GovernmentCountry: Europe
Commission 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
Issued by European Commission
· Directorate-General for Health and Food Safety
Executive Summary:
Commission Implementing Regulation (EU) 2025/1418 renews the authorisation for a 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 poultry, weaned piglets, pigs for fattening, and sows. The additive, belonging to the zootechnical additives category and the digestibility enhancers functional group, is authorised until 7 August 2035. The regulation repeals Implementing Regulations (EU) No 290/2014 and (EU) No 1138/2014.
Key Points / Main Content:
* **Renewal of Authorisation:**
* The preparation of endo-1,3(4)-beta-glucanase and endo-1,4-beta-xylanase produced with Talaromyces versatilis IMI CC 378536 is re-authorised as a feed additive.
* The additive falls under the "zootechnical additives" category and the "digestibility enhancers" functional group.
* The authorisation is valid until 7 August 2035.
* **Safety Assessment:**
* The European Food Safety Authority (EFSA) concluded that the additive remains safe for the target animal species, consumers, and the environment under the currently authorised conditions of use.
* The additive is considered non-irritant to eyes and skin but a potential respiratory sensitiser, and solid formulations are potential dermal sensitisers.
* **Usage Conditions and Specifications:**
* The additive composition, identification number (4a1604i), and the name of the authorisation holder (Adisseo France S.A.S.) are specified in the Annex.
* Minimum and maximum content levels are defined for different animal categories (poultry, weaned piglets, pigs for fattening, and sows).
* Specific activity units (VU/kg) are provided for both solid and liquid forms of the additive.
* **Analytical Methods:**
* Viscosimetric methods are prescribed for quantifying endo-1,3(4)-beta-glucanase and endo-1,4-beta-xylanase activity in feed additives, premixtures, and compound feed.
* **Repeal of Previous Regulations:**
* Implementing Regulations (EU) No 290/2014 and (EU) No 1138/2014 are repealed.
* **User Safety Measures:**
* Feed business operators must establish operational procedures and organisational measures to address potential risks from the additive.
* Personal protective equipment (breathing and skin protection) should be used when risks cannot be eliminated through procedures and measures.
Impact Analysis:
* **Adisseo France S.A.S. (Authorisation Holder):**
* Impact: Continued authorisation to market and sell the specified feed additive.
* Action Required: Ensure compliance with the conditions and specifications outlined in the Annex, including proper labelling and user safety information.
* **Feed Business Operators (Manufacturers of Premixtures and Compound Feed):**
* Impact: Continued use of the authorised feed additive in their products.
* Action Required: Implement operational procedures and organisational measures to mitigate potential risks to users, including the provision of appropriate personal protective equipment.
* **Animal Feed Users (Farmers):**
* Impact: Access to a re-authorised feed additive for poultry, weaned piglets, pigs for fattening, and sows.
* Action Required: Follow the directions for use provided by the authorisation holder and feed business operators, including adhering to safety measures.
* **Enforcement Authorities:**
* Impact: Responsible for monitoring and enforcing compliance with the regulation.
* Action Required: Ensure that the feed additive meets the specified requirements and that feed business operators are implementing appropriate safety measures.
Key Entities Referenced
European Union: A political and economic union of member states located primarily in Europe.
COMMISSION IMPLEMENTING REGULATION EU 2025/1418: A regulation concerning the renewal of authorisation of a feed additive.
Regulation EC No 1831/2003: Regulation of the European Parliament and of the Council on additives for use in animal nutrition.
Adisseo France S.A.S.: Holder of the authorisation for the feed additive.
Talaromyces versatilis IMI CC 378536: The strain of microorganism used to produce the feed additive.
European Food Safety Authority: An agency of the European Union that provides independent scientific advice and communication on risks associated with the food chain.
Commission Regulation EC No 378/2005: Commission Regulation on detailed rules for the implementation of Regulation EC No 1831/2003.
Ursula VON DER LEYEN: The President of the European Commission.
Official Journal EN
of the European Union L series
2025/1418 18.7.2025
COMMISSION 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 versatilisIMI 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
(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 and renewing such an authorisation.
(2) A preparation of endo-1,3(4)-beta-glucanase and endo-1,4-beta-xylanase produced with Talaromyces versatilisIMI 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 versatilisIMI 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.
(1) OJ L 268, 18.10.2003, p. 29, ELI: http://data.europa.eu/eli/reg/2003/1831/oj.
(2) 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).
(3) 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).
ELI: http://data.europa.eu/eli/reg_impl/2025/1418/oj 1/5EN
OJ L, 18.7.2025
(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 versatilisIMI 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 versatilisIMI 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.
(4) EFSA Journal 2025;23:e9131, https://doi.org/10.2903/j.efsa.2025.9131.
(5) 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).
2/5 ELI: http://data.europa.eu/eli/reg_impl/2025/1418/ojEN
OJ L, 18.7.2025
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
ELI: http://data.europa.eu/eli/reg_impl/2025/1418/oj 3/5ANNEX
Minimum Maximum
Identifica
content content End of
tion Name of the Species or Maxi
Composition, chemical formula, period of
number of holder of Additive category mum Other provisions
description, analytical method Units of activity/kg of complete authorisa
the feed authorisation of animal age
feedingstuff with a moisture tion
additive
content of 12 %
Category: zootechnical additives. Functional group: digestibility enhancers.
4a1604i Adisseo Endo-1,3(4)- beta- Additive composition All — End — 1. In the directions for 7 August
France S.A.S. glucanase (EC poultry o-1,3(4)- use of the additive 2035
Preparation of endo-1,3(4)-beta-
3.2.1.6) Endo-1,4- species beta- and premixture, the
glucanase (EC 3.2.1.6) and
beta-xylanase (EC glucanase storage conditions
endo-1,4-beta-xylanase (EC 3.2.1.8)
3.2.1.8) Piglets 1 500 VU and stability to heat
produced with Talaromyces versatilisIMI
(weaned) treatment shall be
CC 378536 having a minimum
activity of: Endo-1,4-b indicated.
Pigs for eta-
— solid form: endo-1,3(4)-beta-
fattening xylanase 2. For use in sows from
glucanase 30 000 VU(1)/g and
1 100 VU one week before
endo-1,4-beta- xylanase 22 000
Sows farrowing until the
VU/g;
end of the lactation
— liquid form: endo-1,3(4)-beta-
period.
glucanase 7 500 VU/ml and
endo-1,4- beta-xylanase 5 500
3. For users of the
VU/ml.
additive and
premixtures, feed
Characterisation of the active substance
business operators
Endo-1,3(4)-beta-glucanase (EC shall establish
3.2.1.6) and endo-1,4-beta-xylanase operational
(EC 3.2.1.8) produced with Talaromyces procedures and
versatilisIMI CC 378536 organisational
4/5
ELI:
http://data.europa.eu/eli/reg_impl/2025/1418/oj
EN
OJ
L,
18.7.2025Minimum Maximum
Identifica
content content End of tion Name of the Species or Maxi
Composition, chemical formula, period of
number of holder of Additive category mum Other provisions
description, analytical method Units of activity/kg of complete authorisa
the feed authorisation of animal age
feedingstuff with a moisture tion
additive
content of 12 %
Analytical method(2) measures to address
the potential risks
For the quantification of endo-1,3(4)-
resulting from their
beta-glucanase activity in the feed
use. Where those
additive, premixture and compound
risks cannot be
feed:
eliminated by such
— viscosimetric method based on procedures and
decrease in viscosity produced by measures, the
action of endo-1,3(4)-beta- additive and
glucanase on the glucan substrate premixtures shall be
barley betaglucan at pH = 5,5 used with personal
and 30 °C. breathing and skin
For the quantification of (only for the solid
endo-1,4-beta- xylanase activity in the formulations of the
feed additive, premixture and additive) protective
compound feed: equipment.
— 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.
(1) 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.
(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/2025/1418/oj
5/5
OJ
L,
18.7.2025
EN