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

Renewal of authorisation

Article 1

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.

Repeals

Article 2

Implementing Regulations (EU) No 290/2014 and (EU) No 1138/2014 are repealed.

Entry into force

Article 3

This Regulation shall enter into force on the twentieth day following that of its publication in the Official Journal of the European Union.

ANNEXSupplementary provisions

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 Units of activity/kg of complete feedingstuff with a moisture content of 12 % 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 VU  ( 1 ) /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  ( 2 ) 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 )   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 .