Commission Implementing Regulation (EU) 2025/284 of 12 February 2025 concerning the renewal of the authorisation of a preparation of endo-1,4-beta-xylanase produced with Trichoderma reesei MUCL 49755, endo-1,3(4)-beta-glucanase produced with Trichoderma reesei MUCL 49754 and polygalacturonase produced with Aspergillus fijiensis CBS 589.94 as a feed additive for weaned piglets and the authorisation of that preparation as a feed additive for suckling piglets (holder of authorisation: AVEVE BV) and repealing Implementing Regulation (EU) No 527/2011
Data as of 2026-07-04 · Compiled from an official source version. Later amendments or repeals may not be reflected; the official text prevails. · Read the official text ↗
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 for weaned piglets, subject to the conditions laid down in that Annex.
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 suckling piglets, subject to the conditions laid down in that Annex.
Repeal
Implementing Regulation (EU) No 527/2011 is repealed.
Transitional measures
1. The feed additive endo-1,4-β-xylanase produced by Trichoderma reesei (MUCL 49755), endo-1,3(4)-β-glucanase produced by Trichoderma reesei (MUCL 49754) and polygalacturonase produced by Aspergillus aculeatus (CBS 589.94), as authorised by Implementing Regulation (EU) No 527/2011, and premixtures containing that additive, which are intended for weaned piglets and which are produced and labelled before 5 September 2025 in accordance with the rules applicable before 5 March 2025 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 weaned piglets and which are produced and labelled before 5 March 2026 in accordance with the rules applicable before 5 March 2025 may continue to be placed on the market and used until the stocks concerned are exhausted.
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.
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. 4a14 AVEVE BV Endo-1,4- beta-xylanase (EC 3.2.1.8) Endo-1,3(4)-beta- glucanase (EC 3.2.1.6) Polygalacturonase (EC 3.2.1.15) Additive composition Preparation of endo-1,4-beta-xylanase produced with Trichoderma reesei MUCL 49755, endo-1,3(4)-beta-glucanase produced with Trichoderma reesei MUCL 49754 and polygalacturonase produced with Aspergillus fijiensis CBS 589.94 having a minimum activity of: solid form: Endo-1,4-beta-xylanase: 21 400 XU ( 1 ) /g Endo-1,3(4)-beta-glucanase: 12 300 BGU ( 2 ) /g Polygalacturonase: 460 PGLU ( 3 ) /g. liquid form: Endo-1,4-beta-xylanase: 10 700 XU/g Endo-1,3(4)-beta-glucanase: 6 150 BGU/g Polygalacturonase: 230 PGLU/g. Characterisation of the active substance endo-1,4-beta-xylanase (EC 3.2.1.8) produced with Trichoderma reesei MUCL 49755, endo-1,3(4)-beta-glucanase (EC 3.2.1.6) produced with Trichoderma reesei MUCL 49754 and polygalacturonase (EC 3.2.1.15) produced with Aspergillus fijiensis CBS 589.94 Analytical method ( 4 ) For the determination of endo-1,4-beta-xylanase in the feed additive and premixtures: — colorimetric (DNS) method based on the enzymatic hydrolysis of the oat spelt xylan substrate For the determination 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 For the determination of endo-1,3(4)-beta-glucanase in the feed additive and premixtures: — colorimetric (DNS) method based on the enzymatic hydrolysis of the barley beta-glucan substrate For the determination of endo-1,3(4)-beta-glucanase in compound feed: — colorimetric method based the enzymatic reaction of endo-1,3(4)-beta-glucanase on the azo barley glucan substrate For the determination of polygalacturonase in the feed additive and premixtures: — colorimetric (DNS) method based on the enzymatic hydrolysis of the pectin substrate For the determination of polygalacturonase in compound feed: — viscosimetric method based on decrease in viscosity produced by action of polygalacturonase on the pectin substrate Piglets (weaned and suckling) - Endo-1,4-beta-xylanase: 2 140 XU Endo-1,3(4)-beta-glucanase: 1 230 BGU Polygalacturonase: 46 PGLU - 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 and skin protective equipment. 5 March 2035 ( 1 ) 1 XU is the amount of enzyme which releases 1 μmol of reducing sugar per minute from xylan of oat spelt at pH 4,8 and 50 °C. ( 2 ) 1 BGU is the amount of enzyme which releases 1 μmol of reducing sugar per minute from β-glucan of barley at pH 5,0 and 50 °C. ( 3 ) 1 PGLU is the amount of enzyme which releases 1 μmol of reducing sugar per minute from polymethyl galacturonic acid (low methylation degree) at pH 4,8 and 35 °C. ( 4 ) 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 .
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