Commission Implementing Regulation (EU) 2026/2079 of 17 September 2026 concerning the authorisation of a preparation of alpha-galactosidase produced with Aspergillus tubingensis ATCC SD 6740 and endo-1,4-beta-xylanase produced with Trichoderma orientale CBS 139997 as a feed additive for weaned piglets (holder of authorisation: Industrial Técnica Pecuaria, S.A.)
In force
Version historyWe hold this version only; in force from 2026-09-17.
Data as of 2026-10-08 · Compiled from an official source version. Later amendments or repeals may not be reflected; the official text prevails. · Read the official text ↗
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.
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 additive Name of the holder of authorisation Name of the 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 feed with a moisture content of 12 % Category: zootechnical additives. Functional group: digestibility enhancers. 4a33 Industrial Técnica Pecuaria, S.A. Endo-1,4-beta-xylanase (EC 3.2.1.8) and alpha-galactosidase (EC 3.2.1.22) Additive composition Preparation of endo-1,4-beta-xylanase (EC 3.2.1.8) produced with Trichoderma orientale CBS 139997 and alpha-galactosidase (EC 3.2.1.22) produced with Aspergillus tubingensis ATCC SD 6740 having a minimum enzyme activity of: 50 AXC ( 1 ) /g of additive and 40 GALU ( 2 ) /g of additive Solid form Characterisation of the active substance Endo-1,4-beta-xylanase (EC 3.2.1.8) produced with Trichoderma orientale CBS 139997 and alpha-galactosidase (EC 3.2.1.22) produced with Aspergillus tubingensis ATCC SD 6740 Analytical method ( 3 ) For the quantification of endo-1,4-beta-xylanase in the feed additive, premixtures and compound feed: — colorimetric method based enzymatic reaction of endo-1,4-beta-xylanase i) on a wheat arabinoxylan substrate (for the feed additive and premixtures) and ii) on an azo-xylan substrate (for compound feed). For the quantification of alpha-galactosidase in the feed additive, premixtures and compound feed: — colorimetric method based on the enzymatic reaction of alpha-galactosidase on the para-nitrophenyl-alpha-D-galactopyranoside substrate. Weaned piglets — 25 AXC 20 GALU — 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, eye and skin protective equipment. 8 October 2036 ( 1 ) One unit of endo-1,4-beta-xylanase activity (AXC) is the amount of enzyme, which liberates 0,058 micromoles per minute of reducing sugars, expressed as xylose equivalents, from a wheat arabinoxylan substrate at pH 4,7 and 30 °C. ( 2 ) One unit of alpha-galactosidase activity (GALU) is defined as the amount of enzyme which degrades one micromole per minute of para-nitrophenyl-alpha-D-galactopyranoside at pH 5,5 and 37 °C. ( 3 ) 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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