Commission Implementing Regulation (EU) 2026/356 of 18 February 2026 concerning the authorisation of a preparation of endo-1,4-beta-xylanase produced with Bacillus subtilis LMG S-15136 as a feed additive for gestating sows (holder of authorisation: Puratos NV)
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 ↗
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. 4a1606i Puratos NV Endo-1,4-beta-xylanase (EC 3.2.1.8) Additive composition Preparation of endo-1,4-beta-xylanase (EC 3.2.1.8) produced with Bacillus subtilis LMG S-15136 having a minimum activity of: 400 IU ( 1 ) /g. Solid form and liquid form Characterisation of the active substance Endo-1,4-beta-xylanase (EC 3.2.1.8) produced with Bacillus subtilis LMG S-15136 Analytical method ( 2 ) For the quantification of xylanase activity in the feed additive: — colorimetric method measuring reducing sugars released by action of xylanase on birchwood xylan substrate in the presence of 3,5-dinitrosalicylic acid (DNS). For the quantification of xylanase activity in premixtures, compound feed: — colorimetric method measuring water soluble dye released by action of xylanase from azurine cross-linked wheat arabinoxylan substrates. Gestating sows — 10 IU — 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, skin and eye protective equipment. 11 March 2036 ( 1 ) 1 IU is defined as the amount of enzyme which liberates one micromole of reducing sugars (xylose equivalents) from birchwood xylan per minute at pH 4,5 and 30 °C. ( 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 .
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