Commission Implementing Regulation (EU) 2017/211 of 7 February 2017 concerning the authorisation of a preparation of endo-1,4-beta-xylanase (EC 3.2.1.8) produced by Bacillus subtilis (LMG-S 15136) as a feed additive for poultry, weaned piglets and pigs for fattening, and amending Regulations (EC) No 1259/2004, (EC) No 1206/2005, and (EC) No 322/2009 and repealing Regulation (EC) No 516/2007 (holder of authorisation Beldem, a division of Puratos NV) (Text with EEA relevance. )
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.
Amendment to Regulation (EC) No 1259/2004
Annex VI to Regulation (EC) No 1259/2004 is deleted.
Amendment to Regulation (EC) No 1206/2005
In Annex I to Regulation (EC) No 1206/2005, the entry E 1606 endo-1,4-beta-xylanase (EC 3.2.1.8), is deleted.
Amendment to Regulation (EC) No 322/2009
Annex I to Regulation (EC) No 322/2009 is deleted.
Repeal
Regulation (EC) No 516/2007 is repealed.
Transitional measures
The preparation specified in the Annex, and feed containing that preparation, which are produced and labelled before 28 August 2017 in accordance with the rules applicable before 28 February 2017 may continue to be placed on the market and used until the existing stocks 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 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 of zootechnical additives. Functional group: digestibility enhancers 4a1606i Beldem, division of 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 by Bacillus subtilis LMG-S 15136 having a minimum activity of 400 IU ( 1 ) /g Solid form and liquid form. Poultry — 10 IU — 1. In the directions for use of the additive and premixture, indicate the storage conditions and stability to pelleting. 2. For use in weaned piglets up to 35 kg of body weight. 3. For users of the additive and premixtures, feed business operators shall establish operational procedures and organisational measures to address potential risks resulting from its use. Where those risks cannot be eliminated or reduced to a minimum by such procedures and measures, the additive and premixtures shall be used with personal protective equipment, including breathing protection. 28 February 2027 Characterisation of the active substance Endo-1,4-beta-xylanase (EC 3.2.1.8) produced by Bacillus subtilis LMG-S 15136 Weaned piglets — 10 IU — 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 and feedingstuffs: — colorimetric method measuring water soluble dye released by action of xylanase from azurine cross-linked wheat arabinoxylan substrates. Pigs for fattening — 10 IU — ( 1 ) 1 IU corresponds to 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://ec.europa.eu/jrc/en/eurl/feed-additives/evaluation-reports
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