Commission Implementing Regulation (EU) 2021/981 of 17 June 2021 concerning the renewal of the authorisation of a preparation of endo-1,4-beta-xylanase produced by Aspergillus niger CBS 109.713 and endo-1,4-beta-glucanase produced by Aspergillus niger DSM 18404 as a feed additive for poultry species, ornamental birds and weaned piglets (holder of the authorisation: BASF SE), and repealing Regulation (EC) No 271/2009 and Implementing Regulation (EU) No 1068/2011 (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 ↗
The authorisation of the preparation of endo-1,4-beta-xylanase produced by Aspergillus niger CBS 109.713 and endo-1,4-beta-glucanase produced by Aspergillus niger DSM 18404 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.
1. The preparation of endo-1,4-beta-xylanase produced by Aspergillus niger CBS 109.713 and endo-1,4-beta-glucanase produced by Aspergillus niger DSM 18404 and premixtures containing it, which are produced and labelled before 8 January 2022 in accordance with the rules applicable before 8 July 2021 may continue to be placed on the market and used until the existing stocks are exhausted. 2. Feed materials and compound feed containing the preparation referred to in paragraph 1, which are produced and labelled before 8 July 2022 in accordance with the rules applicable before 8 July 2021 may continue to be placed on the market and used until the existing stocks are exhausted, where they are intended for food-producing animals. 3. Feed materials and compound feed containing the preparation referred to in paragraph 1, which are produced and labelled before 8 July 2023 in accordance with the rules applicable before 8 July 2021 may continue to be placed on the market and used until the existing stocks are exhausted, where they are intended for non-food-producing animals.
Regulation (EC) No 271/2009 and Implementing Regulation (EU) No 1068/2011 are repealed.
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 feed with a moisture content of 12 % Category: zootechnical additives. Functional group: digestibility enhancers. 4a7 BASF SE Endo-1,4-beta- xylanase (EC 3.2.1.8) and endo-1,4-beta- glucanase (EC 3.2.1.4) Additive composition Preparation of endo-1,4-beta-xylanase (EC 3.2.1.8) produced by Aspergillus niger CBS 109.713 and endo-1,4-beta-glucanase (EC 3.2.1.4) produced by Aspergillus niger DSM 18404 having a minimum activity of 5 600 TXU ( 1 ) and 2 500 TGU ( 2 ) /g in solid or liquid form ---------------- Characterisation of active substance Endo-1,4-beta-xylanase (EC 3.2.1.8) produced by Aspergillus niger CBS 109.713 and endo-1,4-beta- glucanase (EC 3.2.1.4) produced by Aspergillus niger DSM 18404 -------------- Analytical method ( 3 ) For quantification of endo-1,4-beta-xylanase in the feed additive, premixtures, feed materials and compound feed: Viscosimetric method based on decrease of viscosity produced by action of endo-1,4-beta- xylanase on the xylan containing substrate (wheat arabinoxylan) at pH = 3,5 and 55 °C. For quantification of endo-1,4-beta-glucanase in the feed additive, premixtures, feed materials and compound feed: Viscosimetric method based on decrease of viscosity produced by action of endo-1,4-beta- glucanase on the glucan containing substrate (barley betaglucan) at pH = 3,5 and 40 °C. Chickens for fattening and reared for laying Laying hens All minor poultry species for fattening and laying Ornamental birds - 280 TXU 125 TGU - 1. In the directions for use of the additive and premixture, 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 potential risks resulting from their 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 skin and breathing protection. 8 July 2031 Turkeys Weaned piglets 560 TXU 250 TGU ( 1 ) One TXU is defined as the amount of enzyme that liberates 5 μmol of reducing sugars (xylose equivalents) from wheat arabinoxylan per minute at pH = 3,5 and 55 °C ( 2 ) One TGU is defined as the amount of enzyme that liberates 1 μmol of reducing sugars (glucose equivalents) from barley betaglucan per minute at pH = 3,5 and 40 °C ( 3 ) 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
Source: EUR-Lex (Publications Office of the EU), © European Union, reuse permitted under Commission Decision 2011/833/EU.