
Article 1 
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.
Article 2 
This Regulation shall enter into force on the 20th day following its publication in the Official Journal of the European Union.
This Regulation shall be binding in its entirety and directly applicable in all Member States.Done at Brussels, 19 April 2011.
For the Commission
The President
José Manuel BARROSO
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
4a10 Danisco Animal Nutrition Endo-1,4-beta-xylanaseEC 3.2.1.8SubtilisinEC 3.4.21.62Alpha-amylaseEC 3.2.1.1 
 Additive composition
Preparation of endo-1,4-beta-xylanase produced by Trichoderma reesei (ATCC PTA 5588), alpha-amylase produced by Bacillus amyloliquefaciens (ATCC 3978) and subtilisin produced by Bacillus subtilis (ATCC 2107), solid form having a minimum activity of:
— endo-1,4-beta-xylanase 1 500 U/g,
— subtilisin 20 000 U/g,
— alpha-amylase 2 000 U/g.
 Characterisation of the active substance
Endo-1,4-beta-xylanase produced by Trichoderma reesei (ATCC PTA 5588), alpha-amylase produced by Bacillus amyloliquefaciens (ATCC 3978) and subtilisin produced by Bacillus subtilis (ATCC 2107).
 Analytical methods
Determination of the active substance in the additive, premixtures and feedingstuffs.
 Endo-1,4-beta-xylanase: colorimetric method based on the quantification of water soluble dyed fragments produced by the action of endo-1,4-beta-xylanase on commercially available azurine cross-linked wheat arabinoxylan substances.
 Alpha-amylase: colorimetric method based on the quantification of water soluble dyed fragments produced by the action of alpha-amylase on commercially available azurine cross-linked starch polymer substances.
 Subtilisin: colorimetric method based on the quantification of water soluble dyed fragments (azurine) produced by the action of subtilisin on commercially available cross-linked casein substances. Laying hens — 
 endo-1,4-beta-xylanase
300 U
 subtilisin
4 000 U
 alpha-amylase
400 U — 
1. In the directions for use of the additive, indicate the storage temperature, storage life, and stability to pelleting.

2. For use in compound feed rich in starch and non-starch polysaccharides (mainly arabinoxylans and beta-glucans), e.g. containing more than 40 % maize.

3. For safety reasons: breathing protection, glasses and gloves shall be used during handling.
 10 May 2021



