LegalizeCommission Implementing Regulation (EU) No 389/2011 of 19 April 2011 concerning the authorisation of an enzyme preparation of endo-1,4-beta-xylanase, subtilisin and alpha-amylase as feed additive for laying hens (holder of authorisation Danisco Animal Nutrition) Text with EEA relevance
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.
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 | ||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 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 | Units of activity/kg of complete feedingstuff with a moisture content of 12 % | Units of activity/kg of complete feedingstuff with a moisture content of 12 % | Other provisions | End of period of authorisation | ||||||
| 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 | Category of zootechnical additives. Functional group: digestibility enhancers | Category of zootechnical additives. Functional group: digestibility enhancers | Category of zootechnical additives. Functional group: digestibility enhancers | Category of zootechnical additives. Functional group: digestibility enhancers | Category of zootechnical additives. Functional group: digestibility enhancers | Category of zootechnical additives. Functional group: digestibility enhancers | Category of zootechnical additives. Functional group: digestibility enhancers | Category of zootechnical additives. Functional group: digestibility enhancers | Category of zootechnical additives. Functional group: digestibility enhancers | Category of zootechnical additives. Functional group: digestibility enhancers |
| 4a10 | Genencor International B.V. | Endo-1,4-beta-xylanase EC 3.2.1.8 Subtilisin EC 3.4.21.62 Alpha-amylase EC 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 [^E0001]/g, — subtilisin 20 000 U [^E0002]/g, — alpha-amylase 2 000 U [^E0003]/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 [^E0004] 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 | — | Other provisions | End of period of authorisation | 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 |
1 U is the amount of enzyme which liberates 0,5 μmol of reducing sugar (expressed as xylose equivalents) from a cross-linked oat spelt xylan substrate per minute at pH 5,3 and 50 °C.
1 U is the amount of enzyme which liberates 1 μmol of phenolic compound (tyrosine equivalents) from a casein substrate per minute at pH 7,5 and 40 °C.
1 U is the amount of enzyme which liberates 1 μmol of glucosidic linkages from a water insoluble cross-linked starch polymer substrate per minute at pH 6,5 and 37 °C.
Details of the analytical methods are available at the following address of the European Union Reference Laboratory for Feed Additives: www.irmm.jrc.be/eurl-feed-additives
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