LegalizeCommission Implementing Regulation (EU) 2020/995 of 9 July 2020 concerning the authorisation of a preparation of endo-1,4-beta-xylanase produced by Aspergillus oryzae (DSM 26372) as a feed additive for lactating sows (holder of authorisation DSM Nutritional Products Ltd represented by DSM Nutritional Products Sp. Z o.o) (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 as set out in the Annex.
Article 2
This Regulation shall enter into force on the twentieth day following that of 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 | |||||||
| 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. | |||||||
| 4a1607i | Name of the holder of authorisation | Additive | Composition, chemical formula, description, analytical method | Species or category of animal | Maximum age | DSM Nutritional Products Ltd represented by DSM Nutritional Products Sp. Z o.o | Endo-1,4-beta-xylanase (EC 3.2.1.8) | Other provisions | End of period of authorisation | Additive composition: Preparation of endo-1,4-beta-xylanase (EC 3.2.1.8) produced by Aspergillus oryzae (DSM 26372) having a minimum activity of: Solid form: 1 000 FXU [^E0001]/g Liquid form: 650 FXU/ml Characterisation of active substance: Endo-1,4-beta-xylanase (EC 3.2.1.8) produced by Aspergillus oryzae (DSM 26372) Analytical method [^E0002]: For quantification of endo-1,4-beta-xylanase produced by Aspergillus oryzae (DSM 26372) in a feed additive: — colorimetric method measuring coloured compound produced by the dinitro salicylic acid (DNSA) and the xylosylic moieties released by the action of xylanase on arabinoxylan. For quantification of endo-1,4-beta-xylanase produced by Aspergillus oryzae (DSM 26372) in premixtures and feedingstuffs: — colorimetric method measuring water soluble dye released by action of xylanase from dye-labelled oat spelt azo-xylan. | Lactating sows | - | 200 FXU | - | 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, eyes and breathing protection. | 30.7.2030 |
1 FXU is the amount of enzyme which liberates 7,8 μmol of reducing sugars (xylose equivalents) from azo-wheat arabinoxylan per minute at pH 6,0 and 50 °C.
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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