LegalizeCommission Implementing Regulation (EU) 2023/1713 of 7 September 2023 concerning the authorisation of a preparation of endo-1,4-beta-xylanase produced by Trichoderma reesei ATCC PTA-5588, protease produced by Bacillus subtilis CBS 148232 and alpha-amylase produced by Bacillus licheniformis ATCC SD-6525 for chickens for fattening, chickens reared for laying and minor poultry species (holder of authorisation: Danisco (UK) Ltd represented in the Union by Genencor international B.V.) (Text with EEA relevance)
Article 1
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.
Article 2
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.
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 |
|---|---|---|---|---|---|---|---|---|---|
| Units of activity/kg of complete feedingstuff with a moisture content of 12 % | |||||||||
| Category of zootechnical additives. Functional group: digestibility enhancers | |||||||||
| 4a40 | Genencor International B.V. | Endo- 1,4-beta-xylanase (EC 3.2.1.8), protease (EC 3.4.21.62) and alpha-amylase (EC 3.2.1.1) | Additive composition Preparation of endo-1,4-beta-xylanase produced by Trichoderma reesei ATCC PTA-5588, protease produced by Bacillus subtilis CBS 148232 and alpha-amylase produced by Bacillus licheniformis ATCC SD-6525 with a minimum activity of: Endo-1,4-beta-xylanase: 20 000 UX (1)/g Protease: 40 000 UP (2)/g Alpha-amylase: 2 000 UA (3)/g Solid form Characterisation of the active substance Endo-1,4-beta-xylanase (EC 3.2.1.8) produced by Trichoderma reesei ATCC PTA-5588, protease (EC 3.4.21.62, also known as ‘subtilisin’) produced by Bacillus subtilis CBS 148232 and alpha-amylase (EC 3.2.1.1) produced by Bacillus licheniformis ATCC SD-6525 Analytical method (4) For the quantification of endo-1,4-beta-xylanase in the feed additive, premixtures and compound feeds: colorimetric method, based on the enzymatic hydrolysis by xylanase of an azurine cross-linked wheat arabinoxylan substrate at pH 4,2 and 50 °C; For the quantification of protease in feed additive and premixtures and compound feeds: colorimetric method based on the enzymatic hydrolysis by protease of a dyed cross-linked casein substrate at pH 10,0 and 50 °C; For the quantification of alpha-amylase in feed additive, premixtures and compound feeds: colorimetric method based on the enzymatic hydrolysis by amylase of an azurine cross-linked starch polymer substrate at pH 8,0 and 40 °C. | Chickens for fattening Chickens reared for laying Minor poultry species for fattening and reared for laying | — | Endo-1,4-beta-xylanase 2 000 UX Protease 4 000 UP Alpha-amylase 200 UA | — | 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 its use. Where those risks cannot be eliminated by such procedures and measures, the additive and premixtures shall be used with personal breathing, eye and skin protective equipment. | 28 September 2033 |
| (1) One unit of endo-1,4-beta-xylanase activity (UX) is the amount of enzyme, which liberates 0,48 micromoles per minute of reducing sugars, expressed as xylose equivalents, from a wheat arabinoxylan substrate at pH 4,2 and 50 °C. (2) One unit of protease activity (UP) is defined as the amount of enzyme which liberates 2,3 micrograms per minute of phenolic compounds, expressed as tyrosine equivalents from a casein substrate at pH 10,0 and 50 °C. (3) One unit of alpha-amylase activity (UA) is the amount of enzyme required to release, in the presence of an excess of alpha-glucosidase, 0,20 micromoles per minute of glucosidic linkages, expressed as p-nitrophenol equivalents, from a maltoheptasoide substrate at pH 8,0 and 40 °C. (4) Details of the analytical methods are available at the following address of the Reference Laboratory: https://joint-research-centre.ec.europa.eu/eurl-fa-eurl-feed-additives/eurl-fa-authorisation/eurl-fa-evaluation-reports_en. |
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