LegalizeCommission Implementing Regulation (EU) 2024/1058 of 10 April 2024 concerning the renewal of the authorisation of a preparation of endo–1,4-beta-xylanase produced by Aspergillus oryzae DSM 33700 as a feed additive for poultry for fattening, weaned piglets, pigs for fattening, lactating sows and laying hens, the change of the terms of the authorisation and authorisation of new uses of that preparation as a feed additive for all poultry species and all Suidae (holder of authorisation: DSM Nutritional Products Ltd, represented by DSM Nutritional Products Sp. z o.o.) and repealing Implementing Regulations (EU) No 1206/2012, (EU) No 2020/995 and (EU) 2020/1034
Article 1
Renewal of authorisation
The authorisation of the preparation specified in the Annex, belonging to the additive category ‘zootechnical additives’ and to the functional group ‘digestibility enhancers’, is renewed for poultry for fattening, weaned piglets, pigs for fattening, lactating sows and laying hens, subject to the conditions laid down in that Annex.
Article 2
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 for all poultry species other than poultry for fattening and laying hens, and all Suidae other than weaned piglets, pigs for fattening and lactating sows, subject to the conditions laid down in that Annex.
Article 3
Repeals
Implementing Regulations (EU) No 1206/2012, (EU) No 2020/995 and (EU) 2020/1034 are repealed.
Article 4
Transitional measures
Article 5
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 feed 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: zootechnical additives. Functional group: digestibility enhancers. | |||||||||
| 4a1607ii | Novozymes A/S | Endo–1,4-beta-xylanase (EC 3.2.1.8) | Additive composition Preparation of endo–1,4-beta-xylanase (EC 3.2.1.8) produced by Aspergillus oryzae DSM 33700 having a minimum activity of: Solid form: 1 000 FXU (1)/g Liquid form: 650 FXU/ml Characterisation of the active substance Endo–1,4-beta-xylanase (EC 3.2.1.8) produced by Aspergillus oryzae DSM 33700. Analytical method (2) For the quantification of endo–1,4-beta-xylanase in the 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 the quantification of endo-1,4 -beta-xylanase in premixtures and compound feed: — colorimetric method measuring water soluble dye released by action of xylanase from dye-labelled oat spelt azo-xylan. | All poultry species | — | 100 FXU | — | 1. In the directions for use of the additive and premixtures, 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 protective equipment, including breathing protection, eye protection and skin protection. | 1 May 2034 |
| All Suidae | 200 FXU | ||||||||
| (1) One xylanase unit (FXU) is the amount of enzyme which liberates 7,8 micromoles of reducing sugars (xylose equivalents) from azo-wheat arabinoxylan per minute at pH 6,0 and 50 °C. (2) 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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