LegalizeCommission Implementing Regulation (EU) 2018/1090 of 31 July 2018 concerning the authorisation of a preparation of endo-1,4-beta-xylanase and endo-1,3(4)-beta-glucanase produced by Komagataella pastoris (CBS 25376) and Komagataella pastoris (CBS 26469) as a feed additive for chickens for fattening, chickens reared for laying, turkeys for fattening, all avian species reared for laying or for breeding purposes, weaned piglets and minor porcine species (weaned) (holder of the authorisation Kaesler Nutrition GmbH) (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 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 | Name of the 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 feed with a moisture content of 12 % | |||||||||
| Category of zootechnical additives. Functional group: digestibility enhancers | |||||||||
| 4a28 | Kaesler Nutrition GmbH | Endo-1,4- beta-xylanase (EC 3.2.1.8) Endo-1,3(4)- beta-glucanase (EC 3.2.1.6) | Additive composition Preparation of endo-1,4-beta-xylanase produced with Komagataella phaffii DSM 25376 and endo-1,3(4)-beta-glucanase produced with Komagataella phaffii DSM 26469 having a minimum activity of: 25 000 LXU (1) and 2 200 LGU (2)/g. Solid and liquid form. Characterisation of the active substance Endo-1,4- beta-xylanase (EC 3.2.1.8) produced with Komagataella phaffii DSM 25376 and endo-1,3(4)- beta-glucanase (EC 3.2.1.6) produced with Komagataella phaffii DSM 26469 Analytical method (3) For the determination of xylanase in the feed additive, premixtures and compound feed: — colorimetric method based on the quantification of water soluble dyed fragments produced by the action of endo-1,4-β-xylanase on cross-linked wheat arabinoxylan. For the determination of β-glucanase in the feed additive, premixtures and compound feed: — colorimetric method based on the quantification of water soluble dyed fragments produced by the action of 1,4-β-β-gluconases on cross-linked azo-barley-glucan. | Chickens for fattening Turkeys for fattening All avian species reared for laying or for breeding purposes | - | 1 400 LXU 120 LGU | - | 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 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. | 21.8.2028 |
| Piglets (weaned) Minor porcine species (weaned) | 700 LXU 60 LGU | ||||||||
| (1) 1 LXU is the amount of enzyme that releases one μmole of reducing sugar equivalents per minute (as xylose from birch xylan) at pH 5,5 and 50 °C. (2) 1 LGU is the amount of enzyme which liberates one μmole of reducing sugar equivalents per minute (as glucose from barley glucan) at pH 5,5 and 50 °C. (3) 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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