LegalizeCommission Implementing Regulation (EU) 2023/1703 of 7 September 2023 concerning the renewal of the authorisation of a preparation of endo-1,4-beta-xylanase produced by Trichoderma reesei CBS 143953 and endo-1,3(4)-beta-glucanase produced by Trichoderma reesei CBS 143945 as a feed additive for poultry species, weaned piglets, pigs for fattening, lactating sows and minor porcine species (weaned piglets, pigs for fattening and lactating sows), the authorisation of that preparation for suckling piglets and minor porcine species (suckling piglets) (holder of authorisation: Danisco (UK) Ltd, trading as Danisco Animal Nutrition and represented by Genencor International B.V.) and repealing Regulation (EU) No 337/2011 and Implementing Regulation (EU) 2016/997 (Text with EEA relevance)
Article 1
Renewal of the 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 species, weaned piglets, pigs for fattening, lactating sows and minor porcine species (weaned piglets, pigs for fattening and lactating sows), 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 for suckling piglets and minor porcine species (suckling piglets) as an additive in animal nutrition, subject to the conditions laid down in that Annex.
Article 3
Repeals
Regulation (EU) No 337/2011 and Implementing Regulation (EU) 2016/997 are repealed.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 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. | |||||||||
| 4a15 | Genencor International B.V. | 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 by Trichoderma reesei CBS 143953 and endo-1,3(4)-beta-glucanase produced by Trichoderma reesei CBS 143945 having a minimum activity of: — 12 200 U (1)/g endo-1,4-beta-xylanase — 1 520 U (2)/g endo-1,3(4)-beta-glucanase Solid and liquid form Characterisation of the active substance Endo-1,4-beta-xylanase (EC 3.2.1.8) produced by Trichoderma reesei CBS 143953 and endo-1,3(4)-beta-glucanase (EC 3.2.1.6) produced by Trichoderma reesei CBS 143945 Analytical method (3) For quantification of the active substances in the additive, premixtures and compound feeds: — colorimetric method measuring water soluble dye released by action of endo-1,4-beta-xylanase from azurine cross-linked wheat arabinoxylan substrates; — colorimetric method measuring water soluble dye released by action of endo-1,3(4)-beta-glucanase from azurine cross-linked barley beta-glucan substrates. | Laying hens | — | Endo-1,4-beta-xylanase 1 830 U Endo-1,3(4)-beta-glucanase 228 U | — | 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 the potential risks resulting from their use. Where those risks cannot be eliminated by such procedures and measures, the additive and premixtures shall be used with personal breathing, skin and eye protective equipment. | 28 September 2033 |
| Lactating sows Minor porcine species (lactating sows) | — | Endo-1,4-beta-xylanase 1 220 U Endo-1,3(4)-beta-glucanase 152 U | — | ||||||
| Other poultry Suckling piglets Weaned piglets Pigs for fattening Minor porcine species (suckling piglets, weaned piglets and pigs for fattening) | — | Endo-1,4-beta-xylanase 915 U Endo-1,3(4)-beta-glucanase 114 U | — | ||||||
| (1) One U of endo-1,4-beta-xylanase is the amount of enzyme that liberates 0,48 μmol of reducing sugar (xylose equivalents) per minute from a wheat arabinoxylan at pH 4,2 and 50 °C. (2) One U of endo-1,4-beta-glucanase is the amount of enzyme that liberates 2,4 μmol of reducing sugar (glucose equivalents) per minute from a barley glucan at pH 5,0 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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