Contents
Article 1Renewal 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 2Authorisation#
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 3Repeals#
Regulation (EU) No 337/2011 and Implementing Regulation (EU) 2016/997 are repealed.
Article 4Transitional measures#
1.The preparation specified in the Annex and premixtures containing that preparation, which are intended for poultry species, weaned piglets, pigs for fattening and minor porcine species (weaned piglets and pigs for fattening) and are produced and labelled before 28 March 2024 in accordance with the rules applicable before 28 September 2023, may continue to be placed on the market and used until the existing stocks are exhausted.
2.Compound feed and feed materials containing the preparation specified in the Annex, which are intended for poultry species, weaned piglets, pigs for fattening and minor porcine species (weaned piglets and pigs for fattening) and are produced and labelled before 28 September 2024 in accordance with the rules applicable before 28 September 2023, may continue to be placed on the market and used until the existing stocks are exhausted.
Article 5Entry 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.
| 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 compositionPreparation 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:12200 U/g endo-1,4-beta-xylanase1520 U/g endo-1,3(4)-beta-glucanaseSolid and liquid formCharacterisation of the active substanceEndo-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 143945Analytical methodnoteFor 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 1830 UEndo-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 sowsMinor porcine species (lactating sows) | — | Endo-1,4-beta-xylanase 1220 UEndo-1,3(4)-beta-glucanase 152 U | — | ||||||
| Other poultrySuckling pigletsWeaned pigletsPigs for fatteningMinor porcine species (suckling piglets, weaned piglets and pigs for fattening) | — | Endo-1,4-beta-xylanase 915 UEndo-1,3(4)-beta-glucanase 114 U | — |
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