LegalizeCommission Implementing Regulation (EU) No 1110/2011 of 3 November 2011 concerning the authorisation of an enzyme preparation of endo-1,4-beta-xylanase produced by Trichoderma reesei (CBS 114044) as a feed additive for laying hens, minor poultry species and pigs for fattening (holder of authorisation Roal Oy) 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 20th day following 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 | ||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 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 | Units of activity/kg of complete feedingstuff with a moisture content of 12 % | Units of activity/kg of complete feedingstuff with a moisture content of 12 % | Other provisions | End of period of authorisation | ||||||
| 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 | Category of zootechnical additives. Functional group: digestibility enhancers. | Category of zootechnical additives. Functional group: digestibility enhancers. | Category of zootechnical additives. Functional group: digestibility enhancers. | Category of zootechnical additives. Functional group: digestibility enhancers. | Category of zootechnical additives. Functional group: digestibility enhancers. | Category of zootechnical additives. Functional group: digestibility enhancers. | Category of zootechnical additives. Functional group: digestibility enhancers. | Category of zootechnical additives. Functional group: digestibility enhancers. | Category of zootechnical additives. Functional group: digestibility enhancers. | Category of zootechnical additives. Functional group: digestibility enhancers. |
| 4a8 | Roal Oy | Endo-1,4-beta-xylanase EC 3.2.1.8 | Additive composition Preparation of endo-1,4-beta-xylanase produced by Trichoderma reesei (CBS 114044) having a minimum activity of: solid form: 4 × 106 BXU [^E0001]/g liquid form: 4 × 105 BXU/g Characterisation of the active substance endo-1,4-beta-xylanase produced by Trichoderma reesei (CBS 114044) Analytical method [^E0002] In the additive and the premixture: reducing sugar assay for endo-1,4- beta-xylanase by colorimetric reaction of dinitrosalicylic acid reagent on reducing sugar yield at pH 5,3 and 50 °C In the feedingstuffs: colorimetric method measuring water soluble dye released by the enzyme from azurine crosslinked wheat arabinoxylan substrate | Minor poultry species other than laying birds | — | 8 000 BXU | — | Other provisions | End of period of authorisation | 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 to 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. | 24 November 2021 | ||||
| 4a8 | Roal Oy | Endo-1,4-beta-xylanase EC 3.2.1.8 | Additive composition Preparation of endo-1,4-beta-xylanase produced by Trichoderma reesei (CBS 114044) having a minimum activity of: solid form: 4 × 106 BXU [^E0001]/g liquid form: 4 × 105 BXU/g Characterisation of the active substance endo-1,4-beta-xylanase produced by Trichoderma reesei (CBS 114044) Analytical method [^E0002] In the additive and the premixture: reducing sugar assay for endo-1,4- beta-xylanase by colorimetric reaction of dinitrosalicylic acid reagent on reducing sugar yield at pH 5,3 and 50 °C In the feedingstuffs: colorimetric method measuring water soluble dye released by the enzyme from azurine crosslinked wheat arabinoxylan substrate | Laying hens | — | 12 000 BXU | — | ||||||||
| 4a8 | Roal Oy | Endo-1,4-beta-xylanase EC 3.2.1.8 | Additive composition Preparation of endo-1,4-beta-xylanase produced by Trichoderma reesei (CBS 114044) having a minimum activity of: solid form: 4 × 106 BXU [^E0001]/g liquid form: 4 × 105 BXU/g Characterisation of the active substance endo-1,4-beta-xylanase produced by Trichoderma reesei (CBS 114044) Analytical method [^E0002] In the additive and the premixture: reducing sugar assay for endo-1,4- beta-xylanase by colorimetric reaction of dinitrosalicylic acid reagent on reducing sugar yield at pH 5,3 and 50 °C In the feedingstuffs: colorimetric method measuring water soluble dye released by the enzyme from azurine crosslinked wheat arabinoxylan substrate | Laying birds of minor poultry species | — | 24 000 BXU | — | ||||||||
| 4a8 | Roal Oy | Endo-1,4-beta-xylanase EC 3.2.1.8 | Additive composition Preparation of endo-1,4-beta-xylanase produced by Trichoderma reesei (CBS 114044) having a minimum activity of: solid form: 4 × 106 BXU [^E0001]/g liquid form: 4 × 105 BXU/g Characterisation of the active substance endo-1,4-beta-xylanase produced by Trichoderma reesei (CBS 114044) Analytical method [^E0002] In the additive and the premixture: reducing sugar assay for endo-1,4- beta-xylanase by colorimetric reaction of dinitrosalicylic acid reagent on reducing sugar yield at pH 5,3 and 50 °C In the feedingstuffs: colorimetric method measuring water soluble dye released by the enzyme from azurine crosslinked wheat arabinoxylan substrate | Pigs for fattening | — | 20 000 BXU | — |
1 BXU is the amount of enzyme which liberates 1 nmol reducing sugars as xylose from birch xylan per second at pH 5,3 and 50 °C.
Details of the analytical methods are available at the following address of the Reference Laboratory: https://ec.europa.eu/jrc/en/eurl/feed-additives/evaluation-reports
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