LegalizeCommission Implementing Regulation (EU) 2019/1324 of 5 August 2019 concerning the authorisation of a preparation of endo-1,4-beta-xylanase produced by Bacillus subtilis LMG S-27588 as a feed additive for chickens for fattening or reared for laying, turkeys for fattening or reared for breeding, minor poultry species for fattening or reared for laying or for breeding, weaned piglets, pigs for fattening and minor porcine species (holder of authorisation Puratos) (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 as set out in the 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 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. |
| 4a30 | EW Nutrition GmbH | Endo-1,4-beta-xylanase EC 3.2.1.8 | Additive composition: Preparation of endo-1,4-beta-xylanase produced by Bacillus subtilis LMG S-27588 having a minimum activity of: 500 ADXU [^E0001]/g Solid form and liquid form Characterisation of the active substance: Endo-1,4-beta-xylanase produced by Bacillus subtilis LMG S-27588 Analytical method [^E0002] For the quantification of endo-1,4-beta-xylanase activity in the feed additive: — colorimetric method measuring reducing sugars released by action of endo-1,4-beta-xylanase on beechwood xylan substrate in the presence of 3,5-dinitrosalicylic acid (DNS). For the quantification of endo-1,4-beta-xylanase activity in premixtures and feedingstuffs: — colorimetric method measuring water soluble dye released by action of endo-1,4-beta-xylanase from azurine cross-linked arabinoxylan substrates. | Chickens for fattening or reared for laying Turkeys for fattening or reared for breeding Minor poultry species for fattening or reared for laying or breeding | — | 100 ADXU | — | 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 resulting from its 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, including breathing and skin protection. | 26 August 2029 | ||||
| 4a30 | EW Nutrition GmbH | Endo-1,4-beta-xylanase EC 3.2.1.8 | Additive composition: Preparation of endo-1,4-beta-xylanase produced by Bacillus subtilis LMG S-27588 having a minimum activity of: 500 ADXU [^E0001]/g Solid form and liquid form Characterisation of the active substance: Endo-1,4-beta-xylanase produced by Bacillus subtilis LMG S-27588 Analytical method [^E0002] For the quantification of endo-1,4-beta-xylanase activity in the feed additive: — colorimetric method measuring reducing sugars released by action of endo-1,4-beta-xylanase on beechwood xylan substrate in the presence of 3,5-dinitrosalicylic acid (DNS). For the quantification of endo-1,4-beta-xylanase activity in premixtures and feedingstuffs: — colorimetric method measuring water soluble dye released by action of endo-1,4-beta-xylanase from azurine cross-linked arabinoxylan substrates. | Weaned piglets Pigs for fattening Minor porcine species for fattening | — | 100 ADXU | — |
One ADXU is the amount of enzyme which liberates one micromole of reducing sugars (xylose equivalent) per minute from beechwood xylan at pH 6,0 and 70 °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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