LegalizeCommission Implementing Regulation (EU) 2021/1426 of 31 August 2021 concerning the authorisation of serine protease produced by Bacillus licheniformis DSM 19670 as a feed additive for chickens for fattening (holder of the authorisation: DSM Nutritional Products Ltd., represented in the Union by DSM Nutritional Products Sp. z o.o.) (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 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 feed with a moisture content of 12 % | |||||||||
| Category of zootechnical additives Functional group: digestibility enhancers | |||||||||
| 4a13 | Novozymes A/S | Serine protease (EC 3.4.21.-) | Additive composition: Solid and liquid preparation of serine protease (EC 3.4.21.-) produced by Bacillus licheniformis DSM 19670 having a minimum activity of 75 000 PROT (1)/g | Chickens for fattening | - | 15 000 PROT | 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 by inhalation, dermal contact or eyes contact. 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 eyes, skin and breathing protection. | 21 September 2031 | |
| Characterisation of the active substance: Serine protease (EC 3.4.21.-) produced by Bacillus licheniformis DSM 19670 | |||||||||
| Analytical method (2) For the quantification of the serine protease activity in the feed additive, premixtures, compound feed and feed materials: — colourimetric method based on the enzymatic reaction of serine protease on the Suc-Ala-Ala-Pro-Phe-pNA substrate. | |||||||||
| (1) One PROT is the amount of enzyme that releases 1 μmol of p-nitroaniline from 1mM substrate (Suc-Ala-Ala-Pro-Phe-pNA) per minute at pH 9,0 and temperature 37 °C. (2) 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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