Authorisation
1. The preparation specified in the table in this schedule, 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 set out in the table in this schedule.
Table
| Column 1 | Column 2 | |
|---|---|---|
| Additive | Serine protease | |
| Identification number of the additive | 4a13 | |
| Authorisation holder | DSM Nutritional Products Ltd in Switzerland | |
| Additive category | Zootechnical additives | |
| Functional group | Digestibility enhancers | |
| Additive composition | Solid and liquid preparation of serine protease (EC 3.4.21.-1) | |
| ||
| Characterisation of the active substance(s) | Serine protease (EC 3.4.21.-1) produced by Bacillus licheniformis DSM 19670 CAS number: 37259-58-8 (serine protease)(2) EINECS number: 253-431-3(3) IUB number: 3.4.21.-1(4) | |
| Analytical methods(5) | For quantification of serine protease activity in the feed additive, premixtures, compound feed and feed materials: | |
| ||
| Species or category of animal | Chickens for fattening | |
| Maximum age | Not applicable | |
| Content of Serine protease (units of activity/kg of complete feed with a moisture content of 12%) | Minimum content | 15,000 PROT/kg |
| Maximum content | No maximum | |
| Other provisions | In the directions for use of the additive and premixtures, the storage conditions and stability to heat treatment must be indicated. | |
One PROT is the amount of serine protease that liberates one micromole/minute of para-nitroaniline (pNA) from 1 millimolar (mM) Suc-Ala-Ala-Pro-Phe-pNA substrate at pH 9 & 37°C.
This is a reference to the CAS Registry Number assigned to this preparation by the Chemical Abstracts Service https://cas.org/cas-data/cas-registry.
The EINECS number is given in the European Inventory of Existing Commercial Substances, as published in O.J. No. C146A, 15.6.90, p.1.
This is the identification number allotted by the International Union of Biochemistry (IUB), which is now the International Union of Biochemistry and Molecular Biology (IUBMB) iubmb.org.
Details of the analytical methods are set out in the document referenced “Ares(2019)6802986 – 04/11/2019” and last updated 27 January 2020. The document is available at the following address: https://ec.europa.eu/jrc/en/eurl/feed-additives/evaluation-reports/fad-2019-0010.