The Feed Additives (Authorisations) (England) Regulations 2022

Regulation 3

SCHEDULE 3Authorisation of a preparation of Serine protease (EC 3.4.21.-) produced by Bacillus licheniformis (DSM 19670) (identification number 4a13) as a feed additive for chickens for fattening

This schedule has no associated Explanatory Memorandum

The preparation of Serine protease (EC 3.4.21.-) produced by Bacillus licheniformis (DSM 19670), belonging to the additive category ‘zootechnical additives’ and to the functional group ‘digestibility enhancers’, is authorised as an additive in animal nutrition in accordance with the specifications in the following table.

(1)

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.

(2)

This is a reference to the CAS Registry Number assigned to this preparation by the Chemical Abstracts Service http://cas.org/cas-data/cas-registry.

(3)

The EINECS number is given in the European Inventory of Existing Commercial Substances, as published in O.J No. C146A, 16.6.90, p.1.

(4)

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) https://iubmb.org.

(5)

Details of the analytical methods set out in the document referenced “Ares(2019)6802984 - 04/11/2019” and last updated 27th January 2020. The document is available at the following address: https://ec.europa.eu/jrc/en/eurl/feed-additives/evaluation-reports/fad-2019-0010.

(6)

Content of Serine protease: units of activity/kg of complete feed with a moisture content of 12%.

AdditiveSerine protease (EC 3.4.21.-)
Identification number of the additive4a13
Authorisation holderDSM Nutritional Products Ltd (Switzerland)
Additive categoryZootechnical additives
Functional groupDigestibility enhancers
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

Characterisation of the active substance(s)

Serine protease (EC 3.4.21.-) 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.-(4).

Analytical methods (5)

For quantification of 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.

Species or category of animalChickens for fattening
Maximum ageNot applicable
Minimum content (6)Minimum level: 15,000 PROT/kg
Maximum content(6)No maximum
Other provisionsIn the directions for use of the additive and premixtures, the storage conditions and stability to heat treatment must be indicated.