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

Regulation 3(1)

The preparation specified in the table, 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.

Additive

Serine protease (EC 3.4.21.-)

Identification number of the additive

4a13

Authorisation holder

DSM Nutritional Products Ltd (Switzerland)

Additive category

Zootechnical additives

Functional group

Digestibility 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(2): 37259-58-8 (serine protease)

  • EINECS number(3): 253-431-3

  • IUB number(4): 3.4.21.-

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 animal

Chickens for fattening

Maximum age

None

Minimum content(6)

15,000 PROT(1)/kg

Maximum content(6)

None

Other provisions

In the directions for use of the feed additive and premixtures, the storage conditions and stability to heat treatment must be indicated.

(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)

CAS Registry Number® assigned to this preparation by the Chemical Abstracts Service https://www.cas.org/cas-data/cas-registry.

(3)

European Inventory of Existing Commercial Substances, number as published in OJ No C 146 A, 15.6.90, p.1.

(4)

Identification number assigned by the International Union of Biochemistry (IUB), now the International Union of Biochemistry and Molecular Biology (IUBMB) iubmb.org.

(5)

Details of the analytical methods set out in the document referenced “Ares(2019)6802984 - 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.

(6)

Content of Serine protease in PROT/kg of complete feed with a moisture content of 12%.