The Feed Additives (Authorisations) (Scotland) Regulations 2022

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)
		Produced by Bacillus licheniformis DSM 19670 Having a minimum activity of 75,000 PROT/g(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:
		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		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.

(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 https://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, 15.6.90, 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) iubmb.org.

(5)

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.