The Feed Additives (Authorisations) (Scotland) Regulations 2023

Regulation 3(1)

SCHEDULE 9Renewal of authorisation of a preparation of endo-1,4-beta-xylanase (EC 3.2.1.8) produced from Trichoderma reesei (CBS 114044) (identification number 4a8i) as a feed additive for piglets (weaned), chickens for fattening, chickens reared for laying, turkeys for fattening and turkeys reared for breeding

This schedule has no associated Policy Notes

Authorisation

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(1).

Table

Column 1		Column 2
Additive		Endo-1,4-beta-xylanase (EC 3.2.1.8)
Identification number		4a8i
Authorisation holder		Roal Oy
Additive category		Zootechnical additives
Functional group		Digestibility enhancers
Additive composition		Preparation of endo-1,4-beta-xylanase (EC 3.2.1.8) produced by fermentation with Trichoderma reesei (CBS 114044) having a minimum enzyme activity of 160 000 BXU/g for both solid and liquid forms(2)
Characterisation of the active substance(s)		Endo-1,4-beta-xylanase (EC 3.2.1.8) produced by fermentation with Trichoderma reesei (CBS 114044)
Characterisation of the active substance(s)		CAS No: 9025-57-4(3) EC (IUBMB) No: 3.2.1.8(4) EINECS No: 232-800-2(5)
Analytical methods(6)		1. For the quantification of endo-1,4-beta-xylanase (EC 3.2.1.8) in the feed additive and premixtures:
		Colorimetric method based on the enzymatic reaction of endo-1,4-beta-xylanase on the birch xylan substrate at pH 5.3 and 50°C
		2. For the quantification of endo-1,4-beta-xylanase (EC 3.2.1.8) in feed materials and compound feed:
		Colorimetric method based on the enzymatic reaction of endo-1,4-beta-xylanase on the azurine cross-linked wheat arabinoxylan substrate at pH 5.3 and 50°C
Species or category of animal		Piglets (weaned) Chickens for fattening Chickens reared for laying Turkeys for fattening Turkeys reared for breeding
Maximum age		No maximum
Content of endo-1,4-beta-xylanase (EC 3.2.1.8) (units of activity (BXU/kg) of complete feed with a moisture content of 12%)	Minimum content	Chickens for fattening, chickens reared for laying: 8,000 BXU/kg Turkeys for fattening, turkeys reared for breeding: 16,000 BXU/kg Piglets (weaned): 24,000 BXU/kg
	Maximum content	No maximum
Other provisions		The storage conditions and stability to heat treatment must be stated in the directions for use of the feed additive and premixture

(1)

This authorisation is a renewal (with modifications) of the authorisation granted under Commission Regulation (EC) No 902/2009. That Regulation is revoked by regulation 7, and schedule 14, of these Regulations. The explanatory note to these Regulations sets out the modifications made to that authorisation.

(2)

Enzyme activity expressed in birch xylan units (BXU), where one BXU is the amount of enzyme which liberates 1 nanomole of reducing sugars as xylose from birch xylan per second at pH 5.3 and 50°C.

(3)

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.

(4)

This is the identification number assigned by the International Union of Biochemistry and Molecular Biology (IUBMB) https://iubmb.org.

(5)

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.

(6)

Details of the analytical methods are set out in the document referenced “Ares(2019)3101222-10/05/2019” and “JRC F.5/CvH/MGH/AS/Ares” and last updated on 2 July 2019. The document is available at the following address: https://joint-research-centre.ec.europa.eu/publications/fad-2018-0071_en.