The Feed Additives (Authorisations) (Wales) Regulations 2023

Regulation 3(1)

SCHEDULE 9 Renewal 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

The preparation of endo-1,4-beta-xylanase (EC 3.2.1.8) 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).

(1) Enzyme activity expressed in birch xylan units (BXU), where 1 BXU is the amount of enzyme which liberates 1 nanomole (nmol) of reducing sugars as xylose from birch xylan per second at pH 5.3 and 50°C
(2) CAS Registry Number® assigned to this preparation by the Chemical Abstracts Service https://www.cas.org/cas-data/cas-registry.
(3) Identification number allocated by the International Union of Biochemistry and Molecular Biology (IUBMB) https://iubmb.org.
(4) European Inventory of Existing Commercial Substances, as published in OJ No C 146A, 15.6.90, p.1.
(5) 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. Available at: https://joint-research-centre.ec.europa.eu/publications/fad-2018-0071_en.
(6) Content of endo-1,4-beta-xylanase (units of activity/kg of complete feed with a moisture content of 12%).
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(1)
Characterisation of the active substance(s)	Endo-1,4-beta-xylanase (EC 3.2.1.8) produced by fermentation with Trichoderma reesei (CBS 114044) CAS number: 9025-57-4(2) EC (IUBMB) number: 3.2.1.8(3) EINECS number: 232-800-2(4)
Analytical methods(5)	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
	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 arabino xylan 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	None
Minimum content(6)	For piglets (weaned): 24,000 BXU/kg
	For chickens for fattening, chickens reared for laying: 8,000 BXU/kg
	For turkeys for fattening, turkeys reared for breeding: 16,000 BXU/kg
Maximum content(6)	None
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 of the authorisation granted under Commission Regulation (EC) 902/2009, which is revoked by regulation 7 of, and Schedule 14 to, these Regulations, but see the transitional provision in regulation 4. This feed additive was also previously authorised as a feed additive for laying hens, minor poultry species and pigs for fattening under Commission Implementing Regulation (EU) No1110/2011, which expired on 24 November 2021 and is revoked by regulation 7 of, and Schedule 14 to, these Regulations.