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
Regulation 3
The preparation of endo-1,4-beta-xylanase (EC 3.2.1.8), 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.
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
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 no: 9025-57-4 EC (IUBMB) no: 3.2.1.8 EINECS no: 232-800-2
Analytical methods		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		Not applicable
Content of Endo-1,4-beta-xylanase (units of activity (BXU)/kg of complete feed with a moisture content of 12%)	Minimum content	For chickens for fattening and chickens reared for laying: 8,000 BXU/kg For turkeys for fattening and turkeys reared for breeding: 16,000 BXU/kg For 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) 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.		
(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) This is the identification number allocated by the International Union of Biochemistry and Molecular Biology (IUBMB) https://iubmb.org.		
(4) 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.		
(5) Details of the analytical method is set out in the document referenced “Ares(2019)3101222-10/05/2019” and last updated on 2nd July 2019, available at: https://joint-research-centre.ec.europa.eu/publications/fad-2018-0071_en.		
This authorisation is a renewal of the authorisation granted under Commission Regulation (EC) 902/2009. 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 (“EUR 2011/1110”). EUR 2011/1110 expired on 24 November 2021. EUR 902/2009 and 2011/1110 are revoked by regulation 7 of, and Schedule 14 to, these Regulations. This renewal differs from the previous authorisation as the identification number has been updated from “4a8” to “4a8i” and the minimum level of stock enzyme is reduced from 4,000,000 BXU/g in solid form and 400,000 BXU/g in liquid form.