The Feed Additives (Authorisations) (Wales) Regulations 2023

Regulation 3(1)

SCHEDULE 1 Renewal of authorisation of a preparation of endo-1,4-beta-xylanase (EC 3.2.1.8) produced from Trichoderma reesei (CBS 143953) (formerly Trichoderma reesei (ATCC PTA 5588)) (identification number 4a11) as a feed additive for chickens for fattening, laying hens, turkeys for fattening, ducks, minor poultry species, weaned piglets, and piglets for fattening, and its authorisation as a feed additive extending existing uses to cover all poultry species, piglets (suckling and weaned), pigs for fattening, and minor porcine species

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) 1 unit (“U”) is the amount of enzyme that releases 0.48 micromoles (μmol) of reducing sugar (xylose equivalent) per minute from wheat arabino xylan at pH4.2 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 “JRC.D.5/FSQ/CvH/DM/ag/ARES(2012)353089” and last updated 6 June 2016. Available at: https://joint-research-centre.ec.europa.eu/publications/fad-2011-0030_en.
(6) The enzyme activity for endo-1,4-beta-xylanase is defined in the document referenced “JRC.DG.D.6/CvH/DM/hn/ARES(2010)-375745” and last updated 6 June 2016. Available at: https://joint-research-centre.ec.europa.eu/publications/fad-2010-0007_en .
(7) 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	4a11
Authorisation holder	Danisco (UK) Ltd
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 143953) with a minimum enzyme activity of 40,000 U/g(1)
Characterisation of the active substance(s)	Endo-1,4-beta-xylanase (EC 3.2.1.8) produced by fermentation with Trichoderma reesei (CBS 143953) CAS number: 9025-57-4(2) EC (IUBMB) number: 3.2.1.8(3) EINECS number: 232-800-2(4)
Analytical methods(5)(6)	For quantification of endo-1,4-beta-xylanase enzyme activity in the feed additive, premixtures, feed materials and compound feed: Colorimetric method measuring water soluble dye released by action of endo-1,4-beta-xylanase from azurine cross-linked wheat arabino xylan substrate
Species or category of animal	All poultry species Piglets (suckling and weaned) Pigs for fattening Minor porcine species
Maximum age	None
Minimum content(7)	For all poultry species: 625 U/kg
	For piglets (suckling and weaned), pigs for fattening, minor porcine species: 2000 U/kg
Maximum content(7)	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 contains a renewal (with modification) of the authorisations granted under Commission Regulation (EU) No 9/2010, Commission Implementing Regulation (EU) No528/2011 and Commission Implementing Regulation (EU) No1021/2012. Those Regulations are revoked by regulation 7 of, and Schedule 14 to, these Regulations.