Regulation 3(1)

SCHEDULE 1Renewal 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

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		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(2)
Characterisation of the active substance(s)		Endo-1,4-beta-xylanase (EC 3.2.1.8) produced by fermentation with Trichoderma reesei (CBS 143953)
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 method(6)		For quantification of endo-1,4-beta-xylanase enzyme activity in the feed additive, premixtures, feed materials and compound feed:
Analytical method(6)		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		No maximum
Content of endo-1,4-beta-xylanase (EC 3.2.1.8) (units of activity/kg of complete feed with a moisture content of 12%)	Minimum content	All poultry species: 625 U/kg Piglets (suckling and weaned), pigs for fattening and minor porcine species: 2000 U/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 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, and schedule 14, of these Regulations. The explanatory note to these Regulations sets out the modifications made to those authorisations.

(2)

Enzyme activity: one unit is the amount of enzyme which releases 0.48 micromoles (μmol) of reducing sugar (xylose equivalent) per minute from wheat arabino xylan at pH 4.2 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 “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.