Authorisation
The preparation specified in the Annex, 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 laid down in that Annex.
Entry into force
This Regulation shall enter into force on the twentieth day following that of its publication in the Official Journal of the European Union.
ANNEXSupplementary provisions
ANNEX
Identification number of the additive
Name of the holder of authorisation
Name of the additive
Composition, chemical formula, description, analytical method
Species or category of animal
Maximum age
Minimum content
Maximum content
Other provisions
End of period of authorisation
Units of activity/kg of complete feed with a moisture content of 12 %
Category: zootechnical additives. Functional group: digestibility enhancers.
4a33
Industrial Técnica Pecuaria, S.A.
Endo-1,4-beta-xylanase (EC 3.2.1.8) and alpha-galactosidase (EC 3.2.1.22)
Additive composition
Preparation of endo-1,4-beta-xylanase (EC 3.2.1.8) produced with Trichoderma orientale CBS 139997 and alpha-galactosidase (EC 3.2.1.22) produced with Aspergillus tubingensis ATCC SD 6740 having a minimum enzyme activity of:
50 AXC ( 1 ) /g of additive and 40 GALU ( 2 ) /g of additive
Solid form
Characterisation of the active substance
Endo-1,4-beta-xylanase (EC 3.2.1.8) produced with Trichoderma orientale CBS 139997 and alpha-galactosidase (EC 3.2.1.22) produced with Aspergillus tubingensis ATCC SD 6740
Analytical method
( 3 )
For the quantification of endo-1,4-beta-xylanase in the feed additive, premixtures and compound feed:
—
colorimetric method based enzymatic reaction of endo-1,4-beta-xylanase (i) on a wheat arabinoxylan substrate (for the feed additive and premixtures); and ii) on an azo-xylan substrate (for compound feed).
For the quantification of alpha-galactosidase in the feed additive, premixtures and compound feed:
—
colorimetric method based on the enzymatic reaction of alpha-galactosidase on the para-nitrophenyl-alpha-D-galactopyranoside substrate.
Turkeys for fattening
Turkeys reared for reproduction
—
18 AXC
14 GALU
—
1.
In the directions for use of the additive and premixtures, the storage conditions and stability to heat treatment shall be indicated.
2.
For users of the additive and premixtures, feed business operators shall establish operational procedures and organisational measures to address the potential risks resulting from their use. Where those risks cannot be eliminated by such procedures and measures, the additive and premixtures shall be used with personal breathing, eye and skin protective equipment.
13 August 2036
( 1 ) One unit of endo-1,4-beta-xylanase activity (AXC) is the amount of enzyme, which liberates 0,058 micromoles per minute of reducing sugars, expressed as xylose equivalents, from a wheat arabinoxylan substrate at pH 4,7 and 30 °C.
( 2 ) One unit of alpha-galactosidase activity (GALU) is defined as the amount of enzyme which degrades one micromole per minute of para-nitrophenyl-alpha-D-galactopyranoside at pH 5,5 and 37 °C.
( 3 ) Details of the analytical methods are available at the following address of the Reference Laboratory: https://joint-research-centre.ec.europa.eu/eurl-fa-eurl-feed-additives/eurl-fa-authorisation/eurl-fa-evaluation-reports_en .