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.
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
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 feedingstuff with a moisture content of 12 %
Category of zootechnical additives. Functional group: digestibility enhancers
4a22
Adisseo France S.A.S.
Endo-1,4-beta-xylanase EC 3.2.1.8
and
Endo-1,3(4)-beta-glucanase EC 3.2.1.6
Additive composition
Preparation of endo-1,4-beta-xylanase (EC 3.2.1.8) and endo-1,3(4)-beta-glucanase (EC 3.2.1.6) produced by Talaromyces versatilis sp. nov. IMI CC 378536 and Talaromyces versatilis sp. nov. DSM 26702 having a minimum activity of:
—
solid form: endo-1,4-beta-xylanase 22 000 VU/g and endo-1,3(4)-beta-glucanase 15 200 VU ( 1 ) /g;
—
liquid form: endo-1,4-beta-xylanase activity of 5 500 VU/ml and endo-1,3(4)-beta-glucanase 3 800 VU/ml.
Characterisation of the active substance
Endo-1,4-beta-xylanase (EC 3.2.1.8) and endo-1,3(4)-beta-glucanase (EC 3.2.1.6) produced by Talaromyces versatilis sp. nov. IMI CC 378536 and Talaromyces versatilis sp. nov. DSM 26702.
Analytical method
( 2 )
For the quantification of endo-1,4-beta-xylanase activity:
—
viscosimetric method based on decrease in viscosity produced by action of endo-1,4-beta-xylanase on the xylan containing substrate (wheat arabinoxylan).
For the quantification of endo-1,3(4)-beta-glucanase activity:
—
viscosimetric method based on decrease in viscosity produced by action of endo-1,3(4)-beta-glucanase on the glucan substrate barley betaglucan at pH = 5,5 and 30 °C.
Laying hens
—
Endo-1,4-beta-xylanase 1 100 VU
Endo-1,3(4)-beta-glucanase 760 VU
—
1.
In the directions for use of the additive and premixture, indicate the storage conditions and stability to pelleting.
2.
For users of the additive and premixtures, feed business operators shall establish operational procedures and organisational measures to address potential risks resulting from its use. Where those risks cannot be eliminated or reduced to a minimum by such procedures and measures, the additive and premixtures shall be used with personal protective equipment, including breathing, and skin protections.
28 February 2027
( 1 ) 1 VU (viscosimetric unit) is the amount of enzyme which hydrolyses the substrate (barley betaglucan and wheat arabinoxylan, respectively), reducing the viscosity of the solution, to give a change in relative fluidity of 1 (dimensionless unit)/min at 30 °C and pH 5,5.
( 2 ) Details of the analytical methods are available at the following address of the Reference Laboratory: https://ec.europa.eu/jrc/en/eurl/feed-additives/evaluation-reports