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.
Amendments to Regulation (EC) No 255/2005
In Annex II to Regulation (EC) No 255/2005, entry E 1601 on endo-1,3(4)-beta-glucanase EC 3.2.1.6 and endo-1,4-beta-xylanase EC 3.2.1.8 is deleted.
Repeal
Regulation (EC) No 668/2003 is repealed.
Transitional measures
The preparation specified in the Annex, and feed containing that preparation, which are produced and labelled before 7 May 2018 in accordance with the rules applicable before 7 November 2017 may continue to be placed on the market and used until the existing stocks are exhausted.
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
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.
4a1601
Andrés Pintaluba S.A.
Endo-1,3(4)-beta-glucanase EC 3.2.1.6
and endo-1,4-beta-xylanase EC 3.2.1.8
Additive composition:
Preparation of endo-1,3(4)-beta-glucanase (EC 3.2.1.6) and endo-1,4-beta-xylanase (EC 3.2.1.8) produced by Aspergillus niger (NRRL 25541) having a minimum activity of: endo-1,3(4)-beta-glucanase 1 100 U ( 1 ) /g and endo-1,4-beta-xylanase 1 600 U ( 2 ) /g.
(solid form)
Characterisation of the active substance:
Endo-1,3(4)-beta-glucanase (EC 3.2.1.6) and endo-1,4-beta-xylanase (EC 3.2.1.8) produced by Aspergillus niger (NRRL 25541).
Analytical method
( 3 )
For the characterisation in the feed additive and premixtures of:
—
endo-1,3(4)-beta-glucanase activity: colorimetric method measuring reducing sugar (glucose equivalents) released by the action of endo-1,3(4)-beta-glucanase on barley beta-glucan substrate in presence of 3,5-dinitrosalicil acid (DNS);
—
endo-1,4-beta-xylanase activity: colorimetric method measuring reducing sugar (glucose equivalents) released by the action of endo-1,4-beta-xylanase on oat xylan substrate in presence of 3,5-dinitrosalicil acid (DNS).
For the characterisation in the feed of:
—
endo-1,3(4)-beta-glucanase activity: colorimetric method measuring depolymerised soluble fragments released by the action of endo-1,3(4)-beta-glucanase on azo-barley-glucan;
—
endo-1,4-beta-xylanase activity: colorimetric method measuring depolymerised soluble fragments released by the action of endo-1,4-beta-xylanase on azo-xylan.
Chickens for fattening
Laying hens
Pigs for fattening
Minor poultry species
Minor porcine species for fattening
—
Endo-1,3(4)-beta-glucanase 138 U
Endo-1,4-beta-xylanase
200 U
—
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 potential risks resulting from their 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 skin, eyes and breathing protections.
7.11.2027
( 1 ) 1 U (unit) endo-1,3(4)-beta-glucanase is the amount of enzyme which liberates 1 μmole of reducing sugar (glucose equivalents) from oat beta-glucan per minute at 30 °C and pH 4.
( 2 ) 1 U (unit) endo-1,4-beta-xylanase is the amount of enzyme which liberates 1 μmole of reducing sugar (xylose equivalents) from oat xylan per minute at 30 °C and pH 4.
( 3 ) 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