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 feed 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: zootechnical additives. Functional group: digestibility enhancers
4a46
Nutrex N.V.
6-phytase (EC 3.1.3.26)
Additive composition
Preparation of 6-phytase (EC 3.1.3.26) produced by Komagataella phaffii CGMCC 7.19 having a minimum activity of:
Powder form: 100 000 FTU ( 1 ) /g.
Granulate form: 10 000 FTU/g
Thermostable granulate form: 10 000 FTU/g
Liquid form: 10 000 FTU/mL
Characterisation of the active substance
6-phytase (EC 3.1.3.26) produced by Komagataella phaffii CGMCC 7.19.
Analytical method
( 2 )
For the quantification of 6-phytase activity in the feed additive:
—
colorimetric method based on the enzymatic reaction of phytase on phytate – VDLUFA 27.1.4.
For the quantification of 6-phytase activity in premixtures:
—
colorimetric method based on the enzymatic reaction of phytase on phytate – VDLUFA 27.1.3.
For the quantification of 6-phytase activity in compound feed:
—
colorimetric method based on the enzymatic reaction of phytase on phytate – EN ISO 30024.
All poultry species for fattening
All poultry species reared for laying
Ornamental birds
—
500 FTU
—
1.
In the directions for use of the additive and premixture, 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 and skin protective equipment.
1 May 2034
( 1 ) One phytase unit (FTU) is the amount of enzyme that releases 1 μmol of inorganic phosphate from phytate per minute at pH 5,5 and 37 °C.
( 2 ) 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