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
4a48
Novozymes A/S
6-phytase (EC 3.1.3.26)
Additive composition
Preparation of 6-phytase (EC 3.1.3.26) produced with
Aspergillus oryzae DSM 33737 having a minimum activity of:
Solid form: 10 000 FYT ( 1 ) /g.
Liquid form: 20 000 FYT/g.
Characterisation of the active substance
6-phytase (EC 3.1.3.26) produced with Aspergillus oryzae DSM 33737
Analytical method
( 2 )
For the quantification of phytase activity in the feed additive, premixtures and compound feed:
—
colorimetric method based on the enzymatic reaction of phytase on the phytate
—
EN ISO 30024.
Poultry for laying or reproduction
-
200 FYT
-
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 eye (only for the two solid formulations), breathing and skin protective equipment.
28 May 2036
Piglets of porcine species
Porcine species for fattening
Porcine species reared for reproduction
200 FYT
( 1 ) One phytase unit (FYT) is the amount of enzyme that liberates 1 μmol of inorganic phosphate per minute from sodium phytate at 37 °C, pH 5,5
( 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