
Article 1 
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.
Article 2 
This Regulation shall enter into force on the twentieth day following that of its publication in the Official Journal of the European Union.
This Regulation shall be binding in its entirety and directly applicable in all Member States.Done at Brussels, 16 December 2020.
For the Commission
The President
Ursula VON DER LEYEN
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.
4a32 Huvepharma EOOD 6-phytase (EC 3.1.3.26) Additive compositionPreparation 6-phytase (EC 3.1.3.26) produced by Komagataella phaffii (DSM 32854) with a minimum activity of5 000 FTU/g in granular form5 000 FTU/g in coated form5 000 FTU/g in liquid form 
— all poultry species
— ornamental birds
— piglets
— pigs for fattening
— sows
— minor porcine species for fattening or reproduction - 250 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 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 protective equipment, including breathing, eye and skin protections.
 6.1.2031
Characterisation of the active substance6-phytase (EC 3.1.3.26) produced by fermentation with Komagataella phaffii DSM 32854
Analytical methodFor the quantification of phytase activity in the feed additive:
— colorimetric method based on the enzymatic reaction of phytase on the phytate – VDLUFA 27.1.4
— For the quantification of phytase activity in premixtures:
— colorimetric method based on the enzymatic reaction of phytase on the phytate -VDLUFA 27.1.3
— For the quantification of phytase activity in feed materials and compound feed:
— colorimetric method based on the enzymatic reaction of phytase on the phytate – EN ISO 30024

