Commission Implementing Regulation (EU) 2020/2121 of 16 December 2020 concerning the authorisation of a preparation of 6-phytase produced by Komagataella phaffii DSM 32854 as a feed additive for all poultry species, ornamental birds, piglets, pigs for fattening, sows and minor porcine species for fattening or reproduction (holder of authorisation: Huvepharma EOOD) (Text with EEA relevance)

• CELEX: Implementing Regulation (EU) 2020/2121
• Articles: 3

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.

Schedules & Appendices

ANNEX

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 composition

Preparation 6-phytase (EC 3.1.3.26) produced by Komagataella phaffii (DSM 32854) with a minimum activity of

5 000 FTU  ( 1 ) /g in granular form

5 000 FTU/g in coated form

5 000 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 substance

6-phytase (EC 3.1.3.26) produced by fermentation with Komagataella phaffii DSM 32854

Analytical method

( 2 )

For 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

( 1 )   1 FTU is the amount of enzyme that releases 1 micromole of inorganic phosphate from sodium phytate per minute under reaction conditions of pH 5,5 and 37 °C

( 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