Commission Implementing Regulation (EU) 2020/1799 of 30 November 2020 concerning the authorisation of a preparation of 6-phytase produced by Komagataella phaffii CGMCC 12056 as a feed additive for laying hens and other laying birds (holder of authorisation: Andrés Pintaluba S.A.) (Text with EEA relevance)

• CELEX: Implementing Regulation (EU) 2020/1799
• 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

Unit of activity/kg of complete feedingstuff with a moisture content of 12 %

Category of zootechnical additives. Functional group: digestibility enhancers

4a31

Andrés Pintaluba S.A.

6-phytase

(EC 3.1.3.26)

Additive composition

Preparation of 6-phytase (EC 3.1.3.26)

produced by Komagataella phaffii (CGMCC 12056) having a minimum activity of:

Solid form: 20 000 U  ( 1 ) /g

Liquid form: 20 000 U/ml

laying hens and other laying birds

-

300 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 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 personal protective equipment, including breathing protection.

21.12.2030

Characterisation of the active substance

6-phytase (EC 3.1.3.26) produced by fermentation with Komagataella phaffii CGMCC 12056

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 )   One unit is the amount of enzyme which releases one micromole 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://ec.europa.eu/jrc/en/eurl/feed-additives/evaluation-reports