Commission Implementing Regulation (EU) 2017/895 of 24 May 2017 concerning the authorisation of a preparation of 3-phytase produced by Komagataella pastoris (CECT 13094) as a feed additive for chickens for fattening and laying hens (holder of authorisation Fertinagro Nutrientes S.L.) (Text with EEA relevance. )

• CELEX: Implementing Regulation (EU) 2017/895
• 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

4a25

Fertinagro Nutrientes S.L.

3-phytase

EC 3.1.3.8

Additive composition

Preparation of 3-phytase produced by Komagataella pastoris (CECT 13094) having a minimum activity of: 1 000 FTU  ( 1 ) /ml

Liquid form

Characterisation of the active substance

3-phytase (EC 3.1.3.8) produced by Komagataella pastoris (CECT 13094)

Analytical method

( 2 )

For the quantification of 3-phytase activity in the feed additive:

—

colorimetric method based on the enzymatic reaction of phytase on the phytate

For the quantification of 3-phytase activity in feedingstuffs:

—

colorimetric method based on the enzymatic reaction of phytase on the phytate — EN ISO 30024

Chickens for fattening

—

500 FTU

—

1.

In the directions for use of the additive and premixtures, the storage conditions and stability to heat treatment shall be indicated.

2.

Recommended maximum dose for chickens for fattening and laying hens: 1 000 FTU/kg complete feed.

3.

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.

14 June 2027

Laying hens

1 000 FTU

( 1 )   1 FTU is the amount of enzyme which liberates 1 micromole of inorganic phosphate per minute from a sodium phytate substrate 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