Commission Implementing Regulation (EU) 2025/1392 of 15 July 2025 concerning the authorisation of a preparation of 3-phytase produced with Komagataella phaffii CECT 13171 as a feed additive for poultry species for fattening or reared for laying or for breeding, minor poultry species for breeding, laying hens and pigs for fattening of all Suidae species (holder of authorisation: Fertinagro Biotech S.L.)

• CELEX: Implementing Regulation (EU) 2025/1392
• Articles: 3

Article 1 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.

Article 2 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.

Schedules & Appendices

ANNEX

ANNEX

Identification number of the feed 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: zootechnical additives. Functional group: digestibility enhancers.

4a50

Fertinagro Biotech S.L.

3-phytase

(EC 3.1.3.8)

Additive composition

Preparation of 3-phytase produced with Komagataella phaffii CECT 13171 having a minimum activity of:

Solid form: 10 000 FTU  ( 1 ) /g

Liquid form: 1 000 FTU/mL.

Characterisation of the active substance

3-phytase produced with Komagataella phaffii CECT 13171.

Analytical method

( 2 )

For the quantification of 3-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 species for fattening or reared for laying or for breeding

Minor poultry species for breeding

Pigs for fattening of all Suidae species

—

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.

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 breathing and skin protective equipment.

5 August 2035

Laying hens

1 000 FTU

( 1 )   1 FTU is the amount of enzyme that releases 1 μmol of inorganic phosphate from sodium phytate per minute at 37 °C and 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 .