Commission Implementing Regulation (EU) 2016/899 of 8 June 2016 concerning the authorisation of a 6-phytase produced by Trichoderma reesei (ATCC SD-6528) as a feed additive for all poultry species and all porcine species (other than suckling piglets) (holder of authorisation Danisco (UK) Ltd) (Text with EEA relevance)

• CELEX: Implementing Regulation (EU) 2016/899
• 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 active substance/kg of complete feedingstuff with a moisture content of 12 %

Category: Zootechnical additives. Functional group: digestibility enhancers.

4a24

Danisco (UK) Ltd

6-phytase EC 3.1.3.26

Additive composition

Preparation of 6-phytase produced by Trichoderma reesei (ATCC SD-6528) having a minimum activity of 15 000 U  ( 1 ) /g.

Liquid form

Characterisation of the active substance

6-phytase (EC 3.1.3.26) produced by Trichoderma reesei (ATCC SD-6528)

Analytical method

( 2 )

For the quantification of 6-phytase activity in the feed additive:

—

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

For the quantification of 6-phytase activity in premixtures and feedingstuffs:

—

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

All poultry species

All porcine species (other than suckling piglets)

—

250 U

—

1.

In the directions for use of the additive and premixture the storage conditions and stability to pelleting shall be indicated.

2.

Maximum recommended dose: 2 000 U/kg feed.

3.

For users of the additive and premixtures in a feed business, operational procedures and appropriate organisational measures shall be established to address hazards by inhalation, dermal contact or eye contact. Where the dermal, inhalator or eye exposure cannot be reduced to an acceptable level by these procedures and measures, the additive and premixtures shall be used with appropriate personal protective equipment.

29 June 2026

( 1 )   1 U 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