Commission Implementing Regulation (EU) 2023/668 of 22 March 2023 concerning the authorisation of a preparation of endo-1,4-beta-xylanase produced by Komagataella phaffii ATCC PTA-127053 as a feed additive for all laying poultry (holder of authorisation: Kemin Europa N.V.) (Text with EEA relevance)

• CELEX: Implementing Regulation (EU) 2023/668
• 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

4a36

Kemin Europa N.V.

Endo-1,4-beta-xylanase (EC 3.2.1.8)

Additive composition

Preparation of endo-1,4-beta-xylanase (EC 3.2.1.8) produced by Komagataella phaffii ATCC PTA-127053 with a minimum activity of:

3 000 000 U  ( 1 ) /g

Solid form

Characterisation of the active substance

Endo-1,4-beta-xylanase (EC 3.2.1.8) produced by Komagataella phaffii ATCC PTA-127053

Analytical method

( 2 )

For the determination of endo-1,4-beta-xylanase in the feed additive:

—

colorimetric method based on the enzymatic hydrolysis of endo-1,4-beta-xylanase on the beechwood xylan substrate.

For the determination of endo-1,4-beta-xylanase in premixtures and compound feed:

—

colorimetric method based the enzymatic reaction of endo-1,4-beta-xylanase on the azurine cross-linked wheat arabinoxylan substrate.

All laying poultry

—

45 000 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 their 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 appropriate personal protective equipment, including breathing and skin protection.

13.4.2033

( 1 )   One U unit is the amount of enzyme that releases 0,0067 μmol of reducing sugar (xylose equivalent) per minute and per gram of enzyme product at 50 °C and pH 5,3.

( 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