Commission Implementing Regulation (EU) 2023/669 of 22 March 2023 concerning the authorisation of a preparation of endo-1,4-beta-xylanase produced by Komagataella phaffii DSM 33574 as a feed additive for all poultry species for fattening and all poultry species reared for laying and reared for breeding (holder of authorisation: BioResource, international, Inc. represented in the Union by Pen & Tec Consulting, S.L.U.) (Text with EEA relevance)

• CELEX: Implementing Regulation (EU) 2023/669
• 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

4a35

BioResource International, Inc. represented in the Union by Pen &

Tec Consulting, S.L.U.

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 DSM 33574 with a minimum activity of:

150 000 XU  ( 1 ) /g

Solid form

Characterisation of the active substance

Endo-1,4-beta-xylanase (EC 3.2.1.8) produced by Komagataella phaffii (DSM 33574)

Analytical method

( 2 )

For the determination of endo-1,4-beta-xylanase activity in the feed additive: colorimetric (DNS) method based on the enzymatic hydrolysis of the beechwood xylan substrate.

For the determination of endo-1,4-beta-xylanase activity in compound feed: colorimetric method based on the enzymatic reaction of endo-1,4-beta-xylanase on the Xy1X6 substrate.

All poultry species for fattening

All poultry species reared for laying or reared for breeding purposes

—

10 000 XU

—

1.

The additive shall not be used in premixtures.

2.

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

3.

For users of the additive, 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 shall be used with personal protective equipment, including breathing, skin and eyes protection.

13.4.2033

( 1 )   One XU unit is the amount of enzyme which releases 1 nano-mol of reducing sugar (xylose equivalent) per second from xylan of beechwood at 50 °C and pH 6,0.

( 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