Commission Implementing Regulation (EU) 2018/1569 of 18 October 2018 amending Implementing Regulation (EU) No 1110/2011 concerning the authorisation of an enzyme preparation of endo-1,4-beta-xylanase produced by Trichoderma reesei (CBS 114044) as a feed additive for laying hens, minor poultry species and pigs for fattening (holder of authorisation Roal Oy) (Text with EEA relevance.)

• CELEX: Implementing Regulation (EU) 2018/1569
• Articles: 3

Article 1

The Annex to Implementing Regulation (EU) No 1110/2011 is replaced by the text set out in the Annex to this Regulation.

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

‘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.

4a8

Roal Oy

Endo-1,4-beta-xylanase

EC 3.2.1.8

Additive composition

Preparation of endo-1,4-beta-xylanase produced by Trichoderma reesei (CBS 114044) having a minimum activity of:

solid form: 4 × 10 6 BXU  ( 1 ) /g

liquid form: 4 × 10 5 BXU/g

Characterisation of the active substance

endo-1,4-beta-xylanase produced by Trichoderma reesei (CBS 114044)

Analytical method

( 2 )

In the additive and the premixture: reducing sugar assay for endo-1,4- beta-xylanase by colorimetric reaction of dinitrosalicylic acid reagent on reducing sugar yield at pH 5,3 and 50 °C

In the feedingstuffs: colorimetric method measuring water soluble dye released by the enzyme from azurine crosslinked wheat arabinoxylan substrate

Minor poultry species other than laying birds

—

8 000 BXU

—

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 to 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 personal protective equipment.

24 November 2021

Laying hens

12 000 BXU

Laying birds of minor poultry species

24 000 BXU

Pigs for fattening

20 000 BXU

’

( 1 )   1 BXU is the amount of enzyme which liberates 1 nmol reducing sugars as xylose from birch xylan per second at pH 5,3 and 50 °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