Commission Implementing Regulation (EU) 2023/1332 of 29 June 2023 concerning the renewal of the authorisation of a preparation of endo-1,4-beta-xylanase produced by Trichoderma reesei CBS 114044 as a feed additive for chickens for fattening, chickens reared for laying, turkeys for fattening, turkeys reared for breeding and weaned piglets (holder of the authorisation: Roal Oy), and repealing Regulation (EC) No 902/2009 (Text with EEA relevance)

• CELEX: Implementing Regulation (EU) 2023/1332
• Articles: 5

Article 1 Renewal of the authorisation

The authorisation of the preparation specified in the Annex, belonging to the additive category ‘zootechnical additives’ and to the functional group ‘digestibility enhancers’, is renewed subject to the conditions laid down in that Annex.

Article 2 Transitional measures

1.   The preparation of endo-1,4-beta-xylanase produced by Trichoderma reesei CBS 114044 and premixtures containing it, which are produced and labelled before 20 January 2024 in accordance with the rules applicable before 20 July 2023 may continue to be placed on the market and used until the existing stocks are exhausted.

2.   Feed materials and compound feed containing the preparation referred to in paragraph 1, which are produced and labelled before 20 July 2024 in accordance with the rules applicable before 20 July 2023 may continue to be placed on the market and used until the existing stocks are exhausted, where they are intended for food-producing animals.

Article 3 Repeal of Regulation (EC) No 902/2009

Regulation (EC) No 902/2009 repealed.

Article 4 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 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 feed with a moisture content of 12 %

Category of zootechnical additives. Functional group: digestibility enhancers.

4a8i

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: 160 000 BXU  ( 1 ) /g

liquid form: 160 000 BXU/g

Characterisation of the active substance

Endo-1,4-beta-xylanase (EC 3.2.1.8) produced by Trichoderma reesei CBS 114044

Analytical method

( 2 )

Characterisation of the active substance 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;

Characterisation of the active substance in the compound feed: colorimetric method measuring water soluble dye released by the enzyme from azurine crosslinked wheat arabinoxylan substrate.

Chickens for fattening and chickens reared for laying

-

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 resulting from their use. Where those risks cannot be eliminated by such procedures and measures, the additive and premixtures shall be used with personal protective equipment, including breathing, skin and eye protection for solid forms, and breathing protection for liquid forms.

20 July 2033

Turkeys for fattening and turkeys reared for breeding

16 000 BXU

Piglets (weaned)

24 000 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