Commission Implementing Regulation (EU) 2021/329 of 24 February 2021 concerning the renewal of the authorisation of a preparation of endo-1,4-beta-xylanase and endo-1,3(4)-beta-glucanase for chickens for fattening (holder of the authorisation: AVEVE NV), and repealing Regulation (EC) No 1091/2009 (Text with EEA relevance)

• CELEX: Implementing Regulation (EU) 2021/329
• Articles: 5

Article 1

The authorisation of the preparation of endo-1,4-beta-xylanase produced by Trichoderma longibrachiatum (formerly identified as Trichoderma reesei ) MUCL 49755 and endo-1,3(4)-beta-glucanase produced by Trichoderma longibrachiatum (formerly identified as Trichoderma reesei ) MUCL 49754, belonging to the additive category ‘zootechnical additives’ and to the functional group ‘digestibility enhancers’ is renewed subject to the conditions laid down in the Annex.

Article 2

1.   The preparation of endo-1,4-beta-xylanase produced by Trichoderma longibrachiatum (formerly identified as Trichoderma reesei ) MUCL 49755 and endo-1,3(4)-beta-glucanase produced by Trichoderma longibrachiatum (formerly identified as Trichoderma reesei ) MUCL 49754 and premixtures containing it, which are produced and labelled before 17 September 2021 in accordance with the rules applicable before 17 March 2021 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 point 1, which are produced and labelled before 17 March 2022 in accordance with the rules applicable before 17 March 2021 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

Regulation (EC) No 1091/2009 is repealed.

Article 4

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.

4a9

Aveve NV

Endo-1,4-beta-xylanase (EC 3.2.1.8) and Endo-1,3(4)-beta-glucanase (EC 3.2.1.6)

Additive composition:

Preparation of endo-1,4-beta-xylanase (EC 3.2.1.8) and endo-1,3(4)-beta-glucanase (EC 3.2.1.6) having a minimum activity of 40 000 XU  ( 1 ) /g and 9 000 BGU  ( 2 ) /g in solid and liquid form

Chickens for fattening

-

3 000 XU 675 BGU

-

1.

In the directions for use of the additive and premixture, indicate the storage temperature, storage life, and stability to heat treatment.

2.

For use in feed rich in starch and non-starch polysaccharides (mainly beta-glucans and arabinoxylans).

3.

For users of the additive and premixtures, feed business operators shall establish operational procedures and organisational measures to address potential risks by inhalation and dermal contact. 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 protection and gloves.

17.3.2031

Characterisation of the active substances:

Endo-1,4-beta-xylanase (EC 3.2.1.8) produced by Trichoderma longibrachiatum MUCL 49755 and endo-1,3(4)-beta-glucanase (EC 3.2.1.6) produced by Trichoderma longibrachiatum MUCL 49754

Analytical method

( 3 )

Characterisation of the active substance in the additive:

—

colorimetric method based on reaction of dinitrosalicylic acid on reducing sugar produced by action of endo-1,4-beta-xylanase on a xylan containing substrate;

—

colorimetric method based on reaction of dinitrosalicylic acid on reducing sugar produced by action of endo-1,3(4)-beta-glucanase on a β-glucan containing substrate.

Characterisation of the active substances in the feed

—

colorimetric method measuring water soluble dye released by action of endo-1,4-beta-xylanase from dye cross-linked wheat arabinoxylan substrate;

—

colorimetric method measuring water soluble dye released by action of endo-1,3(4)-beta-glucanase from dye cross-linked barley betaglucan substrate.

( 1 )   1 XU is the amount of enzyme which liberates 1 micromole of reducing sugars (xylose equivalents) per minute from xylan of oat spelt at pH 4,8 and 50 °C.

( 2 )   1 BGU is the amount of enzyme which liberates 1 micromole of reducing sugars (cellobiose equivalents) per minute from ß-glucan of barley at pH 5,0 and 50 °C.

( 3 )   Details of the analytical methods are available at the following address of the Reference Laboratory: http://irmm.jrc.ec.europa.eu/EURLs/EURL_feed_additives/Pages/index.aspx