Commission Implementing Regulation (EU) 2024/2180 of 2 September 2024 concerning the authorisation of a preparation of endo-1,4-beta-xylanase, endo-1,4-beta-glucanase and xyloglucan-specific-endo-beta-1,4-glucanase produced with Trichoderma citrinoviride DSM 33578 as a feed additive for sows of all Suidae species (holder of authorisation: Huvepharma EOOD)

• CELEX: Implementing Regulation (EU) 2024/2180
• Articles: 3

Article 1 Authorisation

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 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 feed 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: zootechnical additives. Functional group: digestibility enhancers

4a39

Huvepharma EOOD

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

Endo-1,4-beta-glucanase (EC 3.2.1.4) Xyloglucan-specific-endo-beta-1,4-glucanase (EC 3.2.1.151)

Additive composition

Preparation of endo-1,4-beta-xylanase, endo-1,4-beta-glucanase and xyloglucan-specific-endo-beta-1,4-glucanase produced with Trichoderma citrinoviride DSM 33578 having a minimum activity of:

Endo-1,4-beta-xylanase: 15 000 EPU  ( 1 ) /g,

Endo-1, 4-beta-glucanase: 1 000 CU  ( 2 ) /g,

Xyloglucan-specific endo- beta-1,4-glucanase: 1 000 XGU  ( 3 ) /g.

Granulated or liquid form.

Characterisation of the active substance

Endo-1,4-beta-xylanase (EC 3.2.1.8), endo-1,4-beta-glucanase (EC 3.2.1.4) and xyloglucan-specific-endo-beta-1,4-glucanase (EC 3.2.1.151) produced with Trichoderma citrinoviride DSM 33578

Analytical method

( 4 )

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

—

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

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

—

colorimetric method based on the quantification of water soluble dyed fragments (azurine) produced by the action of endo-1,4-beta-glucanase on azurine-crosslinked cellulose.

For the determination of xyloglucan-specific-endo-beta-1,4-glucanase activity in the feed additive, premixtures and compound feed:

—

colorimetric method based on the quantification of soluble dyed labelled fragments produced by the action of xyloglucan-specific-endo-beta-1,4-glucanase on xyloglucan substrate.

Sows of all Suidae species

-

Endo-1,4-beta-xylanase 1 500 EPU

Endo-1, 4-beta- glucanase 100 CU

Xyloglucan- specific endo- beta-1,4-glucanase 100 XGU

-

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 the 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 breathing and skin protective equipment.

23 September 2034

( 1 )   One EPU unit is the amount of enzyme which liberates 0,0083 micromoles of reducing sugars (xylose equivalents) from oat spelt xylan per minute at pH 4,7 and 50 °C.

( 2 )   One CU unit is the amount of enzyme that liberates 0,128 micromoles of reducing sugars (glucose equivalents) from barley beta-glucan per minute at pH 4,5 and 30 °C.

( 3 )   One XGU unit is the amount of enzyme that releases low-molecular fragments from dyed xyloglucan in amount equal to the amount of such fragments liberated from 1 unit enzyme standard under the conditions of the assay (50 °C and pH 4,5).

( 4 )   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 .