Commission Implementing Regulation (EU) 2020/1371 of 1 October 2020 concerning the authorisation of a preparation of endo-1,4-beta-xylanase and endo-1,4-beta-glucanase as a feed additive for lactating sows (holder of the authorisation BASF SE) (Text with EEA relevance)

• CELEX: Implementing Regulation (EU) 2020/1371
• 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.

4a7

BASF SE

Endo-1,4-beta- xylanase (EC 3.2.1.8) and endo-1,4-beta- glucanase (EC 3.2.1.4)

Additive composition

Preparation of endo-1,4-beta-xylanase (EC 3.2.1.8) produced by Aspergillus niger CBS 109.713 and endo-1,4-beta-glucanase (EC 3.2.1.4) produced by Aspergillus niger DSM 18 404 having a minimum activity of 5 600 TXU  ( 1 ) and 2 500 TGU  ( 2 ) /g in solid or liquid form

Lactating sows

-

560 TXU 250 TGU

-

1.

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

22 October 2030

Characterisation of active substance

Endo-1,4-beta-xylanase (EC 3.2.1.8) produced by Aspergillus niger CBS 109.713 and endo-1,4-beta- glucanase (EC 3.2.1.4) produced by Aspergillus niger DSM 18 404

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 or reduced to a minimum by such procedures and measures, the additive and premixtures shall be used with personal protective equipment, including skin, eyes and breathing protection.

Analytical method

( 3 )

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

Viscosimetric method based on decrease of viscosity produced by action of endo-1,4-beta- xylanase on the xylan containing substrate (wheat arabinoxylan) at pH = 3,5 and 55 °C.

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

Viscosimetric method based on decrease of viscosity produced by action of endo-1,4-beta- glucanase on the glucan containing substrate (barley betaglucan) at pH = 3,5 and 40 °C.

( 1 )   One TXU is defined as the amount of enzyme that liberates 5 μmol of reducing sugars (xylose equivalents) from wheat arabinoxylan per minute at pH = 3,5 and 55 °C.

( 2 )   One TGU is defined as the amount of enzyme that liberates 1 μmol of reducing sugars (glucose equivalents) from barley betaglucan per minute at pH = 3,5 and 40 °C.

( 3 )   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