Commission Implementing Regulation (EU) 2020/1377 of 1 October 2020 concerning the authorisation of a preparation of endo-1,4-beta-xylanase produced by Bacillus subtilis (LMG S-15136) as a feed additive for suckling piglets, all minor porcine species other than reproductive animals (holder of authorisation Beldem, a division of Puratos NV) (Text with EEA relevance)

• CELEX: Implementing Regulation (EU) 2020/1377
• 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

Unit of activity/kg of complete feedingstuff with a moisture content of 12 %

Category of zootechnical additives. Functional group: digestibility enhancers

4a1606i

Beldem a division of Puratos NV

Endo-1,4-beta-xylanase

EC 3.2.1.8

Additive composition:

Preparation of endo-1,4-beta-xylanase

produced by Bacillus subtilis LMG S-15136 having a minimum activity of: 400 IU  ( 1 ) /g

Solid form and liquid form

Suckling piglets

Minor porcine specis other than reproductive animals

-

10 IU

-

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 its 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 breathing and skin protection.

22.10.2030

Characterisation of the active substance:

Endo-1,4-beta-xylanase

produced by Bacillus subtilis LMG S-15136

Analytical method

( 2 )

For the quantification of endo-1,4-beta-xylanase activity in the feed additive:

—

colorimetric method measuring reducing sugars

released by action of endo-

1,4-beta-xylanase on birchwood xylan substrate in the presence of 3,5-dinitrosalicylic acid (DNS).

For the quantification of endo-1,4-beta-xylanase activity in premixtures and feedingstuffs:

—

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

( 1 )   One IU is the amount of enzyme which liberates one micromole of reducing sugars (xylose equivalent) per minute from birchwood xylan at pH 4,5 and 30 °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