Commission Implementing Regulation (EU) 2021/1413 of 27 August 2021 concerning the authorisation of endo-1,4-beta-xylanase produced by Bacillus subtilis LMG-S 15136 as a feed additive for lactating sows (holder of the authorisation Beldem, division of Puratos NV) (Text with EEA relevance)

• CELEX: Implementing Regulation (EU) 2021/1413
• 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 feed with a moisture content of 12 %

Category: zootechnical additives. Functional group: digestibility enhancers.

4a1606i

Beldem, division of Puratos NV

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

Additive composition:

Preparation of endo-1,4-beta-xylanase (EC 3.2.1.8) produced by Bacillus subtilis LMG-S 15136 having a minimum activity of 400 IU   ( 1 ) /g.

Solid and liquid form.

Lactating sows

-

10 IU

-

1.

In the directions for use of the additive and premixture, 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 by inhalation, dermal contact or eyes 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 personal protective equipment, including eyes, skin and breathing protection.

19.9.2031

Characterisation of the active substance:

Endo-1,4-beta-xylanase (EC 3.2.1.8) produced by Bacillus subtilis LMG-S 15136.

Analytical method   ( 2 )

For the quantification of xylanase activity in the feed additive:

—

colorimetric method measuring reducing sugars released by action of xylanase on birchwood xylan substrate in the presence of 3,5-dinitrosalicilic acid (DNS).

For the quantification of xylanase activity in premixtures, compound feed and feed materials:

—

colorimetric method measuring water soluble dye released by action of xylanase from azurine cross-linked wheat arabinoxylan substrates.

( 1 )   1 IU corresponds to the amount of enzyme which liberates one micromole of reducing sugars (xylose equivalents) from birchwood xylan per minute 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