This Regulation shall enter into force on the twentieth day following that of its publication in the

Official Journal of the European Union.

This Regulation shall be binding in its entirety and directly applicable in all Member States.

Done at Brussels, 27 August 2021.

For the Commission

The President

Ursula VON DER LEYEN

(1)

OJ L 268, 18.10.2003, p. 29

(2) EFSA Journal 2019;17(11):5892.

(3) EFSA Journal 2021;19(3):6456.

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.

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.