02011R1068 — EN — 23.06.2017 — 001.001


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COMMISSION IMPLEMENTING REGULATION (EU) No 1068/2011

of 21 October 2011

concerning the authorisation of an enzyme preparation of endo-1,4-beta-xylanase produced by Aspergillus niger (CBS 109.713) and endo-1,4-beta-glucanase produced by Aspergillus niger (DSM 18404) as a feed additive for chickens reared for laying, turkeys for breeding purposes, turkeys reared for breeding, other minor avian species (other than ducks for fattening) and ornamental birds (holder of authorisation BASF SE)

(Text with EEA relevance)

(OJ L 277 22.10.2011, p. 11)

Amended by:

 

 

Official Journal

  No

page

date

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COMMISSION IMPLEMENTING REGULATION (EU) 2017/950 of 2 June 2017

  L 143

5

3.6.2017




▼B

COMMISSION IMPLEMENTING REGULATION (EU) No 1068/2011

of 21 October 2011

concerning the authorisation of an enzyme preparation of endo-1,4-beta-xylanase produced by Aspergillus niger (CBS 109.713) and endo-1,4-beta-glucanase produced by Aspergillus niger (DSM 18404) as a feed additive for chickens reared for laying, turkeys for breeding purposes, turkeys reared for breeding, other minor avian species (other than ducks for fattening) and ornamental birds (holder of authorisation BASF SE)

(Text with EEA relevance)



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 20th day following 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.

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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

Endo-1,4-beta-glucanase

EC 3.2.1.4

Additive composition

Preparation of endo-1,4-beta-xylanase produced by Aspergillus niger (CBS 109.713) and endo-1,4-beta-glucanase produced by Aspergillus niger (DSM 18404) having a minimum activity of:

Solid form:

5 600 TXU (1) and 2 500 TGU (2)/g

Liquid form:

5 600 TXU and 2 500 TGU/g

Characterisation of the active substance

endo-1,4-beta-xylanase produced by Aspergillus niger (CBS 109.713) and endo-1,4-beta-glucanase produced by Aspergillus niger (DSM 18404)

Analytical method (3)

For quantification of endo-1,4-beta-xylanase activity:

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 activity:

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.

Minor poultry species for fattening (other than ducks for fattening) and ornamental birds

—

280 TXU

125 TGU

—

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

2.  Recommended doses per kilogram of complete feedingstuffs:

— minor poultry species for fattening (other than ducks) and ornamental birds: 280-840 TXU/125- 375 TGU,

— chickens reared for laying, and all minor avian species for laying: 280-840 TXU/125- 375 TGU,

— turkeys for breeding purposes, turkeys reared for breeding: 560-840 TXU/250-375 TGU.

3.  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 protection and skin protection.

11.11.2021

Chickens reared for laying, and all minor avian species for laying

280 TXU

125 TGU

Turkeys for breeding purposes and turkeys reared for breeding

560 TXU

250 TGU

(1)   1 TXU is the amount of enzyme which liberates 5 micromole of reducing sugars (xylose equivalents) from wheat arabinoxylan per minute at pH 3,5 and 55 °C.

(2)   1 TGU is the amount of enzyme which liberates 1 micromole of reducing sugars (glucose equivalents) from barley ß-glucan 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