Address https://gelex.eu/eli/EU/regulation/2017/950@2017-06-02/en

Contents

1. Preamble
2. 1. Article 1
   2. Article 2
3. ANNEX
4. ANNEX

THE EUROPEAN COMMISSION,

Having regard to the Treaty on the Functioning of the European Union,

Having regard to Regulation (EC) No 1831/2003 of the European Parliament and of the Council of 22 September 2003 on additives for use in animal nutrition, and in particular Article 13(3) thereof,

Whereas:

(1) Regulation (EC) No 1831/2003 provides for the authorisation of additives for use in animal nutrition and for the grounds and procedures for granting such authorisation.

(2) The use of the 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) was authorised for 10 years 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 by Commission Implementing Regulation (EU) No 1068/2011.

(3) In accordance with Article 13(3) of Regulation (EC) No 1831/2003, the holder of the authorisation has proposed changing the terms of the authorisation of that preparation by reducing its minimum content from 560 TXU/kg to 280 TXU/kg and from 250 TGU/kg to 125 TGU/kg of the complete feedingstuff as regards the use on chickens reared for laying, and all avian species for laying. The application was accompanied by the relevant supporting data. The Commission forwarded that application to the European Food Safety Authority (the Authority).

(4) The Authority concluded in its opinion of 20 October 2016 that, under the new proposed conditions of use, the 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) has the potential to be efficacious at the requested minimum doses of 280 TXU/kg and 125 TGU/kg of complete feedingstuff on chickens reared for laying, and all avian species for laying. The Authority does not consider that there is a need for specific requirements of post-market monitoring. It also verified the report on the method of analysis of the feed additive in feed submitted by the Reference Laboratory set up by Regulation (EC) No 1831/2003.

(5) The assessment of the 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) shows that the conditions for authorisation, as provided for in Article 5 of Regulation (EC) No 1831/2003 are satisfied.

(6) Implementing Regulation (EU) No 1068/2011 should therefore be amended accordingly.

(7) The measures provided for in this Regulation are in accordance with the opinion of the Standing Committee on Plants, Animals, Food and Feed,

HAS ADOPTED THIS REGULATION:

Article 1

The Annex to Implementing Regulation (EU) No 1068/2011 is replaced by the Annex to this Regulation.

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.

This Regulation shall be binding in its entirety and directly applicable in all Member States. Done at Brussels, 2 June 2017. For the Commission The President Jean-Claude Juncker

ANNEX

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 Endo-1,4-beta-glucanase EC 3.2.1.4 Minor poultry species for fattening (other than ducks for fattening) and ornamental birds — 280 TXU 125 TGU — 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

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: 5600 TXU and 2500 TGU/g

Liquid form: 5600 TXU and 2500 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

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.

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.

Versions

1. 2017-06-02