# L_2014295EN.01004901.xml

| 11.10.2014 | EN | Official Journal of the European Union | L 295/49 |
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11.10.2014

EN

Official Journal of the European Union

L 295/49

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COMMISSION IMPLEMENTING REGULATION (EU) No 1070/2014

of 10 October 2014

amending Regulation (EC) No 271/2009 as regards the minimum content 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) as a feed additive for laying hens (holder of authorisation BASF SE)

(Text with EEA relevance)

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 (1), 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. |
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(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 weaned piglets, chickens for fattening, laying hens, turkeys for fattening and ducks for fattening by Commission Regulation (EC) No 271/2009 (2), 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) and for pigs for fattening by Commission Implementing Regulation (EU) No 1404/2013 (4). |
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(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 weaned piglets, chickens for fattening, laying hens, turkeys for fattening and ducks for fattening by Commission Regulation (EC) No 271/2009 (2), 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) and for pigs for fattening by Commission Implementing Regulation (EU) No 1404/2013 (4).

| (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 laying hens. The application was accompanied by the relevant supporting data. The Commission forwarded that application to the European Food Safety Authority (hereinafter ‘the Authority’). |
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(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 laying hens. The application was accompanied by the relevant supporting data. The Commission forwarded that application to the European Food Safety Authority (hereinafter ‘the Authority’).

| (4) | The Authority concluded in its opinion of 20 May 2014 (5) 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 laying hens. 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. |
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(4)

The Authority concluded in its opinion of 20 May 2014 (5) 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 laying hens. 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. |
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(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) | Regulation (EC) No 271/2009 should therefore be amended accordingly. |
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(6)

Regulation (EC) No 271/2009 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, |
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(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

In the Annex to Regulation (EC) No 271/2009, in the column ‘Minimum content’ corresponding to the entry for laying hens, ‘560 TXU’ is replaced by ‘280 TXU’ and ‘250 TGU’ is replaced by ‘125 TGU’.

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, 10 October 2014.

For the Commission

The President

José Manuel BARROSO

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(1)  
  OJ L 268, 18.10.2003, p. 29.

1

(2)  Commission Regulation (EC) No 271/2009 of 2 April 2009 concerning the authorisation of a preparation of endo-1,4-beta-xylanase and endo-1,4-beta-glucanase as a feed additive for weaned piglets, chickens for fattening, laying hens, turkeys for fattening and ducks for fattening (holder of the authorisation BASF SE) (OJ L 91, 3.4.2009, p. 5).

2

(3)  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) (OJ L 277, 22.10.2011, p. 11).

3

Aspergillus niger

Aspergillus niger

(4)  Commission Implementing Regulation (EU) No 1404/2013 of 20 December 2013 concerning the authorisation of a 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 pigs for fattening (holder of authorisation BASF SE) (OJ L 349, 21.12.2013, p. 88).

4

Aspergillus niger

Aspergillus niger

(5)  
  EFSA Journal 2014; 12(6):3723.

5

EFSA Journal 2014

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