# L_2010003EN.01001001.xml

| 7.1.2010 | EN | Official Journal of the European Union | L 3/10 |
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7.1.2010

EN

Official Journal of the European Union

L 3/10

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COMMISSION REGULATION (EU) No 9/2010

of 23 December 2009

concerning the authorisation of the endo-1,4-beta-xylanase produced by Trichoderma reesei (ATCC PTA 5588) as a feed additive for chickens for fattening, laying hens, ducks and turkeys for fattening (holder of authorisation Danisco Animal Nutrition, Finnfeeds International Limited)

(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 9(2) 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) | In accordance with Article 7 of Regulation (EC) No 1831/2003, an application was submitted for the authorisation of the preparation set out in the Annex to this Regulation. That application was accompanied by the particulars and documents required under Article 7(3) of Regulation (EC) No 1831/2003. |
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(2)

In accordance with Article 7 of Regulation (EC) No 1831/2003, an application was submitted for the authorisation of the preparation set out in the Annex to this Regulation. That application was accompanied by the particulars and documents required under Article 7(3) of Regulation (EC) No 1831/2003.

| (3) | The application concerns the authorisation of the enzyme preparation of endo-1,4-beta-xylanase produced by Trichoderma reesei (ATCC PTA 5588) as a feed additive for chickens for fattening, laying hens, ducks and turkeys for fattening, to be classified in the additive category ‘zootechnical additives’. |
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(3)

The application concerns the authorisation of the enzyme preparation of endo-1,4-beta-xylanase produced by Trichoderma reesei (ATCC PTA 5588) as a feed additive for chickens for fattening, laying hens, ducks and turkeys for fattening, to be classified in the additive category ‘zootechnical additives’.

| (4) | The European Food Safety Authority (the Authority) concluded in its opinions of 12 and 19 September 2007 (2), of 22 November 2007 (3) and of 2 July 2009 (4) that the enzyme preparation of endo-1,4-beta-xylanase produced by Trichoderma reesei (ATCC PTA 5588) does not have an adverse effect on animal health, human health or the environment and that the use of that preparation improves the performance of the animals. 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 Community Reference Laboratory set up by Regulation (EC) No 1831/2003. |
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(4)

The European Food Safety Authority (the Authority) concluded in its opinions of 12 and 19 September 2007 (2), of 22 November 2007 (3) and of 2 July 2009 (4) that the enzyme preparation of endo-1,4-beta-xylanase produced by Trichoderma reesei (ATCC PTA 5588) does not have an adverse effect on animal health, human health or the environment and that the use of that preparation improves the performance of the animals. 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 Community Reference Laboratory set up by Regulation (EC) No 1831/2003.

| (5) | The assessment of that preparation shows that the conditions for authorisation, provided for in Article 5 of Regulation (EC) No 1831/2003, are satisfied. Accordingly, the use of that preparation should be authorised, as specified in the Annex to this Regulation. |
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(5)

The assessment of that preparation shows that the conditions for authorisation, provided for in Article 5 of Regulation (EC) No 1831/2003, are satisfied. Accordingly, the use of that preparation should be authorised, as specified in the Annex to this Regulation.

| (6) | The measures provided for in this Regulation are in accordance with the opinion of the Standing Committee on the Food Chain and Animal Health, |
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(6)

The measures provided for in this Regulation are in accordance with the opinion of the Standing Committee on the Food Chain and Animal Health,

HAS ADOPTED THIS REGULATION:

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.

Done at Brussels, 23 December 2009.

For the Commission

The President

José Manuel BARROSO

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

1

(2)  
  The EFSA Journal (2007) 548, p. 1.

2

The EFSA Journal

(3)  
  The EFSA Journal (2007) 586, p. 1.

3

The EFSA Journal

(4)  
  The EFSA Journal (2009) 1183, p. 1.

4

The EFSA Journal

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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 |
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| Units of activity/kg of complete feedingstuff with a moisture content of 12 % |
| Category of zootechnical additives. Functional group: digestibility enhancers |
| 4a11 | Danisco Animal Nutrition, legal entity Finnfeeds International Limited | Endo-1,4-β-xylanase
  EC 3.2.1.8 | Additive composition
  Preparation of endo-1,4-β-xylanase (EC 3.2.1.8) produced by Trichoderma reesei

  (ATCC PTA 5588) with a minimum activity of 40 000 U (1)/g
  Characterisation of the active substance
  Endo-1,4-β-xylanase (EC 3.2.1.8) produced by Trichoderma reesei (ATCC PTA 5588) | Chickens for fattening | — | 625 U | — | 1. | In the directions for use of the additive and premixture, indicate the storage temperature, storage life, and stability to pelleting. |

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

4a11

Danisco Animal Nutrition, legal entity Finnfeeds International Limited

Endo-1,4-β-xylanase

EC 3.2.1.8

Additive composition

Preparation of endo-1,4-β-xylanase (EC 3.2.1.8) produced by Trichoderma reesei

(ATCC PTA 5588) with a minimum activity of 40 000 U (1)/g

Characterisation of the active substance

Endo-1,4-β-xylanase (EC 3.2.1.8) produced by Trichoderma reesei (ATCC PTA 5588)

Chickens for fattening

—

625 U

—

1.

In the directions for use of the additive and premixture, indicate the storage temperature, storage life, and stability to pelleting.

| 2. | For use in feed rich in starch and non starch polysaccharides (mainly arabinoxylans), e.g. containing more than 40 % wheat or 60 % maize. |
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2.

For use in feed rich in starch and non starch polysaccharides (mainly arabinoxylans), e.g. containing more than 40 % wheat or 60 % maize.

13.1.2020

Laying hens

2 500 U

Ducks

625 U

Turkeys for fattening

1 250 U

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(1)  1 U is the amount of enzyme which liberates 0,5 μmol of reducing sugar (expressed as xylose equivalents) from a cross-linked oat spelt arabinoxylan substrate at pH 5,3 and 50 °C in one minute.

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