# L_2009256EN.01002301.xml

| 29.9.2009 | EN | Official Journal of the European Union | L 256/23 |
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29.9.2009

EN

Official Journal of the European Union

L 256/23

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COMMISSION REGULATION (EC) No 902/2009

of 28 September 2009

concerning the authorisation of an enzyme preparation of endo-1,4-beta-xylanase produced by Trichoderma reesei (CBS 114044) as a feed additive for weaned piglets, chickens for fattening, chickens reared for laying, turkeys for fattening and turkeys reared for breeding (holder of authorisation Roal Oy)

(Text with EEA relevance)

THE COMMISSION OF THE EUROPEAN COMMUNITIES,

Having regard to the Treaty establishing the European Community,

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) | This Regulation authorises an enzyme preparation of endo-1,4-beta-xylanase as a feed additive for weaned piglets, chickens for fattening, chickens reared for laying, turkeys for fattening and turkeys reared for breeding. |
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(2)

This Regulation authorises an enzyme preparation of endo-1,4-beta-xylanase as a feed additive for weaned piglets, chickens for fattening, chickens reared for laying, turkeys for fattening and turkeys reared for breeding.

| (3) | 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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(3)

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.

| (4) | The European Food Safety Authority (the Authority) performed the risk assessment in accordance with Article 8(3) of Regulation (EC) No 1831/2003. |
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(4)

The European Food Safety Authority (the Authority) performed the risk assessment in accordance with Article 8(3) of Regulation (EC) No 1831/2003.

| (5) | The application concerns the authorisation of the preparation of endo-1,4-beta-xylanase produced by Trichoderma reesei (CBS 114044) as a feed additive for weaned piglets, chickens for fattening, chickens reared for laying, turkeys for fattening and turkeys reared for breeding, to be classified in the additive category ‘zootechnical additives’. |
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(5)

The application concerns the authorisation of the preparation of endo-1,4-beta-xylanase produced by Trichoderma reesei (CBS 114044) as a feed additive for weaned piglets, chickens for fattening, chickens reared for laying, turkeys for fattening and turkeys reared for breeding, to be classified in the additive category ‘zootechnical additives’.

| (6) | The Authority concluded in its opinions of 21 May 2008 (2) and 21 April 2009 (3) that the preparation of endo-1,4-beta-xylanase produced by Trichoderma reesei (CBS 114044) does not have an adverse effect on animal health, human health or the environment and that the use of that preparation can have a significant benefit on body weight gain and feed conversion. The Authority did 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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(6)

The Authority concluded in its opinions of 21 May 2008 (2) and 21 April 2009 (3) that the preparation of endo-1,4-beta-xylanase produced by Trichoderma reesei (CBS 114044) does not have an adverse effect on animal health, human health or the environment and that the use of that preparation can have a significant benefit on body weight gain and feed conversion. The Authority did 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.

| (7) | 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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(7)

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.

| (8) | 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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(8)

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, 28 September 2009.

For the Commission

Androulla VASSILIOU

Member of the Commission

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

1

(2)  
  The EFSA Journal (2008) 712, pp. 1-20.

2

The EFSA Journal

(3)  
  The EFSA Journal (2009) 1058, pp. 1-6.

3

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 |
| 4a8 | Roal Oy | Endo-1,4-beta-xylanase
  EC 3.2.1.8 | | Additive composition:
  Preparation of endo-1,4-beta-xylanase produced by Trichoderma reesei (CBS 114044) having a minimum activity of: | solid form: 4 × 106 BXU (1)/g |

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

4a8

Roal Oy

Endo-1,4-beta-xylanase

EC 3.2.1.8

Additive composition:

Preparation of endo-1,4-beta-xylanase produced by Trichoderma reesei (CBS 114044) having a minimum activity of:

solid form: 4 × 106 BXU (1)/g

| | liquid form: 4 × 105 BXU/g |
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liquid form: 4 × 105 BXU/g

| | Characterisation of the active substance:
  endo-1,4-beta-xylanase produced by Trichoderma reesei (CBS 114044) |
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Characterisation of the active substance:

endo-1,4-beta-xylanase produced by Trichoderma reesei (CBS 114044)

| | Analytical method (2):
  In the additive and the premixture: reducing sugar assay for endo-1,4-beta-xylanase by colorimetric reaction of dinitrosalicylic acid reagent on reducing sugar yield at pH 5,3 and 50 °C
  In the feedingstuffs: colorimetric method measuring water soluble dye released by the enzyme from azurine crosslinked wheat arabinoxylan substrate |
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Analytical method (2):

In the additive and the premixture: reducing sugar assay for endo-1,4-beta-xylanase by colorimetric reaction of dinitrosalicylic acid reagent on reducing sugar yield at pH 5,3 and 50 °C

In the feedingstuffs: colorimetric method measuring water soluble dye released by the enzyme from azurine crosslinked wheat arabinoxylan substrate

Piglets

(weaned)

—

24 000 BXU

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| 1. | In the directions for use of the additive and premixture, indicate the storage temperature, storage life, and stability to pelleting. |
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1.

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

| 2. | For piglets (weaned) up to 35 kg of body weight. |
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2.

For piglets (weaned) up to 35 kg of body weight.

| 3. | For use in compound feed rich in non-starch polysaccharides (mainly arabinoxylans), e.g. containing more than 20 % wheat. |
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3.

For use in compound feed rich in non-starch polysaccharides (mainly arabinoxylans), e.g. containing more than 20 % wheat.

| 4. | For safety reasons: breathing protection, glasses and gloves shall be used during handling. |
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4.

For safety reasons: breathing protection, glasses and gloves shall be used during handling.

19 October 2019

Chickens for fattening

8 000 BXU

Chickens reared for laying

8 000 BXU

Turkeys for fattening

16 000 BXU

Turkeys reared for breeding

16 000 BXU

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(1)  1 BXU is the amount of enzyme which liberates 1 nmol reducing sugars as xylose from birch xylan per second at pH 5,3 and 50 °C.

(2)  Details of the analytical methods are available at the following address of the Community Reference Laboratory: www.irmm.jrc.be/crl-feed-additives

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