# L_2011287EN.01002701.xml

| 4.11.2011 | EN | Official Journal of the European Union | L 287/27 |
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4.11.2011

EN

Official Journal of the European Union

L 287/27

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COMMISSION IMPLEMENTING REGULATION (EU) No 1110/2011

of 3 November 2011

concerning the authorisation of an enzyme preparation of endo-1,4-beta-xylanase produced by Trichoderma reesei (CBS 114044) as a feed additive for laying hens, minor poultry species and pigs for fattening (holder of authorisation Roal Oy)

(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 enzyme preparation of endo-1,4-beta-xylanase produced by Trichoderma reesei (CBS 114044). The 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 enzyme preparation of endo-1,4-beta-xylanase produced by Trichoderma reesei (CBS 114044). The 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 (CBS 114044) as a feed additive for laying hens, minor poultry species and pigs 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 (CBS 114044) as a feed additive for laying hens, minor poultry species and pigs for fattening, to be classified in the additive category ‘zootechnical additives’.

| (4) | The use of that preparation has been authorised for 10 years for chickens for fattening and chickens reared for laying, turkeys for fattening, turkeys reared for breeding and for weaned piglets by Commission Regulation (EC) No 902/2009 (2). |
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(4)

The use of that preparation has been authorised for 10 years for chickens for fattening and chickens reared for laying, turkeys for fattening, turkeys reared for breeding and for weaned piglets by Commission Regulation (EC) No 902/2009 (2).

| (5) | New data were submitted in support of the application for the authorisation of the enzyme preparation of endo-1,4-beta-xylanase produced by Trichoderma reesei (CBS 114044) for laying hens, minor poultry species and pigs for fattening. The European Food Safety Authority (‧the Authority‧) concluded in its opinion of 14 June 2011 (3) that, under the proposed conditions of use, 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 improve the laying performance of the hens and the growth performance of other minor poultry species and pigs for fattening. 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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(5)

New data were submitted in support of the application for the authorisation of the enzyme preparation of endo-1,4-beta-xylanase produced by Trichoderma reesei (CBS 114044) for laying hens, minor poultry species and pigs for fattening. The European Food Safety Authority (‧the Authority‧) concluded in its opinion of 14 June 2011 (3) that, under the proposed conditions of use, 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 improve the laying performance of the hens and the growth performance of other minor poultry species and pigs for fattening. 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.

| (6) | The assessment of endo-1,4-beta-xylanase produced by Trichoderma reesei (CBS 114044) shows that the conditions for authorisation, as provided for in Article 5 of Regulation (EC) No 1831/2003, are satisfied. Accordingly, the use of this preparation should be authorised as specified in the Annex to this Regulation. |
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(6)

The assessment of endo-1,4-beta-xylanase produced by Trichoderma reesei (CBS 114044) shows that the conditions for authorisation, as provided for in Article 5 of Regulation (EC) No 1831/2003, are satisfied. Accordingly, the use of this preparation should be authorised as specified in the Annex to this Regulation.

| (7) | 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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(7)

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, 3 November 2011.

For the Commission

The President

José Manuel BARROSO

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

1

(2)  
  OJ L 256, 29.9.2009, p. 23.

2

(3)  
  EFSA Journal 2011;9(6):2277.

3

EFSA Journal 2011

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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

Minor poultry species other than laying birds thereof

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8 000 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 safety: breathing protection, glasses and gloves shall be used during handling. |
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2.

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

24 November 2021

Laying hens and laying birds of minor poultry species

24 000 BXU

Pigs for fattening

24 000 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 Reference Laboratory: http://irmm.jrc.ec.europa.eu/EURLs/EURL_feed_additives/Pages/index.aspx

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