# L_2012347EN.01001201.xml

| 15.12.2012 | EN | Official Journal of the European Union | L 347/12 |
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15.12.2012

EN

Official Journal of the European Union

L 347/12

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COMMISSION IMPLEMENTING REGULATION (EU) No 1206/2012

of 14 December 2012

concerning the authorisation of a preparation of endo-1,4-beta-xylanase produced by Aspergillus oryzae (DSM 10287) as a feed additive for poultry for fattening, weaned piglets and pigs for fattening and amending Regulations (EC) No 1332/2004 and (EC) No 2036/2005 (holder of the authorisation DSM Nutritional Products)

(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. Article 10 of that Regulation provides for the re-evaluation of additives authorised pursuant to Council Directive 70/524/EEC (2). |
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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. Article 10 of that Regulation provides for the re-evaluation of additives authorised pursuant to Council Directive 70/524/EEC (2).

| (2) | A preparation of endo-1,4-beta-xylanase (EC 3.2.1.8) produced by Aspergillus oryzae (DSM 10287) was authorised without a time limit in accordance with Directive 70/524/EEC as a feed additive for use on chickens for fattening, turkeys for fattening and piglets by Commission Regulation (EC) No 1332/2004 (3) and authorised for four years for pigs for fattening and ducks by Commission Regulation (EC) No 2036/2005 (4). That preparation was subsequently entered in the Register of feed additives as an existing product, in accordance with Article 10(1) of Regulation (EC) No 1831/2003. |
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(2)

A preparation of endo-1,4-beta-xylanase (EC 3.2.1.8) produced by Aspergillus oryzae (DSM 10287) was authorised without a time limit in accordance with Directive 70/524/EEC as a feed additive for use on chickens for fattening, turkeys for fattening and piglets by Commission Regulation (EC) No 1332/2004 (3) and authorised for four years for pigs for fattening and ducks by Commission Regulation (EC) No 2036/2005 (4). That preparation was subsequently entered in the Register of feed additives as an existing product, in accordance with Article 10(1) of Regulation (EC) No 1831/2003.

| (3) | In accordance with Article 10(2) of Regulation (EC) No 1831/2003 in conjunction with Article 7 of that Regulation, an application was submitted for the re-evaluation of that preparation of endo-1,4-beta-xylanase (EC 3.2.1.8) produced by Aspergillus oryzae (DSM 10287), as a feed additive for chickens and turkeys for fattening, weaned piglets, pigs for fattening and ducks and, in accordance with Article 7 of that Regulation, for a new use for all poultry species for fattening, requesting that additive to be classified in the additive category ‘zootechnical additives’. 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 10(2) of Regulation (EC) No 1831/2003 in conjunction with Article 7 of that Regulation, an application was submitted for the re-evaluation of that preparation of endo-1,4-beta-xylanase (EC 3.2.1.8) produced by Aspergillus oryzae (DSM 10287), as a feed additive for chickens and turkeys for fattening, weaned piglets, pigs for fattening and ducks and, in accordance with Article 7 of that Regulation, for a new use for all poultry species for fattening, requesting that additive to be classified in the additive category ‘zootechnical additives’. 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’) concluded in its opinion of 12 June 2012 (5) that, under the proposed conditions of use, the preparation of endo-1,4-beta-xylanase (EC 3.2.1.8) produced by Aspergillus oryzae (DSM 10287), does not have an adverse effect on animal health, human health or the environment, and that it has a potential to favourably affect animal performance in chickens for fattening, turkeys for fattening and ducks for fattening. This conclusion can be extrapolated to all minor poultry species for fattening. It is also concluded that the additive has the potential to favourably affect animal performance in piglets 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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(4)

The European Food Safety Authority (‘the Authority’) concluded in its opinion of 12 June 2012 (5) that, under the proposed conditions of use, the preparation of endo-1,4-beta-xylanase (EC 3.2.1.8) produced by Aspergillus oryzae (DSM 10287), does not have an adverse effect on animal health, human health or the environment, and that it has a potential to favourably affect animal performance in chickens for fattening, turkeys for fattening and ducks for fattening. This conclusion can be extrapolated to all minor poultry species for fattening. It is also concluded that the additive has the potential to favourably affect animal performance in piglets 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.

| (5) | The assessment of the preparation of endo-1,4-beta-xylanase (EC 3.2.1.8) produced by Aspergillus oryzae (DSM 10287) shows that the conditions for authorisation, as 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 the preparation of endo-1,4-beta-xylanase (EC 3.2.1.8) produced by Aspergillus oryzae (DSM 10287) shows that the conditions for authorisation, as 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) | As a consequence of the granting of a new authorisation under Regulation (EC) No 1831/2003, Regulations (EC) No 1332/2004 and (EC) No 2036/2005 should therefore be amended accordingly. |
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(6)

As a consequence of the granting of a new authorisation under Regulation (EC) No 1831/2003, Regulations (EC) No 1332/2004 and (EC) No 2036/2005 should therefore be amended accordingly.

| (7) | Since safety reasons do not require the immediate application of the modifications to the conditions of authorisation, it is appropriate to allow a transitional period for interested parties to prepare themselves to meet the new requirements resulting from the authorisation. |
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(7)

Since safety reasons do not require the immediate application of the modifications to the conditions of authorisation, it is appropriate to allow a transitional period for interested parties to prepare themselves to meet the new requirements resulting from the authorisation.

| (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

Authorisation

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

Amendments to Regulation (EC) No 1332/2004

Regulation (EC) No 1332/2004 is amended as follows:

| (1) | Article 1 is replaced by the following:

  ‘Article 1
  The preparation belonging to the group ‘Enzymes’, as set out in Annex II, is authorised for use without a time limit as additive in animal nutrition under the conditions laid down in that Annex.’; |
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(1)

Article 1 is replaced by the following:

‘Article 1

The preparation belonging to the group ‘Enzymes’, as set out in Annex II, is authorised for use without a time limit as additive in animal nutrition under the conditions laid down in that Annex.’;

| (2) | Annex I is deleted. |
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(2)

Annex I is deleted.

Article 3

Amendment to Regulation (EC) No 2036/2005

In Annex III to Regulation (EC) No 2036/2005, the entry for No 5, Endo-1,4-beta-xylanase EC 3.2.1.8, is deleted.

Article 4

Transitional measures

The preparation specified in the Annex and feed containing that preparation, which are produced and labelled before 4 July 2013 in accordance with the rules applicable before 4 January 2013 may continue to be placed on the market and used until the existing stocks are exhausted.

Article 5

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, 14 December 2012.

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 270, 14.12.1970, p. 1.

2

(3)  
  OJ L 247, 21.7.2004, p. 8.

3

(4)  
  OJ L 328, 15.12.2005, p. 13.

4

(5)  EFSA Journal 2012; 10(7):2790.

5

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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 |
| 4a1607 | DSM Nutritional Products | Endo-1,4-beta-xylanase
  EC 3.2.1.8 | | Additive composition

  Preparation of endo-1,4-beta-xylanase produced by Aspergillus oryzae (DSM 10287) having a minimum activity of: | Solid form: 1 000 FXU (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

4a1607

DSM Nutritional Products

Endo-1,4-beta-xylanase

EC 3.2.1.8

Additive composition

Preparation of endo-1,4-beta-xylanase produced by Aspergillus oryzae (DSM 10287) having a minimum activity of:

Solid form: 1 000 FXU (1)/g

| | Liquid form: 650 FXU/ml |
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Liquid form: 650 FXU/ml

| | Characterisation of the active substance

  endo-1,4-beta-xylanase produced by Aspergillus oryzae (DSM 10287) |
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Characterisation of the active substance

endo-1,4-beta-xylanase produced by Aspergillus oryzae (DSM 10287)

| | Analytical method
   (2)

  For quantification of endo-1,4-beta-xylanase produced by Aspergillus oryzae (DSM 10827) in a feed additive:
  Colorimetric method measuring water soluble dyed fragments released by endo-1,4-beta-xylanase from azo-wheat-arabinoxylan substrate dyed with remazol-brilliant blue.
  For quantification of endo-1,4-beta-xylanase produced by Aspergillus oryzae (DSM 10827) in premixtures and feedingstuffs:
  Colorimetric method measuring water soluble dyed fragments released by endo-1,4-beta-xylanase from azurin-cross linked wheat arabinoxylan substrate. |
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Analytical method
   (2)

For quantification of endo-1,4-beta-xylanase produced by Aspergillus oryzae (DSM 10827) in a feed additive:

Colorimetric method measuring water soluble dyed fragments released by endo-1,4-beta-xylanase from azo-wheat-arabinoxylan substrate dyed with remazol-brilliant blue.

For quantification of endo-1,4-beta-xylanase produced by Aspergillus oryzae (DSM 10827) in premixtures and feedingstuffs:

Colorimetric method measuring water soluble dyed fragments released by endo-1,4-beta-xylanase from azurin-cross linked wheat arabinoxylan substrate.

Poultry for fattening

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100 FXU

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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. | Recommended maximum dose per kilogram of complete feedingstuff for:






  — | poultry for fattening: 200 FXU |
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2.

Recommended maximum dose per kilogram of complete feedingstuff for:

—

poultry for fattening: 200 FXU

| — | piglets (weaned): 400 FXU |
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—

piglets (weaned): 400 FXU

| — | pigs for fattening: 200 FXU. |
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—

pigs for fattening: 200 FXU.

| 3. | For use in feed rich in non-starch polysaccharides (mainly arabinoxylans) |
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3.

For use in feed rich in non-starch polysaccharides (mainly arabinoxylans)

| 4. | For use in weaned piglets up to approximately 35 kg. |
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4.

For use in weaned piglets up to approximately 35 kg.

| 5. | For safety: breathing protection and gloves shall be used during handling. |
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5.

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

4 January 2023

Piglets (weaned)

Pigs for fattening

200 FXU

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(1)  1 FXU is the amount of enzyme which liberates 7,8 micromole of reducing sugars (xylose equivalents) from azo-wheat arabinoxylan per minute at pH 6,0 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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