# L_2008149EN.01003301.xml

| 7.6.2008 | EN | Official Journal of the European Union | L 149/33 |
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7.6.2008

EN

Official Journal of the European Union

L 149/33

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COMMISSION REGULATION (EC) No 505/2008

of 6 June 2008

concerning the authorisation of a new use of 3-phytase (Natuphos) as a feed additive

(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) | 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 authorisation of a new use of the enzyme preparation 3-phytase (Natuphos 5000, Natuphos 5000 G, Natuphos 5000 L, Natuphos 10000 G and Natuphos 10000 L) produced by Aspergillus niger (CBS 101.672) as a feed additive for sows, to be classified in the additive category ‘zootechnical additives’. |
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(3)

The application concerns authorisation of a new use of the enzyme preparation 3-phytase (Natuphos 5000, Natuphos 5000 G, Natuphos 5000 L, Natuphos 10000 G and Natuphos 10000 L) produced by Aspergillus niger (CBS 101.672) as a feed additive for sows, to be classified in the additive category ‘zootechnical additives’.

| (4) | The use of that preparation was authorised for weaned piglets, pigs for fattening and chickens for fattening by Commission Regulation (EC) No 243/2007 (2), for laying hens and turkeys for fattening by Commission Regulation (EC) No 1142/2007 (3) and for ducks by Commission Regulation (EC) No 165/2008 (4). |
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(4)

The use of that preparation was authorised for weaned piglets, pigs for fattening and chickens for fattening by Commission Regulation (EC) No 243/2007 (2), for laying hens and turkeys for fattening by Commission Regulation (EC) No 1142/2007 (3) and for ducks by Commission Regulation (EC) No 165/2008 (4).

| (5) | New data were submitted in support of the application for authorisation for sows. The European Food Safety Authority (‘the Authority’) concluded in its opinion of 15 June 2006 (5) that the enzyme preparation Natuphos (3-phytase) produced by Aspergillus niger (CBS 101.672) does not have an adverse effect on consumers, users or the environment and that it is efficacious in improving digestibility of feedingstuffs. In its opinion of 12 December 2007 (6) the Authority concluded that the use of that preparation is safe for sows. 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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(5)

New data were submitted in support of the application for authorisation for sows. The European Food Safety Authority (‘the Authority’) concluded in its opinion of 15 June 2006 (5) that the enzyme preparation Natuphos (3-phytase) produced by Aspergillus niger (CBS 101.672) does not have an adverse effect on consumers, users or the environment and that it is efficacious in improving digestibility of feedingstuffs. In its opinion of 12 December 2007 (6) the Authority concluded that the use of that preparation is safe for sows. 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.

| (6) | 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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(6)

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.

| (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, 6 June 2008.

For the Commission

Androulla VASSILIOU

Member of the Commission

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(1)  
  OJ L 268, 18.10.2003, p. 29. Regulation as amended by Commission Regulation (EC) No 378/2005 (OJ L 59, 5.3.2005, p. 8).

1

(2)  
  OJ L 73, 13.3.2007, p. 4.

2

(3)  
  OJ L 256, 2.10.2007, p. 20.

3

(4)  
  OJ L 50, 23.2.2008, p. 8.

4

(5)  Opinion of the Scientific Panel on Additives and Products or Substances used in Animal Feed and of the Scientific Panel on Genetically Modified Organisms on the safety and efficacy of the enzyme preparation Natuphos (3-phytase) produced by Aspergillus niger. The EFSA Journal (2006) 369, 1-19.

5

Aspergillus niger. The EFSA Journal

(6)  Scientific Opinion of the Panel on Additives and Products or Substances used in Animal Feed on ‘Safety of the enzymatic preparation of Natuphos (3-phytase) for sows’. The EFSA Journal (2007) 614, 1-5.

6

The EFSA Journal

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ANNEX

| Identification number of the additive | Name of the holder of authorisation | Additive
  (trade name) | 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 |
| 4a1600 | BASF SE | 3-phytase
  EC 3.1.3.8
  (Natuphos 5000 Natuphos 5000 G Natuphos 5000 L Natuphos 10000 G Natuphos 10000 L) | | Additive composition
  3-phytase produced by Aspergillus niger (CBS 101.672) having a minimum activity of: | Solid form: 5 000  FTU (1)/g |

Identification number of the additive

Name of the holder of authorisation

Additive

(trade name)

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

4a1600

BASF SE

3-phytase

EC 3.1.3.8

(Natuphos 5000 Natuphos 5000 G Natuphos 5000 L Natuphos 10000 G Natuphos 10000 L)

Additive composition

3-phytase produced by Aspergillus niger (CBS 101.672) having a minimum activity of:

Solid form: 5 000  FTU (1)/g

| | Liquid form: 5 000  FTU/ml |
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Liquid form: 5 000  FTU/ml

| | Characterisation of the active substance
  3-phytase produced by Aspergillus niger (CBS 101.672) |
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Characterisation of the active substance

3-phytase produced by Aspergillus niger (CBS 101.672)

| | Analytical method (2)

  Colorimetric method measuring inorganic phosphate released by the enzyme from phytate substrate |
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Analytical method (2)

Colorimetric method measuring inorganic phosphate released by the enzyme from phytate substrate

Sows

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500  FTU

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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 dose per kilogram of complete feedingstuff: 500 FTU. |
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2.

Recommended dose per kilogram of complete feedingstuff: 500 FTU.

| 3. | For use in feed containing more than 0,36 % phytin bound phosphorus. |
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3.

For use in feed containing more than 0,36 % phytin bound phosphorus.

27 June 2018

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(1)  1 FTU is the amount of enzyme which liberates 1 micromole of inorganic phosphate per minute from sodium phytate at pH 5.5 and 37 °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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