# L_2007256EN.01002001.xml

| 2.10.2007 | EN | Official Journal of the European Union | L 256/20 |
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2.10.2007

EN

Official Journal of the European Union

L 256/20

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COMMISSION REGULATION (EC) No 1142/2007

of 1 October 2007

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 5 000, Natuphos 5 000 G, Natuphos 5 000 L, Natuphos 10 000 G and Natuphos 10 000 L) produced by Aspergillus niger (CBS 101 672) for laying hens and turkeys for fattening 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 5 000, Natuphos 5 000 G, Natuphos 5 000 L, Natuphos 10 000 G and Natuphos 10 000 L) produced by Aspergillus niger (CBS 101 672) for laying hens and turkeys for fattening to be classified in the additive category ‘zootechnical additives’.

| (4) | The use of that enzyme preparation was authorised for weaned piglets, pigs for fattening and chickens for fattening by Commission Regulation (EC) No 243/2007 (2). |
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(4)

The use of that enzyme preparation was authorised for weaned piglets, pigs for fattening and chickens for fattening by Commission Regulation (EC) No 243/2007 (2).

| (5) | The European Food Safety Authority (the Authority) concluded in its opinion of 17 April 2007 that the enzyme preparation 3-phytase (Natuphos 5 000, Natuphos 5 000 G, Natuphos 5 000 L, Natuphos 10 000 G and Natuphos 10 000 L) produced by Aspergillus niger (CBS 101 672) does not have an adverse effect on animal health, human health or the environment (3). It further concluded that preparation does not present any other risk which would, in accordance with Article 5(2) of Regulation (EC) No 1831/2003, exclude authorisation. According to that opinion, the use of that preparation does not have an adverse effect on these additional animal categories. The opinion of the Authority recommends appropriate measures for user safety. It does not consider that there is a need for specific requirements of post market monitoring. This opinion also verifies 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)

The European Food Safety Authority (the Authority) concluded in its opinion of 17 April 2007 that the enzyme preparation 3-phytase (Natuphos 5 000, Natuphos 5 000 G, Natuphos 5 000 L, Natuphos 10 000 G and Natuphos 10 000 L) produced by Aspergillus niger (CBS 101 672) does not have an adverse effect on animal health, human health or the environment (3). It further concluded that preparation does not present any other risk which would, in accordance with Article 5(2) of Regulation (EC) No 1831/2003, exclude authorisation. According to that opinion, the use of that preparation does not have an adverse effect on these additional animal categories. The opinion of the Authority recommends appropriate measures for user safety. It does not consider that there is a need for specific requirements of post market monitoring. This opinion also verifies 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, 1 October 2007.

For the Commission

Markos KYPRIANOU

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)  Opinion of the Scientific Panel on Additives and Products or Substances used in Animal Feed on the safety and efficacy of the enzyme preparation of Natuphos (3-phytase) produced by Aspergillus niger for laying hens and turkeys for fattening. Adopted on 17 April 2007. The EFSA Journal (2007) 472, 1-4.

3

Aspergillus niger

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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 Aktiengesellschaft | 3-phytase EC 3.1.3.8
  (Natuphos 5 000 Natuphos 5 000 G Natuphos 5 000 L Natuphos 10 000 G Natuphos 10 000 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 |

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 Aktiengesellschaft

3-phytase EC 3.1.3.8

(Natuphos 5 000 Natuphos 5 000 G Natuphos 5 000 L Natuphos 10 000 G Natuphos 10 000 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

| | 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.

Laying hens

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250 FTU

| 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: 300-400 FTU. |
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2.

Recommended dose per kilogram of complete feedingstuff: 300-400 FTU.

| 3. | For use in feed containing more than 0,23 % phytin bound phosphorus. |
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3.

For use in feed containing more than 0,23 % phytin bound phosphorus.

22.10.2017

Turkeys for fattening

250 FTU

| 1. | In the direction of use of the additive and premixtures, indicate the storage life and stability in pelleting. |
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1.

In the direction of use of the additive and premixtures, indicate the storage life and stability in 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 0,23 % phytin bound phosphorus. |
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3.

For use in feed containing more than 0,23 % phytin bound phosphorus.

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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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