# L_2009297EN.01000601.xml

| 13.11.2009 | EN | Official Journal of the European Union | L 297/6 |
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13.11.2009

EN

Official Journal of the European Union

L 297/6

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COMMISSION REGULATION (EC) No 1088/2009

of 12 November 2009

concerning the authorisation of a new use of an enzyme preparation of 6-phytase produced by Aspergillus oryzae (DSM 17594) as a feed additive for weaned piglets, pigs for fattening, poultry for fattening and poultry for laying (holder of authorisation DSM Nutritional Products Ltd., represented by DSM Nutritional Products Sp. Z.o.o.)

(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 the authorisation of a new use of the enzyme preparation of 6-phytase produced by Aspergillus oryzae (DSM 17594) as a feed additive for weaned piglets, pigs for fattening, poultry for fattening and poultry for laying, to be classified in the additive category ‘zootechnical additives’. |
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(3)

The application concerns the authorisation of a new use of the enzyme preparation of 6-phytase produced by Aspergillus oryzae (DSM 17594) as a feed additive for weaned piglets, pigs for fattening, poultry for fattening and poultry for laying, to be classified in the additive category ‘zootechnical additives’.

| (4) | The use of that preparation was authorised for ten years by Commission Regulation (EC) No 270/2009 (2) for chickens for fattening. |
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(4)

The use of that preparation was authorised for ten years by Commission Regulation (EC) No 270/2009 (2) for chickens for fattening.

| (5) | New data were submitted in support of the application for authorisation for weaned piglets, pigs for fattening, poultry for fattening and poultry for laying. The European Food Safety Authority (‘the Authority’) concluded in its opinion of 14 May 2009 (3) that the enzyme preparation of 6-phytase produced by Aspergillus oryzae (DSM 17594) does not have an adverse effect on animal health, human health or the environment and that the use of that preparation improves the digestibility of dietary phosphorus. 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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(5)

New data were submitted in support of the application for authorisation for weaned piglets, pigs for fattening, poultry for fattening and poultry for laying. The European Food Safety Authority (‘the Authority’) concluded in its opinion of 14 May 2009 (3) that the enzyme preparation of 6-phytase produced by Aspergillus oryzae (DSM 17594) does not have an adverse effect on animal health, human health or the environment and that the use of that preparation improves the digestibility of dietary phosphorus. 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.

| (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) | As a consequence of the granting of a new authorisation under Regulation (EC) No 1831/2003, Regulation (EC) No 270/2009 should be repealed. |
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(7)

As a consequence of the granting of a new authorisation under Regulation (EC) No 1831/2003, Regulation (EC) No 270/2009 should be repealed.

| (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

Regulation (EC) No 270/2009 is repealed.

Article 3

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, 12 November 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)  
  OJ L 91, 3.4.2009, p. 3.

2

(3)  
  The EFSA Journal (2009) 1097, p. 1.

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 |
| 4a6 | DSM Nutritional Products Ltd. represented by DSM Nutritional Products Sp. Z.o.o. | 6-phytase
  EC 3.1.3.26 | | Additive composition:
  Preparation of 6-phytase produced by Aspergillus oryzae (DSM 17594) having a minimum activity of: | Solid form: 10 000  FYT (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

4a6

DSM Nutritional Products Ltd. represented by DSM Nutritional Products Sp. Z.o.o.

6-phytase

EC 3.1.3.26

Additive composition:

Preparation of 6-phytase produced by Aspergillus oryzae (DSM 17594) having a minimum activity of:

Solid form: 10 000  FYT (1)/g

| | Liquid form: 20 000  FYT/g |
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Liquid form: 20 000  FYT/g

| | Characterisation of the active substance:
  6-phytase produced by Aspergillus oryzae

  (DSM 17594) |
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Characterisation of the active substance:

6-phytase produced by Aspergillus oryzae

(DSM 17594)

| | Analytical method (2)

  Colorimetric method based on reaction of vanadomolybdate on inorganic phosphate produced by action of 6-phytase on a phytate-containing substrate (sodium phytate) at pH 5,5 and 37 °C, quantified against a standard curve from inorganic phosphate. |
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Analytical method (2)

Colorimetric method based on reaction of vanadomolybdate on inorganic phosphate produced by action of 6-phytase on a phytate-containing substrate (sodium phytate) at pH 5,5 and 37 °C, quantified against a standard curve from inorganic phosphate.

Piglets (weaned)

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1 500  FYT

| 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. | Recommended dose per kilogram of complete feedingstuff:






  — | poultry for fattening: 1 500 -3 000  FYT; |
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3.

Recommended dose per kilogram of complete feedingstuff:

—

poultry for fattening: 1 500 -3 000  FYT;

| — | poultry for laying: 600-1 500  FYT; |
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—

poultry for laying: 600-1 500  FYT;

| — | piglets (weaned) and pigs for fattening: 1 500 -3 000  FYT |
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—

piglets (weaned) and pigs for fattening: 1 500 -3 000  FYT

| 4. | For use in compound feed containing more than 0,23 % phytin-bound phosphorus |
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4.

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

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

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

1 December 2019

Pigs for fattening

1 500  FYT

Poultry for fattening

1 500  FYT

Poultry for laying

600  FYT

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(1)  One FYT is the amount of enzyme that releases 1 μmol of inorganic phosphate from phytase per minute under reaction conditions with a phytate concentration of 5,0 mM at pH 5,5 and a temperature of 37 °C during 30 minutes of incubation.

(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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