# L_2012035EN.01000601.xml

| 8.2.2012 | EN | Official Journal of the European Union | L 35/6 |
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8.2.2012

EN

Official Journal of the European Union

L 35/6

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COMMISSION IMPLEMENTING REGULATION (EU) No 98/2012

of 7 February 2012

concerning the authorisation of 6-phytase (EC 3.1.3.26) produced by Pichia pastoris (DSM 23036) as a feed additive for chickens and turkeys for fattening, chickens reared for laying, turkeys reared for breeding, laying hens, other avian species for fattening and laying, weaned piglets, pigs for fattening and sows (holder of authorisation Huvepharma AD)

(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 6-phytase (EC 3.1.3.26) produced by Pichia pastoris (DSM 23036). 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 6-phytase (EC 3.1.3.26) produced by Pichia pastoris (DSM 23036). 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 6-phytase (EC 3.1.3.26) produced by Pichia pastoris (DSM 23036) as a feed additive for chickens and turkeys for fattening, chickens reared for laying, turkeys reared for breeding, laying hens, other avian species for fattening and laying, weaned piglets, pigs for fattening and sows, to be classified in the additive category ‘zootechnical additives’. |
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(3)

The application concerns the authorisation of 6-phytase (EC 3.1.3.26) produced by Pichia pastoris (DSM 23036) as a feed additive for chickens and turkeys for fattening, chickens reared for laying, turkeys reared for breeding, laying hens, other avian species for fattening and laying, weaned piglets, pigs for fattening and sows, to be classified in the additive category ‘zootechnical additives’.

| (4) | The European Food Safety Authority (‘the Authority’) concluded in its opinion of 11 October 2011 (2) that, under the proposed conditions of use, 6-phytase (EC 3.1.3.26) produced by Pichia pastoris (DSM 23036) does not have an adverse effect on animal health, human health or the environment, and that its use can improve the phosphorus digestibility in all target species and performance parameters in avian species. 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 11 October 2011 (2) that, under the proposed conditions of use, 6-phytase (EC 3.1.3.26) produced by Pichia pastoris (DSM 23036) does not have an adverse effect on animal health, human health or the environment, and that its use can improve the phosphorus digestibility in all target species and performance parameters in avian species. 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 6-phytase (EC 3.1.3.26) produced by Pichia pastoris (DSM 23036) 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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(5)

The assessment of 6-phytase (EC 3.1.3.26) produced by Pichia pastoris (DSM 23036) 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.

| (6) | 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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(6)

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, 7 February 2012.

For the Commission

The President

José Manuel BARROSO

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

1

(2)  
  EFSA Journal 2011; 9(11):2414.

2

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 |
| 4a16 | Huvepharma AD | 6-phytase
  (EC 3.1.3.26) | | Additive composition:

  Preparation 6-phytase (EC 3.1.3.26) produced by Pichia pastoris (DSM 23036) with a minimum activity of: | 4 000 OUT (1)/g in solid form |

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

4a16

Huvepharma AD

6-phytase

(EC 3.1.3.26)

Additive composition:

Preparation 6-phytase (EC 3.1.3.26) produced by Pichia pastoris (DSM 23036) with a minimum activity of:

4 000 OUT (1)/g in solid form

| | 8 000 OTU/g in liquid form |
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8 000 OTU/g in liquid form

| | Characterisation of the active substance:

  6-phytase (EC 3.1.3.26) produced by Pichia pastoris (DSM 23036) |
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Characterisation of the active substance:

6-phytase (EC 3.1.3.26) produced by Pichia pastoris (DSM 23036)

| | Analytical method
   (2):
  Colorimetric method based on the quantification of the inorganic phosphate released by the enzyme from the sodium phytate |
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Analytical method
   (2):

Colorimetric method based on the quantification of the inorganic phosphate released by the enzyme from the sodium phytate

Chickens for fattening

Chickens reared for laying

Laying hens

Other avian species other than turkeys for fattening and turkeys reared for breeding

Sows

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125  OTU

—

| 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 for all authorised species: 500 OTU/kg of complete feedingstuff. |
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2.

Recommended maximum dose for all authorised species: 500 OTU/kg of complete feedingstuff.

| 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.

| 4. | For safety: breathing protection, glasses and gloves shall be used during handling. |
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4.

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

28 February 2022

Turkeys for fattening

Turkeys reared for breeding

Pigs for fattening

Piglets (weaned)

250  OTU

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(1)  1 OTU is the amount of enzyme that catalyses the release of 1 micromole of inorganic phosphate per minute from 5,1 mM sodium phytate in pH 5,5 citrate buffer at 37 °C, measured as the blue P-molybdate complex colour at 820 nm.

(2)  Details of the analytical methods are available at the following address of the Community Reference Laboratory: http://irmm.jrc.ec.europa.eu/EURLs/EURL_feed_additives/Pages/index.aspx

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