# L_2017326EN.01004401.xml

| 9.12.2017 | EN | Official Journal of the European Union | L 326/44 |
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9.12.2017

EN

Official Journal of the European Union

L 326/44

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COMMISSION IMPLEMENTING REGULATION (EU) 2017/2274

of 8 December 2017

concerning the authorisation of a new use of a preparation of 6-phytase (EC 3.1.3.26) produced by Komagataella pastoris (DSM 23036) as a feed additive for fish (holder of authorisation Huvepharma EOOD)

(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 a preparation of 6-phytase (EC 3.1.3.26) produced by Komagataella pastoris (DSM 23036) as a feed additive for fish. 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 a preparation of 6-phytase (EC 3.1.3.26) produced by Komagataella pastoris (DSM 23036) as a feed additive for fish. That application was accompanied by the particulars and documents required under Article 7(3) of Regulation (EC) No 1831/2003.

| (3) | That application concerns the authorisation of a preparation of 6-phytase (EC 3.1.3.26) produced by Komagataella pastoris (DSM 23036) as a feed additive for fish to be classified in the additive category ‘zootechnical additives’. |
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(3)

That application concerns the authorisation of a preparation of 6-phytase (EC 3.1.3.26) produced by Komagataella pastoris (DSM 23036) as a feed additive for fish to be classified in the additive category ‘zootechnical additives’.

| (4) | The use of that preparation was authorised for 10 years 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 by Commission Implementing Regulation (EU) No 98/2012 (2). |
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(4)

The use of that preparation was authorised for 10 years 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 by Commission Implementing Regulation (EU) No 98/2012 (2).

| (5) | The European Food Safety Authority (‘the Authority’) concluded in its opinion of 21 March 2017 (3) that, under the proposed conditions of use, preparation of 6-phytase (EC 3.1.3.26) produced by Komagataella pastoris (DSM 23036) does not have an adverse effect on animal health, human health or the environment. It concluded that the additive has the potential to be efficacious in rainbow trout and salmon and this conclusion can be extrapolated to all finfish. 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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(5)

The European Food Safety Authority (‘the Authority’) concluded in its opinion of 21 March 2017 (3) that, under the proposed conditions of use, preparation of 6-phytase (EC 3.1.3.26) produced by Komagataella pastoris (DSM 23036) does not have an adverse effect on animal health, human health or the environment. It concluded that the additive has the potential to be efficacious in rainbow trout and salmon and this conclusion can be extrapolated to all finfish. 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.

| (6) | The assessment of preparation of 6-phytase (EC 3.1.3.26) produced by Komagataella 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 that preparation should be authorised as specified in the Annex to this Regulation. |
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(6)

The assessment of preparation of 6-phytase (EC 3.1.3.26) produced by Komagataella 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 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 Plants, Animals, Food and Feed, |
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(7)

The measures provided for in this Regulation are in accordance with the opinion of the Standing Committee on Plants, Animals, Food and Feed,

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 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, 8 December 2017.

For the Commission

The President

Jean-Claude JUNCKER

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

1

(2)  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) OJ L 35, 8.2.2012, p. 6.

2

(3)  
  EFSA Journal 2017;15(4):4763.

3

EFSA Journal 2017;15(4):4763

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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 EOOD | 6-phytase
  (EC 3.1.3.26) | Additive composition

  Preparation 6-phytase (EC 3.1.3.26) produced by Komagataella pastoris (DSM 23036) with a minimum activity of: | 4 000 OTU (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 EOOD

6-phytase

(EC 3.1.3.26)

Additive composition

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

4 000 OTU (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 Komagataella pastoris (DSM 23036)

Analytical method
   (2)

For quantification of 6-phytase in feed:

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

Fish

—

500 OTU

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| 1. | In the directions for use of the additive and premixture, the storage conditions and stability to heat treatment shall be indicated. |
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1.

In the directions for use of the additive and premixture, the storage conditions and stability to heat treatment shall be indicated.

| 2. | For use in feed containing more than 0,23 % phytin-bound phosphorus. |
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2.

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

| 3. | For users of the additive and premixtures, feed business operators shall establish operational procedures and organisational measures to address potential risks resulting from its use. Where those risks cannot be eliminated or reduced to a minimum by such procedures and measures, the additive and premixtures shall be used with protective equipment, including breathing and skin protections. |
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3.

For users of the additive and premixtures, feed business operators shall establish operational procedures and organisational measures to address potential risks resulting from its use. Where those risks cannot be eliminated or reduced to a minimum by such procedures and measures, the additive and premixtures shall be used with protective equipment, including breathing and skin protections.

29.12.2027

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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 Reference Laboratory: http://ec.europa.eu/jrc/en/eurl/feed-additives/evaluation-reports.

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