# L_2018065EN.01001701.xml

| 8.3.2018 | EN | Official Journal of the European Union | L 65/17 |
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8.3.2018

EN

Official Journal of the European Union

L 65/17

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COMMISSION IMPLEMENTING REGULATION (EU) 2018/338

of 7 March 2018

concerning the authorisation of a preparation of 6-phytase, produced by Aspergillus niger (DSM 25770) as feed additive for chickens for fattening, chickens reared for laying, pigs for fattening, sows, minor porcine species for fattening or for reproduction, turkeys for fattening, turkeys reared for breeding, all other avian species (excluding laying birds) and weaned piglets (holder of the authorisation BASF SE)

(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, produced by Aspergillus niger (DSM 25770). 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, produced by Aspergillus niger (DSM 25770). 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 the preparation of 6-phytase produced by Aspergillus niger (DSM 25770) as a feed additive for chickens for fattening, chickens reared for laying, pigs for fattening, sows, minor porcine species for fattening or for reproduction, turkeys for fattening, turkeys reared for breeding, all avian species for fattening or growing or reared for laying and weaned piglets to be classified in the additive category ‘zootechnical additives’. |
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(3)

That application concerns the authorisation of the preparation of 6-phytase produced by Aspergillus niger (DSM 25770) as a feed additive for chickens for fattening, chickens reared for laying, pigs for fattening, sows, minor porcine species for fattening or for reproduction, turkeys for fattening, turkeys reared for breeding, all avian species for fattening or growing or reared for laying and weaned piglets to be classified in the additive category ‘zootechnical additives’.

| (4) | The European Food Safety Authority (‘the Authority’) concluded in its opinion of 28 September 2017 (2) that, under the proposed conditions of use, the preparation of 6-phytase produced by Aspergillus niger (DSM 25770) does not have an adverse effect on animal health, human health or the environment, and that it improves the zootechnical performance and/or phosphorus utilisation in the target 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 28 September 2017 (2) that, under the proposed conditions of use, the preparation of 6-phytase produced by Aspergillus niger (DSM 25770) does not have an adverse effect on animal health, human health or the environment, and that it improves the zootechnical performance and/or phosphorus utilisation in the target 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 the preparation of 6-phytase produced by Aspergillus niger (DSM 25770) 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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(5)

The assessment of the preparation of 6-phytase produced by Aspergillus niger (DSM 25770) 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.

| (6) | 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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(6)

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, 7 March 2018.

For the Commission

The President

Jean-Claude JUNCKER

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

1

(2)  
  EFSA Journal 2017; 15(11)5024.

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 |
| 4a27 | BASF SE | 6-phytase
  EC 3.1.3.26 | Additive composition:

  Preparation of 6-phytase, produced by Aspergillus niger (DSM 25770) with a minimum content of:
  Solid form: 5 000 FTU (1)/g
  Liquid form: 5 000 FTU/g

  Characterisation of the active substance:

  6-phytase produced by Aspergillus. niger (DSM 25770)

  Analytical method
   (2):
  For the quantification of phytase activity in the feed additive:






  — | colorimetric method based on the enzymatic reaction of phytase on the phytate |

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

4a27

BASF SE

6-phytase

EC 3.1.3.26

Additive composition:

Preparation of 6-phytase, produced by Aspergillus niger (DSM 25770) with a minimum content of:

Solid form: 5 000 FTU (1)/g

Liquid form: 5 000 FTU/g

Characterisation of the active substance:

6-phytase produced by Aspergillus. niger (DSM 25770)

Analytical method
   (2):

For the quantification of phytase activity in the feed additive:

—

colorimetric method based on the enzymatic reaction of phytase on the phytate

For the quantification of phytase activity in premixtures:

| — | colorimetric method based on the enzymatic reaction of phytase on the phytate — VDLUFA 27.1.3 |
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colorimetric method based on the enzymatic reaction of phytase on the phytate — VDLUFA 27.1.3

For the quantification of phytase activity in feedingstuffs:

| — | colorimetric method based on the enzymatic reaction of phytase on the phytate — EN ISO 30024 |
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—

colorimetric method based on the enzymatic reaction of phytase on the phytate — EN ISO 30024

Pigs for fattening

Sows

Minor porcine species for fattening or for reproduction

—

100 FTU

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

| 2. | For users of the additive and premixtures, feed business operators shall establish operational procedures and organisational measures to address potential risks resulting from their 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 personal protective equipment, including breathing protection. |
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2.

For users of the additive and premixtures, feed business operators shall establish operational procedures and organisational measures to address potential risks resulting from their 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 personal protective equipment, including breathing protection.

| 3. | For use in weaned piglets up to 35 kg. |
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3.

For use in weaned piglets up to 35 kg.

28.3.2028

Weaned piglets

125 FTU

Chickens for fattening

Chickens reared for laying

750 FTU

Turkeys for fattening

Turkeys reared for breeding

All other avian species (excluding laying birds)

125 FTU

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

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