# L_2020319EN.01002601.xml

| 2.10.2020 | EN | Official Journal of the European Union | L 319/26 |
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2.10.2020

EN

Official Journal of the European Union

L 319/26

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COMMISSION IMPLEMENTING REGULATION (EU) 2020/1376

of 1 October 2020

concerning the authorisation of a preparation of 6-phytase, produced by Komagataella phaffii (CGMCC 12056) as feed additive for turkeys for fattening, turkeys reared for breeding, piglets (suckling and weaned) and minor porcine species (holder of the authorisation Andrés Pintaluba S.A)

(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, two applications were submitted for the authorisation of a preparation of 6-phytase, produced by Komagataella phaffii (CGMCC 12056). 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, two applications were submitted for the authorisation of a preparation of 6-phytase, produced by Komagataella phaffii (CGMCC 12056). That application was accompanied by the particulars and documents required under Article 7(3) of Regulation (EC) No 1831/2003.

| (3) | Those applications concern the authorisation of the preparation of 6-phytase produced by Komagataella phaffii (CGMCC 12056) as a feed additive for turkeys for fattening, turkeys reared for breeding, piglets (suckling and weaned) and minor porcine species to be classified in the additive category ‘zootechnical additives’. |
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(3)

Those applications concern the authorisation of the preparation of 6-phytase produced by Komagataella phaffii (CGMCC 12056) as a feed additive for turkeys for fattening, turkeys reared for breeding, piglets (suckling and weaned) and minor porcine species to be classified in the additive category ‘zootechnical additives’.

| (4) | The European Food Safety Authority (‘the Authority’) concluded in its opinions of 7 October 2019 (2) that, under the proposed conditions of use, the preparation of 6-phytase produced by Komagataella phaffii (CGMCC 12056) does not have an adverse effect on animal health, consumer safety or the environment. It also concluded that the additive should be regarded as a respiratory sensitiser. Therefore, the Commission considers that appropriate protective measures should be taken to prevent adverse effects on human health, in particular as regards the users of the additive. The Authority concluded that the additive showed improvements on the phosphorus utilisation and content. This conclusion can be extended to turkeys reared for breeding. 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 opinions of 7 October 2019 (2) that, under the proposed conditions of use, the preparation of 6-phytase produced by Komagataella phaffii (CGMCC 12056) does not have an adverse effect on animal health, consumer safety or the environment. It also concluded that the additive should be regarded as a respiratory sensitiser. Therefore, the Commission considers that appropriate protective measures should be taken to prevent adverse effects on human health, in particular as regards the users of the additive. The Authority concluded that the additive showed improvements on the phosphorus utilisation and content. This conclusion can be extended to turkeys reared for breeding. 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 Komagataella phaffii (CGMCC 12056) 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 Komagataella phaffii (CGMCC 12056) 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, 1 October 2020.

For the Commission

The President

Ursula VON DER LEYEN

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

1

(2)  
  EFSA Journal 2019;17(11):5893 and EFSA Journal 2019;17(11):5894.

2

EFSA Journal 2019

EFSA Journal 2019

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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 |
| --- | --- | --- | --- | --- | --- | --- | --- | --- | --- |
| Unit of activity/kg of complete feedingstuff with a moisture content of 12 % |
| Category of zootechnical additives. Functional group: digestibility enhancers |
| 4a31 | Andrés Pintaluba S.A. | 6-phytase
  EC 3.1.3.26 | Additive composition

  Preparation of 6-phytase (EC 3.1.3.26)
  produced by Komagataella phaffii (CGMCC 12056) having a minimum activity of:
  Solid form: 20 000 U (1)/g
  Liquid form: 20 000 U/ml | Turkeys for fattening
  Turkeys reared for breeding | - | 250 U | - | 1. | In the directions for use of the additive and premixtures, the storage conditions and stability to heat treatment shall be indicated. |

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

Unit of activity/kg of complete feedingstuff with a moisture content of 12 %

Category of zootechnical additives. Functional group: digestibility enhancers

4a31

Andrés Pintaluba S.A.

6-phytase

EC 3.1.3.26

Additive composition

Preparation of 6-phytase (EC 3.1.3.26)

produced by Komagataella phaffii (CGMCC 12056) having a minimum activity of:

Solid form: 20 000 U (1)/g

Liquid form: 20 000 U/ml

Turkeys for fattening

Turkeys reared for breeding

-

250 U

-

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 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 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 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 personal protective equipment, including breathing protection.

22 October 2030

Piglets

(suckling and weaned)

Minor porcine species (suckling and weaned)

-

1000 U

-

Characterisation of the active substance:

6-phytase (EC 3.1.3.26) produced by Komagataella phaffii (CGMCC 12056)

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 – VDLUFA 27.1.4 |
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colorimetric method based on the enzymatic reaction of phytase on the phytate – VDLUFA 27.1.4

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

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(1)  One unit is the amount of enzyme which releases one micromole of inorganic phosphate from phytate per minute 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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