# L_2023084EN.01000701.xml

| 23.3.2023 | EN | Official Journal of the European Union | L 84/7 |
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23.3.2023

EN

Official Journal of the European Union

L 84/7

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COMMISSION IMPLEMENTING REGULATION (EU) 2023/668

of 22 March 2023

concerning the authorisation of a preparation of endo-1,4-beta-xylanase produced by Komagataella phaffii ATCC PTA-127053 as a feed additive for all laying poultry (holder of authorisation: Kemin Europa N.V.)

(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 endo-1,4-beta-xylanase produced by Komagataella phaffii ATCC PTA-127053. 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 endo-1,4-beta-xylanase produced by Komagataella phaffii ATCC PTA-127053. 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 preparation of endo-1,4-beta-xylanase produced by Komagataella phaffii ATCC PTA-127053 as a feed additive for all laying poultry, to be classified in the additive category ‘zootechnical additives’ and in the functional group ‘digestibility enhancers’. |
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(3)

The application concerns the authorisation of a preparation of endo-1,4-beta-xylanase produced by Komagataella phaffii ATCC PTA-127053 as a feed additive for all laying poultry, to be classified in the additive category ‘zootechnical additives’ and in the functional group ‘digestibility enhancers’.

| (4) | The European Food Safety Authority (‘the Authority’) concluded, in its opinion of 29 June 2022 (2), that, under the proposed conditions of use, the preparation of endo-1,4-beta-xylanase produced by Komagataella phaffii ATCC PTA-127053 did not have an adverse effect on consumer safety or the environment. As regards the target species, the Authority concluded that the additive is safe and has the potential to be efficacious for laying hens when added to feed at 45 000 U/kg and that the conclusions on laying hens can be extrapolated to all laying poultry species. |
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(4)

The European Food Safety Authority (‘the Authority’) concluded, in its opinion of 29 June 2022 (2), that, under the proposed conditions of use, the preparation of endo-1,4-beta-xylanase produced by Komagataella phaffii ATCC PTA-127053 did not have an adverse effect on consumer safety or the environment. As regards the target species, the Authority concluded that the additive is safe and has the potential to be efficacious for laying hens when added to feed at 45 000 U/kg and that the conclusions on laying hens can be extrapolated to all laying poultry species.

| (5) | The Authority concluded that that additive was not irritant to eyes and skin but was considered a dermal and respiratory sensitiser. |
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(5)

The Authority concluded that that additive was not irritant to eyes and skin but was considered a dermal and respiratory sensitiser.

| (6) | The Authority considered that there was no 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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(6)

The Authority considered that there was no 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.

| (7) | The assessment of the preparation of endo-1,4-beta-xylanase produced by Komagataella phaffii ATCC PTA-127053 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. 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. |
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(7)

The assessment of the preparation of endo-1,4-beta-xylanase produced by Komagataella phaffii ATCC PTA-127053 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. 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.

| (8) | 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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(8)

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, 22 March 2023.

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 2022;20(7):7439.

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 |
| 4a36 | Kemin Europa N.V. | Endo-1,4-beta-xylanase (EC 3.2.1.8) | Additive composition

  Preparation of endo-1,4-beta-xylanase (EC 3.2.1.8) produced by Komagataella phaffii ATCC PTA-127053 with a minimum activity of:
  3 000 000 U (1)/g
  Solid form

  Characterisation of the active substance

  Endo-1,4-beta-xylanase (EC 3.2.1.8) produced by Komagataella phaffii ATCC PTA-127053

  Analytical method
   (2)

  For the determination of endo-1,4-beta-xylanase in the feed additive:






  — | colorimetric method based on the enzymatic hydrolysis of endo-1,4-beta-xylanase on the beechwood xylan substrate. |

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

4a36

Kemin Europa N.V.

Endo-1,4-beta-xylanase (EC 3.2.1.8)

Additive composition

Preparation of endo-1,4-beta-xylanase (EC 3.2.1.8) produced by Komagataella phaffii ATCC PTA-127053 with a minimum activity of:

3 000 000 U (1)/g

Solid form

Characterisation of the active substance

Endo-1,4-beta-xylanase (EC 3.2.1.8) produced by Komagataella phaffii ATCC PTA-127053

Analytical method
   (2)

For the determination of endo-1,4-beta-xylanase in the feed additive:

—

colorimetric method based on the enzymatic hydrolysis of endo-1,4-beta-xylanase on the beechwood xylan substrate.

For the determination of endo-1,4-beta-xylanase in premixtures and compound feed:

| — | colorimetric method based the enzymatic reaction of endo-1,4-beta-xylanase on the azurine cross-linked wheat arabinoxylan substrate. |
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—

colorimetric method based the enzymatic reaction of endo-1,4-beta-xylanase on the azurine cross-linked wheat arabinoxylan substrate.

All laying poultry

—

45 000 U

—

| 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 appropriate personal protective equipment, including breathing and skin 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 appropriate personal protective equipment, including breathing and skin protection.

13.4.2033

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(1)  One U unit is the amount of enzyme that releases 0,0067 μmol of reducing sugar (xylose equivalent) per minute and per gram of enzyme product at 50 °C and pH 5,3.

(2)  Details of the analytical methods are available at the following address of the Reference Laboratory: https://joint-research-centre.ec.europa.eu/eurl-fa-eurl-feed-additives/eurl-fa-authorisation/eurl-fa-evaluation-reports_en

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