# L_2023155EN.01001101.xml

| 16.6.2023 | EN | Official Journal of the European Union | L 155/11 |
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16.6.2023

EN

Official Journal of the European Union

L 155/11

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COMMISSION IMPLEMENTING REGULATION (EU) 2023/1169

of 15 June 2023

concerning the authorisation of a preparation of endo-1,4-beta-xylanase, endo-1,4-beta-glucanase and xyloglucan-specific endo-beta-1,4-glucanase produced by Trichoderma citrinoviride DSM 33578 as a feed additive for poultry for fattening, poultry reared for laying and reared for breeding, and ornamental birds (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 an 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 an 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, endo-1,4-beta-glucanase and xyloglucan-specific endo-beta-1,4-glucanase produced by Trichoderma citrinoviride DSM 33578. 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 a preparation of endo-1,4-beta-xylanase, endo-1,4-beta-glucanase and xyloglucan-specific endo-beta-1,4-glucanase produced by Trichoderma citrinoviride DSM 33578. The 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 endo-1,4-beta-xylanase, endo-1,4-beta-glucanase and xyloglucan-specific endo-beta-1,4-glucanase produced by Trichoderma citrinoviride DSM 33578 as a feed additive for all poultry species, ornamental birds and piglets, to be classified in the category ‘zootechnical additives’ and in the functional group ‘digestibility enhancers’. |
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(3)

That application concerns the authorisation of the preparation of endo-1,4-beta-xylanase, endo-1,4-beta-glucanase and xyloglucan-specific endo-beta-1,4-glucanase produced by Trichoderma citrinoviride DSM 33578 as a feed additive for all poultry species, ornamental birds and piglets, to be classified in the category ‘zootechnical additives’ and in the functional group ‘digestibility enhancers’.

| (4) | The European Food Safety Authority (‘the Authority’) concluded in its opinion of 23 November 2022 (2) that, under the proposed conditions of use, the preparation of endo-1,4-beta-xylanase, endo-1,4-beta-glucanase and xyloglucan-specific endo-beta-1,4-glucanase produced by Trichoderma citrinoviride DSM 33578 does not have adverse effects on animal health, consumer safety or the environment. The Authority also concluded that the preparation should be considered a respiratory sensitiser but, in the absence of data, could not conclude on the irritancy potential of the preparation to skin. The Authority also concluded that the preparation of endo-1,4-beta-xylanase, endo-1,4-beta-glucanase and xyloglucan-specific endo-beta-1,4-glucanase produced by Trichoderma citrinoviride DSM 33578 has the potential to be efficacious in poultry for fattening, poultry reared for laying and reared for breeding, and ornamental birds. However, owing to the lack of sufficient data, the Authority could not conclude on the efficacy of the preparation for laying hens and weaned piglets. The Authority considered that there was no need for specific requirements of post-market monitoring. It also verified the report on the methods 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 23 November 2022 (2) that, under the proposed conditions of use, the preparation of endo-1,4-beta-xylanase, endo-1,4-beta-glucanase and xyloglucan-specific endo-beta-1,4-glucanase produced by Trichoderma citrinoviride DSM 33578 does not have adverse effects on animal health, consumer safety or the environment. The Authority also concluded that the preparation should be considered a respiratory sensitiser but, in the absence of data, could not conclude on the irritancy potential of the preparation to skin. The Authority also concluded that the preparation of endo-1,4-beta-xylanase, endo-1,4-beta-glucanase and xyloglucan-specific endo-beta-1,4-glucanase produced by Trichoderma citrinoviride DSM 33578 has the potential to be efficacious in poultry for fattening, poultry reared for laying and reared for breeding, and ornamental birds. However, owing to the lack of sufficient data, the Authority could not conclude on the efficacy of the preparation for laying hens and weaned piglets. The Authority considered that there was no need for specific requirements of post-market monitoring. It also verified the report on the methods 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 endo-1,4-beta-xylanase, endo-1,4-beta-glucanase and xyloglucan-specific endo-beta-1,4-glucanase produced by Trichoderma citrinoviride DSM 33578 shows that the conditions for authorisation, as provided for in Article 5 of Regulation (EC) No 1831/2003, are satisfied for poultry for fattening, poultry reared for laying and reared for breeding, and ornamental birds. Accordingly, the use of that preparation should be authorised for those animal species and categories. In addition, 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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(5)

The assessment of the preparation of endo-1,4-beta-xylanase, endo-1,4-beta-glucanase and xyloglucan-specific endo-beta-1,4-glucanase produced by Trichoderma citrinoviride DSM 33578 shows that the conditions for authorisation, as provided for in Article 5 of Regulation (EC) No 1831/2003, are satisfied for poultry for fattening, poultry reared for laying and reared for breeding, and ornamental birds. Accordingly, the use of that preparation should be authorised for those animal species and categories. In addition, 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.

| (6) | It has been proposed to, and accepted by, the applicant to submit supplementary information addressing the shortcomings identified in the Authority’s opinion concerning the efficacy of the preparation for laying hens and weaned piglets. |
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(6)

It has been proposed to, and accepted by, the applicant to submit supplementary information addressing the shortcomings identified in the Authority’s opinion concerning the efficacy of the preparation for laying hens and weaned piglets.

| (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

Authorisation

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

Entry into force

This Regulation shall enter into force on the twentieth day following that of its publication in the Official Journal of the European Union.

Official Journal of the European Union.

This Regulation shall be binding in its entirety and directly applicable in all Member States.

Done at Brussels, 15 June 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(12):7702.

2

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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 |
| --- | --- | --- | --- | --- | --- | --- | --- | --- | --- |
| Units of activity/kg of complete feedingstuff with a moisture content of 12 % |
| Category of zootechnical additives. Functional group: digestibility enhancers |
| 4a39 | Huvepharma EOOD | Endo-1,4-beta- xylanase (EC 3.2.1.8)
  Endo-1,4-beta-glucanase (EC 3.2.1.4) Xyloglucan-specific endo-beta-1,4-glucanase (EC 3.2.1.151) | Additive composition

  Preparation of endo-1,4-beta-xylanase, endo-1, 4-beta-glucanase and xyloglucan-specific endo-beta-1,4-glucanase produced by Trichoderma citrinoviride DSM 33578 with a minimum activity of:
  Endo-1,4-beta-xylanase: 15 000 EPU (1)/g
  Endo-1, 4-beta-glucanase: 1 000 CU (2)/g
  Xyloglucan-specific endo-beta-1,4-glucanase: 1 000 XGU (3)/g
  Solid or liquid form

  Characterisation of the active substance

  Endo-1,4-beta-xylanase (EC 3.2.1.8), endo-1,4-beta-glucanase (EC 3.2.1.4) and xyloglucan-specific endo-beta-1,4-glucanase (EC 3.2.1.151) produced by Trichoderma citrinoviride DSM 33578

  Analytical method
   (4)

  For the determination of endo-1,4-beta-xylanase activity in the feed additive, premixtures and compound feeds: colorimetric method measuring water soluble dye released by action of endo-1,4-beta-xylanase from azurine cross-linked wheat arabinoxylan substrate.
  For the determination of endo-1,4-beta-glucanase activity in the feed additive, premixtures and compound feeds: colorimetric method based on the quantification of water soluble dyed fragments (azurine) produced by the action of endo-1,4-beta-glucanase on azurine-crosslinked cellulose.
  For the determination of xyloglucan-specific endo-beta-1,4-glucanase activity in the feed additive, premixtures and compound feeds: colorimetric method based on the quantification of soluble dyed labelled fragments produced by the action of xyloglucan-specific endo-beta-1,4-glucanase on xyloglucan substrate. | Poultry for fattening
  Poultry reared for laying and reared for breeding
  Ornamental birds | - | Endo-1,4-beta-xylanase 1 500 EPU
  Endo-1, 4-beta-glucanase 100 CU
  Xyloglucan-specific endo-beta-1,4-glucanase 100 XGU | - | 1. | In the directions for use of the additive and premixture, 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

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

Category of zootechnical additives. Functional group: digestibility enhancers

4a39

Huvepharma EOOD

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

Endo-1,4-beta-glucanase (EC 3.2.1.4) Xyloglucan-specific endo-beta-1,4-glucanase (EC 3.2.1.151)

Additive composition

Preparation of endo-1,4-beta-xylanase, endo-1, 4-beta-glucanase and xyloglucan-specific endo-beta-1,4-glucanase produced by Trichoderma citrinoviride DSM 33578 with a minimum activity of:

Endo-1,4-beta-xylanase: 15 000 EPU (1)/g

Endo-1, 4-beta-glucanase: 1 000 CU (2)/g

Xyloglucan-specific endo-beta-1,4-glucanase: 1 000 XGU (3)/g

Solid or liquid form

Characterisation of the active substance

Endo-1,4-beta-xylanase (EC 3.2.1.8), endo-1,4-beta-glucanase (EC 3.2.1.4) and xyloglucan-specific endo-beta-1,4-glucanase (EC 3.2.1.151) produced by Trichoderma citrinoviride DSM 33578

Analytical method
   (4)

For the determination of endo-1,4-beta-xylanase activity in the feed additive, premixtures and compound feeds: colorimetric method measuring water soluble dye released by action of endo-1,4-beta-xylanase from azurine cross-linked wheat arabinoxylan substrate.

For the determination of endo-1,4-beta-glucanase activity in the feed additive, premixtures and compound feeds: colorimetric method based on the quantification of water soluble dyed fragments (azurine) produced by the action of endo-1,4-beta-glucanase on azurine-crosslinked cellulose.

For the determination of xyloglucan-specific endo-beta-1,4-glucanase activity in the feed additive, premixtures and compound feeds: colorimetric method based on the quantification of soluble dyed labelled fragments produced by the action of xyloglucan-specific endo-beta-1,4-glucanase on xyloglucan substrate.

Poultry for fattening

Poultry reared for laying and reared for breeding

Ornamental birds

-

Endo-1,4-beta-xylanase 1 500 EPU

Endo-1, 4-beta-glucanase 100 CU

Xyloglucan-specific endo-beta-1,4-glucanase 100 XGU

-

1.

In the directions for use of the additive and premixture, 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 by such procedures and measures, the additive and premixtures shall be used with personal breathing and skin protective equipment. |
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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 by such procedures and measures, the additive and premixtures shall be used with personal breathing and skin protective equipment.

6.7.2033

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(1)  One xylanase unit (EPU) is the amount of enzyme which liberates 0,0083 micromoles of reducing sugars (xylose equivalents) from oat spelt xylan per minute at pH 4,7 and 50 °C.

(2)  One glucanase unit (CU) is the amount of enzyme that liberates 0,128 micromoles of reducing sugars (glucose equivalents) from barley beta-glucan per minute at pH 4,5 and 30 °C.

(3)  One xyloglucanase unit (XGU) is the amount of enzyme that releases low-molecular fragments from dyed xyloglucan in the amount equal to the amount of such fragments liberated from 1 unit enzyme standard under the conditions of the assay (50 °C and pH 4,5).

(4)  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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