# L_2021304EN.01001801.xml

| 30.8.2021 | EN | Official Journal of the European Union | L 304/18 |
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30.8.2021

EN

Official Journal of the European Union

L 304/18

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COMMISSION IMPLEMENTING REGULATION (EU) 2021/1413

of 27 August 2021

concerning the authorisation of endo-1,4-beta-xylanase produced by Bacillus subtilis LMG-S 15136 as a feed additive for lactating sows (holder of the authorisation Beldem, division of Puratos NV)

(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 Bacillus subtilis LMG-S 15136. 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 produced by Bacillus subtilis LMG-S 15136. 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 (EC 3.2.1.8) produced by Bacillus subtilis LMG-S 15136 as a feed additive for lactating sows to be classified in the additive 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 (EC 3.2.1.8) produced by Bacillus subtilis LMG-S 15136 as a feed additive for lactating sows 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 opinions of 7 October 2019 (2) and 27 January 2021 (3) that, under the proposed conditions of use, the preparation of endo-1,4-beta-xylanase produced by Bacillus subtilis LMG-S 15136 does not have an adverse effect on animal health, consumer safety or the environment. The Authority concluded that that additive should be considered a respiratory sensitiser and a potential dermal 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 has a potential to be efficacious as a zootechnical additive in sows during the lactation period. 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) and 27 January 2021 (3) that, under the proposed conditions of use, the preparation of endo-1,4-beta-xylanase produced by Bacillus subtilis LMG-S 15136 does not have an adverse effect on animal health, consumer safety or the environment. The Authority concluded that that additive should be considered a respiratory sensitiser and a potential dermal 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 has a potential to be efficacious as a zootechnical additive in sows during the lactation period. 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 endo-1,4-beta-xylanase produced by Bacillus subtilis LMG-S 15136 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 endo-1,4-beta-xylanase produced by Bacillus subtilis LMG-S 15136 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, 27 August 2021.

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):5892.

2

(3)  EFSA Journal 2021;19(3):6456.

3

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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 feed with a moisture content of 12 % |
| Category: zootechnical additives. Functional group: digestibility enhancers. |
| 4a1606i | Beldem, division of Puratos NV | 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 Bacillus subtilis LMG-S 15136 having a minimum activity of 400 IU  (1)/g.
  Solid and liquid form. | Lactating sows | - | 10 IU | - | 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 feed with a moisture content of 12 %

Category: zootechnical additives. Functional group: digestibility enhancers.

4a1606i

Beldem, division of Puratos NV

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 Bacillus subtilis LMG-S 15136 having a minimum activity of 400 IU  (1)/g.

Solid and liquid form.

Lactating sows

-

10 IU

-

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 by inhalation, dermal contact or eyes contact. 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 eyes, skin and 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 by inhalation, dermal contact or eyes contact. 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 eyes, skin and breathing protection.

19.9.2031

Characterisation of the active substance:

Endo-1,4-beta-xylanase (EC 3.2.1.8) produced by Bacillus subtilis LMG-S 15136.

Analytical method  (2)

For the quantification of xylanase activity in the feed additive:

| — | colorimetric method measuring reducing sugars released by action of xylanase on birchwood xylan substrate in the presence of 3,5-dinitrosalicilic acid (DNS). |
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colorimetric method measuring reducing sugars released by action of xylanase on birchwood xylan substrate in the presence of 3,5-dinitrosalicilic acid (DNS).

For the quantification of xylanase activity in premixtures, compound feed and feed materials:

| — | colorimetric method measuring water soluble dye released by action of xylanase from azurine cross-linked wheat arabinoxylan substrates. |
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—

colorimetric method measuring water soluble dye released by action of xylanase from azurine cross-linked wheat arabinoxylan substrates.

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(1)  1 IU corresponds to the amount of enzyme which liberates one micromole of reducing sugars (xylose equivalents) from birchwood xylan per minute at pH 4.5 and 30 °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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