# L_2022043EN.01000701.xml

| 24.2.2022 | EN | Official Journal of the European Union | L 43/7 |
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24.2.2022

EN

Official Journal of the European Union

L 43/7

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COMMISSION IMPLEMENTING REGULATION (EU) 2022/270

of 23 February 2022

correcting Implementing Regulation (EU) 2021/1410 concerning the authorisation of a preparation of Bacillus licheniformis DSM 28710 as a feed additive for laying hens, minor poultry species for laying, poultry species for breeding and ornamental birds (holder of authorisation Huvepharma 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) | The use of a preparation of Bacillus licheniformis DSM 28710 as a feed additive was authorised for laying hens, minor poultry species for laying, poultry species for breeding and ornamental birds by Commission Implementing Regulation (EU) 2021/1410 (2) for a 10-year period. |
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(1)

The use of a preparation of Bacillus licheniformis DSM 28710 as a feed additive was authorised for laying hens, minor poultry species for laying, poultry species for breeding and ornamental birds by Commission Implementing Regulation (EU) 2021/1410 (2) for a 10-year period.

| (2) | In the Annex to Implementing Regulation (EU) 2021/1410, an incorrect identification of the species, for which the additive is authorised, which excluded turkeys for breeding, was inserted in the column ‘Species or category of animal’. |
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(2)

In the Annex to Implementing Regulation (EU) 2021/1410, an incorrect identification of the species, for which the additive is authorised, which excluded turkeys for breeding, was inserted in the column ‘Species or category of animal’.

| (3) | Implementing Regulation (EU) 2021/1410 should therefore be corrected accordingly. For the sake of clarity, it is appropriate to replace the whole Annex to that Implementing Regulation. |
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(3)

Implementing Regulation (EU) 2021/1410 should therefore be corrected accordingly. For the sake of clarity, it is appropriate to replace the whole Annex to that Implementing Regulation.

| (4) | In order to allow feed business operators to adapt the labelling of the additive and feed containing it to the corrected terms of authorisation, a transitional period should be provided for as regards the placing on the market of those products. |
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(4)

In order to allow feed business operators to adapt the labelling of the additive and feed containing it to the corrected terms of authorisation, a transitional period should be provided for as regards the placing on the market of those products.

| (5) | In order to preserve the legitimate expectations of the interested parties in relation to the terms of the authorisation of the additive, this Regulation should enter into force as a matter of urgency. |
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(5)

In order to preserve the legitimate expectations of the interested parties in relation to the terms of the authorisation of the additive, this Regulation should enter into force as a matter of urgency.

| (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 Annex to Implementing Regulation (EU) 2021/1410 is replaced by the Annex to this Regulation.

Article 2

1.   The preparation specified in the Annex and premixtures containing that substance, which are produced and labelled before 25 August 2022 in accordance with the rules applicable before 25 February 2022 may continue to be placed on the market until the existing stocks are exhausted.

2.   Feed materials and compound feed containing the preparation and premixtures referred to in paragraph 1 which are produced and labelled before 25 February 2023 in accordance with the rules applicable before 25 February 2022 may continue to be placed on the market until the existing stocks are exhausted.

Article 3

This Regulation shall enter into force on the 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, 23 February 2022.

For the Commission

The President

Ursula VON DER LEYEN

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

1

(2)  Commission Implementing Regulation (EU) 2021/1410 of 27 August 2021 concerning the authorisation of a preparation of Bacillus licheniformis DSM 28710 as a feed additive for laying hens, minor poultry species for laying, poultry species for breeding and ornamental birds (holder of authorisation Huvepharma NV) (OJ L 304, 30.8.2021, p. 8).

2

Bacillus licheniformis

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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 |
| --- | --- | --- | --- | --- | --- | --- | --- | --- | --- |
| CFU/kg of complete feedingstuff with a moisture content of 12 % |
| Category: zootechnical additives. Functional group: gut flora stabilisers |
| 4b1828 | Huvepharma NV | Bacillus licheniformis DSM 28710 | Additive composition

  Preparation of Bacillus licheniformis DSM 28710
  containing a minimum of:
  3,2 × 109 CFU/g of additive
  Solid form

  Characterisation of the active substance

  Viable spores of Bacillus licheniformis DSM 28710

  Analytical method
   (1)

  For the enumeration of Bacillus licheniformis DSM 28710 in additive, premixture and feedingstuffs:






  — | Spread plate method EN 15784 |

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

CFU/kg of complete feedingstuff with a moisture content of 12 %

Category: zootechnical additives. Functional group: gut flora stabilisers

4b1828

Huvepharma NV

Bacillus licheniformis DSM 28710

Additive composition

Preparation of Bacillus licheniformis DSM 28710

containing a minimum of:

3,2 × 109 CFU/g of additive

Solid form

Characterisation of the active substance

Viable spores of Bacillus licheniformis DSM 28710

Analytical method
   (1)

For the enumeration of Bacillus licheniformis DSM 28710 in additive, premixture and feedingstuffs:

—

Spread plate method EN 15784

For the identification of Bacillus licheniformis DSM 28710:

| — | Pulsed Field Gel Electrophoresis (PFGE) |
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—

Pulsed Field Gel Electrophoresis (PFGE)

Laying hens

Minor poultry species for laying

Poultry species for breeding

Ornamental birds

-

1,6 × 109

-

| 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. | May be used in feed containing the following permitted coccidiostats: diclazuril and lasalocid A sodium. |
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2.

May be used in feed containing the following permitted coccidiostats: diclazuril and lasalocid A sodium.

| 3. | For users of the additive and premixtures, feed business operators shall establish operational procedures and appropriate organisational measures to address hazards by inhalation, dermal contact or eyes contact. Where the dermal, inhalation or eyes exposure 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 skin, eyes and breathing protection. |
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3.

For users of the additive and premixtures, feed business operators shall establish operational procedures and appropriate organisational measures to address hazards by inhalation, dermal contact or eyes contact. Where the dermal, inhalation or eyes exposure 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 skin, eyes and breathing protection.

19.9.2031

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(1)  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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