# L_2022043EN.01001001.xml

| 24.2.2022 | EN | Official Journal of the European Union | L 43/10 |
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24.2.2022

EN

Official Journal of the European Union

L 43/10

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COMMISSION IMPLEMENTING REGULATION (EU) 2022/271

of 23 February 2022

correcting Implementing Regulation (EU) 2020/1760 concerning the authorisation of the preparation of Bacillus subtilis DSM 25841 as a feed additive for all porcine species, including sows, other than lactating sows in order to have a benefit in suckling piglets (holder of authorisation Chr. Hansen A/S)

(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 Bacillus subtilis DSM 25841 as a feed additive was authorised for all porcine species, including sows, other than lactating sows in order to have a benefit in suckling piglets by Commission Implementing Regulation (EU) 2020/1760 (2) for a 10-year period. |
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(1)

The use of Bacillus subtilis DSM 25841 as a feed additive was authorised for all porcine species, including sows, other than lactating sows in order to have a benefit in suckling piglets by Commission Implementing Regulation (EU) 2020/1760 (2) for a 10-year period.

| (2) | In the Annex to Implementing Regulation (EU) 2020/1760, a wrong identification number was inserted in the column ‘Identification number of the additive’. |
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(2)

In the Annex to Implementing Regulation (EU) 2020/1760, a wrong identification number was inserted in the column ‘Identification number of the additive’.

| (3) | Implementing Regulation (EU) 2020/1760 should therefore be corrected accordingly. For the sake of clarity, it is appropriate to replace the whole Annex to that Implementing Regulation by the corrected version thereof. |
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(3)

Implementing Regulation (EU) 2020/1760 should therefore be corrected accordingly. For the sake of clarity, it is appropriate to replace the whole Annex to that Implementing Regulation by the corrected version thereof.

| (4) | In order to allow feed business operators to adapt the labelling of the additive and feed containing it to the corrected terms of the 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 the 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) 2020/1760 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) 2020/1760 of 25 November 2020 concerning the authorisation of the preparation of Bacillus subtilis DSM 25841 as a feed additive for all porcine species, including sows, other than lactating sows in order to have a benefit in suckling piglets (holder of authorisation Chr. Hansen A/S) (OJ L 397, 26.11.2020, p. 6).

2

Bacillus subtilis

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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 | Minimum content | Maximum content | Other provisions | End of period of authorisation |
| --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- |
| CFU/kg of complete feedingstuff with a moisture content of 12 % | CFU/l of water for drinking |
| Category of zootechnical additives. Functional group: gut flora stabilisers |
| 4b1902 | Chr. Hansen A/S | Bacillus subtilis

  DSM 25841 | Additive composition

  Preparation of Bacillus subtilis DSM 25841 containing a minimum of 1,25 × 1010 CFU/g of additive
  Solid form

  Characterisation of the active substance

  Viable spores of Bacillus subtilis DSM 25841

  Analytical method
   (1)

  For identification of Bacillus subtilis DSM 25841: Identification: Pulsed Field Gel Electrophoresis (PFGE)
  For enumeration of Bacillus subtilis DSM 25841 in the feed additive, premixtures and feedingstuffs: Spread plate method using tryptone soya agar – EN 15784 | All porcine species, including sows,
  other than lactating sows in order to have a benefit in suckling piglets | - | 5 × 108 | - | 1,7 × 108 | - | 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

Minimum content

Maximum content

Other provisions

End of period of authorisation

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

CFU/l of water for drinking

Category of zootechnical additives. Functional group: gut flora stabilisers

4b1902

Chr. Hansen A/S

Bacillus subtilis

DSM 25841

Additive composition

Preparation of Bacillus subtilis DSM 25841 containing a minimum of 1,25 × 1010 CFU/g of additive

Solid form

Characterisation of the active substance

Viable spores of Bacillus subtilis DSM 25841

Analytical method
   (1)

For identification of Bacillus subtilis DSM 25841: Identification: Pulsed Field Gel Electrophoresis (PFGE)

For enumeration of Bacillus subtilis DSM 25841 in the feed additive, premixtures and feedingstuffs: Spread plate method using tryptone soya agar – EN 15784

All porcine species, including sows,

other than lactating sows in order to have a benefit in suckling piglets

-

5 × 108

-

1,7 × 108

-

1.

In the directions for use of the additive and premixtures, the storage conditions and stability to heat treatment shall be indicated.

| 2. | The additive may be used in water for drinking. |
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2.

The additive may be used in water for drinking.

| 3. | For use of the additive in water for drinking the homogenous dispersion of the additive shall be ensured. |
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3.

For use of the additive in water for drinking the homogenous dispersion of the additive shall be ensured.

| 4. | 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: a potential respiratory sensitiser, potential skin irritant and potential eyes or dermal sensitiser. 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. |
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4.

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: a potential respiratory sensitiser, potential skin irritant and potential eyes or dermal sensitiser. 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.

16.12.2030

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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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