# L_2021304EN.01002101.xml

| 30.8.2021 | EN | Official Journal of the European Union | L 304/21 |
| --- | --- | --- | --- |

30.8.2021

EN

Official Journal of the European Union

L 304/21

---

COMMISSION IMPLEMENTING REGULATION (EU) 2021/1414

of 27 August 2021

correcting Implementing Regulation (EU) 2021/422 concerning the authorisation of a preparation of Enterococcus faecium DSM 7134 as a feed additive for laying hens (holder of authorisation: Lactosan GmbH & Co KG)

(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 the preparation Enterococcus faecium DSM 7134 as a feed additive was authorised for laying hens by Commission Implementing Regulation (EU) 2021/422 (2) for a 10-year period. |
| --- | --- |

(1)

The use of the preparation Enterococcus faecium DSM 7134 as a feed additive was authorised for laying hens by Commission Implementing Regulation (EU) 2021/422 (2) for a 10-year period.

| (2) | In the Annex to Implementing Regulation (EU) 2021/422, the wrong identification number of the additive has been inserted in the column ‘Identification number of the additive’. |
| --- | --- |

(2)

In the Annex to Implementing Regulation (EU) 2021/422, the wrong identification number of the additive has been inserted in the column ‘Identification number of the additive’.

| (3) | The European Food Safety Authority (‘the Authority’) concluded in its opinion of 30 September 2020 (3) that the additive may be used via water for drinking, as part of the conditions of use subject to the safety and efficacy assessment. The specification deriving from that conclusion was not included in the column ‘Other provisions’ of the Annex to Implementing Regulation (EU) 2021/422, and should therefore be added therein for reasons of legal certainty. |
| --- | --- |

(3)

The European Food Safety Authority (‘the Authority’) concluded in its opinion of 30 September 2020 (3) that the additive may be used via water for drinking, as part of the conditions of use subject to the safety and efficacy assessment. The specification deriving from that conclusion was not included in the column ‘Other provisions’ of the Annex to Implementing Regulation (EU) 2021/422, and should therefore be added therein for reasons of legal certainty.

| (4) | The Authority’s opinion also indicated that the additive is not a dermal or ocular irritant, but a potential dermal and respiratory sensitiser. The Annex to Implementing Regulation (EU) 2021/422, in the column ‘Other provisions’, erroneously refers to the use of breathing protection, glasses and gloves as personal protection equipment, while it should instead refer to the use of breathing and skin protection in order to take appropriate account of the Authority’s opinion concerning users’ safety. |
| --- | --- |

(4)

The Authority’s opinion also indicated that the additive is not a dermal or ocular irritant, but a potential dermal and respiratory sensitiser. The Annex to Implementing Regulation (EU) 2021/422, in the column ‘Other provisions’, erroneously refers to the use of breathing protection, glasses and gloves as personal protection equipment, while it should instead refer to the use of breathing and skin protection in order to take appropriate account of the Authority’s opinion concerning users’ safety.

| (5) | In the Annex to Implementing Regulation (EU) 2021/422, a minor clerical error has been made as regards the name of the authorisation holder. |
| --- | --- |

(5)

In the Annex to Implementing Regulation (EU) 2021/422, a minor clerical error has been made as regards the name of the authorisation holder.

| (6) | Implementing Regulation (EU) 2021/422 should therefore be corrected accordingly. For the sake of clarity, it is appropriate to replace the whole Annex to the said Implementing Regulation by the corrected version thereof. |
| --- | --- |

(6)

Implementing Regulation (EU) 2021/422 should therefore be corrected accordingly. For the sake of clarity, it is appropriate to replace the whole Annex to the said Implementing Regulation by the corrected version thereof.

| (7) | 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. |
| --- | --- |

(7)

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.

| (8) | 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. |
| --- | --- |

(8)

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.

| (9) | The measures provided for in this Regulation are in accordance with the opinion of the Standing Committee on Plants, Animals, Food and Feed, |
| --- | --- |

(9)

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) 2021/422 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 1 December 2021 in accordance with the rules applicable before 31 August 2021 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 31 August 2022 in accordance with the rules applicable before 31 August 2021 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, 27 August 2021.

For the Commission

The President

Ursula VON DER LEYEN

---

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

1

(2)  Commission Implementing Regulation (EU) 2021/422 of 9 March 2021 concerning the authorisation of a preparation of Enterococcus faecium DSM 7134 as a feed additive for laying hens (holder of authorisation: Lactosan GmbH & Co KG) (OJ L 83, 10.3.2021, p. 25).

2

Enterococcus faecium

(3)  EFSA Journal 2020;18(11):6277.

3

---

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 |
| 4b1841 | Lactosan GmbH & Co KG | Enterococcus faecium DSM 7134 | Additive composition

  Preparation of Enterococcus faecium

  DSM 7134
  containing a minimum of:
  Powder: 1x1010 CFU/g of additive
  Granules (microencapsulated): 1x1010

  CFU/g of additive | Laying hens | - | 1 x 109 | - | 5 x 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

4b1841

Lactosan GmbH & Co KG

Enterococcus faecium DSM 7134

Additive composition

Preparation of Enterococcus faecium

DSM 7134

containing a minimum of:

Powder: 1x1010 CFU/g of additive

Granules (microencapsulated): 1x1010

CFU/g of additive

Laying hens

-

1 x 109

-

5 x 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 via water for drinking. |
| --- | --- |

2.

The additive may be used via water for drinking.

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

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 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.’ |
| --- | --- |

4.

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.’

30.3.2031

Characterisation of the active substance:

Viable cells of Enterococcus faecium DSM 7134

Analytical method
   (1)

For enumeration: Spread plate method using bile esculin azid agar (EN 15788).

For identification: Pulsed Field Gel Electrophoresis (PFGE).

---

(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

1

---