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)

• CELEX: Implementing Regulation (EU) 2021/1414
• Articles: 4

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.

Schedules & Appendices

ANNEX

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: 1x10 10 CFU/g of additive

Granules (microencapsulated): 1x10 10

CFU/g of additive

Laying hens

-

1 x 10 9

-

5 x 10 8

-

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.

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.’

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