Commission Implementing Regulation (EU) 2021/1424 of 31 August 2021 concerning the renewal of the authorisation of a preparation of Enterococcus faecium DSM 7134 as a feed additive for chickens for fattening, and repealing Regulation (EU) No 998/2010 (holder of authorisation Lactosan GmbH & Co KG) (Text with EEA relevance)

• CELEX: Implementing Regulation (EU) 2021/1424
• Articles: 4

Article 1

The authorisation of the preparation specified in the Annex, belonging to the additive category ‘zootechnical additives’ and to the functional group ‘gut flora stabilisers’, is renewed subject to the conditions laid down in that Annex.

Article 2

Regulation (EU) No 998/2010 is repealed.

Article 3

This Regulation shall enter into force on the twentieth 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

Other provisions

End of period of authorisation

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

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: 1 × 10 10 CFU/g of additive

Granules (microencapsulated): 1x10 10

CFU/g of additive

Chickens for fattening

-

5 × 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.

May be used in feed containing the following permitted coccidiostats: robenidine hydrochloride, maduramicin ammonium, diclazuril, decoquinate, halofuginone hydrobromide, monensin sodium and lasalocid A sodium.

3.

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. 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 breathing and skin protection.

21 September 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