Commission Implementing Regulation (EU) 2019/1315 of 2 August 2019 concerning the authorisation of a preparation of Enterococcus faecium DSM 7134 as a feed additive (in water for drinking) for sows (holder of authorisation Lactosan GmbH & Co) (Text with EEA relevance.)

• CELEX: Implementing Regulation (EU) 2019/1315
• Articles: 3

Article 1 Authorisation

The preparation specified in the Annex, belonging to the additive category ‘zootechnical additives’ and to the functional group ‘gut flora stabilisers’, is authorised as an additive in animal nutrition as set out in that Annex.

Article 2 Entry into force

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/l of water for drinking

Category of zootechnical additives. Functional group: gut flora stabilisers.

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Lactosan Starterkulturen GmbH & Co

Enterococcus faecium DSM 7134

Additive composition

Preparation of Enterococcus faecium DSM 7134 containing a minimum of:

Powder: 1 × 10 10 CFU/g of additive

Characterisation of the active substance

Viable cells of Enterococcus faecium DSM 7134

Analytical method

( 1 )

For enumeration: spread plate method using bile esculin azide agar (EN 15788)

For identification: pulsed field gel electrophoresis (PFGE)

Sows

—

2,5 × 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.

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 protection and gloves.

3.

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

25 August 2029

( 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