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.
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 .
ANNEXSupplementary provisions
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.
4b1841
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