The authorisation of the additive specified in the Annex, belonging to the additive category βzootechnical additivesβ and to the functional group βgut flora stabilisersβ, is renewed subject to the conditions laid down in that Annex.
Regulation (EC) No 538/2007 is repealed.
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
(Trade name)
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
Starterkulturen
GmbH & Co
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
Piglets (weaned)
β
0,5 x 10 9
4 x 10 9
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, skin and eye protections.
26 February 2030
Characterisation of the active substance:
Viable cells of Enterococcus faecium DSM 7134
Analytical method
Β ( 1 )
For enumeration: spread plate method using bile esculin azide agar (EN 15788)
For identification: pulsed field gel electrophoresis (PFGE)
Β
Β
Β
Β
Pigs for fattening
β
0,2 x 10 9
1 x 10 9
26 February 2030
( 1 ) Β Β 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