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, subject to the conditions laid down 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
Name of the 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 feed with a moisture content of 12 %
CFU/l of water for drinking
Category: zootechnical additives. Functional group: gut flora stabilisers
4b1708
Chr. Hansen A/S
Enterococcus lactis
NCIMB 11181
Additive composition
Preparation of Enterococcus
lactis NCIMB 11181 containing a minimum of: Solid form: 5 × 10 10 CFU/g additive;
Solid water-soluble form: 2 × 10 11 CFU/g additive.
Characterisation of the active substance
Viable cells of Enterococcus lactis
NCIMB 11181
Analytical method
( 1 )
Enumeration of the active substance in the feed additive, premixtures, compound feed and water for drinking: spread plate method using Bile Esculin Azide agar – EN 15788
Identification: Pulsed-Field Gel Electrophoresis (PFGE) – CEN/TS 17697 or DNA sequencing methods
Poultry for fattening and reared for laying or reproduction
Ornamental birds
—
3 × 10 10
—
1,5 ×10 10
—
1.
In the directions for use of the additive and premixtures, the storage conditions, the stability to heat treatment and the stability in water for drinking shall be indicated.
2.
The additive may be used via water for drinking.
3.
The water-soluble formulation of the additive shall be used via water for drinking.
4.
The additive may be used simultaneously with the following coccidiostats, in accordance with their respective conditions of authorisation as feed additives: monensin sodium and decoquinate.
5.
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 by such procedures and measures, the additive and premixtures shall be used with personal eye (only for the solid formulation), breathing, and skin protective equipment.
16 June 2036
( 1 ) Details of the analytical methods are available at the following address of the Reference Laboratory: https://joint-research-centre.ec.europa.eu/eurl-fa-eurl-feed-additives/eurl-fa-authorisation/eurl-fa-evaluation-reports_en .