
Article 1 
The authorisation of the additive 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Regulation (EC) No 538/2007 is repealed.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.
This Regulation shall be binding in its entirety and directly applicable in all Member States.Done at Brussels, 5 February 2020.
For the Commission
The President
Ursula VON DER LEYEN
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 LactosanStarterkulturenGmbH & Co Enterococcus faecium DSM 7134 Additive composition:Preparation of Enterococcus faeciumDSM 7134containing a minimum of:Powder: 1x1010 CFU/g of additiveGranules (microencapsulated): 1x1010 CFU/g of additive Piglets (weaned) — 0,5 x 109 4 x 109 
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 faeciumDSM 7134
Analytical methodFor enumeration: spread plate method using bile esculin azide agar (EN 15788)For identification: pulsed field gel electrophoresis (PFGE)
    Pigs for fattening — 0,2 x 109 1 x 109 26 February 2030
