
Article 1 
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.
Article 2 
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, 15 July 2020.
For the Commission
The President
Ursula VON DER LEYEN
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/kg of complete feedingstuff with a moisture content of 12 %
Category of zootechnical additives. Functional group: gut flora stabilisers
4b1825 Lactosan GmbH & Co. KG Bacillus subtilisDSM 28343 Additive compositionPreparation of Bacillus subtilis DSM 28343 containing a minimum of 1 × 1010 CFU/g of additiveSolid form———————————————Characterisation of the active substanceViable spores of Bacillus subtilis DSM 28343———————————————Analytical methodFor identification of Bacillus subtilis DSM 28343 in the feed additive, premixtures and feedingstuffs: Pulsed Field Gel Electrophoresis (PFGE)For enumeration of Bacillus subtilis DSM 28343 in the feed additive, premixtures and feedingstuffs: Spread plate method using tryptone soya agar – EN 15784 Calves for rearingPigs for fattening -- 1 × 1092 × 108 - 
1. In the directions for use of the additive and premixtures, the storage conditions and stability to heat treatment shall be indicated.

2. The use in calves for rearing shall be restricted to milk replacers.

3. For users of the additive and premixtures, feed business operators shall establish operational procedures and organisational measures to address potential risks from their 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.
 5 August 2030
