
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 as set out 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, 2 August 2019.
For the Commission
The President
Jean-Claude JUNCKER
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
4b1893 Cargill Incorporated, represented by Provimi Holding BV Bacillus amyloliquefaciens NRRL B-50508, Bacillus amyloliquefaciens NRRL B-50509 andBacillus subtilis NRRL B-50510 
Preparation of Bacillus amyloliquefaciens NRRL B-50508, Bacillus amyloliquefaciens NRRL B-50509 and Bacillus subtilis NRRL B-50510 containing a minimum of: Bacillus spp. 2,5 × 109 CFU/g (ratio 1:1:1)

Powder form

Viable spore of Bacillus amyloliquefaciens NRRL B-50508, Bacillus amyloliquefaciens NRRL B-50509 and Bacillus subtilis NRRL B-50510

For the identification: Pulsed Field Gel Electrophoresis (PFGE)

For enumeration in the feed additive, premixtures and feedingstuffs: Spread plate method on tryptone soya agar (EN 15784)
 Pigs for fatteningMinor porcine species for fattening — 1,5 × 108 — 
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 and skin protection.
 25 August 2029
