Commission Implementing Regulation (EU) 2018/1081Show full title

Commission Implementing Regulation (EU) 2018/1081 of 30 July 2018 concerning the authorisation of the preparation of Bacillus subtilis C-3102 (DSM 15544) as a feed additive for pigs for fattening (holder of the authorisation Asahi Calpis Wellness Co. Ltd, represented by Asahi Calpis Wellness Co. Ltd Europe Representative Office) (Text with EEA relevance)

ANNEX

a

Details of the analytical methods are available at the following address of the Reference Laboratory: www.irmm.jrc.ec.europa.eu/crl-feed-additives

Identification number of the additiveName of the holder of authorisationAdditiveComposition, chemical formula, description, analytical methodSpecies or category of animalMaximum ageMinimum contentMaximum contentOther provisionsEnd of period of authorisation
CFU/kg of complete feedingstuff with a moisture content of 12 %
Category of zootechnical additives. Functional group: gut flora stabilisers
4b1820Asahi Calpis Wellness Co. Ltd, represented in the European Union by Asahi Calpis Wellness Co. Ltd Europe Representative Office Bacillus subtilis C-3102 (DSM 15544)

Additive composition

Bacillus subtilis C-3102 (DSM 15544) with minimum of 1,0 × 1010 CFU/g

Solid form

Characterisation of the active substance

Viable spores (CFU) of Bacillus subtilis C-3102 (DSM 15544)

Analytical method a

Enumeration: spread plate method using tryptone soya agar in all target matrices (EN 15784:2009)

Identification: pulsed-field gel electrophoresis (PFGE).

Pigs for fattening1,5 × 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 of 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.

20.8.2028