
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, 14 June 2013.
For the Commission
The President
José Manuel BARROSO
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
4b1890 Biomin GmbH Bifidobacterium animalis ssp. animalisDSM 16284, Lactobacillus salivarius ssp. salivarius DSM 16351 and Enterococcus faecium DSM 21913 
 Additive composition
Preparation in form of a mixture of:

 Bifidobacterium animalis ssp. animalis DSM 16284 containing a minimum of 3 × 109 CFU/g additive
 Lactobacillus salivarius ssp. salivarius DSM 16351 containing a minimum of 1 × 109 CFU/g additive
 Enterococcus faecium DSM 21913 containing a minimum of 6 × 109 CFU/g additiveSolid preparation (ratio 3:1:6)
 Characterisation of active substance
Viable cells of Bifidobacterium animalis ssp. animalis DSM 16284, Lactobacillus salivarius ssp. salivarius DSM 16351, and Enterococcus faecium DSM 21913
 Analytical methods
For the enumeration of:

 Bifidobacterium animalis ssp. animalis DSM 16284: spread plate method EN 15785
 Lactobacillus salivarius ssp. salivarius DSM 16351: spread plate method EN 15787
 Enterococcus faecium DSM 21913 spread plate method EN 15788For the identification:
Pulsed Field Gel Electrophoresis (PFGE) Chickens for fattening — 1 × 108 1 × 109 
1.. In the directions for use of the additive and premixture, indicate the storage temperature, storage life and stability to pelleting.
2.. The additive may be used with feed containing the following coccidiostats: maduramicin ammonium, diclazuril or robenidine hydrochloride.
3.. For safety: breathing protection, glasses and gloves shall be used during handling. 5 July 2023

