
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 
In the Annex to Regulation (EC) No 1444/2006, in the second column, name of the holder of authorisation, the term ‘Calpis Co., Ltd represented in the Community by Orffa International Holding BV’ is replaced by the term ‘Asahi Calpis Wellness Co. Ltd, represented in the European Union by Asahi Calpis Wellness Co. Ltd Europe Representative Office’.
Article 3 
Regulation (EU) No 333/2010 is amended as follows:

((a)) in the title, the term ‘holder of authorisation Calpis Co. Ltd Japan, represented in the European Union by Calpis Co. Ltd Europe Representative Office’ is replaced by the term ‘holder of authorisation Asahi Calpis Wellness Co. Ltd, represented in the European Union by Asahi Calpis Wellness Co. Ltd Europe Representative Office’;
((b)) in the Annex, in the second column, name of the holder of authorisation, the term ‘Calpis Co. Ltd Japan, represented in the European Union by Calpis Co. Ltd Europe Representative Office, France’ is replaced by the term ‘Asahi Calpis Wellness Co. Ltd, represented in the European Union by Asahi Calpis Wellness Co. Ltd Europe Representative Office’.
Article 4 
Regulation (EU) No 184/2011 is amended as follows:

((a)) in the title, the term ‘holder of authorisation Calpis Co. Ltd Japan, represented by Calpis Co. Ltd Europe Representative Office’ is replaced by the term ‘holder of authorisation Asahi Calpis Wellness Co. Ltd, represented in the European Union by Asahi Calpis Wellness Co. Ltd Europe Representative Office’;
((b)) in the Annex, in the second column, name of the holder of authorisation, the term ‘Calpis Co. Ltd Japan, represented by Calpis Co. Ltd Europe Representative Office, France’ is replaced by the term ‘Asahi Calpis Wellness Co. Ltd, represented in the European Union by Asahi Calpis Wellness Co. Ltd Europe Representative Office’.
Article 5 
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, 8 June 2016.
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
4b1820 Asahi Calpis Wellness Co. Ltd, represented in the European Union by Asahi Calpis Wellness Co. Ltd Europe Representative Office Bacillus subtilis C-3102 (DSM 15544) 
Bacillus subtilis C-3102 (DSM 15544) with minimum of 1,0 × 1010 CFU/g

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

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

Identification: pulsed-field gel electrophoresis (PFGE).
 Laying hens — 3 × 108 — 
1. In the directions for use of the additive, premixture and compound feedingstuff indicate the storage temperature, storage life and stability to pelleting shall be indicated.

2. For users of the additive and premixtures in a feed business, operational procedures and appropriate organisational measures shall be established to address hazards by inhalation, dermal contact or eyes contact. Where the dermal, inhalator or eyes exposure cannot be reduced to an acceptable level by these procedures and measures, the additive and premixtures shall be used with appropriate personal protective equipment.
 29 June 2026
Ornamental fish 1 × 1010
