
Article 1 
Clostridium butyricum (CBM 588) as specified in the Annex may be placed on the market in the Union as a novel food ingredient to be used in food supplements with a maximum dose of 1,35 × 108 CFU per day without prejudice to the specific provisions of Directive 2002/46/EC.
Article 2 
The designation of Clostridium butyricum (CBM 588) authorised by this Decision on the labelling of the foodstuffs containing it shall be ‘Clostridium butyricum MIYAIRI 588 (CBM 588)’ or ‘Clostridium butyricum (CBM 588)’.
Article 3 
This Decision is addressed to Miyarisan Pharmaceutical Co. Ltd, 1-10-3, Kaminakazato, Kita-Ku, Tokyo 114-0016, Japan.
Done at Brussels, 11 December 2014.
For the Commission
Vytenis ANDRIUKAITIS
Member of the Commission
ANNEX
DefinitionClostridium butyricum (CBM 588) is a Gram-positive, spore-forming, obligate anaerobic, non-pathogenic, non-genetically modified bacterium.DescriptionWhite or pale grey tablets with characteristic odour and sweet taste.


Total viable aerobic count Not more than 103 CFU/g
Escherichia coli Not detected in 1 g
Staphylococcus aureus Not detected in 1 g
Pseudomonas aeruginosa Not detected in 1 g
Yeast and moulds Not more than 102 CFU/g
