2014/907/EU: Commission Implementing Decision of 11 December 2014 authorising the placing on the market of Clostridium butyricum (CBM 588) as a novel food ingredient under Regulation (EC) No 258/97 of the European Parliament and of the Council (notified under document C(2014) 9345)
Data as of 2026-07-04 Β· Compiled from an official source version. Later amendments or repeals may not be reflected; the official text prevails. Β· Read the official text β
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 Γ 10 8 CFU per day without prejudice to the specific provisions of Directive 2002/46/EC.
The designation of Clostridium butyricum (CBM 588) authorised by this Decision on the labelling of the foodstuffs containing it shall be β Clostridium butyricum MIYAIRI 588 (CBM 588)β or β Clostridium butyricum (CBM 588)β.
This Decision is addressed to Miyarisan Pharmaceutical Co. Ltd, 1-10-3, Kaminakazato, Kita-Ku, Tokyo 114-0016, Japan.
SPECIFICATION OF CLOSTRIDIUM BUTYRICUM (CBM 588)
ANNEX SPECIFICATION OF CLOSTRIDIUM BUTYRICUM (CBM 588) Definition : Clostridium butyricum (CBM 588) is a Gram-positive, spore-forming, obligate anaerobic, non-pathogenic, non-genetically modified bacterium. Description : White or pale grey tablets with characteristic odour and sweet taste. Microbiological criteria: Total viable aerobic count Not more than 10 3 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 10 2 CFU/g
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