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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)

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)

Regulation (EC) No 258/97 · Decision · 4 articles

Data as of 2026-07-04 · Compiled from an official source version. Later amendments or repeals may not be reflected; the official text prevails. · Read the official text ↗

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 × 10 8 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.

Supplementary provisions

SPECIFICATION OF CLOSTRIDIUM BUTYRICUM (CBM 588)

ANNEXSupplementary provisions

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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Source: EUR-Lex (Publications Office of the EU), © European Union, reuse permitted under Commission Decision 2011/833/EU.

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