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)

• CELEX: Regulation (EC) No 258/97
• Articles: 4

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.

Schedules & Appendices

ANNEX 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