Clostridium butyricum: authorised novel food in the EU

Conditions of use and maximum levels

Table 1, column "Conditions under which the novel food may be used", as written:

• Food Supplements as defined in Directive 2002/46/EC: 1,35 × 108 CFU/day

Additional specific labelling requirements

The designation of the novel food on the labelling of the foodstuffs containing it shall be ‘Clostridium butyricum MIYAIRI 588 (CBM 588)’ or ‘Clostridium butyricum (CBM 588)’

Specification (Table 2)

Table 2 of the Annex, row with the same name, as written:

Description/Definition:

Clostridium butyricum (CBM-588) is a Gram-positive, spore-forming, obligate anaerobic, non-pathogenic, non-genetically modified bacterium. Depository number FERM BP-2789

Microbiological criteria:

Total viable aerobic count: ≤ 103 CFU/g

Escherichia coli: Not detected in 1 gStaphylococcus aureus: Not detected in 1 g

Pseudomonas aeruginosa: Not detected in 1 g

Yeast and moulds: ≤ 102 CFU/g

Source and version

Implementing Regulation (EU) 2017/2470, Annex, Union list of novel foods, Table 1. Consolidated text of 10 August 2026. The text above is copied from that document without change except that amendment markers are removed. It is not advice and it does not decide whether a particular product is covered.

• Consolidated text on EUR-Lex

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