Clostridium butyricum TO-A: 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, excluding infants and young children, and pregnant and lactating women: 1,0 × 108 CFU/day for children from 3 to < 10 years 2,0 × 108 CFU/day for adolescents from 10 to < 14 years 2,8 × 108 CFU/day for adolescents from 14 to < 18 years 3,2 × 108 CFU/day for adults, excluding pregnant and lactating women

Additional specific labelling requirements

1. The designation of the novel food on the labelling of the foodstuffs containing it shall be ‘Clostridium butyricum TO-A’. 2. The labelling of food supplements containing Clostridium butyricum TO-A shall bear a statement that the food supplements should not be consumed by: a) pregnant and lactating women b) infants and children under 3 years of age c) infants and children under 10 years of age d) infants and children under 14 years of age e) infants, children and adolescents under 18 years of age depending on the age group the food supplements is intended for.

Specification (Table 2)

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

Description/Definition

Clostridium butyricum TO-A, is a gram-positive, spore-forming, obligate anaerobic, non-pathogenic, non-genetically modified bacterium. The TO-A strain is deposited under number FERM BP-10866.

The novel food is produced by anaerobic fermentation of Clostridium butyricum TO-A followed by centrifugation and spray-drying and mixed with potato starch (to stabilise the spores by keeping a dry environment).

The novel food is a mixture of viable spores and vegetative cells with about 85 % (range: 74 %-89 %) of spores.

Characteristics/criteria

C. butyricum TO-A: 1-7 × 109 CFU/g

Moisture: < 5 %

Coliforms: < 10 CFU/g

TAMC: ≤ 1 × 103 CFU/g

TYMC: ≤ 1 × 102 CFU/g

Salmonella spp.: not detected in 25 g

Abbreviations: CFU, colony forming units; TAMC, total aerobic microbial count; TYMC, total yeast and mould count.

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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