Commission Implementing Regulation (EU) 2025/2233 of 6 November 2025 authorising the placing on the market of Clostridium butyricum TO-A as a novel food and amending Implementing Regulation (EU) 2017/2470
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 ↗
1. Clostridium butyricum TO-A is authorised to be placed on the market within the Union. Clostridium butyricum TO-A shall be included in the Union list of novel foods set out in Implementing Regulation (EU) 2017/2470. 2. The Annex to Implementing Regulation (EU) 2017/2470 is amended in accordance with the Annex to this Regulation.
Only the company TOA Biopharma Co. Ltd. ( 19 ) is authorised to place on the market within the Union the novel food referred to in Article 1, for a period of 5 years from 27 November 2025, unless a subsequent applicant obtains an authorisation for the novel food without reference to the scientific data protected pursuant to Article 3 or with the agreement of the company TOA Biopharma Co. Ltd.
The scientific data contained in the application file and fulfilling the conditions laid down in Article 26(2) of Regulation (EU) 2015/2283 shall not be used for the benefit of a subsequent applicant for a period of 5 years from the date of entry into force of this Regulation without the agreement of the company TOA Biopharma Co. Ltd.
This Regulation shall enter into force on the twentieth day following that of its publication in the Official Journal of the European Union.
ANNEX The Annex to Implementing Regulation (EU) 2017/2470 is amended as follows: (1) In Table 1 (Authorised novel foods) the following entry is inserted: Authorised novel food Conditions under which the novel food may be used Additional specific labelling requirements Other requirements Data protection ‘ Clostridium butyricum TO-A Specified food category Maximum levels 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. Authorised on 27 November 2025. This inclusion is based on proprietary scientific evidence and scientific data protected in accordance with Article 26 of Regulation (EU) 2015/2283. Applicant: TOA Biopharma Co. Ltd., 2-1-11, Sasazuka, Shibuya, Tokyo, Japan. During the period of data protection, the novel food Clostridium butyricum TO-A is authorised for placing on the market within the Union only by TOA Biopharma Co. Ltd., unless a subsequent applicant obtains authorisation for the novel food without reference to the proprietary scientific evidence or scientific data protected in accordance with Article 26 of Regulation (EU) 2015/2283 or with the agreement of TOA Biopharma Co. Ltd. End date of the data protection: 27 November 2032’ Food supplements as defined in Directive 2002/46/EC, excluding infants and young children, and pregnant and lactating women 1,0 × 10 8 CFU/day for children from 3 to < 10 years 2,0 × 10 8 CFU/day for adolescents from 10 to < 14 years 2,8 × 10 8 CFU/day for adolescents from 14 to < 18 years 3,2 × 10 8 CFU/day for adults, excluding pregnant and lactating women (2) in Table 2 (Specifications), the following entry is inserted: Authorised Novel Food Specifications ‘ Clostridium butyricum TO-A 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 × 10 9 CFU/g Moisture: < 5 % Coliforms: < 10 CFU/g TAMC: ≤ 1 × 10 3 CFU/g TYMC: ≤ 1 × 10 2 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.’
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