,On 10 November 2025, the European Commission officially authorized the marketing of Clostridium butyricum TO-A as a novel food through Delegated Regulation (EU) 2025/2233, which also amends Implementing Regulation (EU) 2017/2470 to include this novel food in the Union list.
The application for authorization was originally submitted on 10 November 2021 by TOA Biopharma Co. Ltd., seeking approval to use Clostridium butyricum TO-A in food supplements for the general population above 3 months of age, in accordance with Article 10(1) of Regulation (EU) 2015/2283.
On 8 June 2022, the Commission requested a scientific opinion from the European Food Safety Authority (EFSA). EFSA delivered its assessment on 25 March 2025, concluding that the strain is safe when used at the following maximal intake levels:
• 1.0 × 10⁸ CFU/day for children aged 3–<10 years
• 2.0 × 10⁸ CFU/day for adolescents aged 10–<14 years
• 2.8 × 10⁸ CFU/day for adolescents aged 14–<18 years
• 3.2 × 10⁸ CFU/day for adults excluding pregnant and lactating women
Based on EFSA’s conclusions, the Commission determined that Clostridium butyricum TO-A meets the safety conditions for authorization. As a result, it is now permitted for placement on the EU market and will be formally added to the Union list of approved novel foods.
The regulation also introduces amendments to the Annex of Implementing Regulation (EU) 2017/2470, reflecting the inclusion of this new entry.
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