Clostridium butyricum TO-A as a novel food in supplements: WGS without botulinum neurotoxin genes, counts according to ISO 15213 as sulphite-reducing anaerobes, spores 74–89 %; a corrigendum shortens data protection to 2030
Commission Implementing Regulation (EU) 2025/2233, published on 7 November 2025, authorises Clostridium butyricum TO-A (TOA Biopharma Co. Ltd.) in food supplements: 1.0 × 10⁸ CFU per day for children aged 3–10, 2.0 × 10⁸ for 10–14, 2.8 × 10⁸ for 14–18 and 3.2 × 10⁸ for adults, excluding pregnant and lactating women. The applicant sought use from 3 months of age; EFSA narrowed the group to persons over 3 years.
- Specification: 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, no Salmonella in 25 g. The product is a mixture of spores (about 85 %, range 74–89 %) and vegetative cells with potato starch; the strain is deposited under number FERM BP-10866.
- According to the EFSA opinion, the C. butyricum count in 5 batches was determined according to ISO 15213:2003 as sulphite-reducing anaerobes (3.9–5.3 × 10⁹ CFU/g), metals according to EN 15510:2007, mercury according to EN 13806:2003, and other microbiology according to ISO 4833-1, ISO 21527-2, ISO 6579-1, ISO 4832 and ISO 16649-2. Silicon at 18–19 mg/kg comes from the antifoaming agent E 900.
- Whole genome sequencing and 16S rRNA confirmed the species (ANI 99.99 % with the type strain KNU-L09). A search of the VFDB database found no genes for α, β, ε toxins or BoNT/A–G neurotoxins. EFSA considered the resistance to gentamicin, kanamycin and streptomycin (kanamycin and streptomycin MIC 128 mg/L against cut-off values of 16 and 8 mg/L) an intrinsic trait of anaerobes.
- In the stability study (25 °C, < 60 % relative humidity) the bacterial count fell after 25 months on average from 3.8 × 10⁹ to 1.7 × 10⁹ CFU/g. A corrigendum of 1 December 2025 changes the end date of data protection from 27 November 2032 to 27 November 2030.