Safety of Clostridium Butyricum TO-A as a Novel Food Pursuantto Regulation (EU) 2015/2283

Abstract

Following a request from the European Commission, the EFSA Panel on Nutrition,Novel Foods and Food Allergens (NDA) was asked to deliver an opinion onClostridium butyricum TO-A as a novel food (NF) pursuant to Regulation (EU)2015/2283. The NF, which is proposed by the applicant to be used as a food sup-plement, is sufficiently characterised. The information provided on the produc-tion process, composition, stability and specifications of the NF is sufficient anddoes not raise safety concerns. Based on the findings of a repeated dose 90- dayoral toxicity study in rats, and considering an uncertainty factor of 200, the Panelestimated a safe dose in humans of 4.5 × 10 6 colony forming unit (CFU)/kg bodyweight (bw) per day. However, considering that appropriate initial bacteria coloni-sation of the gastrointestinal tract in humans, in particular during the first 3 yearsof life, profoundly affects health during infancy and childhood, that disruptionsto the microbiota early in life can have lasting health effects into adulthood, andtaking into account that the 90-day oral toxicity study was conducted in adult rats,the Panel considers that the target population for the NF should be restricted tochildren above 3 years of age, adolescents and adults, excluding pregnant andlactating women. The Panel concludes that the NF, C. butyricum TO-A, is safe at1.0 × 10 8 CFU/day for other children (3 to < 10 years), 2.0 × 10 8 CFU/day for adoles-cents from 10 to < 14 years, 2.8 × 10 8 CFU/day for adolescents from 14 to < 18 yearsand 3.2 × 10 8 CFU/day for adults, excluding pregnant and lactating women.