Safety of Clostridium butyricum TO‐A as a novel food pursuant to Regulation (EU) 2015/2283

TL;DR

This paper evaluates the safety of Clostridium butyricum TO-A as a novel food supplement for specific age groups, excluding pregnant and lactating women.

Contribution

The paper provides a safety assessment and recommended daily doses for Clostridium butyricum TO-A based on toxicity studies and microbiota considerations.

Findings

Clostridium butyricum TO-A is safe at specified doses for children above 3 years, adolescents, and adults.

The safe dose is estimated based on a 90-day toxicity study in rats and an uncertainty factor.

Pregnant and lactating women are excluded from the target population due to microbiota development concerns.

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 on Clostridium 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 supplement, is sufficiently characterised. The information provided on the production process, composition, stability and specifications of the NF is sufficient and does not raise safety concerns. Based on the findings of a repeated dose 90‐day oral toxicity study in rats, and considering an uncertainty factor of 200, the Panel estimated a safe dose in humans of 4.5 × 106 colony forming unit (CFU)/kg body weight (bw) per day. However, considering that appropriate initial bacteria colonisation of the gastrointestinal tract in humans, in particular during the first 3 years of life, profoundly affects health during infancy and childhood, that disruptions to the microbiota early in life can have lasting health effects into adulthood, and taking 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 to children above 3 years of age, adolescents and adults, excluding pregnant and lactating women. The Panel concludes that the NF, C. butyricum TO‐A, is safe at 1.0 × 108 CFU/day for other children (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 and 3.2 × 108 CFU/day for adults, excluding pregnant and lactating women.