Abstract
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 the safety of freeze‐dried viable Anaerobutyricum (A.) soehngenii CH106 as a novel food (NF) pursuant to Regulation (EU) 2015/2283. The applicant intends to market the NF in food supplements for adults at a maximum dose of 2.0 × 109 active fluorescent units (AFU)/day, corresponding to 2.9 × 107 AFU/kg body weight per day. The information on the identity, production process, composition, stability and specifications of the NF is sufficient and does not raise safety concerns. There are no concerns regarding genotoxicity of the NF. A human intervention study with the NF, in which half of the proposed dose was given to the participants for 3 months, did not reveal any safety concerns. One 90‐day oral toxicity study in Wistar rats was provided from which the Panel identified the highest dose tested in males, i.e. 4.7 × 1010 AFU/kg bw per day, as the NOAEL. The margin of exposure between the NOAEL and the maximum proposed daily dose of the NF is 1621, which the Panel considers to be sufficient. Considering that appropriate initial bacteria colonisation of the gastrointestinal tract in humans profoundly affects health during infancy and childhood, that little is known on how the maternal microbiota shapes the maternal–fetal immune system during pregnancy and that disruptions to the gut microbiota early in life can have lasting health effects into adulthood, the Panel considers that pregnant and lactating women should be excluded from the target population. The Panel concludes that the NF, freeze‐dried viable A. soehngenii CH106, is safe at 2.0 × 109 AFU/day for the general adult population, excluding pregnant and lactating women.