The European Food Safety Authority (EFSA) has concluded that freeze-dried viable Anaerobutyricum soehngenii CH106 is safe for use in food supplements for the general adult population at a maximum dose of 2.0 × 10^9 active fluorescent units (AFU) per day, but recommends excluding pregnant and lactating women from the target population. The opinion, adopted on 1 July 2026 and published on 28 July 2026, follows an application by Caelus Pharmaceuticals BV submitted on 6 July 2022 under the EU's Novel Food Regulation (EU) 2015/2283.
The EFSA Panel on Nutrition, Novel Foods and Food Allergens (NDA) based its assessment on data provided by the applicant, including a human intervention study and a 90-day oral toxicity study in rats. The panel identified a no-observed-adverse-effect level (NOAEL) of 4.7 × 10^10 AFU/kg body weight per day from the rat study, resulting in a margin of exposure of 1621 relative to the proposed human dose, which it deemed sufficient. No genotoxicity concerns were identified. However, the panel noted that disruptions to gut microbiota early in life can have lasting health effects and that little is known about how maternal microbiota shapes the maternal–fetal immune system during pregnancy. Therefore, it recommended excluding pregnant and lactating women from the target population.
The strain, derived from the parental strain Eubacterium hallii L2-7 originally isolated from infant faeces, was subjected to random mutagenesis to render it tetracycline-sensitive. EFSA's Panel on Biological Hazards (BIOHAZ) evaluated A. soehngenii in 2023 and 2026 for inclusion in the qualified presumption of safety (QPS) list but did not recommend it due to limited knowledge on its use in food and feed chains, although no safety concerns were identified. The novel food is intended for use in food supplements for adults, excluding infants and young children. The applicant has also requested data protection under Article 26 of Regulation (EU) 2015/2283.
The opinion is a scientific assessment and does not constitute an authorization to market the product, which must be granted by the European Commission. The Commission will now consider EFSA's opinion in its decision on whether to authorize the novel food for the EU market.