Safety of Rhizomucor pusillus biomass powder as a novel food pursuant to 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 on the safety of the Rhizomucor pusillus biomass powder as a novel food (NF) pursuant to Regulation (EU) 2015/2283. The NF is a filamentous fungus biomass powder. The novel food is intended for use as an ingredient in various food products, targeting the general population when used as a food ingredient or whole food, individuals above 18 years excluding pregnant and lactating women in the case of food supplements, and adults for meal replacement for weight control. 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 data provided the Panel considers that there are no concerns regarding genotoxicity. Results from the 90‐day study did not show effects of toxicological relevance for humans up to the highest dose tested (19,668 mg/kg body weight (bw) per day). Under the proposed conditions of use, the highest intake estimates of the NF range from 539 to 1013 mg/kg bw per day. Taking into account the production process, the identity and compositional characterisation data and the lack of toxicity in the provided studies, the Panel considers that the resulting margin of exposure (MoE) for each population group is sufficient (37 for infants, 19 for young children, 26 for other children, 34 for adolescents and 31 for adults). The Panel considers that the likelihood of the NF triggering allergic reactions is low. The Panel concludes that the NF is safe under the proposed conditions of use.