Safety of the fungal biomass from Fusarium species strain flavolapis as a novel food pursuant to Article 10 of Regulation (EU) 2015/2283

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 fungal biomass from <i>Fusarium</i> species strain <i>flavolapis</i> as a novel food (NF) pursuant to Regulation (EU) 2015/2283. The NF as the frozen form of the <i>Fusarium</i> sp. str. <i>flavolapis</i> (named by the applicant), which is proposed by the applicant to be used as an ingredient in several food categories, 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 conducted with the dehydrated NF, and considering the evidence for thyroidal effects along with the lack of robustness of other findings at the low dose tested, the Panel considers the lowest dose tested as the no observed adverse effect level (NOAEL), i.e. 2744 mg/kg bw per day of the NF in a dehydrated form, corresponding to approximately 10,400 mg/kg bw per day NF. Under the proposed conditions of use, the highest intake estimates of the NF range from 189 to 556 mg/kg bw per day. Applying a default uncertainty factor of 200 to the NOAEL, the Panel considers that the margins of exposure (i.e. 55 in adolescents and 19 in infants) between the intake of the NF at the proposed use and use levels and the NOAEL from the 90-day study are insufficient. The Panel considers that it is likely that the NF may trigger allergic reactions in allergic subjects. The Panel concludes that, based on the available data, the safety of the NF, i.e. biomass of <i>Fusarium</i> strain <i>flavolapis</i> (F. sp. strain flavolapis) fungus, cannot be established.