EFSA Unable to Confirm Safety of Fusarium flavolapis Fungal Protein as a Novel Food

On September 8, 2025, the European Food Safety Authority (EFSA) released a scientific opinion through its Panel on Nutrition, Novel Foods and Food Allergens (NDA) concerning the safety of a fungal protein derived from Fusarium species strain flavolapis, which was proposed for use as a novel food ingredient under Regulation (EU) 2015/2283.

Following a request from the European Commission, the NDA Panel evaluated the frozen fungal biomass form of Fusarium sp. strain flavolapis, intended by the applicant for inclusion in several food categories. While EFSA stated that the production process, composition, and stability were sufficiently characterized and did not raise immediate concerns, the overall assessment raised important safety issues.

According to the Panel’s findings, results from a repeated 90-day oral toxicity study in rats using the dehydrated form of the fungal protein indicated potential thyroid-related effects. The Panel established a No Observed Adverse Effect Level (NOAEL) at 2,744 mg/kg body weight per day (dehydrated form), equivalent to approximately 10,400 mg/kg body weight per day in its hydrated form. However, the estimated human intake levels under the proposed use ranged from 189 to 556 mg/kg body weight per day, leading to narrow margins of exposure — specifically 55 for adolescents and 19 for infants.

Applying a standard uncertainty factor of 200, EFSA concluded that these margins are insufficient to ensure safety. Furthermore, the Panel highlighted that the novel food may trigger allergic reactions, particularly in individuals sensitive to fungal allergens.

In summary, EFSA concluded that the safety of the fungal biomass produced by Fusarium flavolapis could not be established based on the current data. Additional studies addressing long-term toxicity, allergenicity, and dose-response relationships would be necessary before regulatory approval.