The European Food Safety Authority (EFSA) has concluded that fungal biomass from Fusarium sp. strain flavolapis is safe as a novel food under revised proposed conditions of use, following a reassessment of updated exposure estimates submitted by the applicant. In a technical report published on 22 July 2026, EFSA found that the reduced use levels and narrower food categories result in lower estimated intakes, yielding sufficient margins of exposure relative to the no observed adverse effect level (NOAEL) identified in a 90-day toxicity study. This reverses EFSA's 2025 opinion, which had deemed the safety of the novel food unestablished due to insufficient margins of exposure under the originally proposed conditions.
The report, prepared at the request of the European Commission, evaluates revised exposure estimates for the fungal biomass, which is intended for use as a protein-rich ingredient in food products. The applicant submitted new proposed food categories and reduced use levels, along with updated intake estimates. EFSA applied the same methodology used in its 2025 safety assessment to analyze the revised data. The agency concluded that for all population groups, the resulting margins of exposure are now considered sufficient, allowing the novel food to be deemed safe under the revised conditions.
The decision impacts several stakeholders. For the applicant company, the clearance opens the door to market authorization in the EU, potentially creating a new revenue stream from a novel protein source. EU food manufacturers gain access to an alternative protein ingredient, which could help diversify supply chains and meet consumer demand for sustainable proteins. However, EU consumers may face higher prices for products containing the novel ingredient, as novel foods often command a premium. EU regulatory bodies, including the Commission, will now proceed with the formal authorization process, which may involve further scrutiny of labeling and monitoring requirements. The trade-off lies between enabling innovation in the food sector and ensuring consumer safety, with EFSA's revised assessment balancing both by tightening use conditions to achieve acceptable exposure levels.
Institutional follow-up will involve the European Commission drafting an implementing regulation to authorize the novel food under Regulation (EU) 2015/2283, likely within the coming months. The EFSA report serves as the scientific basis for this decision, and the Commission may also consider post-market monitoring obligations.