Meeting

Fusarium str. Flavolapis Biomass (FY PROTEIN™) Discussion Paper

Last updated: 16 June 2025

Committee Paper for Discussion - ACNFP/172/01

Advisory Committee For Novel Foods and Processes

Application for authorisation of Fusarium str. Flavolapis Biomass (FY PROTIEM™) as a novel food.

Application Number - RP1637

Issue

An application has been received under the novel food authorisation process, (assimilated regulation 2015/2283 EU) for Fusarium str. flavolapis biomass (Fy Protein™). 

The Committee is asked to advise on whether the available data provides an adequate basis for a risk assessment, and whether the novel food is safe and not nutritionally disadvantageous under the proposed use and use levels. 

A draft Committee Advice Document has been prepared to support the review of this novel food application. Members are asked to review the CAD and provide comments as part of the wider assessment of the dossier.

Background

  1. In July 2022, the FSA received the submission for Fusarium str. flavolapis biomass from The Fynder Group, Inc. The novel food is a protein derived from mycelial biomass from the strain flavolapis in the Fusarium genus of fungi. The strain was isolated from a sample taken in Yellowstone National Park, Wyoming, USA. It is proposed to be used as a protein ingredient in various food categories for the general population. 
  2. The application dossier is attached as Annex I, the annexes to the dossier attached as Annex II. In light of recent discussions on microbial sources of protein additional information was requested ahead of the review. The responses to this are provided in Annex III. All annexes contain confidential information. 
  3. To note, this novel food is authorised in Singapore (August 2021), Canada in January 2023 (with recommendations) and has been consumed in the USA since 2021. This information is referenced in support of the history of use section.

Committee Action Required

  • The Committee is asked whether the available data provide a satisfactory basis for evaluating the safety of this novel food ingredient?
  • If so, the Committee is asked whether it is content to recommend approval of the novel food as an ingredient to be added to the range of foods specified?
  • If not, the Committee is asked to indicate what additional data would be required?

 

ACNFP Secretariat 

June 2025

Annexes

Annex I – Dossier

Annex II – Supporting documents 

Annex III – Request for further information response and supporting documents.