EU approves first novel mycelium protein for health foods

Fermotein has crossed the regulatory line that alternative proteins have been chasing for years. The European Commission adopted an implementing regulation on 17 June authorising Rhizomucor pusillus mycelium as a novel food, after a positive vote from the Standing Committee on Plants, Animals, Food and Feed on 13 May and a positive EFSA opinion on 1 December 2025. The Protein Brewery says it is the first novel mycelium ingredient authorised under the EU Novel Food framework, which gives formulators a clear path to market instead of a science project stranded in pilot scale.

For manufacturers, the change is practical as much as symbolic. Fermotein is a fermented fungal biomass powder rich in protein, fibre, vitamins and minerals, and The Protein Brewery says the EU authorisation covers health and wellness applications including protein powders, supplements, bars, dairy alternatives, meal replacements and other better-for-you foods. The company also holds five years of protection over the supporting safety studies, alongside its patented production process, which gives it a stronger commercial moat than a dossier alone would provide.

The commercial proof point is that Fermotein is already sold in Singapore and the United States. The Protein Brewery says it expects to supply 600 metric tonnes in 2027 from its Breda facility, backed by customer commitments in Europe, the U.S. and Singapore. That makes the EU clearance less like a starting pistol than a scale-up accelerant: the ingredient now has regulatory footing in three markets, with the company saying its novel food dossier was first filed in May 2020 and that extra studies stretched the process to six years.

The timing matters because The Protein Brewery raised €30 million in Series B funding on 22 September 2025 from Novo Holdings, Invest-NL, the Brabant Development Agency, Unovis Asset Management and Madeli, money aimed at production capacity and market rollout. It also lands as other fermentation-led protein companies keep drawing capital, including Solar Foods, which secured €77.8 million from Business Finland for Factory 02 expansion in Lappeenranta. Mycelium still has to prove it can win in the messy middle between novelty and volume, but Fermotein now has something many alternative proteins have lacked: a validated regulatory dossier, live sales outside Europe and a route into products that consumers already buy.