EU approves The Protein Brewery’s mycelium ingredient for market entry

The European Commission adopted the implementing regulation for The Protein Brewery’s Fermotein on June 17, clearing the Breda, Netherlands company’s Rhizomucor pusillus mycelium ingredient for EU market entry once the act is published in the Official Journal.

The approval follows a positive scientific opinion from the European Food Safety Authority on December 1, 2025, and a favourable vote by the Standing Committee on Plants, Animals, Food and Feed on May 13, 2026. The Protein Brewery filed the Fermotein dossier in May 2020, making this a six-year route from submission to clearance. Once the regulation is published, it enters into force 20 days later.

Fermotein is a whole-food mycoprotein ingredient with complete protein, prebiotic fibre, micronutrients and bioactives. It is approved in Singapore, where the Singapore Food Agency cleared it for import, manufacture and sale on March 25, 2024, and it has self-GRAS status in the United States. Regulatory dossiers are also advancing in the United Kingdom, Canada and Australia/New Zealand.

In September 2025, The Protein Brewery raised €30 million in Series B funding from Invest-NL, Brabant Development Agency, Novo Holdings, Unovis Asset Management and Madeli. The round will support commercial expansion, production capacity and Fermotein development. The EU decision is the first novel mycelium ingredient authorised for sale across the bloc under the Novel Foods framework, and the first new mycoprotein authorisation since the regulation was introduced in the late 1990s.

Thijs Bosch, the company’s chief executive, called the approval “a historical precedent” and said it “shows that the EU Novel Food framework can recognize a novel mycelium ingredient on its scientific merits.”