The Protein Brewery's Fermotein Becomes First Mycelium Ingredient Approved for Sale in the EU
- Julie Kriegshaber
- 1 hour ago
- 3 min read
The European Commission has granted novel food authorisation to Fermotein, a mycoprotein powder made from the fungal strain Rhizomucor pusillus, making it the first whole-food mycelium ingredient approved for sale across the EU.
The approval followed a positive scientific opinion from the European Food Safety Authority (EFSA) and a unanimous vote by all 27 EU member states, six years after The Protein Brewery first filed its regulatory dossier in May 2020.
The decision sets a regulatory precedent for the wider mycelium protein sector, with industry observers noting that future applicants should benefit from a clearer and faster pathway through EFSA.
An Approval Six Years in the Making
Dutch fermentation startup The Protein Brewery has secured what its CEO Thijs Bosch describes as "a historical precedent in food technology": the first novel food authorisation for a whole-cell mycelium ingredient in the European Union. The European Commission formally amended its list of authorised novel foods to include Fermotein, the company's flagship product derived from Rhizomucor pusillus, a heat-tolerant, acid-resistant fungal strain. The regulation will be published in the EU's official journal and enter into force 20 days thereafter, with a commercial launch planned for Q3 2026.
The journey began in May 2020, when The Protein Brewery, formed that year as a demerger from industrial biotech company BioscienZ BV, submitted its regulatory dossier. The process required two additional rounds of costly studies, requested two and four years after initial submission, as EFSA defined assessment criteria for a category of ingredient it had not previously evaluated. A positive scientific opinion from EFSA followed in December 2025, with the Standing Committee on Plants, Animals, Food and Feed voting in favour in May 2026.
What Fermotein Is, and How It Is Made
Fermotein is produced by growing Rhizomucor pusillus mycelium in fermentation tanks using glucose as a feedstock. The biomass is then pasteurised, dried, and milled into a powder. The Protein Brewery uses a non-sterile fermentation process, which the company says structurally reduces both capital and operating costs compared with conventional biotech fermentation approaches.
The resulting ingredient is approximately 50% complete protein, with a Protein Digestibility-Corrected Amino Acid Score (PDCAAS) of 1, meaning it meets the full amino acid requirements used in nutritional assessment. Around 30–35% of its composition is dietary fibre. The ingredient also contains naturally occurring micronutrients and bioactives, including spermidine, a polyamine that human studies and mechanistic research have associated with cellular maintenance pathways, though the company has not made specific clinical health claims in its authorisation filing.
The EC has designated the ingredient as "Rhizomucor pusillus mycelium" for back-of-pack labelling purposes. Consumer-facing language used by distribution partners in the US and Singapore includes terms such as "mycoprotein powder" and "fermented protein."
A Precedent With Commercial Momentum
Fermotein already holds regulatory approval in Singapore and self-affirmed GRAS (Generally Recognised As Safe) status in the United States, where The Protein Brewery has been shipping commercial volumes through a distribution partner. The company reports that its 2026 capacity is fully committed and its 2027 allocation is booking out. It anticipates supplying 600 metric tonnes in 2027 from its facility in Breda, the Netherlands, scaling to over 2,000 tonnes by 2029.
Target applications include ready-to-mix protein powders, bars, and dairy alternatives, with early customer interest concentrated among active nutrition brands seeking a single ingredient that delivers protein, fibre, and bioactives together. The company is also exploring the ingredient's potential as a natural GLP-1 modulator, though this remains at an exploratory stage.
Limitations and the Road Ahead
The six-year timeline drew pointed comment from Lea Seyfarth, policy manager at the Good Food Institute Europe, who called for EFSA's capacity to be increased and for regulators to provide substantive scientific guidance to applicants before submission. The Protein Brewery's CEO echoed this, suggesting the upcoming EU Biotech Act could mandate pre-submission scientific dialogue between applicants and EFSA.
The company expects UK approval later in 2026 and is advancing dossiers in Canada and Australia/New Zealand. For other mycoprotein developers eyeing the EU market, the precedent is now set; how much it accelerates future reviews will depend largely on whether EFSA receives the additional resources its critics say it needs.