The first novel mycelium ingredient authorized for sale in the EU under the Novel Food Regulation should hit the market in Q3, 2026, after the European Commission gave The Protein Brewery’s Fermotein mycoprotein its stamp of approval, six years after it submitted a dossier.
The decision follows a positive vote of the Standing Committee on Plants, Animals, Food and Feed in May and a positive scientific opinion published by the European Food Safety Authority (EFSA) in December.
Fermotein—which the EC says can be labeled as Rhizomucor pusillus mycelium—is approved for sale in Singapore and has self-GRAS status in the US, with regulatory dossiers advancing in the UK, Canada and Australia/New Zealand.
The Protein Brewery anticipates supplying 600 metric tons of Fermotein in 2027 from its demo-scale factory in Breda in the Netherlands to meet customer commitments in Europe, the US and Singapore, with production capacity increasing to >2,000 tons by 2029.
CEO Thijs Bosch told AgFunderNews: “The unit economics improve materially as we scale through our planned capacity build-out. Our production process uses non-sterile fermentation, which structurally lowers capital and operating costs compared to other biotech fermentation approaches, and that cost advantage compounds as volumes grow.”
Asked about the naming conventions, he said: “The Latin name is the regulatory designation for the back-of-pack labelling of foods containing Fermotein, not the consumer-facing language. We see our US and Singapore customers using “mycoprotein powder”, “mycelium protein” or “fermented protein” in consumer-facing language. As the mycelium category grows, we expect the consumer language to become mainstream, just as ‘plant-based protein’ did before it.”
“This sets a historical precedent in food technology. The EU system has now confirmed that a novel, whole-food mycelium ingredient fits in the existing Novel Food framework, a pathway the wider European food biotech sector has watched closely for years.” Thijs Bosch, CEO, The Protein Brewery
GFI Europe: Regulators need to move more quickly
Lea Seyfarth, policy manager at nonprofit think tank the Good Food Institute Europe, welcomed the news but said the fact approval had taken six years “shows the need to ensure the regulatory framework keeps pace with European food innovation.”
She added: “The EU should prevent unnecessary future delays by boosting the European Food Safety Authority’s capacity and enabling regulators to provide extended scientific advice and detailed guidance to applicants before submission.”
Bosch explained: “The duration was largely a function of being first. Fermotein is the first novel mycelium ingredient to successfully go through EFSA, which meant assessment questions were being defined as we went, including two rounds of additional, costly studies requested two and four years after initial submission.
“The current funding environment makes a six-year regulatory timeline genuinely difficult for early-stage companies, and one structural improvement we would welcome is for EFSA to have a mandate to discuss study designs scientifically with applicants, which the upcoming EU Biotech Act could enable. The good news for the companies following us is that the precedent is now set, so the next mycelium applicants should have a clearer and faster path.”
Beyond alt meat…
Quorn—which grows a filamentous fungus called Fusarium venenatum in fermentation tanks to make meat alternatives—has been in a field of one for many years. However, a flurry of startups has recently emerged developing whole biomass products from various microbes, from Nature’s Fynd and Superbrewed Foods to Infinite Roots, Enifer, ENOUGH Foods, The Better Meat Co, MyForest Foods, MOA Foodtech, and Meati Foods.
Several other players such as Unibio and Calysta are also growing protein-rich ingredients with microbes using gas fermentation (rather than using sugars as feedstocks) with an initial focus on animal feed and petfood.
While most mycoprotein players are focused on alt meat, however, Fermotein is a protein-rich powder that can be used in a wide range of applications, The Protein Brewery CEO Thijs Bosch told AgFunderNews.
“We made a conscious choice to produce a powder instead of a wet mycoprotein. We can now easily export Fermotein to markets like the US and Singapore. It’s very neutral tasting and comprises about 50% complete protein, 35% healthy fibers and is full of vitamins and minerals so is mainly used as a nutritional ingredient.”
Things in Singapore are “progressing well, with our distribution partner there focused on nutritional powders,” said Bosch. “In the US, we have been shipping commercial volumes through our distribution partner under self-affirmed GRAS status. Our capacity for 2026 is sold out, and our capacity for 2027 is booking out quickly,
“The customers buying in for the EU are primarily innovative, fast-moving brands in active nutrition looking for an all-in-one ingredient that delivers complete protein, fiber, and bioactives in a whole-food solution. Ready-to-Mix (RTM) is the most compelling near-term application. We are also seeing strong interest from clean-label bar and dairy alternative formulators, who view Fermotein as a nutritional upgrade to existing concepts rather than a replacement ingredient, which is how plant-based proteins have been positioned.”
