EU clears The Protein Brewery’s Fermotein, opening door for first mycelium novel food launch in Europe

The European Commission has approved Fermotein, a mycoprotein ingredient developed by The Protein Brewery, for sale in the European Union under the Novel Food Regulation, marking a major milestone for the food biotechnology sector and setting the stage for its commercial launch expected in the third quarter of 2026. The decision, reported by AgFunderNews, comes six years after the company first submitted its regulatory dossier and follows a positive scientific assessment by the European Food Safety Authority (EFSA) and endorsement from the Standing Committee on Plants, Animals, Food and Feed.

The approval makes Fermotein the first novel mycelium-based ingredient authorized for human consumption in the EU, establishing a precedent for other companies developing microbial proteins and whole biomass fermentation products. The ingredient, described by EU regulators as Rhizomucor pusillus mycelium, has already received clearance in Singapore and holds self-affirmed GRAS status in the United States, while additional regulatory processes continue in markets including the United Kingdom, Canada, and Australia-New Zealand.

According to The Protein Brewery, initial industrial production will begin at its demonstration facility in Breda, Netherlands, with planned output of around 600 metric tons in 2027. The company expects to scale production beyond 2,000 tons by 2029 as demand increases across Europe, the United States, and Asia. The firm says its fermentation process, which operates under non-sterile conditions, reduces both capital investment and operating costs compared to conventional precision fermentation systems, providing a structural advantage as production volumes expand.

CEO Thijs Bosch said the approval represents a turning point for the category. “This sets a historical precedent in food technology,” Bosch told AgFunderNews. “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.”

Bosch added that the extended approval timeline was largely due to Fermotein being the first ingredient of its kind evaluated by EFSA, which required additional scientific clarification during the process. “Assessment questions were being defined as we went, including two rounds of additional, costly studies requested two and four years after initial submission,” he said. “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.”

The European approval has been closely watched by the alternative protein industry, where regulatory uncertainty has often been cited as one of the main barriers to scale. The outcome is expected to accelerate investment interest in microbial and fermentation-derived food ingredients, particularly those targeting protein enrichment and clean-label nutrition applications.

Policy analysts have also highlighted the significance of the decision for regulatory efficiency. Good Food Institute Europe policy manager Lea Seyfarth welcomed the approval but noted the lengthy timeline. She said the six-year process demonstrates the need for regulatory frameworks that can keep pace with innovation in food technology.

Seyfarth argued that greater scientific engagement between regulators and applicants earlier in the process could help reduce delays. She suggested that stronger guidance and expanded capacity at EFSA could streamline future applications, particularly as more companies enter the mycoprotein and precision fermentation space.

The approval also highlights growing competition in the microbial protein sector, where companies are developing ingredients derived from fungi, yeast, algae, and bacteria. Established players such as Quorn Foods have long dominated the mycoprotein category using filamentous fungi fermentation, but a new wave of startups is expanding the field into new applications and formats.

Among them are companies such as Nature’s Fynd, Meati Foods, ENOUGH, Infinite Roots, and others working on whole biomass fermentation or alternative microbial protein systems. Some firms, including Calysta and Unibio, are using gas fermentation technologies to produce protein ingredients for animal feed and pet food markets, reflecting a broader diversification of microbial biotechnology applications.

Unlike many competitors focused on structured meat alternatives, Fermotein is positioned as a versatile nutritional powder designed for broad food and beverage applications. According to Bosch, it contains approximately 50% complete protein, 35% dietary fiber, and a range of micronutrients, making it suitable for use in formulations such as ready-to-mix nutrition products, protein bars, and dairy alternatives.

“We made a conscious choice to produce a powder instead of a wet mycoprotein,” Bosch said. “It is very neutral tasting and is mainly used as a nutritional ingredient. The customers buying in the EU are primarily innovative, fast-moving brands in active nutrition looking for an all-in-one ingredient.”

He added that demand is particularly strong in the ready-to-mix (RTM) segment, where formulators are seeking multifunctional ingredients that combine protein, fiber, and clean-label positioning. Interest is also growing among manufacturers of bars and dairy alternatives looking to improve nutritional profiles without significantly altering product taste or texture.

The company’s commercial expansion strategy is already partially in motion. Bosch confirmed that 2026 production capacity is fully allocated and that 2027 capacity is rapidly being reserved by customers across multiple markets. Distribution partnerships in Singapore are focused on nutritional powders, while shipments to the United States have already been made under self-affirmed GRAS status.

Industry observers say the EU approval could mark a broader inflection point for fermentation-based food innovation in Europe, particularly as policymakers evaluate new frameworks such as the upcoming EU Biotech Act, which could further shape how scientific studies and safety assessments are coordinated between regulators and applicants.

As the first mycelium ingredient to successfully complete the EU Novel Food process, Fermotein’s authorization is expected to serve as a reference case for future filings, potentially shortening approval timelines for similar products and encouraging further investment in microbial protein platforms.