EFSA Greenlights Fermotein: The Protein Brewery Nears European Market Entry for Its Fungal-Derived Mycoprotein

Courtesy: The Protein Brewery

The Protein Brewery has taken a decisive step toward bringing its flagship ingredient, Fermotein®, to consumers across Europe. The Dutch food-tech company announced that the European Food Safety Authority (EFSA) has issued a positive scientific opinion for the fermented fungal ingredient. This milestone places Fermotein one approval away from being authorized for sale across the EU.

For an industry that has spent years navigating the complexities of Europe’s novel foods framework, the EFSA opinion represents both validation and momentum. Fermotein is now positioned to become the first fungal biomass ingredient to complete the EU’s novel food assessment, marking a significant moment for the continent’s fast-growing fermentation sector.

A New Class of Fungal Protein Approaches Market Readiness

Fermotein is a whole-food mycoprotein derived from Rhizomucor pusillus, a hardy fungal strain capable of thriving in low pH and high-temperature environments. Produced through a controlled fermentation process, the ingredient is dried into a neutral-flavored powder rich in protein, dietary fiber, essential amino acids, vitamins, and minerals. Its composition makes it suitable for applications spanning active nutrition, better-for-you snacking, plant-based dairy alternatives, and even GLP-1-adjacent wellness products.

EFSA’s scientific panel found no safety concerns across production, composition, stability, allergenicity, or genotoxicity. While the opinion does not yet constitute approval, it enables the European Commission and EU member states to prepare the final authorization that would add Fermotein to the bloc’s official novel foods catalogue.

The decision follows a regulatory review process stretching more than five years. As early industry pioneers, The Protein Brewery faced a longer pathway than companies entering more established categories. Still, the company’s team has framed the conclusion as proof of the robustness of their science and the maturation of the fermentation landscape.

Building a Global Regulatory Footprint

The EFSA opinion adds to a growing list of international approvals. Fermotein already holds self-affirmed GRAS status in the United States and secured regulatory clearance in Singapore in 2024. With a GRAS reform underway in the US, The Protein Brewery has now formally notified the FDA and expects a “no questions” letter by mid-2026.

The company is also pursuing authorization in the United Kingdom, signaling an ambition to establish Fermotein as a globally accessible ingredient platform. These regulatory advances arrive shortly after the company closed a €30 million Series B round led by global investors, including Novo Holdings, the parent company of Ozempic-maker Novo Nordisk.

A Scalable Ingredient for a Changing Food System

Beyond its safety profile, Fermotein’s appeal lies in its functional performance and environmental footprint. Compared to conventional proteins, the ingredient boasts strong efficiency metrics: it requires minimal land and water, generates a fraction of beef’s emissions, and delivers significantly higher protein yields per hectare when compared to both animal and plant sources.

At the same time, its mild sensory profile allows formulators to incorporate it into beverages, bars, baked goods, dairy alternatives, and performance-nutrition products without overhauling recipes or relying on masking agents. This versatility has attracted interest from manufacturers in both Europe and the United States, including CK Ingredients, which is already experimenting with Fermotein in product development pipelines.

Demand is also emerging from consumers navigating the rise of GLP-1 weight-management drugs. With its high fiber content and complete amino acid profile, Fermotein aligns with dietary needs focused on muscle retention, satiety, and gut health, areas where food companies are racing to offer new solutions.

From Pilot Scale to Commercial Reality

The Protein Brewery currently produces Fermotein at its pilot facility in Breda, where it can generate around 100 kilograms per day. The company expects to expand capacity in the coming months to meet anticipated commercial launches in 2026, particularly as new customers in active nutrition, snacking, and plant-forward categories begin integrating the ingredient into their formulations.

Fermotein will be featured at this year’s Food Ingredients Europe event in Paris, where the company aims to deepen partnerships across the continent ahead of the final regulatory decision. For The Protein Brewery, this moment represents more than a technical milestone; it signals the emergence of fungal fermentation as a central pillar in Europe’s future food landscape.

As the Commission moves toward final approval, Fermotein stands poised to enter the European market at a time of growing demand for nutrient-dense, low-impact proteins. If authorized, it could mark the arrival of a new generation of microbial ingredients designed for both human and planetary health, positioning The Protein Brewery as one of the category’s earliest movers with commercial-ready scale.