The Protein Brewery wins EFSA backing for Fermotein as Europe’s first approved fungal biomass novel food

The Protein Brewery received a major regulatory boost today as the European Food Safety Authority issued a positive scientific opinion for Fermotein, the company’s fermented fungal biomass ingredient. The assessment, published 1 December, confirmed that the novel food is safe under the proposed conditions of use, clearing a path toward the next stage of authorization in the European Union.

Based in Breda, the Netherlands, The Protein Brewery develops fungi-based ingredients aimed at improving the nutritional profile and sustainability of everyday foods. Fermotein, its flagship product, is a fermented fungal biomass powder with a wholefood composition and a nutritional profile rich in protein, fiber, vitamins, and minerals. The ingredient, also referred to as mycoprotein, is designed for use in a wide range of foods and beverages, including supplements and meal replacements.

EFSA’s scientific opinion found that the company’s data on the production process, composition, stability, and specifications met the requirements for safety assessment. The authority also concluded that there were no concerns regarding genotoxicity and that the likelihood of allergic reactions was low.

Dr Yvonne Dommels, Director of Nutrition & Regulatory Affairs at The Protein Brewery, said the decision represented an important breakthrough for both the company and the wider EU food sector. “We are very pleased with this incredible milestone for The Protein Brewery and the EU food industry as a whole, for the first-ever fungal biomass to go through the novel food system,” she said. She added that although the process took longer than anticipated, working closely with EFSA had paid off. “The next step is for the European Commission and the member states to authorize Fermotein and integrate it into the Union list of novel foods.”

The company has already secured several approvals beyond Europe. Fermotein received self-affirmed GRAS status in the United States in 2021 and regulatory clearance in Singapore in 2024. The positive EFSA opinion now brings the ingredient closer to market entry in Europe, a significant milestone as The Protein Brewery expands its commercial partnerships.

CEO Thijs Bosch said the decision aligned closely with the company’s mission to support healthier and more sustainable diets. “The Protein Brewery sees tremendous potential to enhance the nutritional landscape of everyday food and drink choices for the busy and aging European population,” he said. Bosch noted rising demand for convenient, high-protein, high-fiber foods that do not compromise on taste or texture. He said Fermotein can help meet those expectations by enriching traditional and modern formulations alike. “Moreover, Fermotein has a very low environmental footprint,” he added.

Bosch highlighted Fermotein’s complete amino acid profile, its wholefood nature, and the absence of typical organoleptic drawbacks that sometimes accompany other alternative protein ingredients. These qualities, he said, were already reflected in commercial traction. The company is seeing “significant sales” of Fermotein in the United States, and its first customers in Singapore are preparing to launch products in the first quarter of 2026.

Beyond the EU, The Protein Brewery is also working through additional regulatory pathways. It is awaiting novel food authorization in the UK and expects to receive a no-further-questions letter from the US Food and Drug Administration in early to mid-2026.

For the company, EFSA’s opinion represents a key moment in its broader effort to accelerate the global protein transition. The Protein Brewery aims to bring safe, nutritious, and sustainable solutions to a range of food categories, from active nutrition to everyday meals. With Europe now moving toward formal authorization, Fermotein is positioned to become part of the continent’s next wave of ingredient innovation.