Today marks a pivotal development in the alternative protein sector. The first mycoprotein has successfully navigated the novel food assessment in Europe, obtaining a favorable scientific opinion from the European Food Safety Authority (EFSA).
While this finding does not make it the first mycoprotein ingredient sold in Europe, it could become the first to enter the bloc since the EU Novel Food Regulation was established in 1997, pending approval from the Commission and member states.
Dr. Yvonne Dommels, director of nutrition and regulatory affairs at The Protein Brewery, emphasizes that this is an “incredible milestone” for the EU food industry. She notes, “It’s the first-ever fungal biomass to go through the novel food system.”
Duration of the Novel Food Process for Mycoprotein
The EFSA evaluation process is often lengthy. Nevertheless, Nikolaus Kriz, the new head of EFSA, aims to expedite risk assessments. However, the timeline reflects the complexities involved; The Protein Brewery took over five years to complete the novel food evaluation.
CEO Thijs Bosch explains, “We submitted to EFSA in May 2020, and they started the process in January 2021.” This duration underscores the thoroughness required to assess production methods, composition, and stability—all without safety concerns. EFSA has also confirmed low risks regarding genotoxicity and allergic reactions.
However, the journey toward market approval does not conclude here. The next step involves government bodies authorizing Fermotein and adding it to the Union list of novel foods. Bosch remains optimistic about market entry.
“We expect a positive response from the EC, and therefore market approval from the member states,” he asserts.
Fermotein Readies for Food and Beverage Integration
With a supportive scientific opinion secured, The Protein Brewery is poised to commence commercialization in Europe next year, aiming for broad integration into the food and beverage industry.
From Q3 2026, Bosch anticipates Fermotein will enhance a variety of food and drink products. Composed of around 50% protein and 35% fiber, it is also rich in essential vitamins and minerals. Furthermore, it contributes to satiety, suggesting its potential utility in GLP-1 companion products aimed at weight management.
Initial traction is expected within the active nutrition segment, including functional dietary supplements and premium sports nutrition. “We’re already seeing traction in this segment in the US at the moment,” Bosch reveals, “due to our unique combination of protein and fiber as a whole-food solution.”
Fermotein has already secured regulatory approval in the US and Singapore. Recently, The Protein Brewery raised €30 million in Series B funding, which will bolster its efforts in key markets while pursuing further geographical expansion.
This milestone may well be the foundation for a broader integration of diversified fungal-based proteins within Europe’s food system.
