Today marks big news for the alternative protein industry. The first-ever mycoprotein has successfully passed through the novel food assessment process in Europe, and secured a positive scientific opinion from the European Food Safety Authority (EFSA).
No, this landmark finding won’t make it the first mycoprotein ingredient sold in Europe. But if the Commission and member states agree, it will be the first to enter the bloc after the EU Novel Food Regulation came into effect, all the way back in 1997.
It’s an “incredible milestone” for the EU food industry, says Dr Yvonne Dommels, director of nutrition and regulatory affairs at The Protein Brewery, the start-up making the novel mycoprotein ingredient it’s coined Fermotein. “It’s the first-ever fungal biomass to go through the novel food system.”
How long does the novel food process take for mycoprotein?
The EFSA process is notoriously slow, although its new head Nikolaus Kriz tells us speeding up risk assessments is his guiding light. Still, it’s not there yet, and there’s proof in how long it took The Protein Brewery to pass through the novel food system.
“We submitted to EFSA in May 2020 and they started the process in January 2021,” explains CEO Thijs Bosch.
That means it took more than five years for the food safety agency to assess the production process, composition, stability, and specifications were sufficient, with no safety concerns. EFSA also notes there were no concerns on genotoxicity (when a substance damages genetic material like DNA, genes or chromosomes), and the risk of allergic reactions is low.
But the market approval process doesn’t end there. The next step is for the Commission and member states to authorise Fermotein and integrate it into the Union list of novel foods. Bosch isn’t predicting any friction during market entry.
“We expect a positive response from the EC, and therefore market approval from the member states.”
New mycoprotein prepares to enter food and drink
With a positive scientific opinion now secured, and hopes the next stage in the approval process will run smoothly, The Protein Brewery is preparing to start commercialising in Europe next year.
From Q3 2026, Bosch expects to see Fermotein adding key nutrients to a wide range of food and beverage products. The ingredient is made up of around 50% protein, 35% fibre, and is rich in vitamins and minerals. It also plays a role in satiety, explains the CEO, suggesting potential use in GLP-1 companion products for weight management.
But initial traction is expected to be seen amongst active nutrition customers, whether via functional dietary supplements or 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 fibre as a whole-food solution.”
Fermotein has already received regulatory approval in the US and Singapore, and with a recently closed €30m in Series B funding under its belt, The Protein Brewery plans to double down on key markets, while continuing its geographical expansion.
This milestone may be just the beginning for diversified fungal-based proteins in Europe’s food system.
