The Protein Brewery: EFSA publishes a positive scientific opinion on Fermotein as a “novel” food

The Protein Brewery, which specializes in fungi-based food ingredients, has received a positive opinion from the European Food Safety Authority (EFSA) stating that the novel food is safe under the proposed conditions of use.

The Dutch food-tech company hails its Fermotein innovation as a fermented fungal mycoprotein with a highly nutritious, healthy, protein-rich, and high fiber profile. It is produced via a “novel” strain (Rhizomucor pusillus), and The Protein Brewery has been working to obtain EFSA approvals for the last five years.

Yvonne Dommels, director of nutrition & regulatory affairs at The Protein Brewery, speaks to Food Ingredients First about how EFSA’s evaluation concluded that the data provided on production process, composition, stability, and specifications are sufficient, and do not raise safety concerns.

What are the key challenges and learnings your team faced in navigating the EU novel food approval process for Fermotein?

Dommels: With EFSA, you are in a team marathon against time. The process took us over five years from submission to approval. It’s a rigorous process of managing expectations and timelines: getting the dossier submitted, following up on clock-stop questions and study requests, and ensuring the highest-quality studies and data to prove the safety of our strain and our product, Fermotein. This is done in collaboration with a network of experts and labs. Challenges include that the process required extensive safety, compositional, and toxicological data, alongside collaboration and discussion with regulators. Our biggest learning is that you need to prepare for all studies that are requested in the EFSA guidelines. Long-term, detailed planning is therefore essential when pioneering our new category of nutritional mycoprotein powder.

With GRAS status in the US and approval in Singapore already in place, how do the regulatory requirements in Europe compare, and what does this mean for global market expansion?

Dommels: Europe’s requirements for food safety are more comprehensive, with EFSA demanding a greater depth of evidence for production processes, quality, safety of the strain and product, and allergenicity risk, than in other regions. Having EFSA’s stamp of approval significantly strengthens our global credibility and creates the foundation for expansion into other markets. Now that we have regulatory approval on three continents (N. America via the US, Asia via Singapore, Europe), we are well-positioned for commercialization worldwide. 

Fermotein is described as a whole food solution with high protein and fiber. From a product development perspective, how does it integrate into F&B applications without compromising taste and texture? 

Dommels: From over thousands of strains, we selected our specific strain for nutrition, yield, reduced environmental impact, and neutral taste. Due to the neutral flavor profile, Fermotein can be added without masking systems. The product successfully builds the texture of ready-to-mix powders, beverages, and bars. We typically collaborate closely with customers on application trials, sharing our learnings from MVP concepts all the way to branded products and consumer feedback. 

How does Fermotein differentiate itself from other mycoproteins or alternative protein sources currently available in the market?

Dommels: Fermotein is a nutritious mycoprotein powder and a whole food ingredient, meaning it delivers virtually a complete set of nutrients across macros (50% complete protein, PDCAAS 1, and 30% fiber), minerals, and vitamins (also carb-free). Its unique nutrient profile makes it a superfood for the active nutrition umbrella segment, and an ideal candidate for longevity, gut health, weight management, and performance benefits. As a result, we are not pursuing segments that many other mycoprotein companies are pursuing, like meat replacers. Our application scientist is currently trialing formulations for meal replacers; he says: “You can basically live on Fermotein.” And compared to vegan protein alternatives (such as pea and soy), we are sensorially superior and much more neutral.

Achieving EFSA approval proved the safety of our product. Now we are trying to prove the true nutritional benefits of our product through clinical studies. We foresee significant benefits of consuming Fermotein as a whole-food supplement for gut health, satiety (GLP-1), metabolic health, and cognitive function. 

You mention Fermotein has a low environmental footprint. Could you quantify its sustainability impact compared to traditional protein sources, particularly in the context of large-scale food production? 

Dommels: Wageningen Food & Biobased Research conducted a screening LCA in 2024 of large-scale Fermotein production. These data indicate that Fermotein has a lower land use and lower CO2 footprint compared to dairy proteins like whey, when produced on a large scale. 

With the growing trend toward convenience-driven and health-focused food products, which segments of the F&B industry do you see as the fastest adopters for Fermotein?

Dommels: Several converging trends play directly to Fermotein’s strengths. Consumers are actively moving away from “plant-based swaps” and looking for nutritious, minimally processed, whole food ingredients that support long-term health, backed by scientific evidence, particularly around the segments of longevity, gut health, weight management, and performance. Therefore, consumers are looking outside of the plant kingdom, into the fungi kingdom. Fermotein is a natural, minimally processed whole-food ingredient that is nutrient-dense and rich in macro- and micronutrients, which directly addresses all these trends.

In terms of gut health: #FiberMaxxing is one of the most visible health trends. Fiber is a science-backed macro-nutrient, one that people are lacking (25-35 g daily), and is recognized as a building block for good gut health. GLP-1 agonists have taken the market by storm and will only become more widespread with government support, such as the pending US pilot to make Medicare and Medicaid dollars available for weight loss (not only chronic diseases).

Now that EFSA has issued its opinion, what are the next steps for commercial rollout in Europe?

Dommels: We first expect a positive response from the European Commission and, therefore, approval from the member states. Then we will start commercializing in the EU in Q3 2026. 

What are the opportunities to expand Fermotein into functional foods, sports nutrition, or other specialized food categories?

Dommels: Right now, we are primarily interested in active nutrition. Fermotein is already fit-for-purpose, in terms of health benefits, taste, function, and scalability, for active nutrition market opportunities. Active nutrition encompasses supplements in different formats such as ready-to-mix drinks, sports beverages, functional bars, and capsules.