For the first time since the Novel Foods regulation was introduced in the late 1990s, this week saw the authorisation of a new novel mycoprotein ingredient in the European Union. In the context of increasing instability in food supply chains and the growing need for more sustainable ways of producing nutritious, affordable, tasty protein foods, the news comes as a promising signal. 

The authorisation means Dutch startup the Protein Brewery will now be able to sell their new ingredient (called Fermotein) across the EU. While this is undoubtedly a genuine milestone, it was a very long time coming – taking a total of six years from the initial regulatory submission to ultimate approval. While this product of EU research and innovation was submitted for approval here first in 2020, the company’s more recent applications in the US and Singapore were approved more than a year ago. The lag leaves question marks around whether Europe’s current innovation environment can ever hope to deliver on its ambitions of global competitiveness without a more robust commitment to regulatory capacity and efficiency.

How is this mycoprotein made and what makes it a novel food?

This new ingredient is produced using biomass fermentation, just like the mycoprotein already available in Europe (for example, foods sold under the name Quorn). What is different about this one is that it is the first to use a new kind of filamentous fungi – a species called R. pusillus. While the use of this fungus in food is not new (it has been found naturally occurring in traditional fermented foods and has long been used to produce enzymes used in cheesemaking), what is new is using it as a primary ingredient in its own right.

The fermentation process is similar to that used to brew beer, and results in an ingredient high in complete protein and dietary fibre, containing various important vitamins and minerals. The initial uses it has been designed for in the EU context focus on enhancing the nutritional profile of plant-based dairy foods, incorporation into flours and doughs for baking, and use as a functional protein source for sports or personalised nutrition.

Mycoprotein, in addition to its nutritional profile, also performs well on sustainability. A study conducted at Wageningen University and Research commissioned by The Protein Brewery found that Fermotein requires five to 30 times less water and five to 20 times less land per kg of protein compared to conventional dairy¹. It also relies on shorter supply chains compared with industrial animal agriculture, offering a tool for diversification and improved food security. 

As recent events have shown, a resilient food system is not just a nice-to-have. The EU’s agrifood sector is heavily dependent on imports of high-protein animal feed, with 66% of animal feed imported, and soybean meal self-sufficiency at just 4%. With climate change advancing and global instability worsening, this presents a growing risk. To mitigate it, we need to diversify our protein supply and expand the range of tasty, affordable, nutritious options made in more sustainable ways. 

This challenge is not unique to Europe, meaning leadership on protein diversification also represents a distinct opportunity on the international stage. Europe is home to world-leading academic institutions and researchers at the cutting edge of the field, as well as a diverse ecosystem of startups and spinouts. Recent research conducted by Systemiq aimed to quantify this opportunity, and suggests that with the right support and investment, alternative proteins could contribute €111 billion to the EU economy each year by 2040 and support 414,000 jobs, 16% of which would be in arable agriculture².

But more support is needed to unlock those rewards, and to date, the track record leaves room for improvement. While Europe’s food regulations are world-leading in their robustness, the systems underpinning them are often opaque and under-resourced. These high standards must continue to be upheld – but that can be done while also improving efficiency.

The regulatory picture

These delays impact the rate at which these foods can support diversification and resilience, but not just because they delay people from actually being able to eat them. Holdups also put the brakes on the building of infrastructure, the development of local supply chains and investment in research and innovation, ripple effects which are both up- and downstream of regulatory approval. If this uncertainty continues, the promising ecosystem growth Europe has seen over the last decade could begin to falter, as companies opt to scale up elsewhere – meaning the EU could miss out on the sustainability, health, economic and food security benefits of protein diversification. In an emerging field such as this, the window of opportunity is not open indefinitely.

The good news is that this is solvable. EFSA needs the capacity to handle applications more efficiently – but efficiency will also increase when applicants can provide high-quality, complete dossiers from the beginning.

Clearer and up-to-date pre-submission guidance would help applicants submit well-structured applications the first time, reducing unnecessary back-and-forth. Moreover, if innovators could get early scientific advice from EFSA on testing strategies and study design before submitting their dossier, they could navigate the process with greater certainty. This early dialogue also allows EFSA to anticipate food trends, build expertise, and streamline risk assessments.

At the same time, the regulatory framework must keep up with the pace of innovation. When a completely new product like The Protein Brewery’s mycoprotein arrives, regulators are often assessing the underlying technology for the first time. Tools such as regulatory sandboxes can provide a supervised framework where regulators and innovators can generate practical knowledge under controlled conditions. Without bypassing any safety requirements, this setup allows regulators to proactively gather data, while helping innovators clarify exactly how existing rules apply to their products. The result of this is better regulatory preparedness and stronger applications, which together lead to more predictability and enable greater efficiency in the authorisation process.

The Novel Foods Regulation offers a world-leading framework for assessing the safety of new foods. The task now is to make it work at the speed the food system needs.

Looking ahead

Fermotein’s arrival on the EU market is exciting, and one of only a handful of novel alternative protein approvals handed down to date. 

But if Europe is serious about building food sovereignty, meeting its climate targets, and realising the economic potential of protein diversification, a six-year approval timeline cannot be the standard. The next generation of sustainable food innovations is already in the pipeline, but they can’t deliver on their potential until they are approved for sale.

1. Rodriquez-Illera, M., Siccema, J., Broeze, J. (2024). Benchmark comparisons of Fermented protein products’ environmental foodprints (Fermoprints). Wageningen Food & Biobased Research. ↩︎
2.  Systemiq (2026). Seizing the economic opportunity of alternative proteins: Delivering prosperity from farm to factory ↩︎

Author

Lea Seyfarth Policy Manager

Lea works with policymakers to create a robust, clear and evidence-based regulatory environment for the sustainable protein sector.