Precision fermentation is ready. EU novel food approval isn’t.

The EU keeps precision fermentation-derived foods safe. But is it also keeping them off European tables altogether?

Precision fermentation uses engineered microorganisms such as yeast, bacteria or fungi to produce specific food ingredients in controlled fermentation systems.  These ingredients can include animal-free proteins, carbohydrates, sweeteners, or fats. In practice that means milk proteins without cows, egg proteins without hens, and other functional ingredients that offer more sustainable alternatives to conventional animal-derived or plant-extracted components. 

The science is moving fast. The regulation is not. 

Bringing precision fermentation-derived ingredients to market remains far more difficult in the European Union than in the United States. In the US, the Food and Drug Administration (FDA) uses a “Generally Recognized as Safe” (GRAS) framework that can enable market entry in roughly a year. In the EU, the Novel Food authorisation process, including safety assessment by the European Food Safety Authority (EFSA), often takes 2.5 to 4 years or more. This has created a widening regulatory gap. By 2026, multiple precision fermentation-derived food proteins have been cleared in the US, whereas none (yes, zero!) have yet been approved in Europe. 

This article examines the reasons behind this disparity – including EFSA’s extensive data requirements, transparency rules, and procedural complexities – and explores how these factors impact innovation and market access. 

Two systems, two speeds

The EU: pre-market authorisation under the Novel Food Regulation

In the EU, precision fermentation-derived ingredients often fall under the Novel Foods Regulation (EU) 2015/2283 if they were not widely consumed in Europe before 1997. To enter the market, companies must apply for pre-market authorisation, providing a comprehensive scientific dossier to the European Commission who then requests EFSA to perform a full safety assessment. 

The approval process involves several stages: 

• dossier validation, including compliance with transparency requirements 

• EFSA’s scientific risk assessment 

• risk management steps by the European Commission and Member States, who review EFSA’s opinion and 

• formal authorization of the product into the EU’s Union List of authorised novel foods 

On paper, the system looks manageable. EFSA is expected to deliver an opinion within 9 months and an overall decision in about 18 months. In practice, the timeline is rarely that short. Delays due to protracted validations, multiple rounds of questions, and procedural complications have pushed EFSA’s average evaluation time to roughly 2.5 years, with some cases taking well over 4 years. 

For example, the only two EU applications so far for fermentation-derived animal proteins (both for β-lactoglobulin, a milk protein) illustrate the sluggish pace: Perfect Day submitted a dossier in mid-2022, but the application remained in EFSA’s preliminary validation phase for over a year before being declared not valid in 2024, meaning the actual risk assessment had not even begun. Similarly, Remilk’s 2023 application was first invalidated for not meeting new study notification rules. Although the dossier was resubmitted in 2024, the company ultimately withdrew the application after further data requirements and possibly concerns around confidentiality. 

As of early 2026, EFSA has yet to issue any safety opinion for any major precision-fermented protein, and thus none are approved for sale in the EU. By contrast, the United States has rapidly evaluated and cleared multiple such ingredients. 

The United States: GRAS as a faster route to market 

Under the US system, precision fermentation-derived ingredients can often be commercialised through the GRAS pathway rather than through a formal pre-market approval process. Companies assemble the expert evidence needed to support safety under the intended conditions of use, and then either self-affirm GRAS status or submit a GRAS notification to the FDA for confirmation. 
In practice, obtaining a “no questions” letter from the FDA through a GRAS notice tends to take about one year. Some firms go a step further and launch under self-affirmed GRAS while the FDA review is ongoing without waiting for FDA’s formal review, provided they are confident in their safety data. 
This flexible approach, essentially an honor system backstopped by FDA oversight, has enabled a much faster rollout of precision-fermentation ingredients in the United States. Since 2018, at least seven novel proteins produced via precision fermentation, including animal-free dairy proteins, egg proteins, collagen peptides, sweet proteins and heme ingredients, have entered the US market through GRAS clearance or related pathways.
The contrast with Europe is striking.

Precision fermentation products: EU vs. US status

The pattern is clear. Several high-profile fermentation-based food innovations reached American consumers years before they might become available in Europe. In some cases, European review began only after the FDA process had already finished. In others, companies did not even bother to apply in the EU, prioritising regions with faster or more predictable pathways.

The case of the animal-free dairy proteins is telling. Between 2019 and 2024, Perfect Day, Remilk, and New Culture each obtained US clearance for their fermentation-derived milk proteins. The EU has still not approved any comparable protein ingredient. This “GRAS gap” is part of a broader pattern in food tech, where innovators often treat the EU as a later-stage market rather than a first launch market.

Why is the EU slower?

The longer timelines in Europe do not result from a single rule. They come from several overlapping features of the current system.

Transparency added process, documents, and failure points

The EU’s Transparency Regulation, which took effect in 2021, added further steps that slow down approvals. Before submitting a novel food dossier, companies must pre-register every safety study with EFSA, and agree and prepare for broad publication of all non-confidential dossier content.

The intention was to improve openness and public confidence in food safety decision-making. In practice, this has added a substantial amount of administrative work. Non-compliance has proven costly: dozens of applications have been rejected at the initial stage for failing to meet the transparency requirements. The need to redact confidential information for public versions of documents and to manage large highly technical data submissions has introduced additional complexity.

A practical example is the mandatory Appendix D in the novel food dossier. It is a large, protected Excel file, which needs to be converted to a PDF file for earmarking and redaction when data confidentiality is requested. Turns out that it is not a simple task. It creates a highly technical document-handling task that sits well outside what most applicants would expect from a scientific risk assessment process.

The suitability check can take months and still end in rejection

The rigorous admissibility check, referred to as the “suitability check”, is meant to take place within 30 working days. If anything is missing, unclear, or incorrectly formatted, the clock stops while the applicants fix issues. In practice, these validations have often taken far longer than 30 days, especially for first-of-kind products. Since 2021, this early phase has become a major source of uncertainty and delay. It is highly questionable if these additional layers improve public trust.

Clock-stops make nine months meaningless

Even after an application passes validation and EFSA begins its scientific risk assessment, the process rarely moves in a straight line. Applicants typically receive several rounds of “additional information requests” i.e. questions, and each round stops the clock until the company prepares and submits a response with the requested data, which then must be reviewed and deemed satisfactory by EFSA.

On average, two or three clock-stop rounds occur in a novel food assessment. A 2025 analysis found that applicants took an average of around 130 days to respond to each EFSA request, and the time spent waiting for and addressing these queries accounted for roughly half of the total EFSA evaluation period. What is formally described as a nine-month scientific review can therefore extend into several years.

EFSA’s answer has been to call for better and more complete dossiers. That is understandable in principle. In practice, it is difficult to deliver a near-perfect file when meaningful scientific pre-submission advice remains non-existent. Most applicant companies already do their best and use experienced consultants to support regulatory submissions, yet the process still produces repeated rounds of clarification and delay.

A highly rigorous system can become an overly cautious one

First-of-kind products are treated with extreme

EFSA’s scientific reputation is built on rigour, and that rigour is one of the strengths of the EU system. At the same time, it often leads to a very cautious approach, especially with first-of-their-kind products. Without prior EU approvals to serve as reference points, companies are expected to address every conceivable risk in detail, and each novel food is evaluated case-by-case.

This ensures a high level of safety. It can also lead to over-engineered study packages and data requirements that feel disproportionate to the actual risk profile of the product. Some industry experts argue that EFSA’s requirements verge on attempting to prove zero risk, making it excessively burdensome for innovators.

Innovation is happening, just not first in Europe

The market consequences are already visible. In the United States, consumers have had access and companies have been able to commercialise precision fermentation-derived product for years, well ahead of their European counterparts. Ice cream made with Perfect Day’s non-animal dairy proteins has been on American shelves since 2020. Bakeries have used fermentation-derived egg whites in product lines. Just recently, EVERY’s precision-fermented egg white was launched as baking ingredient for consumers. Impossible Foods’ plant-based burgers using fermentation-derived heme – a flagship food tech innovation – have been widely sold in the US since 2019.

In Europe, these ingredients are still unavailable pending regulatory clearance.

This delay affects more than consumer choice. European food manufacturers are also left waiting for functional, sustainable and nutritious ingredients that have already been proven to be safe, commercially viable and popular in other markets.

The business response: launch elsewhere first

From a business perspective, the EU’s lengthy, uncertain approval process has discouraged startups from launching their products in Europe early or at all. Many innovators instead prioritise the United States or other faster jurisdictions such as Singapore, for initial launch. That allows them to generate revenue, validate demand and build consumer acceptance while EU assessments are still ongoing.

This sequential strategy is now common. Companies launch in the US first and in some cases postpone or pause efforts in Europe altogether or until the regulatory environment becomes more accommodating. For early-stage ventures, the opportunity cost of a multi-year delay in Europe, combined with the cost of lost market opportunity and higher regulatory expenses is very difficult to justify to investors. The result is a a growing perception that Europe is an unfriendly environment for food tech startups, which risks an innovation drain, where talent and capital are pushed toward countries with more navigable regulatory environments.

Confidentiality concerns also deter companies

The EU’s public disclosure of application data also raises intellectual property concerns. Companies may worry that critical formulation details, genetic sequence data, or other commercially sensitive information could become publicly visible during the application process. This could give competitors insight into their innovations. While applicants can request certain confidential business information be kept secret, EFSA applies strict criteria for granting confidentiality, and non-confidential parts of the dossier, including study results, are published by default.

This does not prevent filing, but it can shape strategy. Some companies delay EU applications until they are confident their IP can be protected or until they no longer fear being scooped by competitors. This too, can slow European market entry.

Europe risks losing more than time

Over time, if the EU continues to lag in approvals, European food manufacturers and consumers remain at a disadvantage. Food companies might be unable to source the latest functional or sustainable ingredients, affecting their ability to innovate. Investors and venture capital in food tech may also recalibrate their strategies, favouring companies that target the more predictable regulatory environments first. There is anecdotal evidence that some European startups, in fields like alternative proteins, have shifted commercial focus, headquarters or R&D activities to the US to leverage the friendlier regulatory climate.

Ultimately, this creates a real economic disadvantage. Products developed in Europe may scale up abroad first and return to Europe only later (if at all) as imports. The value is captured by other countries that might have otherwise benefited the European economy and consumers.

Can the EU catch up without compromising safety?

European regulators and policymakers have recognised the need to balance safety and innovation. They have begun exploring measures to speed up novel food authorisations and reduce unnecessary burdens. In late 2025, the European Commission proposed a “Biotechnology and Industrial Fermentation” initiative often referred to as the Biotech Act. Its aim is to strengthen Europe’s bioeconomy and make the path to market more workable for biotechnology-based products.

For novel foods, the most relevant proposals include stronger guidance and support from EFSA, earlier pre-submission consultations with EFSA scientists to clarify what data is needed for a successful application, and more expert staff resources to handle novel food files. The goal is to prevent avoidable delays by ensuring companies get it right the first time.

These are welcome signals. Earlier advice could help reduce incomplete dossier submissions and limit unnecessary clock-stops from additional questions. At the same time, the proposals remain modest. The Biotech Act does not change the 18-month approval deadlines, nor does it introducing more experimental tools such as regulatory sandboxes for novel foods. These were excluded due to political concerns.

Nonetheless, the increased focus on facilitating novel food assessments marks a policy shift. EU officials now openly acknowledge that long authorisation timelines have become a barrier to food innovation and that reform is needed.

Europe needs a safer system that is also workable

The difference between the EU and US regulatory systems for precision fermentation-derived foods has clear consequences. The EU’s protracted novel foods pathway, with its stringent data demands and procedural complexities, is slow, administratively demanding and difficult to predict. This delays consumer access to beneficial innovations and influences company strategies. The US GRAS system is faster and more flexibile, which is why it has become the preferred first route for many of these products.

That does not mean Europe should copy the US model. It does mean the EU needs a more agile and predictable framework if it wants to catch up and be competitive in food tech and alternative proteins.

Precision fermentation is likely to become an important and commercially significant part of sustainable food production. If the EU wants European companies and consumers to benefit from this growing wave of food innovation, it will need a more open-minded view of what the future of food can be and close the regulatory gap.

Get in touch to discuss your regulatory strategy!

Nina Vartiainen Head of Consulting, PhD +358 40 664 2330 nina.vartiainen@biosafe.fi 🗓️  Book an appointment in Nina's calendar »

 

Contact our experts and book an appointment for a free short consultation »