There is a number that should concern anyone building a precision fermentation company in Europe, and it is zero.
As of mid-2026, the European Food Safety Authority has not issued a single safety opinion on a major precision-fermented protein. Not one animal-free dairy protein, egg protein or fermentation-derived collagen is authorised for sale in the European Union. Over the same period, at least seven such proteins have entered the United States market through the GRAS pathway.
This is not a story about European regulators being unusually cautious in their scientific judgement. It is a story about a process that, in several documented cases, never reached the point of scientific judgement at all.
Two applications, neither assessed
The clearest illustration is that only two EU applications have ever been filed for fermentation-derived animal proteins. Both were for β-lactoglobulin, the whey protein that gives animal-free dairy its functional behaviour. Neither was ever scientifically assessed.
Perfect Day submitted its dossier in mid-2022 for β-lactoglobulin produced in Trichoderma reesei. The application sat in EFSA’s preliminary validation phase for more than a year before being declared not valid in April 2024. Nearly two years elapsed and the risk assessment never began. This is a company that had already held a US “no questions” letter since March 2020 under GRAS Notice 863 — clearance that took roughly twelve months from submission and put animal-free ice cream on American shelves that same year.
Remilk filed in 2023 for β-lactoglobulin produced in Komagataella phaffii. The initial dossier failed the suitability check because its supporting studies had not been pre-notified to EFSA, a requirement introduced by the Transparency Regulation. A revised application in 2024 passed validation. The company then withdrew it, choosing to focus on other markets. Remilk had received its US no-questions letter in February 2023 under GRAS Notice 1056, roughly eleven months after filing, and had already been selling in the US since 2022 under self-affirmed GRAS.
Two applications. Two companies with US clearance already in hand. Neither reached EFSA’s scientific review. That outcome tells you more about process design than about the safety of β-lactoglobulin.
What the gap actually looks like
The divergence is not confined to dairy proteins.
| Ingredient (company) | US status | EU status |
|---|---|---|
| Soy leghemoglobin (Impossible Foods) | GRN 737, cleared July 2018; colour additive 2019 | Filed Nov 2019. EFSA positive opinions 2024. Still awaiting Commission and Member State authorisation |
| β-Lactoglobulin (Perfect Day) | GRN 863, cleared March 2020 (~12 months) | Filed mid-2022, declared not valid April 2024 |
| Ovalbumin (The EVERY Company) | GRN 967, cleared Sept 2021 (~12 months) | No application filed |
| β-Lactoglobulin (Remilk) | GRN 1056, cleared Feb 2023 (~11 months) | Filed 2023, revised 2024, withdrawn |
| Brazzein (Oobli) | GRN 1142, cleared March 2024 | No application filed |
| Casein (New Culture) | Self-affirmed GRAS 2024 | No application filed |
| Collagen peptides (Geltor) | GRN 1171, cleared Oct 2024 (~11 months) | No application filed |
Read the right-hand column carefully. In four of seven cases the European entry is not “pending” or “under review.” It is no application filed. These companies did not lose a European regulatory argument. They declined to have one.
The Impossible Foods row deserves particular attention, because it is the closest thing to a success story and it is still not finished. Soy leghemoglobin was filed in the EU in November 2019. EFSA delivered positive scientific opinions in 2024 — five years later — and final authorisation still awaits the European Commission and Member States. The same ingredient has been in American burgers since 2019.
Why the timelines diverge
On paper the EU system looks workable. EFSA is expected to deliver an opinion within nine months, with an overall decision in roughly eighteen. In practice, average evaluation time has stretched to around 2.5 years, and some files have run well past four. Three mechanisms account for most of that gap.
The suitability check has become a gate, not a formality
Before scientific assessment begins, a dossier must pass an admissibility review — the “suitability check” — nominally within 30 working days. If anything is missing, unclear or incorrectly formatted, the clock stops while the applicant fixes it.
For first-of-kind products, these validations routinely run far beyond 30 days. Perfect Day’s file spent over a year in this phase before failing it. The significance is easy to miss: a dossier can consume years of a company’s regulatory budget and produce no scientific finding whatsoever. There is no opinion to appeal, no data gap to close, no substantive objection to answer. The file simply never qualified for review.
Transparency rules added failure points
The EU’s Transparency Regulation, effective 2021, requires applicants to pre-register every safety study with EFSA before submission, and to prepare all non-confidential dossier content for publication.
The intent — public confidence in food safety decisions — is legitimate. The operational consequence is that dozens of applications have been rejected at the initial stage for failing to meet transparency requirements rather than for any safety concern. Remilk’s first rejection was exactly this: studies not pre-notified.
The administrative texture matters more than it should. Appendix D of the novel food dossier is a large protected Excel file that must be converted to PDF for earmarking and redaction when confidentiality is requested — a document-handling exercise that sits well outside anything resembling scientific risk assessment, and one that has proven a non-trivial source of error.
Clock-stops make the nine-month target meaningless
Once assessment does begin, EFSA typically issues two or three rounds of additional information requests. Each stops the clock until the applicant responds and EFSA deems the response satisfactory.
A 2025 analysis published in npj Science of Food found applicants took an average of around 130 days to respond to each request, and that waiting for and addressing these queries accounted for roughly half of the total EFSA evaluation period. A formally nine-month scientific review therefore routinely extends across several years.
EFSA’s stated remedy is better dossiers. That is reasonable in principle. It is difficult in practice when meaningful scientific pre-submission advice is largely unavailable — most applicants already engage experienced regulatory consultants and still produce files that generate repeated rounds of clarification.
The confidentiality problem nobody wants to discuss publicly
There is a second-order effect that rarely appears in policy documents.
EU rules publish non-confidential dossier content by default, including study results. Applicants can request confidentiality for specific commercial information, but EFSA applies strict criteria. For a company whose entire competitive position rests on strain engineering and fermentation process parameters, the prospect of publishing detailed technical data is not a neutral administrative step.
Remilk’s withdrawal has been attributed in part to further data requirements and possible concerns around confidentiality. Whether or not that was decisive in that case, the strategic logic is straightforward: a company may rationally delay EU filing until its intellectual property position is secure enough that disclosure is survivable.
This is worth stating plainly because it is a genuine trade-off rather than a flaw. Public disclosure of safety data is defensible on its own terms. But it has a cost in filing behaviour, and pretending otherwise makes the timeline problem harder to diagnose.
What this means if you are building one of these companies
The observable industry response has been to sequence markets rather than fight the process.
Launch in the US or Singapore first. The GRAS pathway allows companies to assemble safety evidence, submit a notification, and reach market in roughly a year — or to launch under self-affirmed GRAS while FDA review proceeds, as Remilk did in 2022. Revenue and consumer validation arrive years earlier.
Treat the EU as a later-stage market. This is now common enough to be the default assumption. It has a compounding consequence: European food manufacturers cannot source ingredients that are demonstrably safe, commercially proven and already on shelves elsewhere.
Budget for a process, not a decision. The relevant planning figure is not EFSA’s nine-month target. It is 2.5 to 4 years, with a real probability that the file fails validation before assessment begins. For a venture-backed company, a multi-year delay of uncertain outcome is difficult to justify to investors against a twelve-month alternative.
The strategic risk for Europe is not consumer choice. It is that products developed in European labs scale abroad first and return, if at all, as imports — with the economic value captured elsewhere.
This is already visible in the funding data. Europe was the strongest single geography for alternative protein investment in the twelve months to July 2026, taking 62% of disclosed capital — while remaining a market where none of these proteins can legally be sold. European investors are backing European companies whose revenue must come from elsewhere. We break that down in our analysis of where alternative protein capital actually went.
Does the Biotech Act fix this?
In late 2025 the European Commission proposed a Biotechnology and Industrial Fermentation initiative, commonly called the Biotech Act. For novel foods, the relevant provisions include stronger EFSA guidance, earlier pre-submission consultation with EFSA scientists, and additional expert staffing for novel food files.
These are genuine improvements and they target the right failure mode. Most EU delay originates in dossiers that are incomplete relative to expectations that were never communicated in advance. Pre-submission advice attacks that directly.
But the proposals are modest, and it is worth being precise about what they do not do.
The Biotech Act does not change the 18-month decision framework. It does not introduce regulatory sandboxes for novel foods — these were excluded on political grounds. It does not alter the transparency requirements that have caused multiple first-stage rejections, nor the clock-stop mechanism that consumes roughly half of evaluation time.
A company filing in 2027 should expect better guidance and a materially similar timeline.
What has changed is the framing. EU officials now openly acknowledge that authorisation timelines have become a barrier to food innovation. That is a shift from a few years ago, and it is the precondition for larger reform — but it is not itself the reform.
The counter-argument
It would be incomplete to present this only as European failure.
EFSA’s rigour is a real asset. The GRAS system is, structurally, an honour system with FDA oversight — companies may self-affirm safety and go to market without any regulatory review at all. New Culture’s casein is on that basis: self-affirmed in 2024, no FDA notification submitted. Reasonable people can hold that a pre-market authorisation requirement is the correct policy for novel proteins entering the food supply at scale, and that Europe’s slowness is the visible cost of a choice worth making.
The EU also has genuine approvals in adjacent categories. Human milk oligosaccharides including 2′-fucosyllactose have been authorised since 2016. The Protein Brewery received a positive EFSA opinion for its Fermotein mycoprotein. The system is not incapable of clearing fermentation-derived ingredients — it has not yet cleared a fermentation-derived animal protein.
The strongest version of the criticism is therefore narrower and harder to dismiss: the problem is not that Europe assesses rigorously. It is that companies are failing before assessment, on procedural grounds, after multi-year waits. A system that rejected precision-fermented proteins on scientific merit would be defensible. A system where the two filed applications never reached scientific review is failing at something other than science.
What to watch
Three things will indicate whether the gap is closing.
Does any β-lactoglobulin dossier pass validation? No fermentation-derived animal protein has yet cleared this stage. The first one that does — and how long its subsequent assessment takes — is the real test.
Does soy leghemoglobin complete authorisation? EFSA delivered positive opinions in 2024. If Commission and Member State sign-off extends deep into 2026 and beyond, the bottleneck is not only EFSA but the risk-management stage that follows it.
Do pre-submission consultations begin, and do they reduce clock-stops? This is the Biotech Act’s most substantive novel-food provision. If applicants filing in 2027 face fewer additional information requests, it worked. If clock-stops continue consuming half the evaluation period, the Act addressed guidance while the mechanism causing delay remained untouched.
Until then, the planning assumption for anyone building in this category remains unchanged: the United States is where precision-fermented protein reaches market, and Europe is where it arrives later.