Q: Let’s start with a reality check. When did your regulatory process for EFSA actually begin?

A: We have a novel mycelium strain. Because it wasn’t consumed  in Europe prior to 1997, it’s classified as a “novel food.”
 We submitted ourdossier on 16 May 2020. The EC then took it into consideration and formally asked EFSA for an opinion in January 2021. So it’s been almost five years for the whole process process.

Initially, the expectation was roughly two years to approval, so the idea was to launch into the European market by 2023. But we kept having “stop the clock” moments and new questions, so it took much longer. EFSA finally formed their opinion on 29 September (this year), and we received the positive opinion notification on Monday the 1^st of December, which was a huge relief.

Q: For founders listening, what does an EFSA positive opinion actually mean commercially?

A: A positive EFSA opinion means the EFSA expert panel has evaluated the dossier and considers the novel food safe under the proposed conditions of use.

From there:

Once the formal approval is granted and the novel food is integrated in the Union list of novel foods, you can legally sell the ingredient across the entire European Union.

Q: So can you already sell in the Netherlands today, or do you still have to wait?

A: We still have to wait. The EFSA opinion is positive, but we need the formal ECauthorization before we can sell in the Netherlands or anywhere else in the EU.

Q: Why does the remaining step take 7 months and not another five years?

A: At this stage, no new scientific data or additional safety studies should be required. The scientific assessment is done.

The remaining steps are largely administrative and political: Commission processing, member-state voting, and formal listing. That’s why it’s months, not years.

Q: How big a deal is this? Where does your approval sit in the broader landscape?

A: We’re the first novel fungal biomass mycoprotein ever to receive a positive EFSA opinion.

Existing fungal biomass products like Quorn use strains that were already in use before 1997, so they’re not considered “novel food.” Most other mycoprotein companies have chosen non-novel strains for this reason.

We chose a novel strain, which is why we went through this full novel food process. There are several other dossiers in the pipeline—companies doing fungal fermentation, bacterial fermentation (like Solar Foods), etc.—but each dossier is different and there are no guarantees. Our case is more of a hopeful signal and proof of progress for the ecosystem.

Q: You’ve raised about €52M in total. If I’m a startup planning a regulatory budget, what kind of cost should I assume for EFSA and global regulatory?

A: We get this question a lot. The key point: it’s not just about hiring a consultant. You need internal regulatory expertise too.

In our case:

●      We have a team member with ~25 years of regulatory and nutrition science experience (Dr. Yvonne Dommels) who spends roughly 50% of her time on regulatory.

●      We also work with external regulatory consultants.

For EFSA plus parallel work on global regulatory (e.g., EFSA, FDA “no questions,” UK FSA, etc.), I would budget around $0.5M–$1M, depending on complexity.

And that’s just direct spend. The biggest cost is often the time-to-market delay: years of not being able to sell your product.

Q: So if I’m raising a round and building a financial model, is it fair to earmark roughly $1M for global regulatory?

A: Yes, as a ballpark for a complex ingredient going through multiple jurisdictions, $1M is a reasonable planning assumption. It could be more if your technology is more complex (e.g., cultivated meat) or if you need additional studies.

Q: On cultivated meat especially, people worry that one member state can blow up an EU approval. Is that true?

A: Not exactly. It’s not that a single member state can kill the approval.

However, if enough member states vote against a dossier, it can become very difficult—potentially blocking EU-wide authorization. That’s why the political dimension matters.

It’s not just “one state gets a veto and everyone else still sells”; in practice, significant opposition can jeopardize the entire EU approval.

Q: Do you expect that kind of opposition for your ingredient?

A: We don’t think so. Our ingredient is:

●      Not a direct replacement for a specific crop that farmers are growing,

●      Not a  meat replacement,

●      A nutritional product that contributes to a healthy diet,

●      And from a food safety perspective, produced in a very clean, controlled bioreactor environment.

Q: Let’s talk strategy. What’s one structural choice in your regulatory journey that really helped?

A: Singapore.

The Singapore Food Agency (SFA) has:

●      Strong internal expertise,

●      Good access to scientists,

●      And a reputation for being efficient and clear.

When you submit there, you may not get an automatic approval, but you’ll know where you stand within 1-2 years,, not 5 years. That clarity is incredibly valuable.

Q: Did you need a subsidiary in Singapore to apply?

A: No. We didn’t set up a subsidiary beforehand; we applied from abroad. The key value is that you can sell in Singapore once approved.

We received SFA approval last year, and the process was roughly 12 months end-to-end.

Q: In hindsight, what order would you recommend for founders?

A: We did EFSA first, then Singapore, then others. If we started over, I would:

●      Start Singapore, EFSA, and USA (FDA) in parallel.

That way:

●      You get a faster outcome in Singapore,

●      Learn a lot from SFA’s questions,

●      And can use those insights to strengthen your EFSA and FDA dossiers.

Q: Can you give a cost range specifically for Singapore?

A: Singapore is generally much cheaper than EFSA:

●      Think tens of thousands of euros,

●      Not hundreds of thousands.

It’s still non-trivial, but relative to EFSA, it’s a much lighter financial lift.

Q: Any guidance on choosing regulatory consultants? Can you share who you used?

A: We can’t share specific names. But a few principles:

●      Get a very good regulatory consultant. A stronger dossier means fewer “stop the clocks,” fewer follow-up questions, and a smoother timeline.

●      Combine external and internal expertise. Someone internally should understand the science and regulations deeply enough to:

○      Challenge consultants,

○      Write large parts of the dossier,

○      And respond intelligently to regulator questions.

There are a small number of well-known firms in this niche. It’s not a huge market; founders can identify them with a bit of digging.

Q: What’s been the impact of the EFSA opinion on investors and customers so far?

A: It’s very fresh—we got the news on Monday the 1^st of December, and it’s now Wednesday one week later—but the impact is already clear:

●      Investors:
 Our outreach is much stronger when we can say: “EFSA has issued a positive opinion.” It dramatically increases confidence in our product and our execution.

●      Corporate customers (especially in Europe):
 Many of them are here at FI Europe. Before, it was all hypothetical—“once we get approval…”
 Now, they know:

○      They’ll be able to formulate with our ingredient,

○      And realistically get products to market after summer 2026.

●      It’s not a distant, theoretical future anymore. It’s real and time-bound.

For us, this approval is huge. It changes the tone of every conversation—from “if” to “when and how”.Subscribe to FoodTech Weekly