Stephen O’Rourke is a regulatory consultant with hands-on experience in medtech and foodtech. He supports startups and SMEs with EU, US, and global compliance frameworks, including MDR, FDA, and novel food. He was a 2024 European Parliament candidate with a focus on science, mental health, and innovation policy. Originally from Ireland, he has lived in Scotland and Germany and is in the process of relocating to Helsinki, Finland.
The views expressed in this article are the author’s own and do not necessarily represent those of AgFunderNews.
Europe talks a big game on sustainable food innovation. But newly published data reveals a brutal truth: novel food authorizations in the EU take 2.5 years on average—and sometimes as long as six years—just to receive an EFSA opinion. For many startups, that’s a death sentence.
A comprehensive review of 292 EFSA applications submitted between 2018 and 2024 shows that even when applicants succeed (which they do in 87% of cases), the regulatory process still consumes startup runway, delays market traction, and leaves sustainable ingredients trapped in the lab.
The data: 2.5 years and counting
The recent analysis (published in npj Science of Food) breaks down the delays in detail:
- EC verification: 114 ± 181 days
- EFSA suitability check: 185 ± 122 days
- EFSA evaluation: 629 ± 338 days
- Time to publication: 48 ± 16 days
- Total: 937 ± 436 days (approximately 2.56 years)
Even worse, applicants receive 2.7 additional data requests (ADRs) on average, each taking 130 days to respond to—almost half the total EFSA evaluation time.
When 87% approval isn’t enough
You would think a high approval rate means the system works. But in reality, the process is so burdensome that startups risk collapse before they ever get a decision.
Many of the delays are administrative:
- The Transparency Regulation (EU) 2019/1381 introduced mandatory study notifications—30 applications were rejected for missing this step, with an average delay of 10.6 months.
- The European Commission refers all novel food applications to EFSA, even when a scientific opinion isn’t strictly necessary under Article 11.
- There are no fixed timelines for responding to ADRs—leading to open-ended exchanges that sap momentum.
Real-world consequences
The impact of these delays isn’t theoretical.
- Startup funding cycles rarely survive multi-year waiting periods.
- Sustainable ingredients such as coffee by-products, fungi, or novel plant proteins remain stuck in approval purgatory.
- The EU falls behind faster regulators like the US FDA or Singapore Food Agency, which have leaner, phased, or conditional approval models.
- One example: Coffee cherry pulp, a by-product with functional and nutritional benefits, is still largely inaccessible in the EU due to regulatory hurdles—despite being approved in other markets.
How to fix it: Practical reforms
There are actionable ways to preserve EFSA’s safety standards while accelerating access:
- Use Article 11 discretion
The EC can bypass EFSA opinion when safety is already established (e.g. previously assessed substances or minor variations)
- Create fast-track channels
Pre-evaluated or low-risk ingredients should follow simplified review tracks
- Support better dossiers up front
Pre-submission coaching and improved guidance would reduce ADR cycles
- Impose structured timelines for ADRs
Fixed response windows and coordinated Q&A could shave months off evaluations
A turning point for EU food innovation
The EU’s Farm to Fork strategy, the Green Deal, and its Net Zero ambitions all rely on unlocking sustainable food innovation.
Yet the current novel food process risks killing momentum before it starts. For founders dealing with this system, working with a regulatory partner who understands both the scientific and procedural landscape can make the difference between a two-year delay and timely market access.
EFSA does critical work – and Europe’s high safety bar should remain. But science and safety must not be held hostage by unnecessary bureaucracy. Without reform, we risk losing the next generation of food innovation to faster-moving markets.
The post Guest article: EU novel food delays. Why bureaucracy is choking off food innovation appeared first on AgFunderNews.
Â
