Regulatory consultant Stephen O’Rourke argues why the EU’s current novel food regulation is slow, and what it can learn from competitors.
When startups develop novel food ingredients, from precision-fermented proteins to algae-based fats, they inevitably run up against the same challenge: getting regulatory approval.
In Europe, that means submitting a detailed novel food dossier to the European Food Safety Authority (EFSA). But what happens to that data once submitted? In most cases, it becomes “confidential by default”, and that raises deeper questions about transparency, trust, and the pace of food innovation.
The current system: slow, opaque, and cautious
EFSA’s approach to novel food applications is cautious by design. Companies submit extensive documentation covering composition, toxicology, manufacturing processes, and proposed uses. Much of this data is treated as confidential unless the applicant agrees otherwise or EFSA decides that specific information must be made public.
In practice, while EFSA does publish a list of applications under assessment, the public has no access to the full content of those dossiers, including the specific scientific rationale, data models, or risk concerns being reviewed. EFSA publishes a final opinion if one is reached, though there is no visibility into the review process itself, nor any obligation to explain delays, withdrawals, or failed submissions.
While this protects trade secrets, it creates an ecosystem where other stakeholders, too, including competitors, researchers, investors, and even consumers, have limited visibility into what kinds of products are being reviewed, where they are in the process, and why some are delayed or rejected.
Why transparency matters
Food safety is a public good. When regulatory processes are opaque, it can undermine public trust, especially when it comes to novel technologies like cultured meat, precision fermentation, or synthetic biology. Without transparency, confusion and speculation fill the gap, creating mistrust where clarity is most needed.
Moreover, it creates inefficiencies: multiple companies may duplicate effort, or pursue similar applications without realising that EFSA has already issued clarifications or raised concerns about comparable substances.
Other models: What the UK and US are doing differently
The UK’s Food Standards Agency (FSA), post-Brexit, has experimented with a regulatory sandbox model for cultivated meat that encourages open dialogue between applicants and regulators. More notably, they offer structured pre-application support and publish limited information about applications in progress.
In the US, the GRAS (Generally Recognized As Safe) notification process often results in public postings of company-submitted safety summaries and FDA responses. While they are redacted for trade secrets, they are still accessible to scientists, investors, and even competitors. This creates a richer ecosystem of shared knowledge and regulatory learning.
These alternative models demonstrate how transparency doesn’t have to come at the cost of safety, and in fact, can improve trust and regulatory efficiency.
The downside of secrecy: chilling innovation
Startups, especially those navigating EFSA’s long timelines, often operate in near-silence for two to three years while their dossier sits under review. This not only slows down innovation, but can scare off investors, who are reluctant to fund what they cannot see or benchmark against. When no one knows what has been approved or rejected, and why, the system becomes harder to navigate.
Time for a shift? Rethinking transparency
A more balanced model is needed. One that protects genuine proprietary information, while also releasing anonymised summaries, procedural timelines, or outcome rationales.
Imagine a system where:
– Applicants consent to summary publication at submission.
– EFSA shares anonymised rejection reasons.
– Public dashboards track dossier status.
– Industry can learn from precedent without compromising IP.
Would this benefit startups and SMEs? Very much so. It would help EFSA itself, an agency with world-class scientists who are sometimes constrained by outdated confidentiality rules. Greater transparency would reduce repetitive questions, make workflows more efficient, and allow the agency’s scientific work to be better understood and trusted by the public.
Final thoughts
The “confidential by default” culture served a purpose when food innovation moved slowly. In today’s fast-evolving foodtech world, where scientific literacy and public scrutiny are both rising, the EU must modernise how it balances IP protection with public transparency.
Trust in novel foods will depend not only on their safety, but on how that safety is demonstrated, communicated, and understood. It’s time to bring more light into the system.
Without reform, we risk turning Europe’s food safety system into a bottleneck instead of a bridge — one that slows down the very innovation it was designed to protect.
That light isn’t just for startups or regulators. It’s for the public as well, who deserve a clearer view of how safety decisions are made. Making these systems more understandable, more visible, and more connected to real-world innovation must be part of how we build trust in the future of food.
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