Challenges and Solutions in EU Novel Food Authorization

Stephen O’Rourke is a regulatory consultant with extensive hands-on experience in medtech and foodtech. He supports startups and SMEs with compliance frameworks spanning the EU, US, and globally, including MDR, FDA, and novel food regulations. A 2024 candidate for the European Parliament, Stephen concentrates on science, mental health, and innovation policy. Originally from Ireland, he has lived in Scotland and Germany and is currently relocating to Helsinki, Finland.

The views expressed in this article are the author’s own and do not necessarily reflect those of AgFunderNews.

The Slow Road to Novel Food Authorizations in Europe

Despite Europe’s ambitious rhetoric surrounding sustainable food innovation, newly published data unveils a stark reality: the average duration for novel food authorizations in the EU is a staggering 2.5 years. In some unfortunate cases, this can stretch to six years purely for an EFSA opinion, posing dire challenges for startups seeking timely market access.

Key Insights from Recent Analyses

A comprehensive study involving 292 EFSA applications submitted between 2018 and 2024 highlights the pressing challenges:

• EC verification takes an average of 114 ± 181 days.
• EFSA suitability checks average 185 ± 122 days.
• The EFSA evaluation phase consumes 629 ± 338 days.
• Publication time takes another 48 ± 16 days.
• Overall, this totals approximately 937 ± 436 days, or roughly 2.56 years.

In addition, applicants typically face 2.7 additional data requests (ADRs) per application, each requiring an average of 130 days to respond to—almost half of the total EFSA evaluation time.

The Paradox of High Approval Rates

While one might assume that an 87% approval rate indicates a well-functioning system, the reality is that startups often find themselves at risk of collapse long before a decision is reached.

Administrative Delays Undermine Progress

Several administrative factors contribute to these delays:

• The Transparency Regulation (EU) 2019/1381 mandates study notifications, leading to rejections of 30 applications for non-compliance and causing an average delay of 10.6 months.
• All novel food applications are referred to EFSA by the European Commission, even in cases where a scientific opinion is not strictly necessary under Article 11.
• The absence of fixed timelines for responding to ADRs results in prolonged, open-ended exchanges that drain momentum.

Real-World Implications of Delays

The ramifications of these delays are tangible and distressing:

• Startup funding cycles rarely withstand multi-year waiting periods.
• Sustainable ingredients, such as coffee by-products, fungi, or novel plant proteins, remain stuck in regulatory limbo.
• The EU increasingly lags behind more agile regulators like the US FDA and the Singapore Food Agency, which operate under streamlined, phased, or conditional approval models.
• For instance, coffee cherry pulp—a by-product with significant functional and nutritional benefits—is largely inaccessible in the EU due to regulatory hurdles, even as it is approved in other markets.

Proposed Reforms to Expedite Novel Food Approval

Practical reforms can help maintain EFSA’s safety standards while improving access:

1. Utilize Article 11 Discretion: The European Commission should exercise discretion to bypass EFSA opinion when safety is already established, such as for previously assessed substances or minor variations.
2. Create Fast-Track Channels: Low-risk or pre-evaluated ingredients should be eligible for simplified review processes.
3. Enhance Dossier Preparation: Offering pre-submission coaching and improved guidance can help reduce the number of ADRs.
4. Implement Structured ADR Timelines: Establish fixed response periods and coordinated Q&A sessions to expedite evaluations.

A Critical Juncture for EU Food Innovation

The EU’s Farm to Fork strategy, Green Deal, and Net Zero ambitions hinge on unlocking innovative sustainable food solutions. However, the current novel food authorization process puts this momentum at risk.

In navigating this complex system, collaborating with a regulatory expert who comprehends both the scientific and procedural landscapes can be the deciding factor between prolonged delays and swift market entry.

While EFSA plays an essential role in ensuring food safety, science and safety must not be impeded by excessive bureaucracy. Without urgent reforms, Europe risks losing the next wave of food innovation to competitors with more agile regulatory environments.