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By Agroempresario.com
Europe positions itself as a leader in sustainable food innovation, yet new data reveals a significant bottleneck: the EU’s novel food authorization process takes on average 2.5 years, sometimes up to six years, just to obtain an EFSA opinion. For startups and SMEs in foodtech, this bureaucratic delay can be a fatal barrier.
A detailed review of 292 EFSA novel food applications between 2018 and 2024 highlights that despite an 87% approval rate, the drawn-out process drains startup resources, delays market entry, and traps promising sustainable ingredients in regulatory limbo.
The data published in npj Science of Food breaks down the delays as follows:
The total averages around 937 days—approximately 2.56 years.
Adding to the delay, applicants face an average of 2.7 Additional Data Requests (ADRs), each taking 130 days to answer, accounting for almost half of EFSA’s evaluation period.
An 87% approval rate might suggest an efficient system, but the reality is more complex. The bureaucratic burden leads many startups to exhaust funding before market entry. Several administrative factors exacerbate delays:
These delays have serious impacts. Startups working on sustainable ingredients such as coffee by-products, fungi, and novel plant proteins find themselves stalled. Funding cycles rarely stretch across multi-year regulatory waits, forcing many promising innovations to be shelved or abandoned.
Compared to more agile regulators like the US FDA or the Singapore Food Agency—who use phased or conditional approvals—the EU lags behind, risking losing its competitive edge in food innovation.
A notable example is coffee cherry pulp, a nutrient-rich by-product approved in multiple global markets but still largely inaccessible in the EU due to regulatory bottlenecks.
Stephen O’Rourke, a regulatory consultant with extensive foodtech expertise, suggests actionable reforms that maintain EFSA’s high safety standards while speeding up novel food authorizations:
Europe’s Farm to Fork strategy, the Green Deal, and Net Zero goals depend heavily on unlocking sustainable food innovations. However, the current novel food process risks killing innovation momentum before it starts.
Founders navigating this complex system benefit greatly from regulatory partners who understand both the science and bureaucracy—potentially turning a multi-year delay into timely market access.
EFSA’s rigorous safety work is essential, but science and safety must not be hostage to excessive bureaucracy. Without reform, the EU risks losing the next generation of food innovation to faster-moving global markets.
