European regulatory delays in novel food approvals stifle food innovation progression
The European Union (EU) is renowned for its stringent food safety regulations, but this rigorous approach has led to a prolonged novel food authorization process, with some applications taking up to six years[1][2][3]. This lengthy timeline poses significant challenges for startups in the foodtech sector, particularly in terms of resource drain, market entry delay, and innovation stagnation[1][2][4].
The European Food Safety Authority (EFSA) plays a critical role in the evaluation process, which includes complex validation steps and frequent requests for additional data[1][2][3]. On average, applicants receive 2.7 additional data requests (ADRs), each taking 130 days to respond to, nearly half the total EFSA evaluation time[3].
The impact of these delays is not theoretical; it has real-world consequences for startups. With funding cycles rarely surviving multi-year waiting periods, startups face the risk of collapsing before they ever receive a decision[1][2]. Without reform, we risk losing the next generation of food innovation to faster-moving markets[4].
To address these challenges and enhance the EU's competitive position in sustainable food innovation, several reforms are suggested:
1. **Streamline Data Requests**: Implement a more efficient system for handling ADRs, reducing the average time spent on these requests[3]. 2. **Enhance Regulatory Transparency**: Provide clearer guidelines and more predictable timelines to help applicants better plan their regulatory strategies[4]. 3. **Invest in Digital Tools**: Leverage AI and digital technologies to accelerate the evaluation process and reduce bureaucratic hurdles[5]. 4. **Increase Funding Support**: Offer targeted funding initiatives to support startups throughout the lengthy approval process[4]. 5. **Encourage Pre-Submission Consultations**: Facilitate early consultations between applicants and regulatory bodies to ensure smoother submissions and fewer data requests[3].
The Farm to Fork strategy, the Green Deal, and the EU's Net Zero ambitions all rely on unlocking sustainable food innovation. As such, reforming the novel food authorization process is crucial for the EU to remain a global leader in the field.
Stephen O'Rourke, a regulatory consultant with experience in medtech and foodtech, emphasizes the importance of these reforms. Originally from Ireland, he has lived in Scotland and Germany and is currently in the process of relocating to Helsinki, Finland. O'Rourke was a 2024 European Parliament candidate with a focus on science, mental health, and innovation policy.
A comprehensive review of 292 EFSA applications between 2018 and 2024 shows that even when applicants succeed, the regulatory process still consumes startup runway, delays market traction, and leaves sustainable ingredients trapped in the lab[4]. One example of a delayed ingredient is coffee cherry pulp, which is still largely inaccessible in the EU due to regulatory hurdles, despite being approved in other markets.
The EU falls behind faster regulators like the US FDA or Singapore Food Agency, which have leaner, phased, or conditional approval models[4]. To maintain its competitive edge, the EU must address these delays and streamline its novel food authorization process.
- The prolonged novel food authorization process in the European Union (EU), with some applications taking up to six years, significantly challenges startups in the foodtech sector, especially when it comes to resource drain, market entry delay, and innovation stagnation.
- The European Food Safety Authority (EFSA) is a critical player in the evaluation process, which involves complex validation steps and frequent requests for additional data, with applicants receiving an average of 2.7 additional data requests (ADRs) each taking 130 days to respond to.
- The real-world consequences of these delays are evident; startups face the risk of collapsing before they receive a decision due to funding cycles seldom surviving multi-year waiting periods.
- To address these challenges and boost the EU's competitive standing in sustainable food innovation, potential reforms include streamlining data requests, enhancing regulatory transparency, investing in digital tools, increasing funding support, and encouraging pre-submission consultations.
- The Farm to Fork strategy, the Green Deal, and the EU's Net Zero ambitions hinge on unlocking sustainable food innovation, making reforming the novel food authorization process essential for the EU to remain a global leader in the field.
- A review of 292 EFSA applications between 2018 and 2024 demonstrates that even when applicants succeed, the regulatory process still depletes startup resources, delays market traction, and keeps sustainable ingredients trapped in the lab.
- Faster regulators like the US FDA or Singapore Food Agency, with leaner, phased, or conditional approval models, pose a competitive threat to the EU's market position.
- To maintain its competitive edge, the EU needs to address these delays and streamline its novel food authorization process, ensuring a more efficient and innovative food-and-drink industry that contributes to the home-and-garden, lifestyle, global-cuisines, sustainable-living, and policy-and-legislation sectors while accounting for issues such as crime-and-justice, accidents (including car-accidents and fires), war-and-conflicts, general-news, and migration.
