The European regulatory landscape for novel foods is facing unprecedented strain as the volume of applications continues to grow.
With an average of 40 submissions annually – up from fewer than ten a decade ago – the system is under pressure to evaluate a flood of innovations, including cultured meat, algae-based ingredients, and engineered nanomaterials.
Speaking at Fi Europe 2024 in Frankfurt, Hans Verhagen, founder of Food Safety and Nutrition Consultancy, addressed these challenges. Drawing on his extensive experience, including his role as chair of EFSA’s novel foods working group, Verhagen highlighted the complexities of navigating Europe’s rigorous regulatory framework.
EFSA serves as the scientific body responsible for evaluating novel food dossiers. Its assessments focus on ensuring safety, addressing potential health risks, and confirming that proposed uses are nutritionally appropriate. For traditional foods from third countries, a simplified notification process is available, provided that the product has a documented history of safe use over at least 25 years.
Verhagen highlighted some recently approved novel foods that have contributed to the rapid rise in novel food applications to EFSA, including cultivated apple fruit cell, coffee leaves used as the basis for a type of tea, and chia seeds. More broadly, categories of novel foods that have seen particularly high numbers of applications in the past five years include micro-organisms, fungi, or algae; new or intentionally modified molecular structures; and plants or their parts. In addition, Verhagen anticipates that novel proteins – especially from cultivated sources – insects, and food with a mineral origin will contribute to future novel food applications.
The growing workload has stretched EFSA’s resources, contributing to longer evaluation timelines. Under Regulation (EU) 2015/2283, novel food applications are expected to be reviewed within nine months. In practice, however, authorisations often take about three years to complete. Verhagen attributed these delays to EFSA’s detailed safety assessment process, which frequently involves multiple rounds of questions and requests for supplementary data.
For smaller companies, these protracted timelines could pose a significant barrier to market entry. Startups and smaller companies that depend on approval of a novel food can struggle to secure funding or investor confidence while waiting for regulatory approval.
In light of these trends, on September 2024, EFSA released updated guidance for novel food applications, reflecting advancements in food technology and changing consumer demands. The revised guidelines place new emphasis on products derived from cell cultures and engineered nanomaterials. EFSA also added twenty algae species to the Union List of Novel Foods, allowing for direct market entry without the need for extensive authorisation.
Cultivated meat is a particularly complicated type of novel food facing a range of regulatory responses. For example, in Europe, tastings – a key step in gaining investor confidence – are restricted until safety is formally established. This creates a “catch-22” scenario for startups. To address this, the Netherlands recently introduced a code of practice allowing limited tastings under controlled conditions, a move Verhagen praised as a pragmatic solution to foster innovation while upholding safety standards.
The EU Transparency Regulation, which came into force in 2021, has added another layer of complexity. Under this regulation, most aspects of a dossier, including non-confidential supporting data, are made publicly accessible. While this promotes openness, it requires companies to carefully balance compliance with safeguarding proprietary information.
To address these challenges, Verhagen recommended that applicants “make a clever dossier” by focusing on the most relevant and scientifically robust data. Pre-submission meetings, introduced under the updated guidance, also offer an opportunity for companies to align their submissions with EFSA’s expectations, potentially avoiding costly delays.
Despite the rigorous novel foods framework, a notable issue remains the presence of unregulated or unauthorised products on the market. Verhagen highlighted that certain foods and ingredients, which should undergo novel food evaluations, bypass the regulatory process entirely.
A paper on this topic, co-authored by Verhagen, lists products that exploit ambiguities in regulatory definitions, such as the “significant degree” of prior consumption or the “significant changes” arising from new production processes.
Examples include imported ingredients like camel milk or exotic fruits, which may not have a clear history of consumption in the EU prior to 1997 but evade classification as novel foods. Similarly, products derived from novel production techniques, such as cryogenically processed cocoa butter, fall into this category. The safety of these products is not always guaranteed, as they bypass the rigorous evaluation required for officially recognised novel foods.
These regulatory “grey areas” could undermine consumer trust and create an uneven playing field for companies adhering to compliance requirements. They also complicate enforcement efforts, as national authorities must balance resource limitations with the need to monitor non-compliant products effectively.
Addressing the challenges facing novel foods in Europe requires a collaborative approach between regulators, industry stakeholders, and academic experts. Verhagen emphasised that while EFSA’s updated guidance provides a robust foundation for evaluations, additional measures could help alleviate bottlenecks.
Proposals include expanding EFSA’s resources to manage the growing number of applications more efficiently and increasing transparency in enforcement to reduce the prevalence of grey market products. Furthermore, fostering international dialogue could help Europe incorporate best practices from other regions.
For businesses, early engagement with EFSA through pre-submission meetings and a clear understanding of updated guidelines will remain critical in navigating the complexities of the approval process.
