The research, conducted by regulatory experts at FoodChain ID, found that delays due to suitability checks and additional data requests are largely responsible for the long waits.
Lead author Jerome Le Bloch warned that such inefficiencies could discourage applicants from engaging with European regulatory processes and prevent the EU from transitioning to sustainable food practices.
“Europe risks falling behind other developed regions that have similarly rigorous, yet more streamlined, authorization frameworks,” he told NutraIngredients. “The current lengthy delays are hindering the growth of European companies, limiting innovation and ultimately putting jobs and investment at risk.”
“Faster approvals are critical to bringing innovative, health-promoting, and environmentally sustainable ingredients—such as new protein sources—to European consumers,” he added. “Delays in authorizing these novel foods not only hold back promising sectors but also undermine Europe’s ability to transition toward more sustainable food systems.”
The problem with long waits
Published in npj Science of Food, the study evaluated 292 novel food applications between January 2018 and October 2024. The researchers found that the validation phase took, on average, 10 months to complete, with the scientific evaluation taking anywhere from six months to four and a half years.
Food regulation expert Luca Bucchini said these long waiting times not only hold back innovation but also cause real challenges for new businesses entering the market.
“Start-ups need funding to start the novel food process and keep going; they can only generate revenue if they have a product on the market,” he told NutraIngredients. “Assuming they secure budget for the NF [Novel Foods] application, then investors would need to sit back and wait for an unclear amount of time, possibly years, while staff need to be paid, and the start-up needs to keep going.”
Bucchini said this is deterring companies from setting up their businesses in Europe, as regulatory processes in other parts of the world are considerably more efficient.
“The long novel food approval process is not compatible with today’s fast moving world,” he said. “That’s why it is often reasonable for European businesses and start-ups to first enter the Asian or the U.S. market. You can have quicker regulatory approval and bring the product to the market sooner.”
Indeed, Patrick Coppens, Director of Regulatory and Scientific Affairs at Food Supplement’s Europe, says novel food approvals typically take 12 months in the U.S.
“In the US, the Generally Recognized as Safe, or GRAS, process is a lot quicker, as it does not require pre-market authorization and can de based on self-affirmation of safety,” he told NI. “Even GRAS applications notified to the FDA are usually assessed within one year.”
However, EFSA argues the research overlooks a key aspect of the novel food application process. Indeed, the study found that the time taken by applicants to answer EFSA’s additional data requests (ADRs) represents around half (47%) of the total evaluation time, with applicants taking an average of 130 days to answer a single ADR.
“One key element that appears to be underrepresented in the analysis is the critical role of additional data requests in the risk assessment process,” an EFSA spokesperson told NutraIngredients.
“EFSA operates within a legally defined nine-month legal deadline for novel food risk assessment, which pauses only when awaiting further data from applicants. EFSA has no control over the quality or timeliness of these responses. The conclusion of our assessments consistently remains close to the legal deadline of nine months. Thus, the overall duration of the process often reflects the time applicants take to generate and submit additional evidence.”
But Le Bloch says EFSA’s team of experts currently have ‘broad discretion’ to request additional data, and this can lead to disproportionate demands that may not be justified. He therefore recommends establishing a regulatory oversights panel to better oversee such requests.
“It’s not possible to challenge [additional data] requests, as they almost systematically reject scientific rationales,” Le Bloch said. “Enhancing oversight would ensure assessments are grounded in realistic expectations and better reflect the practical realities of developing new ingredients.”
What can be done to speed up the process?
In order to put Europe on equal footing with the rest of the world, Le Bloch recommends two other key strategies for EFSA to implement.
This includes offering formal pre-submission consultations so that applicants have clarity on what is required of them and are better equipped to provide good quality and complete applications. He also recommends refining the role of the European Commission and Member States in triggering EFSA evaluations.
“According to the current regulation, European Commission and Member States must decide whether an EFSA evaluation is needed or not,” he said. “Currently, EFSA evaluations are requested systematically, even for ingredients that clearly pose no safety concerns. A more nuanced and risk-based decision-making process by the Commission and Member States would help avoid unnecessary EFSA assessments, speeding up approvals for low-risk novel foods.”
EFSA has also identified some mitigation measures to help applicants better understand regulatory expectations and ensure a smoother risk assessment process. This includes the recently updated Novel Food Guidance and an increased number of clarification teleconferences.
“The efficiency of EFSA’s assessments remains a key institutional priority, and we will continue working closely with all stakeholders to ensure that safe, innovative products reach the EU market as swiftly as possible,” the spokesperson said.
There was some positive news, too. The research found that EFSA only rejected 30 applications, corresponding to a positive opinion rate of 86.8%. Bucchini described this finding as a ‘silver lining’.
“A positive opinion rate of 86.81% is great and is what you want to see when you advise companies to submit,” he said. “[The process] could be faster and better—but it’s not bad.”
Source: npj Science of Food. doi: 10.1038/s41538-025-00492-x. “The novel food evaluation process delays access to food innovation in the European Union”. Authors: J. Le Bloch, et al.
