According to an analysis of the European Union’s novel food framework published as a chapter in the Encyclopedia of Food Security and Sustainability, almost 300 novel food applications were submitted between 2018 and 2024, covering products ranging from precision fermentation-derived ingredients and cultivated meat to algae, insects and plant extracts.
The authors, who are affiliated with food safety and quality solutions firm FoodChainID, reported that authorizations take an average of 937 days (around 2.6 years) to reach a European Food Safety Authority (EFSA) opinion. They found that applicants spend nearly half of that evaluation period responding to requests for additional scientific data. Despite these delays, 86.8% of applications received a positive opinion.
Jerome Le Bloch, head of scientific affairs at Foodchain ID and co-author of the chapter, noted that changes to the current regulation framework are required if Europe is to remain competitive in emerging areas such as precision fermentation and other novel food technologies.
“Europe needs a more proportionate approach that maintains consumer safety while giving innovative companies a credible route to market,” he said.
How the Novel Food process currently works
The EU first introduced a harmonized novel food framework in 1997 through Regulation (EC) No. 258/97, requiring companies to seek approval through individual Member States before a novel food could be marketed in the EU. The EU then replaced this framework with Regulation (EU) 2015/2283, which has applied since Jan. 1, 2018.
Under the current system, companies must submit applications directly to the European Commission, while EFSA carries out an independent scientific safety assessment. If EFSA issues a positive opinion and Member States agree, the Commission adds the product to the Union List of authorized novel foods, allowing it to be sold across the EU.
“While this ensures a thorough evaluation and allows applicants to provide clarification and new data, it can also significantly extend timelines and contribute to perceived regulatory bottlenecks,” the chapter authors wrote.
Le Bloch believes the 2018 reforms delivered their primary objective by making the system more transparent and predictable but that the improvements have not translated into a faster or more efficient evaluation process.
“By introducing a centralized system and clearer guidance from EFSA, the reforms simplified the application process and provided applicants with more explicit scientific requirements,” he said. “While the framework itself has improved, the practical reality of the evaluation process remains challenging, with lengthy assessments continuing to create bottlenecks.”
Repeated data requests create novel food approval bottlenecks
Le Bloch noted that the biggest challenges now lie in the scientific evaluation itself, describing the current system as a greater drag on Europe’s competitiveness than the previous novel food regime because approvals take longer and require more costly data generation.
According to the newly published chapter, EFSA is likely to make repeated requests for further scientific data—a major factor contributing to the time required for an application to progress from submission to a scientific opinion. Novel food applications receive an average of 2.7 requests for additional information from EFSA, with applicants spending around 47% of the total evaluation period responding to these queries.
“The frequency of ADR (additional data requests), and the time spent by applicants to answer, shows that only a rigorous and cross-cutting approach adopted by the applicants when preparing the respective application dossiers can lead to scientifically sound dossiers,” the chapter authors wrote.
Le Bloch attributes the lack of scientific dialogue for the delays.
“There is still no possibility to exchange with EFSA on the scientific content of the application,” he said. “EFSA performs a case-by-case evaluation which may sometimes be quite surprising.”
Despite the availability of and access to guidance documents, companies cannot always predict what evidence will be required for a particular ingredient. As a result, they often invest in additional studies only after EFSA raises questions during the assessment process.
“While EFSA tries to stay up to date with new methods and technologies and provide support to SMEs, its experts are largely reacting to innovation rather than anticipating it,” Le Bloch said. “The current framework tries to keep pace with food innovation, but it is too slow and ultimately slows innovation in Europe under the pretext of consumer safety.”
Is EFSA asking for too much?
While Le Bloch supports the EU’s rigorous safety standards, he noted that the current assessment process is not always proportionate to the risks posed by individual ingredients.
“EFSA sometimes accepts deviation from the standard assessment for a specific ingredient, which is not accepted for another one,” he said. “As EFSA opinions do not cover all data and discussion, there is still a lack of clarity and transparency.”
As one example, he cited botanical extracts, where EFSA often requires a full compositional characterization of an ingredient, even though this is not always technically achievable.
“As it’s impossible to characterize 100% of a botanical extract, this requirement appears disproportionate for some applications,” he said. “If the toxicological data perfectly substantiates its safety, one may ask why a full characterization is still required.”
According to Le Bloch, these additional data requests increase costs and approval timelines without necessarily improving consumer safety.
“I have many examples of EFSA questions and requests which are disproportionate,” he said. “They create a clear barrier to innovation due to the costs and timeline needed to perform additional studies and tests.”
Europe may be losing the innovation race
Le Bloch warned that prolonged regulatory timelines could deter investment in European food innovation by making it harder for companies to plan their route to market, potentially prompting them to launch outside the EU first.
“Companies do not prioritize the EU when they are seeking global market access,” he said.
He pointed to one case in which an application was submitted to both Europe and the United States using the “exact same data”. While the ingredient was authorized in the United States in less than six months, five years later it is still under evaluation in Europe following additional questions, “even though the ingredient is fully characterized and its safety has been demonstrated according to EFSA requirements.”
Despite delays, he believes shifting geopolitical dynamics could make Europe more attractive to some international companies, particularly Asian firms looking beyond the U.S. market, although he stressed this reflects wider political factors rather than improvements to the EU regulatory system.
EFSA gets it right on precision fermentation
Although he admits being generally quite critical of EFSA, Le Bloch acknowledged that EFSA has made significant progress in preparing for one of the fastest-growing areas of food innovation: precision fermentation.
EFSA guidance on microorganism-derived novel foods published in 2024 clearly sets out the scientific requirements for ingredients produced using microbial fermentation.
“The recent guidance on microorganisms is really well done and provides all requirements depending on the characteristics of the ingredient,” he said. “This guidance is pragmatic, so clearly, for precision fermentation, EFSA has done a great job.”
He believes the guidance is particularly important because microorganisms are now central to many novel food applications, noting that almost half of the projects he is consulted involve micro-organisms, either as biomass or as production organisms.
EFSA's updated guidance for microorganism risk assessment
EFSA updated guidance saught to replace and harmonize previous sector-specific requirements with a single, science-based framework. By incorporating advances in microbial genomics, genetic engineering and risk assessment, the updated guidance aimed to provide companies with clearer, more consistent requirements, support innovation and improve the efficiency and predictability of EU regulatory assessments.
What needs to change?
Le Bloch identified meaningful pre-submission scientific advice between applicants and EFSA as the most significant opportunity to improve the authorization process.
“EFSA should put in place real and valid pre-submission advice, with the possibility for applicants to validate protocols and to have access to experts when they are facing technical difficulties,” he said.
The challenge is that companies are expected to decide which studies to carry out without knowing whether EFSA will consider the evidence sufficient. As a result, they often spend months after submitting an application responding to additional data requests that could have been avoided through earlier scientific dialogue.
“If made in a transparent manner, with real scientific discussion between applicants and EFSA experts, such advice may change the whole process, with more robust applications submitted to EFSA, fewer additional requests and a faster analysis due to better compliance with experts’ expectations,” Le Bloch said.
Source: Reference Module in Food Science; doi: 10.1016/B978-0-443-40334-7.00072-1; “Novel Foods in Europe: Regulation, Risk Assessment, and the Future of Food Innovation.” Authors: J. Le Bloch, et al,
