What are the data requirements for cell-based and precision fermentation novel food applications in the EU

Cell-based and precision fermentation products that qualify as novel foods under EU Regulation (EU) 2015/2283 generally require authorisation before being placed on the EU market. Applications must include scientific evidence demonstrating product safety, including data on composition, manufacturing processes, nutritional characteristics, toxicology and allergenicity, as applicable.

While these products offer significant commercial potential, preparing a novel food application can require extensive scientific and safety data. Applicants who underestimate these requirements may face substantial delays if key data gaps are identified during EFSA’s assessment.

In this blog, we outline the regulatory considerations for cell-based products and products derived from precision fermentation. We also highlight common data gaps, explain how these can affect the application process and discuss how early regulatory planning can help avoid unnecessary delays.

What data are required for cell-based novel foods in the EU?

Cultivated meat, seafood and dairy products are produced from cells grown outside the animal. As neither the production method nor the resulting final food product has a history of consumption in the EU before 1997, cell-based products fall within the definition of the novel food. In practice, this means that a product-specific novel food application is likely to be required, rather than relying on a traditional food notification route (also under the Novel Food Regulation) or an existing authorisation for a novel food with a similar product specification.

In practice, a full dossier needs to address the cell source and cell line history, the composition of the finished product compared with its conventional counterpart, manufacturing process, proposed conditions of use, anticipated intake, nutritional, toxicological and allergenicity data, etc. Because published literature on cultivated products remains limited, much of the required evidence may need to be generated specifically for the application, with significant implications for development timelines and costs.

Common data gaps in cell-based novel food applications

• Established cell lines vs primary cells: EFSA expects different evidence depending on the cell source – genetic and phenotypic identity and stability for established (immortalised) lines, and biopsy location, cell type and genetic identity for primary cells.
• Absence of infectivity risk: applicants must demonstrate the absence of any risk of infectivity from viruses (including species-specific testing) or other zoonotic agents, with prion testing required where health information on the source animal is limited.
• Full traceability of input materials: culture media, growth factors and any other production inputs need their functional role, specification and EU regulatory status documented as part of the production process description, not just the cells themselves.
• Batch-based compositional evidence: composition and its variability generally need to be supported by data from at least five independently produced batches, generated at, or representative of, industrial production scale.
• Toxicological testing scaled to history of use: where there is no established comparator or history of safe use to rely on, EFSA’s tiered toxicological testing approach can call for repeated-dose studies rather than relying on compositional similarity alone.

What data are required for precision fermentation novel foods in the EU?

Precision fermentation uses microorganisms to manufacture specific proteins or other functional ingredients on a commercial scale. Although fermentation is a well-established technology, EFSA’s assessment focuses on the safety of both the production organism and the produced substance. The use of a production strain that doesn’t qualify for EFSA’s Qualified Presumption of Safety (QPS) approach, or the production of a novel or insufficiently characterised target protein, will require additional data and a more detailed safety assessment than the use of a QPS-qualified microorganism or a well-characterised protein with an established history of safe use.

This assessment typically focuses on numerous areas including strain characterisation and genetic stability, as well as confirming the absence of toxigenicity and pathogenicity traits or antimicrobial resistance in the production organism, absence of viable cells in the end product, and a detailed safety and allergenicity assessment of the protein or ingredient itself. Addressing these aspects proactively can help avoid significant delays during the review process.

Common data gaps in precision fermentation novel food applications

• Whole genome sequencing of the production strain: required to characterise the strain and confirm the absence of acquired antimicrobial resistance genes of clinical relevance, toxigenicity and pathogenicity traits.
• Viable-cell and residual-DNA testing scoped by strain status: the presence of viable cells must be analysed for biomasses, non-QPS taxonomic units, QPS strains qualified ‘for production purposes only’ and non-QPS or GM production strains. Residual DNA must be analysed for GM production strains and non-GM strains carrying acquired antimicrobial resistance genes – a more precise scope than a blanket absence claim.
• Allergenicity requirements that depend on the protein’s source: the data needed differ depending on whether the novel food contains no protein from the production process, is derived from a known allergenic source (with or without mandatory allergen labelling), or has unknown allergenic potential. For a novel protein of unknown allergenic potential, which is common in precision fermentation, EFSA applies a tiered approach: amino acid sequence homology comparison (via FASTA or BLAST) against known allergens, using a default threshold of 35% identity over at least 80 amino acids, with specific IgE binding tests on at least three batches if cross-allergenicity is indicated.
• Batch-based compositional and impurity data: composition and variability generally need to be supported by at least five independently produced batches, with metabolites of safety concern specifically investigated for substances produced by microbial fermentation.
• Toxicological testing of the target protein itself: where the protein, as distinct from the host organism, lacks a documented history of safe use, EFSA’s tiered approach can require repeated-dose toxicity studies in addition to strain safety data.

How can Medfiles support cell-based and precision fermentation novel food applications?

Medfiles’ Food and Feed team supports companies throughout the Novel Food application process, from early regulatory classification and strategy to dossier preparation and submission. Our experts review existing data, identify gaps and define scientific and safety data requirements in accordance with current EFSA guidance. For cell-based products, this includes assessing cell sources, manufacturing processes and product safety data. For precision fermentation products, our support covers production strain characterisation, manufacturing process documentation and safety assessment of the resulting ingredient.

Our team has nearly 30 years of experience in food safety regulation and over 25 years of expertise in novel foods. Our multidisciplinary team includes regulatory specialists, toxicologists, risk assessors and food safety experts, bringing together experience from national regulatory authorities, EFSA, the European Commission and the food industry.

Involving regulatory experts early in product development can help anticipate data requirements, reduce the risk of avoidable delays and establish a realistic timeline for EU market entry.

Authors:

Amin Yousefvand, Regulatory Affairs Expert

Amin joined Medfiles in 2025 and works in projects related to food and animal feed product development, regulatory affairs, and food supplements. His work involves collaboration with companies on projects concerning novel foods, postbiotics, functional ingredients, feed additives, and food supplements.

Amin holds a Ph.D. in Food Microbiology and Technology and has over a decade of academic and industry experience, including research and teaching at the University of Helsinki. He has expertise in microbiology, fermentation technologies, food safety, and bioactive and antimicrobial compounds, as well as experience in designing research studies, preparing EU regulatory dossiers in line with EFSA guidance, and supporting submissions to FDA.

Mari Lyyra, Regulatory Affairs Manager, Food and Feed

Mari Lyyra holds an M.Sc. in Public Health, specialising in clinical nutrition, and is a licensed nutritionist. Early in her career, Mari began focusing on food regulatory tasks in the EU. With over 25 years of extensive experience, she is well-versed in regulatory and scientific work related to traditional foods, food supplements, functional foods with health claims, food additives, food enzymes, and innovative ingredients. 

Since 1999, Mari has concentrated particularly on novel foods, which has become her primary area of expertise. She has been involved in dozens of favourable novel food projects and dossiers in the EU. In addition to EU legislation and novel foods, she has also mastered US food legislation and practices, including GRAS and NDI for last 10 years. 

Over the past decade, she has also trained in animal feed regulations and contributed to numerous animal feed projects. Mari brings extensive experience in expert and strategic consulting for clients across various projects in both the EU and the United States. She has authored numerous articles for food journals and contributed to peer-reviewed scientific publications. In recent years, Mari has delivered several lectures on food regulation at various Nordic and international events.

Ingrid Hagberg, Regulatory Affairs Expert & Toxicologist, Food and feed

Ingrid joined Medfiles in autumn 2023 as a Toxicologist and Regulatory Affairs Expert. Since then, she has been involved in projects related to food, feed, and cosmetics. Before joining Medfiles, Ingrid worked at Health Canada, where she evaluated and managed risks associated with chemical substances in food.

During this time, she developed strong expertise in the regulatory risk assessment of food-related substances such as contaminants and food flavourings. This has given Ingrid deep knowledge in using toxicology in risk assessment which she expertly uses in her food, feed, and cosmetics projects at Medfiles. She also has several years of experience as a food inspector for the Government of Canada, where she carried out regulatory tasks in food safety and labelling.

As a native English speaker, Ingrid excels in communicating with international agencies and preparing high-quality reports. She holds a B.Sc. in Food Science from Carleton University (Canada) and an M.Sc. in Toxicology from the University of Eastern Finland. Her combined background in food science and toxicology offers a rare and valuable skillset that directly benefits our clients.

Read more about Ingrid

See also:

• Food and feed innovation funding: key programmes and requirements
• Free webinar: Is your ingredient a novel food? Understanding regulatory status and the consultation procedure in the EU
• Free webinar: EFSA’s new novel food guidance – what to know?
• Algiecel & Medfiles: collaborating on EU regulation for novel ingredients