Since 2020, the EU has invested over €250 million in alternative protein research. Despite this, it takes several years in the approval process for many start-ups and innovators before their products reach consumers. A new ATOVA report explores the factors behind the EU novel food approval process and presents insights from industry stakeholders.
This conversation opens a series of texts exploring perspectives on Novel Foods from different stakeholders within the food system. Each piece in the series will focus on a different viewpoint, alternating between industry actors, consumer organisations, and academia, to provide a broader, multi-stakeholder understanding.
This first piece coincides with the release of a new report by ATOVA’s team, prepared as part of the EPIC-SHIFT project. The document gives insight into how applicants experience the approval process for Novel Foods based on alternative proteins in the EU. To provide a taste of what can be found in the report, we spoke with Caroline Idowu, one of the co-authors and a regulatory specialist at ATOVA.
Caroline Idowu – Regulatory Specialist at ATOVA Regulatory Consulting, based in Barcelona. As part of Atova’s team, she helps provide scientific and regulatory advice to the alternative protein and food-tech industry and supports companies developing novel foods and navigating the application submission process in the EU and other global markets such as the US, Singapore, Canada, Australia, and New Zealand.
Julia Hava – Communications Lead at the EPIC-SHIFT project, representing EIT Food. She leads the Communication and Dissemination of the project, shaping how insights reach stakeholders. With a background in development studies and participatory approaches, she focuses on planning and facilitating stakeholder engagement, bridging insights between policymakers, industry, and the public. Julia also conducted the interview, guiding the discussion throughout.
Why the Report Matters
Policymakers and risk assessors are aware of some of the issues and have continually been responsive to requests for change and further support for applicants. Yet, procedures remain challenging, particularly for smaller companies and start-ups that are often at the forefront of developing new, innovative ingredients, while at the same time often dependent on external funding. Our goal is to shed light on how some companies navigate the EU Novel Food approval process and, from the feedback, highlight potential opportunities to make the system more efficient, transparent, and innovation-friendly.
Julia: Why was this assessment of the regulatory framework on market access needed? What gap does it address?
Caroline: While the EU actively supports the development of the alternative protein sector through innovation and research funding, thanks to multidisciplinary projects such as EPIC-SHIFT and PLANTOMYC, significant barriers to market entry remain.
These particularly affect developers working with new technologies and increasingly complex ingredients that fall within scope of the EU Novel Food Regulation and therefore require prior approval before they can be placed on the market. Through our work at ATOVA, we observe these challenges first-hand and we have gathered applicants’ perspectives in a report developed under the EPIC-SHIFT project.
Who Took Part in the Study
Julia: Can you tell us about the companies that participated in the interviews that you conducted?
Caroline: We interviewed 15 companies in total: 14 start-ups and SMEs, and one multinational, at different stages of the Novel Food application process, from early-stage development and dossier (application) preparation to post-dossier submission and authorisation. Their products and ingredients were diverse.
Among the participants were companies developing ingredients derived from:
- Fungi and bacteria, including biomass derived from microbial fermentation and purified proteins produced by precision fermentation
- Microalgae and macroalgae
- Insects
- Plant-derived proteins
Check the accompanying graphic to better understand what it takes to bring a Novel Food product to market in the EU
Novel food application procedure (no date) European Food Safety Authority. Available at: https://www.efsa.europa.eu/en/applications/novel-food (Accessed: 10 December 2025).
From Submission to Market
Julia: How long does it take from submission to approval?
Caroline: On average, it takes 2.5 years from dossier submission to the publication of EFSA’s opinion, with an additional seven months to obtain final approval, though some companies have experienced much longer timelines, even as long as six years. EFSA’s legislation provides a nine-month timeframe for the risk assessment.
However, this timeline is paused whenever the applicant must respond to an additional data request (ADR), as is often the case. Multiple ADRs can be issued over the course of the application validity check and the risk assessment.
Highlights
“A critical point that came up repeatedly in these interviews is the need for more meaningful pre-submission advice. Currently, applicants can seek pre-submission advice from EFSA as outlined in EU legislation however, this advice is explicitly framed as general and non-binding which limits the extent of detailed, case-specific feedback that can be provided. In contrast, in certain countries, such as Singapore and the US, applicants can receive more tailored feedback on their application strategy and proposed data sets, which they consider very helpful.”
— Caroline Idowu, ATOVA
The report highlights:
Based on the feedback from interviewees, the report suggests, among other things, proposals that would better support applicants, such as:
- More substantive pre-submission advice
- Deeper engagement with EFSA scientific officers during post-submission clarification calls, to understand the rationale behind additional data requests. This would allow companies to plan the resources needed for the process more effectively, including staff and the engagement with the investors.
- More targeted technical guidance
Read more in the full report, Impact Assessment of the Regulatory Framework on Market Access of Novel Foods Based on Alternative Protein Sources (NFAP).
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