The New Foods RegLab

Understanding the novel-food guidance and requirements is complex – and EFSA’s expectations often exceed the requirements stated in the guidelines, with applicants needing to translate general guidance into case-specific scientific and regulatory strategies based on their specific novel-food ingredient and production process. Although EFSA’s guidance provides an essential framework for applicants, it cannot anticipate every technical question or scenario that may arise during the assessment of a novel food. Consequently, the process can be difficult to navigate without experience.

In practice, administrative or scientific requirements that are not fully understood or adequately addressed at the time of submission often result in requests for clarification, additional information, or further studies, all contributing to longer assessment timelines and increased costs for applicants.

EFSA already provides pre-submission support to novel-food applicants, including opportunities for advice and engagement during application preparation. Its 2026 call for expressions of interest, open until 18 November 2026, offers novel-food SMEs general pre-submission advice in an online meeting about the application requirements, either before the required studies start or during the final preparation of the application.^{Note 3} This is a welcome step, but the advice remains general in scope. Currently, it is still not possible to discuss specific study designs or technical questions with EFSA’s pre-submission team.

We welcome the expanded pre-submission advice for novel foods proposed in the European Commission’s proposal for a European Biotech Act of December 2025.^{Note 4}

The New Foods RegLab aims to inform how this advice is designed. By bringing together applicants, regulatory experts, and other stakeholders, the RegLab identifies the parts of the current guidance that applicants find difficult to interpret or apply in practice, as well as questions and uncertainties that recur during dossier preparation.

The project team collects this evidence through a structured gap analysis with each participating company, along with a workshop in Brussels, and feeds the anonymised findings back to EFSA and the European Commission, showing where greater clarity, practical examples, or more targeted regulatory engagement would make the novel-food pathway more predictable and efficient.

Regulatory sandboxes let innovators test products under the supervision of a regulator. The New Foods RegLab tests something else: it creates a practical environment to explore how applicants understand and apply the EFSA Guidance related to the novel-food authorisation process in order to build an efficient regulatory process and help identify where gaps in this understanding might affect the quality of novel-foods dossiers.

The RegLab is a two-way learning platform. Applicants benefit directly by working through their concrete questions with experienced regulatory experts, thereby gaining a clearer understanding of the requirements, and identifying areas that may need further consideration before submission. At the same time, the RegLab captures recurring questions, uncertainties, and practical challenges across different applicants and product categories. The project team turns these insights into recommendations for the European Commission and EFSA, so that the whole system benefits from the experience of individual applicants.

Based on design thinking, the RegLab is a prototype for a cross-border regulatory learning platform for novel foods, made for applicants. It was developed with regulatory experts who have a proven track record in successful novel-food dossiers, and draws on best practices from other jurisdictions.

In applicant-centred workshops, participants bring their concrete questions and challenges regarding the guidance documents. Together with experts, they explore how the guidance can be interpreted and applied in practice, and identify areas where further clarity or support may be needed. They also simulate the type of questions and dialogue that could form part of future pre-submission engagement, with the applicant explaining and justifying their approach.
The project team then turns these lessons into a framework of recommendations for the expanded EU pre-submission advice.

• Two days in Brussels with leading food-safety regulatory experts who have a proven record, built over more than 15 years of taking novel-food dossiers through the EU authorisation procedure.
• You will work on your product and your open questions, based on the novel-foods guidance documents.
• A structured look at your own regulatory position, strategy, its gaps, and your next steps.
• A policy session on the political context shaping the introduction of the pre-submission advice under Biotech Act 1 and 2.
• You will work with a peer group of companies working with the same guidance documents, all in different product categories and company sizes.
• Your experience will contribute to the bigger picture. Insights from the workshop will help to inform our recommendations on the future of pre-submission advice and regulatory engagement with the relevant stakeholders.

EFSA has already taken important steps to improve applicant support. The RegLab is a complementary, applicant-centred mechanism to help understand how that framework works in practice and generate evidence that can inform its further development.

Your questions on the EFSA guidance become part of the evidence for a concrete framework for pre-submission advice.

The workshops run under the Chatham House Rule. Only general conclusions and learnings will be included in our follow-up recommendations.

Required from participants:
one named person who will attend the workshop in Brussels and commit to preparation time before the workshop.

Participation is free of charge. Participants cover their own travel expenses.

Companies who are planning on bringing a novel food to the EU market and are currently looking to strengthen their understanding and in-house experience of the EU novel-food authorisation process. We welcome companies established in the EU and companies from outside the EU that are preparing to enter the EU market.

We select the cohort based on four criteria.

• Product categories: precision fermentation, biomass fermentation, cell-cultivated products, plant-based novel ingredients, algae and microalgae, insect protein, and other novel foods.
• Companies across all stages: startups before and after first revenue, scale-ups and established companies, with or without an in-house regulatory team.
• Regulatory stage: before submission or in early-stage dossier preparation. Companies that already hold an authorisation in other jurisdictions such as the US, Singapore, Australia and New Zealand, or the UK, are also welcome.
• Concrete questions: You do not need to have a complete EU dossier or a fully developed regulatory strategy to participate. We are particularly interested in companies with concrete regulatory questions, uncertainties, or challenges that show where or how the current guidance is difficult to apply in practice.

We are building a pre-competitive cohort of up to ten companies. We do not select direct competitors in order to ensure that every participant can speak openly at the same table. The cohort will reflect the market in terms of product categories and company size.