IN Brief:
- The Ministry of Future Affairs has launched New Foods RegLab for companies preparing EU novel-food applications.
- Up to ten companies will attend a Brussels workshop on 19–20 January 2027, led by Atova Regulatory Consulting.
- Applications close on 30 November 2026, with findings intended to inform future regulatory guidance rather than influence individual authorisation decisions.
The Ministry of Future Affairs has launched New Foods RegLab, an independent regulatory learning programme for companies preparing novel-food applications in the European Union. The initiative will bring together up to ten businesses for a two-day workshop in Brussels on 19 and 20 January 2027, examining how applicants interpret regulatory guidance and identify evidence requirements before submitting their dossiers.
Applications are open until 30 November 2026 to companies based inside and outside the EU, including British food technology developers seeking access to the European market. Participants do not need a completed regulatory dossier or a fully developed authorisation strategy. The organisers intend to select non-competing businesses from different product categories and stages of development, allowing common difficulties to be examined without requiring participants to disclose commercially sensitive information to competitors.
Atova Regulatory Consulting will lead the workshop on behalf of the Ministry of Future Affairs, drawing on specialists experienced in preparing and assessing novel-food dossiers. Participants will review their proposed regulatory positions, examine how existing guidance applies to their products and consider further work required before submitting an application. The discussions will operate under the Chatham House Rule, while the organisers intend to draw anonymised lessons from the programme.
New Foods RegLab is not operated by the European Food Safety Authority or another public regulator. It does not permit companies to test products under relaxed safety requirements, grant market authorisation or alter statutory assessment procedures. Products requiring novel-food authorisation must still complete the relevant EU process before they can lawfully enter the market.
The programme follows the exclusion of novel foods from the regulatory sandbox provisions proposed in the European Commission’s first Biotech Act. The Ministry of Future Affairs has instead developed an independent mechanism intended to improve understanding of the existing system. Its accompanying policy paper proposes wider regulatory learning arrangements through which experience from different applications could inform more consistent advice and clearer guidance.
EU novel-food dossiers can require extensive information about an ingredient’s identity, composition, manufacturing process, specifications, stability, intended uses, anticipated consumption and safety. The evidence needed varies with the product and its production method. A protein produced through precision fermentation, for example, may require detailed characterisation of the production organism, the fermentation process, downstream purification and the resulting ingredient.
Developers must establish that the material described in the application is sufficiently representative of the ingredient they intend to manufacture commercially. A laboratory process may demonstrate that a microorganism produces a target protein, but subsequent changes in fermentation conditions, separation methods or formulation can affect the composition of the final product. Regulatory preparation therefore has to develop alongside the manufacturing process rather than being postponed until the equipment and product specification are finalised.
Uncertainty about which evidence is required can become costly during assessment. An applicant may need additional analytical work, manufacturing records or safety information if its submission leaves questions unresolved. Requests for supplementary data can interrupt an assessment while the developer obtains the necessary results, potentially extending the time between the original submission and an eventual decision.
The Ministry of Future Affairs argues that examining regulatory strategies before submission could help companies identify such gaps earlier. That is an intended benefit rather than a demonstrated outcome of RegLab. No participating cohort has yet completed the programme, and the organisers have not established a measured reduction in assessment time or the number of subsequent information requests.
Existing pre-submission arrangements generally address the needs of individual applicants. RegLab is designed to add a separate learning process by identifying questions and misunderstandings that recur across different businesses. If several developers interpret the same requirement differently, the organisers hope that anonymised information about those difficulties can inform future guidance without disclosing the details of individual applications.
The distinction between company-specific advice and broader learning is central to the initiative. A company must still generate the evidence necessary to demonstrate its product’s safety, while regulators remain responsible for the scientific and legal decisions. RegLab’s proposed contribution is to improve the preparation of applications and identify where existing explanations may be insufficient for businesses developing unfamiliar technologies.
The organisers intend to share anonymised recommendations with EFSA and the European Commission after the initial workshop. Neither institution is required to adopt those recommendations, and the initiative does not create a new channel through which participating companies can secure preferential decisions. Any changes to official advice or assessment practice would remain subject to the institutions’ own responsibilities.
The programme draws inspiration from regulatory learning undertaken in the United Kingdom around cell-cultivated food. That experience provides a reference for collaboration between developers and technical specialists, although the British and EU authorisation systems remain legally distinct. Participation in New Foods RegLab will not establish authorisation or regulatory clearance in either jurisdiction.
The initiative is supported by Dutch organisations including the Province of Zuid-Holland, LIOF and ROM-Nederland. The Ministry of Future Affairs intends to use the first cohort to examine practical problems encountered by businesses preparing applications, then develop recommendations concerning the future structure and delivery of pre-submission support.
Companies planning to submit EU novel-food applications within the next two years are among those eligible to participate. The organisers have asked applicants to commit one representative to both workshop days and complete preparatory work before attending. This arrangement should allow the discussions to examine real proposed products and regulatory positions rather than hypothetical cases disconnected from an applicant’s development programme.
The first workshop will take place in January 2027, after which the proposed recommendations can be assessed against the experience of the selected companies. The practical test will be whether the programme identifies recurring gaps in regulatory preparation that can be addressed through clearer guidance while preserving the scientific evidence and safety standards required for every novel-food authorisation.
