FRNº 32EU Policy & Regulation

EU novel-food approvals average 2.5 years; new RegLab targets the delay

EU novel-food approvals average 2.5 years against an 18-24 month statutory window. The Ministry of Future Affairs opens a Brussels RegLab cohort in January 2027 to compress timelines for operators.

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Menu du jour

  1. First course

    EU novel-food authorisation averages 2.5 years against an 18-24 month statutory window, with some applications exceeding five years, per an analysis of 292 applications cited by the Ministry of Future Affairs.

  2. Second course

    The New Foods RegLab was launched on 15 October 2026; the first Brussels cohort runs in January 2027 with up to 10 non-competing companies and a two-day programme led by Atova Regulatory Consulting.

  3. Third course

    Applications for the first RegLab cohort close on 30 November 2026; participating experts each hold more than 15 years of novel-food dossier experience.

  4. Fourth course

    Anonymised RegLab findings will feed into EFSA and the European Commission as input for pre-submission advice under the proposed Biotech Act I and Biotech Act II.

The EU novel-food authorisation process takes an average of two and a half years against an 18-24 month statutory timeframe, with some applications exceeding five years, according to an analysis of 292 applications cited by the Ministry of Future Affairs on 15 October 2026.

On that date the Ministry launched the New Foods RegLab, a cross-border regulatory learning platform designed to help novel-food developers and national authorities share anonymised insights and shorten approval timelines for products ranging from precision-fermented dairy proteins to cultivated meat.

The statutory pre-market authorisation window for novel foods sits at 18-24 months. The Ministry said the actual average is two and a half years, with more than five years recorded in the most protracted cases. Administrative friction during the validation stage and requests for additional data during scientific evaluation account for most of the overrun, the Ministry argued, attributing delays to knowledge-transfer gaps and process design rather than the underlying rules.

What does the RegLab actually do?

The first cohort runs in Brussels in January 2027. Up to 10 non-competing companies will join a two-day programme led by Atova Regulatory Consulting under the Chatham House Rule. Applications close on 30 November 2026. Participants need not have filed an EU dossier or finalised a regulatory strategy to take part.

Food-safety experts running the sessions each have more than 15 years of experience with novel-food dossiers. The programme will examine participants' regulatory positions, identify gaps and run a policy session on the planned pre-submission advice under the Commission's forthcoming Biotech Act I and Biotech Act II. Anonymised findings will feed into the European Food Safety Authority (EFSA) and the European Commission as part of policy recommendations on expanded pre-submission advice.

Anna Handschuh, founder and managing director of the Ministry of Future Affairs, said: "The EU wants to introduce a much broader pre-submission advice for novel-food applicants. However, this would only help one applicant at a time. Shared cross-border learning platforms as enhanced collaboration mechanisms can inform a whole system and support food safety, competitiveness and strategic autonomy."

Handschuh pointed to the UK's cultivated-meat regulatory sandbox as a working precedent, and to national AI regulatory sandboxes under the AI Act and the European Forum for Innovation Facilitators in financial services as opt-in models the Ministry wants to replicate for novel foods.

Why does this matter for European hospitality and food operators?

Novel-food pipelines feed directly into European restaurant, hotel and contract-catering menus, where precision-fermented dairy and egg proteins, mycelium-based ingredients and cultivated seafood are moving from pilot to procurement. A consistent two-and-a-half-year approval lag delays product launches, complicates menu planning for operators running multi-site concepts and pushes European food-tech capital toward the United States, where authorisation pathways are shorter.

The Ministry's paper also links the issue to strategic autonomy, citing the EU's growing dependence on imported inputs critical to food supply, many of which are manufactured in China. Public investment channelled through the biotechnology IPCEI for food and feed will deliver more value if operators and assessors share a common reading of authorisation requirements, the Ministry argued.

What happens next?

The RegLab sits inside the Ministry's first Future Prototype, "Building on Draghi: Regulatory Learning With The New Foods RegLab", and feeds into Biotech Act I, which the Ministry proposes should contain a targeted provision enabling Member States to set up joint regulatory dialogue and learning platforms covering emerging biotechnologies including food biomanufacturing. Biotech Act II would follow with a longer-term legal and funding framework, potentially drawing on Horizon Europe or the European Competitiveness Fund. Participation remains voluntary; safety standards stay unchanged.

The initiative is supported by the Dutch Province of Zuid-Holland, LIOF and ROM-Nederland. The Commission has not yet confirmed a timetable for Biotech Act I.

via FoodBev (Source)

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Elena Vasquez

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News editor covering regulation, policy and their impact on European hospitality industry at Eurotables Report.

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