EFSA pushes for AI and sandboxes to speed novel food approvals

The European Food Safety Authority (EFSA) has called for a faster, AI-enabled system to assess novel foods. This delay far exceeds the EU's legal timeline of seven months and is hampering sustainable food innovation.

EFSA’s paper highlights how its document-centred approach slows risk assessments and hinders evidence reuse across domains. Scientific opinions, data sets, and models are often produced and stored as separate artefacts. This limits reuse, increases manual work, and makes connecting evidence harder. The agency's updated guidance on novel foods outlines high-level scientific requirements but acknowledges it is not exhaustive.

Current EU novel food approval process faces significant delays

Despite a seven-month legal timeline, the average approval takes 30 months due to data gaps, manual processes, and sequential validation steps. Applicants build safety dossiers which are validated by the European Commission before going to EFSA. EFSA's suitability check takes 30 days, followed by a scientific risk assessment that can take nine months or longer if more data is needed. After EFSA's opinion, the Commission drafts an implementing regulation requiring approval from 55% of member states.

In reality, the average clearance time is 30 months and can stretch to five years. This contrasts with average timelines of 12 to 24 months in Singapore, Australia and New Zealand. According to GFI Europe, uncertainty over what data to provide has led to lengthy authorisation delays. The EU’s novel food regulatory framework is among the strictest in the world.

EFSA proposes AI-enabled, human-led model to modernize assessments

EFSA aims to build an integrated, end-to-end AI-supported system connecting data, governance, and expertise to accelerate risk assessments. The proposed model requires connecting scientific evidence, data governance, digital platforms, and legal compliance into one coherent operating model. Incoming dossiers and mandates would be converted into structured digital objects.

The agency states risk assessments need to become faster and fit-for-purpose. It must build its own specialist expertise internally to carry out assessments efficiently. EFSA also needs to address a lack of open-access information about rapidly developing food innovations.

EU policymakers debate including novel foods in regulatory sandboxes

MEPs, member states, and industry groups challenge the Commission’s exclusion of novel foods from the Biotech Act sandbox, citing innovation and preparedness benefits. Cultivated meat and precision fermentation are listed among EFSA’s priority scientific areas for sustainable innovation. MEPs on the Committee on the Environment, Climate and Food Safety have said the blanket exclusion should be removed. Member states like Germany and the Netherlands have called for a rethink.

Regulatory sandboxes are controlled, time-limited environments where businesses and regulators can design standards for new products. The European Commission proposed excluding novel foods from its food and feed sandboxes under the first Biotech Act. That decision could still be overturned as discussions in the Parliament and Council continue. Food and biotech trade groups representing Nestlé, Coca-Cola, Danone and Mars pushed back earlier this year, arguing the omission is not justified.

Industry and experts endorse EFSA’s call for sandbox inclusion and systemic reform

GFI Europe and experts like Lea Seyfarth affirm EFSA’s paper strengthens the case for sandboxes and proactive regulatory readiness for cultivated meat and precision fermentation. The Good Food Institute welcomed EFSA’s paper, arguing the highlighted issues show the need for novel foods to be included in sandboxes. GFI Europe says sandboxes are especially useful for alternative proteins being assessed for the first time.

Policy manager Lea Seyfarth said it was positive to see EFSA acknowledge the need to keep pace with innovation and develop a more proactive system. She said EU policymakers must look at the evidence and reverse the Commission’s proposal to exclude novel foods from the Biotech Act’s sandbox scheme. The European Parliament and Council will continue negotiating the Biotech Act, with the inclusion of novel foods in the sandbox scheme still undecided.