Why almost every novel food application gets stopped

91% of post-2018 dossiers received at least one additional data request. What drives these clock stops and what can applicants do about it.

If you are preparing a novel food application for the EU market, here is a number worth knowing: 91% of post-2018 dossiers with available data received at least one additional data request from EFSA (Neytinck et al., 2025).

An additional data request — formally, an ADR — is EFSA's way of telling the applicant that something in the dossier is missing, incomplete, or not sufficiently documented. When an ADR is issued, the assessment clock stops. It resumes only when the applicant provides the requested information.

The cost of clock stops

Clock stops are not minor administrative delays. Based on available data from post-2018 dossiers, roughly half of the total time between submission and published opinion is spent in clock-stop periods (Neytinck et al., 2025). That is months of waiting — not for EFSA to review, but for the applicant to produce information that could have been included in the original submission.

The median total time from application to published opinion is around 16 months. The nine-month statutory deadline for EFSA to deliver its opinion has, in available data, never been met.

Each clock stop carries costs beyond the delay itself: additional consultant fees for preparing responses, potential need for new studies that were not originally planned, and delayed market access for a product that may already have manufacturing capacity in place.

What triggers an ADR

The areas most frequently flagged are not exotic edge cases. They are the foundational sections of the dossier.

Product characterisation and identity is the most common trigger. EFSA needs to know exactly what the novel food is — at the species, strain, or molecular level. Ambiguity here blocks the entire assessment, because every other section depends on the panel knowing what is being evaluated.

Production process documentation is frequently flagged alongside identity. If EFSA cannot understand how the product is made, it cannot assess whether the specifications are achievable or whether the compositional data is representative of what consumers will actually eat.

Compositional data is the area with the largest variety of requests (Ververis et al., 2020). Insufficient batch numbers, missing contaminant analyses, unvalidated methods, and incomplete mass balances are recurring themes.

Toxicological data triggers ADRs when studies are incomplete, when the test material does not match the product, or when the genotoxicity battery does not meet current EFSA requirements.

What applicants can do

The patterns are documented. EFSA's 2024 scientific guidance specifies exactly what each section requires. The published opinions show what the panel actually checks. The working group minutes reveal how the assessment proceeds in practice.

Three concrete actions reduce ADR risk:

Start with specifications. Define the novel food precisely before generating any other data. Every subsequent section — compositional analysis, toxicological studies, stability testing — depends on a clear, unambiguous identity.

Use five batches. EFSA's 2024 guidance explicitly requires a minimum of five independent, representative production batches for compositional characterisation. Submitting with fewer is a near-certain ADR.

Check cross-section consistency. The most consequential findings are often not within a single section but between them — a mismatch between the production process described and the compositional data submitted, or toxicological studies conducted on material that does not match the final product specifications.

The 16% that never start

Before EFSA even begins its assessment, 16% of applications are rejected as invalid (Neytinck et al., 2025). These dossiers fail the European Commission's initial completeness check — they are missing entire sections or fundamental administrative requirements.

This is entirely avoidable. The ESFC submission platform provides a structured template that maps directly to EFSA's assessment framework. Completing every field is not a guarantee of validity, but leaving sections empty guarantees rejection.

Sources

- Neytinck, J. et al. (2025). Analysis of novel food application timelines and outcomes. *npj Science of Food*. - Ververis, E. et al. (2020). Novel foods in the European Union. *Food Research International*. - EFSA (2024). Scientific Guidance for the preparation of applications for authorisation of novel foods. *EFSA Journal*.