A formal request from EFSA for missing or insufficient information in a novel food dossier.
An additional data request (ADR) is a formal communication from EFSA's NDA Panel to the applicant, requesting information that is missing, incomplete, or insufficiently documented in the submitted dossier. When an ADR is issued, the assessment clock is stopped until the applicant provides the requested data.
ADRs are common. In an analysis of post-2018 dossiers with available data, 91% received at least one additional data request (Neytinck et al., 2025). The average number of ADRs per dossier was roughly 2–3.
The most frequently flagged areas include product characterisation and identity, production process documentation, and compositional data (Ververis et al., 2020; EFSA NDA Panel Working Group minutes). A single application can receive multiple sequential ADR rounds — complex cases have been observed with three or more rounds.
The cost of an ADR goes beyond the direct work of preparing a response. Each clock stop adds months to the evaluation timeline, delays market access, and may require additional studies that were not originally planned.
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