An optional consultation with EFSA before formally submitting a novel food application.
EFSA offers applicants the option to request pre-submission advice before formally submitting a novel food application. This is a voluntary consultation in which the applicant can discuss specific scientific or methodological questions with EFSA, particularly regarding study design and data requirements.
Pre-submission advice is not an assessment of the application itself. EFSA will not pre-evaluate dossier content or provide a preliminary opinion on the safety of the novel food. Instead, the advice focuses on procedural and methodological guidance — for example, whether a proposed toxicological study design is appropriate, or which analytical methods would be acceptable for characterisation.
The service is intended to help applicants prepare stronger dossiers and reduce the likelihood of additional data requests during the formal assessment. Given that the majority of novel food applications receive at least one ADR, early engagement with EFSA on study design can be a cost-effective investment.
The request for pre-submission advice is submitted through the E-Submission Food Chain (ESFC) platform. EFSA aims to provide a response within 60 working days.
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