Section 1 of an EFSA novel food assessment — establishing exactly what the novel food is.
Identity and specifications is the first of ten mandatory sections in an EFSA novel food dossier. It requires the applicant to establish unambiguously what the novel food is and how it can be distinguished from other substances. This section is the single most common reason EFSA stops the clock on an application.
For biological sources, the section must include taxonomic identification at species and, where relevant, strain level. For chemical substances, structural characterisation (molecular formula, molecular weight, stereochemistry) is required. All novel foods must include detailed specifications: purity criteria, limits for contaminants and residual solvents, and a clear distinction between what constitutes the novel food versus the source material.
Batch-to-batch consistency must be demonstrated across a minimum of five independent, representative production batches, as specified in EFSA's 2024 scientific guidance. The specifications must be supported by analytical data with validated methods.
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