Plain-language definitions for the terms that matter when preparing an EFSA novel food dossier. Each entry links to the relevant guidance and assessment section.
A novel food must clear admissibility before assessment begins — and every missing detail risks a clock-stop that adds months before the Panel can adopt its opinion.
Hover or tap any underlined term. The same definition is one glance away, wherever it appears.
Any food not significantly consumed in the EU before 15 May 1997.
Read more →A formal request from EFSA for missing or insufficient information in a novel food dossier.
Read more →A pause in EFSA's assessment timeline while the applicant responds to an additional data request.
Read more →EFSA's Panel on Nutrition, Novel Foods and Food Allergens — responsible for novel food safety assessments.
Read more →The EU register of authorised novel foods, specifying conditions of use and labelling requirements.
Read more →A simplified pathway for foods with a history of safe use in a third country outside the EU.
Read more →An optional consultation with EFSA before formally submitting a novel food application.
Read more →The European Commission's online platform for submitting novel food applications and related documents.
Read more →Section 1 of an EFSA novel food assessment — establishing exactly what the novel food is.
Read more →Section 2 — a complete description of how the novel food is manufactured, including safety-relevant controls.
Read more →Section 3 — analytical characterisation of the novel food's composition across representative production batches.
Read more →Section 4 — evidence that the novel food remains safe and within specification throughout its shelf life.
Read more →Section 5 — the specific food categories, target populations, and maximum intake levels proposed by the applicant.
Read more →Section 7 — safety studies including genotoxicity, subchronic toxicity, and where needed, reproductive and chronic studies.
Read more →Section 10 — evaluation of the novel food's potential to cause allergic reactions.
Read more →Section 8 — studies on absorption, distribution, metabolism, and excretion of the novel food in the body.
Read more →Production of specific compounds using genetically modified or selected microorganisms as cell factories.
Read more →Food produced from animal or plant cell and tissue cultures, also known as cultivated meat or cellular agriculture.
Read more →Protein derived from farmed insects — one of the most advanced novel food categories in the EU, with several authorised species.
Read more →Microscopic algae cultivated for food use — subject to specific characterisation and contamination requirements.
Read more →No Observed Adverse Effect Level — the highest dose in a study at which no adverse effects are detected.
Read more →A statistical modelling approach for deriving a reference point from toxicological data — increasingly preferred by EFSA over NOAEL.
Read more →A comparative approach to demonstrate that a novel food is essentially the same as an existing, safe counterpart.
Read more →An estimate of how much of the novel food a consumer would ingest daily, across population groups and food categories.
Read more →Ask Borgh directly and get an answer with references to EFSA guidance.
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