Section 7 — safety studies including genotoxicity, subchronic toxicity, and where needed, reproductive and chronic studies.
The toxicological data section presents the safety studies conducted to evaluate the novel food's potential for adverse effects. It is typically the most extensive section in a novel food dossier, reflecting the depth of evidence EFSA requires to establish safety.
The standard toxicological package includes an in vitro genotoxicity battery (bacterial reverse mutation test, in vitro mammalian cell micronucleus test, and in some cases a chromosomal aberration test) and a 90-day oral toxicity study in rodents conducted according to OECD Test Guideline 408. Depending on the novel food type and intended use, additional studies may be required: reproductive and developmental toxicity, chronic toxicity, or carcinogenicity studies.
EFSA expects all toxicological studies to be conducted in compliance with Good Laboratory Practice (GLP) principles. The test material used in studies must be representative of the novel food as described in the identity and compositional data sections — a frequent ADR trigger is a mismatch between the tested material and the product intended for the market.
The outcome of the toxicological assessment is typically expressed as a NOAEL (No Observed Adverse Effect Level) or a benchmark dose, which forms the basis for the safety margin calculation relative to estimated human intake.
No Observed Adverse Effect Level — the highest dose in a study at which no adverse effects are detected.
Benchmark DoseA statistical modelling approach for deriving a reference point from toxicological data — increasingly preferred by EFSA over NOAEL.
ADME StudiesSection 8 — studies on absorption, distribution, metabolism, and excretion of the novel food in the body.
Paste a section and Borgh will flag the gaps that matter — with references to the relevant EFSA guidance.
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