An estimate of how much of the novel food a consumer would ingest daily, across population groups and food categories.
Dietary exposure assessment estimates the amount of a novel food (or a specific constituent) that consumers would ingest on a daily basis, taking into account the proposed use levels, the food categories in which the novel food would be used, and the consumption patterns of different population groups across EU Member States.
EFSA expects exposure to be estimated for all relevant population groups, including infants, toddlers, children, adolescents, adults, the elderly, and pregnant or lactating women. The assessment must consider both average consumers and high consumers (typically the 95th percentile of consumption) to identify potential risk for the most exposed groups.
The standard tool for dietary exposure assessment in the EU is the EFSA Comprehensive European Food Consumption Database, which provides consumption data from national dietary surveys across Member States. For food additives and similar applications, the FAIM (Food Additive Intake Model) tool provides a standardised framework.
The exposure assessment directly links the proposed uses section to the toxicological evaluation: EFSA compares estimated human intake with the toxicological reference point (NOAEL or BMDL) to determine whether the margin of exposure is sufficient to conclude safety.
Section 5 — the specific food categories, target populations, and maximum intake levels proposed by the applicant.
NOAELNo 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.
Paste a section and Borgh will flag the gaps that matter — with references to the relevant EFSA guidance.
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