Proposed Uses and Use Levels

This section defines where and how the novel food is intended to be used: which food categories (using the FoodEx2 classification system), at what maximum levels, and for which population groups. The proposed uses directly determine the scope of the dietary exposure assessment and, consequently, the toxicological evaluation.

EFSA evaluates whether the proposed use levels, combined with anticipated consumption patterns across EU population groups, result in an intake that is safe. Inconsistencies between proposed use levels and the intake assessment are a known trigger for additional data requests.

The applicant must specify use levels per food category with sufficient precision. Vague descriptions such as "various food applications" or "as needed" are not acceptable. Where a novel food is proposed for use in food supplements, the maximum daily dose must be stated explicitly.

EFSA's Food Additive Intake Model (FAIM) tool or similar exposure modelling approaches are typically expected for estimating dietary exposure across different population groups, including vulnerable populations such as infants, children, and pregnant women.