35.

Where, for any of the effects set out in point 23 a reference value has been identified, the risk characterisation shall entail comparison of the reference value with the evaluation of the dose/concentration to which the population will be exposed. Where a reference value cannot be established a qualitative approach shall be used. Assessment factors account for the extrapolation from animal toxicity to the exposed human population. The setting of an overall assessment factor considers the degree of uncertainty in inter-species and intra-species extrapolation. In the absence of suitable chemical-specific data, a default assessment factor of 100 is applied to the relevant reference value. Additional elements can also be considered for assessment factors, including toxicokinetics and toxicodynamics, the nature and severity of the effect, human (sub-)populations, exposure deviations between study results and human exposure with regard to frequency and duration, study duration extrapolation (e.g. sub-chronic to chronic), dose-response relationship and the overall quality of the toxicity data package.

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Source: EUR-Lex (Cellar) · retrieved 2026-10-29 · Text as adopted (Official Journal); later amendments are not incorporated in this text.