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61.

Typically, the margin of exposure (MOE_(ref)) — the ratio between the dose descriptor and the exposure concentration — is in the region of 100, but a MOE_(ref) that is higher or lower than this may also be appropriate depending on, among other things, the nature of the critical effects and the sensitivity of the population.

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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.