1.1.3. Historical human data

As a general rule, in accordance with Article 7(3) of Regulation (EC) No 1272/2008, tests on humans shall not be performed for the purposes of this Regulation. However, existing historical human data, such as epidemiological studies on exposed populations, accidental or occupational exposure data, biomonitoring studies, clinical studies and human volunteer studies performed in accordance with internationally accepted ethical standards shall be considered. Data collected on humans shall not be used to lower the safety margins resulting from tests or studies on animals. The strength of the data for a specific human health effect depends, among other things, on the type of analysis and the parameters covered, and on the magnitude and specificity of the response and consequently the predictability of the effect. Criteria for assessing the adequacy of the data include: the proper selection and characterisation of the exposed and control groups; adequate characterisation of exposure; sufficient length of follow-up for disease occurrence; valid method for observing an effect; proper consideration of bias and confounding factors; and a reasonable statistical reliability to justify the conclusion. In all cases adequate and reliable documentation shall be provided.

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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.