1.1. Use of existing data

1.1.1. Data on physical-chemical properties from experiments not carried out according to GLP or the relevant test methods. Data shall be considered to be equivalent to data generated by the corresponding test methods if the following conditions are met: adequacy of the data for the purpose of classification and labelling and risk assessment; sufficient adequate and reliable documentation is provided to assess the equivalency of the study; and the data are valid for the endpoint being investigated and the study is performed using an acceptable level of quality assurance. 1.1.2. Data on human health and environmental properties from experiments not carried out according to GLP or the relevant test methods. Data shall be considered to be equivalent to data generated by the corresponding test methods if the following conditions are met: adequacy of the data for the purpose of classification and labelling and risk assessment; adequate and reliable coverage of the key parameters/endpoints foreseen to be investigated in the corresponding test methods; exposure duration comparable to or longer than the corresponding test methods if exposure duration is a relevant parameter; adequate and reliable documentation of the study is provided; and the study is performed using a system of quality assurance. 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.