Division II.6.1.3

Studies relevant to the establishment of a pharmacological ADI shall identify or characterise the mode of action, the dose-response relationship and identify a NOEL or BMDL, where possible and shall be used as a starting point from which a pharmacological ADI is derived. Where appropriate data are available from studies in humans (e.g. for substances with a history of use in human medicine) these shall usually be the most useful in identifying a pharmacological NOEL or BMDL. Guidance published by the F1appropriate authority on the establishment of pharmacological ADI^f1 shall be followed.