Risk assessment of 'endocrine substances': Guidance on identifying endocrine disruptors

Both sets of data (evidence of the adverse effect in apical studies and conclusive mode of action knowledge) are essential in order to correctly identify endocrine disruption according to accepted definitions. As the legislation seeks to regulate chemicals on a mode of action rather than the more traditional approach of adverse endpoints, then conclusive evidence of the mode of action of concern should be presented. From a human safety perspective and in the absence of any compelling data that endocrine active chemicals exert their adverse effects through anything other than a threshold mechanism there is no scientific justification for not using a margin of exposure approach to risk assessment in order to best protect human health.