3.11.1. Definitions and general considerations
3.11.1.1. Definitions
For the purposes of Section 3.11, the following definitions shall apply:
‘endocrine disruptor’ means a substance or a mixture that alters one or more functions of the endocrine system and consequently causes adverse effects in an intact organism, its progeny, populations or subpopulations;
‘endocrine disruption’ means the alteration of one or more functions of the endocrine system caused by an endocrine disruptor;
‘endocrine activity’ means an interaction with the endocrine system that may result in a response of that system, of target organs or target tissues, and that confers on a substance or the mixture the potential to alter one or more functions of the endocrine system;
‘adverse effect’ means a change in morphology, physiology, growth, development, reproduction or lifespan of an organism, system, population or subpopulation that results in an impairment of functional capacity, an impairment of the capacity to compensate for additional stress or an increase in susceptibility to other influences;
‘biologically plausible link’ means the correlation between an endocrine activity and an adverse effect, based on biological processes, where the correlation is consistent with existing scientific knowledge.
3.11.1.2. General considerations
3.11.1.2.1. Substances and mixtures fulfilling the criteria of endocrine disruptors for human health based on evidence referred to in Table 3.11.1 shall be considered to be known, presumed or suspected endocrine disruptors for human health unless there is evidence conclusively demonstrating that the adverse effects are not relevant to humans.
3.11.1.2.2. Evidence that is to be considered for classification of substances in accordance with other Sections of this Annex may also be used for classification of substances as an endocrine disruptor for human health where the criteria provided in this Section are met.