Division (1) A substance shall be considered as having endocrine-disrupting properties that may cause adverse effect in humans if, based on points (a) to (d) of point (2), it is a substance that meets all of the following criteria, unless there is evidence demonstrating that the adverse effects identified are not relevant to humans:

it shows an adverse effect in an intact organism or its progeny, which is a change in the morphology, physiology, growth, development, reproduction or life span of an organism, system or (sub)population 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;

it has an endocrine mode of action, i.e. it alters the function(s) of the endocrine system;

the adverse effect is a consequence of the endocrine mode of action.