A report from the Endocrine Disrupters Expert Advisory Group (ED EAG, a sub-group of the ad hoc group of Commission Services, EU Agencies and Member States for the Community Strategy on Endocrine Disrupters) discusses the key scientific issues relevant to the identification of endocrine disrupting substances (EDs). To identify an ED, it was agreed that an adverse effect, with convincing evidence of a biologically plausible causal link to an endocrine disrupting mode of action, should be demonstrated.

While the ED EAG could not provide a full evaluation of the adequacy of currently available test methods for endocrine disruption, it acknowledged that existing standardised assays might miss some sensitive endpoints. The group also noted that there are no standardised assays currently available in mammals which allow the investigation of the effects of early life or in utero exposure on health later in life (e.g. cancer incidence, menopause and senescence).

Meanwhile, the German Federal Institute for Risk Assessment (BfR) has proposed a new concept for the assessment of EDs. The concept described is designed to provide a harmonised approach for the evaluation and approval/authorisation of EDs within the major EU regulations. The first stage consists of hazard identification, and an assessment of whether the adverse effects observed in animals are relevant to humans. This is followed by an evaluation of the specificity, severity, reversibility, potency and consistency of the effects. In the final stage, the substances are differentiated into EDs of higher or lower regulatory concern, to facilitate a clear decision about further regulatory measures in accordance with the provisions of the various EU regulations. 

Munn S & Goumenou M (2013). European Commission, Joint Research Centre. Key scientific issues relevant to the identification and characterisation of endocrine disrupting substances. EUR 25919 EN.


German Federal Institute for Risk Assessment (BfR). BfR concept for assessment of endocrine disrupting substances under different regulations. BfR Information of 26th March 2013.



The above item was taken from the May 2013 issue of Toxicology and Regulatory News which is sent automatically to members of bibra (click here for more details).

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