The report will be used by the European Commission, with other input such as the European Food Safety Authority’s (EFSA) Scientific Committee opinion to provide the scientific basis for criteria to identify endocrine disrupting substances.
The JRC was asked in 2011 by the EC Directorate General for Environment to set up and chair an Endocrine Disrupters Expert Advisory Group (ED EAG).
The group involves toxicologists and ecotoxicologists with regulatory endocrinology backgrounds, industry associations and non-governmental consumer/environmental protection organisations.
“During the discussion it became obvious that some of the proposed factors were connected to the identification of EDs, while other factors were more connected to a characterisation of the hazard posed,” said the report.
Current method gaps
The group conceded it was not able to provide a full evaluation of the adequacy of the currently available test methods in the time available but did provide some observations.
“Existing standardised assays might miss some endpoints sensitive to endocrine disruption and it was acknowledged that there was no standardised assay currently available in mammals that allows the investigation of early life/in utero exposure on effects which may appear in later life stages...”
They agreed that convincing evidence of an adverse effect from a biologically plausible causal link to an endocrine disrupting mode of action and disruption of the endocrine system was not a secondary consequence of non endocrine-mediated systemic toxicity was relevant for ED identification.
Relevance to humans and wildlife populations should be assumed in the absence of appropriate data demonstrating non-relevance, added the group.
According to a 2002 International Programme on Chemical Safety (IPCS) and World Health Organization (WHO) definition: “An endocrine disrupter is an exogenous substance or mixture that alters function(s) of the endocrine system and consequently causes adverse health effects in an intact organism, or its progeny, or (sub)populations”.
Severity of effect, irreversibility, lead toxicity and potency were considered not relevant for ED identification but could provide information to the further characterization of any hazard.
However, Susy Brescia, health and safety executive, from the UK stated that the final report is not a true reflection of all her views.
"This expert disagrees that hazard identification is equivalent to identification of an endocrine disrupter (as implied by the report) and hence that hazard characterisation cannot be used, on a scientific basis, for identification of EDs," she said in an addendum to the report.
“The elements of hazard characterisation are considerations of the science and play an important role in the identification of EDs (especially if these EDs are going to be regulated in a number of contexts).
“Hazard characterisation is a critical step of hazard assessment; elements of hazard characterisation have been applied for decades and are still applied in the toxicological and ecotoxicological hazard identification system of the CLP Regulations."