Report summary
Based on the data which has been collated in this project this section draws conclusions on:
? The need for further data on the potential endocrine disrupting effects of the 12 individual substances to humans and/or wildlife within the context of information on general systemic toxicity and data on the potential for exposure of target
groups of humans and/or wildlife;
? General issues related to the assessment of endocrine disruption;
? Implementation of a framework for reviewing the potential endocrine disrupting effects of other substances of concern.
However, the conclusions drawn need to be considered within the overall scope and aims of the project and, therefore, some background information has been presented below to set this section in context with the rest of the report.
In order to carry out the review process an evaluation framework has been developed to review the nature and extent of endocrine disrupting effects of identified chemicals (and potentially others in the future) based on robust datasets. However, it needs to be recognised that the framework does not involve carrying out a full Risk Assessment of a substance under the Existing Substances Regulation 793/93.
In the review the International Programme for Chemical Safety (IPCS) definition of an endocrine disrupter has been adopted, namely that it 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?. As
a result the review considers other mechanisms of action than oestrogenicity and anti-oestrogenicity including androgenicity and anti-androgenicity, effects on thyroid function and effects on hormone secretion and synthesis and steroidogenesis, where relevant data are available.
The conclusions from the reviews are based on currently available reproduction and developmental toxicity data which has generally not been produced with a view to specifically assessing the potential endocrine disrupting effects of a substance. As a result there may be evidence of reproductive, embryotoxic or foetotoxic effects of a substance but not necessarily data on accompanying changes in endocrine function (for example changes in hormone levels). The conclusions have also taken into account whether reproductive and/or developmental changes in target groups of
humans and/or wildlife occur at or below those doses/concentrations causing general systemic toxicity.
In considering the conclusions it also needs to be recognised that:
? The results of this study can serve as an input to policy discussions which might then, for example, mandate a full risk assessment within the context of existing legislation (under Directive EEC 793/93). This may require further testing or
monitoring data for certain of the substances reviewed.
? In the future new techniques will be developed to assess endocrine disrupting properties of chemicals and these may provide data on the 12 substances which means the current conclusions have to be revisited. The approach taken at that moment will be determined by the Commission in consultation with stakeholders and the Scientific Committees of the Commission.
Full report available at:
http://ec.europa.eu/environment/endocrine/documents/wrc_report.pdf
