The identification and the evaluation of the endocrine disruptor substances (EDs) are becoming, and they will become, a high priority of the risk assessment in the European regulatory framework.
The issue is listed among the cut off criteria of the Regulation concerning the Plant Protection Products (Regulation EC 1107/2009) but currently the criteria have not yet been defined and EDs are or shall be classified in accordance with the CLP Regulation (Regulation EC 1272/2008) as carcinogenic and toxic for reproduction, category 2.
OECD is working in the meantime on the revision of the Conceptual Framework (CF) of the EDs and the European Commission asked EFSA to review the existing information related to the testing and assessment of the endocrine active substances and the EDs.
Due to the partial overlap of EDs effects with other critical ones, the actual testing strategy doesn’t allow to fully identify these types of substances. The OECD approach is a tiered approach based on different information levels. The first level consists of existing data and non-test information as physical and chemical properties, epidemiological and field studies, ecotoxicological data from standardized or non-standardized tests, read-across, chemical categories, modeling tools as QSAR and in silico.
Other two levels consist of in vitro and in vivo assays providing data about the selected mechanisms/pathways of the substance.
The latest two levels are in vitro and in vivo assays providing data of adverse effects on the endocrine relevant endpoints over extensive parts of the organisms life cycle. The whole data set will provide all the information needed to decide whether a substance is an ED or not.
Some testing guidelines have been specifically developed for this goal, other ones provide useful information and many more belong to the ongoing program.
We could think that the creation of the EDs category has a strong impact on the European market, in particular for fungicides group, but it is important to remark that the risk assessment takes into account not only the hazard but also the exposure scenarios…