Hormonal disruption is a hot topic these days. Following 2016 draft EU legislation setting scientific criteria for identifying EDs (under plant protection and biocidal products Regulations), EFSA and ECHA have issued a draft guidance document on this subject. It includes advice on how to gather, evaluate and consider all relevant ED information, conduct a mode-of-action (MoA) analysis, and apply a weight-of-evidence (WoE) approach to establish whether these criteria are met.

Although the ED criteria apply to any endocrine-disrupting MoA, the new guidance only covers those related to “estrogen, androgen, thyroid and steroidogenic” (EATS) modalities. These pathways have the best characterised MoAs and have well-established test guidelines (both in vitro and in vivo), with general agreement on the interpretation of results. As we increase our understanding of how other endocrine modalities (beyond EATS) may lead to adverse effects, we will be more able to identify EDs. The guidance is currently tailored to vertebrates (mammals, fish, birds, etc.), as these are the animals for which we have the greatest knowledge of the endocrine system (and widest availability of test methods).

The guidance is currently open for public consultation but is anticipated to be finalised and applicable from 7 June 2018.

References

European Food Safety Authority/European Chemicals Agency (2017). Guidance for the identification of endocrine disruptors in the context of Regulations (EU) No 528/2012 and (EC) No 1107/2009. https://comments.echa.europa.eu/Comments_cms/ED_Guidance%20for%20public%20consultation_20171207.pdf

 

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