The European Commission (EC) requested EFSA and ECHA to develop a common guidance document (GD) for the implementation of the hazard-based criteria to identify endocrine disruptors (ED) in the context of Regulations (EC) No. 1107/2009 and (EU) No. 582/2012. This GD is currently available for public consultation, with interested parties invited to comment on the draft GD by 31 January 2018.
The draft GD (https://comments.echa.europa.eu/Comments_cms/ED_Guidance%20for%20public%20consultation_20171207.pdf) is written to provide guidance for applicants (and competent regulatory authorities) on how to carry out the ED hazard assessment in line with the stipulations set out in the ED criteria and how to apply a weight of evidence approach. The draft GD only covers the so-called EATS (Estrogen, Androgen, Thyroid and Steroidogenesis) modalities, as these are currently the best characterized pathways; with the GD limited to vertebrate non-target organisms, i.e. mammals, fish, amphibians and reptiles.
A list of uncertainties that should be considered when applying ED assessments in accordance with the approach detailed in the GD and recommendations for applicants and risk assessors for future research needs are given. Additional considerations on how to assess potential for thyroid disruption are provided in order to establish quantitative differences between humans and test species and thereby assess human relevance. A list of databases, software tools and literature (Q)SARs links / availability are also provided.
For advice on risk assessment and further information on the registration of plant protection products, biocides or general chemicals, or any other regulatory issues, please contact JSC on +44 (0)1423 520245,email@example.com
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