July 12 2018 — July 12 2018

Expert Insights: Smithers Viscient Webinar Series

Regulations (EU) No 528/2012 and (EC) No 1107/2009: An overview of the draft guidance for the identification of endocrine disruptors in context.

Last December the European Food Safety Authority (EFSA) and the European Chemicals Agency (ECHA) issued a joint, harmonized, draft guidance document: Guidance for the identification of endocrine disruptors in the context of Regulations (EU) No 528/2012 and (EC) No 1107/2009. The guidance laid out the scientific criteria necessary to evaluate the endocrine disrupting potential of plant protection products (PPP) and biocidal products (BP). The guidance is limited to humans and non-target vertebrates (mammals, fish, birds, amphibians and reptiles) and only covers estrogen, androgen, thyroid and steroidogenesis (EATS) modalities.

This webinar will discuss key aspects of the guidance document, including new key phrases like EATS mediated parameters and sensitive to but not diagnostic of EATS mediated parameters, new considerations like maximum tolerated concentrations in ecotoxicology studies, relevant OECD tests and potential strategies for assembling and collecting the necessary data for assessment. We will also walk through the assessment strategy flow chart using the new terminology and understanding where and how to use some of the proposed test methods.

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