Endocrine Disruptors - ED

Are you concerned about the latest developments regarding the assessment of endocrine disrupting (ED) properties and its possible consequences for biocides and your biocidal product authorisations?

The EU has finally agreed upon the long awaited scientific criteria for the evaluation of substances with a potential for ‘endocrine disruption‘. The corresponding recently issued ECHA/EFSA ED guidance for plant protection products and biocides (June 2018) requires a highly complex and challenging assessment for all substances. According to the CA-Document “CA-Jan18-Doc.7.3.b” (March 2018), the evaluating body for biocides is now obliged to also consider the ED properties of a biocidal product (b.p.) in any procedure that is still under the evaluation phase as soon as the Regulation (EU) 2017/2100 setting out scientific criteria for the determination of endocrine-disrupting properties, becomes applicable. As a consequence, from 07 June 2018 the evaluating competent authority will assess the potential ED properties of biocidal products. Please note that this means in practice that this evaluation will relate not only to the active substance(s) but also to co-formulant(s) contained in the biocidal product(s). With a view to the ED assessment co-formulants represent a particular challenge in terms of available data package and data access possibly requiring a revised assessment strategy.

If you need help understanding the guidance for identifying endocrine disrupting chemicals (link) then maybe you should consider joining us in Vienna at the Chemical Watch Biocides Europe 2018 Event (27-29 November 2018) where we are giving a workshop on the 29th of November on “Understanding the guidance for identifying endocrine disrupting chemicals” .

Programme

Presenters:

Dr Martina Duft, Biologist, Expert Environmental Safety/Regulatory Affairs, knoell Germany GmbH
Dr Michael Werner, Senior Expert, Regulatory Toxicology Biocides, knoell Germany GmbH

09.00 - 14.50

  • Introduction on endocrine disruptors: regulatory background, history, criteria and guidance
  • Stepwise approach: overview on the main requirements of the new guidance
  • First steps: Gathering and assembly of data – targeted literature search, data bases, QSAR profilin and reporting of data
  • Investigation of ED properties with a focus on EATS endpoints: Specific toxicological and ecotoxicological study types
  • Identification and assessment of ED properties for human health and environment: evaluation of all available data
  • Assembly of the lines of evidence, evaluation of completeness of data
  • Weight of evidence evaluation: bringing together an overall argumentation
Deirdre Lawler Head of Business Unit Chemicals & Biocides - Biocides
+49 214 20658-220 +49 214 20658-200 send mail