Event overview
Are you concerned about the latest developments regarding the assessment of endocrine disrupting (ED) properties? Wonder about the possible consequences for biocides and plant protection products?
Martina Duft and Daniela Fruth (knoell Germany) will be guiding and equipping you with the necessary know-how and tools in the challenging landscape of the required endocrine disruptor assessment and provide you with valuable guidance for identifying endocrine disrupting chemicals in the biocides and crop protection area.
This course will provide you (risk assessors, regulatory managers and (eco-)toxicologists engaged with the assessment of biocidal and crop protection active substances/products) with comprehensive background information and in-depth insight into the new EU Endocrine Disruptor criteria, and the recent ECHA/EFSA Guidance.
Background:
The EU has finally agreed upon the long-awaited scientific criteria for the evaluation of substances with a potential for ‘endocrine disruption‘. The new ECHA/EFSA guidance for the identification of endocrine disruptors, published in June 2018 and applicable for plant protection products and biocides, requires a highly complex and challenging assessment for all substances.
Particularly when dealing with such substances on a global scale, you may be facing substantial uncertainty regarding data requirements, testing and assessment strategies as well as impact outside the EU market.
In the field of biocides and plant protection products, the evaluating bodies are now obliged to also consider the ED properties of substances/products in any procedure that is still under the evaluation phase.
As a consequence, from 07 June 2018 the evaluating competent authorities are assessing the potential ED properties of biocidal products, and since 10 November 2018 for plant protection products. Additionally for biocides, besides active substances also co-formulants contained in the biocidal products must be assessed.
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.
Topics covered:
- Regulatory background and history of endocrine disruptors
- Definition and criteria of endocrine disruptors
- The main requirements of the new ED guidance
- Gathering and assembly of data
- Toxicological and ecotoxicological study types
- Assembly of the lines of evidence, evaluation of completeness
- Case studies for human health and non-target organisms
- Assessing the biological plausible link between observed effects and ED activity
- Regulatory consequences for applicants and implications on dossier preparation for biocides and crop protection products
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