Are you concerned about the latest developments regarding the assessment of endocrine disrupting (ED) properties and its possible consequences for biocides and plant protection products?
knoell Germany GmbH is pleased to announce a brand new one day training course on Understanding the guidance for identifying endocrine disrupting chemicals in the biocides and crop protection area.
This workshop will provide risk assessors and regulatory managers 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.
The main objective of the training course is to equip the participants with the necessary know-how and tools in the challenging landscape of the required endocrine disruptor assessment.
The EU has finally agreed upon the long awaited scientific criteria for the evaluation of substances with a potential for ‘endocrine disruption‘. The recently issued ECHA/EFSA guidance for the identification of endocrine disruptors, applicable for plant protection products and biocides (June 2018), 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 authority are assessing the potential ED properties of biocidal products, and since 10 November 2018 for plant protection products. Additionally for biocides, beside 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.
- Introduction on endocrine disruptors: Regulatory background, history, criteria and guidance
- Stepwise approach: Overview on the main requirements of the new ED guidance
- First steps: Gathering and assembly of data – targeted literature search, data bases, QSAR profiling 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 - – Case studies for human health and non-target organisms
- Mode of Action Analysis – assessing the biological plausible link between observed effects and ED activity
- Regulatory consequences for applicants and overall implications on dossier preparation for biocides and agrochemicalscrop protection products: Derogations human health/environment