Agenda
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Registration
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Background and Introduction
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Introduction on endocrine disruptors: Regulatory background, history, criteria and guidance
- Definition and criteria
- Regulatory history
- New EU ED criteria Biocides and Crop Protection Products
- New ECHA/EFSA ED Guidance
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Stepwise approach: Overview on the main requirements of the new ED guidance
- Scope of the ED Guidance
- Assessment strategy for determining potential ED properties
- Overview on information sources and guidance
- Recommendations for applicants and evaluating authorities
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First steps: Gathering and assembly of data – targeted literature search, data bases, QSAR profiling and reporting of data
- Process of data gathering: Relevance and reliability of data
- Developing search strategy protocols
- Databases, software tools and literature-derived (Q)SARs
- Reporting the available information relevant for ED assessment
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Refreshment break
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Investigation of ED properties with a focus on EATS endpoints: Specific toxicological study types
- Strategy for endocrine disruptor identification
- Human health-related endpoints: OECD Conceptual Framework and OECD GD 150
- Limitations of testing guidelines
- Epidemiology data
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Investigation of ED properties with a focus on EATS endpoints: Specific ecotoxicological study types
- Environment/Ecotoxicity-related endpoints: OECD Conceptual Framework and OECD GD 150
- In vitro and in vivo test methods and parameters for non-target organisms
- Epidemiological data, field studies and population models
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Assembly of the lines of evidence, evaluation of completeness of data
- Assembly of the lines of evidence: Adversity vs. endocrine activity
- Empirical support vs. expert judgement
- Analysis of the evidence and conclusions on potential ED properties
- Sufficiency/completeness of data for assessment and generation of information
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Lunch
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Weight of evidence evaluation: Bringing together an overall argumentation – Case studies for human health and non-target organisms
- WoE methodology for adversity and ED activity and mode of action analysis
- Annex E table: revisions and changes
- Practical exercises for human health and non-target organisms
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Mode of Action Analysis – Assessing the biological plausible link between observed effects and ED activity
- Identification of the need for MoA analysis
- Interlinkage of molecular initiating event and key events
- Examples for plausible link between adversity - ED activity and need for further information
- Limitations and issues
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Refreshment break
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Regulatory consequences for applicants and overall implications on dossier preparation for biocides and crop protection products: Derogations human health/environment
- Outcomes on ED assessment
- Regulatory consequences for humans and non-target organisms in the biocides and crop protection area
- Impact on ongoing evaluations, approvals and renewals
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Questions and Discussion
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End of workshop
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Course leaders:
