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Agenda

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    Trainers:

    Martina Duft Martina Duft
    Senior Expert Regulatory Ecotoxicology, knoell Germany GmbH
    Daniela Fruth Daniela Fruth
    Expert Product Compliance, Merck Electronics KGaA

  3. Registration

  4. Background and Introduction

  5. 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

  6. 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

  7. 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

  8. Refreshment break

  9. 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

  10. 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

  11. 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

  12. Lunch

  13. 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

  14. 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

  15. Refreshment break

  16. 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

  17. Questions and Discussion

  18. End of workshop

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