Programme

  1. Registration

  2. Background and Introduction

  3. 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
  4. 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
  5. 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
  6. Refreshment break

  7. 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
  8. 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
  9. 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
  10. Lunch

  11. 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
  12. 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
  13. Refreshment break

  14. 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
  15. Questions and Discussion

  16. End of workshop

  17.  

    Course leaders:

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