Workshop

September 23rd and 24th, 2019 – Conference
September 25th, 2019 – Workshop
Berlin, Germany

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Wednesday, 25th September 2019

8.30 Reception and Coffee

9.00 to 16.30 Understanding the Guidance for Identifying Endocrine Disrupting Chemicals

Breaks will be arranged flexibly.

Your Workshop Facilitators

Dr Martina Duft, Biologist, Expert Environmental Safety/Regulatory Affairs,
knoell Germany GmbH, Germany

Dr Daniela Fruth
Food Chemist, Regulatory Toxicology Biocides, knoell Germany GmbH,
Germany

Content of the Workshop

This workshop will provide the target audience (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.
 

Program:

• Introduction on endocrine disruptors: regulatory background, history, criteria and guidance
• Stepwise approach: overview on the main requirements of the new 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: 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
 

Agenda

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

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

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

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

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

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

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

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

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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