In collaboration with Die Akademie Fresenius
March 13-14, 2024
A Practical Guide to the ECHA/EFSA Endocrine Disruptors Guidance
Presentation of the course:
This training will provide you with practical knowledge on how to implement the requirements included in the ECHA/EFSA ED Guideline for the different relevant regulations: REACH, BPR and PPPs. You will learn about the most important aspects of EDs in general and the ECHA/EFSA guideline and how the guideline impacts the BPR, REACH and PPP Regulation
This course is aimed at professionals working in the fields of Regulatory affairs, Registration, Exposure assessment, Risk assessment and Toxicology in the sector of Plant protection industry, Biocide Producers, Chemical Industry (REACH), Scientific and regulatory consultancies
Programme:
The course will cover the following topics:
- Introduction
- General overview ED (definition, biological / scientifical background)
- General overview ED (short history)
- General overview OECD 150
- ECHA/EFSA Guideline and ECETOC implementation (the 7 steps)
- General overview of the two guidelines
- Practical implementation of the two guidelines for regulatory purposes
- Impact on BPR regulation
- Regulatory aspects of the ED properties
- Identification of ED in Biocides
- Update data requirements
- Practical steps for evaluating co-formulants
- Guidance on human health information
- Case study
- Impact on PPP Regulation
- Regulatory aspects of the ED properties
- Insights for active substances approval
- Impact on REACH Regulation
- Regulatory aspects of the ED properties
- Overview of endocrine disruptor SVHC and listed in Annex XIV (REACH)
- Assessment of the toxicological endpoint triggering ED properties
- Risk assessment for the Application for Authorisation
- Status of ED in other Regulations
- CLP: new risk classes
