A Practical Guide to the ECHA/EFSA Endocrine Disruptors Guidance: Biocides, REACH and PPPs

Day 1

Introduction

• General overview ED (definition, biological/scientific background)
• General overview ED (short history)

General overview OECD 150

• General overview of the guideline
• Principles of OECD 150
• Methods for the evaluation of EDs properties

ECHA/EFSA Guideline and ECETOC implementation (the 7 steps)

• General overview of the two guidelines
• Methods for the evaluation of EDs properties
• Practical implementation of the guidelines for regulatory purposes
• General overview of the two guidelines (Human Health and Environmental)
• Case studies (Human Health and Environmental

Day 2

Impact on BPR

• Regulatory aspects of the ED properties
• Regulatory requirements for active substances and biocidal products
• Regulatory consequences for active substances and products
• Identification of ED in Biocides
• EDs assessment of biocidal products
• Case study

Impact on PPP Regulation

• Regulatory aspects of the ED properties
• Identification of EDs in PPP
• Insights and practical steps for active substances approval
• Case studies & Insights for co-formulants

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

Learning Objectives:

• The most important aspects of EDs in general and the ECHA/EFSA guideline
• How the guideline impacts the BPR regulation
• How the guideline impacts REACH
• How the guidline impacts the PPP Regulation

Professionals working in the fields of:

• Regulatory affairs
• Registration
• Exposure assessment
• Risk assessment
• Toxicology

Sectors that should take part:

• Plant Protection industry
• Biocide Producers
• Chemical Industry (REACH)
• Scientific and regulatory consultancies