Course Overview

In this 2-day course we will cover the information requirements under REACH with regard to substance properties, exposure, use and risk management measures, in the context of the chemical safety assessment. The aim is to help the course attendees with their preparation for fulfilling their obligations under the REACH Regulation.

The course covers the collection of available information regarding the intrinsic properties of substances to be registered, the assessment of this information against the requirements specified by REACH, the identification of data gaps and the generation of the additional information required to fill the data gaps. The course will provide information on conducting Chemical Safety Assessments and preparing Chemical Safety Reports, when required. A CSR may be required as part of a registration dossier, as part of an authorisation application, or as part of downstream user obligations. It also sets out the basic principles for authorities preparing a risk assessment. This may be needed in support of a restriction proposal, of a proposal to include substances into the authorisation regime, or as part of a Substance Evaluation. We will also look at the hazard assessment, this part of the course covers information requirements on intrinsic properties of a substance under REACH, including information gathering, non-testing approaches and the so-called integrated testing strategies for generating the relevant and required information on each endpoint.

Course attendees will learn how to characterise hazards, including where possible derivation of DNELs and PNECs, means the determination of Derived No-Effect-Levels (DNEL) (or other qualitative or semi-quantitative measures of potency of the substance and integrated testing strategies for the relevant human health endpoints), and the determination of Predicted No-effect-Effect levels (PNEC) and integrated testing strategies for the environment endpoints. Also, we will explain how to assess whether or not a substance is persistent, bioaccumulative and toxic (PBT) or very persistent and very bioaccumulative (vPvB). Another subject which will be covered in this course is the exposure assessment, in particular how to describe uses, how to collect information on operational conditions and risk management measures, and how to carry out exposure estimates.

The course will discuss the general description of identified uses and how to give exposure scenarios a short title. Attendees will learn how to define Risk management measures, and Operational conditions for building of exposure scenarios. The Risk characterisation, which combines the information on hazard and exposure in the risk characterisation ratio or in qualitative risk characterization, will be discussed as well. Also, we will explain the format and requirements for preparing the chemical safety report. This includes how to use the CSR template as published on the ECHAs website and how to use IUCLID5 to prepare a CSR. Preparing the extensions to the safety data sheet (SDS) and the communication of the exposure scenario information within the supply chain will conclude the 2-day training course.

Course Agenda

Day 1

• Introduction
• Explanation of Terms
• Data Gap Analysis and Testing Strategies
• Hazard Assessment
  • Information Requirements
  • Characterization of Hazards
  • Dose- or Concentration Response Characterization
  • Physico-chemical properties
  • Determination of Derived No-Effect-Levels (DNELs)
  • Determination of Predicted No-Effect-Levels (PNECs)
• Q&A and Workshop

Day 2

• Review Moving forward with Registration: CSA/CSR/ES/eSDS Day 1 - Q&A
• PBT and vPvB Assessment
  • Emission Characerization
• Exposure Assessment
  • Description of Uses (Use Descriptor System)
  • Conditions of Use (RMMs, OCs)
  • Exposure Estimation
• Risk Characterization
  • Information on Hazard and Exposure
  • Robustness of Risk estimates
  • Uncertainty Assessment
  • Qualitative Risk characterization
• Chemical Safety Report
  • Requirements
  • Format
  • Preparing CSRs in IUCLID5
• Extension of the SDS - Exposure Scenarios
  • Core Contents of Exposure Scenarios
  • Format of Exposure Scenarios
  • Finalise Exposure Scenarios
  • Implementing and Communicating Exposure Scenario Information in the Supply chain
• Q&A and Workshop

Prerequisites

This course is designed for people who are already familiar with REACH or people who have completed ChemADVISOR’s REACH Essentials Course.

Course Certification

This course is worth 2.17 Industrial Hygiene CM Points 

• 2010 (Approval #: 10-462)
• 2011 (Approval #: 10-3876)

Upcoming Course Dates