Module 53: Chemical Safety Assessment – The Science And Theory For Risk Characterisation (53.023)

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Module 53, Chemical Safety Assessment – The Science And Theory For Risk Characterisation 

Under good practice for Product Stewardship and to meet requirements under REACH, it is necessary to assess the risk from the known uses of the materials you supply.

So that you know if a particular use has an acceptable level of risk, an assessment is needed in which scenarios for exposure are compared with known hazardous properties. This process of comparison between hazard and exposure is known as risk characterisation and is needed for REACH registration of substances and presented as the ‘Chemical Safety Report’ (CSR).

The findings of the CSR are summarised in the extended SDS of a substance, and if supplying a mixture, the substances present in the mixture that contribute to any hazard must all be considered.

This course, delivered live online over two consecutive mornings, aims to cover the basic science and principles of chemical safety assessment and the CSR, dealing mainly with the technical concepts including the DNEL / DMEL and PNEC and the science behind exposure estimates.

The module also considers how the Chemical Safety Report is to be used as a basis of preparing exposure scenarios to prepare the extended SDS for substances and mixtures. It provides a good foundation for Module 20 'The Extended SDS - Understanding Exposure Scenarios'.

Exercises and illustrations of real CSR will be held throughout the day to assist in the understanding of the concepts introduced

PLEASE NOTE: IMPORTANT PRE-TRAINING INFORMATION

This is not an "Introduction to REACH" course; some knowledge of the principles of REACH and chemistry is essential. This is predominantly a science-based day to consider how to characterise risk.

During the practical session, we will demonstrate several tools including the Chemical Safety Assessment and Reporting tool (CHESAR), the targeted risk assessment model (ECETOC TRA) and EUSES (European Union System for the Evaluation of Substances) software.

Who Should Attend

The module is designed for those involved in chemical safety assessment and communication, within the context of product stewardship and with a particular focus on supply regulations, including REACH and writing extended SDS

Those attending should already understand the broad concepts of chemical supply legislation, including REACH, and also understand the science of data assessment including physico-chemical data, basic toxicology and basic ecotoxicity.

Note: The regulatory and technical requirements covered by this module relate to EU and GB REACH.

Benefits Of Attending?

Attendance on this module will ensure that you are up to date with the requirements for the preparation of exposure scenarios and exposure estimates. To ensure the most effective training with optimum involvement in participative exercises, there will be a limit of 14 on the number attending.

Module 53 should be seen as an extension of the scientific content of the toxicology and ecotoxicology modules and the scientific basis for Module 20 ‘Exposure Scenarios’ module. If planning to attend Module 20, Module 53 will provide an important basis for understanding the technical content.

This module will cover the following points to assist writers.

• • Technical and regulatory background
• • Basic principles of risk assessment, Legislative framework, Environmental and health hazards, Exposure modes, Background to EU methods / Technical Guidance Document / models 
• • Chemical Safety Assessment
• • Interpretation and understanding of test data, What to look for in test reports, Quality of supplier safety data sheets, Looking for anomalies in data, Difficult materials, Identification of hazard from minimal data, Computer models, read across and educated guessing (SAR)Environmental and health hazards 
• • Derived Endpoints
• • Understanding PNECs and DNELs Patterns of exposure
• • Exposure Scenarios / Exposure Estimates
• • Patterns of exposure, Understanding exposure scenarios, Use of default data, Environmental and workplace exposure, Exposure of general public
• • The Chemical Safety Report
• • Overview of document, Purpose of document, Formatting and content, Communication through supply chain, Links with SDS
• • ‘Advanced’ testing and data gathering; further ‘higher tier’ options for risk assessment
• • Environmental fate and the effects on treatment plants, Persistence and bioconcentration, long-term health effects.

Module Tutor

The training will be given by Mark Selby of Denehurst Chemical Safety Ltd. Mark had many years’ experience with a major test house before setting up his own business and runs the very successful CHCS modules on ecotoxicology, advanced SDS writing and Exposure Scenarios. 

The departure of the UK from the EU does not impact on the either the importance of the understanding and collating hazard and exposure data to estimate risk.

Module Presentation

We will deliver this training using online training software, which we have used successfully for other CHCS training courses. You can use the software, free-of-charge on Windows, Macs, smartphones and tablets.

The sessions will run live and delegates can interact with the tutor and other delegates using their device microphone. The tutor will use a PowerPoint presentation, just as they would in face-to-face training. We will provide you with copies of the presentation and all other supporting documentation in advance of the training, by email.

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