This book is an essential guide and support to
understanding of the science and policy, procedure and practice
that underpins the REACH risk assessments required for the use and
placing on the market of chemicals in the European Union. A clear
understanding of information provision and how this affects the
assessment of chemical safety is fundamentally important to the
success of policy on chemicals and ultimately to the sustainability
of the chemicals industry.

Within the book, the scientific processes that underpin the
policy are explained in a practical way. Importantly,
it includes coverage of techniques to help solve the problems of
using potentially risky and hazardous chemicals through the use of
less hazardous alternatives and 'green chemistry', and
also the analysis of the risks of the use of the most hazardous
substances against the social and economic benefits of
use.

Chemical Risk Assessment: A Manual for REACH covers
the following main themes: i) Assessment of chemical risk; ii)
Risk management; iii) Hazard reduction, substitution and green
chemistry; iv) Risk versus benefit - socio-economic
analysis.

The book acts as a practical guide and overview to
chemicals risk assessment and risk management (in the EU context),
as well as a support text for planning for the challenges of the
future, which will see ever-increasing pressure to withdraw
hazardous substances from the EU (and global) market, balanced
against opportunities for innovation in the development of less
hazardous chemicals.

Dr Peter Fisk, Managing Director, is a chemist, with 15 years experience in industrial research and development, and over 13 years as a consultant working for regulatory authorities, industry and publishers. He has a background in laboratory science, and methods of chemical property prediction, as well as wide knowledge of chemical regulation.

The REACH (Registration, Evaluation, Authorisation & restriction of CHemicals) Regulation governs the manufacture and use of chemicals in the European Union (EU), and has a major impact on all aspects of the chemical industry. This book explains, in terms that are understandable to non-experts, what the Regulation requires, accurately, completely and concisely.

The content is designed to be of use to a wide readership including:
• Business managers needing to understand the commercial impacts
• Scientists planning work programmes for assessment of hazard and risk
• Product stewards considering the implications of placing substances on the EU market
• Users of chemicals understanding information needs
• Consultants requiring a guide to help them to advise their clients

Produced by well-known expert consultants, this manual offers a route through REACH in a single text. Also including references to official sources and special sections on green chemistry and alternatives, this book will prove invaluable to those working in or for the chemicals supply chain.

This book is an essential guide and support to understanding of the science and policy, procedure and practice that underpins the REACH risk assessments required for the use and placing on the market of chemicals in the European Union. A clear understanding of information provision and how this affects the assessment of chemical safety is fundamentally important to the success of policy on chemicals and ultimately to the sustainability of the chemicals industry.

Within the book, the scientific processes that underpin the policy are explained in a practical way. Importantly, it includes coverage of techniques to help solve the problems of using potentially risky and hazardous chemicals through the use of less hazardous alternatives and 'green chemistry', and also the analysis of the risks of the use of the most hazardous substances against the social and economic benefits of use.

Chemical Risk Assessment: A Manual for REACH covers the following main themes: i) Assessment of chemical risk; ii) Risk management; iii) Hazard reduction, substitution and green chemistry; iv) Risk versus benefit socio-economic analysis.

The book acts as a practical guide and overview to chemicals risk assessment and risk management (in the EU context), as well as a support text for planning for the challenges of the future, which will see ever-increasing pressure to withdraw hazardous substances from the EU (and global) market, balanced against opportunities for innovation in the development of less hazardous chemicals.

List of Tables xvii

List of Contributors xix

Introduction xxi

1. Introduction: Policy and Scientific Context of Chemicals Risk and Risk Management 1

1.1 Overview of the Risk Assessment of Chemical Substances 4

1.2 Chemical Hazard and Risk Programmes 5

1.2.1 REACH Overview 5

1.2.2 Registration 6

1.2.3 Evaluation 8

1.2.4 Authorisation and Restriction 11

1.2.5 Hazard and Risk Communication 14

1.2.6 Hazards 16

1.2.7 Overview of Types of Exposure 17

1.2.8 Overview of Risk Characterisation 19

1.2.9 Successful Interaction with REACH: Registration, Evaluation and Authorisation 21

1.2.10 Regulation and Assessment of Hazardous Chemicals Outside of the European Union 24

2. Roles and Responsibilities in REACH 39

2.1 The Structure and Responsibilities of the Authorities 39

2.1.1 Role of the ECHA 39

2.1.2 The Role of the Member State Committee (MSC) 40

2.1.3 The Role of the Member State Competent Authorities (MSCA) 40

2.2 Forum Enforcement Project REACH-EN-FORCE-1 41

2.3 Future Aims of the HSE (an Example of a ECHA-Related Authority Acting in the UK) 41

2.4 What Does REACH Require as Regards Enforcement? 41

2.5 What Powers Do Enforcing Authorities Have? 42

2.6 The Responsibilities of Industry 42

2.6.1 Responsibilities of the Manufacturer 42

2.6.2 Responsibilities of the Importer 43

2.6.3 The Only Representative 43

2.6.4 Responsibilities of the Downstream User 43

2.7 Communication in the Supply Chain and with Regulators 44

2.7.1 Use Descriptor System 44

3. Control of Chemicals Legislative and Policy Context 57

3.1 How EU Chemical Legislation Evolved 57

3.2 Air Quality Regulations 63

3.3 Water Framework Directive 64

3.4 Carcinogens at Work 65

3.5 Cosmetics 66

3.6 Biocidal and Plant Protection Products 67

3.7 Nationally (UK)-Implemented Legislative and Policy Frameworks 68

3.7.1 Workplace Exposure 68

3.7.2 Control of Substances Hazardous to Health Regulations (COSHH) 2002 69

3.7.3 Dangerous Substances and Explosive Atmospheres Regulations (DSEAR) 2002 72

3.8 UK Environmental Regulation 74

3.8.1 Overview and IPPC 74

3.8.2 Waste (England and Wales) Regulations 2011 SI 988 75

3.8.3 Water Legislation in the UK 75

3.8.4 Directive 2006/118/EC on the Protection of Groundwater against Pollution and Deterioration 77

3.8.5 Groundwater (England and Wales) Regulations 2009 (SI 2009 No. 2902) 77

3.8.6 Air Legislation in the UK 77

4. Identification of Substances for REACH Practicalities 81

4.1 Substance Identification 81

4.1.1 Types of Substances 82

4.1.2 Mono-Constituent Substances 82

4.1.3 Multi-Constituent Substances (MCSs) 82

4.1.4 Substances with Unknown or Variable Composition, or of Biological Origin (UVCBs) 82

4.1.5 Nanomaterials 83

4.1.6 Articles 84

4.1.7 EC …