Cover -- Title Page -- Copyright -- Contents -- List of Figures -- List of Tables -- List of Contributors -- Preface -- Chapter 1 Introduction: Policy and Scientific Context of Chemicals Risk and Risk Management -- 1.1 Overview of the Risk Assessment of Chemical Substances -- 1.2 Chemical Hazard and Risk Programmes -- 1.2.1 REACH Overview -- 1.2.2 Registration -- 1.2.3 Evaluation -- 1.2.4 Authorisation and Restriction -- 1.2.5 Hazard and Risk Communication -- 1.2.6 Hazards -- 1.2.7 Overview of Types of Exposure -- 1.2.8 Overview of Risk Characterisation -- 1.2.9 Successful Interaction with REACH: Registration, Evaluation and Authorisation -- 1.2.10 Regulation and Assessment of Hazardous Chemicals Outside of the European Union -- Chapter 2 Roles and Responsibilities in REACH -- 2.1 The Structure and Responsibilities of the Authorities -- 2.1.1 Role of the ECHA -- 2.1.2 The Role of the Member State Committee (MSC) -- 2.1.3 The Role of the Member State Competent Authorities (MSCA) -- 2.2 Forum Enforcement Project-REACH-EN-FORCE-1 -- 2.3 Future Aims of the HSE (an Example of a ECHA-Related Authority Acting in the UK) -- 2.4 What Does REACH Require as Regards Enforcement? -- 2.5 What Powers Do Enforcing Authorities Have? -- 2.6 The Responsibilities of Industry -- 2.6.1 Responsibilities of the Manufacturer -- 2.6.2 Responsibilities of the Importer -- 2.6.3 The Only Representative -- 2.6.4 Responsibilities of the Downstream User -- 2.7 Communication in the Supply Chain and with Regulators -- 2.7.1 Use Descriptor System -- Chapter 3 Control of Chemicals-Legislative and Policy Context -- 3.1 How EU Chemical Legislation Evolved -- 3.2 Air Quality Regulations -- 3.3 Water Framework Directive -- 3.4 Carcinogens at Work -- 3.5 Cosmetics -- 3.6 Biocidal and Plant Protection Products.

3.7 Nationally (UK)-Implemented Legislative and Policy Frameworks -- 3.7.1 Workplace Exposure -- 3.7.2 Control of Substances Hazardous to Health Regulations (COSHH) 2002 -- 3.7.3 Dangerous Substances and Explosive Atmospheres Regulations (DSEAR) 2002 -- 3.8 UK Environmental Regulation -- 3.8.1 Overview and IPPC -- 3.8.2 Waste (England and Wales) Regulations 2011 SI 988 -- 3.8.3 Water Legislation in the UK -- 3.8.4 Directive 2006/118/EC on the Protection of Groundwater against Pollution and Deterioration -- 3.8.5 Groundwater (England and Wales) Regulations 2009 (SI 2009 No. 2902) -- 3.8.6 Air Legislation in the UK -- Chapter 4 Identification of Substances for REACH-Practicalities -- 4.1 Substance Identification -- 4.1.1 Types of Substances -- 4.1.2 Mono-Constituent Substances -- 4.1.3 Multi-Constituent Substances (MCSs) -- 4.1.4 Substances with Unknown or Variable Composition, or of Biological Origin (UVCBs) -- 4.1.5 Nanomaterials -- 4.1.6 Articles -- 4.1.7 EC Number -- 4.2 Sameness -- 4.3 Essentially-Pure Substances -- 4.4 Approaching the Substance Data Set-Understanding the Substance -- Chapter 5 Physico-Chemical Properties for REACH-Purpose and Practicalities -- 5.1 Physico-Chemical Properties -- 5.2 Strategy in Physico-Chemical Testing Plans -- 5.2.1 Tier 1 Tests -- 5.2.2 Tier 2 Tests -- 5.2.3 Tier 3 Tests -- 5.3 Difficult-to-Measure Substances -- 5.3.1 Multiconstituent or UVCB Substances (Mixtures) -- 5.3.2 Poorly Soluble Substances -- 5.3.3 Volatile Substances -- 5.3.4 Unstable Substances Either by Hydrolysis, Photolysis or Oxidation -- 5.3.5 Ionisable Substances -- 5.3.6 Surface Active Substances -- 5.4 Hazardous Physico-Chemical Data -- 5.5 Relationship between Physico-Chemical Tests -- 5.6 Application of Physico-Chemical Test Data -- 5.7 Can Physico-Chemical Tests Be Omitted?.

5.8 (Q)SAR and Physico-Chemical Tests -- 5.9 (Quantitative) Structure-Activity Relationships ((Q)SAR) -- Chapter 6 Assessing and Documenting the Intrinsic Properties of Substances in REACH -- 6.1 Introduction to REACH Data Requirements -- 6.1.1 Strictly Controlled Conditions -- 6.2 Hazards -- 6.3 PBT -- 6.4 Equivalent Concern -- 6.4.1 Adversity -- 6.4.2 Mode of Action -- 6.5 Test Proposal Rule -- 6.6 Availability of Existing Data and Rights of Access -- 6.7 Data Reliability -- 6.8 Data Gaps-Options for Surrogate Data for Description of Hazard and Risk-Including Read-Across -- 6.9 Read-Across -- Chapter 7 Assessing Environmental Properties Data -- 7.1 Environmental Properties Data -- 7.1.1 PNECs -- 7.1.2 Classification and Labelling (C&L) -- 7.1.3 PBT -- 7.2 Environmental Fate -- 7.2.1 Degradation -- 7.2.2 Bioaccumulation -- 7.2.3 Adsorption -- 7.3 Ecotoxicology -- 7.3.1 Introduction -- 7.3.2 Hazard Assessment and Risk Characterisation -- 7.3.3 Data Review -- 7.3.4 Testing of Difficult Substances -- 7.3.5 (Q)SARs, Data Waiving and EPM -- 7.3.6 Further Testing -- 7.3.7 Toxicity to Sewage Treatment Plant Microorganisms -- 7.4 Turning Intrinsic Properties into `No-Effect' Concentrations -- 7.4.1 Selecting a Suitable Starting Point for a PNEC Calculation -- 7.4.2 Calculating a PNEC Using Assessment Factors -- 7.4.3 Calculating a PNEC Using Sensitivity Distribution -- 7.4.4 Calculating a PNEC Using Equilibrium Partitioning -- 7.4.5 Intermittent versus Continuous Releases -- Chapter 8 Environmental Exposure -- 8.1 Substance Identity and Approach to Exposure Assessment -- 8.2 Characterising Releases -- 8.2.1 Evaluating Use Pattern -- 8.3 Evaluating Releases -- 8.3.1 Reality Checking-Top Down and Bottom Up -- 8.4 Documentation for the Registration -- 8.4.1 Uncertainty -- 8.5 Local Scale Releases -- 8.5.1 Site Size.

8.5.2 Site Inspections -- 8.6 Exposure Assessment-Models or Measurements? -- 8.6.1 Using Measurements -- 8.6.2 Using Models -- 8.6.3 Models or Measurements-Recommended Approach -- 8.6.4 Tools -- 8.7 Water -- 8.7.1 Release via Waste-Water -- 8.7.2 River Environment -- 8.7.3 Marine Environment -- 8.7.4 Sediments -- 8.8 Soil -- 8.8.1 WWTP Sludge and Agricultural Soil -- 8.8.2 Deposition -- 8.8.3 Biodegradation in Soil -- 8.8.4 Crops and Grassland -- 8.8.5 Industrial Soil -- 8.9 Air -- 8.9.1 Air in the Standard PEC Models -- 8.9.2 Ozone Depletion and Other Specific Effects -- 8.9.3 Long Range Pollutants -- 8.10 The Food Chain -- 8.10.1 Biomagnification -- 8.10.2 Secondary Poisoning -- Chapter 9 Assessing the Hazards to Human Health from Chemicals -- 9.1 Mammalian Toxicology -- 9.2 Exposure Routes and Local/Systemic Effect Types -- 9.3 Acute and Chronic Effects -- 9.4 Influences on Toxicity -- 9.5 How Chemicals Cause Harm -- 9.5.1 Asphyxiants -- 9.5.2 Narcotics -- 9.5.3 Irritants and Corrosives -- 9.5.4 Sensitisation (Allergic Reactions) -- 9.5.5 Carcinogenicity -- 9.5.6 Genotoxic Effects -- 9.5.7 Reproductive and Developmental Effects -- 9.5.8 Target Organ Effects -- 9.6 Toxicokinetics -- 9.7 Toxicological Testing -- 9.7.1 Data Gaps -- 9.7.2 Data Waiving -- 9.7.3 Acute Toxicity Studies -- 9.7.4 Short-Term, Repeated Dose Studies -- 9.7.5 Long-Term (Chronic) Studies -- 9.7.6 Other Systemic Effects -- 9.7.7 Local Effects -- 9.8 Genetic Toxicology -- 9.8.1 Introduction -- 9.8.2 Hazard Assessment -- 9.8.3 Risk Assessment -- 9.9 Turning Intrinsic Properties into `No-Effect' Levels -- 9.9.1 Special Cases -- Chapter 10 Human Exposure to Chemicals -- 10.1 Exposure -- 10.2 Exposure to Chemicals in the Workplace -- 10.2.1 First Tier Models -- 10.2.2 Higher Tier Models -- 10.2.3 Risk Management Measures.

10.2.4 Exposure in the Professional Use Setting -- 10.2.5 Models -- 10.2.6 Measurements -- 10.3 Risk Management Measures -- 10.4 Consumer Exposure -- 10.4.1 General Considerations for Exposure Estimation for Consumers -- 10.4.2 Tier 1 Models -- 10.4.3 Refinement of Initial Exposure Estimates, Higher Tier Models and Measurements -- 10.4.4 Risk Management Measures-Consumers -- 10.5 Indirect Exposure (Humans via the Environment) -- 10.6 Risk due to Physico-Chemical Hazard -- Chapter 11 Managing Hazard and Risk -- 11.1 Characterisation, Assessment and Management of Risk -- 11.2 What Is `Risk' under REACH? -- 11.3 What Are Risk Reduction and Risk Management? -- 11.3.1 Risk -- 11.3.2 How Can Risks Be Controlled Adequately? -- 11.4 Where Safe Levels Cannot Be Established-CMRs and PBTs (and vPvBs) -- 11.5 Responsibilities in the Supply Chain-Introduction -- 11.6 Regulatory Requirements -- 11.7 Guidance -- 11.8 The Extended Safety Data Sheet -- 11.8.1 Current issues surrounding the use of eSDS by DUs -- 11.9 When Communication Is Difficult -- 11.10 Exposure Measurements in the Workplace-Occupational Hygiene -- 11.11 Control of Environmental Releases-Abatement Techniques -- 11.11.1 Engineering Controls -- 11.11.2 Enclosure and Containment -- 11.11.3 Bunding -- 11.11.4 Dedicated Equipment -- 11.11.5 Investment and Scale of Use-Economic Viability -- 11.11.6 Waste Stream Treatments -- 11.11.7 WWTP Treatments -- 11.11.8 Custom and Practise -- 11.11.9 Handling Standards -- 11.11.10 Clean-Down Practises -- 11.12 Effectiveness of Risk Reduction-Risk Management Options -- 11.13 Types of Risk Management-in the Workplace -- 11.13.1 Options Overview -- 11.13.2 Understanding Assumptions and Critical Issues -- 11.13.3 Risk Management Measures -- 11.14 Types of Risk Management-for the Environment -- 11.14.1 Unacceptable Risk.

11.14.2 Options Overview.