Peter Fisk

Chemical Risk Assessment

A Manual for Reach

• Gebundenes Buch

Produktbeschreibung

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.

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Produktdetails

• Verlag: Wiley
• Seitenzahl: 418
• Erscheinungstermin: 28. Januar 2014
• Englisch
• Abmessung: 251mm x 177mm x 27mm
• Gewicht: 779g
• ISBN-13: 9781119953685
• ISBN-10: 1119953685
• Artikelnr.: 39532706

Autorenporträt

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.

Inhaltsangabe

List of Figures xv
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 Number 84
4.2 Sameness 85
4.3 Essentially-Pure Substances 85
4.4 Approaching the Substance Data Set - Understanding the Substance 86
5. Physico-Chemical Properties for REACH - Purpose and Practicalities 89
5.1 Physico-Chemical Properties 89
5.2 Strategy in Physico-Chemical Testing Plans 91
5.2.1 Tier 1 Tests 91
5.2.2 Tier 2 Tests 92
5.2.3 Tier 3 Tests 93
5.3 Difficult-to-Measure Substances 94
5.3.1 Multiconstituent or UVCB Substances (Mixtures) 94
5.3.2 Poorly Soluble Substances 94
5.3.3 Volatile Substances 94
5.3.4 Unstable Substances Either by Hydrolysis, Photolysis or Oxidation 94
5.3.5 Ionisable Substances 95
5.3.6 Surface Active Substances 95
5.4 Hazardous Physico-Chemical Data 95
5.5 Relationship between Physico-Chemical Tests 95
5.6 Application of Physico-Chemical Test Data 96
5.7 Can Physico-Chemical Tests Be Omitted? 96
5.8 (Q)SAR and Physico-Chemical Tests 97
5.9 (Quantitative) Structure-Activity Relationships ((Q)SAR) 97
6. Assessing and Documenting the Intrinsic Properties of Substances in
REACH 103
6.1 Introduction to REACH Data Requirements 103
6.1.1 Strictly Controlled Conditions 104
6.2 Hazards 108
6.3 PBT 108
6.4 Equivalent Concern 109
6.4.1 Adversity 109
6.4.2 Mode of Action 110
6.5 Test Proposal Rule 110
6.6 Availability of Existing Data and Rights of Access 111
6.7 Data Reliability 111
6.8 Data Gaps - Options for Surrogate Data for Description of Hazard and
Risk - Including Read-Across 111
6.9 Read-Across 113
7. Assessing Environmental Properties Data 115
7.1 Environmental Properties Data 115
7.1.1 PNECs 115
7.1.2 Classification and Labelling (C&L) 116
7.1.3 PBT 116
7.2 Environmental Fate 116
7.2.1 Degradation 117
7.2.2 Bioaccumulation 120
7.2.3 Adsorption 121
7.3 Ecotoxicology 123
7.3.1 Introduction 123
7.3.2 Hazard Assessment and Risk Characterisation 123
7.3.3 Data Review 127
7.3.4 Testing of Difficult Substances 127
7.3.5 (Q)SARs, Data Waiving and EPM 128
7.3.6 Further Testing 129
7.3.7 Toxicity to Sewage Treatment Plant Microorganisms 129
7.4 Turning Intrinsic Properties into 'No-Effect' Concentrations 130
7.4.1 Selecting a Suitable Starting Point for a PNEC Calculation 131
7.4.2 Calculating a PNEC Using Assessment Factors 131
7.4.3 Calculating a PNEC Using Sensitivity Distribution 133
7.4.4 Calculating a PNEC Using Equilibrium Partitioning 133
7.4.5 Intermittent versus Continuous Releases 134
8. Environmental Exposure 137
8.1 Substance Identity and Approach to Exposure Assessment 137
8.2 Characterising Releases 138
8.2.1 Evaluating Use Pattern 138
8.3 Evaluating Releases 139
8.3.1 Reality Checking - Top Down and Bottom Up 141
8.4 Documentation for the Registration 142
8.4.1 Uncertainty 142
8.5 Local Scale Releases 142
8.5.1 Site Size 142
8.5.2 Site Inspections 143
8.6 Exposure Assessment - Models or Measurements? 143
8.6.1 Using Measurements 143
8.6.2 Using Models 145
8.6.3 Models or Measurements - Recommended Approach 145
8.6.4 Tools 145
8.7 Water 146
8.7.1 Release via Waste-Water 146
8.7.2 River Environment 148
8.7.3 Marine Environment 149
8.7.4 Sediments 149
8.8 Soil 149
8.8.1 WWTP Sludge and Agricultural Soil 149
8.8.2 Deposition 149
8.8.3 Biodegradation in Soil 150
8.8.4 Crops and Grassland 150
8.8.5 Industrial Soil 150
8.9 Air 150
8.9.1 Air in the Standard PEC Models 150
8.9.2 Ozone Depletion and Other Specific Effects 150
8.9.3 Long Range Pollutants 151
8.10 The Food Chain 151
8.10.1 Biomagnification 151
8.10.2 Secondary Poisoning 151
9. Assessing the Hazards to Human Health from Chemicals 153
9.1 Mammalian Toxicology 153
9.2 Exposure Routes and Local/Systemic Effect Types 153
9.3 Acute and Chronic Effects 154
9.4 Influences on Toxicity 154
9.5 How Chemicals Cause Harm 155
9.5.1 Asphyxiants 155
9.5.2 Narcotics 155
9.5.3 Irritants and Corrosives 155
9.5.4 Sensitisation (Allergic Reactions) 156
9.5.5 Carcinogenicity 156
9.5.6 Genotoxic Effects 157
9.5.7 Reproductive and Developmental Effects 157
9.5.8 Target Organ Effects 157
9.6 Toxicokinetics 157
9.7 Toxicological Testing 158
9.7.1 Data Gaps 159
9.7.2 Data Waiving 159
9.7.3 Acute Toxicity Studies 159
9.7.4 Short-Term, Repeated Dose Studies 160
9.7.5 Long-Term (Chronic) Studies 160
9.7.6 Other Systemic Effects 161
9.7.7 Local Effects 162
9.8 Genetic Toxicology 162
9.8.1 Introduction 162
9.8.2 Hazard Assessment 163
9.8.3 Risk Assessment 166
9.9 Turning Intrinsic Properties into 'No-Effect' Levels 166
9.9.1 Special Cases 169
10. Human Exposure to Chemicals 171
10.1 Exposure 171
10.2 Exposure to Chemicals in the Workplace 173
10.2.1 First Tier Models 173
10.2.2 Higher Tier Models 174
10.2.3 Risk Management Measures 174
10.2.4 Exposure in the Professional Use Setting 175
10.2.5 Models 176
10.2.6 Measurements 178
10.3 Risk Management Measures 179
10.4 Consumer Exposure 179
10.4.1 General Considerations for Exposure Estimation for Consumers 180
10.4.2 Tier 1 Models 180
10.4.3 Refinement of Initial Exposure Estimates, Higher Tier Models and
Measurements 181
10.4.4 Risk Management Measures - Consumers 181
10.5 Indirect Exposure (Humans via the Environment) 182
10.6 Risk due to Physico-Chemical Hazard 182
11. Managing Hazard and Risk 185
11.1 Characterisation, Assessment and Management of Risk 185
11.2 What Is 'Risk' under REACH? 186
11.3 What Are Risk Reduction and Risk Management? 187
11.3.1 Risk 187
11.3.2 How Can Risks Be Controlled Adequately? 189
11.4 Where Safe Levels Cannot Be Established - CMRs and PBTs (and vPvBs)
190
11.5 Responsibilities in the Supply Chain - Introduction 190
11.6 Regulatory Requirements 191
11.7 Guidance 193
11.8 The Extended Safety Data Sheet 193
11.8.1 Current issues surrounding the use of eSDS by DUs 194
11.9 When Communication Is Difficult 194
11.10 Exposure Measurements in the Workplace - Occupational Hygiene 195
11.11 Control of Environmental Releases - Abatement Techniques 196
11.11.1 Engineering Controls 196
11.11.2 Enclosure and Containment 197
11.11.3 Bunding 197
11.11.4 Dedicated Equipment 197
11.11.5 Investment and Scale of Use - Economic Viability 197
11.11.6 Waste Stream Treatments 197
11.11.7 WWTP Treatments 198
11.11.8 Custom and Practise 198
11.11.9 Handling Standards 198
11.11.10 Clean-Down Practises 198
11.12 Effectiveness of Risk Reduction - Risk Management Options 200
11.13 Types of Risk Management - in the Workplace 201
11.13.1 Options Overview 202
11.13.2 Understanding Assumptions and Critical Issues 202
11.13.3 Risk Management Measures 202
11.14 Types of Risk Management - for the Environment 203
11.14.1 Unacceptable Risk 203
11.14.2 Options Overview 203
11.14.3 When a Data Set Is Not Complete 204
11.14.4 When a Data Set Is as Complete as It Can Be 204
11.14.5 Understanding Assumptions and Critical Issues 204
11.14.6 Strategies to Reduce the Amount of Substance Released to the
Environment 204
11.15 Consumer Protection 205
12. Avoiding the Use of Hazardous Substances: Substitution and Alternatives
207
12.1 Properties That Contribute to Hazard and Risk for Human Health and the
Environment 209
12.2 Assessment of Alternatives - Replacement of Use 210
12.3 What Is an Alternative? 211
12.4 Analysis of Alternatives 211
12.5 Substitution - Replacement with Substances of Reduced Hazard 211
12.5.1 Examples of Voluntary Substitution 212
12.5.2 Regulation-Led Substitution - Case Studies 213
12.6 Sustainability and Green Chemistry 218
12.7 What Is Green Chemistry in Practice? Principles and Concepts 219
12.7.1 Why Is Green Chemistry Important? 220
12.7.2 Research in Green Chemistry 220
12.7.3 Substance Design 220
12.7.4 Process Design 222
13. Hazards, Risks and Impacts - The Development and Application of
Frameworks for the Assessment of Risk 225
13.1 Policy Context - Risk, Hazard and the Precautionary Principle 226
13.1.1 Assessment Frameworks - Hazard and Risk and Impacts 230
13.1.2 Precaution - Where No Safe Level Can Be Established 232
13.1.3 Application of Assessment Frameworks to Human Health and
Environmental Protection 234
13.2 From Hazards to Risks to Impacts - Understanding the Implications of
Exposure to Dangerous Chemicals 235
13.2.1 Introduction: The Need for a Culture of Safety 236
13.2.2 Responsible Care® 238
13.2.3 Standards and Management Tools 239
13.2.4 Risk Control and Management 241
13.2.5 Risk Control and Management in REACH 241
13.3 Risk Management Options - REACH Processes for Control of Hazardous and
Risky Substances 244
13.3.1 Restrictions and Authorisations in REACH 244
13.3.2 Restrictions 246
13.3.3 Authorisations 247
14. Socio-Economic Analysis in REACH 251
14.1 Background - the Need for and Development of Socio-Economic Analysis
in the Regulation of Chemicals 253
14.2 What Is SEA and Why Is It Needed and Applied in REACH? 254
14.2.1 What Is SEA within REACH? 254
14.3 Role, Purpose and Performing an SEA in REACH 255
14.3.1 Role and Purpose of an SEA in REACH 255
14.3.2 Doing an SEA in REACH 256
14.4 The Difficulties of Moving from Risks to Impacts 256
14.5 Regulatory Processes - Who Are the Decision Makers and What Are Their
Roles? 265
14.6 The Wider Benefits of Performing an SEA 265
14.7 Developments and the Future 267
15. REACH: How It Is Working and May Develop 269
15.1 Introduction 269
15.2 Experiences and Observations 269
15.2.1 Observations 270
15.3 Basics of Successful Submission 271
15.4 Testing, Prediction and Read-Across 271
15.5 The Community Rolling Action Plan 272
15.6 EU and National Responsibilities 272
15.7 Risk-Based Regulation and the Precautionary Approach 272
15.8 Higher Tiers of Assessment 273
15.9 REACH Developments 274
15.9.1 Methods of Operation and Constant Change 274
15.9.2 Improved Efficiency of Operation 275
15.9.3 Increased Scope 275
15.9.4 Policy Development on the Control of Chemicals - EU and Global
Perspectives 276
15.10 Rationalising Overlap with Other Legislation 276
15.11 Scientific Developments and Challenges 278
15.12 Impact on Industry 278
15.12.1 Manufacturers and Importers 278
15.12.2 Downstream Users and Consumers 278
15.12.3 Innovation 279
15.13 ECHA Evaluation Report 2012 279
16. Resources, Official Guidance, Further Reading and Centres of Expertise
283
16.1 Introduction to Resources and Organisations 283
16.1.1 Official Journal 283
16.1.2 ECHA and REACH-IT 284
16.1.3 CEFIC and Sector Groups 285
16.1.4 IUCLID Guidance 285
16.1.5 ECETOC 286
16.1.6 OECD 286
16.1.7 EU JRC 286
16.2 Facts and Statistics 286
Appendix A Substance Classification and Labelling under REACH 317
A.1 Important Differences 319
A.1.1 Physico-Chemical Hazards 320
A.1.2 Health Hazards 320
A.1.3 Environmental Hazards 321
A.1.4 Supplementary Labelling Requirements under the CLP Regulations 321
A.2 CLP Symbols 322
A.2.1 Comparison of DSP/DPD with CLP 2008 325
A.3 Specific Target Organ Systemic Toxicity - Single Exposure 334
A.3.1 Carcinogenic Substances 335
A.3.2 Mutagenic Substances 337
A.3.3 Effect during Lactation 337
A.3.4 Aquatic Environment 338
A.3.5 Ozone 338
A.4 Harmonised Classification and Labelling 339
Appendix B Further Discussion of Substance Identification and Sameness 341
B.1 Substance Identifiers 341
B.1.1 EC Name 341
B.1.2 CAS Registry Number (CAS# or CAS No.) 341
B.1.3 SMILES 341
B.1.4 InChI 342
B.2 Substance Analysis 342
B.2.1 Sameness 343
B.2.2 Impurities 344
B.2.3 Departures from the Agreed Norm 344
B.3 Straightforward Organic Substances 345
B.3.1 Identity 345
B.3.2 Purity and Characterisation 346
B.4 Complex Organic Substances 347
B.5 Inorganic Substances 348
B.5.1 Structure 349
B.5.2 Elemental Quantification 349
B.6 Analysis of UVCBs 349
Appendix C Tools for REACH Compliance: IUCLID, Chesar and In-House
Databases 351
C.1 International Uniform Chemical Information Database (IUCLID) 351
C.2 IUCLID and PPORDs 354
C.3 Submission of PPORD to ECHA 354
C.3.1 IUCLID Submission 354
C.3.2 Notification by REACH-IT 355
C.4 Chesar 356
C.4.1 Introduction 356
C.4.2 Chesar Functionalities or Organisation of the Tool 356
C.4.3 Assessment workflow of Chesar 358
C.5 Advice on Storing of Data Outside of the IUCLID 358
C.5.1 Structure 359
C.5.2 Identifiers 360
C.5.3 Mechanistic Issues 360
C.5.4 Identification and Expression of Substance Identity 361
C.5.5 Result Values 361
C.5.6 SMILES and Textual Representations of Structure 361
C.5.7 Modifications to the Data Set 361
C.5.8 Composited Fields and Repeated Processes 361
C.5.9 Duplicates 362
C.5.10 Validation 362
C.5.11 Checking 363
C.5.12 Study Reports and Cataloguing 363
C.5.13 Snapshots and Backups 364
Appendix D Glossary 365
Index 383