Hazardous chemicals : control and regulation in the European market

This practice-oriented guide covers the handling and use of hazardous chemicals at the workplace, including labelling and storage, transportation, occupational safety and proper registration with the European authorities. Current European Union legislation and directives are cited throughout the text, making this a valuable reference for companies and institutions both inside and outside of the EU common market.

Author Notes

Herbert F. Bender a lecturer at the University of Heidelberg, and more recently at the universities of Darmstadt and Mannheim
Philipp Eisenbarth is a member of several working groups within the German Federal Ministry of Labor and Social Affairs

Preface	p. V
1 Regulations of the European Union Concerning Chemicals	p. 1
1.1 The European Institutions	p. 1
1.2 European Legislation	p. 3
1.3 Definitions	p. 5
References	p. 6
2 Toxicological Basics	p. 7
2.1 Incorporation Pathways	p. 7
2.1.1 Oral Incorporation	p. 9
2.1.2 Dermal Incorporation	p. 9
2.1.3 Inhalative Incorporation	p. 10
2.2 Metabolism	p. 11
2.3 Acute Effect	p. 13
2.4 Effect in the Case of Repeated Incorporation	p. 14
2.5 Sensitizing (Allergenic) Effect	p. 16
2.6 Toxic Properties and Developmental Defects	p. 18
2.7 Fertility Damage Effect	p. 21
2.8 Carcinogenic Effects	p. 22
2.8.1 Cancer-activating Factors	p. 23
2.8.2 Chemical Carcinogens	p. 26
2.8.2.1 Carcinogenic Potency	p. 27
2.8.2.2 Concentration	p. 27
2.8.3 Natural Carcinogens	p. 28
2.9 Mutagenic Properties	p. 29
2.9.1 Point Mutations	p. 29
2.9.2 Chromosome Mutations	p. 29
2.9.3 Genom Mutations	p. 31
2.10 Aerosols	p. 31
2.10.1 Respirable Particles "E"	p. 32
2.10.2 Alveolar Dust Parliamentary Party "A"	p. 32
2.10.3 Respirable Fibers	p. 32
3 Classification of Substances and Preparations	p. 37
3.1 The Dangerous Properties	p. 37
3.2 The Acute Toxic Properties	p. 38
3.2.1 Very Toxic Substances	p. 38
3.2.2 Toxic Substances	p. 41
3.2.3 Harmful Substances	p. 44
3.2.4 Corrosive Substances	p. 47
3.2.5 Irritant Substances	p. 49
3.2.6 Sensitization	p. 50
3.2.7 Other Toxicological Properties	p. 50
3.3 Special Toxicological Properties	p. 54
3.3.1 Classification Principles of the European Union	p. 54
3.3.2 Reproductive Toxicity	p. 55
3.3.2.1 Developmental Toxicity	p. 55
3.3.2.2 Impairment of Fertility	p. 53
3.3.3 Carcinogenic Property	p. 60
3.3.4 Mutagenic Property	p. 65
3.4 Environmental Toxicity Property	p. 67
3.4.1 Toxic to the Aquatic Environment	p. 67
3.4.2 Non-aquatic Toxic Property	p. 70
3.5 The Physico-chemical Properties	p. 71
3.5.1 Extremely Flammable	p. 71
3.5.2 Highly Flammable	p. 72
3.5.3 Flammable	p. 73
3.5.4 Oxidizing Property	p. 73
3.5.5 Explosive Property	p. 74
3.5.6 Additional Physical-chemical Properties	p. 75
3.6 Classification of Substances	p. 76
3.6.1 The Legal Classification (List Principle)	p. 76
3.6.2 Classification Following the Definition Principle	p. 78
3.7 Classification of Preparations	p. 78
3.7.1 Experimental Testing	p. 79
3.7.2 Conventional Method	p. 79
3.7.2.1 General Concentration Limits	p. 80
3.7.2.2 Substance-specific Concentration Limits	p. 83
3.7.2.3 Classification Calculation for Substances with Different Dangerous Ingredients	p. 84
References	p. 87
4 Duties and Obligations when Placing Products on the Market	p. 89
4.1 Labeling of Dangerous Substances and Preparations	p. 89
4.1.1 Labeling of Dangerous Substances	p. 90
4.1.2 Labeling of Dangerous Preparations	p. 96
4.1.3 Special Labeling	p. 96
4.1.4 Exceptions	p. 100
4.2 Safety Data Sheets	p. 100
4.2.1 Exceptions	p. 101
4.2.2 Headings	p. 102
4.3 Restrictions on Marketing	p. 112
4.3.1 Restriction Directive 76/769/EEC	p. 112
4.3.2 The Biocidal Product Directive 98/8/EC	p. 125
4.3.3 Regulation 304/2003/EC: Export and Import of Dangerous Chemicals	p. 127
4.3.4 Regulation 3677/90/EEC	p. 131
4.3.5 Regulation 2037/2000/EC	p. 131
4.3.6 POP Regulation 850/2004/EC	p. 136
References	p. 138
5 Notification of Substances	p. 139
5.1 Full Notification	p. 139
5.1.1 Base Set (Basic Set of Test Requirements)	p. 140
5.1.2 Reduced Requirements for Intermediates	p. 141
5.1.3 Additional Test Program of Level 1	p. 142
5.1.4 Additional Test Program of Level 2	p. 142
5.2 Restricted Notification and Exceptions	p. 143
5.2.1 Limited Quantities	p. 143
5.2.2 Polymers	p. 143
5.2.3 Exceptions to the Requirement for Notification	p. 144
5.3 Renotification of the Same Substance	p. 145
5.4 Follow-up Information	p. 145
References	p. 146
6 Occupational Safety and Health at the Workplace	p. 147
6.1 First European Framework Directive 80/1107/EEC on Chemical, Physical, and Biological Agents at Work and Selected Individual Directives Derived therefrom	p. 148
6.1.1 "Lead Directive" 82/605/EEC	p. 149
6.1.2 "Asbestos Directive" 83/477/EEC	p. 151
6.1.3 Directive 88/364/EEC on Banning Certain Agents	p. 153
6.1.4 Directive 91/322/EEC on Indicative Limit Values	p. 153
6.2 European Framework Directive 89/391/EEC on the Improvement of Safety and Health of Workers at Work, and Selected Individual Directives Derived Therefrom	p. 154
6.2.1 Work Equipment Directive 89/655/EEC	p. 156
6.2.2 Personal Protective Equipment Directive 89/656/EEC	p. 157
6.2.3 Biological Agents Directive 2000/54/EC	p. 158
6.2.4 Safety Sign Directive 92/58/EEC	p. 159
6.2.5 Explosive Atmospheres Directive 1999/92/EC	p. 164
6.3 "Chemical Agents" Directive 98/24/EC	p. 166
6.4 "Carcinogens and Mutagens" Directive 2004/37/EC	p. 181
6.5 Limit Values at the Workplace	p. 187
6.5.1 Indicative Occupational Exposure Limit Values (IOELV)	p. 189
6.5.2 Binding Occupational Exposure Limit Values (BOELV)	p. 197
6.5.3 Biological Limit Values (BLV)	p. 199
6.6 "Pregnant and Breastfeeding Women" Directive 92/85/EEC	p. 200
6.7 "Young People Protection" Directive 94/33/EC	p. 204
6.8 Personal Protective Equipment (PPE)	p. 207
6.8.1 Eye and Face Protection	p. 208
6.8.1.1 Safety Glasses	p. 210
6.8.1.2 Face Shields	p. 212
6.8.2 Gloves for Chemical Protection	p. 213
6.8.2.1 General Guidelines for the Use of Gloves	p. 215
6.8.2.2 Selection of Safety Gloves	p. 216
6.8.2.3 Marking of Gloves	p. 220
6.8.3 Protective Clothing	p. 223
6.8.4 Respiratory Protection	p. 226
6.8.4.1 Filtering Respiratory Devices	p. 230
6.8.4.2 Self-contained Breathing Apparatus	p. 245
6.8.4.3 Respiratory Devices for Self-rescue	p. 252
6.9 Exposure Measurements	p. 256
6.9.1 General Methodology of Exposure Measurements	p. 258
6.9.1.1 Evaluation of Chemicals Present at the Workplace	p. 259
6.9.1.2 Exposure-relevant Work Activities	p. 260
6.9.1.3 Measurement Plan	p. 260
6.9.1.4 Performing Exposure Measurements	p. 261
6.9.1.5 Analysis	p. 263
6.9.1.6 Assessment	p. 263
6.9.1.7 Safety Measures	p. 264
6.9.2 Continuous Exposure Control	p. 265
6.9.3 Direct-reading Measurement Techniques	p. 267
6.9.3.1 Tubes with Direct Indication	p. 267
6.9.3.2 Paper Badges with Direct Indication	p. 273
6.9.3.3 Electrochemical Sensors	p. 275
6.9.3.4 Analytical Instruments	p. 277
6.9.4 Indirect Analytical Procedures for Gases and Vapors	p. 280
6.9.4.1 Personal Air Sampling for Gases and Vapors (Active Sampling)	p. 280
6.9.4.2 Passive Sampling	p. 283
6.9.5 Determination of Solid Particles	p. 284
6.9.5.1 Total Dust Measurements	p. 285
6.9.5.2 Measurement of Fine Dust (Respirable Particles)	p. 287
6.9.5.3 Fiber Measurements	p. 289
6.10 Safe Storage of Chemicals	p. 290
6.10.1 Important Terms, Definitions, and Physical Properties of Combustible Chemicals	p. 290
6.10.2 General Principles of Safe Storage of Chemicals	p. 295
6.10.3 Rules on Mixed Storage	p. 299
6.10.3.1 Storage Classes	p. 299
6.10.3.2 Allocation of Chemicals to Storage Classes	p. 305
6.10.3.3 Rules for Mixed Storage	p. 305
References	p. 312
7 Transportation of Dangerous Goods	p. 319
7.1 International Transportation Legislation	p. 320
7.1.1 Shipping	p. 320
7.1.2 Aircraft	p. 320
7.1.3 Road and Rail	p. 321
7.2 Classification of Dangerous Goods	p. 321
7.2.1 Definitions	p. 322
7.2.1 Class 1: Explosive Substances and Articles	p. 324
7.2.2 Class 2: Gases	p. 326
7.2.3 Class 3: Flammable Liquids	p. 329
7.2.4 Class 4.1: Flammable Solids, Self-reactive Substances and Solid Desensitized Explosives	p. 330
7.2.5 Class 4.2: Substances Liable to Spontaneous Combustion	p. 332
7.2.6 Class 4.3: Substances which, in Contact with Water, Emit Flammable Gases	p. 334
7.2.7 Class 5.1: Oxidizing Substances	p. 335
7.2.8 Class 5.2: Organic Peroxides	p. 336
7.2.9 Class 6.1: Toxic Substances	p. 337
7.2.10 Class 6.2: Infectious Substances	p. 338
7.2.11 Class 7 Radioactive Material	p. 339
7.2.12 Class 8: Corrosive Substances	p. 340
7.2.13 Class 9: Miscellaneous Dangerous Substances and Articles	p. 342
7.3 Globally Harmonized System for the Classification and Labeling of Chemicals (GHS)	p. 343
7.3.1 Labeling	p. 344
7.3.2 Classification	p. 345
7.3.2.1 Explosives	p. 345
7.3.2.2 Flammable Gases	p. 345
7.3.2.3 Flammable Aerosols	p. 346
7.3.2.4 Oxidizing Gases	p. 346
7.3.2.5 Gases Under Pressure	p. 347
7.3.2.6 Flammable Liquids	p. 348
7.3.1.1 Flammable Solids	p. 348
7.3.2.8 Self-reactive Substances	p. 349
7.3.2.9 Pyrophoric Liquids	p. 350
7.3.2.10 Pyrophoric Solids	p. 351
7.3.1.11 Self heating Substances	p. 351
7.3.2.12 Substances which, on Contact with Water, Emit Flammable Gases	p. 352
7.3.2.13 Oxidizing Liquids	p. 352
7.3.2.14 Oxidizing Solids	p. 353
7.3.2.15 Organic Peroxides	p. 354
7.3.2.16 Corrosive to Metals	p. 355
7.3.2.17 Acute Toxicity	p. 356
7.3.2.18 Skin Corrosion/Irritation	p. 359
7.3.2.19 Serious Eye Damage/Eye Irritation	p. 359
7.3.2.20 Respiratory Sensitizer	p. 361
7.3.2.21 Skin Sensitizer	p. 361
7.3.2.22 Mutagenicity	p. 362
7.3.2.23 Carcinogenicity	p. 362
7.3.1.24 Toxic to Reproduction	p. 363
7.3.1.25 Target Organ Systemic Toxicity Following Single Exposure	p. 364
7.3.2.26 Target Organ Systemic Toxicity Following Repeated Exposure	p. 364
7.3.2.27 Acute Hazards to the Aquatic Environment	p. 365
7.3.2.28 Chronic Hazards to the Aquatic Environment	p. 367
References	p. 369
8 REACH	p. 371
8.1 Introduction	p. 371
8.2 Registration	p. 373
8.2.1 Pre-registration	p. 374
8.2.2 Information Requirements	p. 374
8.2.3 Chemical Safety Report	p. 376
8.2.4 Intermediates	p. 378
8.2.5 Safety Data Sheet	p. 380
8.2.6 Interaction in the Supply Chain	p. 381
8.3 Evaluation	p. 382
8.4 Authorization	p. 383
References	p. 384
Subject Index	p. 385

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Author Notes

Table of Contents