Global Regulatory Issues for the Cosmetics Industry

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  • Format: Hardcover
  • Copyright: 2007-08-30
  • Publisher: Elsevier Science Ltd

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The manufacture and use of cosmetics is an international undertaking unparalleled by any other industry. Regulation of this industry, however, is neither universal nor consistent. The purpose of this book (the first of a series) is to simplify the complex global Cosmetic Regulatory landscape by addressing the issues affecting the manufacture, packaging, and marketing of cosmetic products across the globe. Included are several chapters that examine the new European Union REACH regulation (Registration Evaluation and Authorization of CHemicals). Other chapters look at regulatory developments of individual countries, toxicity requirements, as well as how to develop a global regulatory strategy.

Table of Contents

Contributorsp. xi
Prefacep. xiii
Introductionp. xvii
Risk Assessment and Cosmeticsp. 1
Introduction: Risk Perception and Regulationp. 1
Risk and Cosmeticsp. 10
The Risk Assessment Processp. 12
Regulationsp. 14
Role of the Safety Assessorp. 14
Guidancep. 15
Safety Assessmentp. 16
Assessment Contentsp. 17
Other Testsp. 18
Conclusionp. 18
Referencesp. 19
Regulatory Developments in Canada, Japan, Australia, China, and Indiap. 21
Introductionp. 21
Canadap. 22
Japanp. 25
Australiap. 28
Chinap. 29
Indiap. 31
Trade Alliancesp. 31
Californiap. 32
Conclusionp. 32
The REACH Regulation of the European Unionp. 35
Introductionp. 35
Why REACH?p. 36
REACH: Overviewp. 38
REACH: Aimsp. 39
Pre-registrationp. 41
Substance Information Exchange Fora (SIEF)p. 43
Exemptions: Cosmetics?p. 44
Registrationp. 46
Referencesp. 47
REACH: An Example of the New Paradigm in Global Product Regulationp. 49
Introductionp. 49
REACH: "No Data, No Market"p. 51
What is REACH?p. 51
How Does REACH Affect the Cosmetics Industry?p. 52
How will REACH Work?p. 52
What Should Companies be Doing Now?p. 53
Referencesp. 54
Developing a Global Regulatory Strategy: Leveraging Local Knowledge to Drive Rapid Market Entryp. 55
Introductionp. 55
Globalization: "One Size Does Not Fit All!"p. 56
Using Regulatory Compliance for Competitive Advantagep. 56
Organizational Designp. 57
Targeted Capabilityp. 58
Local Knowledgep. 58
Business Engagementp. 59
Cross-Functional Processes, Systems, and Toolsp. 59
Communication Planp. 59
The Global Launch: "Driving with Insights and Regulations"p. 60
Conclusionsp. 62
Cosmetics: Toxicity and Regulatory Requirements in the USp. 63
Introductionp. 63
Regulatory Requirements for Cosmeticsp. 65
Warning Statementp. 66
Ingredient Declarationp. 67
California Proposition 65 and California Safe Cosmetics Act of 2005p. 67
EU Cosmetics Regulationp. 68
The Future of Cosmetics Regulatory Requirementsp. 68
Restricted Substances in Consumer Products: The Challenge of Global Chemical Compliancep. 71
Introductionp. 71
Addressing the Challenges of Emerging Globally Restricted Substances Regulationsp. 73
Restricted Substances: Strategy Definitionp. 74
Steps to Meeting Global Compliance Directivesp. 75
Best Practicesp. 77
Recommendation and Conclusionsp. 79
In Vitro Toxicology for Cosmetics: Regulatory Requirements, Biological Limitationsp. 83
Introductionp. 83
EU Cosmetic Legislation and Animal Testingp. 84
A Viable Timeline?p. 86
Acute Toxicityp. 88
Skin Corrosionp. 92
Skin Irritationp. 93
Eye Irritationp. 95
Skin Sensitizationp. 96
Carcinogenicityp. 100
Reproductive/Developmental Toxicityp. 101
Toxicokineticsp. 103
Absorptionp. 104
Distributionp. 105
Metabolismp. 106
Excretionp. 108
Toxicokineticsp. 108
Other Considerationsp. 109
Conclusionsp. 109
Referencesp. 111
Nanotechnology and Nanomaterial Personal Care Products: Necessary Oversight and Recommendationsp. 117
Introductionp. 117
What is Nanotechnology Anyway? A New World of Tiny Technologyp. 119
Nano Means Fundamentally Differentp. 121
Manufactured and Engineered Nanomaterials vs. Natural Nanoparticlesp. 121
The Next Industrial Revolution? The Stages of Nanotechnology's Predicted Developmentp. 122
Nanomaterials in Consumer Products: The Future is Nowp. 123
Measures of Nanotechnology's Maturationp. 123
What are the Human Health Risks of Nanotechnology and Nanomaterials in Personal Care Products?p. 125
Nanotoxicityp. 126
Unprecedented Mobilityp. 127
The Public at Largep. 128
The Question of Skin Penetrationp. 128
Nanomaterial Worker and Workplace Risksp. 129
What are the Environmental Risks of Nanotechnology and Nanomaterials in Personal Care Products?p. 130
Huge EHS Unknownsp. 131
FDA's Regulatory Stance on Nanotechnology and Nanomaterial Personal Care Productsp. 132
Nanotoxicology: Nano-specific Testing Paradigms Are Requiredp. 133
Nanomaterial Oversight Developments from FDAp. 135
Conclusions and Recommendations for Government and Industryp. 138
Support Much More Vigorous EHS Researchp. 139
Acknowledge the Unknowns and Fundamental Differences of Nanomaterials and Act Accordinglyp. 139
Prepare to Meet the EU Standards: The Burden of Proof Is on Industryp. 140
Transparencyp. 141
Repeating Past Mistakes: Running From Your Product's Label Is Not a Business Planp. 143
Lifecyclep. 143
See the Big Picture: The Question Is Not If, But Whenp. 144
Learn From The Pastp. 144
Referencesp. 145
Navigating the Turbulent Waters of Global Colorant Regulations for Packagingp. 155
Introductionp. 155
Authors's Notep. 155
Definitionsp. 156
United Statesp. 156
Canadap. 156
European Unionp. 156
Asiap. 156
Regulationsp. 157
United Statesp. 157
Personal Care and Cosmeticsp. 157
Drugsp. 157
Other Packaging Concernsp. 158
Canadap. 158
Cosmetics and Personal Carep. 158
Drugsp. 159
European Unionp. 159
Mutual Recognitionp. 159
Colorants Listsp. 159
Ensuring Safetyp. 159
Other Concernsp. 160
Choosing the Right Colorants for Your Productp. 160
Dyesp. 160
Pigmentsp. 161
FD&C Colorantsp. 161
Migrationp. 161
Meeting the Design Challengep. 161
Risk Assessmentp. 162
The Quandry of Non-Regulation Regulationsp. 162
Allergensp. 162
Testingp. 163
Importing Packagingp. 163
Liability Issuesp. 163
Regulations at a Glancep. 164
Indexp. 165
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