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.

Contributors	p. xi
Preface	p. xiii
Introduction	p. xvii
Risk Assessment and Cosmetics	p. 1
Introduction: Risk Perception and Regulation	p. 1
Risk and Cosmetics	p. 10
The Risk Assessment Process	p. 12
Regulations	p. 14
Role of the Safety Assessor	p. 14
Guidance	p. 15
Safety Assessment	p. 16
Assessment Contents	p. 17
Other Tests	p. 18
Conclusion	p. 18
References	p. 19
Regulatory Developments in Canada, Japan, Australia, China, and India	p. 21
Introduction	p. 21
Canada	p. 22
Japan	p. 25
Australia	p. 28
China	p. 29
India	p. 31
Trade Alliances	p. 31
California	p. 32
Conclusion	p. 32
The REACH Regulation of the European Union	p. 35
Introduction	p. 35
Why REACH?	p. 36
REACH: Overview	p. 38
REACH: Aims	p. 39
Pre-registration	p. 41
Substance Information Exchange Fora (SIEF)	p. 43
Exemptions: Cosmetics?	p. 44
Registration	p. 46
References	p. 47
REACH: An Example of the New Paradigm in Global Product Regulation	p. 49
Introduction	p. 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
References	p. 54
Developing a Global Regulatory Strategy: Leveraging Local Knowledge to Drive Rapid Market Entry	p. 55
Introduction	p. 55
Globalization: "One Size Does Not Fit All!"	p. 56
Using Regulatory Compliance for Competitive Advantage	p. 56
Organizational Design	p. 57
Targeted Capability	p. 58
Local Knowledge	p. 58
Business Engagement	p. 59
Cross-Functional Processes, Systems, and Tools	p. 59
Communication Plan	p. 59
The Global Launch: "Driving with Insights and Regulations"	p. 60
Conclusions	p. 62
Cosmetics: Toxicity and Regulatory Requirements in the US	p. 63
Introduction	p. 63
Regulatory Requirements for Cosmetics	p. 65
Warning Statement	p. 66
Ingredient Declaration	p. 67
California Proposition 65 and California Safe Cosmetics Act of 2005	p. 67
EU Cosmetics Regulation	p. 68
The Future of Cosmetics Regulatory Requirements	p. 68
Restricted Substances in Consumer Products: The Challenge of Global Chemical Compliance	p. 71
Introduction	p. 71
Addressing the Challenges of Emerging Globally Restricted Substances Regulations	p. 73
Restricted Substances: Strategy Definition	p. 74
Steps to Meeting Global Compliance Directives	p. 75
Best Practices	p. 77
Recommendation and Conclusions	p. 79
In Vitro Toxicology for Cosmetics: Regulatory Requirements, Biological Limitations	p. 83
Introduction	p. 83
EU Cosmetic Legislation and Animal Testing	p. 84
A Viable Timeline?	p. 86
Acute Toxicity	p. 88
Skin Corrosion	p. 92
Skin Irritation	p. 93
Eye Irritation	p. 95
Skin Sensitization	p. 96
Carcinogenicity	p. 100
Reproductive/Developmental Toxicity	p. 101
Toxicokinetics	p. 103
Absorption	p. 104
Distribution	p. 105
Metabolism	p. 106
Excretion	p. 108
Toxicokinetics	p. 108
Other Considerations	p. 109
Conclusions	p. 109
References	p. 111
Nanotechnology and Nanomaterial Personal Care Products: Necessary Oversight and Recommendations	p. 117
Introduction	p. 117
What is Nanotechnology Anyway? A New World of Tiny Technology	p. 119
Nano Means Fundamentally Different	p. 121
Manufactured and Engineered Nanomaterials vs. Natural Nanoparticles	p. 121
The Next Industrial Revolution? The Stages of Nanotechnology's Predicted Development	p. 122
Nanomaterials in Consumer Products: The Future is Now	p. 123
Measures of Nanotechnology's Maturation	p. 123
What are the Human Health Risks of Nanotechnology and Nanomaterials in Personal Care Products?	p. 125
Nanotoxicity	p. 126
Unprecedented Mobility	p. 127
The Public at Large	p. 128
The Question of Skin Penetration	p. 128
Nanomaterial Worker and Workplace Risks	p. 129
What are the Environmental Risks of Nanotechnology and Nanomaterials in Personal Care Products?	p. 130
Huge EHS Unknowns	p. 131
FDA's Regulatory Stance on Nanotechnology and Nanomaterial Personal Care Products	p. 132
Nanotoxicology: Nano-specific Testing Paradigms Are Required	p. 133
Nanomaterial Oversight Developments from FDA	p. 135
Conclusions and Recommendations for Government and Industry	p. 138
Support Much More Vigorous EHS Research	p. 139
Acknowledge the Unknowns and Fundamental Differences of Nanomaterials and Act Accordingly	p. 139
Prepare to Meet the EU Standards: The Burden of Proof Is on Industry	p. 140
Transparency	p. 141
Repeating Past Mistakes: Running From Your Product's Label Is Not a Business Plan	p. 143
Lifecycle	p. 143
See the Big Picture: The Question Is Not If, But When	p. 144
Learn From The Past	p. 144
References	p. 145
Navigating the Turbulent Waters of Global Colorant Regulations for Packaging	p. 155
Introduction	p. 155
Authors's Note	p. 155
Definitions	p. 156
United States	p. 156
Canada	p. 156
European Union	p. 156
Asia	p. 156
Regulations	p. 157
United States	p. 157
Personal Care and Cosmetics	p. 157
Drugs	p. 157
Other Packaging Concerns	p. 158
Canada	p. 158
Cosmetics and Personal Care	p. 158
Drugs	p. 159
European Union	p. 159
Mutual Recognition	p. 159
Colorants Lists	p. 159
Ensuring Safety	p. 159
Other Concerns	p. 160
Choosing the Right Colorants for Your Product	p. 160
Dyes	p. 160
Pigments	p. 161
FD&C Colorants	p. 161
Migration	p. 161
Meeting the Design Challenge	p. 161
Risk Assessment	p. 162
The Quandry of Non-Regulation Regulations	p. 162
Allergens	p. 162
Testing	p. 163
Importing Packaging	p. 163
Liability Issues	p. 163
Regulations at a Glance	p. 164
Index	p. 165
Table of Contents provided by Ingram. All Rights Reserved.

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Global Regulatory Issues for the Cosmetics Industry

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