Global Regulatory Issues for the Cosmetics Industry, Volume 1, emerged from the first annual Cosmetic Regulatory Forum organized by Health and Beauty America (HBA) in September 2006. It is the first of an annual book mini-series surveying issues in this critical and rapidly changing area. These changes affect the health, safety, and well-being of literally billions of consumers, their governments, and the corporations involved in the prodigious task of not only creating novel, effective and safe products, but also complying with regulations, that vary from country to country. This book begins with a discussion of the risks assessment of cosmetic products. This is followed by separate chapters on the regulatory system in some of the major export markets of Canada and Australasia; the evolution and purpose of the EU's REACH (Registration, Evaluation, Authorization of Chemicals); the issue of cosmetic toxicity; and regulatory requirements and warnings for cosmetic products. Subsequent chapters cover the challenges of global chemical compliance; the development of nanotechnology-based products and their potential impact on human health and the environment; and the various packaging regulations relating to colors and additives for products marketed in North America, the EU, and Asia.

Table of Contents

Contributors Preface Introduction 1 Risk Assessment and Cosmetics 1.1 Introduction: Risk Perception and Regulation 1.2 Risk and Cosmetics 1.3 The Risk Assessment Process 1.3.1 Regulations 1.3.2 Role of the Safety Assessor 1.3.3 Guidance 1.3.4 Safety Assessment 1.3.5 Assessment Contents 1.3.6 Other Tests 1.4 Conclusion References 2 Regulatory Developments in Canada, Japan, Australia, China, and India 2.1 Introduction 2.2 Canada 2.3 Japan 2.4 Australia 2.5 China 2.6 India 2.7 Trade Alliances 2.8 California 2.9 Conclusion 3 The REACH Regulation of the European Union 3.1 Introduction 3.2 Why REACH? 3.3 REACH: Overview 3.4 REACH: Aims 3.4.1 Pre-registration 3.4.2 Substance Information Exchange Fora (SIEF) 3.5 Exemptions: Cosmetics? 3.6 Registration References 4 REACH: An Example of the New Paradigm in Global Product Regulation 4.1 Introduction 4.2 REACH: "No Data, No Market" 4.2.1 What is REACH? 4.2.2 How Does REACH Affect the Cosmetics Industry? 4.2.3 How Will REACH Work? 4.3 What Should Companies Be Doing Now? References 5 Developing a Global Regulatory Strategy: Leveraging Local Knowledge to Drive Rapid Market Entry 5.1 Introduction 5.2 Globalization: "One Size Does Not Fit All!" 5.3 Using Regulatory Compliance for Competitive Advantage 5.3.1 Organizational Design 5.3.2 Targeted Capability 5.3.3 Local Knowledge 5.3.4 Business Engagement 5.3.5 Cross-Functional Processes, Systems, and Tools 5.3.6 Communication Plan 5.4 The Global Launch: "Driving with Insights and Regulations" 5.5 Conclusions 6 Cosmetics: Toxicity and Regulatory Requirements in the


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© 2007
William Andrew
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