COVID-19 Update: We are currently shipping orders daily. However, due to transit disruptions in some geographies, deliveries may be delayed. To provide all customers with timely access to content, we are offering 50% off Science and Technology Print & eBook bundle options. Terms & conditions.
Global Regulatory Issues for the Cosmetics Industry - 1st Edition - ISBN: 9780815515678, 9780815519621

Global Regulatory Issues for the Cosmetics Industry

1st Edition

Author: C.E. Betton
eBook ISBN: 9780815519621
Hardcover ISBN: 9780815515678
Imprint: William Andrew
Published Date: 11th August 2007
Page Count: 232
Sales tax will be calculated at check-out Price includes VAT/GST
Price includes VAT/GST

Institutional Subscription

Secure Checkout

Personal information is secured with SSL technology.

Free Shipping

Free global shipping
No minimum order.

Table of Contents




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


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


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?


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 US

6.1 Introduction

6.2 Regulatory Requirements for Cosmetics

6.2.1 Warning Statement

6.2.2 Ingredient Declaration

6.3 California Proposition 65 and California Safe Cosmetics Act of 2005

6.4 EU Cosmetics Regulation

6.5 The Future of Cosmetics Regulatory Requirements

7 Restricted Substances in Consumer Products: The Challenge of Global Chemical Compliance

7.1 Introduction

7.2 Addressing the Challenges of Emerging Globally Restricted Substances Regulations

7.3 Restricted Substances: Strategy Definition

7.3.1 Steps to Meeting Global Compliance Directives

7.4 Best Practices

7.5 Recommendation and Conclusions

8 In Vitro Toxicology for Cosmetics: Regulatory Requirements, Biological Limitations

8.1 Introduction

8.2 EU Cosmetic Legislation and Animal Testing

8.3 A Viable Timeline?

8.4 Acute Toxicity

8.5 Skin Corrosion

8.6 Skin Irritation

8.7 Eye Irritation

8.8 Skin Sensitization

8.9 Carcinogenicity

8.10 Reproductive/Developmental Toxicity

8.11 Toxicokinetics

8.11.1 Absorption

8.11.2 Distribution

8.11.3 Metabolism

8.11.4 Excretion

8.11.5 Toxicokinetics

8.12 Other Considerations

8.13 Conclusions


9 Nanotechnology and Nanomaterial Personal Care Products: Necessary Oversight and Recommendations

9.1 Introduction

9.2 What is Nanotechnology Anyway? A New World of Tiny Technology

9.2.1 Nano Means Fundamentally Different

9.2.2 Manufactured and Engineered Nanomaterials vs. Natural Nanoparticles

9.2.3 The Next Industrial Revolution? The Stages of Nanotechnology's Predicted Development

9.3 Nanomaterials in Consumer Products: The Future is Now

9.3.1 Measures of Nanotechnology’s Maturation

9.4 What are the Human Health Risks of Nanotechnology and Nanomaterials in Personal Care Products?

9.4.1 Nanotoxicity

9.4.2 Unprecedented Mobility

9.4.3 The Public at Large

9.4.4 The Question of Skin Penetration

9.4.5 Nanomaterial Worker and Workplace Risks

9.5 What are the Environmental Risks of Nanotechnology and Nanomaterials in Personal Care Products?

9.5.1 Huge EHS Unknowns

9.6 FDA’s Regulatory Stance on Nanotechnology and Nanomaterial Personal Care Products

9.7 Nanotoxicology: Nano-specific Testing Paradigms Are Required

9.8 Nanomaterial Oversight Developments from FDA

9.9 Conclusions and Recommendations for Government and Industry

9.9.1 Support Much More Vigorous EHS Research

9.9.2 Acknowledge the Unknowns and Fundamental Differences of Nanomaterials and Act Accordingly

9.9.3 Prepare to Meet the EU Standards: The Burden of Proof is on Industry

9.9.4 Transparency

9.9.5 Repeating Past Mistakes: Running From Your Product's Label is Not a Business Plan

9.9.6 Lifecycle

9.9.7 See the Big Picture: The Question is Not if, But When

9.9.8 Learn from the Past


10 Navigating the Turbulent Waters of Global Colorant Regulations for Packaging

10.1 Introduction

10.1.1 Authors's Note

10.2 Definitions

10.2.1 United States

10.2.2 Canada

10.2.3 European Union

10.2.4 Asia

10.3 Regulations

10.3.1 United States

10.3.2 Canada

10.3.3 European Union

10.4 Choosing the Right Colorants for Your Product

10.4.1 Dyes

10.4.2 Pigments

10.4.3 FD&C Colorants

10.4.4 Migration

10.5 Meeting the Design Challenge

10.5.1 Risk Assessment

10.5.2 The Quandry of Non-Regulation Regulations

10.5.3 Allergens

10.5.4 Testing

10.6 Importing Packaging

10.6.1 Liability Issues

10.7 Regulations at a Glance



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.


No. of pages:
© William Andrew 2007
11th August 2007
William Andrew
eBook ISBN:
Hardcover ISBN:

Ratings and Reviews

About the Author

C.E. Betton