Global Regulatory Issues for the Cosmetics Industry (Personal Care and Cosmetic Technology)

Global Regulatory Issues for the Cosmetics Industry Volume 2

Personal Care and Cosmetic Technology Series Editor: Meyer Rosen President, Interactive Consulting, Inc., NY, USA The aim of this book series is to disseminate the latest personal care and cosmetic technology developments with a particular emphasis on accessible and practical content. These books will appeal to scientists, engineers, technicians, business managers, and marketing personnel. For more information about the book series and new book proposals please contact William Andrew at [email protected]. http://www.williamandrew.com/PersonalCareCosmetic.php

Global Regulatory Issues for the Cosmetics Industry Volume 2

Edited by

Karl Lintner Sederma S.A.S., Enterprise Technology, Croda International Group

N o r w i c h , N Y, U S A

Copyright © 2009 by William Andrew Inc. No part of this book may be reproduced or utilized in any form or by any means, electronic or mechanical, including photocopying, recording, or by any information storage and retrieval system, without permission in writing from the Publisher. Cover by Russell Richardson ISBN: 978-0-8155-1569-2 Library of Congress Cataloging-in-Publication Data Global regulatory issues for the cosmetics industry / edited by Karl Lintner p. cm. Includes bibliographical references. ISBN 978-0-8155-1569-2 volume II (alk. paper) 1. Cosmetics–Law and legislation. 2. Cosmetics industry. I. Lintner, Karl. K3649.G58 2007 344.04’23–dc22 2007022450 Printed in the United States of America This book is printed on acid-free paper. 10 9 8 7 6 5 4 3 2 1 Published by: William Andrew Inc. 13 Eaton Avenue Norwich, NY 13815 1-800-932-7045 www.williamandrew.com

Environmentally Friendly This book has been printed digitally because this process does not use any plates, ink, chemicals, or press solutions that are harmful to the environment. The paper used in this book has a 30% recycled content.

NOTICE To the best of our knowledge the information in this publication is accurate; however the Publisher does not assume any responsibility or liability for the accuracy or completeness of, or consequences arising from, such information. This book is intended for informational purposes only. Mention of trade names or commercial products does not constitute endorsement or recommendation for their use by the Publisher. Final determination of the suitability of any information or product for any use, and the manner of that use, is the sole responsibility of the user. Anyone intending to rely upon any recommendation of materials or procedures mentioned in this publication should be independently satisfied as to such suitability, and must meet all applicable safety and health standards.

REACH for the stars ! to Dominique Stéphane Ingrid Dorothée and to long “suffering” Françoise L.

Contents Contributors

xv

Preface

xix

Introduction

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1

2

3

Green Chemistry: Foundations in Cosmetic Sciences Amy S. Cannon and John C. Warner 1.1 Introduction 1.2 Green Chemistry 1.3 The Twelve Principles of Green Chemistry 1.4 Conclusion REACH—Life In and Outside the EU: How REACH Will Affect the Supply Chain Ruud A. Overbeek, Bruce Calder, Michael Fry, and Roman Humeniuk 2.1 Introduction 2.2 REACH—The Principle Steps 2.2.1 Product Assessment 2.2.2 Preregistration 2.2.3 Registration 2.2.4 Authorization/Restriction 2.3 Phasing and Facing REACH 2.4 REACH—Who and What? 2.5 REACH—Supply Chain Options and Industry Trends 2.6 Conclusion Cosmetic Ingredients: Definitions, Legal Requirements, and an Attempt to Harmonize (Global?) Characterization Karl Lintner 3.1 Introduction 3.2 Cosmetic Ingredients 3.3 Legal Requirements 3.3.1 The Supplier 3.3.1.1 Europe 3.3.1.2 USA 3.3.1.3 Other Countries 3.3.2 The Downstream User

1 1 3 4 14 17

17 18 19 20 20 21 21 24 25 29 31 31 32 32 32 33 33 35 36 vii

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3.4

3.5 4

A Harmonized Ingredient Characterization? 3.4.1 General Information 3.4.1.1 About the Supplier 3.4.1.2 About the Ingredient Purchased 3.4.2 Origin of the Ingredient 3.4.2.1 Vegetal 3.4.2.2 Ingredients of Microbial Origin 3.4.2.3 Animal-Derived Products 3.4.2.4 Mineral 3.4.2.5 Synthetic Material 3.4.3 Physicochemical Properties 3.4.3.1 Microbial Specifications 3.4.4 Toxicological Information 3.4.4.1 Human Safety 3.4.4.2 Ecological (Environmental) Information 3.4.5 Intellectual Property Conclusion

“26 Allergens” in Cosmetics: A Challenge for All Stakeholders Christine Bertram 4.1 Introduction 4.2 History and Aim to Include “26 Allergens” in the 7th Amendment 4.2.1 Nomenclature Challenges 4.2.2 The Basis for the Selection of the “26 Allergens” 4.3 Natural and Synthetic Components in the List of “26 Allergens” 4.3.1 The World of Plants: A Source of Chemicals with Health Benefits, but also Unwanted Side Effects and Adverse Reactions 4.3.2 Identifying the “26 Allergens” in Accordance with the Requirements of the 7th Amendment 4.3.2.1 Analytic Studies 4.3.2.2 Raw Material Questionnaires 4.3.2.3 Ökotest Downgrading System 4.4 Critical Concerns to Treat All “26 Allergens” Alike 4.5 Trade Impacts of the 7th Amendment (Especially on the “26 Allergen” Labeling) 4.6 Conclusion

36 40 40 40 42 43 44 45 45 46 46 47 48 48 49 51 51 55 55 56 57 59 64

65 67 67 67 68 69 75 75

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Manufacturing Cosmetic Ingredients according to Good Manufacturing Practice Principles Iain Moore 5.1 Introduction 5.2 What is GMP? 5.3 Why Should GMP Be Applied to Cosmetic Ingredients? 5.4 What GMP Should Be Applied? 5.5 Key Features of the EFfCI GMP Guide 5.6 Key Differences to IPEC–PQG GMP Guide for Pharmaceutical Excipients 5.7 Conclusions Safe Cosmetics and Regulatory Compliance: From Burden to Opportunity (Cosmetics as Vectors for Bioterrorists?) Preston W. Blevins 6.1 Introduction 6.2 Regulatory Compliance in Related Industries 6.2.1 Pharmaceutical 6.2.2 Safety Aspects in Food and Beverage 6.2.3 “Nutraceuticals” 6.2.4 Possible Catalysts for Future Regulatory Compliance Requirements 6.2.5 A Mini Summary 6.3 The Biotoxin Attack Simulation 6.4 Regulatory Compliance—The Implied Requirements 6.4.1 A Mini Summary 6.5 Satisfying the Implied Requirements 6.5.1 Process-Batch Enterprise Resource Planning 6.5.2 Organize the Workplace—“5S” and Lean Manufacturing 6.5.3 Making Transactional Reporting Easier 6.5.4 Data Security and Validation 6.5.5 Regulatory Compliance Integrated into Work Activities 6.5.6 Visibility into the Warehouse (stockroom) and Factory Operations 6.5.7 Cycle Counting 6.5.8 A Mini Summary 6.6 Leveraging the Implied Requirements 6.7 The Return on Investment 6.8 Conclusion

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79 79 80 83 85 86 90 92 93 93 94 94 96 98 99 99 100 102 104 104 105 105 108 109 109 110 110 112 113 115 119

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Cosmeceutical (Antiaging) Products: Advertising Rules and Claims Substantiation Wen Schroeder 7.1 Introduction 7.1.1 The “Cosmeceutical” Era 7.1.2 The Believability of “Cosmeceutical” Claims 7.2 Making Sense of Cosmetic Product Labeling 7.2.1 A Brief Overview of US Cosmetic Regulations—Product Category and Definition 7.2.2 Product Labeling—Drug or Cosmetic? 7.2.2.1 US Legal Definitions of Drugs and Cosmetics 7.2.2.2 Distinction between Drugs and Cosmetics in the US 7.2.2.3 The Global Situation: Cosmetics versus Drugs 7.2.2.4 What about Borderline Products? 7.2.2.5 “Cosmeceutical” Products Labeling 7.3 Cosmetic Products Advertising 7.3.1 What is Advertising? 7.3.2 US Regulatory Mechanisms over Cosmetic Product Advertising 7.3.2.1 Cosmetic Product Categories 7.3.2.2 Relevant Law and Regulations 7.4 The Situation of the Ever-Creeping Antiaging Cosmetic Product Claims 7.4.1 FDA Enforcement—Product Labeling 7.4.2 FTC Enforcement—Advertising and Claims Substantiation 7.4.2.1 What about Puffery? 7.4.3 NAD Action Case Studies 7.5 Successful Product Positioning and Advertising Strategy 7.5.1 Advanced Marketing and Claims Substantiation Planning—Regulatory Affairs Meets Marketing and Product Positioning 7.5.2 Considering Consumers’ Peace of Mind 7.6 Conclusion 8 Cosmetic Claim Substantiation: Methods and Legal Framework Philippe Masson, Philippe Mondon, and Karl Lintner 8.1 Introduction

121 121 121 122 123 123 125 126 126 128 130 130 133 133 134 134 134 137 137 138 141 142 145

146 148 149 155 155

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What Constitutes a Reasonably Documented Proof of Cosmetic Activity? 8.2.1 Content and Structure of a Well-Documented and Credible Claim Substantiation Dossier 8.2.1.1 Transparency 8.2.1.2 Pertinence 8.2.1.3 General Information Required in Any Study Report 8.2.1.4 Tests Run on Human Volunteers 8.2.1.5 Tests Run on Different Material than Human Beings 8.2.1.6 Mini Summary 8.3 A Short Review of Methods Used To Establish Cosmetic Claim Substantiation 8.3.1 In vitro Tests 8.3.2 Ex Vivo Tests 8.3.3 In Vivo (Clinical) Tests 8.4 Regulatory Aspects 8.4.1 Korea and the Rest of the World 8.4.2 Clinical Studies on Human Volunteers for Cosmetic Purposes 8.5 Conclusion

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The Impact of Global Regulations on Packaging Holly C. Young and Marcus Tirado 9.1 Introduction 9.2 The Importance of Your Package 9.3 Global Packaging Trends and Issues 9.4 Key Global Regulatory Elements for Packaging: The Basics 9.4.1 Definitions: Cosmetic or Drug? 9.4.2 Ingredients on the Label 9.4.3 The Package and Innovation 9.4.4 The Basic Primary and Secondary Components of Package Design 9.4.5 Additional Labeling 9.5 Case Studies 9.5.1 Special Products: Sunscreen for the EU 9.5.2 Special Products: Sunscreen for Canada 9.5.3 Special Products: Sunscreen for the U.S. 9.6 Conclusion

156 157 157 157 158 158 159 160 160 160 162 162 169 170 171 172 175 175 176 176 177 178 179 180 181 184 186 186 186 187 187

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Global Cosmetic Regulations? A Long Way To Go … Sandra B. Schneider 10.1 Introduction 10.2 Australia 10.2.1 Australia’s Cosmetic and Personal Care Products Markets 10.2.2 National Industrial Chemicals Notification and Assessment Scheme 10.2.3 Australian Competition and Consumer Commission 10.2.3.1 Is It a Cosmetic or Therapeutic Product? 10.2.3.2 Acceptable versus Unacceptable Claims 10.2.4 Therapeutic Goods Administration 10.2.5 Certified Organic Personal Care Products 10.3 Brazil 10.3.1 Product Classifications 10.3.2 ANVISA 10.3.2.1 General Labeling Requirements 10.3.2.2 Advertising/Claims 10.3.2.3 Warnings 10.3.2.4 ANVISA Product Notification Requirements, May 2007 10.3.2.5 Import Licensing/Customs Valuation 10.4 Canada 10.4.1 Canadian Cosmetic and Personal Care Market 10.4.2 The Canadian Cosmetic Regulations 10.4.3 Drug Classifications 10.4.3.1 Claims 10.4.4 Country of Origin Marking Program 10.4.5 Raw Material Information 10.5 India 10.5.1 The Indian Cosmetic Market 10.5.2 Cosmetic Regulations 10.5.2.1 Domestic Cosmetic Regulations 10.5.2.2 Import Cosmetic Regulations 10.5.3 Summary 10.6 Russia 10.6.1 The Russian Cosmetic Market 10.6.2 Cosmetic Regulations

189 189 190 190 190 195 196 196 198 200 200 205 205 206 206 207 207 210 211 211 211 213 214 214 216 217 217 219 220 220 223 224 224 225

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10.6.3 10.6.4

Certifications Certification of Imported Ingredients for the Beauty Industry 10.6.5 Updates: Russian Perfumery-Cosmetic Products

11

Global Patent and Trade Mark Strategies: A Must for Everybody? Estelle Haeffner, Virginie Gliubislavich, and Karl Lintner 11.1 Introduction 11.2 Why Protect IP (Inventions and Trade Names)? 11.3 What Types of IP Can You and Do You Want to Protect? 11.3.1 Inventions 11.3.2 Tradenames 11.4 When to Protect Your IP? 11.5 Who Files and How? 11.6 Where to Obtain Protection? 11.6.1 Inventions (Patents) 11.6.1.1 Strategy for Consumer Products 11.6.1.2 Strategy for Upstream Suppliers 11.6.2 Trademarks 11.7 Cost 11.8 How to Defend Your IP? 11.9 Conclusion

Index

228 231 231 235 235 237 238 238 240 242 244 246 246 246 247 247 247 248 249 251

Contributors Christine Bertram CRODAROM S.A.S. Z.A. Les Plaines 48230 Chanac France Preston W. Blevins CFPIM, FBPICS, CIRM, CSCP APICS District Director, Southwest District 312 Rancho Del Oro, Ste 226 Oceanside CA 92057 USA Bruce Calder 2200 West Loop South Suite 200 Houston TX 77027 USA Amy S. Cannon Beyond Benign 66 Cummings Park Woburn MA 01801 USA Michael Fry 2200 West Loop South Suite 200 Houston TX 77027 USA Virginie Gliubislavich Sederma S.A.S. 78610 Le Perray en Yvelines France xv

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Estelle Haeffner, PhD Sederma S.A.S. 78610 Le Perray en Yvelines France Roman Humeniuk 2200 West Loop South Suite 200 Houston TX 77027 USA Karl Lintner, PhD Sederma S.A.S. Enterprise Technology 78610 Le Perray en Yvelines France Philippe Masson EVIC International 33294 Blanquefort France Philippe Mondon, PhD Sederma S.A.S. 78610 Le Perray en Yvelines France Iain Moore Croda Europe Ltd. Cowick Hall, Snaith, Goole East Yorkshire DN14 9AA UK Ruud A. Overbeek Restricted Substances Intertek Group 2200 West Loop South Suite 200 Houston TX 77027 USA

Contributors

Contributors

Meyer R. Rosen FRSC, FACFE, FAIC, CPC, CChE Interactive Consulting, Inc. PO Box 66 East Norwich NY 11732 USA Wen Schroeder SEKI Cosmeticals LLC 232 E. Carrington Lane Appleton WI 54913 USA Sandra Schneider Dougmar Consultants LLC Post Office Box 681 Westhampton New York 11977 USA Marcus Tirado Hirschhorn + Young Graphics, Inc. 151 West 30th Street, 9th floor New York NY 10001 USA John C. Warner Warner Babcock Institute for Green Chemistry 66 Cummings Park Woburn MA 01801 USA Holly C. Young President Hirschhorn + Young Graphics, Inc. 151 West 30th Street, 9th floor New York NY 10001 USA

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Preface This book is the second volume William Andrew Inc. has issued in this increasingly important area. The first book, Global Regulatory Issues for the Cosmetic Industry, Volume 1, edited by C.I. Betton, was based upon the First International Regulatory Summit of HBA Global Expo, held in September 2006. The foundation for this second book in this miniseries is based upon the Second International Safety and Regulatory Summit of HBA Global Expo, held in September 2007. Dr. Karl Lintner, the editor of the book, has also gone beyond the HBA Symposium and found other chapter authors who had important contributions to make. The reason for the present book series is obvious; although governmental regulations of the chemical industry are designed to be a critical part of making our world safer for the people who use these products as well as for the environment we all live in, their wholesale and undifferentiated application to the personal care and cosmetic industry has turned out to be in many cases more complex and difficult than expected. Furthermore, both the “Green” Chemistry Movement and consumer pull have continually contributed to generate legislative initiatives globally, although not in any way harmonized. We have even seen that what began with some fundamental legislation on cosmetic safety in the United States many years ago is now being challenged by individual states such as California, Minnesota, and most recently New Jersey. It has become obvious that some of the states within the United States have generated legislation that goes far beyond Federal Guidelines of the Food and Drug Administration (FDA). It has also been pointed out that the FDA guidelines are aging and may need rejuvenation in light of new technology, new products, and a growing chorus of consumer demand, not only in this country, but also outside of this country—where much of our products in this field are sold. Outside the United States, the 27 countries of the European Union have generated the now well known REACH legislation, which has had, and will continue to have for years to come, an escalating impact on the safety, formulation, and commercialization of both “old” and new products. Industry organizations in many countries such as the United States, the EU, Canada, Australia, Japan, and others are striving to improve communication with legislators and consumers alike. This outreach is grounded in attempts to achieve a balance among various key factors. These include, for example, education of legislators—so regulations are not passed requiring xix

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testing that, at the present time, have no testing protocols available. Other important factors deal with a rapidly changing landscape of new active ingredients. Also, there is increasing recognition of safety issues that were not known about previously, or are grounded in suspicion as there may be finger pointing to a lack of safety without sufficient data to make the scientific community comfortable that the issues are real and therefore require more focused attention. Of course, just because there are no accepted scientific tests for things such as alternatives to animal testing, as just one illustrative example, is to be viewed as an opportunity to generate them; and this, in fact, is what appears to be happening. The broader issues of redefining safety in the context of regulations, is an enormous issue worldwide. Each country, industry organization, and manufacturing company, both of ingredients and of fully formulated products, are being impacted by current and anticipated regulation. Not only what is “in the bottle” is in the spotlight, but also the containers themselves, as the bar has clearly been raised from a regulatory and consumer concern perspective. It has been said that some medium- and smaller-sized companies may go out of business for they cannot afford the costs associated with regulation enhancement. Inevitably, other businesses have been born to support and provide services to these companies. And so it goes …. This book, one of a series on the subject, is intended to provide an update to the rapidly moving changes, thinking, and required actions consistent with the paradigm shift called forth to protect our customers and the world they live in. It is of value not just to regulatory experts, but to the formulators, ingredient suppliers, business, and marketing management. Dr. Karl Lintner’s contribution as editor is to be acknowledged and applauded for taking on the difficult task of providing a snapshot of these changes. Meyer R. Rosen, CPC, CChE, DABFET Fellow of the Royal Society of Chemistry (London) Fellow of the American College of Forensic Examiners Series Editor: William Andrew Inc. “Personal Care & Cosmetic Technology” Series November 2008

Introduction This is the second volume of a series that was born in 2006 on the occasion of the First Regulatory Summit organized during the HBA conference in New York. Although the idea was to put to paper the contributions of the speakers at the summit and to offer them to a wider audience than those present, it became evident that contributions were necessary and welcome from outside sources, experts who had not been involved in the “summit” but whose knowledge of specific domains helped round out the content of the book. This second volume of the series thus continues in this spirit; rather than trying to be faithful “proceedings” of the summit conference, it reaches out to speakers and nonparticipants alike, in order to present an up-to-date perception of some of the issues the cosmetic industry faces today with respect to worldwide regulations. Of course, one small book cannot pretend to address all regulatory issues, nor can it claim to include the very latest developments. Therefore, the aim of an endeavor such as this must be to present topics that are truly of global interest, in a way that is useful for the reader (i.e., contains information about where to look for details and latest updates) and that focuses on practical aspects as well. The title of the series is quite a mouthful: Global Regulatory Issues for the Cosmetic Industry. All of us who work in this field realize the increasing encroachment of regulations and laws, formalities and restrictions imposed on this business. One is entitled to ask the question: Why is this so? Are cosmetic products such a threat to humanity, to human health, and the environment that they need to be scrutinized and regulated in much more detail than, say, the food industry, paint and adhesives, or household chemicals? Does the tiny number of health problems related to cosmetic products justify this outpouring of legislative texts, decrees, directives and amendments? One wonders …. Of course, some of this is self-inflicted: “paraben free”, even “preservative free,” “not tested on animals,” “100% natural,” “better than surgery” “lose inches within days” and so on are claims that really ask for trouble, for regulatory bodies to intervene, be they the Federal Trade Commission (FTC), the Food and Drug Administration (FDA), or any equivalent organization elsewhere. Mercury and hydrocortisone in skin whiteners, hormones in body care, Belladonna extracts in baby creams, and similar horrors, albeit rare and isolated and not in mainstream brands, but spectacularly xxi

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displayed in the media when discovered, make it inevitable that NGOs and consumer groups call for more regulations, more surveillance. Given the well-publicized abuses of this kind and the general public’s perception that cosmetics in general (and skin care/body care products with their often far reaching claims in particular) are futile and outrageously overpriced, it is no surprise that adversaries of this industry have a field day. It is my opinion that this is a shame. Cosmetics, by which we mean all personal care and toiletries products, including some over-the-counter (OTC)/quasidrug products such as sunscreens, as well as soaps, shaving foam and shampoos, make-up, and skin care creams have an important function today. They contribute to general awareness of hygiene (and thus public health) via toothpaste and shower gels, but also to the feeling of well being, pleasure, and happiness of the users. Activities such as those carried out by the charities “Look good, feel better” (in the United States, helping cancer patients improve their mental state) and the “Beauty Centers” of Cosmetic Executive Women (dispensing beauty care to hospital patients in France) are concrete witnesses to the fact that cosmetic benefits overall far outweigh the few and minimal risks that are no bigger (and mostly much smaller) than those associated with any other human life activity. To argue that “cosmetics have no benefit, therefore they must not present any risk” (as has been heard so many times) is just an unacceptable and unscientific simplification for some sensational tabloids. Unless and until this perception of the futility, and sometimes “danger” of cosmetic products is cleared up and overcome, the industry and its upstream, downstream, and side-by-side partners (suppliers, marketers, service providers) have to face the pressure from specific interest groups, the press, and ultimately the regulatory bodies of every country they operate in. Trying to address “global” issues is, however, no small feat. In spite of many years of “harmonization” conferences, publications, and meetings, the world is still miles (and years) away from a global definition of what a “cosmetic product” is, and how it should be regulated. Attempts to a more global approach exist, though, and some progress is visible. The member states of ASEAN have recently adopted a text that mirrors EU regulations of cosmetics in many details; Japan has partially liberalized its cosmetic law to conform more to the spirit of the U.S. and EU legislation. On the other hand, Korea has introduced the category of “functional cosmetics” that resembles the quasidrug category of Japan and/or the OTC cosmetic/drug category of the United States. Rumors have it that European authorities are studying this approach in order to contain and better regulate the increasing brouhaha around “cosmeceuticals” and “active cosmetics.” This is not promising, especially when one realizes that the rewriting (and simplification?)

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of the 76/768/CEE Cosmetics Directive threatens to introduce the first glimmers of ingredient monographs, standardized claim substantiation methods, and the like. The overburdening spirit of REACH legislation and the precautionary principle philosophy have left their traces in stakeholder’s minds. How can it be explained that practically every article dealing with REACH, published over the last years in European dailies, included a boxed insert entitled: REACH and Cosmetics? As if the cosmetic industry was the biggest user of chemicals, the most dangerous branch of the chemical industry? Sure, for some of the reasons given above, it has become an easy target …. There, the word is said: cosmetic industry, as much as it would like this to be forgotten, is part of the chemical industry. Therefore, the first authoritative body that regulates it (and its ingredients) is the ensemble of laws on “chemical substances.” These laws are designed to protect the workers who use the chemicals, and the environment through which they are shipped. The upcoming Global Harmonizing System (GHS) (classification and labeling of dangerous goods) and the European REACH legislation fall into this category; practically all countries have legislation to this effect, and REACH is likely to be followed and implemented (in more or less modified form) in other regions as well. The next layer of regulations concerns the use of these substances to make a finished consumer product. Concepts such as Hazard Analysis Critical Control Point (HACCP), Good Manufacturing Practice (GMP), and Quality Assurance are either legally binding or strongly recommended and modeled on the closely related food or pharmaceutical industry. Although the cosmetic industry is neither as essential to daily survival as food nor as life saving (in many cases) as pharmaceutical products, it seems to inherit the regulatory supervision and restrictions of both extremes of the scale. Finally, having implemented the regulatory layers of ingredient handling and the manufacturing framework, the laws on marketing, advertising, packaging, and claim language (and its substantiation) kick in. Some participants and actors in this field (not all, of course) seem to feel that by going “natural,” “bio,” “organic,” or some such label, they can overcome the “bad chemical image” of the branch and thus—if not avoid—at least alleviate the burdens and restrictions of regulations. “Natural is good,” “Natural is safe,” “Natural is efficacious,” or so the perception goes, even if there is little if any evidence for “natural” being “better.” In the eyes of some, this nevertheless means less need for extensive testing of safety, efficacy, and benefits. This path may turn out, in the long run, riskier and fuller of pitfalls than it would seem at the outset. The future will tell.

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In the meantime, we have to live with these globally increasing, but not really globally harmonized, problems and rules. An exhaustive treatment of all regulations, region by region, aspect by aspect, is of course, not possible in one book. And if one were to try to compile it all, the result would be outdated by the time it appears in print. We have, therefore, tried to address some of the most pressing issues of today, to bind them together with a tentative logical thread. The present book is divided roughly into three sections that address “ingredients,” “manufacturing,” and “finished products”; keynote “book-end” chapters straddle these sections. We start with Professor John Warner’s presentation of “Green Chemistry,” a chapter of global importance, going even beyond the domain of cosmetic chemistry, but of particular relevance in today’s frenzy on going “natural.” Although not a fan of the term “Green Chemistry” myself, I admired John Warner’s beautifully structured talk with this title, at the end of which he concluded—to my relief— that we should get away from “green” chemistry to end up with “responsible” and “intelligent” chemistry, otherwise there will some day be no more chemistry at all! And what a sad world that would be. Dr. Estelle Haeffner’s final chapter on Intellectual Property (patents) alerts us to the fact that all innovation (so much in demand by the industry and the market, and often stifled by this increasing regulatory activity) is quickly squandered if we do not protect it by trade names, models, and patents. Although explaining the extreme complexity of today’s patent law and practice cannot be achieved in a book’s chapter, we get a feel for why it is important to protect ideas, to do it right, and to do it globally (if justified). In between these two covers (so to speak), the following chapters address specific topics. Ruud Overbeek resumes the complex European REACH regulation that came into force in June 2007 (for the first part) and will make its full force being felt as of June 2008. My own chapter on ingredient characterization introduces the various attempts by stakeholders in the United States and in Europe to formalize (and harmonize?) the procedure of description, identification, and specification of cosmetic ingredients; or rather, to be more precise, of ingredients destined to be used in a cosmetic product, as there is no such a priori category or list of substances named “cosmetic ingredients.” Christine Bertram then looks critically at the specific item of the “allergens,” object of the 7th Amendment of the European Cosmetics Directive: the “what” of this legislation, the “why,” and the complexities this text raises with respect to the use of “natural” plant extracts; a skeptical look at the future of similar amendments that may loom ahead as new products are

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introduced into cosmetic formulas and suggestions on how to reanalyze the problem are presented. In the next section, Iain Moore tackles the question: If cosmetic legislation requires GMP compliance for the manufacturing of cosmetic consumer products, what happens to the supplier of the ingredients used by the cosmetic manufacturer? Is GMP also imposed on the upstream supply chain? If so, how far does one have to go up the creek? What are the specificities of GMP compliance (or adherence) for ingredient suppliers? The principles of an ingredient GMP guideline, elaborated by the European Federation for Cosmetic Ingredients (EFfCI) are explained. Preston W. Blevin then analyses the risks of manufacturing cosmetic products and proposes some ideas on how to minimize these risks, by integrating existing regulatory aspects, but also farther-reaching concepts such as HACCP, “5S”, ERP (Enterprise Resource Planning), and others into the equation. Seen in this light, adherence to regulations becomes an investment and an insurance rather than a costly and unavoidable burden. Wen Schroeder opens the third section with an overview of which cosmetic claims are “globally” accepted; she looks at the questions of claim language, the fine line between drug and cosmetic claims and the consequences of going too far, illustrated by a number of concrete examples. Philippe Masson and Dr. Philippe Mondon describe how to carry out studies to support and defend those claims. Be they based on publications of the scientific literature, on in vitro experiments, on clinical data, or on consumer panels, certain minimal requirements need be fulfilled to satisfy the authorities about the validity of the cosmetic messages to the consumer. And then the product composed of all the ingredients, properly manufactured, tested, and advertised, has to be brought to the consumer in a convenient and attractive package which poses further challenges and is subject to specific regulations, detailed in Holly Young’s chapter. In spite of all the talk about globalization, at least in the field of cosmetic products, we are a long way off from harmonized legislation. Sandra Schneider presents insights into the complexities of cosmetic regulations in a non-exhaustive selection of countries (Australia, Brazil, Canada, India and Russia), before Dr. Haeffner et al. remind us, as stated above, that a good product is quickly copied and pirated if adequate protection is not sought. What good does it do to subject yourself to all these regulations if any John Doe can propose a simple copy of your efforts without having had to worry about the pitfalls and obstacles you had to consider? We hope this collection of knowledge and expertise is a worthy sequel to the first volume, useful to the readership, and sufficiently provocative to stir up some discussion on the topics raised. If it is followed by further

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books in the series, there should be—alas—no shortage of topics in the years to come, as any slack in the global regulatory output is unlikely. Finally, I would like to thank all of the authors who have contributed their time, knowledge, and expertise for the benefit of all, to Meyer Rosen for inviting me to try my hand at “editing a book,” and to Martin Scrivener (William Andrew Inc.) for his help and patience throughout this adventure. Karl Lintner, PhD November 2008

1 Green Chemistry: Foundations in Cosmetic Sciences Amy S. Cannon1 and John C. Warner2 1

2

Beyond Benign, Woburn, MA, USA Warner Babcock Institute for Green Chemistry, Woburn, MA, USA

1.1 Introduction The manufacturing industries have been experiencing increasing pressure from regulatory and government agencies and society in general on issues concerning human health and the environment. While sustainability in its “big picture” ideals are easy for individuals to understand, it is at the practical level that clarity is less forthcoming. As corporations strive to meet various sustainability objectives within operations such as recycling and energy audits, fundamental incorporation at the most basic levels often do not exist. Sustainability should include every aspect of an industry’s operations. Green chemistry speaks to the chemists and materials scientists to incorporate sustainable principles into their practices of creating products and developing processes. The field of green chemistry, since its beginnings in the early 1990s, has been growing in the scientific community at an ever-increasing rate. What began as a science around synthetic organic transformations has expanded to incorporate literally every aspect of chemistry, chemical engineering, and manufacturing sciences. K. Lintner (ed.), Global Regulatory Issues for the Cosmetics Industry Vol. 2, 1–16 © 2009 William Andrew Inc.

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In the mid-1990s, the U.S. Environmental Protection Agency (EPA) began an awards program called the Presidential Green Chemistry Challenge Awards [1]. Each year five awards are given out to small and large businesses and academics for technologies that demonstrate the principles of green chemistry and that are also practical and can be commercialized. Green chemistry at its roots is about “real world” solutions to pollution prevention. For a technology to be successful in this awards program, and in fact to be considered “green chemistry,” it is not sufficient for the technology to be merely more benign than alternative technologies, it must also be viable in the marketplace. For a green chemistry technology to be viable in a competitive marketplace, it must satisfy two additional criteria in addition to product safety (Figure 1.1). It must demonstrate superior product performance; for example, environmentally benign cleaners that do not clean will not be desirable. It must also demonstrate appropriate economics. Society has demonstrated its unwillingness to pay a premium for environmentally benign technology. Adding these new criteria to product development is far from an easy task. Yet scientists in industry and academia have risen to the challenge and the more than 60 award winners of the Presidential Green Chemistry Challenge Awards program are testament to the ingenuity and innovation being applied. Interestingly, when one reviews a list of the Presidential Green Chemistry Challenge Award winners, one finds a scarcity of any technologies that

Safety

Green Chemistry

Performance

Cost

Figure 1.1 Three requirements for green chemistry technologies.

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could be classified as belonging wholly to the cosmetics and personal care industry. However, a review of the nomination packages shows that there are very few proposals being submitted from the cosmetics and personal care industry. This is not to say that some green chemistry is not already happening in this industry, but certainly there is a great deal of opportunity.

1.2 Green Chemistry Green chemistry is a set of principles that speak to the design scientist at the earliest part of a product development program. It incorporates downstream implications at the fundamental molecular level. By anticipating potential problems around scale-up associated with regulatory and toxicological issues, it is possible to not only reduce costs from a variety of internalized and externalized sources but also streamline operations by increasing efficiency and time to market. These principles were published in 1998 in the book titled Green Chemistry Theory and Practice [2]. This book is a testament to the concerns of regulatory issues in the cosmetics and personal care industries. This chapter will discuss the twelve principles of green chemistry in the context of the cosmetics and personal care industries and how the concerns can be addressed at a fundamental level (Figure 1.2). While all the examples presented in this chapter may not be directly extracted from technologies immediately recognizable as being from this industry sector, it is hoped that they are similar enough to provide relative illustrative examples.

1. Pollution Prevention. 2. Atom Economy. 3. Less Hazardous Synthesis. 4. Designing Safer Chemicals. 5. Safer Solvents and Auxiliaries. 6. Design for Energy Efficiency. 7. Use of Renewable Feedstocks. 8. Reduce Derivatives. 9. Catalysis. 10. Design for Degradation. 11. Real-time Analysis for Pollution Prevention. 12. Inherently Safer Chemistry for Accident Prevention.

Figure 1.2 The twelve principles of green chemistry [2].

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1.3 The Twelve Principles of Green Chemistry Principle 1: Pollution Prevention. It is better to prevent waste than to treat or clean up waste after it is formed. The first principle is merely a technical restatement of the old adage “a pinch of prevention is worth a pound of cure.” It focuses on looking at the materials flow in a product life cycle, with an eye toward reducing waste before it is ever created, recognizing the costs associated with disposal, cleanup, and remediation. When one considers the ethical and economic implications of using hazardous materials, it becomes immediately obvious that a safer, nontoxic technology (with identical product performance and economics) will always be superior in the marketplace. The economics and product performance is only part of the story. One need only pick up a newspaper, turn on the radio, or watch television to witness the explosion of environmental consciousness in every aspect of society. The demands by consumers for “sustainable” products are only going to increase in the years to come. Pollution prevention is best addressed by creating technologies and products that reduce waste at the very beginning stages of their life cycles. Countless examples are testament to this principle and many speak to the heart of the environmental movement. Environmental disasters are far too common in our history. And, the cleanup is unfortunately quite costly. In the United States, the EPA estimates that nearly $6.5 billion has been spent toward their brownfield initiative since its inception in 1995 [3]. It is estimated that the initiative involves nearly 450,000 brownfield sites throughout the United States. It is evident that it is better to have not created this waste rather than spend billions of dollars for cleanup after the fact. Principle 2: Atom Economy. Synthetic methods should be designed to maximize the incorporation of all materials used in the process into the final product. A typical product life cycle begins with the extraction of raw materials from the earth, followed by the functionalizing of the raw materials into useful feedstock chemicals that can be transformed into the various chemical products that we require for making products. The synthesis of the chemical products involves the use of various reagents in order to create the desired product. Many reagents are used to perform a specific function on the molecule, but are not actually incorporated into the product. The

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reagents that are not incorporated into the product typically result in waste in a chemical process. Throughout the history of chemistry, the quantitative success of a chemical transformation has typically focused on the concept of product yield. This number is based on the number of grams of products synthesized divided by the number of yields theoretically possible. While this measure provides some insight into the productivity of a chemical reaction, or series of reactions, much information is lost. Many synthetic transformations available in the chemist’s toolbox do not merely follow the simple description of compound A is converted to compound B (Figure 1.3). More often than not, these transformations are far more complex with a number of reactants coming together to form a number of products (Figure 1.3). While the desired product may be obtained in high yield, it is possible and in fact often the case that along with the desired product an equivalent amount of some other anticipated by-product is formed. The atom economy of a reaction is based on a calculation developed by Barry Trost [4]: the ratio of the molecular weight of the atoms used to make a product divided by the molecular weight of all the reagents and starting materials used to make the product. It is a simple measure of the amount of waste created in a chemical process based on the atoms used in a process. This principle speaks to developing molecular transformations that incorporate a maximum number of atoms into the final product thus minimizing the atoms that appear as waste. Principle 3: Less Hazardous Synthesis. Wherever practicable, synthetic methodologies should be designed to use and generate substances that possess little or no toxicity to human health and the environment. It is often overlooked that the manufacturing pathway to synthesize a product ultimately may in fact go through a series of chemical intermediates. Idealized reaction: A→B Typical reaction: A + R1 + R2 …→ B + C + D…

Figure 1.3 An idealized versus a typical synthetic transformation. A: Starting material; B: Product; R: Reagent; C, D: Coproducts or by-products.

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This principle seeks to minimize the hazard associated with these intermediates. It is important to make the distinction that this principle is focused on materials that, in a perfect world, should not appear in the product. But, when considering worker exposure and the other associated costs related to disposal and hazardous materials, this is extremely important. Reducing the hazards associated with the way a product is made can drastically reduce worker liabilities and contribute toward worker health and safety. In a typical manufacture of a product, the final step before packaging involves formulation. Formulation is the assembly of various materials acquired internally or from external vendors. It is important to recognize that these ingredient materials are being synthesized somewhere, whether in-house or by the supplier. Some solutions to working with hazardous materials can seem to be successful from the perspective of the formulator; it is in fact possible that somewhere upstream hazardous materials are being used and generated. In a complete life cycle analysis a “not-in-mybackyard” solution is not sufficient. Thus, it is important that the entire supply chain for a product be evaluated and optimized. For example, an outside supplier typically supplies a plastic packaging material for most consumer products. There are several plastic types to choose from and they are often selected by their desired properties so as to contain the consumer product and retain its functionality. Many plastic materials are nontoxic to humans. However, the ways of manufacturing such plastic can be hazardous to the workers who operate and handle the materials during production. Therefore, it is important to reduce the hazard during the creation of such plastic materials. One example where a plastic material was created that accomplished the task of reducing the hazard in a manufacturing setting is that of Cargill Dow’s (now NatureWorks LLC) NatureWorksTM PLA process. In 2002, the company won the Greener Reaction Conditions Award of the Presidential Green Chemistry Challenge Awards for developing a bio-based, compostable polymer that eliminates the use of organic solvents and hazardous materials required to make many other plastic materials [5]. The NatureWorksTM PLA process has been used to create polylactic acid (PLA) polymers based on renewable, bio-based resources. The method for creating the polymers involves a water-based natural process of fermentation [6]. Typical methods for producing other polymers include the use of organic solvents and many hazardous materials. The PLA process employs

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low-temperature, low-toxicity processes that are much safer for the worker. The PLA polymer is currently used for many packaging applications where typical polymers were once used. Principle 4: Safer Chemical Products. Chemical products should be designed to preserve efficacy of function while reducing toxicity. This principle is the most relevant to the consumer. Making a safe product is an obvious goal of all manufacturers. When evaluating chemical risk there are two components that are typically considered: a material’s intrinsic hazard and the exposure to the hazard. While much work has been done traditionally to mitigate exposure of hazards to consumers, green chemistry seeks to address risk by dealing directly with the intrinsic hazard. Of course, this is not an easy task. But the last few decades of mechanistic toxicology have provided deep insight into several of the structure–activity relationships that govern physiological, environmental, and global hazards. While individual practitioners of chemistry cannot be expected to be fully versed in the vast and growing field of molecular toxicology, certain fundamental understandings and resources available must be incorporated in product design. Cosmetic and personal care products are perhaps one of the most important areas where this principle should be applied. It is essential that cosmetic products are made to be as safe as possible due to the close contact of these products with the end users. One example of safer chemical products is that of developing safer permanent wave techniques for hair. Current products that are used employ hazardous chemicals, such as thioglycolic acid (and its derivatives) and hydrogen peroxide [7], to perform chemistry on the hair shaft in order to manipulate the hair. Researchers at the University of Massachusetts Lowell (now at the Warner Babcock Institute for Green Chemistry) have developed a method for treating hair that is waterbased and has demonstrated drastic reductions in toxicity [8]. The method involves a nontoxic, water-based polymeric material that coats the shaft of hair. A photoactive component, thymine, in the polymer will then help to secure the hair in place (Figure 1.4). This technology can result in a reduced hazard and reduced exposure of such hazard to both the salon worker and the consumer. Principle 5: Safer Solvents and Auxiliaries. The use of auxiliary substances (e.g., solvents, separation agents) should be made unnecessary wherever possible and, innocuous when used.

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Figure 1.4 Thymine-based bioinspired photoactive polymers.

The principles discussed so far deal with the molecules undergoing reaction from starting material to product. The chemical manufacturing process is not that simple! To provide appropriate reaction environments, chemists often supply solvents and other materials. From a mass basis, these “other materials” often far exceed the amount of materials actually being synthesized sometimes by as much as 100-fold. This principle seeks to minimize the use and the hazard of these nonparticipatory materials. In addition to the manufacturing process itself, products often have carrier solvents. From a green chemistry perspective, it is best to maximize the ultimately functional material, while minimizing the delivery compound. And, in cases where a carrier solvent is essential for product performance, materials that are innocuous should be developed and used. One example of safer solvents in practice is work being developed at the Warner Babcock Institute for Green Chemistry. The institute is developing nail lacquers that are water-based, therefore, eliminating the use of organic solvents in traditional nail lacquers [9]. The technology employs the same mechanisms involved in that of the permanent wave techniques for hair [7]. The water-based polymeric material is bioinspired and is based

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on mechanisms that occur in human DNA [10]. The polymeric system is water soluble and therefore a completely water-based nail lacquer can be developed that eliminates the need for organic solvents, thus reducing exposure to hazardous solvents. Principle 6: Energy Efficiency. Energy requirements should be recognized for their environmental and economic impacts and should be minimized. Synthetic methods should be conducted at ambient temperature and pressure. In recent years, it has become impossible to escape the implications of energy utilization. With the increased cost of fuels across the board, any process that uses more energy than absolutely necessary becomes a major cost. From a global climate change perspective, this excess energy is likely to be contributing greenhouse gases somewhere along the process. Fundamental thermodynamics of chemical transformations require that activation energies be overcome (Figure 1.5). While a discussion of spontaneity and Gibbs free energy changes is outside the realm of this chapter, simply stated, most chemical reactions need to be heated in order to occur. Energy requirements are also found in many common manufacturing processes such as drying a material or cooling. This principle seeks to develop built-in mechanisms to allow transformations to occur at ambient conditions. One example of a drastic reduction in energy requirements involves that of the development of a method for printing product labels directly on glass. RevTech, Inc., won the Presidential Green Chemistry Challenge Small TS Eact SM Energy

DG

P Reaction Coordinate

Figure 1.5 Reaction coordinate diagram. Eact: Activation energy; TS: Transition state; SM: Starting materials; P: Product; G: Energy.

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Business Award in 2000 for developing the EnvirogluvTM process to print product labels directly on glass, thus replacing traditional labeling techniques [11]. The process involves the use of inks that contain no heavy metals and little to no volatile organic compounds (VOCs). The inks are biodegradable and they make use of ultraviolet light to adhere the ink to the glass, replacing high-temperature ovens typically used in many processes [12]. The process drastically reduced the energy used in a typical high-temperature process, also reducing the associated costs of energy use. Principle 7: Renewable Feedstocks. A raw material of feedstock should be renewable rather than depleting wherever technically and economically practicable. Our society depends on petroleum not only for energy requirements, but also for material goods. Many of the materials in commerce today are based ultimately on petroleum intermediates. The molecular life cycle of most compounds ultimately begins with the synthetic transformations of a petroleum distillate. With all the geopolitical issues associated with petroleum production, distribution, and consumption, it is incumbent on product designers to seek alternative feedstocks. There has been a great deal of work done in the last several years to develop chemical syntheses and products based on biorenewable resources. Unfortunately, an oversimplified view that a material derived as a plant extract must be superior to a petroleum-based material is not quite accurate with the current state of the science. Various extraction technologies use materials that are themselves quite harmful to human health and the environment. One must be sure to evaluate not just the feedstock material but also the extraction process before evaluating relative greenness. Following the entire molecular life cycle, one may discover other negative inputs (such as pesticide, fertilizer use, and high-energy harvesting and acquisition processes). Therefore, a close, careful examination must be undertaken when considering renewable feedstocks. Many research groups have focused on developing bio-based, renewable feedstock materials for applications such as lubricants, polymers, plastics, solvents, agrochemicals, and surfactants, along with many more. The feedstocks are generally plant and agriculturally based materials that can be harvested on a regular basis. Surfactants are one area where research has been rapidly developing around plant-based products [13]. Many surfactants are derived from fatty acids found in plant materials, which are similar

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in functionality to the final product. They are an attractive option that allows for the development of materials that are functional but also derived from renewable resources. Principle 8: Reduce Derivatives. Unnecessary derivatization (blocking group, protection/deprotection, and temporary modification of physical/ chemical processes) should be avoided whenever possible. The development of organic synthesis has seen remarkable innovations and discoveries. Complex organic molecules often have multiple reactive pathways available under a variety of reaction conditions. In order to develop synthetic transformations that select one specific reactive pathway, chemists have often resorted to supplemental modifications of their starting materials to “block” nondesired chemical reactions from happening. While some of these solutions are brilliant and elegant in their efficiency and selectivity, from a green chemistry perspective, they must by default involve the generation of waste. This is because after these “protecting groups” have served their purpose they must be removed via subsequent chemical reactions. From an atom economical perspective, it is impossible for this to decrease the efficiency. An example from the Warner Babcock Institute for Green Chemistry is that of manipulating the properties of a molecule in order to change the desired properties. One model system developed involves the manipulation of a hydroquinone molecule, used for many applications including cosmetic applications [14], in order to make it more or less soluble in water. Rather than changing the structure through traditional derivatization techniques, which employ many hazardous materials, the institute uses a natural process of self-assembly to organize the hydroquinone molecule in a matrix and therefore change the properties [15]. This process has been termed noncovalent derivatization [16] due to the use of natural processes found in nature such as self-assembly and molecular recognition. Principle 9: Catalysis. Catalytic reagents (as selective as possible) are superior to stoichiometric reagents. As discussed in Principle 6, a typical reaction coordinate diagram goes through an activation energy. The field of chemical catalysis is an extremely mature science that has crafted countless reagents that serve to temporarily lower this activation energy. A catalyst is distinct from a typical chemical reactant in that it is used in very small proportions. The idea being that for

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every reactive cycle the catalyst is continuously regenerating. Ratios of reactants to catalyst at the molecular level have been as high as tens to hundreds of millions. This is not unprecedented in nature. Physiological systems are constantly being constructed and maintained by the use of enzymes, which serve as molecular catalysts in molecular biotransformations. While, historically, many catalytic systems are made from heavy metals and elements not often found in physiological systems, in recent years chemists have developed technologies to use enzymes in chemical manufacturing. Enzymatic processes are used throughout biological systems to catalyze transformations. For example, enzymes in our bodies trigger and catalyze a multitude of biochemical events so that our body systems function properly. In product development and product design, we are constantly looking to nature for mechanisms that allow for the catalyzing of a transformation. As an example of an enzymatic catalytic process, we return to the example of the water-based nail lacquer from Principle 5. The polymer mimics the process of thymine photodimerization found in DNA. This process occurs upon too much exposure to UV light and results in the linking of two thymine molecules in human DNA strands. It has been found that an enzyme called DNA photolyase will recognize the thymine dimers and actually unzip them [17]. Therefore, the polymer itself can be removed through a water-based enzymatic system, thus also reducing the exposure to traditional nail lacquer removal products. Principle 10: Design for Degradation. Chemical products should be designed so that at the end of their function they do not persist in the environment, but break down into innocuous degradation products. There is an interesting catch twenty-two in product design when it comes to a product’s ultimate lifetime. While consumers in society demand products that are sturdy, well built, and have appreciable life spans, we have come to find that materials with nearly infinite life spans are a problem in the environment. Compounding the problem of persistence in the environment are recent findings that many materials bioaccumulate throughout ecosystem food cycles. Municipal water treatment systems are not equipped to remove many materials that are finding their way into the environment. This principle focuses on designing materials that are incorporated in various degradative ecological cycles, especially microbial digestion and photochemical breakdown. It is a difficult task to design materials that have “just the right” lifetime so as to provide shelf-life stability, product performance, and product stability.

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The utilization of triggering mechanisms present in natural external systems can be employed after a product’s useful lifetime. In 2004, the Presidential Green Chemistry Challenge Small Business Award was given to Jeneil Biosurfactant Company for developing a natural, low-toxicity, and biodegradable alternative to synthetic surfactants [18]. Surfactants are widely used throughout personal care products and are an essential component to many of these products. Typical surfactants have several concerns, including toxicity and persistence in the environment. It is important for a surfactant, once released into the environment, to biodegrade in our water systems. Jeneil developed a series of rhamnolipid biosurfactant products that provide good emulsification, wetting, detergency, and foaming properties. The rhamnolipid biosurfactant is a naturally occurring glycolipid that is found in soil and plants. The surfactants have reduced toxicity, are made from renewable resources, and are more biodegradable than conventional surfactants [19]. Principle 11: Real-Time Analysis for Pollution Prevention. Analytical methodologies need to be further developed to allow for real-time, in-process monitoring and control prior to the formation of hazardous substances. High-speed manufacturing systems are a key to commercial viability in industry. In chemical synthesis, large-scale batch and flow systems can be designed so as to monitor, in the immediate present, compositions of matter and various physical and chemical properties. By doing so, feedback mechanisms in the manufacturing process can be incorporated to minimize runaway reactions and process errors. While this seems straightforward from an engineering perspective, many chemical systems and processes have not been developed with this “real-time analysis” in mind. Retrofitting existing processes to incorporate emerging analytical technologies or developing new chemical reactions that can take advantage of these technologies is the objective of this principle. Process Analytical Technology (PAT) is a system for designing, analyzing, and controlling manufacturing through timely measurements to ensure the quality of the final product [20]. It is an effective technique for industries to increase throughput, reduce energy, reduce waste, and improve safety conditions in terms of a manufacturing process. By knowing “what you have when you have it,” the optimal conditions can be determined and much waste can be minimized. PAT techniques are many in number and apply to all industrial sectors, including the personal care and cosmetic industries. Appropriate techniques can be employed that ensure thorough

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blending of a formulation and proper encapsulation of an active ingredient, for example. PAT techniques can also be used to verify purity of raw materials, a technique that could potentially save time and money lost in using fouled batches. Principle 12: Inherently Safer Chemistry for Accident Prevention. Substances and the form of a substance used in a chemical process should be chosen so as to minimize the potential for chemical accidents, including releases, explosions, and fires. It is easy to focus exclusively on the potential toxicological problems that could be encountered in a manufacturing process: carcinogenicity, endocrine disruption, mutagenicity, and other acute toxic endpoints are all too real in chemistry. This final principle acknowledges that over and above these concerns, physical hazards such as explosivity and flammability must also be considered in a product design. In much the same way as structure–activity relationships have been developed for physiological toxins, mechanisms of action at the molecular level have been elucidated for these physical hazards as well. Unfortunately, there are far too many examples of cases where explosive or flammable materials were utilized and the result was a disastrous event. A recent incident involved the explosion of an ink manufacturing facility that resulted in the demolition of the facility, along with damage to two dozen houses and leaving nearly 400 people homeless the day before Thanksgiving in 2006 [21]. Fortunately, this event resulted in no deaths. There are countless other tragedies that did result in many lives lost, including one of the most well-known disasters in 1984, in Bhopal, India, where a chemical plant was using a chemical that was water reactive. Upon exposure to water, large amounts of toxic fumes were released to the local community, resulting in thousands of lives lost and many more injured. In order to avoid these sorts of industrial tragedies, safer materials that can accomplish the same task must be employed. Therefore, flammable and highly reactive materials should be avoided whenever possible in order to ensure the safety of workers, along with the surrounding communities.

1.4 Conclusion In conclusion, green chemistry contributes to the holistic view of sustainability. It concerns addressing pollution prevention and hazards at the very

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first stages of product design at the molecular level. Cosmetic and personal care products are designed to interact intimately with humans. Taking a look at the risk equation: Risk = Hazard × Exposure, the focus for these products must be on eliminating the hazard due to their intended exposure. The cosmetics and personal care industry is taking initiatives to strive toward greener processes and products. However, as with all industrial sectors, much more work needs to be done. The need for more alternatives can be seen as a hurdle or as an opportunity. Green chemistry offers an opportunity for chemists and materials scientists to take part in sustainability at perhaps the most important stage of a product’s life cycle. If a product can be designed with little or no waste, using low-energy techniques, from renewable resources and if it will biodegrade when appropriate and not persist in the environment, then it will not only be successful in the marketplace but will also contribute to a sustainable future.

References 1. U.S. EPA, Presidential Green Chemistry Challenge, http://www.epa.gov/ greenchemistry/pubs/pgcc/presgcc.html (accessed February 2008). 2. Anastas P.T., Warner J.C., Green Chemistry Theory and Practice, Oxford University Press, Oxford, England, 1998. 3. U.S. EPA, Brownfields and Land Revitalization, http://www.epa.gov/ brownfields/about.htm (accessed February 2008). 4. Trost, Barry M., Science, 254, pp. 1471–1477, 1991. 5. U.S. EPA. The Presidential Green Chemistry Challenge, Summary of Award Recipients from 1996–2007, p. 60, available at www.epa.gov/greenchemistry (accessed June 2007). 6. NatureWorks, LLC, http://natureworksllc.com/ (accessed February 2008). 7. Wolfram L. “Hair Cosmetics,” in Handbook of Cosmetic Science and Technology, 2nd Edition, Paye M., Barel A.O., Maibach H.I., Eds., Taylor & Francis Group, Boca Raton, FL, p. 518, 2006. 8. Cannon A.S., Raudys J., Undurti A., Warner J.C., “Photoreactive Polymers and Devices for use in Hair Treatments,” PCT Int. Appl. 2004, WO 2004058187. 9. Cannon A. S., Munshi G., Trakhtenerg S., Warner J.C., Green Chemistry Letters and Reviews, 2008 (in press). 10. Lloyd-Kindstr L., Warner J.C., “Thymine-Containing Styrene Polymers as Environmentally Benign Photoresists,” in Biopolymers, Vol. 9, Matsumura S., Steinbüchel A., Eds., Wiley, Weinheim, Germany, pp. 165–174, 2003. 11. U.S. EPA, The Presidential Green Chemistry Challenge, Summary of Award Recipients from 1996–2007, p. 76, available at www.epa.gov/greenchemistry, (accessed June 2007). 12. RevTech, Inc., http://www.revtechuv.com/ (accessed February 2008). 13. Hill K., Pure Appl. Chem., 72(7), pp. 1255–1264, 2000.

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14. Baumann L.S., Martin L.K., “Skin Whitening: New Hydroquinone Combination,” in Handbook of Cosmetic Science and Technology, 2nd Edition, Paye M., Barel A.O., Maibach H.I., Eds., Taylor & Francis Group, Boca Raton, FL, p. 321, 2006. 15. Cannon A.S., Warner J.C., Crystal Growth and Design, 2, p. 255, 2002. 16. Warner J.C., “Pollution Prevention via Molecular Recognition and Self Assembly: Non-Covalent Derivatization,” in Green Chemistry: Frontiers in Benign Chemical Synthesis and Processes, Anastas P., Williamson T., Eds., Oxford University Press, London, pp. 336–346, 1998. 17. Whitfield J.R., Morelli A., Warner J.C., “Enzymatic Reversal of Polymeric Thymine Photocrosslinking with E. coli DNA Photolyase,” J. Macromol. Sci. A, 42, p. 1541, 2005. 18. U.S. EPA, The Presidential Green Chemistry Challenge, Summary of Award Recipients from 1996–2007, p. 36, available at www.epa.gov/greenchemistry, (accessed June 2007). 19. Jeneil Biosurfactant Company, http://www.biosurfactant.com/ (accessed February 2008). 20. U.S. Food and Drug Administration, Office of Pharmaceutical Sciences, “Process Analytical Technology (PAT) Initiative,” http://www.fda.gov/Cder/ OPS/PAT.htm (accessed February 2008). 21. “A Thanksgiving Miracle,” Boston Globe, November 23, 2006.

2 REACH—Life In and Outside the EU: How REACH Will Affect the Supply Chain Ruud A. Overbeek1, Bruce Calder 2, Michael Fry 2, and Roman Humeniuk 2 1

Global Director, Intertek Health & Environmental Services, Restricted Substances and REACH, 2200 West Loop South, Suite 200, Houston, TX 77027, USA 2 Intertek Health & Environmental Services, Intertek Ageus Solutions, 505 March Road, Suite 100, Kanata, Ontario, K2K 3A4, Canada

2.1 Introduction1 As everyone will know, or should know by this time, REACH is a European regulation on Registration, Evaluation, Authorization and Restriction of Chemicals (REACH). It entered into force on June 1, 2007. It streamlines and improves the former legislative framework on chemicals in the European Union (EU). The main aims of REACH are to improve the protection of human health and the environment from the risks that can be posed by chemicals, the promotion of alternative test methods, the free circulation of substances in the internal market, and enhancing competitiveness and innovation. REACH makes the industry responsible for assessing and managing the risks posed by chemicals and for providing appropriate safety information K. Lintner (ed.), Global Regulatory Issues for the Cosmetics Industry Vol. 2, 17–30 © 2009 William Andrew Inc.

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to their users. In parallel, the EU can take additional measures on highly dangerous substances, where there is a need for complementary action at the EU level. Although the REACH regulation itself has been finalized, details of its implementation continue to evolve as they are debated, evaluated, and interpreted. The determination of requirements and responsibilities is a critical aspect in achieving compliance in a correct and cost-efficient manner. In addition, rather than being an expert on all requirements of REACH, companies should focus on the implementation and completion of these specific requirements and responsibilities. In order to achieve a systematic and clear approach to address the requirements of REACH, strong consideration should be given to fostering relationships with key decision makers and organizations in the EU or, alternatively, to work with specialist providers in maintaining these relationships. Other vehicles to access strategic information could include trade associations or competitors facing the same needs and requirements. This chapter will provide guidance on what typical requirements and responsibilities are under REACH, and what options companies have in addressing the REACH requirements and responsibilities, especially when dealing with the complexities of a supply chain.

2.2 REACH—The Principle Steps Although REACH is a cumbersome and overwhelming 849 pages (with guidance documents nearing 3000 pages with many still to be written), it is principally broken down into five stages: Material Safety Data Sheets (MSDSs), Preregistration, Registration, Authorization, and Restrictions. One could consider that the responsibilities are manageable when broken down, namely 1. Product assessment: a. Product definition (substance, preparation, article) b. Supply chain assessment (suppliers, distributors, downstream users)

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c. Substance assessment (phase-in/nonphase-in, candidate Substances of Very High Concern (SVHC)) d. Substance identification 2. Preregistration: a. Information submittal b. Only Representative versus distributor 3. Registration: a. Substance composition b. Data sharing c. Testing d. Chemical Safety Assessment and Report (CSA/CSR) 4. Authorization/Restrictions: a. Possible environmental effects

2.2.1 Product Assessment

The first step in preparing for REACH is to assess your products. This includes defining your products as substances, preparations, or articles. Substances are individual chemical elements and compounds (formaldehyde, propylene glycol, D&C Red #21 Aluminium Lake); preparations are mixtures or solutions composed of two or more substances (cold cream, hairspray, shampoo); and articles are objects with a special shape, surface, or design that determines its function to a greater degree than its chemical composition (televisions, razors, facial cloths). Cosmetics generally fall under the definition of preparations; thus all ingredients require registration (if the tonnage is big enough). Preregistration is an option for existing, “phase-in” substances. This runs from June 1 to December 1, 2008. Generally, substances with an EINECS (European Inventory of Existing Chemical Substances) number are those considered to be phase-in substances. Cosmetics are exempt only from a few specific sections of REACH as they are covered by the European Cosmetics Directive 76/768/EEC. These deal with hazards assessment, authorization, and restrictions due to human health concerns. However, substances in cosmetics are fully in the scope of registration, authorization, and restrictions for nonhuman health-related issues (e.g., environment). Registration exemptions exist for substances occurring in nature (e.g., minerals, ores and natural gas, virgin pressed oil and butters, and other materials) if they are not chemically modified and if the manufacturing process respects the restriction of the corresponding sections in the REACH text.

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Once you have assessed your products, it is important to determine your responsibilities based on your substances and the structure of your supply chain. Legal obligations for REACH begin at the borders of the EU. Companies external to the EU community have no direct legal responsibility, although to ensure continued business in Europe, companies should ensure that the responsible companies down the supply chain have the information they require in order to fulfill any registration obligations. Importers and manufacturers of substances in(to) the EU must take direct responsibility for their substances, unless responsibility is taken by another link in the supply chain. After identifying in-scope substances, correctly calculating the import/ manufacturing tonnage (by adding up the tonnages in each product) and ensuring proper, explicit substance identification is required. Substances with unknown or variable composition, complex reaction products, and biological materials (UVCBs) have very detailed and complicated identification parameters.

2.2.2 Preregistration

Preregistration occurs between June 1 and December 1, 2008. Existing or “phase-in” substances (such as those listed in EINECS and the No Longer Polymers list) have a delayed registration deadline of up to 11 years (dependant on tonnage and hazard level), but only if preregistered. Preregistration is free and only basic substance and company information needs to be submitted. Preregistration is required only for substances that could potentially be imported or manufactured in excess of 1 ton (per legal entity) in the following year.

2.2.3 Registration

Registration is the largest, most important part of REACH. Complete substance identification (including compositional information of multiconstituent substances), testing data, and safety assessments must be submitted to the European Chemicals Agency (ECHA). The amount of testing is based on yearly imported/manufactured tonnage. Testing data increases at each tonnage band: 1–10, 10–100, 100–1,000, 1,000+. Testing can include physicochemical, toxicological, and ecotoxicological data.

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A large part of registration is the testing requirement. Current legislation separates existing and new chemicals, exempting existing chemicals from many information-gathering requirements. REACH, on the other hand, requires that all substances be tested. REACH also states that animal testing must be avoided wherever possible and includes mandatory sharing of vertebrate animal test data and the usage of other data gathering methods where possible. Sharing of other test data is strongly encouraged. For example, the ECHA automatically groups preregistrants and places them in a Substance Information Exchange Forum (SIEF) for each of their substances. Consortia are also being formed by industry to aid in data sharing. These are based either on substances or industry types and allow companies to save time and money. These consortia usually allow members to use available data and registration dossiers in exchange for membership fees.

2.2.4 Authorization/Restriction

The authorization and restriction requirements target known and suspected carcinogens, mutagens, and reproductive toxins as well as persistent bioaccumulative toxins and other chemicals of similar risk. The first candidate SVHC list has been completed will be released and published on the ECHA website by the end of October 2008, companies can prepare themselves by comparing ingredients with current lists of substances subject to restrictions and labeling or notification requirements. These substances will probably be in the first set of substances requiring authorization. Note that although cosmetics are exempt from certain authorization, this is only for human health hazard exposure. Some substances may require authorization or be restricted for use in cosmetics for other reasons (such as environmental issues or bioaccumulation).

2.3 Phasing and Facing REACH Reducing ambiguity and creating a path forward, including definition of requirements, timelines, and decision trees specific to a company’s products and sales model, should chiefly be considered by every company doing business with or within the EU. Such a determination of responsibilities is not only a critical aspect in achieving compliance but also allows that compliance to be reached in a correct and cost-efficient manner.

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In principle, a simplified two-phased approach can be used to meet the requirements of REACH: 1. Phase 1 should address the identification of requirements, responsibilities, preregistration, and timelines, including:  Analysis of key details:  Sales channel  Supply chain  Products and chemicals  Determination of responsibilities  Determination of timelines  Creation of compliance strategy  Creation of decision tree  Where necessary, provision of education and support, both internally and to the supply chain 2. Phase 2 should focus on the execution of responsibilities including documentation, supply chain data gathering, and registration, including:  Data gathering  Program management  Data gathering from supply chain  Preregistration  Documentation  Registration dossiers  CSR (Chemical Safety Reports)  SDS (Safety Data Sheets)  Registration  Registration with the ECHA  Formation of representation in the EU (for non-EU manufacturers)  Reporting  Reporting of ongoing requirements to the ECHA  Disclosure of SVHCs to customers, distributors, and consumers Preregistration will form the first hurdle because companies are now asking who should preregister. It may be that some legal issues, regulatory guidance, and company-to-company agreements take some time. And perhaps clarifications on REACH requirements will only become evident after the preregistration deadline. Companies that see themselves as potential registrants should therefore preregister, even if in doubt.

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Companies without an EU entity will have to either leave preregistration and registration up to a qualified downstream company in the EU or, as explained later in detail, appoint an Only Representative to take responsibility. Many companies are appointing an independent party as their Only Representative, as it allows more mobility in the supply chain, increased security of proprietary information, and it can ensure that actual REACH experts become responsible for their registration. For preregistration, Article 28 of the REACH regulation specifies that the following data are needed: 1. The name of the substance as specified in Section 2 of Annex VI, including its EINECS and CAS (Chemical Abstracts Service) number or, if not available, any other identity codes. 2. The registrant’s name and address and the name of the contact person and, where appropriate, the name and address of the (third party) representing him in accordance with Article 4 as specified in Section 1 of Annex VI. 3. The envisaged deadline for the registration and the tonnage. 4. The name(s) of substance(s) as specified in Section 2 of Annex VI, including their EINECS and CAS number or, if not available, any other identity codes, for which the available information is relevant for the application of Sections 1.3 (on application of quantitative structure-activity relationship (QSAR) techniques) and 1.5 (on application of substance grouping and read-across techniques) of Annex XI. REACH Guidance Document RIP 3.4 provides some insights as to what information may be accessible to other companies (that have preregistered). It is rather unclear what e-mail addresses will be used for different communications, especially as this may be made available to other preregistrants. At this point it is important to consider using a “third party representative” where anonymity may be desired (e.g., for confidentiality reasons). There are different ways to preregister via the REACH IT system. The substances information (via EINECS, CAS number, name) can be submitted either manually or by uploading electronic files.

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2.4 REACH—Who and What? As stated in the REACH regulation, companies wishing to manufacture or import substances into the EU are required to comply with the REACH Regulation in order to avoid penalty or rejection of products in the EU: There is a general obligation for manufacturers and importers of substances to submit a registration to the Agency for each substance manufactured or imported in quantities of 1 ton or above per year. Failure to register means that the substance is not allowed to be manufactured or imported. From the European Commission Guidance Document, February 2007 Although REACH is an EU regulation and has a direct legal implication on companies vested in the EU, companies outside the EU, but doing business with companies in the EU, will also be affected: If a chemical substance in these inventories is imported into the EU ≥ 1 ton/year it needs to be pre-registered and registered by the EU importer or your Only Representative to ensure uninterrupted exports. European Chemical Agency and the European Commission Establishing who is responsible for imports under REACH can prove challenging, especially in terms of defining EU legal entities that depend on the national law where those entities are based and in terms of who is responsible for submitting the registration. First, as stated before, an “importer” under REACH must be actually based in the EU. Fundamentally, a non-EU company, therefore, cannot be responsible for import under REACH. However, a non-EU company can appoint an “Only Representative” that is based in the EU. Then, the EU receiving company, or formal importer, may no longer be considered as an importer under the REACH regulation. manufacturers outside the EU are not covered by REACH. However, an importer of a substance manufactured by a non-EU enterprise or an “only representative” of such an enterprise must, jointly with other EU manufacturers, importers or only representatives, submit the hazard information for the substance … European Commission, Questions and Answers on REACH, February 2007

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Appointing an Only Representative provides various options in the supply chain, which will be discussed later. However, to be a qualified Only Representative there are certain minimum requirements that need to be fulfilled: An “only representative” should have sufficient background in the practical handling of substances and the information related to the relevant substances to fulfill (sic) the obligations of a registrant (importer). In this case, all importers will be regarded as downstream users of the only representative. European Commission Guidance Document, February 2007 Second, the REACH regulation specifies that import relates to the physical introduction of a good into the EU. Usually, the EU-based purchaser of a substance will be responsible for import under REACH as it is receiving goods into the EU. According to the guidance set out in RIP 3.1 and the EU’s REACH Navigator (http://reach.jrc.it/), the substances subject to customs supervision—even when stored or in transit, and provided they are not subject to processing or treatment—are not covered and those physically transporting the goods do not appear to have obligations. But things may get complicated. It may be that a substance is being transported into EU territories by one company, while ownership exchange is occurring via brokers on behalf of other companies, and after a given sale, a customs clearance company physically transfers it to a company for its ultimate use by another company that sells it on the EU market. Who is then responsible for registration? Companies themselves will need to make these judgments and it may then be appropriate to document the reasons for their decision and even check this with the relevant regulators. At the end of the day, regulators will not want to deal with one company blaming another.

2.5 REACH—Supply Chain Options and Industry Trends With the REACH regulation in place and preregistration of substances and preparations looming overhead (June 1, 2008, to December 1, 2008), some very interesting trends are noted across the many players involved.

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Industry trends that once followed a much regimented approach of (pre) registration being handled by those with a legal presence in the EU (a sister company, importer, distributor, etc.), have since morphed to handle the multitude of varying situations in their supply chains. The concept of appointing an Only Representative to handle REACH registration is fast becoming standard practice for manufacturers residing outside the EU. This movement is fed by the following considerations: 







Confidentiality concerns: Suppliers that were once willing to allow a distributor or importer to handle the responsibility now realize that this may compromise their proprietary recipes, paving the way for independent third-party representation. Changing supplier relationships: Companies that rely heavily on their supply chain realize that this supply chain should play an increasingly large role in REACH compliance. a. Companies offloading REACH preregistration through their supply chain are establishing (often through independent outsourced providers) auditing vehicles to ensure that the supply chain is compliant rather than taking a hands-off approach. b. Companies rely heavily on their suppliers’ knowledge of REACH and through supply chain monitoring vehicles are seeking new relationships with more stable supply environments. Simplified management approaches: Since REACH requires a significant effort to manage all substance information, both internally and externally, simplified ways are sought to manage current and future needs, such as a. preregistration of substances under threshold; b. preregistration of substances being considered for future import; c. preregistration of substances up the supply chain to ensure that REACH is properly complied with; d. internal auditing of products, substances, and preparations in order to create a proper strategy and determination of responsibilities; e. supplier monitoring to ensure validity is maintained with all aspects of REACH. Changing roles of independent Only Representatives: Originally created in order to handle registration for companies

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without an EU presence, the value of a third party has shifted into supply chain control. a. Only Representatives do not manufacture any products, and thus are not in competition; b. proprietary information is safe with an independent Only Representation as opposed to the concerns with using a potentially competitive distributor; c. Only Representatives will be objective in their supplier assessments; d. Suppliers that are not able to disclose information can be audited by applying reverse engineering and chemical deformulation approaches without compromising the confidentiality of the formulation. Every company importing substances into the EU, either having responsibilities for registration under REACH by being designated an “importer,” or located outside the EU and using, for example, distribution channels or importers, thus, will have two basic options: 



take responsibility for REACH themselves, ensuring that all chemicals in all products they import into the EU are REACH compliant; pass the responsibility onto their suppliers, using only those who have ensured their products are REACH compliant.

In simple terms, if a company takes direct responsibility for their import in the EU they should have the following minimum considerations: Scenario 1: EU-Based Entity Taking Full Responsibility Advantages 







Maintain control over the products they sell Can ensure experienced in-house staff do things right Will have all chemical data available in the future if needed Independent of supplier

Disadvantages 



 

Have to get information on all chemicals used in all products they sell! Testing, risk assessment, and dossier creation Not necessarily core to the business Needs specialized internal resources

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When appointing an independent party as an Only Representative to ensure that the responsibilities and requirements under REACH are covered, the following considerations have become apparent: Scenario 2: Non-EU Supplier Appoints Independent Party Advantages 











Chemical sales core business of supplier Reduced need for internal resources with importer Can become fully outsourced process (importer and supplier appointed independent provider) No testing or dossier creation by importer Importer would only need a “certificate or report” saying a product/supplier is REACH compliant No confidentiality issues between importer and supplier

Disadvantages 







Limited control on the process, unless there is a defined thirdparty approach, which installs confidence with all parties involved in the supply chain Limits the suppliers to those willing to become compliant Limited direct access to chemical data for the importer Unless the Only Representative appointed is a knowledgeable party fully managing the process, will the suppliers have the knowledge and ability to do this?

Since many companies located in the EU wish business continuation with suppliers located outside the EU, they become fully dependent on the willingness in their supply chain to disclose sufficient information for them to register the substances. Irrespective of the route chosen, the key to REACH compliance is, therefore, the appropriateness and completeness of data and the assurance that the company taking responsibility for registration is capable of handling the requirements under REACH. It is clear that, even without appointing an Only Representation, a third party can be used to approach REACH cost effectively and efficiently. Such measures can include, for example,    

 

participation in REACH SIEFs contact and coordination with SIEF group members data exchange and evaluation intermediary for negotiation with SIEF and consortium members submission of registration applications collection and submission of technical dossiers

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creation and submission of SDSs creation and submission of CSRs authorization negotiations with ECHA  high-level discussions about risk assessments and use of information  notification to the ECHA of quantities of products manufactured/imported and related risk assessments communication concerning substances to downstream users and customers

Appointing a third party to handle certain or all aspects of REACH will enable companies to take a hands-off approach while ensuring an uninterrupted business flow.

2.6 Conclusion Every company that sells its products must assess which specific standards apply to its offerings, and what it must do to ensure that its products are fully compliant with global, existing, and emerging legislation, including the REACH regulation. There is no shortcut; the specifications of each product must be matched carefully to the requirements. That said, though, there are some general-purpose preparations that companies should make. 





  

Create a compliance plan  What information do you have and what is missing?  Education, training, preparation Set up compliance management (information) systems for  Tracking and tracing, registration, and test data  Suppliers: information, auditing, etc. Include materials (disclosure) requirements in your design and specification criteria Collect documentation and proof Measure risk Communicate, communicate, communicate: internally, externally, up and down the supply chain

Yet, the only way to ensure that a product is REACH compliant is to actually understand its chemical makeup. Therefore, a business must ensure that there is a good understanding of the composition of each formulation and the materials used to manufacture their product or, when they cannot get access to the composition, there needs to be a way to ensure that each of the constituents used are actually compliant.

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Since we have few companies left that are vertically integrated, this means we need to engage our supply chains. Typically, many companies demand that suppliers must provide evidence, generally only a declaration, to prove to their customers that they meet the set requirements. Yet, these declarations provide only limited assurance. Chain of custody control will, therefore, become a substantial part of anyone’s strategy. And, a balanced process of engagement and involvement of the supply chain, supported by monitoring and control, needs to be implemented to control risk from noncompliances, but more importantly, to control costs. It may take months or years to execute fully and even then strategies must be reviewed as providers change, as new products are launched, and even further laws and restrictions take effect. Monitoring and control must, therefore, become an ongoing part of everyday business.

Note 1

DISCLAIMER: The information in this chapter does not constitute nor should be used as the basis for definitive advice without checking the primary sources, including the European Union’s REACH regulation.

3 Cosmetic Ingredients: Definitions, Legal Requirements, and an Attempt to Harmonize (Global?) Characterization Karl Lintner Sederma S.A.S., Enterprise Technology, Croda International Group, France

3.1 Introduction All cosmetic products are composed of at least one, most often of many, chemical substances. Even the so-called “natural” cosmetics, and be it a simple (what is simple?) plant oil used for massage, are chemical substances in the eye of the law (“Chemical” does not automatically have to mean “petro”-chemical nor aggressive, toxic, or dangerous as some would have us believe today!). These substances may be of varied origins: mineral, plant derived, synthetic, produced by biotechnology (fermentation), or combinations thereof. No matter their origin, no matter the complexity of blends and mixtures, in the end it always boils down to a collection of atoms and/or molecules. Of course, in many cases “ingredients” found in cosmetic products are not wholly identified in their exact molecular composition or structure, which is why we shall attempt in this chapter to address and clarify the questions of: what constitutes a “cosmetic ingredient”; what legislative framework governs their manufacturing, sale, and K. Lintner (ed.), Global Regulatory Issues for the Cosmetics Industry Vol. 2, 31–53 © 2009 William Andrew Inc.

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use; and how can the industry (both the ingredient suppliers and the finished product formulators) cope with the requirements that differ widely around the world?

3.2 Cosmetic Ingredients Contrary to the legal situation governing pharmaceutical products, where (at least in most countries with corresponding legislation) only substances listed in a controlled compendium (pharmacopeia) or which are supported by an excipient or drug master file can be employed to manufacture the medicament, there is no equivalent restriction on cosmetic products.1 Any cosmetic product may be formulated with any type of ingredient (single substance or blend) as long as the ingredient is not prohibited by a specific “negative” list (such as Annex II of the EU directive or if it meets any conditions of restriction for specific ingredients in Annex III),2 and insofar as the product thus formulated does not endanger human health under normal or reasonably foreseeable conditions of use (or infringe a patent). Hence, the subtle difference in definition: Any nonprohibited substance intentionally added to a cosmetic formula becomes a “cosmetic ingredient” by this fact. Therefore, neither a priori definition nor legislative framework exists for these ingredients.

3.3 Legal Requirements There are two sides to this issue of “obligations with respect to ingredients used in cosmetic products”: the supplier’s side and the downstream user’s side (formulators). 3.3.1 The Supplier

As stated in the introduction, these ingredients (substances or blends) are regulated as chemical substances, and thus fall under the legislation ruling manufacturing, handling, transport, and labeling of chemicals and, if applicable, hazardous or dangerous substances. As the title and theme of this book is related to global regulatory issues for the cosmetic industry, we shall not go into the details of the chemical legislation of every country around the world. These regulations concern hazard identification and communication, risk assessment, worker’s safety, public health, environmental issues,

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transportation, shipping and the like, independent of the uses made of these chemicals; unfortunately, these legal frameworks still differ widely from region to region and from country to country. A short overview shall be given, nevertheless, to show that whatever use is made of chemical substances, they are generally well surrounded by a regulatory framework.

3.3.1.1 Europe

The Dangerous Substance Directive (DSD) of 67/548/CE, its 9 amendments, and 28 adaptations together with the Directive 99/45/CE rule the handling of dangerous materials, their documentation (Material Safety Data Sheets (MSDS)), the classification and labeling of dangerous substances’ containers, and the transport restrictions. This legislation is soon to be replaced in part by REACH in relation to obligations on hazard identification and by a new regulation implementing the Global Harmonization System (GHS) for classification and labeling of chemical substances and preparations. Furthermore, the obligation to notify new substances under Directive 67/548/EEC as amended for the seventh time is presently being replaced by REACH (Registration, Evaluation, Authorization of Chemicals), a Europe-wide effort to improve knowledge and management of chemical substances manufactured, imported, transported, and used within the EU. Chapter 2 of this book by Overbeek et al. deals more specifically with REACH. Chemical Control Legislation in the European Union—Key Legislation. Prior to placing a substance or preparation on the European market, irrespective of ultimate application, the following legislations apply (Table 3.1):    

Dangerous Substances Directive Dangerous Preparations Directive Existing Substances Regulation Marketing & Use Directive

3.3.1.2 USA

The Toxic Substances Control Act (TSCA, pronounced “Tosca”) was enacted in 1976 to give the EPA the ability to track close to 100,000 industrial chemical substances produced in or imported into the United States.

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Table 3.1 Overview of Chemical Control Legislation1 Directive 67/548/EC and subsequent amendments and the 29 Technical Adaptations (the Dangerous Substances Directive)









Directive 88/379/EEC and subsequent amendments and adaptations (the Dangerous Preparations Directive)







Regulation 93/793/EC and related Directive on the Risk Assessment of Existing Chemical Substances









Directive 76/769/EEC and subsequent amendments (the Marketing and Use Directive)



Hazard identification, classification, packaging, and labeling of chemical substances according to their intrinsic properties The distinction between existing and new chemical substances through the creation of an inventory of chemical substances present on the EU market between 1971 and 1981 The obligation to notify new chemical substances prior to placing on the market The risk assessment of notified new chemicals Hazard identification, classification, packaging, and labeling of mixtures of chemical substances Hazard classification based on the composite assessment of the individual substances in a preparation or from the outcome of testing a preparation Formal requirements on hazard communication (SDS) for dangerous substances and preparations Identify the hazards and assess the risks related to the production, distribution, and use of existing chemical substances Protect man and environment from exposure to dangerous chemicals via all possible routes Require manufacturers and importers to provide specific information (so-called HEDSETS) on EINECS-listed chemicals produced or imported in excess of 10 tons per year Establish priority lists of chemicals to be assessed first Enables pan-EU restrictions on the use of substances in specified applications through to bans on marketing and use of substances of concern

HEDSETS: Harmonized electronic data sets. 1 Help for this section from Laurie Hughes, Croda Plc., is gratefully acknowledged.

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Interestingly, substances exclusively destined for and used in cosmetic formulas are exempt from TSCA regulation. Nevertheless, manufacturers and importers of any kind of chemical ingredients are well advised to know the fine points of TSCA, as negligence in respecting the rules can have painful financial consequences (fines), whatever the chemical and/or its intended use. Interested readers should consult http://www.epa.gov/Region5/defs/ html/tsca.htm, as a more detailed discussion of this legislation would go beyond the scope of this chapter and book.

3.3.1.3 Other Countries

Canada has comparable chemical control legislation that is similar in scope and design to the European model, with existing substances listed on the Domestic and Nondomestic Substance Lists (DSL and NDSL: http://www .ccohs.ca/products/databases/dsl.html); in Australia there are the National Industrial Chemicals Notification and Assessment Scheme (NICNAS) (http://www.nicnas.gov.au/) and AICS inventory, in Japan the Chemical Substance Control Law (CSCL), and similar laws concerning “chemicals” of whatever nature or destination exist in Korea and in China. All these countries require registration of new chemicals under certain rules including criteria of volumes, potential danger, and uses. With respect to the obligations of suppliers of chemicals to the cosmetic industry, the adherence to these various legislations, cumbersome as they may sometimes appear, is all there is to it. The supplier has no further obligation that would specifically relate to the application and use of his chemicals, cosmetic or otherwise. Once more, this is different from the field of pharma products, where the manufacturing of active pharmaceutical ingredients (APIs) is subject to the rules and guidelines of Good Manufacturing Practices (GMP), for instance. This distinction is possible, because in the field of regulated drugs the identification of an ingredient, and especially an “active” ingredient, is based on legal ground via a limited list (“positive list”) of allowed chemicals. No such definition for “active,” “cosmetic,” “ingredient” exists in our field except for sunscreen actives, which are cosmetic ingredients in the EU but drug actives in Australia and in the United States. Certainly, GMP guidelines are currently being introduced in Europe for the finished goods manufacturing of cosmetics; however, this obligation does not extend to the ingredient supplier (yet), although the ingredient industry has recognized and developed guidance on appropriate GMP for cosmetic ingredients (see Chapter 5 by Iain Moore).

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3.3.2 The Downstream User

Legal frameworks and requirements for the manufacturer (or importer) of cosmetic finished products (those destined to be sold to the general public) are many, and widely different from country to country.3 In this chapter, we shall concentrate only on those items that concern the ingredients used in the finished product. One concern about ingredients for cosmetic products is correct labeling. All the above-cited legislations require the finished product to carry an ingredient listing that is based on the CTFA (Cosmetic, Toiletries and Fragrance Association) dictionary, the INCI (International Nomenclature of Cosmetic Ingredients) list, or the equivalent Japanese inventory (JCID). The same rule also applies for Canada.4 Furthermore, European legislation (76/768/EEC, the cited directive) requires that the manufacturer or importer of a cosmetic product be in possession of a dossier—the product information package—which includes information about the raw material specifications of each ingredient and the toxicological profile of ingredients in order to carry out the safety assessment of the finished product. These apparently simple requirements, however, lead to a cascade of questions about each ingredient, precisely because there is no such thing as a “Cosmetopeia” with monographs that define, characterize, and specify ingredients. Voices have been heard suggesting that “strategic” or “big volume” ingredients would profit from such an endeavor; however, there is little undertaking at present in this direction. The consequence of this general state of cosmetic legislation is that the entire legal responsibility for the safety, efficacy, and legal conformity of the finished product lies with the manufacturer or importer (the “marketer”). It follows from this that this entity (person or company) does depend, in part, on the supplier of his ingredients to furnish the relevant information. Or does it? What kind of information is necessary, useful, obligatory, and why, and who provides it, will be the subject of the rest of this chapter.

3.4 A Harmonized Ingredient Characterization? In theory, the situation is simple: A chemical supplier knows his products, sells them to a cosmetic formulator who wants and needs to know what he buys; they exchange information on the ingredients that is relevant, useful,

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and reliable and typically agree on a selling specification. This ideal case, however, rarely exists. The market is global, but regulations are not. Interactions between big suppliers and small laboratories or between small suppliers and big formulators modify this “ideal” picture. Complex distribution channels render the communications difficult; more importantly, the “chemicals” in question are often more complex than a single molecular entity, which makes their identification, specification, and characterization more challenging. Therefore, in the absence of worldwide recognized and accepted ingredient monographs,5 the major stakeholders in the industry have devised questionnaires and forms that they address to their suppliers with requests for disclosure of the information as complete as possible. This has not been a complete success throughout the field, as: 







every cosmetic company established their own list of questions (even though much overlap occurs between different questionnaires) with their own priorities, definitions, structure, which puts a heavy burden on small- and medium-sized suppliers who have to fill them out, product by product and customer by customer; many suppliers of ingredients that are used in large volumes in other fields than cosmetics, and for whom the cosmetic market is only a side issue, show no patience with these questionnaires (and the complex secretarial work connected with filling them out), especially when the request comes from small end users; small, specialized ingredient supplier companies do not always have the necessary staff (in number and qualification) to respond to these requests; some data requested would require studies and investigations into the raw material that go far beyond the value of the commercial transaction between the supplier and the downstream user.

Several attempts were thus initiated by trade organizations to establish an “ingredient identification and characterization” format. In France, the FIP (Fédération des Industries de la Parfumerie, now renamed FEBEA), COVREC (Comité de Veille sur la Réglementation Cosmétique), COSMED (Cosmétique de la Méditerranée) and the Ministry of Industry worked on a project to create such a format. In Germany, the TEGEWA (Association

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of Surfactant Suppliers) generated a standardized product information form that responded to at least some of the requests from the cosmetic industry. Most recently, however, CTFA, in collaboration with industry experts, created an Excel® spreadsheet that can be downloaded from the CTFA Web site (recently, CTFA renamed itself PCPC, i.e., Personal Care Product Council).6 This form is quite exhaustive, well organized, and it provides for further detailed, very useful sources, references, and links to local legislation that are beyond the scope of this chapter. Here is the description of this undertaking, as found on the association’s Web site: Standardized Raw Material Information Form (RMIF) The RMIF was developed by the Personal Care Products Council Safety and Regulatory Toxicology Committee (SRTC) to help streamline and communicate useful information regarding the global regulatory, safety and physico-chemical properties of cosmetic ingredients. The form is intended to provide a uniform information base for raw materials which will facilitate communication between raw material suppliers and manufacturers. The form is being offered for guidance purposes only, and should not be construed as a legal standard. Rather, it is intended to serve as a vehicle for information exchange between customers and suppliers. A first look at any of these forms, but especially at the quite exhaustive one from CTFA leaves the reader perplexed: Why would a manufacturer (or importer) of a cosmetic product need so much information, in so much detail? The answer is simple: in today’s environment of product liability law suits, regulatory controls, self imposed standards of quality management (ISO 9000), environmental considerations (ISO 14000), worker’s safety (OHSAS 18000), efforts to implement sustainable development, and fair trade practices, “organic” or “eco/bio” or “natural” certification, every precaution is taken to assure the consistent, constant quality of the finished product going to the market. The more information one gathers about the ingredients used, the easier it is to defend one’s position in case of conflict with authorities, consumer groups, the press, or other contestants. The formulator is focused on the regulatory and risk-related consequence of using the

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“wrong” ingredients and views gathering all of this information as sustaining their assurance process. This is, of course, related to the “precautionary principle” that can be expressed in the following (or similar) terms: The precautionary principle is a moral and political principle which states that if an action or policy might cause severe or irreversible harm to the public, in the absence of a scientific consensus that harm would not ensue, the burden of proof falls on those who would advocate taking the action. Although this idea is brandied for big issues, important political decisions, it has filtered down to influence business practices, sometimes to absurd levels. Thus, there are many pitfalls, as well as illogical or ambiguous situations that arise from these questionnaires. Although I do not condemn (to the contrary!) the attempt to establish a harmonized product information file, nor intend to criticize the work that has been done in that direction, I shall, where I think it appropriate, point out these pitfalls, the cases where pushing the detailed questions too far will lead to confusion rather than clarity. The major justification for a request for information should always be the one concerned with safety and risk for the consumer, the worker and the environment (in that order), and of course, existing regulatory framework. Other items are more in the realm of commercial transactions and should be dealt with accordingly. So much to the question of why. Before going into the details of these questionnaires (of which the CTFA one is presently the most complete) with respect to what?, let us examine briefly the question about who? There can be no doubt that any product information that is requested by the marketer, which goes beyond the legal requirements for chemicals cited above is subject to negotiation between supplier and user. In the end, it is a question of balance of forces between the parties: a large supply company for bulk materials will probably not go to great lengths to answer a small formulating laboratory’s question about, say, “Halal compliance” or “suitability for Japanese quasi-drug use,” especially if the annual purchase of the material is negligible. On the other hand, a small supplier who depends on sales to the cosmetic industry for survival will try, up to a point, to supply as much information voluntarily in order to satisfy the potential customers big or small. Having made these somewhat polemic points about why do we need the data and who will (or should) provide them, we will now try to

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look at the several categories of data usually requested for “ingredient identification”: 1. 2. 3. 4. 5.

General information Origin of the ingredient (plant, animal, mineral, etc.) Physicochemical properties Safety for humans and the environment Regulatory aspects

3.4.1 General Information 3.4.1.1 About the Supplier

Although the CTFA form does not ask many questions about the supplier of the ingredient other than a name, a contact, and email address and phone/fax numbers, other questionnaires want to know about corporate group structure, manufacturing sites, staff, annual turnover, and the like. Items such as the presence or absence of quality assurance systems, disaster recovery plans, environmental protection schemes, and, more recently, a policy of sustainable development implementation all serve a purpose: if these questions are correctly answered, they constitute a kind of guarantee for the marketer that 





the ingredient can and will be supplied in the foreseeable future and beyond, the quality is constant and that any significant changes in characteristics of the ingredient would be notified in time, and the risks of being in the headlines in any negative way are minimized.

3.4.1.2 About the Ingredient Purchased

First there are two main categories to be distinguished: single substances (such as caffeine, glycerin, vitamin C) that are chemically defined, single molecular constituents; and preparations that are inherently or intentional blends of several substances, such as shea butter, glycolic plant extracts, essential oils, premixes with several ingredients, which will require information for each individual constituent as long as it can be defined or characterized. The CTFA spreadsheet takes this complexity automatically into account and provides lines for up to seven ingredients in a blend.

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A problematic question arises for the blends: generally, a compositional statement with percentages for each constituent is requested (in order to comply legally with ingredient labeling which requires weight-descending order). This makes it difficult to maintain confidential proprietary information related to formulation, solubilization, stabilization, and so on, but this seems to be the price for staying in the business, today. A further difficulty is illustrated by the following line (called Lot Declaration, found on page 1 of the CTFA sheet and in many equivalent affidavits): Do you certify that all the lots you supply will comply with all the questions until further notice from you? Yes or No? This question, although well founded and logical, especially in the pharma industry which inspired this approach, and thus present in most questionnaires of this sort, is applicable in the case of  

direct contact between manufacturer and formulator and a supplier essentially working for and with the cosmetic industry.

It is, however, quite illusory to expect this level of traceability and engagement when working through distributors of far away principals, or with big volume suppliers for whom the cosmetic side of their business and its myriad requirements is low on their list of priorities. In these cases, it is the formulator who shoulders the risk of sudden changes in the quality/origin/ specification of the ingredient purchased. Again, the equilibrium of forces in place will determine the outcome. It is, furthermore, quite possible and probable that many chemical suppliers selling their ingredients through distribution channels do not even know that their material ends up in a cosmetic product. They do not have to know this at present, although for larger volumes (>10 tons per year) REACH in Europe will require more upstream/downstream (supplier/user) information exchange. Thus, each ingredient, if supplied as a pure substance or a blend, will have to be identified, usually with a trade name, a chemical name, followed where applicable by CAS (Chemical Abstract Service) numbers, EINECS or ELINCS (European List of Notified Chemical Substances) numbers (in Europe), and similar labels around the world. Manufacturing site, country of origin, tariff codes, although useful, are items that are of secondary importance in the present context.

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3.4.2 Origin of the Ingredient

The question of “feedstock” for each ingredient, meaning “how and from which source is the material obtained,” on the other hand, looks straightforward. Unfortunately, this is far from being the case. Although the following examples are chosen somewhat with a “tongue-in-cheek” attitude, they illustrate the problem: 





A molecule is extracted from a plant, purified to >98% purity, then derivatized in a single chemical step (involving, say, an esterification with methanol, or an ether formation with methyl bromide). Is the substance thus obtained a “plant”derived or a “synthetic” substance? Whichever way Vitamin C is made (from glucose or lactose), involving some fermentation steps and some “chemical” steps such as hydrogenation and oxidation, it is difficult to categorize it as synthetic (hydrogenation, oxidation), plant-derived (glucose), or biotechnologically manufactured (fermentation). An ethoxylated shea butter (plant or synthetic?), calcium carbonate obtained from crushed oyster shells (mineral or animal?), silicate extracted from horsetail (mineral or plant?), a peptide composed of plant-derived amino acids assembled by chemical means, and the list can go on.

All these (and many more) substances really defy a meaningful categorization. Or rather, different people classify these substances differently, depending on their background, philosophy, preference, or (even) needs (for marketing purposes!). Again, we may ask the question of the why? Does it really matter if the approximately 100% pure caffeine (for which the MSDS is frightening, by the way, and independently so whatever the origin of the molecule), used in a “slimming formula,” is obtained from the decaffeination process of coffee beans or by some synthetic route? The regulatory requirement for shipping the material is the same, the toxicity is identical, and the activity in the finished product, together with all safety aspects, is indistinguishable. It is an economical question, or should be. Of course, the answer to this question has been given above, and shall be repeated one last time here: on one hand (and caffeine stands here only as an example of many similar occasions) the marketer prefers, especially today, to be able to say “contains pure plant (natural) caffeine, rather than

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to admit to using “chemicals”; and second, if the substance is indeed plant derived, the formulator wants to be sure that it does not come from a protected (or forbidden) plant, that the resupply is reasonably certain (e.g., countries with political instability, climatic uncertainty, wild spot market price fluctuations), that no child labor is involved in picking the plant in some far away developing country. More reasonable questions concern storage and use conditions, shelf life, labeling, the levels of traceability (how far back can you go?), and so on. Suppose then for the sake of argument (and because it does make sense and is true in many cases) that we can identify the source of the ingredient(s), either as mineral, vegetal, biotechnology derived, animal, or synthetic. Here are some of the follow-up questions to these categories: 3.4.2.1 Vegetal

The most popular type of ingredients at present in the “trend to natural”: questions concern not only the name (scientific Latin and common names), but also the part of the plant used, its geographical origin, the way it is cultured and/or harvested, whether it is sourced from a crop that has been genetically modified (GMO) and whether there is any presence of GMO material, the guarantee that it is not protected by CITES (Convention on International Trade in Endangered Species) or some other biodiversity protection scheme; however, questions about the extraction/manufacturing process of the ingredient again raise the issue of proprietary information being divulged. Similar to the (more or less required) labeling in the food industry, information about the presence of potential allergens (beyond the 26 listed in the seventh amendment to the EU directive cited above, see Chapter 4 by Christine Bertram) such as nuts, proteins, grains, fruit shells, and so on is considered relevant. Given that these latter products are known to cause allergies by oral absorption, their relevance for cosmetic applications (other than toothpaste) is debatable. Although not in the CTFA document, but often asked in individual questionnaires is the item “drug/extract ratio,” meaning how much plant material was used to obtain how much “extract.” Again, this is inspired by monographs of pharmacopeia about plant-derived pharmaceuticals. For cosmetic purposes, this poses often a conundrum: plant material may be

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“fresh” or dried, the “dry” extract obtained from the plant may not be precisely known if the extraction medium does not allow complete separation of solvent and extracted substance (the case of glycerin, for instance); and finally, as color, odor, and content of one or more active molecules in the plant extract are all important quality criteria, the manufacturer of the “botanical” can simply not always guarantee that these three parameters stay constant: if the yield is low in one year, then more plant material is needed to extract the same amount of “active,” but this may lead to increased color and/or odor, and vice versa. Drug/extract ratio

Odor/color

Active molecule

It is quite impossible to guarantee from harvest to harvest that these three parameters stay constant. In order to guarantee one, one has to adjust (and accept changes in) one or two of the other ones. 3.4.2.2 Ingredients of Microbial Origin

Bacteria, moulds, yeast are increasingly being used in fermentation processes to manufacture specific substances, especially for pharma applications where in most cases a purified single chemical entity is obtained and defined with respect to its structure. Sometimes, however, and more so in the cosmetic field, the fermentation process yields a broth that is either devoid of specific marker molecules, or titrated in one or two dominating target substances in solution that have undergone little purification. Unless the ingredient used in the cosmetic finished product contains the microorganism itself, the question about its name, species, and variants, its GMO or pathogenic status is relatively irrelevant. It is the ingredient made from it that has to be evaluated for its properties, activities, and/or risks. There is no way around these questions though, as a listing in the INCI dictionary itself already requires the disclosure of these data. The precautionary principle here means if we do not fully trust the supplier to be perfect in his manufacturing process, then we better not use an ingredient that comes from a pathogen or a genetically modified organism, because it

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might contain something untoward, although the ingredient itself has been shown to be harmless in all applications. Hence all these questions to make sure.

3.4.2.3 Animal-Derived Products

Although animal-derived products certainly should be called “natural” (and thus in today’s trend), they are mostly gone from cosmetic formulations mainly because of the “mad cow” (BSE, i.e., Bovine Spongiform Encephalopathy) and “scrapie” (Ovine SE) scares of the early 1990s. Cosmetic legislation especially in the EU now sets significant requirements to ensure that the source animal by-product is of effectively zero risk in relation to TSE (transmissible SE) transmissibility. There still are some ingredients used in cosmetics that do come from animal sources. Tallow fatty acids, glycerin, fish collagen, beeswax, lanolin, and its derivatives are basic raw materials not much talked about, but still popular with some; they are subject to strict controls on the source of the original animal byproduct, its derivation, and in some instances, the process conditions used to derivatize. Because of the (mostly infinitesimal) risk of TSE through these products, legislation has been passed in many countries prohibiting the use of certain higher risk animal by-products in cosmetics. Hence, the questions about species, geographical origin, organ source, age of animal, and method of processing the ingredient. Furthermore, such as with the plants, it is important not to use animals from some protected species, of course. There is also the fear of the reaction of the market and the backlash to the brand if NGOs campaigned about animal parts being used to make cosmetics!

3.4.2.4 Mineral

Also usually called “natural” (and thus often cited as “pure,” “safe,” “beneficial”), minerals are not exempt from dangers and may thus pose a risk to the consumer if wrongly used or characterized. Here the chemical name, but also the geographical origin, the manufacturing process, the particle size all may have a bearing on the potential risks associated with the mineral. The use of minerals in cosmetic is relatively restricted to certain applications (pigments for make-up, talcum powder, pumice for exfoliants), but considerable quantities of titanium dioxide and zinc oxide are being used safely as UV attenuators in sunscreens and are generally subject to regulatory approvals before their use in cosmetics and sunscreens.

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More recently, interest in precious and semiprecious stones, in gold particles and other luxury items has increased with formulators. Care should nevertheless be taken with these materials as the composition of some beautiful gems (e.g., emeralds) turn out to contain highly toxic material (beryllium, for instance).

3.4.2.5 Synthetic Material

As this “feedstock” category comes right after “mineral,” we can again ask the question: what do we mean by it? If we use sodium chloride (to thicken a shampoo formula), we may buy this from a supplier who makes kitchen salt, harvested and purified from sea water or some salt mine, thus of “mineral” (natural) origin. But if we manufacture the sodium chloride from sodium hydroxide and hydrochloric acid, in solution, it would be synthetic, no? Incredibly, the REACH legislation will distinguish between the two. How far does one have to go to divulge manufacturing processes, feedstock material for a “chemical” synthesis? Can confidentiality be preserved? The question about impurities and residual solvents, however, is important and should not be treated lightly. Nevertheless, rather than asking detailed questions about the synthetic process from a supplier and filling out forms to be filed, it would be more useful in many cases to make sure the supplier has sufficient QA procedures, ISO certifications, or GMP compliance in place. By “polymers,” we usually understand and imply “synthetic polymers,” as opposed to proteins, polysaccharides, and the like. Thus, the same items as for other synthetic substances are requested, where again impurities, including residual monomer content may be of importance. Average molecular mass may help the formulator to assess the likelihood of skin penetration, although this may be dependent on the structure and is controversial.

3.4.3 Physicochemical Properties

So far, we have not yet really identified or characterized an ingredient, just given it a name and a source. All questionnaires have sections covering these analytical items, in more or less detail. The requests can seem daunting for many a supplier. Again, they should be seen in the light of safety and environmental risk (stability, inflammability, solubility), as well as the industrial needs of the user (odor, color, viscosity) that may impact the

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final cosmetic product. Many items on these lists (iodine and acid index, molecular mass, spectrographic, and chromatographic data) are only applicable to certain categories of ingredients. It is recommended to use common sense in filling out these fields. There is, however, another pitfall with this aspect of the questionnaires (CTFA or otherwise): every serious supplier has a product specification for his ingredient, and accompanies the shipment with a Certificate of Analysis on which, usually, the bandwidth of each specified parameter and the analytical result for the batch in question are listed. The published specifications and the Certificate of Analysis are documents that have a certain legal value in the transaction between supplier and client. However, the many items asked for in the questionnaire go far beyond the list of specified (and thus guaranteed) characteristics of the ingredient. The questionnaire seems to ask for many absolute values (melting point, partition coefficient, UV absorption, etc.) whereas the specifications denote a range of values, and do not include the entire list. However, as we have seen above (the paragraph on Lot Declaration), the supplier is asked to certify that each batch delivered will be consistent with the questionnaire as is. Clearly, this is another contradiction, with the information on the questionnaire being indicative and not binding in specification terms in similar way to how information is communicated on a MSDS; that will have to be resolved between the parties with reasonable arguments.

3.4.3.1 Microbial Specifications

As a logical bridge between this section on physical properties and the next on safety aspects of the ingredient, the questions about microbiological data are easy to understand. Spoilage microbes may not only damage the cosmetic finished product, but also endanger consumer’s health if not properly dealt with by using appropriate preservative systems. The formulator is entitled, even required (in Europe), to know the microbiological specifications of the material, the nature and amount of preservatives present in the ingredient (if it is not a pure single substance). Although the supplier has no legal obligation to do challenge tests on his material, it is certainly advisable, when applicable. Information about the search for the presence of pathogens in the product can also be useful and reassuring to the formulator. The Scientific Committee for Consumer Products (SCCP) has set guideline values for cfu/ml (colony forming units/ml) for leave-on and rinse-off products.

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3.4.4 Toxicological Information 3.4.4.1 Human Safety

This chapter is not the place to discuss in detail the way to do risk assessment (as required) for the finished product, nor how to establish the toxicological profile of an ingredient or ingredient blend. The CTFA questionnaire lists the following items to be answered: Acute oral toxicity Subchronic toxicity (28/90 day test) Dermal irritation Mucous membrane irritation (eye) Percutaneous absorption Mutagenicity (Ames) Genotoxicity Comedogenicity Dermal sensitization Photoirritation Phototoxicity Photosensitization Reproductive toxicity Inhalation toxicity Teratogenicity Toxicokinetics Carcinogenicity LD50 LOEL/NOEL The recommendations of the SCCP in Europe (http://www.leffingwell. com/cosmetics/vol_3en.pdf) for establishing the safety of an ingredient are very similar (with the exception of comedogenicity). Acute toxicity Skin absorption Skin irritation Mucous membrane irritation Skin sensitization Subchronic toxicity Mutagenicity Phototoxicity and photomutagenicity (in case of UV-light-absorbing substances) Human data (if available)

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When considerable oral intake can be expected or when the data on skin absorption indicate a considerable penetration of the ingredients through the skin, taking into account the toxicological profile of the substance and its chemical structure, the following further information may be necessary: Toxicokinetics Teratogenicity, reproduction toxicity, carcinogenicity, and additional genotoxicity Metabolism studies Before any reader faints in protest and desperation over these lists, it should be stressed that these are worst case scenarios and not a checklist, not an obligatory catalogue of “things to do”! In a regulatory environment, where cosmetic products (as defined initially in Section 3.2) are not subject to premarketing approval or registration, the responsibility for the safety of the consumer product lies entirely with the manufacturer/marketer. Scientific bodies such as CIR (Cosmetic Ingredient Review Committee in the US), SCCP (Europe), and others may evaluate certain ingredients of concern. Whereas CIR only provides an opinion (safe as recommended, tentatively safe, insufficient data, or unsafe) to the industry that then has to decide how to react, the SCCP may make recommendations to the EU authorities to restrict or prohibit an ingredient. As the number of substances that can be evaluated by these bodies in a given period is very small, the request by the formulator toward his supplier about the safety aspects of the proposed ingredient (approximately1,500 new entrants in the CTFA/INCI dictionary every two years) is understandable. The risk assessment for the finished cosmetic product must take into account not only the toxicity data of the ingredient(s) but also the exposure, use level, usage, and skin penetration of the final formula. The type and quantity of information on the ingredient necessary to carry out this risk assessment thus varies from ingredient to ingredient, from formula to formula and is subject to negotiation and cooperation between supplier and user. The question of who? Supplies the information (other than the one imposed on the supplier by some chemical laws) becomes an object of commercial activity, not regulatory obligation. 3.4.4.2 Ecological (Environmental) Information

Questions about persistence of the ingredients in the environment, biodegradability, aquatoxicity, and the like can also be quite exhaustive but only

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marginally relevant to cosmetic application. On one hand, these data are usually required by the previously cited legislation on chemical substances (TSCA, REACH, etc.), often increasingly detailed as a function of tonnage and should thus be of little concern to the user if he works with a serious and respectable supplier; but on the other hand, the question of “sustainable development” and its consequences lead formulators (and the marketing department) to select—whenever possible—ingredients that are more acceptable by these standards than others. REACH will require an environmental-risk assessment for ingredients used in cosmetics. This will become a significant development in ingredient selection in the future. For large-volume items (surfactants for shampoos and shower gels, synthetic polymers) this makes perfect sense; for small-volume ingredients that go, say, into make-up, to name an example, the possible environmental impact should be rather small. Is the molecular diameter (in Ångström!) really relevant to a new anticaking agent for compressed powders? Further regulatory information. The following questions are taken from the CTFA spreadsheet Is the ingredient a carcinogen/mutagen/reproductive toxicant as defined in Annex 1 Directive 67/548/EEC? Is the ingredient listed in the European Dangerous Substance Directive (67/548/EEC: 79/831/EEC)? Is the ingredient in compliance with European Cosmetic Directive (76/768/EEC)? Information on suitability for Japanese Quasi-Drug use? Is the ingredient found to be carcinogenic by IARC? Is the ingredient found to be carcinogenic by NTP? Is the ingredient found to be carcinogenic by OSHA? Does this material contain any chemical listed by California’s Proposition 65 inclusive of any impurities, residues, catalysts, monomers, by-products? Are you in compliance with the 7th Amendment of the European Cosmetic Directive 74/768/EEC on animal testing? Is the ingredient classified as a VOC or ROG? (Choose from list) If yes, what is the classification? (Choose from list) What is the partial pressure of the material? (mm Hg at ST) What is the MIR value? (g O3 formed/g M reacted) And this is just the beginning. Other questions pop up in addition in other questionnaires, such as “conformity to the EU Biocide Directive,” Korean registration for Functional Cosmetics, matters related to export

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restrictions, etc. The items of compliance with EU regulation can be further detailed: ingredient not listed in Annex II, not one of the 26 allergens, not animal tested, restricted by any of the other Annexes III–VI of this same regulation? 3.4.5 Intellectual Property

Questions on intellectual property (IP) status interestingly also make their appearance in this context. Although not directly related to (government) regulatory issues, it is useful for the formulator to know if the ingredient purchased is free to practice in all circumstances and applications. This is a thorny issue that is dealt with in more detail in a separate chapter (Chapter 11 by Haeffner et al.) of this book.

3.5 Conclusion By now, any reader who has come so far and who intends to propose a (new) ingredient to the cosmetic industry may well have become entirely discouraged. The problem is—as the title of this book gently indicates— the world “global.” Even a small supplier, wherever located and even without the ambition of exporting his ingredients outside his own country, will be faced by these questions because the cosmetic industry is, already, increasingly global. Big and middle size companies formulate for the whole world, manufacture in many different countries and are thus faced with the complexities of national legislations every day. They are also exposed to mostly unjustified attacks, from various sides (individuals, consumer groups, competitors, the media, the Internet) against which they need to demonstrate coherent care in selecting their ingredients and making sure they are “safe” and acceptable in all conceivable ways and circumstances. The author is aware of the fact that much that has been said here is known and self evident for the big players and stake holders in the industry, both suppliers and users. However, it is the middle- and small-size companies on both sides of the fence that also contribute much to the livelihood and innovative process so important for continued success with the consumers. For them, the hurdles that have arisen over the last 10–15 years have become awesome, and often incomprehensible. It is hoped that the present chapter (and the book as a whole) sheds some clarity on the whys and hows of these issues.

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It was after the EU voted the Sixth Amendment to the 76/768 Directive in 1993, requiring more information on the ingredients as part of the obligation to main product information available to regulators and enforcement agencies, that these questionnaires popped up, initially from the big players in the field. Slowly, the practice spread to the whole branch and beyond European frontiers. And recently, attempts to harmonize the approach were made. Unfortunately, there are still discrepancies galore: the CTFA spreadsheet, often cited in this chapter, is not yet widely known, especially outside the United States; huge as it is, for certain formulating companies it still is not complete enough, and they require additional information from their suppliers. COLIPA (European Cosmetic Toiletry and Perfumery Association) in Europe has no equivalent document that might be the basis for discussion and eventual unification; only the German TEGEWA file (although tailored to their chemical products) and an unofficial and so far incomplete try by French trade associations might be used to initiate global harmonization of these documents. The relief for the supplier who presently has to fill out several seemingly similar but still distinct questionnaires from different sources, for every product proposed to the cosmetic industry, will be audible. A question remains: What about the 6,000 or more substances listed in the CTFA/INCI dictionary that were there before these questionnaires appeared? Have they all undergone the same scrutiny in the meantime? Do well-documented questionnaires of this type exist for all of the ingredients used in cosmetics? Logically they should, but the author has no concrete information on this. With all that has been said here, it should be clear that there will be no way back. Suppliers who cannot or will not supply a modicum of reliable, coherent, and documented information will have increasing difficulties selling their ingredients to the cosmetic industry. This may lead to a consolidation of smaller companies into bigger entities where sufficient staff for regulatory affairs can cope with this avalanche of questions. There is, of course, also the risk that a number of ingredients that cannot support the work and testing required to answer these questions will disappear from the market, that innovation will be hampered and limited to bigger structures. But even smaller formulating laboratories that do not have the clout to obtain answers from their suppliers may suffer, as regulatory inspections would point out “insufficient data” in many cases.

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What is the future outlook? The French have a saying: “too high taxes kill the taxes,” meaning that a too greedy state will just drive business away and total tax income will decline rather than rise. Let us hope that cosmetic business, on the way to becoming overregulated and too self-constraining, does not suffer the fate of the dinosaurs.

Notes 1

To clarify: by “cosmetic products” we mean all nonmedical preparations that are destined to be applied to human skin, its appendages (hair, nails, and so on) and external mucosa; thus, toiletries, skin-care products and make-up are all included, more in line with the European definition (Directive 76/768/CE http://ec.europa .eu/enterprise/cosmetics/html/consolidated_dir.htm) than with US industry usage that generally equates the word “cosmetics” only with color cosmetics. 2 There is, to my knowledge, one exception: the quasi-drug regulation of Japan that governs cosmetic products with specific, almost medical claims, that still allows only ingredients selected from a “positive” list to be used in the manufacture of these products. Only in this case is the term “(quasi-drug) cosmetic ingredient” predefined. 3 For US, see http://www.cfsan.fda.gov/~dms/cos-cfr.html; for Europe, see http:// ec.europa.eu/enterprise/cosmetics/html/consolidated_dir.htm, for Japan http://www5 .cao.go.jp/otodb/english/houseido/hou/lh_02070.html or http://www.biojapan.org/ industry/PALoverview.htm. 4 Cf. http://www.hc-sc.gc.ca/cps-spc/pubs/indust/cosmetics-cosmetiques/ingredients_ e.html. 5 The industry is generally of the opinion that monographs are not the answer, as they would severely hamper innovation, flexibility, and choice in formulating their products. 6 http://www.personalcarecouncil.org/Content/NavigationMenu/Services1/ Standardized_Raw_Material_Information_Form_(RMIF)/Standardized_Raw_ Material_Information_Form_(RMIF).htm.

4 “26 Allergens” in Cosmetics: A Challenge for All Stakeholders Christine Bertram CRODAROM S.A.S., Chanac, France

4.1 Introduction This chapter provides a brief outline on the history of identifying fragrance substances responsible for perfume allergy risk in cosmetics, their selection and implementation into EU cosmetics legislation and the global impact of this regulation on manufacturers, dermatologists, toxicologists, and cosmetic customers. A modern globally marketed cosmetic product is the result of a complex combination of demands for uniqueness and aspects like efficacy, safety, aesthetics, art, ethics, and profitability. The need for affordable ingredients, which at the same time comply with factors such as innovation, creativity, and time-tested risk assessments, is a challenge for every new product placement.

K. Lintner (ed.), Global Regulatory Issues for the Cosmetics Industry Vol. 2, 55–78 © 2009 William Andrew Inc.

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In general, 



 

R&D scientists and marketing experts are looking for new active substances and claims; perfumers or cosmetic formulators prefer optimal use levels and typically rank this higher than use restrictions; toxicologists want to minimize health risks; and finally, regulatory affairs managers need to follow all guidelines and regulations as closely as they possibly can.

All these partially conflicting requirements need to be harmonized— regulations are a common tool for this. But regulations are also facing the problem of being already “behind the state of the art” as soon as they become effective: the mills of bureaucracy grind slowly. In some cases, regulations appear to be too strict, in others not strict enough to really address the problem.

4.2 History and Aim to Include “26 Allergens” in the 7th Amendment One purpose of the Directive 2003/15/EC of February, 27, 2003 (commonly called 7th Amendment) was to specify the 26 perfume and aromatic composition substances that have been identified in fragrance-sensitive customers as cause of contact-allergic reactions. With the enforcement of the 7th Amendment (March 11, 2005), the INCI or substance names of these ingredients, have to be mentioned on cosmetic ingredient labels in descending order, if their concentrations in the formulation exceed 0.001% (10 ppm) in leave-on products and 0.01% (100 ppm) in rinse-off products. The remaining fragrance compounds are still globally labeled as “perfume” as before. The directive text states that this approach will facilitate the diagnosis of contact allergies and will help customers to avoid the use of cosmetic products that could potentially be harmful to them, because they have more detailed ingredient information on hands, compared with the general term “perfume.” When the Scientific Committee on Cosmetic and Non-Food Products (SCCNFP, recently renamed SCCP) published their opinion about perfume

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allergy risks in consumers at the end of 1999, it concluded that many individual factors such as experimental and skin conditions, frequency of usage, product type itself, and a great variation in sensitivity between individual patients make it impossible to determine concentration levels of no concern for all fragrance allergy patients. The rising trend of fragrance allergies among eczema patients in the leading cosmetic markets (EU, United States, Japan) in the 1990s and the lack of appropriate perfume ingredient information before enforcing the 7th Amendment made it necessary to improve the consumer information, indicating the presence of the 26 aroma components known for contact allergy risk as soon as they would exceed a certain minimum level in the formulation. SCCNFP indicated in their opinion summary that “in the future other fragrance chemicals may be included (or excluded) depending on the epidemiological and safety data available.” It remains open if “excluded” means “to be listed in Annex II of the Cosmetics directive” (the list of substances forbidden as cosmetic ingredients) or if it means that substances could also be removed from the existing list of “26 allergens” (Annex III) (Table 4.1). 4.2.1 Nomenclature Challenges

Different nomenclatures, including trade names and synonyms of the same substance, are used across the various publications that have fragrances as a main subject; this is especially true when dealing with natural fragrances and essential oils, their safety and use, risk and benefits. One reason for this nomenclature confusion can perhaps be found in the revision of the Cosmetic Ingredients Inventory, made in 2006, which was based on work that had been carried out at least six years before. In addition, the revision of the inventory and nomenclature of perfume and aromatic raw materials had not been officially introduced by the commission until now. Regardless of this relatively unclear starting point, in 2000 SCCNFP published an opinion paper on the first revision of perfume and fragrance inventory in cosmetic products [1], and so some authors may be referring to this nomenclature, especially in more recent publications. Still, since

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Table 4.1 Annex III, Part 1, of Cosmetics Directive (76/768/EEC): List of Commonly Named “26 Allergens” INCI or Substance Name Ref. to Directive 2003/15/EC, Official Journal of the European Union, L66/26, 11.3.2003 Amyl cinnamal Benzyl alcohol Cinnamyl alcohol Citral Eugenol Hydroxycitronellal Isoeugenol Amylcinnamyl alcohol Benzyl salicylate Cinnamal Coumarin Geraniol Hydroxy-methylpentylcyclohexenecarboxaldehyde Anisyl alcohol Benzyl cinnamate Farnesol 2-(4-tert-Butylbenzyl) propionaldehyde Linalool Benzyl benzoate Citronellol Hexyl cinnamaldehyde d-Limonene Methyl heptin carbonate 3-Methyl-4-(2,6,6-tri-methyl-2cyclohexen-1-yl)3-buten-2-one Oak moss extract Treemoss extract

CAS Ref. to Directive 2003/15/ EC, Official Journal of the European Union, L66/26, 11.3.2003 122-40-7 100-51-6 104-54-1 5392-40-5 97-53-0 107-75-5 97-54-1 101-85-9 118-58-1 104-55-2 91-64-5 106-24-1 31906-04-4 105-13-5 103-41-3 4602-84-0 80-54-6 78-70-6 120-51-4 106-22-9 101-86-0 5989-27-5 111-12-6 127-51-5 90028-68-5 90028-67-4

there is more than one IUPAC (International Union of Pure and Applied Chemistry) name of systematic plus semi-trivial nomenclature, more than one chemical name can be found for the same substance. As a consequence, for example, “3-Methyl-4-(2, 6, 6-tri-methyl-2cyclohexen-1-yl)3-buten-2-one” with the CAS No. 127-51-5 is not listed

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in the relevant ingredients inventory (there is no European INCI name listed). With reference to the SCCNFP opinion paper from 2000, its revised name should be changed to Isomethyl-α-ionone. Another example is “2-(4-tert-Butylbenzyl) propionaldehyde,” which is still the official nomenclature in the fragrance inventory (Section II), while in Section I this substance already has the INCI name “Butylphenyl methylpropional.” So both terms might still be used in cosmetic ingredient labeling. A new helpful web address to look for information on cosmetic ingredients is CosIng, the European commission database (http://ec.europa. eu/enterprise/cosmetics/cosing/). All this makes it quite complicated to search the Web or other references for information about toxicology, applications, case reports, etc., and to link information to the right substance (Table 4.2). Before taking a closer look at the consequences of the 7th Amendment and the role of fragrance compounds as contact allergens, it is necessary to understand how these “26 allergens” had been chosen and specified in the Cosmetics Directive. 4.2.2 The Basis for the Selection of the “26 Allergens”

Scientific background information and selection criteria regarding these 26 perfume substances are summarized in an opinion paper of the SCCNFP. This information can be looked up in detail in the document “Fragrance allergy in consumers” (SCCNFP/0017/98 Final, December 1999) [4]. Contact-allergy risks of fragrance ingredients have been highlighted by dermatologists over more than 20 years. The so-called “fragrance mix I (FM I)” had a top ranking in the statistics of contact allergies in the last years, appearing directly after nickel allergy. The mix is composed of Amyl cinnamal Cinnamyl alcohol Cinnamal Eugenol Geraniol Hydroxycitronellal Isoeugenol and Oak moss extract each at 1% solubilized in 5% sorbitan sesquioleate, and it presents a cornerstone in sensitization evaluation by patch test applications.

107-75-5

97-54-1

101-85-9

118-58-1 104-55-2

91-64-5

Hydroxycitronellal

Isoeugenol

Amylcinnamyl alcohol

Benzyl salicylate Cinnamal

Coumarin

5392-40-5

Citral

97-53-0

100-51-6 104-54-1

Benzyl alcohol Cinnamyl alcohol

Eugenol

122-40-7

CAS Ref. to Directive 2003/15/EC, Official Journal of the European Union, L66/26, 11.3.2003

Amyl cinnamal

INCI or Substance Name Ref. to Directive 2003/15/ EC, Official Journal of the European Union, L66/26, 11.3.2003

chromen-2-one

benzyl 2-hydroxybenzoate 3-phenylprop-2-enal

(2E)-3,7-dimethylocta-2,6dienal 2-methoxy-4-prop-2-enylphenol 7-hydroxy-3,7-dimethyloctanal 2-methoxy-4-prop-1-enylphenol (2E)-2-benzylideneheptan-1-ol

Phenylmethanol 3-phenylprop-2-en-1-ol

2-benzylideneheptanal

IUPAC Name (Ref. http://www .chemindustry.com/apps/ chemicals)

Table 4.2 The Confusing Nomenclature of the “26 Allergens”

alpha-Amylcinnamic alcohol Salicyclic acid benzyl ester Cinnamaldehyde, Cinnamic aldehyde Coumarinic lactone

Lilyl aldehyde

4-Allylguaiacol

alpha-Amylcinnamaldehyde, alpha-Amylcinnamic aldehyde (Hydroxymethyl)benzene Cinnamic alcohol, Amylcinnamic alcohol (E)-Geranial

Possible Synonym (Ref. http://www .chemindustry.com/apps/ chemicals)

Coumarin

Benzyl salicylate Cinnamal

No INCI

Isoeugenol

Hydroxycitronellal

Eugenol

Citral

Benzyl alcohol Cinnamyl alcohol

Amyl cinnamal

Cosmetic Ingredient Inventory, Section I, 2006 [2]

Coumarin

Benzyl salicylate Cinnamal

Amylcinnamyl alcohol

Isoeugenol

Hydroxycitronellal

Eugenol

Citral

Benzyl alcohol Cinnamyl alcohol

Amyl Cinnamal

SCCNFP/0389/00 Final Opinion Concerning the 1st Update of the Inventory of Cosmetic Ingredients, Section II, October 2000 [3]

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78-70-6 120-51-4 106-22-9 101-86-0

5989-27-5

111-12-6

127-51-5

90028-68-5

90028-67-4

d-Limonene

Methyl heptin carbonate

3-Methyl-4-(2,6,6-tri-methyl2-cyclohexen-1-yl)3-buten2-one

Oak moss extract

Treemoss extract

80-54-6

4602-84-0

Farnesol

2-(4-tert-Butylbenzyl) propionaldehyde Linalool Benzyl benzoate Citronellol Hexyl cinnamaldehyde

105-13-5 103-41-3

31906-04-4

Hydroxy-methylpentylcyclohexenecarboxaldehyde

Anisyl alcohol Benzyl cinnamate

106-24-1

Geraniol

Not available

(Z)-3-methyl-4-(2,6,6trimethyl-1-cyclohex2-enyl)but-3-en-2-one, alpha-Cetone Not available

1-methyl-4-prop-1-en2-yl-cyclohexene methyl oct-2-ynoate

3,7-dimethylocta-1,6-dien-3-ol benzyl benzoate (3R)-3,7-dimethyloct-6-en-1-ol (2E)-2-benzylideneoctanal

(2E)-3,7-dimethylocta2,6-dien-1-ol 4-(4-hydroxy-4-methylpentyl)cyclohex-3-ene1-carbaldehyde (4-methoxyphenyl) methanol benzyl (E)-3-phenylprop2-enoate 3,7,11-trimethyldodeca2,6,10-trien-1-ol 3-(4-tert-butylphenyl) butanal

Evernia furfuracea extract

Evernia prunastri extract

Methyl pentylacetylene carboxylate alpha-Isomethylionone, gamma-Methylionone

Linalyl alcohol Ascabin beta-Citronellol Hexyl cinnamic aldehyde, alpha-Hexyl-cinnamic aldehyde (+)-Dipentene

Lilial

Evernia prunastri extract No INCI

No INCI

No INCI

No INCI

Butylphenyl methylpropional Linalool Benzyl benzoate Citronellol No INCI

Farnesol

No INCI Benzyl cinnamate

No INCI

Lyral®, HMPCC

Methoxybenzyl alcohol Cinnamic acid, Benzyl ester Polyprenol

Geraniol

Nerol

Evernia prunastri lichen extract Evernia furfuracea lichen extract

Methyl heptinecarbonate Isomethyl-α-ionone

D-limonene

p-tert-Butyl-α-methylhydrocinnamal Linalool Benzyl benzoate Citronellol Hexylcinnamaldehyde

Hydroxymethylpentyl cyclohexene carbaldehyde p-Anisyl alcohol

Geraniol

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In 1989, Fenn reported the relative importance fragrance ingredients in cosmetics have on contact allergies (first position before preservatives); they are frequently used in a rather large number of cosmetics such as fine fragrances, deodorants, soaps, and natural ingredient-based cosmetics. The report also mentions the relatively high concentrations in such cosmetics of more than 1% (in the case of geraniol, eugenol, and hydroxycitronellal) [5]. When reviewing the fragrance-mix contact allergies of the 1990s, it was noted that persons reacted predominately to oak moss extract (30% of the positively tested) and isoeugenol (20% of the positively tested) [6]. In Germany, the number of fragrance-mix positively tested patients increased from 7.4% in 1992 to 10.3% in 1996 [7]. Almost in the same period of time, an increase in fragrance mix allergies in the United States from 11.4% in 1992–1994 up to 14.3% in 1994–1996 was observed and reported by the North American Contact Dermatitis Group [8]. The number and seriousness of all these reports explain the inclusion of the fragrance-mix compounds in the list of the “26 allergens.” But how were the other substances selected—as the “fragrance mix I” only identifies a part of perfume allergies? The other substances were found as a result of persisting investigations of dermatologists, who demanded that the perfume industry publish more detailed perfume composition information. Also general clinical studies/ consumer patch tests on further perfume substances in the 1980s, helped to filter these substances. They are summarized in the comprehensive review paper by De Groot and Frosch [9]. The fragrance industry itself has established a system of self-regulation, based on two important organizations: International Fragrance Association (IFRA) [10] and Research Institute for Fragrance Materials (RIFM) [11]. The results of RIFM’s findings are presented in ingredient monographs published in Food and Chemical Toxicology. Furthermore, they established a worldwide unique database with toxicological data of fragrance substances which members can access. IFRA and RIFM contributed largely to the knowledge about risk and safety assessments of fragrance substances. IFRA was founded in 1973 with the aim to implement a Code of Practice and safety standards, which should be utilized worldwide with the final objective to protect the consumer and

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the environment. Standards and further useful links and information around fragrances can be found on their Web page [12]. Principally, fragrance allergen compounds were selected by the SCCNFP mainly on the basis of dermatological clinical experiences and other scientific investigations of the past years, reflecting their frequency of occurrence as contact allergen by appropriate patch testing, documented in different statistics and the frequency of use as cosmetic ingredients. Only when positive patch test data from more than one patient in more than one independent center were presented, and tests were conducted in accordance with World Health Organization (WHO) and EU criteria (Ref. Annex VI of Directive 67/548/EEC) [13]—without considering animal sensitization tests—the substances were considered to be included in the list of the “26 allergens.” Finally, the SCCNFP came to the conclusion that fragrance chemicals most frequently reported as contact allergen are: 1. 2. 3. 4. 5. 6. 7. 8. 9. 10. 11. 12. 13.

Amyl cinnamal (ingredient of FM I) Amylcinnamyl alcohol (may cross react with amyl cinnamal) Benzyl alcohol Benzyl salicylate Cinnamyl alcohol (ingredient of FM I) Cinnamal (ingredient of FM I) Citral Coumarin Eugenol (ingredient of FM I) Geraniol (ingredient of FM I) Hydroxycitronellal (ingredient of FM I) Hydroxymethylpentylcyclohexenecarboxaldehyde Isoeugenol (ingredient of FM I)

Fragrance chemicals less frequently reported as contact allergens (according to the SCCNFP/0017/98 Final document) are: 1. 2. 3. 4. 5.

Anisyl alcohol Benzyl benzoate Benzylcinnamate Citronellol Farnesol

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6. Hexyl cinnamyl aldehyde (used as positive control substance in animal sensitization tests) 7. Lilial 8. d-Limonene (Oxidization products are strong sensitizers. SCCNFP recommend in its opinion paper to further examine the relationship of contact allergy to oxidation-damaged limonene.) 9. Linalool 10. Methyl heptin carbonate 11. 3-Methyl-4-(2,6,6-trimethyl-2-cyclohexen-1-yl)-3 buten2-one Finally, treemoss and oak moss extract as recognized contact allergens were added to complete the list consisting of 26 fragrance compounds relevant for the 7th Amendment [14].

4.3 Natural and Synthetic Components in the List of “26 Allergens” Treemoss and oak moss extract are natural botanical extracts. Oak moss is obtained from the lichen, Evernia prunastri (L.) Arch. (Usneaceae), growing primarily on oak trees. Treemoss extracts are derived from a mixture of lichens, mainly Evernia furfuracea (L.) Arch. (Usneaceae) growing on Pinus species. Beside these two extracts, 16 substances also occurr in nature as plant components. They are: Benzyl alcohol Cinnamyl alcohol Citral Eugenol Isoeugenol Benzyl salicylate Cinnamal Coumarin Geraniol Anisyl alcohol Benzyl cinnamate Farnesol Linalool

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Benzyl benzoate Citronellol Limonene The other eight substances are exclusively of synthetic origin. This differentiation is important for the “26 allergen” content estimation of vegetable preparations (hydroglycolic extracts, CO2 extracts, resins, waxes, fatty oils, essential oils, distillates, etc). 4.3.1 The World of Plants: A Source of Chemicals with Health Benefits, but also Unwanted Side Effects and Adverse Reactions

The therapeutic and useful effects of plant preparations are well known, they contribute without doubt to the maintenance of health and beauty among all cultures worldwide throughout all times until today. We must not forget, however, the detrimental effects of plant constituents among the different botanical families, genera, and species: for example, skin irritant mustard glycosides in Brassicaceae species such as mustard and radish or phorbolester in some croton species or capsaicinoids in cayenne peppers, phototoxic psoralens in oranges, urushiols in poison ivy and poison oak. None of these irritants belong to the chemical class of fragrance allergens and substances such as urushiol (CAS No. 492-89-7)—a very potent skin irritant and sensitizer—and is not found to be regulated by the cosmetics directive. Moreover, this would not be useful and one should not try to target complete consumer protection by restrictions and regulations of each hazardous compound—the list would be endless. The simple presence of such irritants or sensitizing ingredients in the plant does not justify an immediate ban of the plant for any therapeutic uses: their different localization in plant parts, their often selective solubility, and finally their concentration makes it obligatory to have a differentiated look into each individual plant preparation. In some cases, the known sensitizer is even at the same time the beneficial anti-inflammatory, analgesic and antibacterial active; for example, in the case of Helenalin in Arnica montana. The presence of the naturally occurring “16 allergen substances” in plant preparations depends on various complex factors, such as, the plant itself,

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its chemotypes (the different compositions of, for example, the essential oil components of the same genus and species and of the same genus and different species), the part and amount used for extraction, the manufacturing method and vehicle used, the stability of extracted essential oil components—to name but a few. The fact that an essential oil may have the generally recognized as safe (GRAS) status granted by Flavor and Extract Manufacturer Association (FEMA) and approved by the US Food and Drug Administration (FDA) for food use make them not automatically safe for topical applications. A useful and informative reference book about analytical and scientific approach to aromatherapy, chemistry, and bioactivity of essential oils and their safety issues is the Aromatherapy Science: A Guide for Healthcare Professionals [15]. Some natural essential oils used in aromatherapy or as fragrance components are very typical representatives of one or more of the 16 “allergens,” and the importance of exact knowledge of genus, species, plant part, and country of origin will be shown here with the example of cinnamon. Cinnamal is contained in Cinnamomum ceylanicum BL cinnamon bark oil at approximately 42–76% (Oleum cinnamomi ceylanici, main country of origin: Sri Lanka (Ceylon)). Other typical fragrance components are: 4–10% eugenol, cinnamyl alcohol, cinnamic acid, and practically no coumarin. Cinnamal is also the major ingredient (about 90%) obtained from Cinnamomum cassia NEES cinnamon leaf oil (Oleum cinnamomi cassiae, main country of origin: China). Other typical fragrance components are: very little or no eugenol and linalool, some benzyl benzoate, and more important amounts of coumarin. It is reported that bark oil from Cinnamomi cassiae originating from Nigeria may contain up to 12 % of eugenol and Nigerian leaf oil up to 90% benzyl benzoate. Looking up the composition of Cinnamomum ceylanicum leaf oil we find the main essential oil ingredient to be eugenol with more than 70% among other identified substances such as cinnamal, cinnamyl alcohol, benzaldehyde, and others. Even more confusing is the fact that the quality of Indian Cinnamomum ceylanicum leaf oil is reported to be free of eugenol, but with benzyl benzoate as main component and another chemotype—called “safrol-type”

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with approximately 52% safrol and approximately 46% eugenol and coumarin just as traces [16]. This small example already shows that all plant preparations need to be examined whether they might contain any of the “26 allergens.” In order to fulfill the requirements of labeling according to the 7th Amendment, a prior literature study and a well-documented raw material traceability by the manufacturer of the essential oil or the country of plant harvest could be very helpful as an orientation on the decision, which substances should be subject to further quantitative analysis. In the 2004 issue of the SÖFW Journal, the EFfCI1 Working Group “Ingredients of Natural Origin” [17] reported on a comprehensive literature study using the results of a worldwide database research. The aim of this study was the screening of scientific bibliography data on botany, phytochemistry, and pharmacology, to find out in which of the plants or plant parts any of the 16 natural “fragrance allergens” have been mentioned as components. The complete qualitative report is available to EFfCI members. A list of plants in which nothing points to a presence of any of the “16 allergens” was published. 4.3.2 Identifying the “26 Allergens” in Accordance with the Requirements of the 7th Amendment 4.3.2.1 Analytic Studies

Because a possible labeling first requires the identification and quantification of those substances, analytical methods needed to be established. A GC-MS (gas chromatography–mass spectrometry) quantification of the 26 potential fragrance allergens was developed by the EFFA/IFRA Analytical working group [18] and published by the Journal of Agricultural and Food Chemistry [19]. Details of this version can be seen on the IFRA Web page under “Analytical Methods.” Recently another study concerning GC-MS quantification of suspected volatile allergens in fragrances was published [20]. 4.3.2.2 Raw Material Questionnaires

To fulfill the requirements of the 7th Amendment, cosmetic manufacturers are now requesting additional qualitative and quantitative analyses and

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descriptive information related to the origin, the presence, or absence of any of the “26 allergens” in synthetic and natural cosmetic ingredients, how these were introduced into the formulation (by adding of single synthetic components, via a perfume oil or botanical extract), and whether concentrations are based on conclusions by analogy or analysis, all of which result in an increase of cost, time, and paperwork. In addition, sometimes, not only the explicit identification is requested from the supplier, but also a complete elimination of these substances, or the guarantee to remain below the minimum labeling concentration of any of the “26 allergens” in cosmetic formulations (especially in complex composed plant raw materials). The reason for this is that cosmetic manufacturers fear that, for example, the claim “hypoallergenic” or “for sensitive skin” would not be well compatible with simultaneous labeling of any of the “26 allergens.” 4.3.2.3 Ökotest Downgrading System

Other cosmetic manufacturers consider the “downgrading” system created and promoted by the German consumer magazine Ökotest: When comparative tests are published on cosmetic products, the overall score awarded by Ökotest can suffer, based on established criteria for evaluation of the composition of the products. The downgrading criteria for cosmetics containing any of the “26 allergens” can be traced back in the German magazine Ökotest published in the November 2006 issue [21], which was the revision of an article published in July 2004 [22]. Ökotest bases its criteria on the fragrance allergen risk analysis from Information Network of Departments of Dermatology (IVDK) reported in 2004 and 2007 [23]. According to Ökotest the labeling of Cinnamal Isoeugenol Oak moss Treemoss on a final cosmetic product would lead to a two-point downgrading because these substances are evaluated as leading allergens with high frequency and risk of sensitization.

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The labeling of Hydroxy-methylpentyl-cyclohexenecarboxaldehyde (Lyral®) Hydroxycitronellal Cinnamyl alcohol on a final cosmetic product would lead to a one-point loss, because these allergens are evaluated as less potent sensitizers with low frequency and risk of sensitization. Citral Eugenol Methylheptincarbonate Farnesol Citronellol Geraniol Coumarin Amylcinnamal Benzyl cinnamate would be mentioned by Ökotest as “further fragrances” but would not lead to any downgrading. These substances are found to be very rare contact allergens that could be problematic only for already fragrance-sensitive consumers, but not in general for healthy persons. 2-(4-tert-Butylbenzyl)propionaldehyde (Lilial) Amyl cinnamyl alcohol Benzyl alcohol Benzyl salicylate Hexyl cinnamaldehyde Benzyl benzoate d-Limonene Linalool 3-Methyl-4-(2, 6, 6-tri-methyl-2-cyclohexen-1-yl)3-buten-2-one (alpha-Cetone) will not be mentioned nor lead to downgrading by Ökotest, because sensitization is found too rarely.

4.4 Critical Concerns to Treat All “26 Allergens” Alike Scientific investigations and publications of the last six to seven years reflect, comment, and protest against the disclosure of the “26 allergens.”

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A very critical review is given by T. Burfield, co-founder of Cropwatch,2 on the occasion of the 38th meeting of the International Essential Oil Symposium, Graz, Austria, September 12, 2007 [24]. A short summary of some selected points given in this lecture reads as follows. The natural aroma ingredient industry inside and outside Europe is adversely affected by the over-regulation of the EU, suffering of the “precautionary principle” as the basis for the transformation of scientific opinions into cosmetic directives. Burfield points out that nowadays it is increasingly apparent that there is lack of scientific consensus regarding the risks of fragrance contact allergens as presented by IFRA/RIFM and finally the SCCNFP and newer findings. Burfield gives examples where new scientific research seems neither to impress nor to change the SCCNFP’s opinion about fragrance contact allergens. Take, for example, the case of coumarin:  



 

It can occur in complex botanically derived ingredients. It is part of the so-called fragrance mix II, mentioned as one of the more frequently discovered contact allergens in the SCCNFP position paper for fragrance allergy in 1999. It was evaluated as a less important allergen with regard to frequency of sensitization according to Schnuch et al. [23] It showed no positive reactions to patch testing [25]. The newest findings from Vocanson et al. [26] describe the fact that synthetic coumarin is not an allergen when supplied as >99.9% pure form in comparison with other less pure synthesized coumarin for which the local lymph node assay (LLNA) gave weak to moderate sensitizing results. The sensitization effects were clearly linked to the contaminants included in the “nonpure” form.

The same article states that besides purity of the test substance, the oxidative degradation in the case of linalool and d-limonene are of major importance to determine contact allergy, as, for example, linalool hydroperoxide was determined to be the sensitizer instead of linalool. Burfield lists several studies published after the year 2000 that give many contrary opinions to the SCCNFP paper regarding the purity and selection/identification of test substances, test realizations, concentrations

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of use, interpretation of results, which are therefore in contradiction to the justification of this “26 allergen” selection—among them the article by Schnuch et al. [23]. Schnuch, the head of IVDK [27] carried out a sensitization frequency study on the “26 allergens” in the period from 2003 to 2004 on a number of patients tested with each preparation, ranging from 1,658 (for tree moss) to 4,238 patients for farnesol up to 21,325 patients tested on Lyral® (Hydroxy-methylpentyl-cyclohexenecarboxaldehyde). The results of Schnuch’s findings, Ökotest, and SCCNFP allergy frequency ranking, origin, and FM I or II affiliation are summarized in Table 4.3. Schnuch and colleagues conclude that a differentiated evaluation of “26 allergen” compounds is needed. Based on their findings the 26 fragrances were allocated to three classes according to their importance in terms of frequency of sensitization, amount of exposure or use, and the allergenic potency. This resulted in a classification of important allergens (Xxx), clearly allergenic but less important in terms of sensitization frequency (Xx), and very rare sensitizers or even considered as nonsensitizer (X). When comparing the IVDK findings and Ökotest classification to the SCCNFP opinion about most and less frequently reported contact allergies connected to the listed 26 substances, it can be observed that there is a broad agreement with respect to cinnamal, isoeugenol, hydroxycitronellal, Lyral®, oak moss, and treemoss as important allergens. Concerning farnesol, the classification is indifferent and is seen as a borderline case. Schnuch and his colleagues found that farnesol allergy was quite often associated with nickel allergy. Ökotest justifies their different evaluation saying that even if farnesol is a weak allergen, its frequent occurrence as a contact allergen is associated to a nonfragrance component and therefore this allergen reacts “fragrance-atypical.” Several of the other more frequently observed contact allergens (according to SCCNFP) belong to the FM I (cinnamyl alcohol, eugenol, and geraniol). As mentioned by Frosch et al. [25,28] many of the FM I results in the past were interpreted “false positive.” Schnuch reports that concomitant reactions and so-called cross-reactions have been found: nickel allergy was also associated with cinnamyl alcohol and often citral positive peoples reacted as well on geraniol.

IVDK Classification

X X Xx Xx Xx Xxx Xxx Xx X Xxx Xx Xx Xxx

Ökotest Ranking 2006

/ / –1 0 0 –1 –2 0 / –2 0 0 –1

MF MF MF MF MF MF MF MF MF MF MF MF MF

SCCNFP Opinion: Most and Less Frequently (MF, LF) Reported or Well Recognized (WR) Contact Allergen S S, B S, B S, B S, B S S, B S S, B S, B S, B S, B S

Origin: Synthetic (S), Also Occurring in Botanicals (B), Explicitly Botanical (EB)

Table 4.3 Comparative Ranking of Allergy Frequency Ranking

Amyl cinnamal Benzyl alcohol Cinnamyl alcohol Citral Eugenol Hydroxycitronellal Isoeugenol Amylcinnamyl alcohol Benzyl salicylate Cinnamal Coumarin Geraniol Hydroxy-methylpentylcyclohexene carboxaldehyde

INCI or Substance Name Ref. to Directive 2003/15/EC, Official Journal of the European Union, L66/26, 11.3.2003

122-40-7 100-51-6 104-54-1 5392-40-5 97-53-0 107-75-5 97-54-1 101-85-9 118-58-1 104-55-2 91-64-5 106-24-1 31906-04-4

CAS Ref. to Directive 2003/15/ EC, Official Journal of the European Union, L66/26, 11.3.2003

FM I FM II FM I FM II

FM I FM II FM I FM I FM I

FM I

Part of Fragrance Mix

72 Global Regulatory Issues for the Cosmetics Industry, Vol. 2

X X Xx X X X X

Xxx Xxx

/ / 0 / / 0 /

–2 –2

WR WR

LF LF LF LF LF LF LF

LF LF LF LF

EB EB

S, B S, B S, B S S, B S S

S, B S, B S, B S

Anisyl alcohol Benzyl cinnamate Farnesol 2-(4-tert-Butylbenzyl) propionaldehyde Linalool Benzyl benzoate Citronellol Hexyl cinnamaldehyde d-Limonene Methyl heptin carbonate 3-Methyl-4-(2,6,6-trimethyl-2-cyclohexen1-yl)3-buten-2-one Oak moss extract Treemoss extract 90028-68-5 90028-67-4

78-70-6 120-51-4 106-22-9 101-86-0 5989-27-5 111-12-6 127-51-5

105-13-5 103-41-3 4602-84-0 80-54-6

FM I

FM II FM II

FM II

Notes: For IVDK, Xxx: leading allergen with high frequency of sensitization according to Schnuch et al. [23]; Xx: less important allergen with regard to frequency of sensitization; X: very rare allergen with concern that some substances of this group (e.g. Benzyl benzoate and Hexyl cinnamaldehyde) do not represent a “significant contact allergen” at all. For Ökotest, –2: two-point downgrading; –1: one-point downgrading; 0: mentioning as fragrance component but no downgrading; /: no mentioning, no downgrading.

X Xx Xxx Xx

/ 0 0 /

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Furthermore, the article by the American dermatologist Frances J. Storrs [29], “Allergen of the Year: Fragrance,” describes, in a brief historical background review, how the FM I was created by Dr. Larsen [30] in the late 1970s. She also points out that there was a formulation change, as the initially created FM I contained Peru balsam, synthetic jasmine, treemoss absolute, and amyl cinnamal among other ingredients. The reason why and how this “first FM I” was changed remains unclear. After late 1977, the FM I consisted of the previously listed ingredients. This mix has remained unchanged until 1984 where the total concentration was reduced from 16% to 8% (eight ingredients each at 1%). Storrs reports on the difficulties dermatologists had in the past to interpret fragrance patch results; she complains about imprecise language used in former reports about fragrance allergy and allergic reaction on fragrances. In her article, Storrs also writes about a new “fragrance mix II” with six substances known since several years for their allergenic risk (the 6 are part of “26 allergens”), which have been evaluated in a large epidemiological study in Europe. The test principle was different from the one formerly used with “fragrance mix I” and it was expected to obtain less “false-positive” results than in the past with “mix I” [25,28]. “Fragrance mix II” is composed of: Alpha hexyl cinnamic aldehyde (= hexyl cinnamaldehyde, hexylcinnamal) at 5% Citral at 1% Citronellol at 0.5% Farnesol at 2.5% Hydroxyisohexyl 3-cyclohexene carboxaldehyde (= Lyral®, hydroxymethylpentyl-cyclohexenecarboxaldehyde) at 2.5% Coumarin at 2.5% There are obviously differences between IVDK, Ökotest, and SCCNFP classifications in the case of benzyl alcohol (it is allowed up to a maximum of 1% as a preservative in cosmetics), benzyl salicylate, and amyl cinnamal, where the last is exclusively of synthetic origin. In conclusion, these so-called “26 allergens” should be renamed “alleged 26 allergens”! The need of a more differentiated look at these last scientific findings should lead to a new dialog with the SCCNFP and a rehabilitation of at least some of the 26 substances.

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4.5 Trade Impacts of the 7th Amendment (Especially on the “26 Allergen” Labeling) It is no secret that the labeling of fragrance allergens is seen as a barrier to harmonization in both the United States and Japan. This requires the development of different labels for the EU market, increasing costs for both new and existing products [31]. Also the cost of handling the paperwork to fulfill the analytical and descriptive part, formulation changes, more complex warehousing, artwork for label design and print, and the need for more regulatory specialists who can cope with the increasing demand is seen as a burden on both ends of the supply chain, that is, the cosmetic manufacturers, but even more important and essential, on the side of the perfumery and aroma oil industry and the plant extraction business. The Risk and Policy Analysis report about the Impact of European Regulation on the EU Cosmetics Industry, September 2007 [32] points out that the average total cost to fulfill the demands of the 7th Amendment were 81,250€ (where small cosmetic companies indicated a total cost of 7,000€ and large companies 222,000€, mostly depending on the number of formulations placed on the market.)

4.6 Conclusion In the history of cosmetic regulations, the 7th Amendment has probably caused more controversial discussions than any of the former ones and thus calls for a critical dispute. It seems that without the implementation of fragrance allergen labeling on cosmetic products, manufacturers and scientists might never have looked into the subject “fragrance contact allergy” so closely, as was the case during the past eight to ten years. This alone is an important positive aspect of and for consumerism, since new, important results were published. Contact allergies cause serious health problems and quick solutions to the undesired labeling requirement such as the substitution of known allergens by new, less well-studied fragrance components is no solution, as this could lead to new contact allergies, which again would be against the precaution principle of the Cosmetics Directive. If one were to follow the

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newer research and tests, the “26 allergens” could probably be reduced to 7 or at maximum 16, which would include some of the doubtlessly very potent or frequently positive tested contact allergens such as farnesol, isoeugenol and cinnamal, treemoss, and oak moss, as well as hydroxycitronellal and hydroxy-methylpentyl-cyclohexenecarboxaldehyde as exclusively synthetic components. The SCCNFP opinion concerning the “26 allergens,” although deserving respect, should be reviewed in view of the recent serious reproach that not all 26 substances should be treated alike. Manufacturers, scientists, as well as medical and legal specialists should join forces and try to find a “common denominator” so that new research results can find their way to the Cosmetic Directives and legislation, which then can be used as a reliable basis for any research work and labeling on products—to the benefit of customers and the industry. So, a compromise needs to be found that equally serves the requirement for safety and health and the wish for individuality. Open minds are necessary to detect and carry new, important, and true information. That this issue is not new is shown by the following quote: Whenever a new discovery is reported to the world, they say first, ‘It is probably not true,’ Then after, when the truth of the new proposition has been demonstrated beyond question, they say, ‘Yes, it may be true, but it is not important.’ Finally, when sufficient time has elapsed to fully evidence its importance, they say, ‘Yes, surely it is important, but it is no longer new. —Michel de Montaigne, 1533–1592 [33]

Notes 1

The European Federation for Cosmetic Ingredients (EFfCI; http://www.effci. com/) is a European trade association that represents the chemical and natural ingredients manufacturing industries, the suppliers and service providers for the cosmetic industries. 2 Cropwatch (www.cropwatch.org) established in 2003–2004 is an independent watchdog for aroma trade. Its aim is to ensure sustainability of natural product usage, to resist overexploitation, biopiracy, and regulatory threats from being too restrictive and ill-conceived.

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References 1. http://www.leffingwell.com/cosmetics/out131_en.pdf. 2. Cosmetic Inventory 2006, Section I: Cosmetic Ingredients Other Than Perfume and Aromatic Raw Materials, http://ec.europa.eu/enterprise/cosmetics/ html/cosm_inci_index.htm. 3. SCCNFP/0389/00 Final Opinion Concerning the 1st Update of the Inventory of Ingredients, Section II. 4. Scientific Committee on Cosmetic and Non-Food Products, http://ec.europa .eu/health/ph_risk/committees/sccp/documents/out98_en.pdf. 5. Fenn R.S., “Aroma Chemical Usage Trends in Modern Perfumery,” Perfumer & Flavorist, 14, pp. 1–12, 1989. 6. Schnuch A., Lessmann H., Geier J., Frosch P.J., Uter W., “Contact Allergy to Fragrances: Frequencies of Sensitization from 1996 to 2002. Results of the IVDK,” Contact Dermatitis, 50, pp.65–76, 2004. 7. Uter W., Schnuch A., Geier J., Frosch P., “Epidemiology of Contact Dermatitis. The Information Network of Departments of Dermatology (IVDK) in Germany,” Eur. J. Dermatol., 1, pp. 36–40, 1998. 8. Marks J.G., Belsito D.V., Deleo V.A., et al., “North American Contact Dermatitis Group Patch Test Results for Detection of Delayed Hypersensitivity to Topical Allergens,” Am. Journal Contact Derm., 38: pp. 911–8, 1998. 9. De Groot A.C., Frosch P.J., “Adverse Reactions to Fragrances: A Clinical Review,” Contact Dermatitis, 36: pp. 57–8, 1997. 10. http://www.ifraorg.org/. 11. http://www.rifm.org/index.asp. 12. http://www.ifraorg.org/GuideLines.asp. 13. Dangerous Substance Directive, Annex VI, http://ec.europa.eu/environment/ dansub/pdfs/annex6_en.pdf. 14. SCCNFP/0202/99, http://ec.europa.eu/health/ph_risk/committees/sccp/ docshtml/sccp_out124_en.htm. 15. Lis-Balchin M., Aromatherapy Science: A Guide for Healthcare and Professionals, 1st edition, Pharmaceutical Press, 2005. 16. Hagers Handbuch der Pharmazeutischen Praxis, Springer Medizin Verlag, Heidelberg, CD ROM, 2006. 17. EFfCI Working Group Ingredients of Natural Origin, “Perfume and Aromatic Substances,” SÖFW Journal, No. 4, 2004. 18. European Flavour and Fragrance Association (EFFA), http://www.effa.be/. 19. Chaintreau A., Joulain D., Marin C., Schmidt C.O., Vey M., “GC-MS Quantitation of Fragrance Compounds Suspected to Cause Skin Reactions. Part 1,” J. Agric. Food Chem., 51(22), pp. 6398–6403, 2003. 20. Bassereau M., Chaintreau A., Duperrex S., Joulain D., Leijs H., Loesing G., Owen N., Sherlock A., Schippa C., Thorel P.J., Vey M., “GC-MS Quantification of Suspected Volatile Allergens in Fragrances. 2. Data Treatment Strategies and Method Performances,” J. Agric. Food Chem., 55(1), pp. 25–31, 2007. 21. http://www.oekotest.de/cgi/ot/otgs.cgi?suchtext=&doc=41295&pos=3&split s=0:1651:3025:4556:6183.

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22. Scheidecker K., “Sippenhaft ist aufgehoben,” Ökotest, No. 7, pp. 55–57, 2004. 23. Schnuch A., et al., “Sensitization to 26 Fragrances to Be Labeled According to Current European Regulation,” Contact Dermatitis, 57, pp. 1–10, 2007. 24. Burfield T., “Over-Regulation is Destroying Natural Aromatics,” http://www .cropwatch.org/lecturegraz.pdf. 25. Frosch P.J., et al., “Patch Testing with a New Fragrance Mix—Reactivity to the Individual Constituents and Chemical Detection in Relevant Cosmetic Products,” Contact Dermatitis, 52(4), pp. 216–225, April 2005. 26. Vocanson M., et al., “The Skin Allergenic Properties of Chemicals May Depend on Contaminants—Evidence from Studies on Coumarin,” Int. Arch. Allergy Immunol., 140, pp. 231–238, 2006. 27. IVDK Göttingen, http://www.ivdk.org/ivdk/eng/index.html. 28. Frosch P.J., et al., “Patch Testing with a New Fragrance Mix Detects Additional Patients Sensitive to Perfumes and Missed by the Current Fragrance Mix,” Contact Dermatitis, 52(4): pp. 207–15, April 2005. 29. Storrs F.J., “Allergen of the Year: Fragrance,” Am. Journal Contact Derm., 18(1), pp. 3–7, 2007; http://www.medscape.com/viewarticle/559985. 30. Larsen W.G., “Perfume Dermatitis, a Study of 20 Patents,” Arch. Dermatol., 113, pp. 623–626, 1977. 31. Comparative Study on Cosmetics Legislation in the EU and Other Principal Markets with Special Attention to So-Called Borderline Products, Final Report, August 2004 Prepared for European Commission, DG Enterprise, http://www.rpaltd.co.uk/reports-by-chronology.shtml. 32. http://www.rpaltd.co.uk/documents/J574Cosmetics2.pdf. 33. http://mindprod.com/ethics/quote.html#MONTAIGNE.

5 Manufacturing Cosmetic Ingredients according to Good Manufacturing Practice Principles Iain Moore Croda Europe Ltd., Snaith, Goole, UK

5.1 Introduction In the early part of this decade the European Commission signaled that it would seek to define a good manufacturing practice (GMP) for the manufacture of cosmetics. Although GMP was already a requirement in the Cosmetics Directive 76/768/EEC and its amendments, there was actually no definition of what that good manufacturing practice should be. By February 2004, a draft document defining the good manufacturing practices had been prepared by the commission (04/ENTR/COS/48). Simultaneously the International Standards Organization (ISO) was also drafting a document with the same scope. Following petitioning from industry, the commission ceased work on its own document and signaled it would make reference to the new ISO standard for GMP for cosmetic manufacturing (ISO 22716). This document was published in November 2007.

K. Lintner (ed.), Global Regulatory Issues for the Cosmetics Industry Vol. 2, 79–92 © 2009 William Andrew Inc.

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The initial commission document for the GMP for cosmetics and the early ISO 22716 drafts indicated that the definition of GMP should be applied as written to the manufacture of cosmetic ingredients as well. Had such a path been followed this would have repeated past mistakes in the pharmaceutical sector, so the European Federation for Cosmetic Ingredients (EFfCI)1 took the initiative to define a GMP for ingredients. This chapter will explain why it was necessary to separately define a GMP recommendation for cosmetic ingredients rather than accepting the GMP that has been defined for cosmetics or pharmaceutical starting materials and give a brief overview of the key features of the EFfCI guide.

5.2 What is GMP? First, we should take a look at an often poorly understood term, good manufacturing practice. This is a term in common use across many consumerorientated industries and is particularly associated with pharmaceuticals and food and is also used in other industries. In the cases of food and pharmaceuticals, governments worldwide have mandated that these products should be manufactured in accordance with GMP. These two industries have a different set of specific rules that define GMP. In this respect, the term may well be in common use but the exact details of what GMP actually is depend strongly on that industry. That noted, GMP is always applied in situations where the final product should do no harm to the end user. All the details in the GMP stem from this simple premise. EFfCI has chosen to use the following commonly used definition of GMP: The part of Quality Assurance (QA) which is aimed at ensuring that products are consistently manufactured to a quality appropriate to their intended use. The key words in this statement are consistently and intended use. Thus, it is not enough to make an occasional good product; there is a strong requirement to make one to the same quality time after time. This is a core principle; users of the product require a high degree of assurance that it is of the same quality with each delivery. Yet quality is also a term that has no specific meaning, but the most general one is appropriate here, “the product should be fit for the intended use.” Thus, the use of the product dictates the quality and the extent and detail of GMP required. This definition is an old fashioned way of stating that the manufacturers should perform a suitable risk assessment regarding the use of their product and identify the controls in manufacture that will assure product quality, in

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particular those that will provide a high degree of assurance that the product will not harm the end user. It follows from this view that GMP is a set of rules that can be applied to assure product quality. This aspect is critical because in the past the food and especially the pharmaceutical GMP have been taken verbatim and applied to their suppliers. This has often met with resistance, usually because the detailed rules are designed to provide control over the manufacturing processes and technology in use in those industries. When their suppliers use different technologies to manufacture their products then the risks posed to the end user by their equipment and operations will be different and so some or many of the detailed controls will be of no value, merely adding cost to the operations. Potentially this is disastrous to the supplier and customer as both would be under the impression that the risks to the end user would be minimized through the implementation of the GMP rules. Thus, for example, some of the risks to the end user will be different when making and filling 100,000 tubes of moisturizer in comparison with making 20,000 liters of a bulk liquid. In the former, there will often be no opportunity to remove any particulate contamination from the end product as filtration may not be possible without breaking the emulsion that gives the product its beneficial properties. Therefore, a suitable control for this risk could be to apply air filtration to the manufacturing facility. However, the same may not be true of the bulk liquid. If the processing is contained in sealed units and filtration prior to fill off and dispatch can be implemented then this would be an effective GMP control. In this instance, applying air filtration as well would serve only a marginal or even no additional benefit. Regardless of these differences, it is clear that the same principles are being applied in both cases, namely the avoidance of contamination of the product (moisturizer or bulk ingredient) by particulate contamination. This example illustrates how the common principles of GMP will be applicable in all manufacturing operations and it is from these that the detailed guidance can be built. What are the key principles of GMP?   

The product should not harm the end user. The product should be pure and free from contaminants. There should be defined manufacturing procedures that have been proven to be effective in making products of a consistent quality.

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There should be records of the manufacturing process which demonstrate that the product has been made in accordance with these planned arrangements. Personnel should be competent in the execution of their roles and have sufficient training. Manufacturing equipment should be fit for purpose and maintained in that condition. You cannot inspect quality in the final product.

The first of these principles is the most fundamental—the product should not harm the end user. All the other principles and indeed detailed rules are aimed at providing assurance that the product is safe to use. Historically, GMP grew up as a result of the fact that you cannot perform 100% inspection when making many small components, for example, tablets or tins of food. In such cases, the testing can destroy the item in question! The only way to have confidence that the end product is safe to use is to apply controls throughout the manufacturing process. In this regard GMP is aligned with statistical process control techniques that have widespread application today in the engineering manufacturing industry. However, GMP is based on a softer definition and control of manufacturing, and to a degree it is easier to implement over a wider range of operational activities. But it is this fundamental basis of GMP that also limits its application to other industries, particularly those where you can perform 100% inspection, such as taking a representative sample from 20,000 liters of liquid and testing it. Yes, the liquid has to be homogeneous to ensure that the sample test results apply to the whole of the batch, but in this instance it can be argued that quality can be assured through inspection alone. Yet such an approach highlights another critical aspect that is central to GMP: the problem of only knowing what you know. That is, you only test for characteristics that are part of the product specification. If something has gone wrong in manufacturing the material, which causes some new harmful impurity to be formed, then testing to specification would not look for it and so you could be misled into thinking that the material is suitable when it is not. It is here that the other principles and derived rules in GMP come into play, as they will ensure suitable controls are put in place to manage just this kind of risk. Now, until relatively recently the only definitions of GMP have been for finished pharmaceuticals and food. Several organizations have drafted and

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prepared their own interpretation of GMP to ensure that the key principles are adopted and applied in their particular industry, most notably for pharmaceutical excipients and pharmaceutical active ingredients. These materials are often made by chemical synthesis or biotechnology and so have many similarities in terms of the technology used to make cosmetic ingredients. The main reason these industry specific definitions of GMP were prepared was to ensure the best practices match the risks to end user safety posed by the manufacturing technologies in each sector.

5.3 Why Should GMP Be Applied to Cosmetic Ingredients? Given the key principles of GMP, surely the questions should be why has GMP not previously been applied to the manufacture of Cosmetic Ingredients? There is a risk to the user that the cosmetic may cause them harm, particularly if it is contaminated in some manner. So from a moral position, if an organization is serious and wants to be credible in supplying cosmetic ingredients, then it should be applying the principles of GMP to its manufacturing operations. Legally, in Europe at least, there is no specific legislation that mandates GMP for the preparation of cosmetic ingredients. However, there are two specific updates to the Cosmetics Directive, 76/768/EEC, which do mention GMP for the preparation of cosmetics. These are: 

Council Directive 82/368/EEC amending Article 4.2 Article 4 (updated by Council Directive 82/368/EEC of 17 May 1982) 1. Without prejudice to their general obligations deriving from Article 2, Member States shall prohibit the marketing of cosmetic products containing: (a) substances listed in Annex II … . 2. The presence of traces of the substances listed in Annex II shall be allowed provided that such presence is technically unavoidable in good manufacturing practice and that it conforms to Article 2.Annex II lists substances that are harmful to health and so should not be included in cosmetics above certain limits that have been shown to reduce or eliminate the risk to health. Article 2 of the same directive requires that the fundamental principle of GMP

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be applied to cosmetic products: A cosmetic product put on the market within the Community must not cause damage to human health when applied under normal or reasonably foreseeable conditions of use … . Council Directive 93/35/EEC amending Article 7.a.1.(c) Article 7a.1(c) (updated by Council Directive 93/35/EEC of 14 June 1993) The manufacturer or his agent or the person to whose order a cosmetic product is manufactured or the person responsible for placing an imported cosmetic product on the Community market shall for control purposes keep the following information readily accessible to the competent authorities of the Member State concerned at the address specified on the label in accordance with Article 6(1)(a): the method of manufacture complying with the good manufacturing practice laid down by Community law or, failing that, laid down by the law of the Member State concerned; the person responsible for manufacture or first importation into the Community must possess an appropriate level of professional qualification or experience in accordance with the legislation and practice of the Member State which is the place of manufacture or first importation Initiatives from DG Enterprise.

Thus, the cosmetics directive requires cosmetic manufacturers to apply GMP in their operations. In directive 82/368/EEC, Article 4.2 can be interpreted to apply not only to finished cosmetics but also their ingredients. In this regard there is now an implication that GMP should apply to cosmetic ingredients. Directive 95/35/EEC requires GMP for the manufacture of cosmetics but provides no further clues as to what it should be. It was this article that prompted the EU to begin work on a suitable definition of GMP for cosmetics so that there would be no technical barriers to trade within the community as some member states had signaled that in the absence of a community definition they would introduce their own set of rules. The initial drafts of the “Guidelines on Good Manufacturing Practices for Cosmetic Products” included some 45 references to cosmetic ingredients including the specific application of the GMP to the manufacture of those materials in the scope. This was amended later in the drafting process to make the connection less explicit but it was hard for a cosmetic ingredient manufacturer to demonstrate compliance with the rules and so comply with the GMP themselves, unless they also had them applied by their suppliers.

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Thus, there was no mandate for cosmetic ingredient suppliers to apply GMP to their operations other than those that their customers demanded. The danger in this situation was that the GMP rules would be those designed for the manufacture of cosmetics, which for the most part do not use the technology to be found in the chemical and biological synthesis of the ingredients. Thus, the controls would add little value in assuring end user safety and could result in a false sense of security for both parties. It was against this backdrop that EFfCI seized the imitative and began to develop its own GMP for the manufacture of cosmetic ingredients.

5.4 What GMP Should Be Applied? EFfCI noted that a new GMP Guide for the manufacture of pharmaceutical excipients was being prepared at this time. Pharmaceutical excipients are substances that have no therapeutic value in terms of providing healing to the patient who takes the final pharmaceutical product. But such substances are critical to the administration of those substances. For example, take a tablet of a painkiller. The active ingredient is the substance that relieves the pain (e.g., paracetamol, ibuprofen) but this has to be held in a binder, commonly lactose. Other ingredients can be added to help the tablet disintegrate in the intestinal tract thereby releasing the painkiller, which can be absorbed by the patient. Thus, the properties of excipients mirror those of many cosmetic ingredients and indeed many of these substances are in common use by both industries, particularly those with surface active properties. Thus, several members of EFfCI were also engaged in supplying the pharmaceutical industry and it was these companies that suggested a nascent excipient GMP guide be used as the basis of GMP for cosmetic ingredients. Such an approach was attractive from two viewpoints: 1. the GMP had been defined with the chemical and biotechnological syntheses in mind; 2. many companies supplied both pharmaceutical and cosmetic customers, so having a similar GMP would be easier and more effective to implement. The EFfCI guide was prepared by an international team of cosmetic ingredient suppliers during 2004 and 2005 based on a new definition of Excipient GMP for pharmaceuticals, the IPEC–PQG (International Pharmaceutical Excipients Council–Pharmaceutical Quality Group) Excipient GMP Guide.

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The IPEC and the UK PQG both had a long history of defining excipient GMPs. Their collaboration at this time established a set of GMPs for excipients that matched the manufacturing technologies used to prepare those materials and which gave an appropriate degree of assurance over product quality for pharmaceutical applications. These organizations gave EFfCI permission to use a draft of their Guide and to revise and adapt it to suit the particular needs of the cosmetic ingredient manufacturing sector. The IPEC–PQG Excipient GMP guide was itself a fusion of two earlier documents that these two organizations had developed independently. Through their collaboration a more definitive standards was obtained and one that is increasingly finding worldwide approval. Their guide was aligned with the clause number and titles in ISO 9001:2000. The rationale here was that ISO 9001:2000 had found widespread acceptance in the chemical and biotechnology industries and that it was an excellent foundation on which to build the specific controls required for GMP. In short, organizations would find it simple to implement the GMP requirements on top of their ISO 9001:2000 quality management system. It was because of these key elements of the IPEC–PQG GMP Guide that the EFfCI team was able to keep the majority of the text in their guide, word-identical. This allows manufactures who supply both industries to maximize leverage in the application of what to all intents is one set of management controls, and to be selective where necessary with those needed for pharmaceutical applications, which require a more thorough implementation. This means that the EFfCI GMP can be applied in an effective manner in one manufacturing facility without distorting the cost base.

5.5 Key Features of the EFfCI GMP Guide Many organizations that manufacture chemicals are already registered to ISO 9001:2000. This familiarity with the requirements of that standard meant that it was an obvious choice for the structure of the IPEC–PQG GMP Guide, and EFfCI saw no reason to alter that arrangement. After all many cosmetic ingredient suppliers also supply excipients to the pharmaceutical industry because the functionality offered by these products can often be put to identical uses (e.g., emulsifiers, binders). A double advantage for such organizations was that if they were already compliant with the GMP in the IPEC–PQG GMP Guide then they would be compliant with the GMP in the EFfCI GMP Guide for cosmetic ingredients.

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By aligning the clauses in the guide with the major headings in ISO 9001:2000 organizations will be able to see at a glance where their management systems need to be enhanced and this allows for a simpler uptake in organizations than trying to map the new GMP requirements onto an existing quality management system. The vast majority of the recommendations in the EFfCI GMP Guide do not place any additional requirements on an organization that is already compliant to ISO 9001:2000. The emphasis throughout though is on the key principles of GMP. Within Section 4, Quality Management System, the guide emphasizes the need for written procedures to cover quality critical activities. In this respect, the need for a written document is additional to ISO 9001:200, which somewhat famously only requires six written documents. Such a quality management system was felt to be outside the core principles of GMP where defined procedures are needed to ensure consistent manufacture of products. There was, however, one major addition to ISO 9001:2000 in this section, the inclusion of an additional Clause, 4.3 Change Control. It was felt by both IPEC–PQG and EFfCI that the issue of change control was not clearly emphasized within ISO 9001:2000 and that users would benefit from some further guidance on the subject. For example, one key area that requires effective change control is managing the impact of altering the origin of raw materials (e.g., animal, mineral, vegetable, or “synthetic”), particularly with respect to the effect on the cosmetic customer’s label claims. A basic ISO 9001:2000 quality management system might not have enough sensitivity on this topic, and substituting one supplier of a raw material with another that happens to meet the chemical specification may not highlight the change in origin. ISO9001:2000 is quite explicit and well laid out in regard to Section 5, Management Responsibility, and EFfCI merely repeated much of that standard but with the obvious emphasis on GMP, particularly within the clauses on internal communication. The ISO 9001 clauses on training and competency were compatible with the key GMP principle on this topic and so did not need further amplification. However, the same could not be said of Section 6, Resource Management. This is one of the areas where another additional section was added, 6.2.3 Personnel Hygiene, as this aspect of GMP is of particular concern when products are exposed to the manufacturing environment and thus to

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operational personnel. There is always a risk of product contamination through this vector. Whereas ISO 9001:2000 is very explicit in Sections 6.3, Infrastructure, and 6.4, Work Environment, there is a need to provide a lot of guidance in these areas to ensure that the facilities themselves and the operational environment do not pose a threat to product purity. As a result, several sub clauses to both sections have been added covering subjects such as equipment maintenance, utilities, and water quality. The latter is a key ingredient, either intentionally or otherwise and the control of the water quality is very important especially with regard to microbial issues. Most if not all cosmetic manufacturers consider microbial contamination of the cosmetic as their number one threat to product quality and end-user safety. Within Work Environment, the emphasis is on maintaining product purity through appropriate cleaning routines not only of the manufacturing equipment but also of the facilities themselves (“housekeeping”). The section also introduces the concept of a pest control program. Whereas cosmetic ingredient suppliers will often have such arrangements in place they can be divorced from quality assurance—reports may be issued to site management but the potential impact on product quality is not considered. The EFfCI GMP Guide makes a number of recommendations in this area to ensure that the proper consideration is made of pest control reports in relation to the impact on product quality. Of course, GMP is all about product purity and so Section 7, Product Realization, has a number of key additions to ISO 9001:2000. Key here is the need for good manufacturing records that allow traceability of activities to individuals and to the materials consumed in the production process. That said, there are few additional points until Section 7.4, Purchasing. Here there is a clear need to verify the quality of the purchased material before use (Section 7.4.3) preferably by performing at least an identity test on goods receipt. Very recent incidents with the contamination of glycerin with ethylene glycol have clearly illustrated the risks that organizations can be exposed to if they have not implemented good GMP controls in this area. Production and Service Provision is a major section in the EFfCI GMP Guide and as expected provides a lot of detail over the GMP manufacturing process. Key areas emphasized in the guide link back to the key GMP principles of explicit instructions, cleanliness, control over ingredients including those such as solvents that can be reused and records of equipment use. The key aspects of packaging and labeling of the cosmetic ingredient are

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also covered although additional comments on these topics follow in the sections on Identification and Traceability (Section 7.5.3) and Product Preservation (Section 7.5.5). In this, the need for the package to protect the cosmetic ingredient without interacting with it is made explicit, not only whilst the cosmetic ingredient is on the manufacturing facility but also in the distribution chain. The section concludes with 7.6 Control of Measuring and Monitoring Devices, but the guide merely requotes ISO 9001:2000, which is quite detailed on this subject, as are the early clauses of Section 8, Measurement Analysis and Improvement. But Section 8.2.4, Monitoring and Measurement, contains a wealth of guidance on the GMP principles in this area, covering laboratory testing and release procedures. With regard to the latter the concept of an Out-ofSpecification (OOS) procedure is introduced. This is a key GMP concept and has been reduced to the scientific minimum in the EFfCI GMP Guide. One requirement is to evaluate the reasons for an OOS result and to only discount that result if just cause has been found. Otherwise, the temptation would be to accept and use the result that gives the most favorable outcome. Following the GMP principle of traceability, the guide recommends that samples of each batch (or lot) be retained by the cosmetic ingredient supplier so that the quality of the material can be investigated post manufacture and delivery. The guide also recommends that certificates of analysis be provided with each batch (lot) delivered to customers as this is a key GMP record for both parties. The guide also makes suggestions on how organizations can approach the definition and justification of retest or expiry intervals for their cosmetic ingredients. These are the intervals for which the certificate of analysis remains valid (retest) and for which the cosmetic ingredient is still suitable for purpose (expiry interval). The commonly used term “shelf life” has been avoided because it can be used interchangeably to mean either interval. It should be noted that a retest interval can be extended by retesting the batch in question and if still conforming to specification a revised certificate of analysis can be issued. Of course, the same is not true of the expiry interval as after this time the cosmetic ingredient might have deteriorated in quality such that it cannot be used, and no manner of testing will put that right! Section 8.3, Control of Nonconforming product, includes the concepts of reprocessing (performing a previously executed manufacturing operation

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again) and reworking (performing a new manufacturing operation) in relation to recovery of nonconforming product. The key GMP principles of traceability through preparation of suitable records in regard to what happened and who approved the activity are emphasized in the guide. The remaining sections mirror the corresponding clauses in ISO 9001:2000.

5.6 Key Differences to IPEC–PQG GMP Guide for Pharmaceutical Excipients Reference has been made to the fact that the EFfCI GMP Guide is based on the IPEC–PQG GMP Guide. This guide has been developed to define a suitable GMP for the manufacture of substances that are used as the inactive components in pharmaceutical products. Whereas many such products will also find application as cosmetic ingredients, the standards required to assure end-user safety are much higher in the pharmaceutical industry. After all, pharmaceuticals are used to help people whose health is already compromised. Thus, the GMP in the IPEC–PQG GMP Guide provides a higher degree of assurance about product purity by a more thorough application of the key GMP principles. These are focused on the need to generate a more comprehensive set of knowledge about consistency of the method of manufacture, the impurities, and stability of the product. Such investments require recovery of their associated costs, and in general the GMP required for excipients requires that the GMP be more comprehensively documented and that scientific evidence of product purity and stability be gathered under stricter conditions. The EFfCI GMP Guide, therefore, removed some of these associated costs but maintained the requirement to adopt the key GMP principles. These differences crudely equate to “do GMP” in the EFfCI GMP Guide whereas for pharmaceutical excipients the requirement is to “do and document GMP.” These key differences between the EFfCI GMP Guide and the IPEC–PQG GMP Guide are: 

Change Control (4.3): There remains a need to have a system for managing change and for consideration to be made to notify customers when changes are implemented but does

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not require that the changes be approved by the quality unit (a term used to describe either or both the Quality Control and/or the Quality Assurance departments), nor for there to be suitable records made of the change process as well as the changes themselves nor a consideration of the impact on any regulatory filings. This theme of the quality unit having specified responsibilities associated with being custodians of product quality is a recurring theme for excipients GMP, which is not mirrored in the EFfCI GMP Guide. Consistency of the Manufacturing Process: There is less emphasis on performing studies and documenting this. Such retrospective analysis of processes can yield useful information, but when each batch is subjected to 100% testing the law of diminishing returns applies, which is why it was not included in the EFfCI GMP Guide. Environmental and Production Hygiene Controls: It is rare in the cosmetic ingredient industry for a “clean room” to be required. Even though microbial and particulate controls are necessary for cosmetic ingredients it is usual to be able to meet the necessary standards with an effectively implemented housekeeping and hygiene program. Incoming Materials: There is no stipulation that physical audits be performed on suppliers, rather that they be approved in a suitable manner. Equipment Cleaning: This should be performed, but there is no need to gather evidence of the effectiveness of the cleaning process. Typically for excipients this would require a comprehensive study of surface residues and quantification or residues in rinse solvents, which can involve a major scientific effort. Batch Release: There is no need to evaluate the deviations from the standard conditions for each batch manufactured. Stability studies: There is no requirement to perform these on the product.

Of course, cosmetic ingredient manufacturers and suppliers can choose to adopt a more comprehensive set of GMP recommendations, such as those elaborated in the IPEC–PQG GMP Guide. But the focus in developing the EFfCI GMP Guide was to recognize that resources cannot be allocated to such duties when there is no commercial benefit to be gained. It was preferred to ensure that these resources be directed at actually performing the key GMP principles.

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5.7 Conclusions The EFfCI GMP Guide was developed as a result of the threat that the GMP for final cosmetic manufacture was going to be applied to cosmetic ingredients. Potentially this could have resulted in inappropriate controls and unreasonable costs being imposed on the cosmetic ingredient suppliers. Therefore, the emphasis in the guide was for cosmetic suppliers to concentrate on implementing the key GMP principles during the manufacture and supply of these ingredients. With a sector specific definition of GMP now in place, cosmetic companies and their customers can be assured that the ingredients have a high degree of purity resulting in safer cosmetics. Of course, the successful implementation of the EFfCI GMP Guide will not prevent cosmetic manufacturers from placing other requirements on their suppliers, such as the audits hinted at in ISO 22716:2007. But at least once they arrive they should witness a facility that is making product that is safe and fit for purpose.

Note 1

EFfCI is a European trade association that was established in 2000 to represent the manufacturers of chemical and natural ingredients for the cosmetic industry. It advocates the collective interests of more than 100 cosmetic ingredient companies.

6 Safe Cosmetics and Regulatory Compliance: From Burden to Opportunity (Cosmetics as Vectors for Bioterrorists?) Preston W. Blevins CFPIM, CIRM, CSCP BatchMaster Software, APICS District Director, Oceanside, CA, USA

6.1 Introduction The personal care industry has historically been very progressive on regulatory compliance requirements and has recently moved even more aggressively as evidenced by the second annual HBA (Health & Beauty America) Regulatory Summit, with a name change by CTFA to the Personal Care Products Council (PCPC), a change to better reflect its mission and the enhancement or extension of its Consumer Commitment Code, an obligation and pledge PCPC members must adhere to. The Consumer Commitment Code is focused on world-class operating performance, accurate record keeping, and product safety. The sum of many years of concern for the safety of the personal care consumer and the implementation of effective measures has placed the industry in a unique position: it is the only industry whose chemistry-based products are for all practical purposes self regulated, at least with respect to the US market. Food and beverage, nutraceutical, K. Lintner (ed.), Global Regulatory Issues for the Cosmetics Industry Vol. 2, 93–120 © 2009 William Andrew Inc.

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and pharmaceutical manufacturers cannot all make this claim; regulatory compliance has been imposed on them. Concerns centered on bioterrorism have driven the many new regulatory compliance requirements. The message is that the discipline and required rigor of regulatory compliance lays a foundation for world-class operations, inventory, and supplychain management. Regulatory compliance is not expenditure; it is an investment with a significant return on investment. This discussion will cover the following:      

Regulatory compliance in related industries The biotoxin attack simulation Regulatory compliance—the implied requirements Satisfying the implied requirements Leveraging the implied requirements The return on investment (ROI)

6.2 Regulatory Compliance in Related Industries The principle of the slight advantage applies to this topic; a slight advantage can be leveraged into a big reward. Every aspect of life highlights the validity of this principle, in sports or in any competition. Using golf as an example, the top money earner has only a small percentage advantage over the individual in tenth place, but the reward (money earnings) is significantly greater. There is an axiom that states “if you do not measure it, it will not improve.” Another is that competitive benchmarking helps establish strategic direction and goals. In the context of regulatory compliance, what is happening in related industries may ultimately become a requirement for the personal care industry. Early volunteers’ adoption of risk mitigation procedures also help customers evaluate and chose progressive suppliers. A brief update on what is happening in related industries whose products are chemistry based follows. 6.2.1 Pharmaceutical

This is the most regulated of related industries. Those manufacturing overthe-counter products are subject to the same level of regulatory oversight

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as pharma manufacturers. “Cosmeceutical” products may fall into this same category (but see Chapter 7). When a regulatory requirement is placed on the pharmaceutical industry, it eventually is imposed or adopted by other industries producing chemistrybased products, particularly those products that are ingested or applied to the body and thence absorbed. This particularly impacts those who are contract manufactures: even if the Food and Drug Administration (FDA) does not demand it, the customer will. Risk mitigation is a critical consideration for them. An example of this is 21 CFR Part 11, Dual Electronic Signatures. Its purpose is to make sure the responsible executive or person authorizes or approves an activity, policy, or procedure. Many outside of the pharmaceutical industry are using this same protocol to secure formulation development, and management. There are two new developments that are worth noting. One is the expectation that good manufacturing practice (GMP) requirements will be revised. In the past, the FDA has moved forward at a deliberate pace and did not rush the process of developing and releasing compliance obligations. Near term could mean sometime in the next few years. If we examine the new GMP requirements (which we will do shortly) for supplements, the quality and completeness of the guidelines is viewed by many industry authorities as vastly superior to previous efforts, particularly in trying to educate the manufacturer as to the FDA’s intent and expectation. The other development is the Pedigree Law. Its intent is to end counterfeiting of drugs by managing the traceability through all the levels of the distribution chain of any drug. The noteworthy book, Dangerous Doses [1] chronicles the counterfeiting of high-value drugs in Florida. There are two reasons for this proposed law; one is the economic impact on the drug manufactures, the other the safety of those under treatment who if they do not receive the prescribed medication might die. The really interesting component of the proposed law is the technology component. The FDA is proposing the use of Radio Frequency Identification Device (RFID) technology. RFID is defined in Wikipedia, the online dictionary as: “An automatic identification method, relying on storing and remotely retrieving data using devices called RFID tags or transponders.” An RFID tag is an object that can be applied to or incorporated into a product, animal, or person for the purpose of identification using radio waves. Some tags can be read from several meters away and beyond the line of sight of the reader.

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Most RFID tags contain at least two parts. One is an integrated circuit for storing and processing information, modulating and demodulating a radio frequency (RF) signal, and can also be used for other specialized functions. The second is an antenna for receiving and transmitting the signal. A technology called chipless RFID allows for discrete identification of tags without an integrated circuit, thereby allowing tags to be printed directly onto assets at lower cost than traditional tags. Today, a significant thrust in RFID use is in enterprise supply-chain management, improving the efficiency of inventory tracking and management. The key development and contribution is that RFID will move into the mainstream and be used by formula-based manufacturers to deliver very accurate identification of products, their movement, and thereby a reduction in clerical administrative costs. 6.2.2 Safety Aspects in Food and Beverage

This is the largest formula-recipe based vertical industry worldwide. In North America, there are tens of thousands of food manufactures. There are many microindustry supply-chains. It is an extremely complicated industry to regulate in terms of size and an increasingly global supply-chain. Food manufacturing has become highly centralized and many microverticals are extremely efficient in the distribution of products to the end consumer. Since 9/11 and the passage of the USA Bioterrorism Act, the food industry has had what was in some cases informally imposed controls, which are now enforced formally and by law. A recent study by a respected magazine dedicated to the food industry and its potential problems highlighted the need to understand what a “cause” is and what an “effect” is and the relationship between the two. The survey was conducted by Food Engineering and the top ten critical issues list reads as follows: 1. 2. 3. 4. 5. 6. 7. 8.

Food safety Automation Skilled labor Product traceability Systems integration Maintenance improvements Supply-chain integration Increased capacity

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9. Employee training 10. Improved changeover The initial impression is that the issues are stand alone and are separate issues. In fact they are highly interrelated. Understanding what is the root of a problem versus reacting to the symptom is a key to leveraging regulatory compliance into a competitive advantage. A different view of the top ten list is depicted in Figure 6.1. The most pressing regulatory requirement obligation for most food manufacturers is lot traceability. The USA Bioterrorism Act, Title 111, Subtitle A, Records Maintenance (306) stipulates that a full lot trace history must be presented within twenty-four hours of a request (demand?) from the FDA. A lot trace history must be one up and one down. In practice, particularly for contract manufactures, the real-world demand is four hours and more than one up and one down: risk mitigation rules! There is an interesting trend within the food industry that relates not only to food safety but also to product quality. The evaluation of processes, in combination with the nature of the products being manufactured, using a methodology developed for early space astronauts is becoming the norm, not the exception. This methodology is Hazard Analysis Critical Control Point (HACCP). In some food microverticals, the FDA requires an HACCP plan be developed and adhered to, to minimize the risk of tainted or corrupted food. In other microverticals, it is voluntary. There is a clear trend 1 – FOOD SAFETY

4 – PRODUCT TRACEABILITY

2 – AUTOMATION

8 – SYSTEMS INTEGRATION

3 – SKILLED LABOR

9 – EMPLOYEE TRAINING

7 – SUPPLY CHAIN INTEGRATION

Figure 6.1 Integrated priorities in assuring food safety.

6 – MAINTENANCE IMPROVEMENTS

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worldwide to embrace HACCP voluntarily. A company using and rigorously applying the HACCP methodology has the same acceptance as a manufacturer of quality products as those with ISO 9001:2000 certification. Quality sells! There is a new ISO standard called ISO 22000 that combines ISO 9001 and HACCP. The key point is that an ever growing number of manufactures are analyzing, evaluating, and refining processes and this pre-emptive mind set is becoming the norm not the exception. There is another methodology used by advocates of Lean Manufacturing called Value Stream Mapping (VSM) that is designed to identify wasted time, unnecessary movement of product, and so on and to prioritize the reengineering of processes. Many manufacturers are now considering applying both methodologies at the same time, HACCP for food safety and quality and VSM to eliminate waste and increase efficiency and productivity as well as minimize the time a batch spends in manufacturing. This is a good example of how cross-industry competitive benchmarking can bring opportunities to improve the manufacture of personal care products and gain competitive advantages. 6.2.3 “Nutraceuticals”

There has been a significant development in the “nutraceutical”/nutritional supplements community this year. The FDA has after ten years of deliberation, released GMP requirements specific to the manufacture of nutritional supplements. Finally, this industry has separated itself from their figurative cousin, the food industry. The FDA has done a noteworthy job of listening, collaborating, and communicating everything related to the new regulations. An 800-page preamble to the actual requirements shows their commitment to helping this industry comply and to safeguarding the interests of the consumer. What the new GMPs highlight is the need for rigorous and accurate record keeping. A number of industry trade associations have collaborated and recommend standards in a number of areas to the industry and FDA. One standard is the content of a Certificate of Analysis (COA), which should come in a six part format. Another is the recommended standardization of a vendor–supplier evaluation and certification. Both initiatives bring considerable value to industry in consistency of communication, ability to evaluate objectivity, product safety, and organizational performance. What is also significant is the involvement of professional societies such as the American Society of Quality (ASQ) in communicating the new requirements, encouraging compliance with the requirements, and educating quality professionals as to their obligations.

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It is recommended that progressive executives in the personal care industry track the implementation of these new requirements over the next few years and adopt the discipline required to implement them. Earlier the principle of the slight advantage was discussed, it applies here. 6.2.4 Possible Catalysts for Future Regulatory Compliance Requirements

The amount of imported end products and raw materials has dramatically increased and there are no indications that it will level off in the near future. Sourcing of raw material is now global. The recent experiences with some tainted products and raw materials from the People’s Republic of China have made quality at source a major concern. Revised manufacturing practices have in some cases created problems, an example is the work done during harvesting of food in the field that previously was done in a controlled factory environment. These situations have lowered consumer confidence in product safety to the point that buying habits have changed because of them. This in turn has spurred elected politicians into action. When politicos need to impress their constituents that they are taking action to improve the situation, new regulatory requirements will surely follow. 6.2.5 A Mini Summary

Regulatory compliance is an investment not an expenditure. One way of staying ahead of the situation is studying the developments of other industries whose products are chemistry based and regulated. Competitive benchmarking is a proven method of identifying emerging best practices. Those that adopt and implement them successfully gain competitive advantage. All industries whose products are chemistry based are under increased regulatory compliance requirements. The food industry has been put under intense pressure as a result of the Bioterrorism Act. Control of processes and quality have emerged as key company differentiators. The nutraceuticals industry finally has, after a ten-year wait, new and comprehensive GMP guidelines.

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The increased sourcing of raw materials on a global basis and some highly publicized product recalls are surely to generate more stringent regulatory requirements developed in the future.

6.3 The Biotoxin Attack Simulation Bioterrorism is a real threat. The FDA thinks so; it has initiated a number of major projects that go beyond product safety. For the food industry this has taken the form of food defense with food safety the foundation. One project was the development of computer software to simulate a bioterrorism attack on the food supply-chain. This software was developed by food industry executives together with a food safety center at the University of Minnesota. The software has a database of the properties of various toxins, the medical impact of each toxin, product distribution lead times for various consumable products, historical rate of consumption of a batch by consumers, mortality estimations, and other properties. A goal of the system designers was to allow companies to simulate various scenarios and put in place safeguards based on what was learned in the simulations. The system simulates everything simultaneously and in accelerated time. It was named the Consequences Management System (CMS). In 2006, this system was demonstrated in various food industry forums. One simulation had a biotoxin mixed into a large batch of ice cream, the manufacturing location was in the Midwest and near a large city and the batch was produced in the summer. The toxin chosen has the ability to distribute and blend evenly throughout the batch making the calculation of the dose needed to infect damage on the consumer easy to calculate. Normal testing would not identify the toxin since it was not known to be a common corrupting condition for the manufacture of ice cream. To increase the chances of survival of a person who had ingested this contaminated ice cream they would need a respirator. The results of the simulation were devastating. In it, thousands were hospitalized and thousands died. If it could happen in a batch of food, it could happen in a batch of lotion, creams, or sprays. The toxin could take time to have a medical effect making it even more difficult to track down the source and initiate a product recall. A simulation screen from CMS is illustrated in Figure 6.2.

Figure 6.2 A simulation screen from the Consequences Management System software.

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6.4 Regulatory Compliance—The Implied Requirements The theme of this chapter is regulatory compliance, “from burden to opportunity.” A key to understanding how to make that transition is examining the implied requirements of a few regulations that have their origin in the Bioterrorism Act. One section of the act defines record keeping requirements. These requirements include lot traceability of all ingredients that go into a batch, the batch itself, and who the batch was sold to. A lot trace number must be on every raw material, intermediate, and finished good in the receiving area, QA/testing areas, warehouse, and factory. Many organizations embed the supplier’s lot trace number into their new unique number. A lot numbering scheme must be consistent. The purpose of this lot tracing record keeping requirement is to facilitate a rapid, targeted product recall if needed. Restated, its purpose is to protect the public from tainted products. There is a time response obligation in the regulation that requires a submittal of all lot trace and related information within twentyfour hours when demanded by the FDA or other regulatory authorities. Those operating as contract manufactures often have a response time of four hours imposed on them. Complicating the situation, it is not uncommon for the small-to-medium size manufacture to maintain all this information on multiple spreadsheets’ making the capture and organizing difficult to meet the required response time obligation. For those using spreadsheets there is another problem, the accuracy of the lot-trace information. Just one incorrect lot trace record can create havoc on the whole recall. A number of manufacturers have had to recall far more product than necessary because of data accuracy issues. If the lot trace records must be accurate then every transaction recorded as well as related maintained data must be accurate. Examples of what must be accurate: 





The formula—If there is an error and material is substituted during inventory issuing of material or done at batching there is the possibility of inaccurate information for the batch Work or batch instructions—If important instructions are omitted there will be problems particularly in the case of quality assurance procedures. If instructions are incorrect the operatorworkers will perform work that might not get recorded. Many recalls are related to faulty factory equipment. Receiving and shipping—Transactions must be accurate and complete

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Inventory records—The physical count and the inventory record must match, including lot numbers. The stockroom/warehouse—Put-away and issuing transactions must be accurate Factory reporting—Every work activity must be recorded and be accurate

For all of this to be realized there are a number of organizational and process disciplines that must be in place: 















Defined procedures and processes—GMP requires defined procedures but reducing data errors and mistakes in general needs more forethought. Rationalization and standardization is needed. Organized work areas that incorporate efficient workflows— Disorganized work areas increase the probability of making mistakes. The inefficient flow of work encourages shortcuts and data entry errors. Organized inventory storage areas—Logically organized, secured access to authorized personnel only, and a clean inventory storage areas promote data accuracy and increased productivity. Education and training—On the impact of inaccurate data on company profitability and its inherent risk to effective regulatory compliance. Each individual needs to understand how what they do impacts others and what proven techniques can help them achieve and maintain the required level of data accuracy, more on these techniques later in the chapter. Separate and secure quarantine areas—Comingling can lead to unauthorized materials being used. Convenient data input—Making reporting easy and convenient increases the probability that all data will be reported and done so in a timely fashion. Centralized data—Data do not exist in a vacuum, they are part of a history and contribute to the status of an activity or item. Accurate data are the basis for effective planning and control—Maintaining unintegrated data in the form of multiple spreadsheets makes cost effective regulatory compliance very difficult if not impossible.

The discussion to this point has centered on the need for data accuracy and the reasons for it but not the target level of accuracy. Unfortunately there

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is not a personal care set of accuracy metrics for regulatory compliance but there has been a set of long accepted targets for those who make products such as toasters, computers, airplanes, and electronic “widgets.” The targets:   

Formula accuracy—98% Inventory record accuracy—98% Shipping history accuracy—99%

There are many more measures, but those noted suggest that a very high level of accuracy is needed.

6.4.1 A Mini Summary

Regulatory compliance is an investment not an expenditure. Keeping track of regulatory requirement developments in related industries can be a source of competitive advantage if appropriate developments are implemented in a personal care product manufacturer’s environment. Very high levels of data accuracy are required to satisfy the implied requirements of product safety regulatory compliance. Achieving the required level of data accuracy mandates that all reporting related to formulation development and maintenance, procurement, inventory handling, production, and QA must be accurate.

6.5 Satisfying the Implied Requirements In the early parts of this chapter, we described what was needed, why it was needed but not how to satisfy the need. The “how” will now be discussed through examination of the following:       

Process-batch Enterprise Resource Planning (ERP) Organize the workplace—“5S” and Lean Manufacturing Making transactional reporting easier Data security and validation Compliance integrated into work activities Visibility into the warehouse (stockroom) and factory operations Cycle counting

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6.5.1 Process-Batch Enterprise Resource Planning

ERP is an integrated set of “best practices” covering all of the activities of a manufacturer. It was designed to be deployed using computer software to speed up data gathering and mathematical calculations and create a single unified database (in contrast to independent unconnected spreadsheets). ERP is the result of over thirty years of progressive development and had four major developmental milestones: Material Requirements Planning (MRP), Closed Loop MRP, MRP2, and finally ERP. The patrons of the evolution of ERP were large corporations who could fund the research and development of each step in its evolution. Originally the predecessors of ERP were designed to support a style of manufacturing called “discrete.” Discrete means the production of hard tangible products in batches. These products are used, in contrast to the personal care industry whose products are applied. Over time, enhancements to the ERP model was made to support those producing products continuously, those who manage projects, and those who operate in a regulated environment. ERP also incorporated emerging philosophies such as Lean Manufacturing, Total Quality, Six Sigma, and so on. The cost of computing and associated software costs have come down to the point of being cost effective even for very small companies. Another relatively recent development is the adaptation of ERP for those using the process-batch style of manufacturing such as the personal care industry. ERP is a key contributor to achieving data accuracy and leveraging it into bottom-line profits. It centralizes all data, creates a uniform way of inputting, extracting, and organizing data to facilitate good decision making. ERP also can edit information as it is entered into the system and alert those entering information if it is incorrect: an example is the validation of the raw material with lot-trace number combination. Figure 6.3 is a simplified top-down depiction of ERP for the personal care industry. The reason ERP is discussed first is that it is the foundation for other contributing methodologies or techniques to leverage compliance, and it creates boundaries to preserve the improvements made by other techniques and also makes visible other opportunities for improvement. 6.5.2 Organize the Workplace—“5S” and Lean Manufacturing

Sometimes simple techniques produce significant advantages. “5S” (Five “S”) is one of those techniques. Its central message is that an organized

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Figure 6.3 Diagram of ERP structure.

clean work area fosters improved productivity, reduced confusion, reduced mistakes, and less data accuracy problems. “5S” originated in Japan and it stands for: 1. 2. 3. 4. 5.

Sort Straighten Shine Standardize Sustain

Figure 6.4 depicts the purpose of “5S”—eliminate the confusing mess. What important unreported transaction is at the bottom of a pile of paper in the illustration? What undocumented inventory is kept in production? Cleaning up every work area puts procedural deficiencies in the spotlight: informal procedures whose existence and content is known only to a few

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Figure 6.4 “5S” principles in need of application.

people will become easier to see and formally to incorporate into official corporate procedures; or it will allow to take action to eliminate them if they cause data inaccuracy or add no value to the information or product flows. Another simple but powerful technique is Value Stream Mapping. The purpose of this technique is to identify opportunities to eliminate waste in the form of unproductive time and product movement. If value is not being added it is classified as waste. Product that is sitting for any period of time without value being added is a waste of the time and the money invested in it to date. VSM combines product movement with the information system to support it, no matter the form, spreadsheets included. It is simple, very visual and helps create focus on the areas that need “reengineering”. A recent mapping project looked at one product family and found that the end-to-end lead time was 41 days and the actual value added was 1.5 days. That means money was tied up for almost 40 days before being released through a shipment. Imagine the economic benefit if the total lead times could be reduced by 25% or more.

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On the data accuracy requirement, unconvoluted processes make achieving accuracy earlier. A survey conducted a few years ago showed that over 60% of manufacturing companies, irrespective of industry were engaged in a Lean Manufacturing initiative with “5S” and VSM being the favorite methodologies. Many consider the book Learning to See: Value Stream Mapping to Add Value and Eliminate Muda by Mike Rother and John Shook [2] to be the definitive text. VSM is also strongly associated with improving total quality. It is often taught along with Six Sigma at universities and through courses offered by professional associations. The Six Sigma approach is a set of concepts and practices that key on reducing variability in processes and reducing deficiencies in the product [3]. The respected professional association, the ASQ, even offers certification on Six Sigma [4]. 6.5.3 Making Transactional Reporting Easier

If reporting any activity is difficult or inconvenient, workers and staff will either not report it, or occasionally forget to report the activity, or inadvertently enter some incorrect information. Entering data into multiple spreadsheets or paper-based documents does not make for a transaction friendly environment; this in turn creates opportunities for data inaccuracy. With the cost of a modern computer based ERP system and the declining cost of personal computers (PC), putting a PC at the point of work being performed is economical. Today, almost all workers are PC literate. An ERP system does not need all the data to report a transaction, it only needs the key identifying data, that is, ingredient ID or batch ticket number or lot number and most of the previously stored information will be retrieved and presented to the individual reporting a new activity. At that point, only the new information needs to be entered. An additional advantage of an ERP system is that it will edit the newly entered information against the existing stored information; that is, do the ingredient being issued and the associated lot number match the existing inventory record information, yes or no? If not, the person reporting will be notified of the mismatch and asked to take corrective action. The recent convergence of mobile phone technology and bar-coding has made mobile reporting devices very cost effective. They are the size of a smart mobile phone.

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This development puts the ability to report at the exact point in which work is performed and minimizes the amount of data that must be entered by using one or more bar-codes printed on a specific bin or document. These devices communicate in real-time to the ERP system and it edits the transmitted data for validity and accuracy.

6.5.4 Data Security and Validation

Unauthorized entering of data or access to it can contribute to inaccurate data. An ERP system has a centralized and complete database on every transaction associated with a product, formula, customer, department, supplier, inventory, customer order, purchase order, work-cell, schedule, batch, QA, costs, and financial ledgers. Access to the ERP system is controlled through a role that each system user has assigned to them. They can only see and enter information they have been preauthorized for permissions. The regulatory authorities created a standard called 21 CFR Part 11 to provide guidance to manufacturers. The early adopter of the standard was the pharmaceutical industry. Over time, this standard has been implemented as a de facto standard by other regulated industries whose products are chemistry or nutritionally based. One specific requirement for critical information transactions is Dual Electronic Signatures (DES). The second electronic signature is an affirmation by an authorized individual that the electronic record is correct. The FDA has recommended that the electronic signature be applied to any transaction that was previously required in a paper-based environment. An example were it might be applicable for a personal care products manufacturer would be in the creation of a new formula or modifying an existing formula or in creating a claim statement. A properly designed process-batch ERP system will support both 21 CFR Part 11 and DES.

6.5.5 Regulatory Compliance Integrated into Work Activities

It is very difficult to achieve the required level of data accuracy by treating regulatory compliance obligations as an afterthought. When they are treated as an afterthought, any activity becomes expensive in a hidden and bottom-line, profit-destructive way, and the probability of success is greatly compromised. There is an axiom in operations management—“garbage in, garbage out” that applies to those who try to accommodate operation needs and regulatory compliance requirements separately. The prevalence of

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spreadsheets in many personal care manufacturers suggests there is a big opportunity for improvement. Every transaction in the logistics, inventory management, and manufacturing process requires data to support regulatory compliance. The needs of both operational efficiency and compliance must be designed in and integrated. A properly designed process-batch ERP system accommodates both needs by incorporating them with just a few extra key strokes per transaction. 6.5.6 Visibility into the Warehouse (stockroom) and Factory Operations

Many if not most small-to-medium personal care product manufacturers, particularly those operating off multiple disconnected spreadsheets, paperbased records, and older computer systems have very poor visibility into the warehouse and factory operations. There is a solution, the modern computer-based batch-process ERP system has been designed to provide maximum visibility and controlled access into the enterprise through an extensive menu system with controlled privileges. An analogy of a building seems appropriate; controlled entrance through highly secured doors and visibility through many windows. Instant access to the current status of any item in inventory, its associated lot traceability information, available balance, lot expiration date, lot strength and costs, and so on makes investigating problems and making decisions for a corrective course of action much easier. Combine this with the ability to instantly retrieve when an item was issued, to what batch or customer and which warehouse staff person performed the transaction: the ability to track down the root cause of data accuracy errors significantly improves. Similar visibility exists for the status and history on production batches: what batch is currently open, how far along is it toward completion, what ingredient lot numbers were issued to it, in what production cell is it being blended, what is the QA status, what is the next operational step, who worked on it, when is it scheduled to be completed, and so on. Visibility is a key to achieving the required level of data accuracy if it is used properly. 6.5.7 Cycle Counting

An important contributor to data accuracy and leveraging regulatory compliance into a competitive advantage is cycle counting. The designed purpose

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of cycle counting is to improve inventory record accuracy, which will ensure that the written or computerized record of what is in inventory matches the actual physical count in the warehouse and at the designated storage location. A secondary purpose is to eliminate the annual physical inventory reconciliation that many companies engage in for a variety of reasons. Cycle counting is a technique that has proven effective for over thirty years and is taught in many inventory management courses by universities, professional societies, and associations and for profit educators. It is a technique accepted by most financial audit firms to replace the annual inventory to accurately record the valuation of inventory. Conventional thinking places inventory as an asset, but this perception is in conflict with the inventory management philosophy embedded in ERP that attempts to match supply with demand and minimize residual inventory and classifies excess inventory as waste in that it is money inefficiently stored that could be used or invested with a more productive purpose. There are several variants of cycle counting. The basic approach uses a technique called A, B, C classification that is based on the Pareto Law. Pareto’s Law states that 80% of anything typically occurs within 20% of a population (the 80/20 rule). Cycle counting segregates items by annual usage and total valuation of each item. “A” items have the highest annual financial value based on recent historical usage. The “A” items are counted more frequently than the “B” items that in turn are counted more frequently than the “C” items. The physical counting of items is preplanned based on the ABC classification and are scheduled to be performed in small batches daily. Those who perform a cycle count must be individuals capable of counting in a disciplined and precise manner. While one might assume everyone is capable of this performance, actual testing suggests otherwise. The inclination to be precise and training is required to be an effective cycle counter. The one variant of cycle counting that is most effective is “control group cycle counting.” Its purpose is to not only synchronize the physical count with the recorded count but also in the case of an inaccuracy to identify the root cause that created the inaccuracy by identifying the procedure, circumstance, and individual who made the error and put in motion corrective actions to eliminate it from occurring in the future.

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6.5.8 A Mini Summary

Regulatory compliance is an investment not an expenditure. The CMS software system, an FDA initiative that allows companies to simulate a biotoxin terrorist attack, highlights the obligation to make product safety a priority that supersedes normal business profit and loss considerations. High levels of data accuracy are required to satisfy the implied requirements of product safety regulatory compliance. The current industry situation, widespread use of disconnected information systems highlights the fact that there is much work to be done to meet or to exceed the implied requirements. Satisfying the data accuracy prerequisites lays the foundation for leveraging regulatory compliance into a competitive advantage and an increased bottom-line profit. There are seven key “ingredients” that contribute to this foundation: 1. Process-Batch ERP—A comprehensive planning and control framework based on proven best practices that utilizes a common integrated database. It is superior to the approach used by many personal care products manufacturers that are trying to maintain multiple spreadsheets that at best result in disconnected views of information and poor data quality. 2. Organizing the Workplace by Applying “5S” and Lean Manufacturing Techniques—By applying workplace rationalization and simple analysis techniques to simplify, mistake proof procedures, and eliminate the waste of time, movement, and money throughout the enterprise. 3. Making Transactional Reporting Easier—By placing personal computers networked to the process-batch ERP system using a user interface familiar to the workforce in a location easy to access by authorized personnel. Also, by using bar-code wireless devices to minimize human data input and recording data at the actual point where work is performed. 4. Data Security and Validation—By thinking through who should access or enter specific information and assigning authorizations in combination with the security features of a process-batch ERP. Controlling access improves data

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accuracy and leaves an audit trail on who did what. The real-time editing features of ERP alert authorized users of potential data inaccuracies. 5. Compliance Integrated into Work Activities—The separation of normal transaction reporting and the data needed for compliance record keeping creates a high probability of data inaccuracies. Compliance record keeping requirements must be designed into normal record keeping transactions with minimal number of additional keystrokes. A properly designed process-batch ERP system addresses this requirement. 6. Visibility into the Warehouse (Stockroom) and Factory Operations—If a problem is not easily seen, it is not easily solved. Authorized visibility into all areas is needed for prompt corrective action. Prompt corrective action improves data accuracy. process-batch ERP has predesigned “windows” that provide the visibility needed to take prompt corrective action. 7. Cycle Counting—Inventory record accuracy is a cornerstone for achieving the required accuracy implied in regulatory compliance obligations. Cycle counting is a proven technique that not only helps keep the actual physical count in the warehouse and recorded inventory record in sync, but also helps identify the root cause of the inaccuracy, setting the stage for corrective action.

6.6 Leveraging the Implied Requirements The theme of this chapter is that product regulatory compliance and the disciplines needed to comply with it can be leveraged into financial “bottom-line” benefit. The contributor to this bottom line is superior inventory management. Inventory is the largest operating cost for most manufacturers. ERP is the overall foundation for leveraging compliance but the specific engine for inventory planning and control is that old faithful tool, MRP. It requires high levels of data accuracy to extract the full benefit from it, just like the high levels FDA record keeping demands. MRP is proven, there is extensive knowledge on how to implement it and effectively use it. It can produce an excellent ROI as a study by Clemson University has shown. We will discuss the Clemson study later in Section 6.7.

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According to the APICS Dictionary (12th edition [3]), MRP can be defined as: A set of techniques that uses bill of material data, formulation data, inventory data, and the master production (shipping) schedule to calculate requirements for materials. It makes recommendations to release replenishment orders for material. Further, because it is time-phased, it makes recommendations to reschedule open orders when due dates and need dates are not in phase. Time-phased MRP begins with the items listed on the MPS (shipping schedule) and determines (1) the quantity of all components and materials required to fabricate those items and (2) the date that the components and material are required. Time-phased MRP is accomplished by exploding the bill of material and formula, adjusting for inventory quantities on hand or on order, and offsetting the net requirements by the appropriate lead times. Note: The italicized insertions are by the author and are intended to clarify the definition for those not involved in manufacturing operations. Figure 6.5 highlights MRP’s role in the process-batch ERP framework. APICS-certified practitioners know and understand the underlying calculating logic for MRP, but the majority of small-to-medium sized manufacturers do not and it is hoped that they will read this chapter and take the appropriate action. The logic of MRP is designed to calculate time-phased requirements based on actual, or a combination of actual and planned demand. Incoming demand can come from the Master Production Schedule (MPS) or directly from customer orders. It is designed to balance supply and demand. The information needed is:          

The demand item Its current inventory Current time-phased open commitments Its estimated lead time Its recipe and bill of material Current inventory status of the ingredients needed The current time-phased commitments for each ingredient The lead time for each ingredient Time-phased work-in-progress orders for each ingredient Time-phased purchase orders for each ingredient

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Figure 6.5 MRP is a key to successful ERP implementation.

MRP takes all this data from the ERP database (see the green graphical representation in Figure 6.5) and calculates:    

What is needed? How many? When it should arrive in inventory? When the replenishment activity should begin?

6.7 The Return on Investment Earlier a study conducted by Clemson University on the benefits of using ERP was referred to. The study was published in the APICS Journal. It confirmed the results noted in a study conducted a decade earlier by the University of Minnesota. The referenced study was centered on manufacturing firms in South Carolina, USA, and included companies using the process-batch style of manufacturing. A questionnaire was sent to the

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president or plant manager of 300 different firms that were randomly selected: 107 responded and 33 used MRP, the ingredient planning engine of ERP. The study covered five different metrics that impact business performance and profitability and presented the results in three different time dimensions: pre-ERP, current, and a future estimate of improvement as listed in Table 6.1. An explanation of each metric, how it is calculated, and its benefit. Inventory is the largest single cost for a manufacturer. It represents stored money and there is typically much more than is needed. One performance measure for determining effective inventory management is inventory turns. The APICS Dictionary provides the following definitions: 





Inventory turnover: The number of times that an inventory cycles, or “turns over,” during the year. A frequently used method to compute inventory turnover is to divide the average inventory level into the annual cost of sales. For example, an average inventory of $3 million divided into an annual cost of sales of $21 million means that inventory turned over seven times. Cost of sales: The total cost attached (allocated) to units of finished product delivered to customers during the period. Cost of goods sold: An accounting classification useful for determining the amount of direct materials, direct labor, and allocated overhead associated with the products sold during a given period of time.

Reducing inventory frees up cash for investment in other organization capabilities to improve competitiveness, or it can be given as a dividend payout to shareholders—owners. How much cash can be freed-up? The Clemson

Table 6.1 Estimates of Improvement in ROI after ERP Implementation Metric Inventory turns Lead time (days) On-time delivery (%) Order splits (%) Number of expeditors

Pre-ERP

Current Estimate

Future Estimate

4.5 55.6 73.9 29 10.8

7.9 41.7 88.6 13.5 5.1

11.2 31.8 94.6 2.1 2.1

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study documented that the average annual inventory turns improvement went from four to eight turns, in effect a 50% reduction in inventory! The future expectations of the respondents exceeded the current reported performance. Short delivery lead times create a competitive advantage. Many customers have adopted “Lean Thinking” and want to carry the smallest amount of inventory. If the lead time quoted by supplier “A” is four weeks and supplier “B” quotes three weeks, it means that if “A” is selected the cost of carrying inventory for an additional week is incurred. Projected over the entire inventory of all items held and looked at from a cumulative perspective, the sum of “dead” money invested is substantial. The ability to quote short lead times and ship customer orders consistently on time is a major competitive advantage, particularly when vying with offshore competitors. Predictable, short lead times are viewed as responsiveness by customers. While the lead time reductions listed in the report are impressive, the author has seen dramatically more impressive results in many companies. On-time delivery percentage warrants a definition. The APICS Dictionary defines it as: “A measure (percentage) of meeting the customer’s originally negotiated delivery request date. Performance can be expressed as a percentage based on the number of orders, line items, or dollar value shipped on time.” Note that “negotiated” delivery is in the definition. If the negotiated delivery is greater than the competitors, it might not result in a customer order. Short lead times and on-time delivery in combination are powerful competitive differentiators. Customers value consistency in price competitiveness, responsiveness, quality, and “on-time delivery” from suppliers. When these measures are satisfied, the probability of increased sales is likely. Another benefit is forecasting cash flow. If a company shipped at almost 95% on time, it can look to its accounts receivable ledger and have confidence in projected cash flow and plan accordingly. Order (batch) splitting is a symptom of raw material shortages resulting from inadequate inventory planning and/or poor scheduling or the inability to commit to realistic delivery dates to customers. The problem with

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order splitting is that it compromises the economics used when pricing the customer order and could result in significant profit erosion or loss. Reducing order splitting is really about margin protection. It also reduces the need for “expeditors.” The number of “expeditors” is a direct reflection on the quality of planning, scheduling, and executing to plan. Poor business procedures and discipline generally result in a large number of expeditors. “Expeditors” are a special breed. They understand manufacturing and are adept at “making things happen,” are creative and not averse to breaking a few business rules. Their role is to get important shipments out the door when planning and control systems fail. Because of their skill sets and inclinations a good expeditor in a poorly run company is in high demand and is compensated well financially. The fully loaded cost for these individuals is very high. Their costs are rolled up into company overhead expenses. It is not uncommon for the Chief Executive Officer (CEO) and other senior executives to assume the informal role of an expeditor when they should be focused on strategy, leadership, and operational excellence. In the Clemson study the number of expeditors pre-ERP numbered on average almost eleven per company. The operations practitioner subscribing to the Lean Thinking philosophy would suggest they are basically “waste” and the underlying need for them, poor scheduling, and controls must be eliminated. A key achievement of those in the study was a reduction of expeditors to an average of five with an expectation and target of getting down to two. This is a significant reduction in variable overhead costs and a positive contribution to the bottom line. Perhaps the greatest achievement not reported in the study when discussing the reduction in the number of expeditors, was the freeing up of the senior management’s time to focus more of their time on critical business issues and organizational opportunities for improvement. How to calculate a ROI has been known and widely used for many years. Figure 6.6 depicts the flow of calculations. Disciplined and rigorous regulatory compliance can be leveraged into operational excellence and improved bottom-line profit improvement. Regulatory compliance can be moved from a “burden into an opportunity” as the title of this chapter asserts.

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Figure 6.6 Basic formula of ROI calculation.

6.8 Conclusion Instead of writing another summary of the entire chapter, we suggest to the reader to draw his/her own conclusions by taking a short mini quiz below in which the quintessence of this chapter should stand out: “Regulatory compliance is not a burden but an investment, not an expenditure but an opportunity.” Please reflect on the major points discussed in this chapter and describe the three most important items for each of the following: 





Regulatory compliance in related industries 1. 2. 3. The biotoxin attack simulation 1. 2. 3. Regulatory compliance—the implied requirements 1. 2. 3.

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Satisfying the implied requirements 1. 2. 3. Leveraging the implied requirements 1. 2. 3. The return on investment 1. 2. 3.

References 1. Eban K., Dangerous Doses: A True Story of Cops, Counterfeiters, and the Contamination of America’s Drug Supply, Harcourt, 2006, ISBN-13: 9780156030854. 2. Rother M., Shook J., Learning to See: Value Stream Mapping to Add Value and Eliminate Muda, Edition 1.3, Lean Enterprise Institute, 1999, ISBN: 9780966784305. 3. APICS Dictionary, 12th Edition, http://www.apics.org/default.htm. 4. American Society for Quality, http://www.asq.org/.

7 Cosmeceutical (Antiaging) Products: Advertising Rules and Claims Substantiation Wen Schroeder SEKI Cosmeticals, LLC, Appleton, WI, USA

7.1 Introduction 7.1.1 The “Cosmeceutical” Era

According to a market research report published in February 2005 by BCC Research, baby boomers’ unprecedented purchasing power, coupled with the youth-dominated cultural shift, and modern technological advancement have fueled a rapidly growing US antiaging industry that exceeded $45.5 billion in 2004; $7.7 billion of which was spent on appearance products alone. The annual growth is expected to continue at a stunning rate of 9.5% and the market is expected to reach $72 billion by 2009 [1]. Another market trend report published by the Packaged Facts in 2005 stated that sales of “cosmeceuticals” in the United States would reach $12.4 billion in 2004 (of which $6.4 billion is for the skin-care products) and continue to grow to over $16 billion by 2010. The new product trends would center on “antiaging everything” with a strong demand for botanicals [2]. The annual

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global spending on over-the-counter (OTC) cosmetics and cosmeceuticals to enhance appearance is at an all time high of $230 billion [3]. We have indeed entered the era of “cosmeceutical everything”. Apparently, baby boomers’ obsession to remain forever young is not new. Mankind’s quest for eternal beauty, health, and youthful appearance started at the age of dawn. The current and projected bright outlook of the business is motivated and fueled by the baby boomers’ relentless lust for eternal youth, and further enabled via the seemingly endless supply of new scientific discoveries of the aging process and fantastic claims of more effective delivery systems and exotic new ingredients often touted as the next best “something-ceutical.” A significant amount of media coverage has been devoted to the topic of antiaging in recent years. Antiaging medicine practitioners claim that human life expectancy could be dramatically increased through certain chemical and/or lifestyle interventions including caloric restriction, genetic manipulation, antioxidants, hormone treatments, stem cell replacement therapies, and so on. New cosmeceutical products allegedly incorporating the benefit of such advanced medical interventions arrive at the storefront at an increasingly alarming rate. The many ways a cosmetic product can bring eternal beauty and youth to a consumer appears to be as inexhaustible as the imagination of any creative marketer. It is estimated that an average American encounters at least 1,500 advertising messages daily; many of them contain age-reversing, appearance rejuvenating claims: New, powerful anti-aging skin care Aging is reversible and optional Breakthrough herbaceutical Regenerate damaged skin Penetrates deeply into the layers of the skin Dramatically reduce wrinkles, fine lines Erase wrinkles and boost collagen synthesis within 10 days Anti-inflammatory and healing for sun-damaged skin Stimulates cellular metabolism within days… 7.1.2 The Believability of “Cosmeceutical” Claims

But how convincing are these messages? Judged by the topics of recently published media articles listed below, there appears to be a certain degree of doubt in the consumers’ mind.

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False claims must be abandoned urgently [4] Skin-care industry skipping out on science? [5] Australians don’t believe cosmetic advertising [6] The UK Advertising Standards Authority has clamped down on a number of claims made by major cosmetic companies… [7] Beauty-seekers beware: Largely unregulated ads [8] In the above-cited Australian survey conducted by CoreData and NEWS. com.au, it was reported that 55% of the respondents did not trust the accuracy of the scientific claims made by cosmetic companies and many were cynical about those claims. In addition, how are cosmetic products regulated in terms of advertising and promotion? Are cosmeceutical products a new regulatory subcategory of cosmetic products? Or are they regarded as medicinal products? Are there any specific rules regulating their product claims and substantiation standards?

7.2 Making Sense of Cosmetic Product Labeling 7.2.1 A Brief Overview of US Cosmetic Regulations—Product Category and Definition

The division called “Colors and Cosmetics” within the FDA’s Center for Food Safety and Applied Nutrition (CFSAN) is the regulatory authority for cosmetic products. Except for color additives that must be preapproved, the FDA does not require premarket approval of cosmetics. The registration of cosmetic establishments and ingredient information, although expected, is a voluntary program called Voluntary Cosmetic Registration Program (VCRP) described in 21CFR (Code of Federal Regulations) 710 and 721. It is not an FDA requirement. The FDA does not have the authority to require safety testing of cosmetics by their manufacturers. However, the FDA strongly urges the manufacturers to establish the safety of their products via appropriate safety testing. The FDA requires a warning statement on the label if the safety of the product has not been adequately substantiated. The Center for Food Safety and Applied Nutrition office maintains a postmarketing Adverse Events Reporting System called CAERS. CAERS is used by the FDA to notify companies of any reported illness or injury associated with the use of their products. The FDA intends to use CAERS to formulate postmarketing policies regarding cosmetic products. Two main provisions of the Food, Drug, and Cosmetic Act (FD&C Act) that apply to cosmetics are adulteration and misbranding. The adulteration provision

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addresses the composition of the product, how the product is manufactured, stored, and shipped, and the product container [9]. There are four conditions where a cosmetic may be considered adulterated: 

 



The product contains a potentially harmful substance (in the product itself or the container) that may cause injuries to the consumers upon normal use; The product contains filth; The product is contaminated with filth due to unsanitary manufacturing or storing conditions; The product contains a nonapproved color additive.

The provision of misbranding focuses on the representation of the product [10]. Reasons to cause a product to be considered misbranded could be any of the following: 







The labeling is deemed false or misleading (including what is said and what is not revealed) Required labeling information and its appropriate placement is not included in product labeling The container is filled or represented in a manner the FDA considered deceptive Improper packaging and labeling of color additives.

However, the FDA bears the burden of proof. If the FDA intends to classify a cosmetic as adulterated and remove it from the market place, it must first prove in a court of law that the product may be injurious to users. The FDA can consider a cosmetic misbranded if it determines that the labeling is false and misleading or does not bear the correct, required information, and warning statements. The FDA has no authority to order product recalls, but it can request the company to do so and recommend recall strategies. Once the company initiates the recall, the FDA may actively monitor its progress. The US cosmetic regulations can be summarized below [11–13]: 

 

The FDA can only take postmarket enforcement actions. There are no premarket approval requirements for either the product or the ingredients, except for color additives. There are no user fees requirements. VCRP is strongly encouraged by the FDA but not required.

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There is no mandatory safety-testing requirement. The manufacturer is fully responsible to ensure the safety of each ingredient and finished product. Good manufacturing practice (GMP) is strongly encouraged but not a regulatory requirement.

7.2.2 Product Labeling—Drug or Cosmetic?

The FDA oversees cosmetic labeling in the United States. Cosmetic labeling requirements are listed in Table 7.1. These are very specific requirements governing many labeling design details including the product identity display, the placement of the name and place of business, appropriate ingredient listing, an accurate statement of the net quantity of contents, appropriate directions for safe use, and appropriate warning statements when deemed necessary. Labeling is defined to include all written, printed, or graphic material that appears on the products, containers, packaging inserts, and any material accompanying the product. So effectively, any promotional material and statements including those that appear on the Internet, product catalogs, and flyers are considered cosmetic product labeling. These requirements are regulated under two main regulations: the FD&C Act and the Fair Packaging and Labeling Act (FPLA). The FDA’s main enforcement focus for cosmetic labeling is on “misbranding.” To qualify as a cosmetic product, the labeling must not imply any physiological effect, must not suggest structure/function impact, must not contain ingredients that are Table 7.1 US Cosmetic Labeling Requirements

Product identity statement Net quantity of contents Name and place of business Ingredient declaration Warning statements Direction for use

Outer Container

Inner Container

Relevant Regulation

Required in the principal display panel Required in the principal display panel Required

Not required

FPLA

Required

Required

Not required

FPLA FD&C Act FPLA FD&C Act FPLA

Required

Required

FD&C Act

Not required

Not required

FD&C Act

Required

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commonly regarded as drugs, and must not contain unapproved color additives. Incorporating drug claims in the cosmetic labeling causes the product to be considered misbranded and will lead to the FDA enforcement action.

7.2.2.1 US Legal Definitions of Drugs and Cosmetics

In the United States, the regulatory requirements for cosmetics and drugs are established by the Federal FD&C Act, enacted in 1938, and enforced by the FDA. The act defines cosmetics as: articles intended to be rubbed, poured, sprinkled, or sprayed on, introduced into, or otherwise applied to the human body… for cleansing, beautifying, promoting attractiveness, or altering the appearance. [14] Drugs are defined by the FD&C Act as: (A) articles intended for use in the diagnosis, cure, mitigation, treatment, or prevention of disease…and (B) articles (other than food) intended to affect the structure or any function of the body of man or other animals. [15] 7.2.2.2 Distinction between Drugs and Cosmetics in the US

The biggest distinction between a drug and a cosmetic in the US regulatory environment is that a cosmetic is not allowed to possess any physiological activity as to affect the structure and function of the body. In other word, articles intended to be used “externally” to improve attractiveness or appearance are regulated as cosmetics. But when the intended use is considered to have the potential to change the structure or function of the body, the product will be regulated as a drug. Essentially, cosmetic effects are supposed to be only superficial, while drug effects are physiological in nature. The “superficial effect” and “not affecting the structure and function” clauses are two tests most often used by the FDA to differentiate a drug from a cosmetic in terms of its proper regulatory product classification [16]. A cosmetic product making drug claims on its labeling will be considered misbranded by the FDA. Based on a policy established by the 74th Congress in 1935, products are classified by the Act based on their intended use. A product’s intended use may be established through its direct advertising or product claims.

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However, the FDA advises that consumer perception and expectation of the product also constitutes the basis for determining the intended use, be it through direct advertisement or indirectly implied promotional messages [17,18]. The following examples demonstrate product claims and ingredient listing: Example 1. Product claims stated in the labels, advertising material in the media and on the Internet, and any other relevant promotional materials. The distinction between a drug and a cosmetic is based on whether it claims to affect the structure or function of the body. The FDA considers it a drug claim if the statement indicates that the product will affect the body in some physiological way, even if the effect is only temporary [19]. A shampoo intended for cleaning is regarded as a cosmetic, but a shampoo advertised for preventing or treating dandruff is a drug. A deodorizing body spray is a cosmetic, but the same product claiming an antiperspirant property is considered a drug. A moisturizer that smoothes and softens the skin is a cosmetic, but it legally becomes a drug if the same product claims to penetrate to the inner layer of the epidermis to repair damage, retard aging, stimulate cellular growth, or erase wrinkles. Example 2. Ingredients used and how they are identified. For any retail cosmetic product intended for home use, if it contains ingredients that are commonly regarded as “drugs” (e.g., recognized to have therapeutic benefits), or if the product is represented in such a way as to imply “health” or “nutrient” benefits, the product is considered and regulated as a drug even if no such claims are explicitly made. Therefore, a cosmetic product containing acetaminophen is regarded by the FDA as a drug, even when no claims are made regarding its analgesic or anti-inflammatory properties. Another example is the hormone cream. The FDA considers it false and misleading if the word “hormone” appears in the product labeling or its cosmetic ingredient declaration statement, as it implies drug effectiveness. This is especially so because all hormone ingredients used for cosmetics must not contain biological activity. However, simply incorporating an active ingredient in a cosmetic product does not automatically move it to the drug category. The product only becomes a drug when the chosen active ingredient is well known for its therapeutic uses and when its name identified in the labeling leads the users to expect therapeutic effect. In the case of vitamins, the FDA stipulates

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that the manufacturers should use the proper chemical names in the ingredient label so as not to imply any intended nutrient or health benefit and mislead the consumers. Doing so would make the products misbranded cosmetics. To maintain their “cosmetic” classification, the proper chemical names such as tocopheryl acetate (instead of vitamin E acetate), ascorbyl palmitate (instead of vitamin C palmitate) should be used in the ingredient statement. However, as long as the manufacturers do not make therapeutic claims and mislead the consumers into associating the products with health benefits, the manufacturers are allowed to list vitamins by their common names on the principal display panel of the package [20, 21]. 7.2.2.3 The Global Situation: Cosmetics versus Drugs

The global definition of a therapeutic drug is quite similar, most agreeing that a drug is intended for the diagnosis, cure, mitigation, treatment, or prevention of diseases via some means of physiological action. But when it comes to cosmetics, differences exist in major world markets including Australia, United States, EU, Canada, and Japan. In Australia, a cosmetic is defined as “a substance or preparation intended for placement in contact with any external part of the human body, including the mucous membrane of the oral cavity, and the teeth, with a view to altering the odors of the body; or changing its appearance; or cleansing it; or maintaining it in good condition; or perfuming it; or protecting it.” Similar to the classification standard practiced in the United States, a cosmetic product will be considered a therapeutic good if it intends to treat, alleviate, or prevent disease; or claims to affect the structure or functions of the human body or have therapeutic effects; or contains ingredients possessing therapeutic effects [22]. Two major factors are used to differentiate cosmetics from the therapeutic product: the composition of the product, and the proposed use and claims of the product. According to the third edition of Guidelines for Cosmetic Claims published by the Therapeutic Goods Administration on May 9, 1997, cosmetics may not make therapeutic claims unless they are listed in the Australian Register of Therapeutic Goods. The Canadian Food and Drugs Act defines a cosmetic as “any substance or mixture of substances, manufactured, sold or represented for use in cleansing, improving or altering the complexion, skin, hair or teeth and includes deodorants and perfumes”. Similar to the US FDA, Health Canada further stipulates that claims of physiological effect are not allowed for cosmetics. A cosmetic product making a therapeutic claim (e.g., to prevent or treat

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disease) will be classified as a drug under the Food and Drugs Act and a drug identification number (DIN) will be required. The Japanese Pharmaceutical Affairs Law regulates all pharmaceuticals, quasidrugs, cosmetics, and medical devices in Japan. Its definition of a cosmetic is stated as “a substance with mild effect on the human body which is intended to be put on the human body for the purpose of cleansing, beautifying, enhancing the attraction, changing the appearance, or maintaining the skin or the hair healthy.” This definition allows the cosmetics to have a mild effect on the human body. In the EU, the 7th Amendment of the Cosmetic Directive (original Directive 76/768/EEC) defines a cosmetic as “any substance or preparation intended to be placed in contact with the various external parts of the human body (epidermis, hair system, nails, lips, and external genital organs) or with the teeth and the mucous membranes of the oral cavity with a view exclusively or mainly to cleaning them, perfuming them, changing their appearance and/or correcting body odors and/or protecting them or keeping them in good condition.” The directive further instructs in Article 7a, 1(g), that a proof of effect claimed for the cosmetic product be kept readily accessible to the competent authorities of the member state. Based on this definition, one can expect the cosmetic products to show some “effect.” In terms of the breadth of definition and its interpretation, there are two camps. The United States and Canada adopt the narrower definition while the EU and Japan take the broader view. In addition, the United States places a substantially less amount of restrictions on ingredients and demands less safety testing requirement. Canada defines cosmetics in a similar fashion as the United States, but it imposes a far more extensive list of restrictions and prohibitions on ingredient selection. In contrast, the EU represents the other end of the spectrum; a broader definition accompanied by heavier control over the ingredients and product safety through various positive lists, restricted and prohibited lists, and specific safety testing and data requirements. Japan has a similar definition as the EU but has a much narrower list of product categories. In addition, Japan provides a quasidrug product category that imposes more requirements than it does for cosmetics but not up to the level required for drugs. The Japanese quasidrug category includes hair dyes, acne prevention products, skin and oral disinfectants, bath preparations, and medicated cosmetics such as antidandruff shampoos and rinses, preparations to prevent minor dermatological disorders including rashes, frostbites, chaps, cracks, and pimples. Another important quasidrug claim is “skin whitening.”

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Even though the product classification standard may differ, the regulatory requirements for cosmetics are quite similar for these major markets in terms of demanding the manufacturer to carry the full responsibility of product safety, not requiring premarket product approval and registration, establishing cosmetic-specific GMP industrial guidelines and imposing no restrictions on sales distribution channels. 7.2.2.4 What about Borderline Products?

What are borderline products? These are products that might fit in more than one product category due to overlapping regulatory definitions of different product categories within one country/region, or due to varying product classification standards by different countries/regions. For instance, a sunscreen product containing UV filters, regardless of what type, is considered an OTC drug in the USA. The situation in Canada is a little complicated since the introduction of the Natural Health Products Directorate (NHPD) in 2004. Under the NHPD, some products previously regulated as drugs under the Therapeutic Product Directorate (TPD) (e.g., the Nonprescription Drugs Category IV Monograph Products) are reclassified as natural health products1 (NHP). A sunscreen product may be regulated as an NHP or a drug, depending on the type of UV blockers used [23]. However, this type of product is regulated as a cosmetic in Japan and the EU as long as they adhere to specific ingredient control rules. Ordinance No. 331 of the Japanese Ministry of Health & Welfare and Annex VII of the EU Cosmetic Directive each provides a list of permitted UV filters for use in cosmetics. Table 7.2 lists a few examples of these borderline products. 7.2.2.5 “Cosmeceutical” Products Labeling

“Cosmeceuticals” are a good example of borderline products. The term “cosmeceuticals” was believed to have originated in the 1960s when Raymond E. Reed, then vice president of The Toni Co. published a paper entitled “The Definition of ‘Cosmeceutical’ ” in the Journal of the Society of Cosmetic Chemists [24]. The term was made famous by Dr. Kligman later at a meeting for the Society of Cosmetic Chemists [25]. It has been widely used by the cosmetic industry to refer to cosmetics that also possess druglike effects. Antiaging products are among the fastest growing segment of the skin-care market, many of them are claimed as “cosmeceuticals” able to deliver rejuvenation benefits far beyond skin moisturization or merely covering up wrinkles. Countless new products spring up everyday to claim that they have incorporated the newest science in a bottle to not just retard

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7: Cosmeceutical (Antiaging) Products, Schroeder Table 7.2 Examples of Product Classification in Major World Markets Product

USA

Canada

EU

Japan

Antiacne lotion

OTC drug and cosmetic

Category IV Monograph Product (Drug or NHP)

Medicinal product

Quasidrug

Anticaries toothpaste

OTC drug and cosmetic

Category IV Monograph Product (NHP)

Cosmetic

Quasidrug

Antiperspirant

OTC drug and cosmetic

Category IV Monograph Product (NHP)

Cosmetic

Quasidrug

Hair dye

Cosmetic

Cosmetic

Cosmetic

Quasidrug

Lipstick

Cosmetic

Cosmetic

Cosmetic

Cosmetic

Sunscreen

OTC drug and cosmetic

Category IV Monograph Product (Drug or NHP)

Cosmetic (compliant with Annex VII Ingredients Rule)

Cosmetic (compliant with Ordinance #331 Ingredients Rule)

Source: Risk & Policy Analysts Limited, London, 2004; A Summary of NHP/Drug Classification of TPD Category IV Labeling Standards Ingredients, Health Canada; Australian Government Department of Health & Ageing Therapeutic Goods Administration/NICNAS (National Industrial Chemicals Notification & Assessment Scheme), 2005.

aging, but also make it entirely optional. Consumers are bombarded with ads claiming enhanced cellular turnover rate, DNA repair, molecular energy renewal at the mitochondria level, and collagen synthesis stimulation, and so on. These scientifically sounding claims share one common theme—the products are represented in such a way as to suggest that they do not simply offer “superficial” cosmetic benefits but actually provide meaningful age-reversing or—arresting effects. However, the US FDA flatly refuses to recognize the “cosmeceuticals” as a valid product class, nor does it plan to include it as a subcategory of cosmetics and warned that it will apply the same “structure and function”

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standard to determine the classification of antiaging products. If a product is intended for cosmetic use but its claims also suggest physiological (drug-like) properties, the product will be subjected to both drug and cosmetic regulations [26]. In a policy letter issued in 1987 to cosmetic companies, the FDA stated that claims to have “an effect within the epidermis as the basis for a temporary beneficial effect on wrinkles, lines, or fine lines are unacceptable” drug claims. Words that describe a product to retard, counteract, or control aging, or to rejuvenate, repair, or renew the skin are considered drug claims. However, FDA would not object to claims that “products will temporarily improve the appearance of … outward signs of aging.” Such claims are accepted by the FDA as cosmetic claims [27]. FDA’s stance is further illustrated by the 1989 court case of Estee Lauder v. United States (727 F. Supp. 1) [28]. It is acceptable to advertise the antiwrinkle cream that “diminishes the appearance of fine lines” as a cosmetic, but when it claims to “remove fine lines” or to “reverse the aging process,” it becomes an OTC drug. Under an intercenter agreement, both the CDER and CFSAN may initiate regulatory actions against products that purport to be cosmetics but meet the statutory definition of a drug [29]. Health Canada takes a similar stance on “cosmeceuticals” as the USFDA. It does not recognize them as a legitimate product category. The product will be regulated either as a cosmetic or as a drug depending on the claims it makes and/or the composition of the product. A table of acceptable cosmetic claims is provided in the Guidelines for Cosmetic Manufacturers, Distributors and Importers posted on the official Web site of Health Canada (Table 7.3) [30]. Table 7.3 Canadian Cosmetic Claims Cosmetic

Acceptable Claim

Unacceptable Claim

Moisturizer Contour cream

Fragrance

Softens skin Reduces the look of cellulite Removes oil Helps eliminate odor-causing bacteria Soothes

Antiaging/antiwrinkle product

Helps prevent the look of aging

Heals skin Lose inches; slims/ slimming Stops acne Kills odor-causing germs Causes hormonal attraction Eliminates wrinkles

Acne-prone skin product Mouthwash

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The Australian National Coordinating Committee on Therapeutic Goods gave the following examples as industrial guidance for antiaging cosmetic product claims [31]: 





Acceptable wording for cosmetics:  Cover up or hide age spots or blemishes, dark pigmented areas.  Feel younger or look younger.  Helps prevent, reduce, or slow the signs or appearance of aging.  Moisturize aging skin.  Smooth wrinkles. Unacceptable wording for cosmetics unless sufficiently modified to provide a cosmetic implication:  Antiaging.  Temporarily reduces depth of wrinkles by moisturization. Unacceptable wording for a cosmetic (but not necessarily acceptable for a drug):  Eliminates, prevents, stops, reduces, slows, or reverses aging, wrinkles, premature aging, or aging process.  Rejuvenating cells.  Any references to fading age spots or depigmentation, skin bleaching, and so on.

In the EU, antiaging products were among the 32 “borderline cosmetics” listed by the Council of Europe Publishing in 2000 [32]. These products are not adequately covered by the EU Cosmetic Directive and can be regulated by each different member state differently as consumer products or cosmetics or even drugs, depending on the claims and ingredients used, essentially creating a regulatory and marketing complication for the industry.

7.3 Cosmetic Products Advertising 7.3.1 What is Advertising?

Product advertising is a paid, nonpersonal, mass media-based form of communication directed to a target audience to talk about a certain commercial product. Companies advertise for many reasons, the main one is to drive traffic and sales of their products. Advertising is also useful in creating consumer awareness and establishing new market trends. When used correctly, it is a powerful psychological manipulation as marketers often joke that their success lies in creating something out of nothing.

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There are many forms of advertising: 





Mass media  Print  Broadcast  Others Direct marketing  Mass mailing  Internet  Telemarketing  E-mail marketing Public events  Trade shows, press conferences  Promotional tours, exhibits  Store openings

7.3.2 US Regulatory Mechanisms over Cosmetic Product Advertising 7.3.2.1 Cosmetic Product Categories

US cosmetics are currently grouped into thirteen product categories by the FDA. “Cosmeceuticals” are not an FDA-recognized cosmetic or drug product classification. The official FDA cosmetic product category codes and description are given in Table 7.4. 7.3.2.2 Relevant Law and Regulations

In the United States, advertising of consumer cosmetic products is regulated by several mechanisms: 

Federal law, such as the Federal Trade Commission Act (FTC Act) enforced by the Federal Trade Commission (FTC). The FTC Act prohibits unfair or deceptive practices to influence the consumers [33]. It sets the definition of false advertising and prohibits false advertising for cosmetics [34, 35]. The unfair or deceptive advertising the FTC targets includes both printed and broadcasted matters such as those appearing in the newspapers, magazines, television, and the Internet. Other federal case law affecting advertising includes that of the First Amendment where Congress should not make law

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Table 7.4 US FDA Cosmetic Product Categories Code

Category Description

Product Examples

01

Baby products

02

Bath preparations

03

Eye makeup preparations

04

Fragrance preparations

05

Hair preparations (noncoloring)

06

Hair coloring preparations

Baby shampoos Lotions, oils, powders, and creams Other baby products Bath oils, tablets, and salts Bubble bath Bath capsules Other bath preparations Eyebrow pencil Eyeliner Eye shadow Eye lotion Eye makeup remover Mascara Other eye makeup preparations Cologne and toilet waters Perfumes Powders (dusting and talcum, excluding aftershave talc) Sachets Other fragrance preparations Hair Hair spray (aerosol fixatives) Hair straighteners Permanent waves Rinses (noncoloring) Shampoos (noncoloring) Tonics, dressings, and other hair grooming aids Wave sets Other hair preparations Hair dyes and colors (all types requiring caution statements and patch tests) Hair tints Hair rinses (coloring) Hair shampoos (coloring) Hair color sprays (aerosol) Hair lighteners with color Hair bleaches Other hair coloring preparations (Continued)

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Table 7.4 US FDA Cosmetic Product Categories (Continued ) Code

Category Description

Product Examples

07

Makeup preparations (not eye)

08

Manicuring preparations

09

Oral hygiene products

10

Personal cleanliness

11

Shaving preparations

12

Skin care preparations (creams, lotions, powders, and sprays)

Blushers (all types) Face powders Foundations Leg and body paints Lipstick Makeup bases Rouges Makeup fixatives Other makeup preparations Basecoats and undercoats Cuticle softeners Nail creams and lotions Nail extenders Nail polish and enamel Nail polish and enamel removers Other manicuring preparations Dentifrices (aerosol, liquid, pastes, and powders) Mouthwashes and breath fresheners (liquids and sprays) Other oral hygiene products Bath Soaps and Detergents Deodorants (underarm) Douches Feminine Deodorants Other Personal Cleanliness Products Aftershave Lotion Beard Softeners Men’s Talcum Preshave Lotions (all types) Shaving Cream (aerosol, brushless, and lather) Shaving Soap (cakes, sticks, etc.) Other Shaving Preparations Cleansing (cold creams, cleansing lotions, liquids, and pads) Depilatories Face and neck (excluding shaving preparations) (Continued)

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Table 7.4 US FDA Cosmetic Product Categories (Continued ) Code

13

Category Description

Suntan preparations







Product Examples Body and hand (excluding shaving preparations) Foot powders and sprays Moisturizing Night Paste masks (mud packs) Skin fresheners Other skin care preparations Suntan gels, creams, and liquids Indoor tanning preparations Other suntan preparations

to abridge the freedom of speech while the Supreme Court in the past has ruled that such freedom of expression must also be balanced against competing business interest. State law and local enforcement such as the Federal Mail Fraud Act that is actually enforced by the office of the Attorney General of each individual state [36]. Voluntary industry framework: the National Advertisement Division (NAD) of the Council of Better Business Bureaus acts as the industry’s independent self-regulatory body to monitor the truth and accuracy of national advertising for both broadcast (including the Internet) and printed matters. Private judicial actions under the Lanham Act targeting false and misleading advertising. The injured parties can bring private suits and seek monetary or other compensations for the resulting injuries [37].

7.4 The Situation of the Ever-Creeping Antiaging Cosmetic Product Claims 7.4.1 FDA Enforcement—Product Labeling

The FDA’s main mission is to ensure cosmetic products are safe and properly labeled (differentiation between drug and cosmetic). Its regulatory authority comes from both the FD&C Act and the FPLA. As cosmetics increasingly take on the role of drugs (i.e., “cosmeceuticals” claims including antiaging effect), a growing population is urging for increased FDA

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regulation of cosmetics to protect consumers from unsafe and/or untested products and from deceptive practice. Added to this confusing state is the creeping “organic” and/or “natural” product claims where there is currently no clear regulatory definition, nor is there a designated or collaborative competent authority to oversee the product regulation. The US Department of Agriculture (USDA) currently oversees the “organic” product claims and is developing policy and enforcement rules. Some argue that creating a “cosmeceuticals” category would help the FDA better safeguard consumer health by granting the FDA authority to impose premarket approval and more extensive safety testing requirements. The FDA’s cosmetic regulatory branch has been seriously weakened in recent years due to significant budget constraints, limited resources, and the need to place more priority over other high-profile issues such as AIDS, bioterrorism against food, medical device, and prescription drug safety. The FDA must resort to allocating its resources to handle the most pressing and life-threatening public health issues. Cosmetics generally are not likely to cause serious adverse effects and traditionally have been relatively safer than food, drugs, and medical devices. As a result, the cosmetic industry has not experienced major FDA enforcement actions against extravagant antiaging product claims. However, recent warning letters issued to Basic Research LLC (January 20, 2005) [38] and University Medical Product USA Inc. (January 22, 2004) [39] may indicate a new trend in future FDA enforcement actions. In both cases, the FDA stated that certain claims were considered “structure/function” claims and the cited products were not generally recognized as safe and effective for the intended use, causing the products to be considered as unapproved new drugs. These new drugs may not be marketed without prior FDA New Drug Application approval. Cited by the FDA for violation include some well-known products such as StriVectin-SD, FACE LIFT Collagen 5 products, FACE LIFT Daytime Advanced Retinol-A, Nighttime Advanced Retinol-A, Advanced Under Eye Therapy, Vitamin C AntiWrinkle Patch, and so on. Table 7.5 lists some of the “structure/function” drug claims cited by FDA as inappropriate for cosmetic products. 7.4.2 FTC Enforcement—Advertising and Claims Substantiation

The FTC was first established in 1914; its mission back then was mainly to prevent unfair business competition in the market place. Broader authority has been gradually granted by the Congress over the years and the current

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Table 7.5 Cosmetic Products Cited for “Structure/Function” Drug Claims Cited Product

Examples of Structure/Function Claims Cited by FDA

StriVectin-SD











Collagen5™

   

Vitamin C Anti-Wrinkle Patch™





“Clinically proven to dramatically reduce the appearance of existing stretch mark length, depth, texture, and discoloration.” “A stretch-mark reducing emulsion … to diminish fine lines, wrinkles and crow’s feet.” “[S]uperior wrinkle-reducing properties of a patented oligo-peptide (called Pal-KTTKS) … on ‘photo-aged skin’ … [A] key ingredient in the StriVectin cream.” “[S]ignificant improvement’ in wrinkle depth, length, wrinkle volume …..” “StriVectin-SD actually increases the synthesis of new collagen (StriVectin-SD increases collagen I synthesis by 117%, increases collagen IV synthesis by 357%, and increases glycosaminoglycan synthesis by 267%), making your skin thicker and firmer.” “Is proven to reduce deep wrinkles up to … 70%” “Stimulates your skin’s own collagen building network” “Reduces deep wrinkles from within the skin’s surface …” “Visible results that won’t fade away …” “Vitamin C helps reduce the effects of aging … by helping to strengthen collagen and elastin fibers” “Clinical studies proved a 50% reduction in wrinkles …”

mission aims at protecting America’s consumers by dealing with issues concerning the economic aspects of every American. Under the fair business practice banner, basic advertising requirements (stipulated under the FTC Act, Sections 5 and 12) required by the FTC are summarized below: 







The company must not engage in unfair or deceptive business practices. The product representation must be truthful and not misleading/ deceptive. The objective product claims must be substantiated and supported by reproducible, scientifically valid data produced under competent and reliable scientific supervision. The product disclosures must be clear and conspicuous in terms of prominence, presentation, and placement.

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A 1983 FTC policy statement announced that substantiation needs to pass the “reasonable basis of support” requirement for both the express and implied claims. FTC uses a number of factors to determine the extent of reasonable basis for substantiation, including the type of product, type of claims made, the benefits of a truthful claim, the consequences of a false claim, the ease of developing substantiation, and what experts consider as adequate substantiation [40]. The standards the FTC uses to determine if a company is engaged in unfair business practices include the following [41]: 



Does it cause or is likely to cause substantial consumer injury that could not be reasonably avoided by the consumer? Can the injury be outweighed by the benefit to the consumer?

Deceptiveness is defined by the FTC as follows [42]: 







There must be a representation, omission, or practice likely to mislead the consumer. The judgment is based on the standpoint of the “reasonable consumers.” The overall net impression must be used to make the determination, including the direct, express claims, and those that are implied via the context. The claims must be “material” as to lead to a consumer’s purchase decision.

The FTC’s policy stipulates that “competent and reliable scientific evidence” shall mean the “tests, analyses, research, studies or other evidence based on the expertise of professionals in the relevant area, that has been conducted and evaluated in an objective manner by persons qualified to do so, using procedures generally accepted in the profession to yield accurate and reliable results” [43]. The FTC Act assigns liability broadly; advertisers, ad agencies, and the endorsers all carry various degrees of responsibility. There are many legal remedies and penalties available for the FTC enforcement actions, including warning, injunction, refunds, profits disgorgement, corrective advertising, and surveillance. The FTC also has been known to use litigation via both the administrative and federal courts to make its case.

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In general, the FTC tends to pay more attention to nationwide advertising campaigns that have far-reaching impacts, advertisements raising health and safety concerns, blatantly false or extreme claims, and serious disease claims. In recent years, its focus has been on two product categories: dietary supplements and weight-loss programs or products. In 1993, Revlon, Inc., settled charges of unsubstantiated ad claims with the FTC. The products cited included Ultima II ProCollagen Anticellulite body complex and PhotoAging Shield (PAS). Unsubstantiated claims cited by the FTC include “significantly reduces cellulite,” “reduces skin’s bumpy texture, ripples or slackness caused by cellulite,” “helps disperse toxins and excess water from areas where cellulite appears,” “increases sub-skin tissue strength and tone,” “intended to prevent photo aging,” “,acts as a shield for your skin,” and “… actually intercepts damaging light waves before they penetrate your skin.” In the final consent agreement issued by the FTC on November 17, 1993, Revlon was required to provide scientific evidence to support future claims of the effectiveness of their anticellulite and sunscreen products [44]. Similarly, in a 1995 federal court case, a California-based company, Silueta Distributors, was banned from making unsubstantiated claims for its cellulite reduction cream and ordered to pay $169,339 in redress to the consumers [45]. In recent years, the FTC continues to focus on cracking down false and deceptive cosmeceutical claims especially aimed at the weight-loss/control market segment. The television home shopping retailer, ValueVision International, Inc., was charged by the FTC for making unsubstantiated claims without competent and reliable scientific evidence of several products including the anticellulite NutriFirm Perfect Body Solution lotion and a topical antihair loss solution NutriFirm Vitamin H Serum [46]. In a recent 2004 case, QVC Home Shopping Channel was charged with making false or unsubstantiated claims for several weight-loss products including the “For Women Only,” Lite Bites, and Bee-Alive royal jelly dietary supplements. Its cellulite treatment, Lipofactor Cellulite Target Lotion, was also cited for false and deceptive advertising. QVC was ordered to provide “competent and reliable scientific evidence” to substantiate any claims that their product “can or will cure, treat, or prevent any disease, or have any effect on structure or function of the human body [47].” 7.4.2.1 What about Puffery?

The FTC described puffery as, a term frequently used to denote exaggerations reasonably to be expected of a seller to the degree of quality of his product,

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the truth or falsity of which cannot be precisely determined. In contrast, thereto, the representation as to “the world’s lowest price” is a statement of objective actuality, the truth or falsity of which can be ascertained with factual precision. This representation cannot, therefore, properly be termed “puffing’. It is either true or it is false; and accordingly such a determination must be made. So what exactly is puffery? It is claims that are either so vague or exaggerated to a point that an average, reasonable consumer would simply ignore them. They are considered empty sales talk and the FTC does allow puffery in advertising and sales representations as long as it is presented in the forms of subjective opinions, exaggerations, or vague and general statements with no specific measurable claims and that it speaks of no specific facts [48]. Examples of superlative puffery in cosmetic product advertisements [49]: There’s no softer way to shave by Skintimate Pure natural aloe – is there anything better that soothes summer dry skin? by Vaseline Intensive Care A new fragrance of extraordinary elegance by Coty Incredible lather and incredible skin by Oil of Olay An amazing new micro cleansing formula by Colgate Tartar Control Toothpaste For an extra degree of protection by Degree antiperspirant The right fit for clean teeth by Crest Complete The next revolution in shaving closeness by Gillette The future of eye makeup by Maybelline

7.4.3 NAD Action Case Studies

The advertising industry’s self-regulatory programs encompass several voluntary bodies working in conjunction with each other while under the administrative purview of the Council of the Better Business Bureau (CBBB), to ensure both credibility and impartiality. These self-regulatory bodies include the National Advertising Review Council that sets the policies, the National Advertising Division (NAD) for investigating complaints and determining the appropriate substantiation needed for advertised claims, the National Advertising Review Board (NARB) that handles disputes and appeals (if an advertiser is not satisfied with the NAD decision,

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it can appeal to the NARB for reconsideration) [50], the Children’s Advertising Review Unit (CARU) working with children’s advertisers to ensure that messages targeting young children are truthful, accurate, and sensitive to this particular audience grouping, and the Electronic Retailing SelfRegulation Program (ERSP) whose mission is to enhance consumer confidence in electronic retailing by ensuring the delivery of truthful and accurate claims in national direct response advertising [51]. If the advertiser fails to respond to the NAD inquiry or refuses to provide substantiation evidence, the NAD may refer the case directly to the FTC for further enforcement action. Let us examine a few interesting cases concerning inquiries of certain cosmeceutical product and ingredient claims and their subsequent NAD review decisions, as published in the NAD News Release and Case Reports [53]. Case Study #1: Preval’s age-defying skin care OTC drug product cited by the NAD in a 2007 inquiry conducted under the NAD/CARU/NARB Procedures for the Voluntary Self-Regulation of National Advertising. The decision was published in the NAD® News, December 5, 2007.

Cited Claims









ActiFade combines a cosmetic with powerful medication that will fade sun spots, age spots, and dark discoloration with no greasy mess! ActiFade also contains Vitamin C to reduce the appearance of free radical damage, as well as Shea Butter to soothe and soften your skin. Actively Fades Skin Discoloration 24 hours a Day. Younger-looking skin has never been easier!

NAD Decision after Reviewing Advertiser’s Substantiating Data 





The advertiser provided a reasonable basis for these claims. OK to continue with these claims.

Recommended to modify the claims so that it does not give the unsupported implication that this product can immediately eliminate spots.

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Cited Claims









Try ActiFade and discover the secret to younger-looking skin. Just rub it on and it works. Can you Reverse Age Spots While you Sleep?

Age Spots? Liver Spots? Sun spots? Stop the Spots Look 5, 10, even 20 years younger.

NAD Decision after Reviewing Advertiser’s Substantiating Data



Data insufficient to support the claims, or the implication that the product will completely and permanently eliminate skin discolorations.



Recommended to discontinue the claims and the pre- and posttreatment photographs.

Case Study #2: Antiaging skin-care products marketed by L’Oreal USA in a 2007 NAD advertising review. The decision was published in the NAD® News, August 15, 2007.

Cited Claims







NAD Decision after Reviewing Advertiser’s Substantiating Data

Ultra-Lift with unique dermatological-nutrients refuels cells within skin’s deepest surface layers: IMEGA 3 locks in moisture; VITAMIN A visibly reduces wrinkles; RICE PROTEIN fortifies skin. Now it’s skin care that actually lifts wrinkles from the inside out.



Lycopene is a powerful antioxidant, now it’s in skin care proven to fight fine lines and dullness.







The advertiser provided a reasonable basis for these claims. The portion referring to Vitamin A was recommended to be modified to suggest that it helps to reduce, instead of visibly reduces winkles. Recommended to discontinue or modify so that it does not suggest that the product eliminates lines and wrinkles. Recommended to discontinue or modify so that it does not suggest that lycopene can fight fine lines and dullness.

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Case Study #3: An eye treatment cream product marketed by Intelligent Beauty LLC in another 2007 NAD advertising review. The decision was published in the NAD® News, May 31, 2007.

Cited Claims















Claims that users noted a reduction in winkles and dark circles, and improved skin tone, texture and firmness around the eye. Instantly decreases the appearance of dark circles. Fight aging all day and night with 2 powerful treatments! Dramatically reduces the appearance of dark circles up to 45%. Firms and Smoothes the appearance of wrinkles by 44-98%. A Revolution in Skin Care. Working 24 hours to make your skin more beautiful. The most effective system ever for controlling raccoon eyes, wrinkles and puffiness.

NAD Decision after Reviewing Advertiser’s Substantiating Data 

The advertiser provided a reasonable basis, based on consumer studies, for these claims.



Scientific evidence insufficient to support the express and quantified performance claims. Recommended to discontinue.





 

These were objective superiority claims, not the subjective, superlative puffery permitted by the FTC. Insufficient supporting data. Recommended to discontinue.

7.5 Successful Product Positioning and Advertising Strategy Apparently, the confusing and often contradicting global regulatory definitions and requirements can lead to a marketing nightmare, especially at a time when skin-care product developers enjoy an unprecedented accessibility to new technologies and exotic ingredients that promise to help them formulate the best ever age-defying products. In this highly regulated and interrelated modern world, a company cannot measure its success simply via its ability to come up with the most scientifically advanced formula with measurable and effective skin-care benefits. The biggest challenge

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currently faced by the cosmetic industry is how to walk the fine line when considering the following:     

what we would like to claim for marketing advantages, what we can truthfully say from the scientific point of view, what the consumers will perceive as believable, what our competitors are claiming for their products, and what we are allowed to say under the regulations.

7.5.1 Advanced Marketing and Claims Substantiation Planning—Regulatory Affairs Meets Marketing and Product Positioning

Product developers and marketers have in their arsenal a diverse variety of market research tools to help them narrow down the playing field. They include market trend analyses, Internet consumer surveys, consumer habits and practices studies, preference surveys, and use tests. These studies have a proven track record in helping the company identify the most consumer appealing language that forms the best product selling strategy. It is crucial to obtain comprehensive prior understanding of global regulatory definitions, requirements, and restrictions to ensure smooth sailing of any product marketing scheme. Generally, any corporate advertising review procedure should include the following elements: 



Official corporate policy, SOPs, and authority for approving product advertisements A functional multidisciplinary advertising review and approval committee encompassing the following areas of expertise:  R&D  Market research  Marketing, including the ad agencies  Packaging, including copy writers and graphic designers  Business stakeholders  Regulatory affairs  Environmental, health and safety affairs  Quality assurance  Legal advisory  Medical advisory

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Multifactor risk analyses beyond the “reasonable basis,” such as:  Survey of the competitive landscape  Nature of desirable product claims  Regulatory analysis of product classification and impact to business  Pros and cons of desirable claims and their impact to business  Strength of the available substantiation  Risk of potential disciplinary, litigation, or enforcement actions resulting from regulatory or industrial voluntary guidelines, regulatory enforcement actions, consumer advocacy, and special interest group actions. Integration into early R&D phase Periodic regulatory training and updates Regularly scheduled corporate advertising reviews.

Obviously, additional tools need to be incorporated into the early phase of product development when product positioning has started the exploration effort and while initial marketing scheme is being scoped out. Regulatory analysis tools are useful in identifying the most feasible regulatory product classification path that is compatible with the overall marketing goal. The following is a list of some of the readily available regulatory analysis tools. 



FDA Cosmetic Handbook: http://www.cfsan.fda.gov/~dms/ cos-hdb1.html Official governmental Web sites for pertinent regulatory affairs information:  Agreement on the ASEAN Harmonized Cosmetic Regulatory Scheme: http://www.thaicosmetic.org/documents/ 1agreement.pdf  Australia Regulation of Cosmetic Chemicals—Final Report and Recommendations 2005: http://www.nicnas.gov.au/ Cosmetics/Regulation_Cosmetic_Chemicals_Final_Report_ PDF.pdf  Canada Cosmetic Regulations:  Food & Drug Act: http://laws.justice.gc.ca/en/ShowFullDoc/cs/F-27//20070321/en?command=search&caller=S I&fragment=cosmetic&search_type=all&day=21&mon th=3&year=2007&search_domain=cs&showall=L&stat uteyear=all&lengthannual=50&length=50

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Other cosmetic topics: http://www.hc-sc.gc.ca/cps-spc/ pubs/indust/cosmet_guide/act-loi_e.html  EU Cosmetic Directive: http://ec.europa.eu/enterprise/ cosmetics/html/consolidated_dir.htm  Japan Pharmaceutical Affairs Law: http://www5.cao.go.jp/ otodb/english/houseido/hou/lh_02070.html  Korea Food & Drug Administration: http://www.kfda.go.kr/  United Kingdom—The Cosmetic Products (Safety) Regulations 2004: http://www.opsi.gov.uk/SI/si2004/20042152.htm  US cosmetic regulations:  Food, Drug & Cosmetic Act: http://www.fda.gov/opacom/ laws/fdcact/fdctoc.htm  Other cosmetic topics: http://www.cfsan.fda.gov/~dms/ cos-toc.html  Taiwan Statue for Control of Cosmetic Hygiene: http:// www.doh.gov.tw/ufile/doc/200406_Statute%20for%20 Control%20of%20Cosmetic%20Hygiene.doc CTFA (Cosmetic, Toiletry, and Fragrance Association, USA) International Cosmetic Legal & Regulatory Database: http:// www.ctfainternational.org/ 



From these Web sites, one can search for information on acceptable cosmetic claims, definition, and regulatory allowance for borderline products, as well as risk and benefit analyses of marketing borderline products in regulatory uncertainty. 7.5.2 Considering Consumers’ Peace of Mind

A sound product development strategy must figure in consumer’s peace of mind. Consumers are constantly bombarded with new information on the products they use on a daily basis. Nongovernmental organizations’ (NGOs’) community activism and public consumer education campaign further add to the information explosion. At times, scientific facts and laboratory findings are taken out of context, creating a false, negative impression of product safety among the audience who are not skilled in the art (and/or science). Witnessing the recent lack of official FDA actions while motivated by the global Green Chemistry movement, many consumer advocacy NGOs have taken the lead to become the champion of cosmetic product safety. Front and center of the issue is the need to minimize or eliminate cruelty to animals during scientific research. The result is an overwhelming global acceptance of no animal testing for cosmetic products. The 7th Amendment of

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the EU Cosmetic Directives officially includes the provision of animal testing ban for its member states. When the total animal testing ban is generally regarded as the answer to end all animal cruelty regardless of the availability of alternative testing methods, it presents a special challenge to product developers and marketers. Since the consumers want to be assured of the same high level of product safety regardless of the testing methods employed, in addition to having to meet the scientific challenge of searching for scientifically equivalent animal testing alternatives, they now must also concurrently educate and convince the consumers of the alternative’s predictive power. Most importantly, the animal testing ban does not mean manufacturers are exempt from conducting safety testing. We must also pay attention to the hot debate over controversial ingredients either scientifically proven or perceived by the consumers to be harmful. Included in this list are preservatives such as formaldehyde, alleged endocrine disrupters such as parabens and substances referred to as carcinogenic, mutagenic, or reproductive toxins, and persistent and bioaccumulative toxins.

7.6 Conclusion Today’s consumer product companies face a tremendous task of bringing newer, more value-added products into the market within a much shorter time frame. Aging boomers’ desire to remain forever young will continue to add fuel to the already feverish global growth of the antiaging skin-care product segment. Complex marketing strategies, global supply chain distribution, and product positioning often collide with last minute, unexpected regulatory restraints, causing costly delay in product launch. In extreme cases, the unforeseen and/or unresolved regulatory roadblocks could sink a profitable product line. This is rather unfortunate but avoidable. Incorporating a comprehensive and well-orchestrated regulatory strategy and analysis during the early conceptualization phase is essential in overall product development success. It is imperative that any successful implementation of a global marketing plan takes into consideration different regional regulatory requirements for ingredient selection, product claims, advertisement, and promotional materials. To avoid a financially disastrous last-minute show stopper for any product launch, the best operatic rule for success is to scope out the marketing scheme during the early product development cycle and develop potential claims through careful examination of regulatory allowances and scientific support evidence, taking into consideration current consumer

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perception and awareness, and finally, followed up with a well-designed product safety review and testing, both pre- and postmarket.

Notes 1

Natural health product (NHP) is a product category regulated as drugs in Canada. Products containing ingredients of natural origin with a therapeutic function or claim are NHPs regulated by Health Canada’s Natural Health Products Directorate (NHPD). Each NHP must possess a Natural Product Number (NPN). Products generally include homeopathic products, traditional herbal medicines, and other herbals. 2 The Scientific Committee on Cosmetic Products and Nonfood Products (SCCNFP), recently renamed SCCP (Scientific Committee on Consumer Products) is one of the scientific committees that provides the European Commission with the sound scientific advice needed to establish policy and guidelines pertinent to consumer safety, public health, and the environment. The mandate for the SCCNFP is to address scientific and technical questions concerning consumer health relating to cosmetic products and nonfood products intended for the consumer, especially substances used in the preparation of these products, their composition, use as well as their types of packaging.

References 1. Dvorko J., “Antiaging Products and Services,” BCC Research, Report ID: PHM041A, February 2005. 2. “Market Trends: The US Cosmeceuticals and Anti-Aging Products,” Packaged Facts, Report ID No. LA1037623. January 1, 2005. 3. Briney C., “Industry Growth on the Horizon,” Global Cosmetic Industry, pp. 41–42, 2005. 4. Dweck A.C., “False Claims Must Be Abandoned Urgently,” Asia Pacific Personal Care, November 2007, http://www.personalcaremagazine.com/ Print.aspx?Story=3073. 5. http://www.eurekalert.org/pub_releases/2007-08/acs-sis081007.php. 6. “Australians Don’t Believe in Cosmetic Advertising,” Media Release, April 23, 2007, http://www.newsdigitalmedia.com.au/inc/docs/mediareleases/070423_ News_com_au_Beauty_Survey.pdf. 7. “UK Advertising Authority Upholds Cosmetic Claims,” Breaking News on Cosmetics Formulation & Packaging, Europe, May 11, 2005. http://www .cosmeticsdesign-europe.com/news/ng.asp?id=59933. 8. Gogoi P., “An Ugly Truth about Cosmetics,” Business Week Commentary, November 30, 2004, http://netscape.businessweek.com/bwdaily/dnflash/ nov2004/nf20041130_2214_db042.htm/. 9. FD&C Act [21 U.S.C. 361], Sec. 601. 10. FD&C Act [21 U.S.C. 362], Sec. 602. 11. Termini R.B., “Cosmetics: Regulation, Product Classification, Enforcement, Safety Issues and Specific Terminology” (Chapter 8), in Health Law: Federal

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13. 14. 15. 16. 17. 18. 19. 20. 21. 22. 23. 24.

25.

26. 27. 28.

29.

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Regulation of Drugs, Biologics, Medical Devices, Foods and Dietary Supplements, FORTI, Wynnewood, PA, pp. 312–346, 2003. McEwen Jr., G.N., Murphy E.G., “Cosmetic Claim Substantiation in the United States: Legal Considerations” (Chapter 1), in: Cosmetics—Controlled Efficacy Studies and Regulation, Elsner P., Merk H.F., Maibach H.I., Eds., Springer, Berlin, pp. 3–19, 1999. Cosmetic Handbook, US Food and Drug Administration Center for Food Safety and Applied Nutrition, FDA/IAS Booklet, 1992, http://www.cfsan.fda .gov/~dms/cos-hdb1.html. FD&C Act, Sec. 201(i). FD&C Act, Sec. 201(g)(1). Davis J.B., McNamara S.H., “Regulatory Aspects of Cosmetic Claims Substantiation,” in Cosmetic Claims Substantiation, Aust, L.B. Ed., Marcel Dekker, Inc., New York, pp. 1–20, 1998. Senate Report No. 361, 74th Congress, 1st Session, 4, 1935. Hutt P.B., “The Legal Distinction in the United States Between a Cosmetic and a Drug,” J. Toxicol.—Cut. Ocular Toxicol., 20(2&3), pp. 203–210, 2001. Taylor J.M., Letter from FDA Associate Commissioner for Regulatory Affairs, November 19, 1987. Guide to Inspections of Cosmetic Product Manufacturers, http://www.fda .gov/ora/inspect_ref/igs/cosmet.html. Foulke J.E., “Cosmetic Ingredients: Understanding the Puffery,” FDA Consumer Magazine, May 1992, http://www.fda.gov/fdac/reprints/puffery.html Australian Therapeutic Goods Act of 1989. A Summary of NHP/DRUG Classification of TPD Category IV Labeling Standards Ingredients, http://www.hc-sc.gc.ca/dhp-mps/prodnatur/applications/ licen-prod/monograph/list_mono4_e.html. McNamara S.H., “FDA Regulations of Cosmeceuticals: U.S. Cosmetic and Drug Regulations Pertinent to the Cosmeceutical Issue,” in Cosmeceuticals: Active Skin Treatment. Cosmetics & Toiletries Ingredient Resource Series, pp. 19–25, 1998. Kligman A.M., “‘Cosmeceuticals’: A Broad-spectrum Category between Cosmetics and Drugs,” in “Cosmeceuticals” and Active Cosmetics: Drugs Versus Cosmetics, 2nd Ed., Elsner, P., Maibach, H.I., Eds., Taylor & Francis Group, Boca Raton, pp. 1–9, 2005. Rados C., “Science Meets Beauty: Using Medicine to Improve Appearances,” FDA Consumer Magazine, March–April 2004. “On Limits of Claims for Cosmetics,” FDA Regulatory Policy Letter from John M. Taylor, Associate Commissioner for Regulatory Affairs, to numerous cosmetic skin-care companies, November 19, 1987. See the case of Estee Lauder v. United States Food & Drug Administration, 727 F.Supp. 1 (D.D.C. 1989) where FDA advised the company that by promoting the facial cream as being able to “reverse the aging process,” the product would be regarded as a drug under the FD&C Act. FDA instructed the company to either initiate changes in the labeling and promotional materials of the product or apply for a drug approval. “Intercenter Agreement between the Center for Drug Evaluation and Research and the Center for Food Safety and Applied Nutrition to Assist FDA in

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Global Regulatory Issues for the Cosmetics Industry, Vol. 2 Implementing the Drug and Cosmetic Provisions of the Federal Food, Drug and Cosmetic Act for Products that Purport to be Cosmetics but Meet the Statutory Definition of a Drug,” SFSAN/Office of Cosmetics and Colors, June 1, 2006. Guidelines for Cosmetics Manufacturers, Importers and Distributors, http:// hc-sc.gc.ca/cps-spc/pubs/indust/cosmet_guide/act-loi_e.html. Cosmetic Claims Guidelines, National Coordinating Committee on Therapeutic Goods, 3rd Ed., May 9, 1997, http://www.tga.gov.au/docs/html/cosclaim.htm. Cosmetic Products—Borderline Situations, Council of Europe Publishing, Strasbourg, France, 2001. 15 USC Sec. 5. 15 USC Sec. 15. 15 USC Sec. 12. Mail Fraud Act. 18 USC 1341-1342. The Lanham Act. 15 USC sec. 43(a). FDA Amended Warning Letter from B. Belinda Collins, Director of Denver District, to Basic Research, LLC., dated January 20, 2005. Source: http://www .fda.gov/foi/warning_letters/archive/g5195d.htm. FDA Warning Letter from Alonza E. Cruse, Director of Los Angeles District, to University Medical Products USA, Inc., dated January 22, 2004. Source: http://www.fda.gov/foi/warning_letters/archive/g4511d.htm. FTC Policy Statement Regarding Advertising Substantiation, March 11, 1983. FTC Policy Statement on Unfairness, appended to International Harvester Co., 104 F.T.C. 949, 1070 (1984). FTC Policy Statement on Deception, appended to Cliffdale Associates, Inc., 103 F.T.C. 110, 174 (1984). FTC vs. Prolong Super Lubricants Inc. Decision and Order, Docket No. C-3906. Issued November 22, 1999. Revlon, Inc. To Settle Charges of Unsubstantiated Ad Claims for “AntiCellulite” and Sunscreen Products. FTC Docket No. 9231. FTC File No. 882 3110. August 24, 1993. Federal Court Bans Claims for Sham Cellulite Reduction Cream Featured on National Spanish-Language Television. FTC File No. 922 3343. Civil Action no. C93 4141 SBA. http://www.ftc.gov/opa/predawn/F93/silueta.htm. Television Home Shopping Retailer Settles FTC Charges That Advertising Claims Lacked Scientific Support; Will Offer Refunds. FTC File no. 002 3308. July 11, 2001. http://www.ftc.gov/opa/2001/07/valuevision.htm. FTC Charges QVC Home Shopping Channel with Making Deceptive Claims & Violating FTC Order. FTC Matter no. C-3955. March 24, 2004. http:// www.ftc.gov/opa/2004/03/qvc.htm. Astrachan J.B., Ed., “False Advertising Law Primer,” http://www.about falseadvertising.com/index1_files/False%20Advertising%20Primer.pdf. Preston I.L., “Puffery: Used Because It Works, Legalized Because It Doesn’t” (Chapter 3), in The Great American Blowup—Puffery in Advertising and Selling, revised edition, The University of Wisconsin Press, Madison, Wisconsin, 1996.

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50. “Regulation of Advertising” (Chapter 14), in CTFA Labeling Manual—A Guide to Cosmetic and OTC Drug Labeling and Advertising, Beckley C.C., Ed., 68th Ed., The Cosmetic, Toiletry, and Fragrance Association, Inc., Washington, D.C., pp. 151–17, 2006. 51. Self-Regulatory Programs Mission Statements from the National Advertising Review Council Web site: http://www.narcpartners.org/about/divisions.asp. 52. NAD Press Releases: http://www.nadreview.org/NewsRoom.asp?SessionID= 436834. 53. NAD Case Reports: http://www.nadreview.org/LatestCases.asp?SessionID= 436834.

8 Cosmetic Claim Substantiation: Methods and Legal Framework Philippe Masson1, Philippe Mondon2, and Karl Lintner2 1

EVIC International, Bordeaux Blanquefort, France Sederma S.A.S., Le Perray en Yvelines Cedex, France

2

8.1 Introduction Chapters 7 and 9 of this book touch on the questions of how to distinguish linguistically (and legally) cosmetic products from drugs and how to transmit, via advertising or design on the packaging, a message to the consumer that the product has cosmetic activity, affords skin care or hair care benefits, without crossing the border that separates cosmetic (personal care) products from drugs (health care). We have to admit though that what the consumer wants in many cases is what is now called “cosmeceuticals,” even though the term has no legal basis and is abhorred by many (including these authors) for the confusion it creates. Promises of skin care benefits, especially antiage activities, have been made too often, sometimes too dramatically, for cosmetic companies to step back now and admit only to superficial moisturizing and/or cleaning activities of their products, the more so as quality products of today do

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deliver much more than hype and empty promises. True skin care activity can be developed in a formula, and be proven and (softly) claimed. Wen Schroeder (Chapter 7) concentrates on the wording and the presentation. Even if one succeeds in presenting the finished product such that no doubt exists about its appurtenance to the cosmetic domain, the FTC and NAC in the United States, and similar watchdogs around the world (DGCCRF and BVP in France, ASA in the UK, etc.) are there to make sure that claims, even veiled, do not mislead the consumer as to the real benefits of these products. Now how can these voluntary or authoritative bodies make a judgment as to the veracity of the claims that are being made in advertisements or on the labels on TV or in press communiqués? They do this by asking the product marketer to justify their claims, to lay open the data, and the studies that have led to the claims. As there are no global and even very few local standards (see Korea, Section 8.4.1) on what constitutes “proof” or valid claim substantiation in the cosmetic field, the controlling organisms have to adopt their own, sometimes arbitrary, or inadapted evaluation criteria. In this chapter we shall review some of these criteria as well as some of the more widely used methods and protocols and the legal framework (if any) in which this activity operates.

8.2 What Constitutes a Reasonably Documented Proof of Cosmetic Activity? As we do not want to repeat the content of Chapter 7, we shall (ab)use the standard marketing language of cosmetic claims, for example, when we speak of an “anti-wrinkle effect,” we think of language that in the end will claim “helps to reduce the visible signs of wrinkles and fine lines.” You get the drift … . The list of possible cosmetic claims is almost endless, and actually increases daily with new discoveries of physiological effects in the skin. From moisturizing to oil control, from pore size reduction to cellulite “treatment,” from making wrinkles “disappear” to reducing hair loss (and slowing hair regrowth, but not on the same subjects!), from skin firming to reducing

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puffy eyes and dark circles, from treating stretch marks to spider veins, from volumizing lips to reducing rosacea, the list goes on and on. Whatever the claim, though, the basic dossier necessary to get away with it all in the eyes of lawyers, regulatory supervisory bodies, and in the end, judges, needs credibility based on data, their quality, their amount, their presentation, and their pertinence to the claim being made. 8.2.1 Content and Structure of a Well-Documented and Credible Claim Substantiation Dossier

The efficacy of a cosmetic product should be based on data obtained on the ingredients and/or the finished product [1]. These data may come from 



studies carried out on human volunteers  from self evaluation by the consumers  with trained investigators  and/or with instrumental methods from studies on other objects than human volunteers

Data on the ingredients may sometimes be found in the scientific literature, but more often it is provided by the supplier of the ingredients, if he has sufficient interest in the cosmetic applications of his product. The assembling of the various data should lead to a coherent ensemble that would substantiate the claims being made. Any report on experiments of whatever kind should follow some basic rules. 8.2.1.1 Transparency

The objective of the study and the pertinence of the method being used with respect to the claim should be clearly evident; access to the critical phases of the study and to the raw data should be easy; the objective of the study shall be clearly defined. 8.2.1.2 Pertinence

The experimenter shall explain how and why the method(s) employed are compatible with the aim of the study. If the product being tested is different from the one finally marketed, a justification is required why the change in formula would not alter the tested efficacy.

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8.2.1.3 General Information Required in Any Study Report

The identity of the promoter of the study and of the structure (lab) doing the experiment, the qualification of the experimenter(s) in charge, the location where the study is run and, most important, the identity of the products being tested (batch number and name, date of manufacturing, etc.) are basic requirements. The objective and the pertinence shall be given as well as the dates (beginning and end) of the study period. A precise protocol explaining the HOW of the test is then followed by tables and figures containing the results, with explanation of units, scoring, interpretation, and statistical evaluation; of course, the report shall be signed and dated by the experimenter in charge. Reports should be kept for at least ten years.

8.2.1.4 Tests Run on Human Volunteers

Self evaluations by consumers, also called “in-use tests.” This test allows the marketer to evaluate the acceptance and the efficacy of a finished cosmetic product (or product combination), under normal conditions of use, on a panel of consumers to whom that specific product is targeted. Results (data) are obtained in the form of panelists’ answers to a questionnaire. Because of the subjectivity of these responses, care must be taken to choose an appropriate panel (quantitatively and qualitatively), to elaborate a nonbiased questionnaire and to define, before the study, the method of how the answers will be analyzed (to avoid bias). With a panel of “cosmetically” trained volunteers such as experts in sensorial analysis, the number of participants can be dramatically reduced and the quality of the results improves. Of course, in-use tests can be complemented by studies with instrumental and/or observational methods by an experimenter. Studies with a trained experimenter (without instrumental methods). These studies require well-trained experts (e.g., dermatologists, estheticians, trained technicians) to evaluate by visual, tactile, olfactory means the efficacy of a cosmetic product on human beings. Interrogation of the panelists usually completes the observations. These studies also allow obtaining of some information about the cutaneous tolerance and acceptability of the product, even though this is not the primary objective of the study. The key element for these types of studies is the experimenter himself (herself). The person must be competent and qualified, honest and ethical, and

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must know the context of the study, the requirements of the protocol for which she/he is responsible. This is, of course, true for all studies, but in the case of subjective scoring and evaluation, it takes on particular importance. The final report should contain the CV of the experimenter, the original notes, the frequency of observation, and the criteria for scoring. Justification for the choice of the panel (inclusion and exclusion criteria) is crucial. As to the test method, protocol (open, single, or double blind randomized; type of application of the product such as rinse-off or leave-on; frequency and zones of application; special use constraints; information about abandons during the test), and results in full transparency and structured layout of the raw data are appreciated. If instruments are used in addition to the personal observations by the experimenter, information about the test method, its pertinence, description of the equipment, bibliographical references to prior use of the instrument in similar investigations, experimental conditions (humidity, temperature, etc.) form the basis of a credible report. The other items described above (experimenter’s qualification, description of the panel, inclusion criteria, etc.) apply, of course, too. Results of instrumental experiments should almost always be analyzed by appropriate statistical methods, the choice of which may need justification. Interpretation of the instrumental measurements needs to take into account the performance and limitations of the instrument, the interindividual variability. 8.2.1.5 Tests Run on Different Material than Human Beings

Here we address studies that attempt to establish cosmetic efficacy based on physical, chemical, biochemical, and biological data. Although these experiments cannot claim to supply the same elements of information as studies on human volunteers, they allow the evaluator to estimate skin penetration of an active substance, to understand mechanisms of action and the efficacy of an ingredient, a finished product or a combination of ingredients. Except when a clear correlation can be established between these studies and those carried out on human volunteers, they do not constitute in themselves sufficient proof of the real effect on consumers. As tests on animals (be they for safety or for efficacy) are not acceptable anymore for most cosmetic companies of renown, other methods have become available and accepted.

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Therefore, studies that cannot be performed ethically on human volunteers have to be done on material that yields useful and pertinent information, but does not complain about pain, stress, or other negative aspects. Cell culture studies in vitro allow the investigator to carry out numerous experiments. Histological, but also analytical experiments on skin biopsies (explants from surgery) or on reconstituted 3D skin models can, at least partially, be substituted for equivalent human studies. Reports on these nonhuman support studies must detail and justify the nature and origin of the support (dead animal’s or cadaver skin, monolayer cell culture, 3D full thickness skin, etc.), it shall describe the precise methodology and its relation to the nature of the product being investigated; a description of any equipment used, bibliographical references to the method, special conditions of the study, frequency of measurements and benchmarking to positive and negative controls are sine qua non requirements. As usual, definition of the success criteria, quantities, and concentration levels, statistical analysis of the raw data are all part of a proper approach to using these methods. 8.2.1.6 Mini Summary

It can be assumed that in all countries where claims of cosmetic product activity are challenged by some authority or other, a well-documented report that contains the basic elements described earlier will pass muster and will be accepted as establishing support for the claim. Pertinence of the methods, transparency of the protocol, easy access to the raw data, straight forward statistics, clear lay out, and description of the work with, of course, significant data (preferably against a benchmark) are all very useful to bolster the message to the consumers.

8.3 A Short Review of Methods Used to Establish Cosmetic Claim Substantiation 8.3.1 In vitro Tests

The so-called in vitro methods are those that are carried out on the laboratory bench, using either assay media without cells (acellular experiments such as enzyme inhibition, free radical scavenging, UV absorption) or in the presence of living cells. These cells may be of human origin, neocultured

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in regular intervals (these cells also age and die), preferably from human tissue: keratinocytes, fibroblasts, melanocytes, adipocytes. For screening purposes, immortalized cell lines (murine 3T3 cells, HaCat keratinocytes, HeLa epithelial cells, murine B16 melanoma cells, and many more) can also be used, although these are often quite removed from the physiology of the human skin and extrapolation of results obtained with them is more difficult than from true, normal, nontransformed human skin cells (Figure 8.1). Protocols for studies on these cell cultures are limited only by the imagination of the investigator. One can look at stimulation of the synthesis of macromolecules (collagen, elastin, fibronectin, integrins, glucosaminoglucanes, hyaluronic acid, ceramides, etc.), at the inhibition of their degradation by enzymes (trypsin and chymotrypsin, collagenase, elastase, metallomatrix proteases (MMP), hyaluronidase, etc.). One can observe morphological changes in the cells, measure the release of cytokines, metabolites, inflammatory molecules (prostaglandin, interleukins). It is, of course, possible to study gene activity (with DNA chips and RT-PCR (reverse transcriptasepolymerase chain reaction) technology), to stain and visualize individual proteins with fluorescent probes, and then use image analysis to quantify the effects. The better we understand skin physiology, the more new marker molecules are discovered (for instance, there are now more than 19 types of collagen identified; not all their specific functions have been elucidated), the more in vitro studies with interesting results can be conducted on ingredients. However, it is very difficult to study complete finished formulations in these in vitro models, as most ingredients (surfactants, preservatives, solvents including glycerin) are not compatible with the fragile cells in monolayer experiments.

Figure 8.1 Three types of cells used in in vitro studies: normal human keratinocytes, normal human melanocytes, and human adipocytes.

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Straight extrapolation of any effect observed and established in these in vitro experiments to what may happen on the living skin of people is mostly impossible, although in vitro data may orient later the type of clinical studies to conduct. 8.3.2 Ex Vivo Tests

Using full thickness skin (from surgical explants) or commercial 3D models of reconstituted skin (so-called ex vivo protocols) has several advantages: cells react more like they would in intact skin; interactions between the viable epidermal and the dead cutaneous cells (stratum corneum) and the deeper lying fibroblasts are preserved (up to a point); most important, it is often possible to apply the product (be it an isolated ingredient or a finished formula) topically to these skin models and judge the effect on the deeper layers—a method that integrates (at least in a first approximation) the penetration behavior of the product on panelists’ skin (Figure 8.2). 8.3.3 In Vivo (Clinical) Tests

For the evaluation of the veracity of a claimed cosmetic effect, nothing can beat the in vivo (or clinical) tests. Carried out on a sufficient number of panelists, yielding good statistical significance between the time points T0

Figure 8.2 Explants from surgery, kept in survival medium.

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and Tx, possibly against a positive benchmark or untreated skin, where every panelist is his (her) own control, and using pertinent and reliable instruments, in the hands of a trained expert, they are particularly convincing when in vitro studies exist, which can explain, at least partially, the mechanisms behind the observed macroscopic effects. For the authorities, but also for the consumer, original (but honest) photographs of “before” and “after,” taken under professional conditions of reproducible light, “light temperature,” film quality, camera positioning, and so on are the nec plus ultra. A favorite method consists in taking pictures of a specific region of the skin (wrinkles, cheek, thighs) before the first application of the product tested, and then again (under identical conditions) of the same region after the test. If the test panelists then are challenged to judge these pictures, to classify them (in a blind mode) as to “better” or “worse,” it is possible to measure to which degree the volunteers recognize the true (or perceived) improvement. For this type of study to succeed, given the many individual variations and the subjectivity of the panelists’ appreciation, their lack of training in these matters, it is necessary to work with relatively large groups (~100). But even without pictures, instrumental methods and clinical observations by a trained expert can yield excellent results. For the all important claim of moisturization, the Corneometer® (Courage& Khasaka, Germany) method is the simplest. It consists of measuring the impedance on the surface of the skin. The more moisture there is, the higher the (dimensionless) units on the instrument. Coupled to the Tewameter® (Courage&Khasaka) measurements, which determine the amount of water vapor exiting the skin over time, the Corneometer® studies afford a good idea of skin hydration and barrier integrity. Electron microscopy of individual skin cells, transient thermal transfer (TTT), high-frequency impulses (Moisturemeter®), ATR/FTIR infrared spectroscopy, near infrared (NIR) spectroscopy, and even magnetic resonance can complement the more simple methods. The efficacy of wrinkle “treatment” can also be measured in several ways. A time-tested method consists in obtaining replicas of the skin (usually of the crow’s feet area around the eyes) and applying a profilometry analysis (cast shadows, laser, or stylus) that allows the quantitative determination of wrinkle depth, length, volume, density, and thus calculation to be made

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of the changes between “before” and “after.’ The FOITS (Fast Optical in vivo Topometry of human Skin: projection of interference patterns onto the skin and analysis of the images thus obtained) method gives essentially the same results, with the advantage that the panelist (and the skin) do not have to be touched. Fine lines can be quantified by the VISIA® system (Canfield Inc., USA). Professional quality photography is a useful complement, even if less quantitative in nature (Figure 8.3). Sebum (oily skin) is usually quantified by the Sebumeter® (Courage& Khasaka), which collects the quantity of sebum on a defined surface; the drawback is that it yields only a momentary, absolute, static value that may be influenced by many parameters nonrelated to the skin (climate, stress, and hormonal imbalance). One compares the average Sebumeter® values of a sufficiently large panel (20–30 volunteers) before and after a specified time of daily application of the product (Figure 8.4). The Sebutape® method more than complements the Sebumeter® analysis as it allows to measure sebum secretion in a given interval of time; it is less subject to the cited influences. It consists of first cleaning the skin sites with alcohol, then applying the Sebutape® adhesive film, which will absorb the newly secreted sebum from the active sebum glands and is then quantitatively analyzed by image analysis (Figures 8.5 and 8.6). Again, values are compared between time points T0 and Tx.

Figure 8.3 Application site for skin replicas to study wrinkles.

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3D representation

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Figure 8.4 Image analysis of skin replicas.

Figure 8.5 Application of Sebutape® to the front.

Often tied to hyperseborrhea, the question of “pore size” (e.g., on adolescent skin,) can be quantified by image analysis software of high-quality microphotography of the studied areas. The shine (brilliance) of oily skin, often unseemly and unwanted, can be quantified by brilliance meter methods, or by digitized photography of pictures taken with or without polarized light (a mathematical difference can be calculated then).

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3D representation

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Figure 8.6 Image analysis of Sebutape® films after removal.

Ultrasound echography is used to measure skin layer thickness; depending on the frequency of the ultrasound emitted by the probe, different depths (and skin layers) can be reached; cellulite infiltration in the hypodermis can be visualized and quantified; dermal thickness in “anti-age” treatment is measurable to a high level of precision. Other methods to study “anti-cellulite effects” use profilometry of the skin surface to quantify the “orange peel” skin appearance, magnetic resonance to measure lipid and water ratios in the deeper layers of the skin; of course, the tape measurement of thigh perimeter may still be used (carefully) to indicate “slimming” (not weight loss). Closely related are methods to quantify skin firmness (i.e., elasticity, tonicity, and tissue cohesion). The Cutometer®, Twistometer®, and Ballistometer® methods all work by extending the skin one way or another and optically following the deformation and rebounding of the skin. Nontouch instruments using pulsed air to deform the skin are being developed to eliminate conscious or unconscious bias in these techniques (Figure 8.7).

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Figure 8.7 The Cutometer® and its application in a test.

Skin tone (also called skin color) is measured (in “skin toning/whitening/ brightening” claims as well as in tanning studies) by chromametry with either the Mexameter® (Courage&Khasaka) or the Chromameter® (Minolta), instruments, which can quantify colors in precise values and allow changes in skin color to be followed over time (Figure 8.8).

Figure 8.8 The Minolta Chromameter®.

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Rosacea type symptoms can also be investigated with these techniques. Studies on the hair and the scalp also constitute a wide field of cosmetic investigations. Dandruff treatment, although considered a medication (OTC) in the United States and a quasidrug category in Japan, can be followed by image analysis of high-quality pictures and/or gravimetric (weighing) protocols, by quantifying squames obtained from reproducibly applied DSQUAM® or other adhesives. Hair growth or hair loss is investigated with photo- or videotrichograms (macrophotography of closely cropped hair on the scalp, see Figure 8.9) followed by quantitative image analysis. The quality and “health” (careful use of this word is recommended!) of hair, its strength and compatibility is evaluated by the Diastron® techniques, which measure the force needed to comb a strain of hair, or the resistance to breakage by pulling the hair. A new technique called Flexabrasion (Croda International, Plc, UK) gives more realistic values of the hair strength and surface quality. It consists in subjecting the hair to repeated flexing and movement over a metal string until is breaks.

Figure 8.9 Phototrichogram.

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Electron microscopy pictures of hair surface are also often used to visualize the state of the hair; again, quantification of the surface is possible with powerful image analysis software to indicate smoothness, for instance (Figure 8.10). Research into new, more powerful, more informative techniques of skin and hair investigation is ongoing all around the cosmetic world. No exhaustive list of methods for claim substantiation can, therefore, be established. The above compilation is only a selection of the most commonly used techniques.

8.4 Regulatory Aspects None of the methods described in the previous section—although widely used and accepted—are standardized, nor is there any desire in the industry to establish norms, uniform protocols and/or minimum values required

Longueur = 68.8 μm pt = 7967 NG Echelle = 12000 NG

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for a specific claim. A general guideline on claim substantiation has, nevertheless, been published by COLIPA [1] and a few articles in scientific journals have attempted to set normative examples for, for example, moisturization (see [2–12]). 8.4.1 Korea and the Rest of the World

If we exclude the categories called OTC (United Sates) and quasidrug (Japan) from our discussion, which require government registration and authorization for specific claims (UV protection, dandruff treatment, skin whitening, topical acne products, hand sanitizers and the like; thus these products are more closely related to pharma regulations than cosmetic legislation), then only Korea stands out as a country where three cosmetic claims (wrinkle treatment, skin “whitening,” and also UV protection) are specifically regulated (and possibly other cosmetic claims will become victims of this specific cosmetic law voted in 2001, creating a category of “Functional Cosmetics”). In order to be able to claim an “anti-wrinkle” effect for a cosmetic product sold in Korea, it is necessary that the formula contain the right (i.e., approved) amount of an active ingredient (retinol, for instance), chosen from a published positive list. As there are only four ingredients publicly approved for this claim so far, innovation is hampered, but not totally restricted: any new active ingredient claiming to help reduce wrinkles (or to “lighten the skin color) needs registration with the Korean FDA (KFDA). However, it is not the ingredient itself that is approved and then added to the positive list; the finished product formula has to be submitted with a solid dossier establishing the activity of the new active ingredient. That is, data on the ingredient and its activity are needed that follow closely the guidelines given in Section 8.2.1 earlier. In vitro data on mechanism, bibliographical references with peer reviewed articles, clinical studies on the finished formula (the one destined for the consumer market) on at least 30 panelists, containing the new active against placebo and/or benchmark, will be required. Reports on these studies must include the experimenter’s CV, information about the lab having carried out the investigation, also analytical data on the stability of the ingredient, and many more details need to be submitted required to obtain the right to

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market the product with an antiwrinkle (or skin whitening or sun protection) claim. Although no specific methods are detailed or required in the legislation on “Functional Cosmetics,” the spirit is clearly outlined: the regulators want to understand the mechanism of action of the product(s), want to be convinced of the scientific justification behind it, and want to see vehicle controlled clinical studies with statistically significant data compared with “placebo. This severe view of cosmetic claim substantiation is highly reminiscent of pharmacological studies and registration. 8.4.2 Clinical Studies on Human Volunteers for Cosmetic Purposes

A somewhat different aspect of regulatory activity concerns not the content of a report on claim substantiation, but the type of studies (instrumental or not) carried out on human beings. The field is usually referred to as “biomedical research” and governs the questions of “what type of study is allowed on human volunteers, under which condition.” All methods mentioned in the previous section are of the so-called “noninvasive” type, that is, they present absolutely no risk to the volunteer participating in the study, they do not hurt and do not invade, diminish, or otherwise negatively impact the body. Guidelines of what constitutes “noninvasive” studies not needing the consent of an “ethics committee” and which studies do need this authorization exist, but vary from country to country. For instance, studies using suction blisters to measure blood flow are allowed in Germany, but not in France; Italy is even more liberal, allowing studies on babies and infants. In the United States, even ex vivo studies on surgically removed skin (plastic surgery) are controversial, whereas in France only the consent of the person whose skin was removed is required (this skin is considered biological waste and of no intrinsic value). Of course, any study that hurts, requires removal of skin tissue (punch biopsies), or that otherwise would interfere with normal bodily functions and poses a risk to the volunteer needs justification, close monitoring by regulatory bodies and extreme caution as to the competence of the investigators; often the supervision by a medical doctor is required. A borderline case is given by the UV protection products (sunscreens), as the determination of the sun protection factor (SPF) requires panelists to undergo UV irradiation up to minimum erythematic dosis (MED). “Normal” SPF

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protocols, when run under conditions of Good Clinical Practice (GCP) are usually not required to register with an ethics committee or the authorities. Any significant deviation of the standard protocols, however, is likely to require authorization. Rules and recommendations on biomedical research protocols distinguish between those that afford a benefit to the panelist and those that do not. The latter are rarely admitted in conjunction with invasive techniques. The rules generally disbar panelists from participating in studies when they are pregnant, ill, and/or under chronic medical treatment, when they have participated recently in other studies (no one wants “professional panelists”). For the promoter of, and the entity carrying out the clinical studies, it is important to inform the panelists of the objective of the study, their right to leave the study at any time without justification, the duration of the study, the type of measurement used, and the absolute confidentiality of their identity. An “informed consent” document should be signed by every panelist before including him (her) into the panel. In many countries, rules about the constitution of databases with volunteers’ identities and characteristics (age, sex, skin condition etc.) exist and should be strictly adhered to.

8.5 Conclusion Modern skin-, body- and hair-care cosmetic products take seriously the definition (as laid down in the European Directive of 1976) of what a cosmetic product is (among other things): to beautify and keep the skin in good condition. This somewhat ambiguous wording does include the ideas of restoration, repair, protection, regulation, and modulation of physiological parameters. In the United States, the definition is somewhat more restrictive and even more careful language has to be used (cf. Chapters 7 and 9) to convey the right message to the consumer. Nevertheless, whatever the wording, consumers understand and expect that quality cosmetics can and do afford benefits to the skin, scalp, and hair. If they can perceive these benefits by themselves, brand loyalty is quickly established. But more than that (in-use studies, self evaluation results) is needed to make the first and lasting impression on the market. Authorities, consumer protection groups, NGOs, and competitors have to be convinced that any claims that are made have a real base to them. The present chapter should help the marketer understand what minimum “dossier” is needed to establish credibility and survival of his claims.

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References 1. www.colipa.com/site/download.cfm?SAVE=28503. 2. Berardesca E., “EEMCO Guidance for the Assessment of Stratum Corneum Hydration: Electrical Methods,” Skin Research and Technology, 3, pp. 126–132, 1997. 3. Frosh P.J., Kligman A.M., Non Invasive Methods for the Quantification of Skin Functions, Springler-Verlag, 1993. 4. Höcker H., “Efficacy Testing for Hair Care Products,” Skin Pharmacology and Applied Skin Physiology, 12, pp. 158–165, 1999. 5. Lévêque J.L., “EEMCO Guidance for the Assessment of Skin Topography,” Journal of the European Academy of Dermatology and Venerology, 12, pp. 103–114, 1999. 6. Lodén M., “Efficacy Testing of Cosmetics and other Topical Products,” IFSCC Magazine, 3, pp. 47–53, 2000. 7. Piérard G.E., “EEMCO Guidance for the Assessment of Dry Skin (Xerosis) and Ichthyosis: Evaluation by Stratum Corneum Strippings,” Skin Research and Technology, 2, pp. 3–11, 1996. 8. Piérard G.E., “EEMCO Guidance for the Assessment of Skin Colour,” Journal of the European Academy of Dermatology and Venerology, 10, pp. 1–11, 1997. 9. Piérard G.E., “EEMCO Guidance to the In Vivo Assessment of Tensile Functional Properties of the Skin,” Skin Pharmacology and Applied Skin Physiology, 12, pp. 352–362, 1999. 10. Rietschel R. L., Spencer R.L., Methods for Cutaneous Investigation, Marcel Dekker, 1990. 11. Rogiers V., “Efficacy Claims of Cosmetics in Europe Must be Scientifically Substantiated from 1997 On,” Skin Research and Technology, 1, pp. 44–46, 1995. 12. Stern E., et al., “Views on Claims Support Methods for Hair Care Products” (Chapter 2), in Cosmetic Claims Substantiation, Aust, L.B., Ed., Marcel Dekker, pp. 21–68, 1998.

9 The Impact of Global Regulations on Packaging Holly C. Young and Marcus Tirado Hirschhorn + Young Graphics, Inc., New York, NY, USA

9.1 Introduction As a graphic artist and designer working for over 30 years in this highly technical field of science and regulations, I hope to offer an interpretation of some of the regulations you may read about in this publication—from a completely different point of view. I’m the picture person, the right brain person, the artist, and designer—with the regulatory devil on my shoulder. Therefore, my observations here will reveal the perspective of a designer, not a chemist on existing regulations for package design. I will also examine the design impact of future trends in regulation in the United States and worldwide. It’s important to keep in mind that regulations are continuously changing and evolving in the United States and throughout the world. While there is a movement to harmonize regulations, this is not currently the case. It might take many years, if not decades, to accomplish.

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9.2 The Importance of Your Package Besides the obvious aesthetic reasons, why is the visual image of your package important? One key reason is shelf impact—the impression or lack of impression of your package on the consumer at the time of purchase. Statistics which support the significance of shelf impact: some 70% of all product purchase decisions are actually made at the shelf; a consumer stays in the store an average of 21 minutes with 2.5 minutes at each shelf and they purchase 18 products per visit on the average. Effective package design must win a race against time, competitive products, and the consumers’ decision-making process. This information makes it clear that what your product looks like and how it communicates to the consumer is vital to your success in selling your product. You must take a fresh look at how your product sits on the shelf and what message the consumer might get when viewing the package. A crucial aspect of shelf impact is its relationship to various regulations. You need to understand all of the “stuff” you might have to put on the front of the package to be in compliance. It is critical to the success of your brand to create your brand image within the right regulatory framework. Try to imagine the negative results of your brand and its shelf impact due to the confusion this “stuff” might create. As you look at your product on the shelf with all of your competitors’ products, view it from the consumer’s perspective: how easy is it to understand what the product does for me (the consumer)? Why should I buy this over Brand X? Am I getting value for my money (is the volume or weight the same or better for the price)? The more products come on the market, the more crowded the shelves become, and the consumer has a harder time making choices. My goal is to illustrate the issues to help you create a package that makes it easier for the consumer to decide and ultimately buy your products while following packaging regulations.

9.3 Global Packaging Trends and Issues A significant aspect of packaging has become the trend to create a “Global Package,” in which the product could be sold anywhere in a single package version. This “one-size-fits-all” concept cuts down on the number of variants and inventory. However, there are many issues in global packaging to consider before deciding to move ahead with one package that can be sold in every country in the world.

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One key issue is language. The global marketplace is constantly expanding. For example, just look at how the European Union (EU), has changed over the last few years. Prior to May 2004, the EU consisted of Germany, France, Italy, the Netherlands, Belgium, Luxembourg, Denmark, Ireland, the United Kingdom, Greece, Spain, Portugal, Austria, Finland, and Sweden. In 2004, the EU was joined by the Czech Republic, Cyprus, Estonia, Latvia, Lithuania, Hungary, Malta, Poland, Slovenia, and Slovakia. In less than 5 years, the EU membership increased by 66%—and just recently, Bulgaria and Romania also joined the Union. Ultimately, that means your package must communicate its shelf appeal to consumers in more than two dozen countries, communicating more than two dozen languages, and competing against many locally produced products. Often, this would mean more languages on your package, not just from a regulatory aspect, but also from a marketing one. Another way to view this packaging trend is from a growth perspective: for 2007, the emerging markets in skin care were considered to be Argentina, Brazil, China, India, and Russia. For fragrances, the emerging markets were held to be China, India, and Japan. For hair care, Brazil, Mexico, and Argentina were thought to be the emerging markets. Potentially, each of these countries has a different set of regulations, which do not always correspond with one another. One more global packaging trend that is increasingly more significant is the heightened enforcement which many countries place on their packaging regulations. This enforcement ranges from actual fees and tariffs for banned ingredients to a strict procedure of chemical ingredient legislation such as “Registration, Evaluation, Authorization and Restriction of Chemical substance” (REACH) in the EU. In addition, customs officials are more stringent and aware of what is required on packaging coming into their countries. A customs official can actually halt entry of your products if the packaging does not meet local regulations. Thus, many of these packaging regulations are becoming trade barriers, preventing you from getting your product to consumers outside the United States.

9.4 Key Global Regulatory Elements for Packaging: The Basics The best way to minimize a negative impact on the sale of your product is for you to know what is expected of your packaging at all times. At the

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start of the packaging development process, you must share your knowledge with your packaging professionals. They must know the boundaries and parameters right from the beginning. It is better to know what the basic information is for a particular country or product type at the start, rather than fix it once “legal” looks at it. The global success of your brand relies on your ability to create your packaging and brand image within the right regulatory framework. Let’s look at what these key elements of your packaging might be by first looking at one of the most basic issues: The classification of your product. 9.4.1 Definitions: Cosmetic or Drug?

The first element in your packaging to consider is how it is defined. In some countries, a product might be a drug, a cosmetic, or a separate group entirely, depending on the perspective of the regulatory agency. Cosmetics: In the United States, cosmetics are defined by the Food, Drug and Cosmetic Act (FD&C Act) as “articles intended to be rubbed, poured, sprinkled, or sprayed on or introduced into, or otherwise applied to the human body or any part thereof for cleansing, beautifying, promoting attractiveness, or altering the appearance, and articles intended for use as a component of any such articles; except that such term shall not include soap.” The key section in the U.S. definition of a cosmetic is “beautifying, promoting attractiveness ….” These words keep your product considered a cosmetic and not a drug in the U.S. market. Once a product is considered a drug in the United States, there are a myriad of additional regulations that need to be followed, not only for the packaging but also for testing and manufacturing. Drugs: Drugs, defined by the FD&C Act as well, are “articles intended for use in the diagnosis, cure, mitigation, treatment or prevention of disease in man or other animal; and … articles (other than food) intended to affect the structure or any function of the body of man or other animals ….” This definition also applies to over the counter (OTC) drugs as well. For a drug product in the United States, the important phrases are “intended for use in the diagnosis, cure, mitigation, treatment, or prevention of disease …” and “intended to affect the structure or any function of the body ….” The stated and labeled intention of the product is critical in determining

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whether a product is considered a cosmetic or a drug in the United States. What is required on the packaging from a regulatory perspective differs significantly for drugs. Cosmeceuticals: Another term that is used frequently is “cosmeceuticals.” Currently, the Food and Drug Administration (FDA) and EU regulatory agencies do not recognize this term. There is no separate category of product regulations for “cosmeceuticals,” so a product labeled or marketed as a “cosmeceutical” is either a cosmetic or a drug and must be labeled as required. However, certain countries, such as Japan, Korea and Canada, have categorized “cosmeceuticals” separately within their own regulations. Japan has developed a category called Quasi Drugs, which are defined as “mild medications that are weaker in effect to the body than regular drugs, but are neither intended for the diagnosis, prevention or treatment of disease, nor to affect the structure or function of the body.” Korea established “functional cosmetics” that need registration with the Korean FDA for certain cosmetic claims (skin whitening, antiwrinkle efficacy, and UV protection). Canada has also developed a similar category called Natural Health Products (NHP). The NHPs are categorized not by their intent of the product, but by the selection and use of an active ingredient. The main point is that a product might be a drug, a cosmetic, or a different group altogether depending on the regulations of the country. See Figure 9.1 for an illustration of what countries would consider a certain product a cosmetic versus a drug versus a separate product. Each nation would potentially require a different type of labeling and may not allow packaging with labels from other countries to be sold in their country. 9.4.2 Ingredients on the Label

The second key element to review is the ingredients—focusing only from a labeling perspective, not a scientific one. The names of ingredients for almost all cosmetics are based on the International Nomenclature of Cosmetic Ingredients (INCI). This is an attempt at a universal language of ingredient names that could be used worldwide. While this is a very workable solution for most areas of the world, there are some issues that fall short. For instance, within INCI, there are 57 trivial

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Figure 9.1 Global comparison of the legal separation between cosmetics and drugs. SPF: Sun protection factor.

names that have been set apart by Canadian regulations. The simple U.S. ingredient “water” is “aqua” in the EU. But in Canada, if you use the U.S. INCI version, you must translate it into the French “eau.” However, if the EU INCI version is used exclusively with no U.S. names, Canada does not require French translation. The United States requires the use of “may contain” for color additives, but the EU allows the use of “+/–” in order to transcend the language issue in the 27 EU communities. There is even a discrepancy between the United States and the EU regarding the treatment of color additives in the ingredient. The United States requires the use of U.S. color names (i.e., Carmine) and the EU requires the use of color index numbers (i.e., CI 75470). There is also a significant departure from the use of this universal language of ingredients in countries where the INCI must be translated into the local language, for instance, Spanish for Mexico and Japanese for Japan. A number of countries, such as China and Korea, are considering this type of translation requirement into the local language. 9.4.3 The Package and Innovation

The last key element is the packaging component itself—the bottle, tube, vial, carton, plastic sleeve, etc.—that houses your fabulous product. The

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industry’s focus on innovation now goes beyond the products themselves to the packaging components, with many more innovative packaging ideas, shapes, styles, and materials. However, parts of the package itself may present some regulatory issues, such as recycling, reclaiming, deceptive packaging, or waste. Innovative packaging may look fascinating, but may have insufficient (or virtually nonexistent) labeling room to fit all the required information—a major concern from a design perspective. 9.4.4 The Basic Primary and Secondary Components of Package Design

First, let me make sure you understand what this means. The primary component is the part of the package that comes in direct contact with your product; it is therefore “primary” because it is the primary component that holds the product together. The secondary component would be the outer package, if you choose, such as the carton, sleeve, blister card, etc. Most packaging regulations refer to the secondary component, or outer package—the package seen by the consumer at the time of purchase. If you have no secondary for your product, the regulatory information is required on your primary which then be considered your outer package. If you have both a primary and a secondary, then all of the regulatory information will be required on your secondary, where it can be seen by the consumer. (However, some information may also be required on the primary.) What does a basic primary and secondary package in the United States and EU have to look like? What are the must-haves on the primary and secondary to make it compliant? Many of these regulations have size and placement issues, some of which are mentioned later in this chapter. All countries have mandatory requirements for both the primary and secondary packages, but each country has slight variations. Therefore, it is extremely important to focus on all the details. For the most part, the requirements are relatively similar— but keep in mind that each country has its own language requirements. First, an almost universal requirement for all cosmetics is the “Statement of Identity” (SOI). The SOI is a mandatory requirement in almost all markets unless the product function is obvious from the presentation (the packaging component). For example, an eyebrow pencil looks exactly like an eyeliner pencil, which looks exactly like a lip pencil, yet each has a completely different function, which is NOT obvious from the presentation. For the United States, the SOI must be placed on the Principal Display Panel (PDP) of the outermost packaging and generally parallel to the base.

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There are no specific type size requirements in United States; however, it should be conspicuous in size reasonably related to the most prominent printed information on the PDP. For the EU, the SOI is mandatory, unless the product function is obvious from the presentation (the packaging component). The placement and size of the SOI in the EU is not critical, but it must be marked in clear, legible, and indelible letters. Of course, the concern in the EU is the translation of languages for each member state that your product is sold. Second, the net quantity of contents (weight claim) is one of the most highly regulated requirements. The weight claim follows strict regulations and is usually labeled on both the primary and secondary packaging. However, in most countries, the type size regulations for outer packages do not apply to the inner container. At a minimum, the declaration on the inner package should be clear, legible, and indelible. Most countries have their own requirements on how and where to declare this information. Be sure to verify this for all your prospective markets. In the United States only, the weight claim on the outermost packaging must appear on the PDP, in a specific letter height relative to the square inches of the PDP, located on the bottom 30% and generally parallel to the base. Information printed around the weight claim must be separated by a space equal to the height of the lettering used in the claim. Information printed on either side of the weight claim must be separated from the claim by two “N” spaces. The weight claim must employ both the customary U.S. imperial system and metric equivalent. It is extremely important when converting the weight claim not to numerically round up the weight claim. For the EU, the letter height depends on the volume or weight declared and does not have to be on the PDP. The EU requires only a metric declaration but is not averse to the use of the U.S. declaration in conjunction with a metric declaration. Third, warnings and instructions for use are required to be labeled when mandated by regulation or when deemed necessary for the safe use of the product by the consumer. Typically, warning statements must appear on both the inner and outermost packaging. Warnings must be prominent and conspicuous. Often, the type must be in bold face and a minimum type size may be required depending on the country. The FDA, EU, and other regulatory agencies prescribe specific warnings for certain types of products.

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In addition, certain ingredients and packaging may require special warnings on specific areas of the package (i.e., for aerosols in canisters, the EU requires a flame symbol). Fourth, in most countries, the ingredient listing must be placed only on the outermost packaging. Ingredients must be listed in descending order of concentration. Ingredients must be provided using INCI names. U.S. INCI differs from EU INCI, as noted previously. In addition, some countries may require this information to be translated into the local language. For the United States, the minimum type size should be at least 1/16 of an inch using a lowercase “o.” Type size of 1/32 of an inch may be used when the total surface area available for labeling is less than 12 square inches. The EU has no specific type size requirements, but the ingredient listing must be clear and legible. Fifth, the name and address of the manufacturer, packer, or distributor is required in all countries. If the name on the label is not the name of the manufacturer, then it should be qualified as “Distributed by,” which expresses the connection that the named person has with the product. The statement of the place of business must include the street, address, city, state, and zip code. However, the street may be omitted if it can be found in a current city directory. This information is required on both the primary and secondary packaging with no type size requirement, but it must appear conspicuously. The country of origin must also be placed on the inner and outermost packaging. There is no type size requirement, but it must be legible and indelible. (Note: For products made in the United States, the country of origin is not required.) The country must be provided in its English name. The words, “made in” or “product of” must precede the name of the country in which the article was manufactured. Sixth, for those products with durability over 30 months, the EU has developed a “Period After Opening” (PAO) symbol to signify the durability of a product after opening for the first time. The open jar image with the number of months either inside or alongside the image is required for both the primary and secondary package for the EU only. The number of months corresponds to the amount of useful time that the cosmetic has after opening. Any cosmetic product with a minimum durability under 30 months must bear a “best before” date labeled on the primary and secondary package.

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This requirement is not mandatory when the date of minimum durability exceeds 30 months. These are the basic requirements for packaging in the United States and the EU. There are also a number of additional symbols that may be required for different types of products. 9.4.5 Additional Labeling

Generally, there will always be additional labeling regulations that must be satisfied, depending on the country or region in which you are trying to market your product. The majority of additional labeling is represented by symbols or information stamped or added on the package after it is printed. One increasingly popular symbol used on international cosmetics packaging represents “Organic” labeling. What are the major factors to categorize your product as organic? First, you have to register your product as “Certified Organic.” The USDA-National Organic Program (NOP) is the only U.S. “cosmetic” regulated certification that you can use to become “Certified Organic.” Second, all organic ingredients must be certified USDA-NOP in order for your product to bear the green USDA “Certified Organic” Seal. The EU and Japan also have their own ingredient restrictions and certification processes on “Certified Organic” products. Another symbol on cosmetics packaging is the “Green Dot.” The “Green Dot,” found on the back of almost all cosmetic packaging in the EU, was established in Germany in 1991 to create and promote packaging recovery and recycling. Since then, the EU included the “Green Dot” method in its European “Packaging and Packaging Waste Directive—94/62/EC.” Companies that don’t wish to participate in the Green Dot program are required to collect recyclable packaging themselves. We strongly suggest registering and applying the “Green Dot” to your cosmetic packaging when marketing in the EU. It is a recognized symbol in many European countries that proves that a financial commitment has been made to improve the environment by the manufacturer. The “e” mark is among the most recognizable symbols in European cosmetics packaging. It represents the Average Fill System, introduced in 1979, which recognizes a declared filling of the product and provides a safeguard to prevent under-filling below certain levels. It is required for products 5 g/5 ml or greater. If your package complies with average fill,

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then you may label it with the “e” mark, which allows your goods free movement within the EU. The “e” mark is placed next to the metric weight claim; it must match the height of the weight claim or a minimum height of 3 mm. Always keep in mind that the “e” mark is a custom and unique typeface. The EU requires additional warnings for certain products, especially for potentially dangerous packages such as aerosol canisters. “The Statutory Order about Aerosols” (SOA) specifically covers aerosol regulations. All aerosol products marketed in the EU must be tested in accordance with the technical requirements specified in the Order. Once the aerosol meets the regulations, it must be marked with a laterally reversed epsilon (Э) to show completion. Also, if the content of the aerosol is highly and extremely flammable, then it must bear a black flame on an orange/yellow background. You may find it difficult to meet all of these additional labeling requirements on a small cosmetic package. To aid compliance, the EU developed the “Hand and Book” symbol, which allows you to place certain required information on a leaflet, additional label, tag, tape, or card enclosed as a part of the package. This information cannot be separate from the package. It cannot be left with the sales person, placed on the Internet or located anywhere other than directly with the package. The European Cosmetics Directive provides that the “Hand and Book” symbol must be placed on the outermost packaging so that the consumer is directed to this additional information. If a package does not have sufficient label space, then additional information enclosed may include the ingredient declaration and warnings. Remember, the “Hand and Book” is not a license to conceal required information from the consumer at the point of purchase. It is only used when there is not insufficient label space available. Among the last requirements applied to the package are the expiration date and the batch number. An expiration date is only required for cosmetics if there is a time limit for the product’s safe usage. However, certain markets may require you to research your product and find out if it is considered unsafe after an extended period of time. The batch or lot number, stamped on the package, identifies the production and distribution history of the product. For the most part, the United States and other countries do not regulate expiration dates and batch numbers for most cosmetics. Even though it is not regulated, display of expiration dates and batch numbers is highly recommended; they should be placed on the inner and outermost packaging.

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Some of the information above is mandatory, depending on the requirement for the symbol and the country involved. In addition, there are many symbols used today that have no bearing on regulations and are only used for marketing purposes. It is imperative that you identify what symbols and information are required and what are just parts of your marketing message.

9.5 Case Studies Let us now examine a specific type of product—sunscreens—and how the labeling would differ depending on the market. Review the cosmetics versus OTC chart (Figure 9.1) as we examine a practical comparison of sunscreens for different markets. As mentioned earlier, a key characteristic of most regulations is that they often change, creating the dilemma we face in the visual message of the package and the regulations as they now stand. Some of the following notations are pending as regulations, other notes are recommendations only. 9.5.1 Special Products: Sunscreen for the EU

Even though the EU does not consider sunscreens a drug, the EU Commission is calling for some potential additions to the labeling. First, is the addition of a circle on the front of the package with “UVA” in the middle of the circle. The “UVA” circle shows that this sunscreen has UVA protection as well as the UVB protection indicated by the SPF value. The front of the package may also need wording added under the SPF value for very high, high, medium, or low (depending on the relationship to the number stated). The back (or other) panel may need pictograms to illustrate the various cautions and uses regarding the sun and sunscreens. These pictograms are an attempt to communicate to the consumer without having to translate, thereby transcending the language issues in the 27 EU countries. 9.5.2 Special Products: Sunscreen for Canada

Canada considers these types of products either a drug, which includes a registered drug identification number (DIN) or a natural health care product (NHP) depending on the selected substances or combination of substances manufactured. The labeling for DIN sunscreens is slightly different from those considered NHP sunscreens. However, they both share very specific elements required on the PDP: the product form (cream, lotion, gel, etc.) and DIN or NHP registration number for active ingredients.

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In addition, all products sold in Quebec (a major province of Canada) must have all information printed in English and French, in the same size and prominence, preferably with French labeled first. 9.5.3 Special Products: Sunscreen for the U.S.

There is a new proposed U.S. FDA monograph for sunscreens. While this is only a proposed final monograph, it is advisable to review how this would impact the labeling of sunscreens in the United States. All sunscreens in the United States, even if used in a lipstick, face makeup, or moisturizer, are considered drugs. The majority of the labeling regulations will apply, although there are some considerations for products meant for small areas of the face and lips, or products where the mandatory Drug Facts Panel takes up more than 60% of the area available for labeling. Starting on the front (PDP), the following information is required: the SPF statement must be started as “UVB SPF XX LOW/MEDIUM/HIGH/ HIGHEST” (which corresponds to the number value); an additional statement of UVA needs to be added as “UVA ນນນນ LOW/MEDIUM/HIGH/ HIGHEST” (which corresponds to the star value). The stars mentioned here relate to the new testing noted in the monograph. These stars would be solid or outlined, depending on the level of protection as described in the testing methodology. All of this information must be the same size and prominence. Two additional statements are now also required on the front: “UV rays from the sun are made of UVB and UVA.” and “It is important to protect against both UVB & UVA rays to prevent sunburn and other skin damage.” If the testing warrants, then the packaging may need a statement of water resistance. No notation is currently made on the type size of this information—but it is clear after analyzing all of the required information that the type would be very small for many sunscreen packages, especially for any lip products. This monograph also suggests more information for the warning section of the Drug Facts Panel, including a lengthy warning formally called the “Sun Alert.” The type size and other graphic information for this section of the labeling have not changed from the original OTC monograph of 1999.

9.6 Conclusion As you can see, there are many pieces to the “package puzzle.” Having knowledge and information about the regulations is among the most

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important elements in design—elements that can alter the look of your product very dramatically. It is vital to understand these regulations before the packaging process begins, so the direction given will ensure your success in packaging your product for sale in this “global” marketplace. Solutions abound in this world of innovation. Careful exploration with your packaging professionals will help in this process to ensure that your product has incredible shelf impact while conforming to all packaging regulations.

Bibliography Akerson, James, and Kockrow, Glenda. Regulatory Compliance for the Personal Care Industry, CfPA, New Brunswick, Canada, 2007. Beauty–On-Line. January 7, 2008, http://www.beauty-on-line.com. Beckley, Catherine C., Ed. CTFA Labeling Manual 2006, The Cosmetic, Toiletry, and Fragrance Association, Washington, D.C., 2006. European Union. January 11, 2008, http://europa.eu/. FDA. USA Department of Health and Human Services: Food and Drug Administration. 21 CFR Parts 310, 352, 700, and 740. Sunscreen Drug products For Over-The-Counter Human Use; Final Monograph; Federal Register, Vol. 64, No. 98, 1999. FDA. USA Department of Health and Human Services: Food and Drug Administration. 21 CFR Parts 347 and 352. Sunscreen Drug products For Over-TheCounter Human Use; Proposed Amendment of Final Monograph; Proposed Rule; Federal Register, Vol. 72, No. 165, 2007. FDA. USA Department of Health and Human Services: Food and Drug Administration. 21 CFR Part 201. Over-The-Counter Human Use; Labeling Requirements; Final Rule; Federal Register, Vol. 64, No. 51, 1999. Health Canada. Canadian Ministry of Health, Food and Drug Act, Natural Health Products Directive 2003 P.C. 2003-847, 2003. Health Canada. January 6, 2008, http://www.hc-sc.gc.ca/index_e.html. Rosholt, Azalea P., Esq., Ed. CTFA International Regulatory Resource Manual, The Cosmetic, Toiletry, and Fragrance Association, Washington, D.C., 2006.

10 Global Cosmetic Regulations? A Long Way To Go … Sandra B. Schneider Dougmar Consultants, LLC, Westhampton, NY, USA

10.1 Introduction The countries discussed in this chapter are upwardly mobile nations with great potential for growth in the cosmetic and personal care markets. Financial benefits are waiting to be reaped by individuals and companies who will carefully investigate the rules and regulations necessary to achieve their goal. This chapter is not meant to be a step-by-step regulatory approach to the regulations of Australia, Brazil, Canada, India, and Russia. It is written to give the reader an insight and an overall understanding of what is involved in preparing cosmetics and personal care products for sale around the world. Each country has its own set of changing and evolving rules and regulations that must be navigated through and carefully followed. A manufacturer cannot decide to put their products on the market without a lot of effort and careful study. Claim substantiation data, product stability tests, and microbiological tests including correct packaging and formulae must be available; it takes months and sometimes years before products can be sold in foreign countries.

K. Lintner (ed.), Global Regulatory Issues for the Cosmetics Industry Vol. 2, 189–233 © 2009 William Andrew Inc.

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10.2 Australia 10.2.1 Australia’s Cosmetic and Personal Care Products Markets

Australia’s prosperous economy is ranked third in the United Nations’ 2007 Human Development Index (HDI). Its 2007 cosmetic market was worth over U.S. $657 million with the expectation of about a five percent growth in 2008. Working women with a high disposable income are major consumers; they wear cosmetics daily due to the importance placed on image and the competition in the workforce. Women prefer color cosmetics that preserve and protect their skin against sun damage rather than just improve their appearance. The aging “baby boomer” generation is a generation of innovation driven purchasers; they want cosmetics with age defying properties, foundations that protect the skin against UV rays and reduce the appearance of fine lines, treatment ingredients that help a variety of skin problems, and lip glosses and lipsticks with a plumping effect. Long-lasting lipsticks and convenient color palettes for quick touch-ups are also well received by women who appreciate the convenience of carrying fewer items in their purse. Other key growth areas are men’s grooming products, baby products, dermatological products, “doctor brands,” and aromatherapy products. The Australian cosmetic consumer is both price conscious and fashion focused; they follow styles set by their favorite movie stars, fashion icons, and limited edition color cosmetic ranges. The trend of “organic cosmetics” is rapidly growing in Australia as it is worldwide.

10.2.2 National Industrial Chemicals Notification and Assessment Scheme

The Australian Government has strict regulatory requirements for all cosmetic ingredients used in their country, whether the products are imported or domestic, in order to ensure the safety of the workers handling them, of the environment, and of the consumer. Ingredient safety falls under the National Industrial Chemicals Notification and Assessment Scheme (NICNAS), administered by the National Occupational Health and Safety Commission. NICNAS issues approvals for the use of cosmetic ingredients including legislation that strictly defines “naturally occurring” as unprocessed chemicals in the natural state or extracted only by manual, mechanical,

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gravitational means, dissolution in water, or heating to remove uncombined water, without any chemical change. Cosmetic products must meet the Australian definition of cosmetic under the Industrial Chemicals (Notification and Assessment) Act 1989. Cosmetic means: (a) a substance or preparation intended for placement in contact with any external part of the human body, including: (i) the mucous membranes of the oral cavity; and (ii) the teeth; with a view to: (iii) altering the odors of the body; or (iv) changing its appearance; or (v) cleansing it; or (vi) maintaining it in good condition; or (vii) perfuming it; or (viii) protecting it; and (b) The product must be marketed as a cosmetic taking into account the labeling, packaging, advertising and/or the label statements: - the product must have full ingredient disclosure in accordance with the Trade Practices (Consumer Product Information Standards) (Cosmetics) Regulations 1991; - the product may be presented as being explicitly for cosmetic purposes only; and - the product name would NOT of itself make the product a therapeutic good, unless that name makes a reference to a disease, ailment, defect or injury in persons. A reform of The Industrial Chemicals (Notification and Assessment) Act 1989 for cosmetics came into effect on September 17, 2007, which introduced new cosmetic standards for six cosmetic product categories (see Table 10.1). Under this act the following goods are exempt from the mandatory information standard: 

  

therapeutic goods within the meaning of the Therapeutic Goods Act 1989; cosmetics/toiletries manufactured in Australia for export; free samples of cosmetic/toiletry products; and testers for cosmetic/toiletry products.

The NICNAS Cosmetic Guidelines 2007 provide a guide to the new legislative requirements. All new cosmetic ingredients (not on the Australian

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Table 10.1 Industrial Chemicals (Notification and Assessment) Act 1989, Cosmetics Standard 2007—Schedule 1 Standards

Product Category

1.1 Tinted bases or foundation (liquids, pastes or powders) with sunscreen 1.2 Products intended for application to the lips with sunscreen

2.1 Moisturizing products with sunscreen for dermal application, including antiwrinkle, antiaging, and skin whitening products 2.2 Sunbathing products (oils, creams, or gels, including products for tanning without sun and after sun care products) with an SPF of at least 4 and not more than 15

Item

1. Face and nail

2. Skin care

Both: a. The product must be a secondary sunscreen product within the definition of secondary sunscreen product in AS/NZS 2604:1998 b. Any protection factor or equivalent category description stated on the product’s label must be in accordance with clauses 6.2 and 6.3 of AS/NZS 2604:1998 All of the following: a. The product must be a secondary sunscreen product within the definition of secondary sunscreen product in AS/NZS 2604:1998 (i) not be presented as having a sun protection factor of more than 15; and (ii) not be presented as water-resistant; and (iii) if it is not stable for at least 36 months, then an expiry date or use-by date on its label; (iv) a pack size not larger than 300 mL or 300 g; and (v) not have a therapeutic claim, including any representation about skin cancer, made for it; and

Product Type Standards

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3. Skin care

Antibacterial skin products

(Continued )

b. Any representations in connection with the product about premature skin aging linked to sun exposure may be made only if the product meets the performance requirements for a broad-spectrum product set out in clause 7.2 of AS/NZS 2604:1998 c. Any protection factor or equivalent category description stated on the product’s label must be in accordance with clauses 6.2 and 6.3 of AS/NZS 2604:1998 (AS/ NZS 2604:1998—Sunscreen Products—Evaluation and classification, published by SAI Global) The product must: a. be presented as being active only against bacteria; and b. not be presented as being: (i) active against viruses, fungi or, other microbial organisms (other than bacteria); or (ii) for use in connection with disease, disorders, or medical conditions; or (iii) active against a named bacterium that is known to be associated with a disease, disorder, or medical condition; or (iv) for use in connection with piercing of the skin or mucous membrane, for cosmetic or any other purpose; or (v) for use in connection with any procedure associated with the risk of transmission of disease from contact with blood or other bodily fluids; or

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6. Hair care

Anti-dandruff products

Antiacne products (including spot treatments, cleansers, face scrubs, and masks) Products for care of the teeth and the mouth (e.g., dentifrices, mouth washes, and breath fresheners)

4. Skin care

5. Oral hygiene

Product Category

Item

(vi) for use before physical contact with a person who is accessing medical or health services, or medical or health care procedure; or (vii) for use in connection with a procedure involving venipuncture or delivery of an injection The product must be presented as controlling or preventing acne only through cleansing, moisturizing, exfoliating, or drying the skin Both: a. the only benefits claimed to result from the use of the product must be consequential on improvements to oral hygiene, including for the prevention of tooth decay or the use of fluoride for the prevention of tooth decay; and b. benefits in relation to other diseases or ailments, e.g., gum or other oral disease or periodontal condition, must not be claimed to result from use of the product The product must be presented as controlling or preventing dandruff only through cleansing, moisturizing, exfoliating, or drying the scalp

Product Type Standards

Table 10.1 Industrial Chemicals (Notification and Assessment) Act 1989, Cosmetics Standard 2007—Schedule 1 Standards (Continued )

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Inventory of Chemical Substances (AICS), a listing of all industrial chemicals used in Australia between January 1, 1977, and February 28, 1990) are subject to notification and assessment unless they qualify for an exemption. New industrial chemicals of low regulatory concern may be exempt from notification to NICNAS; most exemption categories require no further action prior to introduction except an annual reporting obligation. Cosmetic chemicals that are never allowed exemptions are:    

Preservatives Coloring agents UV filters Chemicals prohibited or restricted for cosmetic use in the United States or the EU

Sometimes information justifying a chemical exemption must be provided to the Director of NICNAS, who reports to the Minister for Health and Aging through the Parliamentary Secretary. Companies and/or individuals who introduce cosmetic ingredients or import cosmetic products into Australia must be registered with NICNAS regardless of the amount of chemicals imported and/or manufactured in a registration year, September 1 to August 31 of the following year. NICNAS registration is not the registration of individual industrial chemicals or actual products. NICNAS registration is actually the registration of a business. 10.2.3 Australian Competition and Consumer Commission

Cosmetics must be labeled in accordance with the Trade Practices (Consumer Product Information Standards) (Cosmetics) Regulations 1991. The Australian Competition and Consumer Commission (ACCC) publishes a booklet that explains the standards, the responsibilities of suppliers and retailers under it, and the ACCC’s role in enforcing it. Scientific and technical terms and symbols should not be used on the packaging unless they are accompanied by a clear and accurate statement of their meaning. It is not appropriate to rely on consumers to receive a pointof-sale explanation of what the scientific, technical, or other unfamiliar terms mean. Ingredient statements using INCI (International Nomenclature for Cosmetic Ingredients) nomenclature are mandatory for cosmetics. Incidental ingredients, which are ingredients that have no technical or functional

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effect in the product and are present at insignificant levels, including processing aids are not required to be included in the ingredient declaration.

10.2.3.1 Is It a Cosmetic or Therapeutic Product?

Products are determined to be either “cosmetics” or “therapeutic goods” based on two factors: 



Composition of the product (the concentration of a particular ingredient may change the classification of the product) and Proposed use of the product (its classification depends on claims made in package inserts, in advertisements, and product packaging)

Where products are labeled and presented in the marketplace explicitly for cosmetic purposes only, a product name would not make the product a “therapeutic good” unless that name makes a reference to a disease, ailment, or defect of the human body. If a consumer thinks that a product name suggests that the product is likely to be used in, or in connection with preventing, diagnosing, curing, or alleviating that disease, ailment, or defect, the product will be considered to be a “therapeutic good,” and therefore subject to the Therapeutic Goods Act 1989 of February 15, 1991, and the Therapeutic Goods Regulations administered by the Therapeutic Goods Administration. The objective provides a national framework of therapeutic goods regulations in Australia that ensures the quality, safety, and efficacy of medicines.

10.2.3.2 Acceptable versus Unacceptable Claims

A claim can be a word, a sentence, a paragraph, or simply an implication. The table below is a small section of the document issued by the National Coordinating Committee on Therapeutic Goods (NCCTG) (http://www. tga.gov.au/docs/html/ncctg.htm), which provides product claims guidance in relation to cosmetic/therapeutic products. Therapeutic claims for products cannot be made unless the claims are included in the Australian Register of Therapeutic Goods (ARTG). Column A contains claims that are clearly cosmetic-oriented, while Column C contains claims that are clearly unacceptable for a cosmetic. Column B is transitional, and illustrates how the choice of terminology influences the acceptability of a claim:

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Subject Active ingredient

Column A Acceptable wording for a cosmetic

Column B Unacceptable wording for a cosmetic claim unless sufficiently modified to provide a cosmetic implication

Column C Unacceptable wording for a cosmetic (but not necessarily acceptable for a drug) therapeutic ingredient

Aging, antiwrinkle cream

Cover up (hide) age spots (blemishes, dark pigmented areas) Feel (look) younger (youthful) Helps prevent (reduce, slow) the signs (appearance) of aging (age lines, premature aging) Moisturize aging skin, smoothes wrinkles Absorbent that helps keep you dry Antiodorant (deodorant) Fights bad odor Kills odor causing bacteria

Temporarily reduces depth of wrinkles by moisturizing antiaging (antiwrinkle)

Any references to fading age spots (depigmentation, bleaching of the skin) Eliminates (prevents, stops, reduces, slows, reverses) aging (wrinkles, premature aging, aging process)

Helps keep you dry

Antiperspirant Controls moisture (sweat) perspiration Note: Antiperspirants are therapeutic goods

Deodorant

Note: The examples in the tables are only a guide and are not to be taken as the final authority. Cosmetic companies should seek expert/legal advice to ensure that their proposed claims are not in breach of the Therapeutic Goods Act 1989 and/or the Trade Practices Act 1974.

A misleading or deceptive cosmetic claim may be brought to the ACCC by a private party, a competitor, or user of the product. High fines for companies and for individuals or court orders to stop the offending action may result.

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10.2.4 Therapeutic Goods Administration

Sun care products (SPF greater than 4) need to be “listed” in Australia. There is no process for submitting labels to the Therapeutic Goods Administration (TGA) for preapproval. The “listing process” is a self-assessable application system in which a signed statutory declaration on behalf of the sponsor (manufacturer/importer) states that the product’s packaging meets the required standards. Even though the labels are not reviewed and approved at the time of the listing application, the TGA does perform an audit of 25% of the applications received. If the labels do not comply, the TGA has the power to cancel the listing, request the products to be recalled, and impose fines on the company. A partial list of requirements is given below: 1. Product Names: As previously stated product names can be taken as a claim; words such as “treatment” cannot be used in names; it implies that the product is a medicine. Also, the name of a product should distinguish itself from other products; each variety must be clearly distinguishable. 2. “Absolute” Statements: The therapeutic goods legislation uses stricter medicine advertising rules than those permitted for cosmetics; many terms that are considered “cosmetic puffery” become unacceptable if the “absolute” statement cannot be proven in a court of law. 3. Dual Claims: For sunscreens which include therapeutic claims that are associated with other ingredients, those other ingredients must be considered as active ingredients and must be declared quantitatively on the label and included in the application as actives. 4. Dosage Form on the Label: A reference to the dosage form must be made on the front panel of the packaging. In the case of a cream product you need to include on the front panel a reference to cream. This can be done as part of the contents statement or include it as a part of the name. Also, creams are usually described in terms of weight rather than volume. 5. General Packaging:  For all primary and secondary packaging a statement of the recommended storage conditions is required; for room temperature, the statement should be “Store below 30°C.”  Batch numbers and expiry dates must be prefixed by a suitable code. The approved artwork should show the placement

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of the batch number and expiry date. Tubes usually have these details crimped on the end of the tube. SPF must be in letters no less than 1.5 mm and no less than 25% of the largest letter or numeral. The sponsor’s name and address must appear on the primary and secondary packaging. Directions for use must specify the age of the intended users. The recommendation is that sunscreens should not be used on infants six months and under. The directions for use and other information should be consistent on all packaging. Directions for use need to be specific about reapplication after exposure to water, sweating, etc. Also, it is recommended that a reapplication time be included. Sunscreen category description such as “High Protection Sunscreen” should be included. Any reference to a “Poison Information Centre” must include an Australian phone number. The AUST L number that signifies low-risk, self-medication products, such as sunscreens over SPF 4, needs to be placed on the principal panel of the packaging. Declaration of ingredients: Active ingredients must be declared quantitatively with the units. When the ingredients are declared in terms of %, it is required to designate whether this % is representative of w/w, v/v, w/v, or v/w, i.e., for a cream the appropriate units would be %w/w. Ingredient statements: “Listed” TGA products are not required to include the full ingredient declaration. The only ingredients that need to be declared are preservatives and some other specific ingredients. If the product contains methyl and propyl paraben as preservatives, the label must have the statement “Contains hydroxybenzoates.” The Australian Approved Name for these two ingredients, methyl hydroxylbenzoate and propyl hydroxylbenzoate, must be used. The names should be consistent whenever they are written. List of approved terminology for ingredient names, for units of measurement, and for dosage forms can be downloaded from the TGA website: http://www.tga.gov.au. “Drug Facts” Panel: The United States uses the heading “Drug Facts” for OTC products. Although Australia has

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no objection to its use, the word “drugs” has a negative connotation in the Australian market. Therapeutic goods are considered medicines. 6. Botanical Ingredients: Botanical ingredients claims need to be reviewed and a decision is required as to whether these “extra” ingredients should be viewed as actives or as “cosmetic” ingredients.

10.2.5 Certified Organic Personal Care Products

Many companies are trying to take advantage of the worldwide consumer support for organic products in the cosmetic and skin care markets. The word “organic” has become the new buzzword, but in most companies this term is just a marketing tool. However, Australian products that have over 95% organic raw materials in their products with no synthetic ingredients (this includes no nature identical products) can be called “Certified Organic.” In Australia, the AQIS (Australian Quarantine Inspection Service) logo, obtained from an approved organic certification body and displayed on the packaging, ensures that the product has been manufactured totally with natural origin and/or organic ingredients. The ingredients must be certified and they must have the appropriate backup certificates. Every “organic manufacturer” has regular factory audits and their formulae are checked to ensure that every ingredient complies with the Organic Legislation, which includes a section titled “Cosmetics and Skincare”; this legislation can be found on the AQIS website. The rules and guidelines explain both what can and cannot be in cosmetic products and what can be claimed on the label. It also stipulates that only natural source preservatives and no fragrance or parfum can be used. This legislation allows no misleading organic product statements, but raises other problems with worldwide certifying bodies that have different standards. A universal standard needs to be set so that all companies operate with the same set of rules. Some Australian certifying companies have reciprocal arrangements with American, Japanese, and European certifying companies so that once certified the product can use the appropriate logo in each market.

10.3 Brazil Brazil is the largest, most populous, and most industrialized country in South America. It ranks fourth in the global market for cosmetic and toiletry sales.

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Large cities such as Sao Paolo and Rio de Janeiro create huge market outlets for cosmetics and personal care products and double-digit growth is predicted for this market over the next five years due to the growing middle class that has increased consumer consumption. The increasing number of women in the Brazilian workforce creates consumers with disposable incomes who want good quality mass-market personal hygiene products at affordable prices. Hair care produces the highest retail sales within the cosmetics and toiletries market. The color cosmetics market is likely to increase by 18% and men’s cosmetic sales by 20% by the year 2010. Brazil is a member of MERCOSUR, a trade organization formed in 1991, whose purpose is to allow free trade between member states, with the goal of full South American economic integration. This Trade Bloc, comprised of Argentina, Brazil, Paraguay, and Uruguay, is the largest in South America with each country having its own regional organization that issues and harmonizes standards (see Table 10.2). MERCOSUR is similar to the EU, in that it has different legislative and technical committees that create legislation and standards in selected areas that are voted on and if passed they are to be adopted into national law. Over 600 standards have currently been created and adopted by MERCOSUR. Unfortunately, country ratification is lagging. Adopted and proposed MERCOSUR standards are listed on its Web site: www.amn.org.br. MERCOSUR’s five associate members, Chile, Bolivia, Colombia, Ecuador, and Peru, do not have full voting rights or complete access to markets as MERCOSUR’s full members. MERCOSUR’s common external tariff (CET) may be imposed by each MERCOSUR member on products imported from outside the region that transits at least one MERCOSUR member before reaching their final destination. Full CET product coverage, which would result in duty free movement within MERCOSUR, was originally scheduled for implementation in 2006, but has been deferred until 2009. Brazil’s addition of federal and state taxes and charges to imports can double the actual cost of each imported product imported into Brazil. Ingredients used in cosmetics are regulated by the lists of prohibited and restricted substances and positive lists of color additives, UV filters, and preservatives, modeled after the Annexes of the EU Cosmetics Directive. On March 17, 2006, Brazil updated its positive list, UV filters, and its negative list, substances that may not be used in cosmetics. The list of UV filters resembles the EU list, but with some UV filters approved in the United States and not in the EU. The negative list contains 423 substances

Resolution Number 25/05 for Cosmetics, Personal Hygiene Products and Perfumes.

ANMAT, a group within the Ministry of Health, is the competent authority responsible for granting cosmetic approval.

Same as EU Directive.

Legislation

Regulatory enforcement

Cosmetic definition

Argentina

The “Guide for the Registration of Cosmetic in Venezuela, 6th Edition 2000” compiles all the necessary regulations and ingredient lists. The Drug and Cosmetic Directorate under the General Sanitary Control Directorate of the Ministry of Health and Social Welfare is the competent authority for cosmetics.

Products manufactured from natural or synthetic substances to be used on the surface of the human body: skin, hair, lips, nails, external genitals, teeth, and

Uruguayan Law No. 15.443, 15.703, Decree 252/987 and Decree 95/90 Resolution 19/05.

The Chemical and Pharmaceutical Division for Cosmetics of the Ministry of Public Health is the competent authority responsible for cosmetics.

Same as EU Directive.

Health Code, Article 280, Law No. 1119/97, Decree 17057, Decree 9973.

The competent authority responsible for cosmetics is the Paraguayan Ministry of Health.

Same as EU Directive. Cosmetic specialities: Cosmetics that make therapeutic/ preventative claims.

Resolution RDC No. 79, for Cosmetics, Personal Hygiene Products and Perfumes.

The General Office of Cosmetics within the Brazilian Ministry of Health is the competent authority for cosmetics. Product registration and surveillance is carried out by ANVISA a public company that operates under contract to the Ministry of Health.

Same as EU Directive. Cosmetic products: Four categories and two risk groups, but similar regulations apply to each. However, for Category 2

Venezuela

Uruguay

Paraguay

Brazil

Table 10.2 Cosmetic Legislation in MERCOSUR Countries (Full Members)

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Premarket requirements

Companies that manufacture, import, or sell cosmetics must be authorized by ANMAT. Products compliant with ANMAT regulations receive automatic approval and registration.

(Continued )

Establishments that manufacture, distribute, or store cosmetics must be registered with the Ministry of Health and Social Welfare. All manufacturers, distributors, and importers must register with the Mercantile Registry. Importers/ licensees must have a power of attorney/ authorization of distributorship from the foreign brand. Establishments that manufacture, distribute, or store cosmetics must be licensed and registered with the Ministry of Public Health. All cosmetic products must be registered. Uruguay has no lists of approved, prohibited, or restricted ingredients; generally ingredients permitted in the United States, EU, and Japan are accepted.

Cosmetic manufacturing establishments must register with ANVISA. Local importers, manufacturers, and distributors must follow specific requirements. Category 1 products require notification; Category 2 products require registration. Establishments that manufacture, distribute, or store cosmetics must be registered with the Ministry of Health. Registration of all cosmetic products is also required.

oral mucosa in order to clean, perfume, modify appearance, protect, or keep them in good condition and to prevent and correct body odors.

products efficacy data are required to support claims made.

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INCI ingredient listing required. Labeling requirements are listed by ANMAT Disposition 374/2006, Personal Hygiene Products, Cosmetics and Fragrances dated January 23, 2006.

Cosmetic manufacturers responsible for product’s safety. GMP guidance in ANMAT 1107/99 follows the GMP guidelines of Mercosur Resolution 66/96. Safety Tests in ANMAT 1108/99. Data from country of origin is accepted for imports.

Labeling

Testing and safety

Argentina

GMPs are regulated by GMC/Res/92/94 and GMC/Res/66/96 following the WHO GMPs. Cosmetic specialities: C of A by authorized local laboratory using same lot as samples.

INCI ingredient listing is accepted. Color index number must be used. RTM 36/04, Mercosur Resolution GMC/36/99 by decree 10116/00 universal bar codes are required.

INCI ingredient listing required. Expiration dates are necessary.

Cosmetic companies are responsible for their product’s safety. Data proving their safety and efficacy under Resolution 79/00 must be retained. GMP guidance is in Directive 348/97 which follows the Mercosur Resolution 66/96

Paraguay

Brazil

Specific warnings are prescribed depending on the product. Eye and skin irritation data is required. Claims need to be substantiated. All products are analyzed to country’s standards established by the National Institute of Hygiene.

INCI ingredient listing is accepted. Spanish language is mandatory. a. Name of manufacturer or distributor. b. Country of origin c. Weight or volume declaration. d. Any warnings; directions. e. Lot/batch number f. Obligatory health notification number.

No requirements.

Harmonized MERCOSUR regulation (Resolution 66/96) for GMPs.

Venezuela

Uruguay

Table 10.2 Cosmetic Legislation in MERCOSUR Countries (Full Members) (Continued )

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and closely follows the EU list without the category 1 and 2 CMR substances. In addition, the maximum concentrations for certain preservatives may be the same as in the United States, which is higher than is allowed in the EU.

10.3.1 Product Classifications

Cosmetics, personal hygiene products, and perfumes are classified according to the health risk they may present. Cosmetic products fall into one of the two grades. Grade 1 Products: Cosmetic with “no risks” or “risk 1” products with minimal risk, such as soaps, shampoos, shaving creams, aftershave lotions, toothbrushes, dental floss, powders, beauty creams, beauty lotions, oils, makeup, lipstick, lip pencils and liners, eye products, and perfumes. These products no longer need registration, and do not incur administrative fees. However, the Agency must be notified by the cosmetic company using the appropriate form; the product can only be launched on the consumer market 30 days after this notification has been sent. Grade 2 Products: “Risk 2” products that present potential risk, such as antidandruff shampoos, anticaries and antiplaque toothpastes, feminine deodorants, underarm deodorants, chemical skin peelers, lip protectants with sun protection, certain eye area products, UV filters, tanning agents, hair dyes, bleaches, clarifiers, permanent-wave products, hair growers, depilatories, cuticle removers, chemical nicotine stain removers, nail hardeners, insect repellents, and products for children. The company must register the product, pay the administrative fees, and wait for the registration approval. The relevant classification criteria is defined on the basis of product usage purposes, affected body areas, directions for use, and precautions to be taken when using such products. Brazil does not presently have an OTC product category. Thus, sometimes it is very hard to classify an OTC product with the Brazilian legislation.

10.3.2 ANVISA

Brazilian legislation of imported cosmetics products can only be handled by authorized companies registered with Agéncia Nacional de Vigiláncia

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Sanitaria (ANVISA), an agency of the Brazilian Ministry of Health. ANVISA was established in 1999 to protect its population by exercising sanitary control over production and marketing products and services. Foreign companies must either establish a local manufacturing unit, a local office, or appoint the “right” Brazilian distributor to hold the registration with ANVISA in order to distribute their products in Brazil. The selection of the right distributor is essential. The contract between a cosmetic company and its distributor should establish specific clauses, which would allow the transfer of ownership of the registration with ANVISA from the local distributor to the manufacturer. In Brazil, this transfer can only occur if the company opens an office or plant in Brazil, since no registration can be transferred overseas. Contracts should contain a clause that deals with the transfer of ownership, a very important clause because without it there is great difficulty transferring ownership from one agent to another. Besides selecting a distributor, the foreign company should also apply for registration of the trademark and patent at the National Industrial Property Institute (INPI) through a local law firm, a service usually provided by the distributor.

10.3.2.1 General Labeling Requirements

The Brazilian Customer Protection Code, in effect since September 12, 1990, requires that product labels provide consumers with correct, clear, precise, and easily readable information about the product’s quality, quantity, composition, price, guarantee, shelf life, origin, and risks to the consumer’s health and safety. Imported products should bear a Portuguese translation, and all products should use the official metric units or show a metric equivalent. All cosmetic products must obtain a Global Trade Item Number (GTIN) and Bar Code (EAN Code), which must be printed on the label and submitted to ANVISA as part of the notification process. The product label must also contain the expression: Res. ANVISA no. 343/05, followed by the Company Operation Authorization Number (Número da Autorização de Funcionamento de Empresa (AFE)) granted by ANVISA. Product labels must indicate the name and the address of the person responsible for marketing the cosmetic product. Imported products usually have to undergo local over-labeling to comply with these Brazilian regulatory requirements.

10.3.2.2 Advertising/Claims

Brazil’s regulations prohibit therapeutic claims and the use of names of places, symbols, figures, or drawings in labels or advertising that are

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misleading as to the origin of the product. Certain claims, such as “hypoallergenic” or “dermatologist-tested” must be substantiated. The Consumer Protection Code also governs advertising, direct mail, and telemarketing; there is a general prohibition on false or deceptive advertising, including advertising that is deceptive by omission. 10.3.2.3 Warnings

Specific required warnings, which are listed in Brazil’s legislation, are prescribed for aerosols, hair dyes, bleaches, permanent-wave products, neutralizers, depilatories, toothpastes, and mouthwashes, tanning preparations, antiperspirants, and baby products. Sunscreens also have listed their specific required warnings. Brazilian registration is an online Electronic Notification System for Cosmetic Products that are determined to be Risk Grade 1 Products. Registration can only be completed in Portuguese and the Web site is www.anvisa. gov.br. Since March 1, 2007, ANVISA reviews the Web site information and occasionally asks for the Technical Dossier. 10.3.2.4 ANVISA Product Notification Requirements, May 2007

1. The Negative List: If substances are used from the restrictive list for products, a report or the specifications of the raw materials and/or of the final product, proving compliance with the required specifications must be submitted and properly signed. If any of the requirements are not met, the file will be rejected. 2. Positive Lists of Substances: Substances used as preservatives, coloring agents, and sun-block filters in personal hygiene products, cosmetics, and perfumes must be positively listed, and must comply with all established parameters. Lack of compliance with the requirements of these regulations will result in the rejection of the file. 3. Quantitative Formula: If a quantitative listing of the formula is not included, the file will be rejected. 4. Nomenclature—INCI: All raw materials in the cosmetic product must be identified using the INCI declaration in both the technical data of the product and the ingredient statement that appears on the label. If the INCI nomenclature is not used, the file will be rejected.

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5. Error in the Declaration of a Function: The file will be rejected if any substance’s function is incorrectly described in its technical data. This procedure is applied to those substances with functions regulated in the lists of preservatives, coloring agents, and sun-block filters, as well as to those substances that do not have those functions, but which are attributed to them. 6. Physical and Chemical Specifications of the Substances: The range of specifications of the substances or the minimum and maximum limits established by the company for substances that have the maximum concentrations established in the legislation cannot surpass the maximum allowed limit. In the case of a specification that exceeds the maximum limit established in the legislation, the file will be rejected. 7. Stability of the Product: Stability studies performed on this product must take into account the storage conditions of samples, the period of time that the product was subjected to tests, and the results determined from those tests. The absence of a conclusion guaranteeing the period of validity declared on the application form will result in the rejection of the file for lack of compliance. 8. Microbiological Data: Microbiological data in accordance with Brazil’s cosmetic regulations must be submitted; incomplete data will result in the rejection of the file. If the cosmetic product is not susceptible to contamination, the company must send its technical justification to prove that there is no such contamination. If such justification is not sent with the application, the file will be rejected. 9. Certificate of Free Sale: All imported cosmetic products must have a Certificate of Free Sale, authenticated by the consular office in the country of origin. 10. Formula of the Imported Product: The formula declared in the technical data must be in agreement with the formula of the imported product. In case of disagreement, the file shall be rejected. 11. Labeling: All claims stated on the label must be proven by corresponding safety or efficacy tests performed on the finished product. Tests performed only on the active ingredients will not be accepted. Labels containing seals from institutions or recommendations from professionals will

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only be approved after verifying the contents from the sources. Without verification, the label will be approved with corrections, indicating the exclusion of the allegations. 12. Tests: The efficacy and safety tests, submitted in the registration package or of changes in the registration, must refer to the same product as on the registration application form by name or by code. The test shall be accompanied by the tested formulation and by the declaration signed by the person responsible for this test, indicating that the code or the new name declared in the test refers to the same product. The submitted tests shall contain the test methodology, the results, and the conclusion and be signed by the person with responsibility for such tests. Imported products must include a copy of the original tests signed by the person responsible for such tests; the translation of the results must be signed by the responsible technician and by the company’s legal representative. 13. Similarity: “The Guide for the Evaluation of the Safety of Cosmetic Products” assures that these products are safe based on the safety of similar products. Companies that submit efficacy evaluations based on similar products and safety evaluations outside the considerations established in the Guide shall present a “declaration of the reasons” signed by the person responsible for the tests. It should be clarified that the differences between the tested formulas do not affect the performance nor results of the product nor results of the test, considering the methodology used, the purpose of the product, the tested formulation, and the specific test, to prove the product’s similarity. 14. Absence of Tests Established in the Legislation: Specific tests proving the safety of the product must be presented in the file or in the act to change the registration if they have not been submitted before. The absence of these tests will result in the rejection of the file. For sunscreen products the UVA protection tests, the water resistance tests, and the FPS (Facteur de Protection Solaire) tests must also be submitted with the registration application when benefits are attributed to the product. If the FPS test results are not included in the registration package, it will be rejected. The water resistance and UVA protection test results will allow their claims to appear on the label. Test results from an

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accredited U.S. laboratory are accepted if it is a member of the mutual recognition arrangement (MRA) of the International Laboratory Accreditation Cooperation (ILAC) 15. Unsigned Documentation: Submitted documents must be signed by the legal representative and the technical responsible individual or the file will be rejected. 16. Final Art: Properly identified final product art must be submitted for approval before the registration package will be passed. The absence of this art will result in the rejection of the file. 17. Absence of Documents: Any missing documents will result in the rejection of the file. A product registration is valid for five years and can be renewed continuously for another five years. Although this process might be costly and time consuming, registering your products will guarantee several benefits including support by law and compliance with the Brazilian Health regulations, product reliability, access to new markets, and the possibility to import and export without sanitary barriers. Special attention should be paid to the Technical Report that is required by the cosmetics, vitamins, and pharmaceutical manufacturers. The documentation presented for registration, alteration, or revalidation of the registration will be assessed by ANVISA, which will issue its decision through publication in the Federal Government Gazette (Diário Oficial da União (DOU)). 10.3.2.5 Import Licensing/Customs Valuation

All importers must register with the Secretariat of Foreign Trade (SECEX) to access Brazil’s SISCOMEX computerized trade documentation system whose registration requirements are onerous. Fees are assessed for each import statement submitted through SISCOMEX. Most imports into Brazil are covered by an “automatic import license” regime. Cosmetic companies continue to complain of onerous and burdensome import documentation requirements. ANVISA, which must approve product registrations for imported cosmetics, currently takes about three to six months for the registration process for new versions of existing products, and over six months to register new products. Registration of pharmaceutical products can take over one year, since ANVISA requires that a full battery of clinical testing be performed in Brazil, regardless of whether or not the drug already has FDA approval.

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10.4 Canada 10.4.1 Canadian Cosmetic and Personal Care Market

Estimated cosmetic sales in Canada total over C$5.3 billion annually. Cosmetics sales include both beauty preparations such as makeup, fragrance, nail polish, skin creams, and lotions as well as grooming aids, including soap, shampoo, and deodorant. Canada has a problem with shampoo and other personal care counterfeit goods that are openly displayed alongside legitimate products in malls, department stores, and chain stores. The problem is compounded by the fact that if counterfeit products clear Canadian Customs, the enforcement efforts are the responsibility of the Royal Canadian Mounted Police (RCMP) and the local police; both groups lack adequate resources and staff. 10.4.2 The Canadian Cosmetic Regulations

Canadian cosmetics are regulated by the Consumer Product Safety Program of Health Canada, under the Cosmetic Regulations of the Food and Drugs Act, Consumer Packaging and Labeling Act, Hazardous Products Act, and the Quarantine Act. These laws, administered under the Cosmetics Division in the Healthy Environments and Consumer Safety Branch of Health Canada, are intended to prohibit the manufacture of cosmetics and cosmetic-like drugs under non-sanitary conditions or under circumstances that may otherwise cause injury to the health of the consumer. Salons, testers, or professional products have different regulations than those that apply to products sold to the consumer. Advertising Standards Canada (ASC) administers the Guidelines for Cosmetic Advertising and Labeling Claims. Cosmetics in Canada are defined as any “substance or mixture of substances, manufactured, sold or represented for use in cleansing, improving or altering the complexion, skin, hair or teeth and includes deodorants and perfumes.” On November 16, 2006, amendments to the Cosmetic Regulations came into effect requiring ingredient declarations on the outermost packaging or the unit of sale when no folding carton exists for all cosmetic products sold in Canada. Mandatory labeling allows the consumer and the health care professional to have consistent information to assess and assist in the treatment of individuals who have sensitivities to commonly used ingredients for the purpose of treatment and incidence reporting.

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Canada selected INCI from the 10th edition of the Cosmetic Ingredient Dictionary and Handbook published by the former CTFA whose present name is Personal Care Product Council. Canada’s ingredient listings are consistent with the nomenclature used in most countries around the world. Canada maintains:







A dual language requirement that must be honored for all printed packaging except in the INCI ingredient listing; the declaration must not be translated, altered, or embellished except for trivial names. Canadian INCI utilizes trivial names for certain common ingredients under very specific guidelines. European trivial name designations like aqua and cera alba are acceptable in Canada and the EU, but not in the United States. If the company wants a “global” label then the English trivial names, water and beeswax, and the French equivalent, eau and cire d’abeille, must be shown. The Canadian system, which the EU reluctantly accepts, complicates the harmonization process. “Fragrance” and “flavor,” respectively, are the English equivalents to the French “parfum” and “aroma.” These statements must be at the end of the ingredient list, after the ingredients in descending order of concentration (by weight) and the random order of ingredients less than 1%. Ingredient declarations may use +/– (or) [+ or –] as referenced in the regulation applicable to colorants when used on a product with a color range. Either their INCI name or the color index numbers designation may be used. Any permitted ingredient having no designated INCI name must be listed by its chemical name.

Small packages and ornamental containers are subject to a number of offpack labeling and hang-tag exemptions, and special situations may allow alternative ingredient labeling options. Testers and samples are exempt from required ingredient listings because it is assumed that they will be located near their corresponding retail products. The Consumer Packaging and Labelling Act (the “CPLA”) contains packaging and labeling requirements for “prepackaged products.” The CPLA affects not only goods that originate in Canada, but also goods imported into Canada and thereafter sold in prepackaged containers. The CPLA

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defines “prepackaged products” as any product that is packaged in a container in such a manner that it is ordinarily sold to, used, or purchased by the consumer without being re-packaged. The CPLA requires certain information to appear on the product label: (1) the common or generic name of the product; (2) a declaration of net quantity, generally in numerical count or metric units of measurement (although supplementary non-metric measurements may also be used); and (3) the identity and address of the person by or for whom the product was manufactured, sold, or imported If the product is imported, then one of three particular formats must be used: (i) the name and address of the Canadian dealer, preceded by the words “imported by” or “imported for”; or (ii) the country of origin adjacent to the name and address of the Canadian dealer; or (iii) the name and address of the dealer located outside Canada. All manufacturers must submit a Cosmetic Notification form to the Health Protection Branch for each cosmetic product placed on the market. The ten-day feature allows either a manufacturer or an importer ten days to notify the Canadian authorities following first sale of a cosmetic. 10.4.3 Drug Classifications

Canada has two categories for cosmetic-like drugs: natural health products and therapeutic products. Sunburn protectants and other products considered to be cosmetic-like drugs in Canada (OTC drugs in the United States), are not affected by the new cosmetic regulations. They continue to follow the ingredient labeling specified in the Food and Drug Act or Natural Health Product Regulations. The composition of the product determines its classification: 



Natural health products: Products that fall within these regulations include herbal remedies, homeopathic medicines, vitamins, minerals, traditional medicines, probiotics, amino acids, and essential fatty acids. Therapeutic products: All other drug-like cosmetics.

Cosmetics that are classified as non-prescription drugs/OTC are subject to Category IV Monograph requirements and must undergo a premarket approval by the Therapeutic Product Directorate (TPD) or Natural Health

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Products Directorate prior to sale. Drug establishments must be registered and hold a Drug Establishment License. Mandatory product registration must include certification of compliance with the drug GMPs that the product contains no prohibited substances, and that supportive data is accurate and complete with respect to the applicable monograph. Once properly registered as per the Health Canada guidelines, a non-prescription drug product is issued a Drug Identification Number (DIN). It takes several months to actually receive a DIN or a Natural Product Number (NPN) after notification that your application was received. List of product category monographs (used by the personal care industry) Acne Therapy October 12, 2006 Anti-Dandruff Products October 12, 2006 Antiperspirant November 7, 2007 Antiseptic Skin Cleansers December 11, 2006 Diaper Rash Products April 19, 2007 Fluoride-Containing Anti-Caries Products August 16, 2007 Medicated Skin Care Products March 30, 2007 Sunburn Protectants October 12, 2006 In terms of cosmetic ingredient regulation, there is considerable change in the way Health Canada handles raw material safety and environmental impact assessments. For cosmetics, ingredient restrictions are published in several sections of the Cosmetic Regulations, whereas non-prescription drug requirements appear in the Category IV Monographs. 10.4.3.1 Claims

There are prohibitions against making false or misleading statements on product packaging and labeling or in advertising. These prohibitions cover not only the actual words used on labels, or in advertising, but also the general impression conveyed and, accordingly, provide the relevant government body with broad discretion to regulate certain words and symbols. Furthermore, competitors may have a cause of action arising from such statutes. Accordingly, care should be taken ensure that statements are not misleading in any way. Health Canada challenges claims and our industry takes the position that data substantiation supports the claim. 10.4.4 Country of Origin Marking Program

The North American Free Trade Agreement (NAFTA) came into force on January 1, 1994, between Canada, Mexico, and the United States. It strives

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to promote fair competition, increased investment, to protect and enforce intellectual property rights. This agreement affects many areas of trade. Pursuant to the “Country of Origin Marking Program,” certain goods imported for sale in Canada must be marked with their country of origin. This program is governed by three sets of Regulations, the Customs Tariff: 1. Marking of Imported Goods Regulations; 2. Determination of Country of Origin for the Purpose of Marking Goods (NAFTA Countries) Regulations; and 3. Determination of Country of Origin for the Purpose of Marking Goods (Non-NAFTA Countries) Regulations. These regulations differentiate between “NAFTA goods” vs. “non-NAFTA goods.” Two schedules list the imported goods that must be marked with their country of origin and also schedules listing NAFTA and non-NAFTA goods that are exempted from the regulations. The Marking of Imported Goods Regulations provide that the country of origin marking on NAFTA goods may be in English, French, or Spanish, whereas on non-NAFTA goods it may be in English or French. The regulations further require the country of origin to be marked in a manner that is legible, sufficiently permanent and capable of being seen easily under normal handling of the goods or their containers. Also, the regulations state that if the words “Canada” or “Canadian” or the name of any country other than the country of origin appears, then the country of origin must appear in close proximity to such words and must be preceded by words such as “made in,” “produced in,” “printed in,” etc., because displaying another country’s name may mislead the consumer into believing that the product has been made in that other country. The test to determine “country of origin” is different for goods imported from a NAFTA country versus goods imported from a non-NAFTA country. For goods imported from a non-NAFTA country, the country of origin of goods is simply the country in which the goods were “substantially manufactured.” However, since preferential tariff rates are available for certain NAFTA goods, the test to determine country of origin for goods imported from a NAFTA country is much more complex. Accordingly, for goods imported from a NAFTA country, unless the goods are wholly manufactured in a NAFTA country from materials domestically obtained there, the Determination of Country of Origin for the Purpose of Marking Goods (NAFTA Countries) Regulations must be carefully reviewed to determine the country of origin.

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10.4.5 Raw Material Information

Canada’s “Hotlist”: The Cosmetics Division is revising its List of Prohibited and Restricted Cosmetic Ingredients, also known as the “Hotlist,” which has grown to nearly 500 ingredients. Despite the large increase of ingredients, most of the materials are not currently found in cosmetics. In early 2008, the Canadian government proposed to place cyclopentasiloxane D5, a silicone, commonly used in personal care, on its toxic list during a comprehensive safety review of chemicals found in consumer goods. This raw material is considered an environmental hazard to water-based organisms but it is described as being safe at current levels of exposure for humans. If this chemical is not successfuly defended, it will be added to the federal list of substances that are toxic for the environment or human health. Under Canada’s Chemicals Management Plan, over 200 substances that have been identified as potentially hazardous are being reviewed by the government before they release its conclusions about the ingredients at regular intervals over the next few years. A “toxic” chemical may initially only be added to the list, which is the first step in a regulatory process to help the authorities control its use. The next step may be removal from the market. Hopefully this process will be based on science and not politics. CEPA: On the environmental side, regulations were established in 1994 under the Canadian Environmental Protection Act (CEPA), to require “New Substance Notification” when new chemicals or polymers are manufactured or imported into the country. Appropriate documentation is required in order to make an environmental and human safety assessment for chemicals used in specified volumes. Chemicals found unacceptable are deemed “CEPA Toxic.” DSL: Canada has developed a chemical inventory, Domestic Substances List (DSL), of about 23,000 substances. New materials that are regulated under the Food and Drug Act are reported to the DSL, where one of the functions is to determine the potential presence and impact on the environment. Canada VOC Regulations: Canada is proposing volatile organic compound (VOC) regulations for the following personal care categories: 1. heavy duty hand cleaner or soap 2. hair mousse

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3. 4. 5. 6. 7. 8. 9. 10.

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hair shine hair spray hair styling product (all forms) nail polish remover personal fragrance product shaving cream shaving gel antiperspirant and deodorant

The proposed rule permits products that exceed the prescribed VOC limits to be sold only for two years following publication of the final rule, which places an unreasonable burden on manufacturers and retailers to police the extremely small number of non-compliant products that may still be in circulation after two years. Nanotechnology: It has been proposed that nanotechnology be regulated under CEPA. A common definition of nanotechnology applications in our industry needs to be written. Natural and Organic Cosmetics Industries: Natural and organic manufacturers are upset because it is very difficult to sell genuinely natural or organic-based personal care products due to the lack of industry-wide certification that clearly identifies the fact that they comply with standards. Many brands call themselves natural or organic but in actuality they are not, which leaves consumers confused over what is really true.

10.5 India 10.5.1 The Indian Cosmetic Market

India is considered an emerging market due to its one billion plus population and its lucrative trade opportunities. This country comprises only 2.4% of the world’s land area but has the world’s highest population density with the world’s second largest economy. The Indian retail market over the next five years is estimated to grow 30–50% annually, reaching $45 billion by 2010 (according to a report from the market research company the Kline Group), which makes India one of the fastest growing economies in the world. Trade barriers have been slowly reduced since 1992 when the government lifted the ban in the Foreign-Exchange Regulation Act 1973 on reselling by foreign-owned corporations but reform is

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still needed. Key factors necessary for business success in India include finding good partners who have knowledge of the local market and procedural issues, strategic planning, follow-up, and protection of intellectual property. India’s market requires the analysis and knowledge of consumer preferences, distribution channels, local customs, pricing, labeling, and marketing practices. Personal meetings and relationships with potential agents and due diligence are also extremely important. Multiple agents are often required to serve each state in the country. A foreign company or an individual planning to set up business operations in India but choosing not to establish a subsidiary or to form a joint venture with an Indian partner can do so by establishing one of the following offices; each type has very specific requirements. 1. Liaison or Representative Office: A foreign company has a presence in India but does not directly engage in commercial transactions. Its purpose is to oversee their networking efforts, promote awareness of products, and to explore further opportunities for business and investment. 2. Branch Office: An extension of the foreign company that represents the parent company, acts as its buying/selling agent, conducts research for the parent company, carries out import and export trading activities; promotes technical and financial collaborations between Indian and foreign companies, renders professional or consulting services and technical support to the products supplied by the parent/group companies. A branch office is not allowed to manufacture goods directly although it can subcontract this activity to an Indian manufacturer. 3. Project Office: A temporary project office for the parent company. It is essentially a branch office set up for the limited purpose of executing a specific project. Approval for project offices is generally accorded for executing government-supported construction projects or where the projects are financed by Indian and international financial institutions and multilateral organizations. In exceptional cases, approval is also given for private projects. The above entities are not permitted to acquire real estate but they are allowed to lease property in India for a maximum period of five years.

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10.5.2 Cosmetic Regulations

The Government of India—Ministry of Health and Family Welfare (Department of Health) The Drugs and Cosmetics Act and Rules defines a “cosmetic” as: any article intended to be rubbed, poured, sprinkled or sprayed on, or introduced into, or otherwise applied to, the human body or any part thereof for cleansing, beautifying, promoting attractiveness, or altering the appearance, and includes any article intended for use as a component of a cosmetic.” A “drug” includes: (i) all medicines for internal or external use of human beings or animals and all substances intended to be used for or in the diagnosis, treatment, mitigation or prevention of any disease or disorder in human beings or animals, including preparations applied on human body for the purpose of repelling insects like mosquitoes; (ii) such substances (other than food) intended to affect the structure or any function of the human body or intended to be used for the destruction of vermin or insects which cause disease in human beings or animals, as may be specified from time to time by the Central Government by notification in the Official Gazette; (iii) all substances intended for use as components of a drug including empty gelatin capsules; and (iv) such devices intended for internal or external use in the diagnosis, treatment, mitigation or prevention of disease or disorder in human beings or animals, as may be specified from time to time by the Central Government by notification in the Official Gazette, after consultation with the Board;” The Central Government of India regulates cosmetics by The Drug and Cosmetic Act, 1940, amended on June 30, 2005; The Drug and Cosmetic Rules, 1945, amended on June 30, 2005. The Bureau of Indian Standards (BIS) has created several standards such as: 1. List of Safe Colors and Dyes 2. List of Substances Generally Not Recognized as Safe (GNRAS)

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The Department of Metrology (Weights and Measures) deals with labeling and Standards of Weights and Measures (Packaged Commodities) Rules. Ayurvedic, Siddha, and Unani drugs are not dealt with in this chapter. All Central Government’s rules and regulations are interpreted identically within each Indian State. Taxes levied on cosmetics are dependent upon the state where the store is located and the amount of the state taxes depends upon the number of industries in that state. The lower the taxes, the more industry is attracted to that state.

10.5.2.1 Domestic Cosmetic Regulations

Domestic cosmetic companies presently must register their products in their state at a cost equal to approximately U.S. $4.00, by submitting to its Ministry of Health (MOH) the following documents: 1. Product labels—Hindi, the national language, is most widely spoken but in practice English is the language that mostly appears on cosmetic labels; other languages are optional but labels have very limited space. 2. Quantitative list of ingredients with ranges and BIS numbers. 3. GMP statement—general manufacturing method. 4. Product specification. The MOH form allows up to ten product categories to be registered on each form. Registration approval takes two to six weeks and is in effect for five years. No products may be sold by any cosmetic company until the approval is received.

10.5.2.2 Import Cosmetic Regulations

At this time, officially, it is necessary to obtain a “Non-Objections Certificate” (NOC), for each product that a cosmetic company wants to import into India. The NOC is a letter stating that a specific product has been approved by the Central Government and must be in hand before the product can be imported. It is necessary for an Indian importer or an Indian entity to submit the following documents to the MOH when applying for the NOC:

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1. 2. 3. 4. 5. 6.

Product labels Certificate of Free Sale List of ingredients with BIS numbers GMP statement—letter of adherence Quality assurance certificates Manufacturing license—attested by the Indian Consulate in the country where the manufacturing site is located 7. A declaration of compliance stating that the product contains no banned ingredients and that only safe colors and dyes are used The NOC is specific to a product name and manufacturer. If any changes are made to the product, the NOC must be amended. There is no charge for a NOC. It appears that in practice the large corporations have been importing cosmetic products without obtaining a NOC. Indian customs officials (Inspectors) usually stop products only if they perceive the product to be a drug and not a cosmetic based on claims, no therapeutic claims are allowed for cosmetics, and ingredients. Some general regulatory information: 1. Antiaging claims for wrinkles are not considered a drug claim. 2. Whitening products are considered cosmetics. 3. Sunscreens have no special regulations. Approved sun filters and required warnings are listed in the India Standard 4707 (Part 2):2001 Annex D. Inspectors have the right to take samples from incoming shipments for testing or analysis but must forward a receipt to the cosmetic company acknowledging that samples were removed from the shipment. The Indian Government has proposed The Drugs and Cosmetics Rules Amendment Notification No. GSR 63(E) dated February 2, 2007, which specifies that imported cosmetic products would be obliged to register, thus replacing the need for the NOC. Cosmetic products that already have a NOC would have to use the new system; no drug or cosmetic products would be allowed to enter the country without an approved registration. There would be no postmarket surveillance for cosmetics. India signed the WTO (World Trade Organization) Agreement on Technical Barriers to Trade and since this proposed regulation directly affects the

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international trade of cosmetics products, the Government of India is obligated to notify the WTO prior to enacting any changes to the Indian Cosmetics Regulations. The Indian Government is promoting this amendment as a method to insure an increase in consumer product safety and to curtail grey goods and counterfeit imports of cosmetics. But, it appears that this amendment only introduces onerous requirements that would affect worldwide trade among countries that want to sell cosmetic products in India especially for the small and medium-sized companies. The cosmetics industry is a continuously evolving industry always creating new products, and most manufacturers and marketers have established standards, systems, and controls that ensure a high level of product quality and safety. This new system is discriminatory against imported cosmetics in the following aspects. The importer’s registration is valid for three years; the local manufacturer’s certificate is valid for five years. Foreign-owned manufacturing sites receive a five-year certificate. India distinguishes the local certificates as a license to manufacture and the importer’s registration as a license to import. All cosmetics will be treated the same regardless of its product type or risk. The European Cosmetic Trade Association (COLIPA), the Personal Care Product Council (the United States Cosmetic Trade Association, formerly the CTFA), and India’s Cosmetic Trade Association (ISTMA) hope to maintain a notification process that exists in most of the major markets in the world coupled with postmarket surveillance, rather than a premarket registration. This procedure would allow companies to launch products without additional and costly delays as it is needed for a trendsetting industry. Cosmetics are linked to fashion, which frequently changes and demands quick product launches so that companies can remain competitive in the global marketplace. As of this book’s print date, the following are India’s proposed regulations: 1. Separate registrations are necessary for each manu-facturing facility. The registration fee is US $250.00. 2. Product registration for a product such as a lipstick, eye shadow, face powders, where only the colorants differ (shaded product); each product type can be registered once as long as the base is the same.

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3. Local manufacturers have licenses that are controlled by each state while an importer’s license is on the federal level. 4. Facility inspections will not be standard practice for manufacturers that have proven to have high quality products. Inspections will be only for non-proven manufacturers. 5. Importer application will have a six month registration period as an end limit. It is hoped that the process will be completed within one to three months. 6. The safety data from accredited foreign laboratories and manufacturers will be accepted in addition to the data from Indian approved laboratories. 7. When approved, this plan goes into effect within six months to one year. Products already imported into India will not be taken off the shelves. 8. The International Nomenclature for Cosmetic Ingredients (INCI) will be accepted for use in the product’s ingredient statement. 9. Application forms will be available online.

10.5.3 Summary

The proposed rules are in question of India’s WTO commitments to provide national treatment to “like products.” Cosmetics are “feel good products” meant for external application and it is unlikely that any bodily harm will result from their usage. Stringent restrictions are necessary for drugs, but if even some of the same rules are applied to cosmetics it might encourage countries or trade groups to impose restrictions on imports of cosmetics from India. Countries are presently liberalizing world trade and tariff barriers to allow free trade. Sections of India’s present proposal acts as a non-tariff barrier to free trade. The Government of India has been accepting comments from several cosmetic industry trade organizations and talks are in progress which has resulted in some changes, but there is still disagreement among the participants. At this time the Indian Government is not in favor of a manufacturer accountability system which exists in many countries around the world and is the desired method of dealing with cosmetics. They are determined to put into effect a pre-registration system, which they feel works best for them based on their experience with pharmaceuticals.

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Indian regulations become law one year from the acceptance date by the government body that wrote the law.

10.6 Russia 10.6.1 The Russian Cosmetic Market

The Russian Federation has had a fast growing cosmetics and personal care market since the mid-1990s when the first free-standing cosmetic store opened in Moscow. Women would flock to the store forming long lines to look at the products even though most of them could not afford to buy. The Western concept of “looking good” has profoundly impacted the development of the Russian cosmetics and toiletries market. As its economy has prospered, research shows that today more than 90% of Russian women wear lipstick, more than 80% use moisturizing products for skin, 90% use perfumery, and more than 80% of the Russian women use makeup every day. The Euromonitor International also forecasts a 60% overall market growth of Russian cosmetics and toiletries in the next five years. Today, Russian consumers are more willing and able to purchase luxury goods and their selection of products is not based entirely on price; quality and functionality are a key criterion in their purchasing decisions. Niche and premium products sell well; a trend that is most evident in the skin care area. Skin care sales are expected to achieve a 90% increase since manufacturers introduced the concept of “skin types.” Advertisers encourage consumers to use a variety of specially designed products in their daily skin care regimen which has resulted in a positive impact on market growth. Advertising, both traditional and Internet forms, plays a significant role in raising consumer awareness of the range of available cosmetics and knowledge concerning raw ingredients, quality, benefit, and function of a product. The Internet is also a promising outlet for additional sales as more Russian families are buying computers. Meaningful growth is expected in the sun care products sector, influenced by the fact that it is now recommended that people use sun care products all year round. The men’s toiletries and shave products market is wide open and manufacturers see great potential. The above markets present an opportunity for both local and foreign manufacturers to positively impact Russian economic growth. Consequently, foreign companies are beginning to include the Russian market in their strategic planning.

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Distribution networks have greatly improved, enabling supermarkets and chained boutiques to expand geographically. Consumers now have access to products outside of the city centers, and the result is higher sales. The improved networks have also helped to reduce the prevalence of counterfeit products that plague the Russian market. Direct sales greatly impact the cosmetics and toiletries industry, particularly in the skin care and color cosmetics sectors. Well-trained consultants promoting a full range of skin care products, from cleansers and toners to moisturizers and body care, are the key to success. Spa visits are considered by many Russian men and women an essential part of a healthy way of life.

10.6.2 Cosmetic Regulations

The Russian perfumery and cosmetics market offers favorable conditions for launching new products, but receiving the necessary certification for these products can be frustrating. Russia’s import regimes include burdensome certification for cosmetic and personal care products. While some of these requirements address legitimate health and safety concerns, others appear to be unnecessary requirements for imported goods and they unfairly burden importers. Foreign cosmetic companies who want to enter the Russian market should fully understand the requirements for the Certification of Cosmetics. These companies must have a clear understanding of the procedure in order to refrain from paying unnecessary costs and to secure an effective market entry for their products. The main Certification Body of the Russian Federation is the Gosstandart which accredits “organizations” by awarding them a Corresponding License. These organizations review cosmetic certification requests and no fees are involved. There are Russian companies—mediators—that charge high fees to acquire the required certificates from an “organization.” The mediators charge the exporter for simply passing their company’s information directly to the accredited organization. Mediators also offer “Special Certificates” that affirm that “your product” is the best in the marketplace. “Special Certificates” are useless, totally meaningless, and definitely a waste of money. The correct procedure is, first, your products must conform to the Russian standards. Second, a quality certification, GOST R Certification, which

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demonstrates compliance with basic safety requirements and the quality certification system in the Russian Federation must be applied for and approved. GOST R has the same meaning as the ISO 9000 series of certificates for the Western companies. This certification will provide cosmetic products with fast access to the Russian market. Third, all imported cosmetic products must undergo Safety (Hygienic) Certification. The Hygienic Certificate confirms conformity of products and services to the sanitary norms and strict observance of the established rules in the process of manufacture, storage, transportation and the sale of products, and services. Fourth, some cosmetic products are required to undergo registration in the Ministry of Health rather than Hygienic Certification such as those for children, dyes (except for toner shampoos and balms), and permanent wave, bleaching, and self-tanning products, as well as intimate hygiene and professional cosmetic products. The registration of these products is three times more expensive than a hygienic certification. List of perfumery-cosmetic products subject to mandatory certification 1. Face and body care products such as creams, emulsions, milks, gels, jellies, lotions, tonics; oils for skin care refreshment, cleaning, moisturizing, etc.; masks; shower and bath agents, etc.; soaps; deodorants and other agents against sweating; powders (powdered talc) for body care; depilatories; shaving agents. 2. Hair care products such as washing agents; balms, conditioners, lotions, creams, etc.; agents for hair-making and preserving; agents for curling, fixing, unbending; hair colors, shade shampoos, decoloring agents. 3. Decorative cosmetic articles such as lips care agents; makeup for eyes; powders and paints for applying cosmetics; agents for applying cosmetics; nail care and painting. 4. Products for intimate organs such as hygienic packs, pampers, separators, napkins, powders, etc., including perfumery agents. 5. Special cosmetic products such as agents for tanning; agents for tanning with absence of the sunshine; photo-protective agents; agents for skin-whitening; tattoo-making agents, etc. 6. Hygienic and perfuming agents such as perfumes, colognes, and fragrant waters, ether oils, etc. 7. Dental and mouth’s cavity care agents such as toothpastes, gels; toothbrushes; tooth powders, denture-care powders,

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toothbrushes’ bristle-care; chewing gums, breath-care candies; denture-care pills, coloring pills for dental plaque revealing; hygienic lipsticks; dental elixirs, washing agents, deodorants for mouth’s cavities. 8. Skin-protective products such as ointments, creams, pastes, liquids and other washing agents, and some protective cosmetic substances. Liquid Cosmetics: State Standard of the Russian Federation GOST R 51578—2000 Liquid cosmetics are: 1. spirit-based liquid perfumes: perfumes, Cologne waters, perfumery, toilet and aromatic waters; perfumery and toilet waters applied as fragrances; 2. lotions, tonic lotions, and tonics: for a hygienic and/or toning action for care of the skin, hair, and nails; 3. hair waving and setting products: for care of the hair; 4. deodorants and antiperspirant deodorants: for a deodorizing, scenting, and freshening action; The liquid cosmetic standard establishes the general technical requirements and methods for testing with the exception of liquid cosmetics in aerosol containers with a propellant, hair lacquer and nail polishes, cold waves, and products for coloring the hair and lips. Liquid cosmetics must be produced in accordance with the requirements of these standards (see Table 10.3). Acceptance and periodic tests are conducted to verify the compliance of liquid cosmetics with the present standards. Ethyl alcohol must be denatured by additives permitted for use in the Russian Federation. Requirements for ethyl alcohol do not apply to imported liquid cosmetic products. Consumer packages of liquid perfumes containing ethyl alcohol shall bear a printed inscription indicating the volume ratio or strength (relative, % vol.). Liquid perfumes should contain no general toxic properties, nor shall they produce irritating or sensitizing effects on the skin. The maximum capacity of a liquid perfume bottle is 255 cm3. Expiration dates must be established by the manufacturer for each particular liquid cosmetic product.

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Table 10.3 Standards for Production of Liquid Cosmetics Function

Characteristics and Standard

Concen- ExtraGroup trated Scents Scents Appearance Color Fragrance

Persistence of scent (hrs, at least) Transparency (absence of turbidity at temperature, °C) Proportion of ethyl alcohol by volume (%/v, at least)* Total proportion of fragrances by volume (%, at least)

Scents

Perfumed Water

Toilet Water

Eau de Cologne

Scented Water

Transparent liquid Characteristic of the color of the product Characteristic of the fragrance of the product 60 60 50 50 40

24

–

+3

+3

+3

+3

+3

+5

+5

55.0

70.0

85.0

75.0

75.0

80.0

20.0

30.0

15.0

10.0

10.0

4.0

1.5

1.0

*Mandatory for application as of January 1, 2002. Note: For products for use on children, the proportion by volume of ethyl alcohol in liquid perfumes shall be no more than 20%.

10.6.3 Certifications

In order to sell cosmetics or perfumes in Russia, it is necessary to obtain the following two documents: Hygienic Conclusion and Certificate of Correspondence. Hygienic Conclusion: Hygienic Conclusions are issued by the Department of Gossanepednadzor of the Ministry of Public Health:

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National products—on the basis of the results of the hygienic evaluation of products and the expertise of the official documentation that defines product requirements, requirements for its production and application. Imported products—on the basis of evaluation of the Certificate of Safety of the supplying country, and the results of testing the products, hygienic evaluation of products, and formalization of the requirements to the processes of its production, stocking, transportation, application, and utilization that guarantee safety for people.

Certificate of Correspondence: The Gosstandart of the Russian Federation is comprised of several divisions: 1. Central body of Certification of Perfumery and Cosmetic Products and 2. Central body of Certification of Mouth Cavity Hygiene Agents. The Technical Committee of the Gosstandart develops, controls, and issues all regulatory documents. Certification is conducted by the Special Certification Body that has a corresponding license and is accredited by the Gosstandart. Toxicological and clinical studies are conducted by medical bodies accredited by the Ministry of Public Health of the Russian Federation and microbiological and physico-chemical research work is conducted by test centers accredited by the Gosstandart of the Russian Federation. On the basis of the results of this research and the identification of consumer characteristics of a product, the Certificate of Correspondence is issued. The certification application needs to be completed and the following documents should be attached:   



 

contract copy certificate of origin copy company’s registration certificate (of the company that presents a product for certification) hygienic conclusion about safety of this product with test records of four types of safety evaluation safety certificate from the product’s country of origin product samples

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National manufacturers must also submit: 

   

charter of the producer where perfumery-cosmetic production is mentioned qualitative formula quantitative formula technological regulations perfumery-cosmetic production license

The manufacturer, importer, or seller of perfumery-cosmetics gives an Accredited Certification Body, an expert, all the necessary documentation and product samples for testing. The expert also checks the “marking” that should correspond to GOST P51391-99 Perfumery and Cosmetic Products, which is the consumer information mandated by the Consumer’s Rights Protection Law. If a product is imported, this information must be translated into Russian. The Certification Body receives the decision on an application. If the Certificate of Correspondence is granted, it is issued for one year; an inspection is done in six months and samples must be presented again for testing. Special control protocols are issued to the company and the Certificate of Correspondence is marked with a special mark if the manufacturing installation has passed certification and has received a hygienic approval. The certificates can be issued for two or three years with an Obligatory Control. After issuing certificates, certification bodies continue to monitor the advertisement of products that have been certified; in case of violations they can revoke the certificate. Obtaining the above documents requires direct contact between the authorized manufacturer’s representative and experts from the Center of NormSetting and Certification and testing centers accredited by the Ministry of Health. The testing centers assign microbiological, physical chemical, toxicological, and clinical laboratory tests that the products undergo before they can obtain certification. The cost of the hygienic and quality certification depends on the scope of the tests. Either a distributor or a regulatory contact that is authorized by the manufacturer can apply for the certificates; it cannot be done by correspondence. The testing center signs a contract with the authorized manufacturer’s representative to do the certification work and the manufacturer’s representative provides the testing center with its company charter and incorporation documents. The turnaround time for the certificate is about one month. If a company’s application is rejected, the company may file a request for the Gosstandart to review their application.

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10.6.4 Certification of Imported Ingredients for the Beauty Industry

Imports of oils and other ingredients for the cosmetic industry require a hygienic certificate. Russia has a voluntary quality certification, the GOST R Quality Certificate for Cosmetic Ingredients; Russian manufacturers only purchase ingredients that have a GOST R quality certificate. Companies would be advised to obtain this quality certificate when entering the Russian market. The certification procedure for ingredients is about the same as for final beauty products. The Center of Norm-Setting and Certification recommends qualified testing centers to conduct the tests and to review the documents necessary for certification. An authorized representative of the manufacturer signs a contract with a testing center for certification work. The applicant submits the following documents to the testing center: a contract with a Russian partner/distributor for importation of products and a Certificate of Free Sale from the country of origin. The testing center assigns a number of toxicology, microbiology, and physical chemistry and clinical tests that the ingredient must undergo before the above certificates are issued. Again, the certificates cannot be obtained by correspondence and require the personal involvement of the authorized manufacturer’s representative in the procedure. Though the above procedures seem complicated, it is routine work for a qualified Russian distributor or regulatory company. It is highly recommended for companies to work with qualified partners when trying to obtain product or raw material certification. 10.6.5 Updates: Russian Perfumery-Cosmetic Products

In November 2004, Russia proposed new technical regulations for both cosmetics and toiletry products based on the EU model. The proposal was drafted by Russia’s two industry associations, the Perfumery and Cosmetics Association of Russia (PCAR) and the Association of Perfumery, Cosmetics and Household Chemistry Manufacturers (APCoHM), and presented to the State Duma, which in the Russian Federation is the lower house of the Federal Assembly of Russia headquartered in downtown Moscow, for a first hearing in December 2004. The new regulations would allow companies to submit notification papers three days prior to launch. However, companies need to ensure that their infrastructure and quality control are strong, which is costly for the smaller businesses.

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In an attempt to stop the illegal importation of alcohol into Russia under the guise of perfumes, the Russian Federal Law “On State Regulation of Production and Distribution of Ethyl Alcohol, Alcoholic and AlcoholContaining Products” took effect on July 1, 2006. This law had an immediate negative impact on the country’s cosmetic industry. Until the end of 2006 cosmetics and perfumes containing alcohol were called non-food products with alcohol and the excise taxes doubled for products with more than an 80% alcohol. All companies in the alcohol market had to register their product’s movement with the Integrated State Automated Information System (ISAIS), which forced many distributors to decide not to sell products containing alcohol. Consequently, the industry was in disarray for months due to this system. To placate the cosmetic and perfume industry, in December 2006 the Russian government passed a law that withdrew perfumery from participating in the ISAIS. On July 1, 2007, Perfumes and cosmetics makers were worried by the perspective of the lifting of a waiver on the denaturation of imported alcoholic products. If the denaturation requirement is applicable to perfumes and cosmetics, most of the products imported into Russia would become illegal as they comply with different denaturation requirements. The Russian list of permitted denaturants features four items: bitrex, kerosene, benzene, and crotonaldehyde. Apart from bitrex, these substances cannot be used in cosmetics products in the EU. Several countries and the government of the Russia Federation are involved in discussions to try to amend the list of Russian allowable denaturants. As of June 1, 2008, WTO discussions are continuing with the Russian Federation to eliminate measures or to modify them so that they would be consistent with WTO requirements. Russia is working to bring its technical regulations into conformity with international standards. It appears that Russia still hopes that sometime in the near future it will become part of the WTO.

Bibliography ANVISA (2000): Resolution RDC No. 79, of August 28, 2000, on Cosmetics, Personal Hygiene Products and Perfumes, Brasília, Brazil, National Health Administration Agency. “Canada regulators will require ingredient labeling in cosmetics.” Chemical Market Reporter 267.2 (January 10, 2005): 7(1). Business and Company ASAP, Gale, New York Public Library Research Lib., March 19, 2008.

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“Canada regulators will require ingredient labeling in cosmetics.” (Markets plus: cosmetics & personal care). Chemical Market Reporter 267.2 (January 10, 2005): p. 7(1). Business and Company ASAP. CTFA (2007): CTFA International Regulatory Resource Manual, 6th Edition, Washington, DC, USA, Cosmetic, Toiletry and Fragrance Association. “Mercosur sets lab rules.” Soap Perfumery & Cosmetics 78.11 (November 2005): 3(1). Business and Company ASAP, Gale, New York Public Library Research Lib., March 19, 2008. “Russia aligns with Europe on technical regulations.” (Russia Report) (Perfumery and Cosmetics Association of Russia). Cosmetics International 28.641 (November 5, 2004): p. 4(1). Business and Company ASAP. Special Chem Cosmetics—On-Line Newsletter a. “Natural vs. organic vs. certified organic In Australia,” April 23, 2008, Greg Milham. b. “Global Organic Certification,” February 1, 2008, Nick Morante. c. “Cosmetic Regulations in Latin America’s 20 Largest Countries,” March 22, 2007, Dr. Annelie Struessmann. d. “Cosmetic Regulation in North America—USA & Canada,” October 12, 2006 Dr. Annelie Struessmann. http://www.beauty-on-line—On-Line Newsletter: “Moscow (Russia) Perfumes and cosmetics exempted from Russian alcohol law,” June 28, 2007.

Helpful Websites BfR (Federal Institute for Risk Assessment): http://www.bfr.bund.de/cd/ template/index_en Canadian Department of Justice: http://canada.justice.gc.ca/en/ Canadian Hazardous Products Act: http://laws.justice.gc.ca/en/ShowFullDoc/ cs/H-3///en Health Canada: http://www.hcsc.gc.ca/cps-spc/person/cosmet/faq_e.html http://www.hc-sc.gc.ca/cps-spc/person/cosmet/info-ind-prof/hot-list-critique/ hotlist-liste eng.php http://www.anvisa.gov.br http://bilaterals.org http://www.cosmeticdesign.com http://www.cosmeticsinrussia.com http://www.nicnas.gov.au http://www.osec.ch http://www.tga.gov.au/cosmetics http://www.uktradeinvest.gov.uk

11 Global Patent and Trade Mark Strategies: A Must for Everybody? Estelle Haeffner, Virginie Gliubislavich, and Karl Lintner Sederma S.A.S., Le Perray en Yvelines Cedex, France

11.1 Introduction This chapter, as most of the other chapters in this book, is targeted to readers in medium- to small-size companies. It would be a presumption to teach details of Intellectual Property (IP) Law to experts in multinational companies, to advise them on global strategies. On the contrary, in today’s IP legal environment, the authors of this chapter attempt to guide the nonspecialist in helping him/her to decide how to establish a coherent approach to IP protection locally and/or globally. The best advice to the potential inventor and future patent assignee is to consult a law firm specialized in IP protection. Consider the IP counsel as the expert on the laws and the fine details of IP protection; she/he is not necessarily a specialist in cosmetic matters and even less the person to define your strategy. Thus, it is useful to have some basic knowledge of the matter in order to better inform and brief, negotiate, and collaborate with the counsel. This is the main purpose of this chapter.

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IP refers to any creation or product of the human mind or intellect. It can be an invention, an original design, a practical application of a good idea, a mark of ownership such as trademark, literary and artistic works, software code, among other things. Today it is considered a key component of businesses and most successful companies have recognized the crucial role of IP in ensuring their companies’ future. Failure to protect IP may spell the difference between the success and failure of a business entity. The following items are examples of ideas in need of IP protection.        

Copyrights Trademarks Industrial designs Patents Lay-out designs of integrated circuits Protection of undisclosed information Utility model New plant varieties protection

We shall concentrate on patents (inventions) and trademarks (commercial signs of success) and exclude the questions of copyright, utility models, and other subjects from the present discussion as they appear less specific to the field of personal care (cosmetics). The idea of protecting “inventions” goes way back in history, but well documented evidence dates from the fifteenth century. The basis of presentday patent laws was laid in the revolutionary years, 1790 in the United States and 1791 in France, where it was seen as a new democratic institution doing away with royal grants and privileges. Similarly, trademark law—of which certain roots can be detected in antiquity—became codified in Europe and the United States in the nineteenth century. The purposes of the two branches (patents and trademarks) are quite different, however. Patent law rewards the inventor with a monopoly to practice his invention for a certain amount of time without having to compete against (usually cheaper) copies; in exchange, the patent owner lays down (teaches) his invention in great detail, such that all of humanity can profit from the new item. Patent protection law thus encourages innovation, technology investment, and creativity. Trademark protection, on the other hand, although it also confers commercial advantages to the owner, is meant to protect the consumer against being misled by unscrupulous trade practices.

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We shall examine in this chapter the questions of why to protect your IP, what to protect, when to do it, how to do it, where to obtain protection, at what cost, and how to defend your IP eventually.

11.2 Why Protect IP (Inventions and Trade Names)? In today’s global environment, it is increasingly difficult to keep secrets, to guard your technical, commercial, marketing know-how, to control markets, distribution channels, in short to be master of the fate of your products. In the cosmetic field, where innovation is a key driver of success, where brand recognition and fidelity are difficult to achieve and to maintain, it is essential to make sure that the investment a company has made in research and development, in advertising, and in creating an image is not lost in a few weeks or months when a competitor—who did not have to make the same investment—just copies formulas, ingredients, packaging design, and names to profit unduly from your ideas and know-how. A valid, granted patent on your invention, a registration of your trademark, and the design of your original new flask give you the legal handle you need to prevent disloyal competition from hurting your business. In many cases, the existence of a patent and/or a ®/™ sign is a sufficient deterrent, although it is no guarantee. Sometimes, when the stakes are high, lawsuits, injunctions, and stronger means are necessary to defend your IP. A second important reason to file a patent application is mostly of concern in business-to-business (B to B) transaction. The danger of not patenting an invention is that an early customer or a competitor who got wind of your invention patents the idea in the inventor’s place, which then prevents the true inventor from proposing the invention to any other party. This happens more often than might be expected in B-to-B dealings. In such cases, the inventor can take legal action to remedy this situation. However, it is of course preferable to be well protected in the first place and to avoid going through legal proceedings. There are instances, though, when it is preferable NOT to file a patent, especially in fields of process technology and chemical synthesis. When an inventor thinks that there is little chance of other persons developing the same idea within the lifetime of a potential patent (up to 20 years), and/ or when teaching the invention would reveal, at the same time, a whole new field with many possible improvements, variations, and loopholes that

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others might exploit (and thereby restrict his own freedom to practice his invention), then it may be preferable not to patent and to keep the knowhow secret for as long as possible. The danger with this approach is that some other person may still discover/invent the same or very similar process and decide to patent it in which case the original inventor might be infringing this patent, even though she/he has been practicing the invention for a long time. In some countries, there is a way around this problem (France: “enveloppe Soleau,” see Section 11.5); in the United States: the date of creation of the invention (rather than priority date of filing) may allow the original inventor to continue practicing his invention. To register a trademark makes sense, mostly for products sold to the end user (the consumer). A solidly established trademark, protected against similar sounding names and similar looking designs, helps build brand awareness and brand loyalty; it helps the consumer find the product she/he wants and to make quick purchase decisions. Of course, a too well known brand name sometimes enters the language as a generic term and becomes dissociated from the specific product and company it belongs to. This is a problem to worry about when you get to that bridge after having achieved such a success.

11.3 What Types of IP Can You and Do You Want to Protect? 11.3.1 Inventions

In the field of cosmetics (by which we mean all personal care products as they are defined in the various legislations (see Chapters 3, 7, and 9), the following domains of activity and items may lead to patentable inventions: New molecules/substances to use as ingredients (actives, emulsifiers, fragrances, preservatives, etc.) New processes to obtain old or new molecules/substances (ways of synthesis, extraction, purification, solubilization, etc.) New blends (combinations) of substances with beneficial synergistic properties and activities New cosmetic compositions containing the new substances or blends (new presentation forms, vectorization, and delivery forms.) Uses of these new substances and/or these new cosmetic compositions for cosmetic purposes (antiwrinkle, anticellulite, skin toning, oil control, etc.) New uses and applications of known (old) substances New packaging and dispensing material

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In all of the above, we have used the word “new.” This is indeed the essential (but not sufficient) criterion for obtaining a patent. The patent must teach something new, some item from the above list that has never been described in identical way before, anywhere in the world. As an example: if the inventor of the first cosmetic composition containing a liposome filed a patent application on the use of liposomes in cosmetic formulations, characterized by the fact that the liposomes have a diameter ranging between 200 and 1,000 nm, then another inventor, who uses liposomes of a diameter below 200 nm, say at 100 nm, is not only free to practice his invention, but may also try to obtain a patent on his smaller liposomes. They have not been disclosed in the “prior art” and thus they are “new.” However, in order to obtain a patent, a second criterion has to be fulfilled: nonobviousness, also called the “inventive step.” Whereas “novelty” is, in most cases, relatively easy to establish or to reject (by the patent office who examines the patent application), nonobviousness is a more subjective measure and often subject of conflict between patent assignee and patent examiner (or a third-party contestant of the patent). To remain with the previous example: if cosmetic compositions containing liposomes are known as prior art, and liposomes are known to exist with diameters ranging from 20 to 2,000 nm, then it would appear obvious that a cosmetic composition can be made containing liposomes of <200 nm; so even if they are “new” (never described before), they lack the “inventive step,” as it is obvious that a person “skilled in the art” (as the official jargon describes it) would have no problem in putting two and two together to make a cosmetic composition containing the smaller liposomes. A patent application claiming the cosmetic compositions with these smaller liposomes would then (most likely!) be rejected as “obvious and lacking inventive activity.” Unless the inventor can demonstrate a clear, nonobvious advantage for the smaller liposomes over and above the existing knowledge! Unfortunately, these evaluations of obviousness and inventive activity are less and less used by the Patent and Trademark Offices (PTOs) around the world as the discussions with the inventors become drawn out and complex as well as time consuming. The resources of the PTOs are limited, and the officers of the various departments, although trained in, say, chemistry, are not necessarily specialists in all the “arts” on which they have to render judgment to know what is obvious to the average cosmetic formulator. Hence the appearance of many patents, the validity of which has to be contested in court rather than at the PTO.

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A final criterion for patentability is, of course, the industrial application. Simple (or complex) theories of mechanism of action, nebulous ideas, unrealistic, or physically impossible ideas cannot be patented. Some other restrictions (different from region to region) on what can be patented exist, too: “methods” to treat the skin are acceptable in the United States, but not in Europe, where “use for an application” is allowed (but mostly rejected in the United States). A more delicate subject is the “discovery.” In principle, a discovery (say, of an activity of a molecule) cannot be patented. It can be published in the scientific peer reviewed literature; but as the activity of a molecule is inherent in its structure (and in nature), it cannot be patented. The use of this discovery to obtain an effect on the skin, however, is patentable. Much therefore, lies in the wording of the description (called “specification”) and the claims of the patent application.

11.3.2 Tradenames

Coca-Cola®, Xerox®, Chanel®, Nike®, Intel®, Windows®, and thousands of others are well-known trademarks around the world. So the question of what to protect in the field of trade names is clear: if you have a name for your product or service that distinguishes it from potential competitors, you ought to think of registering it as your property. Trademarks are considered “assets” from an accounting standpoint and from a commercial standpoint. Their real value depends, of course, on the sales connected with them and the public awareness of them. The rules that define what can be registered as a “trademark” are complex and vary from country to country. We can only touch a few here, as entire books have been written about this subject. Words from the dictionary cannot be trademarked as such; however, the same word presented in an original design (logo) can be protected as a “model.” Even entire phrases can receive some protection if they are tied (in form and content) to a product or service (“We try harder” from Avis, or “Because you are worth it” from L’Oreal). However, anything contrary to public order (obscenities, inciting to violence) is usually rejected (e.g., years ago the name “VIOL” was submitted for a perfume; this means “rape” in French and was not admitted for registration).

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Easiest to register are nonwords; that is, combination of letters that are removed from day-to-day language, as there is less possible confusion with existing trade names or obvious words. Exxon®, found after a long computer search to replace ESSO (= S.O. = Standard Oil, a trust that was broken up by the courts), is a well-known example. Of course, one wishes to have a nice sounding trade name, one that connects the name to the product and conveys an easily understood meaning. Hence, for instance, the huge number of registered trade names containing the word “hydra” or “hydro” for moisturizing products in our field. The question of “What can I register?” then becomes: what combination of meaningful letters can I still find that is sufficiently distinct from all those that exist already and does not infringe on any other rule? The question of “decency” of the words has to be evaluated in many languages if one wants to create a global brand name. What may sound okay in English is not necessarily acceptable in Finnish or Thai or Farsi. There are databases that can be consulted to check for existing trademarks, although to check for identical “words” is not enough. To register a trade name without needing to fear opposition from the owner of a similar sounding name one needs to check for more than identity of the letter sequence. Much legal precedence exists in the judicial literature on what constitutes trademark infringement. Is a single letter difference between trade names sufficient to be a “distinct” trademark? Usually not. Are two letter substitutions sufficient? It depends on how it sounds, looks, and what it might mean. As an example (a bit farfetched, but real), the words “Energy” and the letters “NRJ” would be considered too close (in sound, when pronounced) to be used on similar, but competing products. In contrast to patentable inventions (see Section 11.3.1), absolute novelty is not a criterion for registration. Only an existing trade name (registered or simply highly renowned and popularly known and used) can be an obstacle to getting your trade name approved and viable. That means, if you have a trade name for a product, but have not registered it, and it is not as recognizable mainstream as Intel® or Coke®, then somebody else might officially register the name and force you to change your name. Priority of use may play a role in a fight for the name, but is no guarantee (unlike in a patent). Hence, for names which you feel important enough to accompany a global launch, registration is recommended, at least in the important markets.

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Almost as important, sometimes maybe even more so, is the protection of a “design model,” for instance, an original design for a perfume flask. Not so much a special dispenser design (this might be patentable), but the “look.” However, the appreciation of which design is distinct enough to merit and succeed registration (and its defense against copycats) is even more difficult than in the case of similar sounding trade names. Written rules of what is acceptable for IP protection and what constitutes infringement are hard to come by, however. Much of it is left to the examiner at the PTO and to judges in case a conflict comes to court.

11.4 When to Protect Your IP? This question is more difficult to answer than it would seem at the outset. Patent when your product is ready for launch and you have all the data; register your trademark at the same time. If it only were that simple. But as it happens, ideas (Prof. Dawkins called them “memes”) are in the air, float around, crystallize, fertilize each other, multiply and spread. Or, in other words, time is of the essence. If you wait too long to decide what and how to patent, somebody may have beat you to the finish line, or the PTO filing office. But filing too early is problematic too. If the invention is still in the early stages, the patent specification (the description part) will be incomplete; crucial experiments may not have been done yet. But the claims can only be based on the specification, which must be, by law, specific enough so that other people, skilled in the art, can repeat and put into practice the invention (even if they have to wait 20 years to profit from it). A patent application is published 18 months after the filing date and becomes a document accessible to anyone in the world. Depending on the degree of novelty and the potential value of the invention, this publication will generate interest with competitors eager to exploit any loopholes. Therefore, a compromise has to be found between filing too early and filing too late when somebody else has, in the meantime, and unbeknownst to you (for 18 months) filed the same or very similar invention. A patent description should contain specific examples, up to a point, the more the better (to bolster the solidity of the patent), although too many examples may give away too much of your underlying knowhow. If several very different uses for a novel ingredient or a new emulsification process or a new dispensing system can be envisaged, the question becomes: file it all in one big document or separate the patent application into several independent patents. No general rule can be given here. If the

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core invention is readily applied to different uses, and they follow logically from the outset, a single patent is probably the better solution (cost is limited to one filing). If it is really actually several inventions, loosely tied together by a common theme, and not inherently unified, then separate applications will be preferable, the more so as the PTO will in most cases oblige you to file divisional patents anyway. In brief, file when you have a solidly documented idea and invention, but before your competitors file their similar idea. In the United States, it is possible to file a “provisional” application in very broad terms, without too many specifications or examples, just to establish the Priority Date, and then, within a year, one files a more detailed specification and more finely tuned claims. Care must be taken, though, not to add truly new material that was “invented” at a date posterior to the original filing, as this would not profit from the first priority date. If you do want to add truly new material that was invented at a date posterior to the original filing, be aware that this new material would not profit from the first priority date but rather from the date of the second filling application. As we are speaking about the date and timelines of filing, we should briefly outline the successive events of a patent application as it moves through the process. The day the first patent application is deposited at the PTO of your (or some other) country is called the priority date. If, after the examination process, a patent is finally granted, the 20-year monopoly will run from the day of the priority date onward. The PTO will acknowledge receipt and registration in their files very rapidly. Then a wait of about nine months ensues, during which the patent application text is analyzed with respect to “novelty”, that is, the PTO examiner searches all public documents at his disposal to look for “prior art”: any document that from afar or closely resembles the invention or speaks of similar matters will be cited by the PTO. A research report will be issued at this time, and sent to the inventor/ assignee/mandate. In this report, all documents that the examiner considers pertinent are included, and specific pages indicated, in respect to the claims made in the application. From this point in time, procedures differ from country to country to such a point that they cannot be detailed here. However, invariant is the continuing time line: if the initial filing has occurred in your home country, you have 12 months from the first filing (priority) date to decide if you want to

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extend the coverage to other countries in the world. In this case, a Patent Cooperation Treaty (PCT) extension is filed before the anniversary of the Priority Date; in this extension one names all the countries one is interested in for protecting the invention. This designation is just like taking an option on these countries. No consequence is incurred if later one does not file in all of these countries. Finally, 30 months after the priority date, the invention has to be presented and submitted (usually in the language of the country, but see below for Europe) in each of the countries where one really wants to obtain protection, that is, one “enters the National Phase.”1 Only now does the real examination of the patent application begin, and only the local patent office can deliver a final verdict: patent granted as filed, patent granted after modification of the claims, or patent rejected outright. This process, from priority date to a final decision by the PTO may take many many years, in extreme cases it may almost go to the end of the validity period of the filing (20 years). It is possible though to speed up the process if that is the wish of the inventing party. This timeline is important to keep in mind so as not to miss a deadline, which in most cases cannot be recovered. So much to the question of when to file a patent. As to trademarks: file immediately when you have a good idea for a name and are reasonably assured that it is original and distinct enough; they are so hard to come by, so difficult to come up with (so many other people are trying to do the same!), which in many cases it is good strategy to register and file a good sounding name as soon as possible, even if you have no product to go with yet. To own a portfolio of trademarks, even unused for the time being, is a real asset. Once you have a product to launch, you can then, in the best case, pick the already registered name and launch immediately. A registered trademark belongs to you for ten years, which can be renewed for further periods of ten years. However, it is necessary to use the trade name in a product or for a commercial purpose; otherwise, a third-party may lay claim to it after five years and obtain the name for his product.

11.5 Who Files and How? A patent application can be filed by the inventor(s) or by the future owner (a corporation) of the patent, if the inventor is, for instance, a salaried employee of a company where the invention was made. It can be filed by

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a mandated firm (patent lawyer) on behalf of the inventor or the owner, hence called the patent assignee. The inventor(s) must be named on the patent application, even if they do not necessarily own the patent. The procedure of filing involves several steps, the most important of which is the writing of the text. A patent consists of a title, an abstract, a specification (detailed description of the invention) and a list of claims. The claims can only be derived from information contained in the specification. It is the content of the claims that is the object of the protection. Anything written in the specification, but that is not claimed (and not awarded by the PTO) will not be protected against infringement. However, it will constitute “prior art” and prevent others from patenting it. Writing of the patent application is best left to trained specialists, as precise wording is of utmost importance. Especially in the field of cosmetic inventions, where so much has already been filed and published, so much prior art has to be taken into account, one has to navigate carefully in order to show novelty and nonobviousness and not overlap with other existing patents. It is also important to include all prior art of which the inventor is aware at the time of writing and filing. As said before, the specification should contain well-chosen examples of practicing the invention (“teaching”). However, care is needed to be certain that the examples are real and can be reproduced by a third party, lest the whole patent is nullified later if it turns out that it contains factual errors or irreproducible results. A constructive dialog between the inventor(s) and/or assignee and the patent counsel who writes the specification and claims is necessary. Discuss the breadth and scope of the invention, of what exactly you want to patent and protect, and what you want to add in the description to cover all bases. The final text is then deposited with the local PTO. It then follows the procedures outlined briefly in the previous section. When you decide to opt for protection in countries outside your home country, a PCT extension may be the recommended path as it gives you further time (to fine tune your invention and the scope of the patent protection you seek) before needing to file individually in the selected countries. As this filing is also associated with cost (see below), it is advantageous to have additional months before deciding geographical coverage (and spending the money). Modifications and additions to the text (specification) can be made at the time of PCT extension, but new claims resulting from these additions will have the PCT filing date as Priority Date, not the original one.

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We have said above that in some cases it is preferable not to file a patent, and have indicated the associated risks. In France a specific provision exists, which affords some protection to an inventor who decides not to patent because of the fear of revealing too much: the inventor can deposit with the local PTO (called INPI) a sealed envelope (of which he keeps a stamped sealed copy) for a very modest fee. This envelope called “Soleau” specifies the invention and a priority date. In case somebody else hits upon the same idea later and decides to patent it, the original inventor can claim priority (the envelope has to be laid open in court). This does not invalidate the patent; however, it grants the original inventor the right to continue exploiting his invention (making and selling his product or services). This right is only valid for the territory of France! Trademarks are filed by whoever will own them; there is no “inventorship” involved. A form is filled out and a tax is paid. It is important to choose the right category of products or services (called “classes”) for the trademark and to specify the type of product the mark will be used with. After filing, a “window for opposition” opens when a third party may claim priority based on their ownership of a similar looking or sounding trademark. These conflicts are mediated by the PTO, but often settled between the parties.

11.6 Where to Obtain Protection? 11.6.1 Inventions (Patents)

This question is as crucial as all the other ones: because filing in a country (the “National Phase”) generates cost (translation, filing taxes, and annuities), it is important to choose the country and region you want/need protection for your invention. Worldwide protection for a small fee would be ideal, but is presently not available. In the cosmetic field, for which this book and chapter are written, there are essentially two types of strategies: one for the product destined to the end-consumer market, and one for the supplier (ingredients, packaging, and design) to the cosmetic industry. 11.6.1.1 Strategy for Consumer Products

These are the questions to ask yourself in deciding in which country to file: Where are your biggest potential markets for your product? Where are your most threatening competitors? Is the market big enough to support the cost of obtaining and maintaining (and defending) your patent? What

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are the chances that somebody really tries to copy your product in a particular country? How difficult is it to practice your invention versus how big is the local market? Would it be realistic to defend your patent in local courts against a local competitor? How long is your product going to be sold in this market before it becomes obsolete? A granted patent has a certain value, although difficult to quantify, for your image and for marketing your product.

11.6.1.2 Strategy for Upstream Suppliers

Some of the questions are the same as above: you need only patent in countries where you have a strong position in a substantial market, where local competitors may undercut you. But is it really necessary to patent in countries where your customers are unlikely to look for an alternate source to your supply? Patent strategy in this case has to take into account not only your own markets but also your customers’ markets, their supply chain logistics, and their flexibility. Except for Japan, where it is always useful to be able to claim a JP filing, the image value of a patent is much less for a supplier than for a finished product. However, as we have seen above, one must be careful to avoid having your business partner patent your own invention in some “selection” patent in a country you have not elected to file in. The notion of “priority” does not seem to be understood in the same way in all countries around the world, even if they have signed the PCT.

11.6.2 Trademarks

Filing for trademark protection makes sense only in countries you really market your products in. Again, the cost of filing and defending a trademark must be weighed against the risk of being copied locally. This risk is quite large for, say, perfumes and high-priced skin care products or big volume shampoos; it is much smaller for suppliers of ingredients, devices, and services. Although trademark filing is by far less costly than filing and maintaining patents, a worldwide registration, even counting only the large- and medium-size countries with notable markets, can become expensive when all the searching for priorities, the counsel, the filing fees are added up.

11.7 Cost Many inventors, small- and medium-size companies, and academic institutions still hesitate to aggressively patent their inventions because of the

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imagined cost involved. Indeed, the bills add up quickly if one is not careful. The costs of a patent filing are composed of: Taxes and filing fees determined by the local PTO for the first filing Fees for PCT extension to other countries Fees for examination Annuities (yearly payments to keep the patent alive, even if not yet granted) these go up in price as the patent becomes older Fees for the patent lawyer who writes the specification and claims, submits the application, and follows it through the procedures Although it is possible to file a local patent in your own country without resorting to a counsel (for international filing it is always necessary to have a mandated certified expert), this needs considerable experience and is not recommended for the newcomer to this field. The initial savings have to be weighed against the risks of an insufficient protection afforded by an “amateur” patent text. The timeline of filing (see Section 11.4) and following the procedures allows you to manage the costs of patenting: initial fees are low (the writing of the specification by a patent attorney will be the biggest initial cost), then the next payment will occur with the PCT extension (12 months later) at which time you will have a better picture of the value of your invention. Another 18 months later, the big decisions on where to file in the National Phase will also incur bigger costs, as translations and local fees and patent counsel fees will accrue. But now, 30 months after initial filing, you will be in a position to estimate market size, potential revenue, competitor’s reaction, and thus to prioritize the IP investments. It is not possible to put precise dollar figures on an average patent filing as too many factors are involved. For trademarks, the cost is lower, as initial filing fees are essentially the only cost involved, unless you file with the help of an IP counsel and/or you have to face opposition to your registration.

11.8 How to Defend Your IP? Once you have acquired your patent and/or trademark, there may come a moment when you will have to ask yourself: what do I do if somebody infringes on my IP? In the cosmetic field – with which we deal here – this

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occurs, unfortunately, more often than is generally suspected. Especially the rise of sales on the Internet has facilitated this “activity.” Still, a large percentage of patents in personal care never need defending. If the stakes are too small, it is rarely worthwhile for a competitor to risk lawsuits, product seizure, and bad publicity by copying your patented invention. Many patents, filed by large multinational companies also act as deterrents because of the size of the company. Who dares take on these giants? If, however, the value of the business generated by the patented product is big enough, potential copycats will try to take part of the cake, of your cake. Before taking action, however, it is important to ascertain, to the best of your knowledge and possibilities that real infringement has occurred. Unfairly attacking a competitor—especially when it is done in public— can lead to you being accused of disloyal competition and libel. Once you are sure that infringement is taking place, you need to work with a patent counsel to confront the opposing party. You can also inform your and the other party’s customers (manufacturers, distributors, etc.) of your patent rights and your willingness to defend them against infringement. If no agreement can be reached outside the courts, a lawsuit is the only way to obtain redress and damages. It is important, however, to weigh the chances of winning, the cost of fighting a lawsuit, and the time it takes to reach a judgment, against the real damages felt in the market, country by country. Unfortunately, this equation does not always come out on the side of justice. But then, why patent if the defense of a patent is so costly and finally uncertain? Because if you don’t, somebody else may do it, and this could be even more damaging for you, in the market. Patent strategy is defense of your ideas and products, but also offensive, often aggressive, seizing of intellectual territory aimed at keeping others at bay, at least temporarily and at least those who cannot risk a patent fight. The same arguments apply essentially to trademarks, although one would expect the costs of defense to be lower, chances of obtaining a just decision (in your favor) by a court are higher, procedures (in general) are shorter.

11.9 Conclusion This chapter cannot and does not pretend to teach all there is to know about patents and trademarks. Whole books are dedicated to these topics.

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It tries, however, to address the essential questions as they may be asked in the particular field of cosmetic products, where strategies on what to patent, where to file, and how much to spend, may be different from automotive or electronic or biotechnology IP. One should keep in mind that patents in general remain in effect—that is, paid for and defendable—for an average of seven years; by then, technology has advanced to a degree that defending the old ideas is hardly worth it (this is an average figure; specific patents may last the full 20 years, for perfumes of long-term brand stability, or especially in pharma products, where development of a drug takes ten years, i.e., half of the life time of the patent). A reasonable strategy would follow the lines of innovation strategy in R&D: from a large selection of initial ideas, various obstacles pare away the impossible ones, the improbable ones, the unworkable ones, the expensive ones, until a valid concept comes out at the end of the funnel. In the same way, filing an inexpensive local patent for any idea that seems to have some merit is a starting point. Then, as ideas and products ripen, adjust the aim, select the countries, the degree of follow-up and investment and narrow the choices down to those inventions that really matter and which you are prepared to defend. Remember that many patent applications never get granted, but their presence in the searchable databases, and publication, that is, in “the public domain,” keeps many a competitor in check, and on their toes, protect against broad selection patents and uphold your image of innovation.

Note 1

There is, as yet, no World Patent, even if the PCT publications are designated as WOxxxxx. A European-wide patent exists now, which makes things a little bit easier for protection in this region. A recent agreement (of “London”) has reduced the number of translations necessary: no longer is it required to translate the specification of the patent into any other language than any of the three official ones (English, German, or French) of the European Patent Office (EPO). However, The London Agreement only applies to states, which have ratified or acceded to the London Agreement. The London Agreement distinguishes between:  States having an official language in common with one of the official languages of the EPO (English, French, and German). These states dispense with translation requirements; and  States having no official language in common with one of the official languages of the EPO. These States may require that a translation of the claims into one of their official languages be supplied.

Index ACCC. See Australian Competition and Consumer Commission Accident prevention inherently safer chemistry for, 14 Adipocytes, 161 Adverse Events Reporting System (CAERS), 123 Advertising, 133–134, 138–142 Advertising Standards Canada (ASC), 211 Aerosols, 183, 185 AFE (Autorização de Funcionamento de Empresa), 206 Agéncia Nacional de Vigilancia Sanitaria, 205–206 Aging, 122, 132–133 AICS. See Australia: Australian Inventory of Chemical Substances Allergens, 43, 51 26 Allergens 7th amendment aim, history include, 56–64 nomenclature challenge, 57–59 trade impacts of, 75 basis for selection, 59–64

challenge for all stakeholders, 55–76 in cosmetics, 55–76 critical concern to, 69–74 labelling, 75 natural component list of, 64–69 synthetic component list of, 64–69 Alpha hexyl cinnamic aldehyde, 61, 74 Alpha-Cetone, 61, 69 7th Amendment, 129, 148. See also 26 Allergens American Society of Quality (ASQ), 98 Amyl Cinnamal, 58–60, 63, 72, 74 Amyl Cinnamyl Alcohol, 69 Anisyl alcohol, 58, 61, 63–64, 73 ANMAT group, 202–204 Annexe III Cosmetics Directive (76/768/EEC), 58 Antiacne products, 194 Antiaging. See Cosmeceutical products Antidandruff, 205 ANVISA company, 202–205 Product Notification Requirements, May 2007, 207–210 251

252

APCoHM. See Association of Perfumery, Cosmetics and Household Chemistry Manufacturers APICS dictionary, 114, 116–117 Argentina, 201, 202, 204 Arnica Montana, 65 ARTG. See Australian Register of Therapeutic Goods Article, 19 Article 4, 23 Article 28 REACH regulation specification, 23 ASC. See Advertising Standards Canada ASQ. See American Society of Quality Assessment product assessment, 19–20 hazards assessments, 19 risk assessment, 27, 29 safety assessment, 20 Association of Perfumery, Cosmetics and Household Chemistry Manufacturers (APCoHM), 231 Atom economy, 4–5 Audit, 26–27, 29 AUST L number, 199 Australia, 190–200 Australia’s Cosmetic and Personal Care Products Markets, 190 Australian Competition and Consumer Commission (ACCC), 195–197 Australian Inventory of Chemical Substances (AICS), 35, 195

Index

Australian Quarantine Inspection Service, 200 Australian Register of Therapeutic Goods (ARTG), 196 Certified Organic Personal Care Products, 200 National Industrial Chemicals Notification and Assessment Scheme, 190–195 Therapeutic Goods Administration, 198–200 Autorização de Funcionamento de Empresa (AFE), 206 Average Fill System, 184 B16, 161 Ballistometer®, 166 Bar-coding, 108 BBB. See Better Business Bureau Benchmark, 160, 163, 170 Benzyl Alcohol, 58, 60–61, 63–64, 69, 72, 74 Benzyl Benzoate, 58, 61, 63, 65–66, 69, 73 Benzyl Cinnamate, 58, 61, 64, 69, 73 Benzyl Salicylate, 58, 60, 63–64, 69, 72, 74 Better Business Bureau (BBB), 142 Bhopal, 14 Biodegradable, 10, 13 Biomedical research, 171–172 Bioterrorism, 94, 100 Bioterrorism Act, 96–97, 99, 102 Biotoxin, 94, 100–101, 112, 119 BIS. See Bureau of Indian Standards (BIS) Borderline products, 130, 148

Index

Botanical ingredients, 200 Brazil, 200–210 ANVISA, 205–210 product classifications, 205 Bureau of Indian Standards (BIS), 219 Butylphenyl Methylpropional, 59, 61 CAERS. See Adverse Events Reporting System Canada, 211–217 Canadian Cosmetic and Personal Care Market, 211 Canadian Cosmetic Regulations, 211–213 Canadian Environmental Protection Act (CEPA), 216 Country of Origin Marketing Program, 214–215 drug classifications, 213–214 raw material information, 216–217 sunscreens, 186–187 Candidate List, 21 Capsaicinoids, 65 CARU. See Children’s Advertising Review Unit CAS number, 23 CAS. See Chemical Abstract Service Catalysis, 11–12 Center for Food Safety and Applied Nutrition (CFSAN), 123, 132 Certificate of Analysis (COA), 98 Certificate of Analysis, 47 Certificate of Correspondence, 228, 229–230 Certificate of Free Sale, 208, 231

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Certified organic personal care products, 184, 200 CET. See Common external tariff (CET) CFSAN. See Center for Food Safety and Applied Nutrition 21CFR, 95, 109 Change Control, 87 Chemical Abstract Service (CAS), 41 Chemical Safety Assessment (CSA), 19 Chemical Safety Report (CSR), 19 Chemical Substance Control Law (CSCL), 35 Children’s Advertising Review Unit (CARU), 143 Chromameter®, 167 Cinnamal, 58–59, 63–64, 66, 68 Cinnamomum cassia NEES, 66 Cinnamomum ceylanicum leaf, 66 Cinnamyl alcohol, 58–60, 63–64, 69 CIR. See Cosmetic Ingredient Review Committee CITES. See Convention on International Trade in Endangered Species Citral, 58, 60, 63–64, 69, 72, 74 Citronellol, 58, 61, 63, 65, 69, 73–74 Claim substantiation, cosmetics cosmetic activity, 156–160 content, structure of well-documented, 157–160 credible claim substantiation dossier, 157–160 human volunteers, test run, 158–160 pertinence, 157 transparency, 157

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cosmetic claim substantiation methods, 160–169 clinical tests, 162–169 Ex vivo tests, 162 In vitro tests, 160–162 legal framework, methods, 155–172 regulatory aspect, 169–172 human volunteers, cosmetic purpose, 171–172 Korea, other contries, 170–171 Claims substantiation, 121–150. See also Cosmeceutical product Claims, 243, 245 Clemson Study, 113, 118 Clinical tests, 162–169 Closed Loop MRP, 105 CMS. See Consequences Management System COA. See Certificate of Analysis COLIPA. See Cosmetic Toiletry and Perfumery Association Color index, 180 Common external tariff (CET), 201 Concerns, confidentiality concerns, 26 Confidentiality, 26–28 Consequences Management System (CMS), 100, 112 Consumer Commitment Code, 93 Consumer Packaging and Labelling Act (CPLA), 211, 212–213 Consumer Product Information Standards, 191, 195 Contamination, 81, 88 Convention on International Trade in Endangered Species (CITES), 43

Index

Copyright, 236 Corneometer®, 163 CosIng, 59 Cosmeceutical products advertising, 133–137 cosmetic product category, 134 law and regulation, 134–137 US regulatory mechanisms, 134–137 advertising rules, 121–150 claims substantiation, 121–150 believability of cosmeceutial claims, 122–123 cosmeceutical era, 121–122 cosmetic product labeling product category, definition, 123–125 product labeling, 125–133 in US drug and cosmetics, 130–133 ever-creeping antiaging situation, 137–145 claim substantiation, advertising, 138–142 FDA enforcement, 137–138 FTC enforcement, 138–142 NAD action, 142–145 product labeling, 137–138 puffery, 141–142 product positioning, advertising strategy, 145–149 US cosmetic regulation, 123–125 boderline product, 130 cosmetic product labeling, 130–133 drug vs cosmetics, 126–130 global situation, 128–130 legal definition of drugs, cosmetics, 126

Index

Cosmeceutical, 121–150, 179. See also Cosmeceutical product COSMED. See Cosmétique de la Méditerranée Cosmetic claims, 128, 132, 148 Canadian cosmetic claims, 132 Cosmetic Ingredient Inventory, 60 Cosmetic Ingredient Review Committee (CIR), 49 Cosmetic ingredients, 32 definitions of, 31–53 to harmonized global characterization, 31–53 legal requirements, 31–53 Cosmetic labeling, 125–126 Cosmetic Notification Form, 213 Cosmetic regulations Canadian cosmetic regulations, 147–148 US cosmetic regulations, 123–125 Cosmetic Toiletries and Fragrance Association (CTFA), 36, 38–40, 43, 48–50, 52, 93, 222 Cosmetic Toiletry and Perfumery Association (COLIPA), 52, 170 Cosmetics, 126, 128, 178–179. See also under Cosmeceutical product Cosmetics Directive, 19 Cosmetics directive 76/768/EEC, 79, 83 Cosmétique de la Méditerranée (COSMED), 37 Cost of goods sold, 116 Cost of sales, 116 Costs, 75 Coumarin, 58, 60, 63–64, 69, 72, 74 Council Directive 82/368/EEC, 83 Council Directive 93/35/EEC, 84

255

Country of Origin Marking Program, 204, 214–215 CPLA. See Consumer Packaging and Labelling Act (CPLA) Cropwatch, 70, 76n2 CSA. See Chemical Safety Assessment CSCL. See Chemical Substance Control Law CSR. See Chemical Safety Report CTFA. See Cosmetic Toiletries and Fragrance Association Customer, 22, 29–30 Cutometer®, 166–167 Cycle Counting, 104, 110–111, 113 Dandruff treatment, 168, 170 Dangerous Preparations Directive, 33–34 Dangerous Substance Directive (DSD), 33, 50 DES. See Dual Electronic Signatures Design, 175–176, 181–184 DGCCRF, 156 Diastron®, 168 DIN. See Drug identification number Directive 2003/15/EC, 56, 58, 60, 72 Disclosure, 22, 29 Distributor, 19, 22, 26–27 d-Limonene, 58, 61, 64, 69–70, 73 DNA, 12 DNA photolyase, 12 Domestic Substance List (DSL), 35, 216 Double blind, 159 Downstream User, 18, 29, 36

256

Drugs, 126, 128, 178–179. See also under Cosmeceutical product Drug Facts, 199–200 Drug Facts Panel, 187 Drug identification number (DIN), 186, 214 DSD. See Dangerous Substance Directive DSL. See Domestic Substance List DSQUAM®, 168 Dual Electronic Signatures (DES), 109 EAN Code, 206 “e” Mark, 184–185 ECHA. See European Chemicals Agency Ecotoxicology, 20 76/768/EEC, 19 EffCI, 67, 76n1 EINECS. See European Inventory of Existing Chemical Substances EINECS number, 19 Electronic Retailing Self-Regulation Program (ERSP), 143 ELINCS. See European List of Notified Chemical Substances Enterprise Resource Planning (ERP), 104–105 Envirogluv™, 10 Environment, 17, 21, 26 Environmental Protection Agency (EPA), 2 EPA. See Environmental Protection Agency, 2 EPO. See European Patent Office ERP. See Enterprise Resource Planning

Index

ERSP. See Electronic Retailing Self-Regulation Program EU Cosmetic Directive 76/768/EEC, 129 EU directive, 32, 43 Eugenol, 58–60, 63–64, 69, 72 European Chemicals Agency (ECHA), 20–21 authorization negotiations with, 29 notification to, 29 registration with, 22 reporting of ongoing requirements to, 22 European Commission, 24–25, 79 European Directive, 172 European Inventory of Existing Chemical Substances (EINECS), 19–20 and CAS number, 23 EINECS number, 19 European List of Notifi ed Chemical Substances (EINECS/ELINCS), 41 European Patent Office (EPC), 250, 250n1 European Union, 17, 30n1 Evernia furfuracea, 61, 64 Evernia prunastri, 61, 64 Ex vivo studies, 171 Excipients, 83, 85–86, 90–91 Exclusion criteria, 159 Existing Substances Regulation, 33 Expeditors, 118 Expiration date, 185 Expiry, 89 Explants, 160, 162 Fair Packaging & Labeling Act (FPLA), 125, 137 Farnesol, 58, 61, 63–64, 69, 73–74

257

Index

Fast Optical invivo Topometry of human Skin (FOITS), 164 FD&C Act. See Food, Drug & Cosmetic Act FDA. See Food and Drug Administration FEBEA. See Féderation des Entreprises de la Beauté Federal Trade Commission (FTC), 134, 138–142, 156 Féderation des Entreprises de la Beauté (FEBEA), 37 Feedstock, 42, 46 renewable, 10–11 Fees, 248 FEMA. See Flavor and Extract Manufacturer Association Fibroblasts, 161–162 Filing, 247 Flavor and Extract Manufacturer Association (FEMA), 66 Flexabrasion™, 168 FM I, 63, 71–72, 74 FOITS. See Fast Optical invivo Topometry of human Skin Food, 80–82 Food & Drug Act, 147 Food and Drug Administration (FDA), 66, 95, 97–98, 100, 102, 109, 112–113 Food safety, 97–98, 100 Food, Drug & Cosmetic Act (FD&C Act), 123, 125–126, 137, 178 FPLA. See Fair Packaging & Labeling Act Fragrance allergy, 57, 59, 70, 74 Fragrance mix I, 59, 62, 74 Fragrance mix II, 70, 74

FTC. See Federal Trade Commission Functional Cosmetics, 50, 170–171, 179 GCP. See Good Clinical Practice Geraniol, 58–59, 61, 63–64, 69, 72 GHS. See Global Harmonization System Gibbs free energy, 9 Global Harmonization System (GHS), 31–53. See also Harmonized Ingredient Characterization Global patent, Trade mark strategies, 235–250 cost, 247–248 inventions, 237–238 inventors/future owner files, 244–246 IP defend, 248–249 IP protection, 242–244 IP types, 238–242 inventions, 238–240 trade names, 240–242 protection, 246–247 consumer product strategy, 246–247 inventions, 246 trade mark, 247 upstream supplier strategy, 247 trade names, 237–238 Global Trade Item Number (GTIN), 206 GMP. See Good manufacturing practice Good Clinical Practice (GCP), 172

258

Good manufacturing practice (GMP), 35, 46, 95, 98–99, 103, 125, 130 applied to cosmetic ingredients, 83–86 EFfCI key features of, 86–90 IPEC–PQG GMP guide key differences to, 90–91 pharmaceutical excipients, 90–91 principles, cosmetic ingredients manufacturing, 79–92 Gosstandart, 225, 229–230 GOST R Certification, 225–227, 231 GRAS status, 66 Green chemistry, 3 foundations in cosmetic sciences, 1–15 twelve principles of, 4–14. See also Twelve Principles Green Dot, 184 Greenhouse gases, 9 GTIN. See Global Trade Item Number (GTIN) Guidance Document, 18 European Commission guidance document, 24 REACH guidance document RIP 3.4, 23 HaCat, 161 HACCP. See Hazard Analysis Critical Control Point Hair care, 194, 201, 206 Hand and Book symbol, 185 Harmonized Ingredient Characterization, cosmetic, 36–51 animal-derived product, 45

Index

ingredient purchased, 40–41 microbial origin ingredient, 44–45 microbial specification, 47 mineral, 45–46 origin of ingredient, 42–43 physicochemical properties, 46–47 supplier, 40 synthetic material, 46 toxicological information, 48–51 ecological information, 49–51 human safety, 48–49 intellectual property, 51 vegetal, 43–44 Hazard global hazard, 7 intrinsic hazard, 7 physical hazards, 14 risk equation of, 15 Hazard Analysis Critical Control Point (HACCP), 97–98 Hazard Identification, 32–34 HDI. See Human Development Index (HDI) Health, 17, 19, 21 Health Canada, 128, 132, 150n1 HeLa, 161 Helenalin, 65 Hexylcinnamal, 61, 74 Hexyl Cinnamaldehyde, 58, 61, 69, 73–74 Holistic, 14 Hotlist, 216 Housekeeping, 88, 91 Human Development Index (HDI), 190 Human studies, 160 Hydroxycitronellal, 60, 62–63, 69, 72, 76

Index

Hydroxyisohexyl 3-cyclohexene carboxaldehyde, 74 Hydroxy-methylpentylCyclohexenecarboxaldehyde, 69, 71, 76 Hygiene personnel hygiene, 87 production hygiene control, 91 Hygienic Conclusion, 228–229 Hypoallergenic, 68 IFRA. See International Fragrance Association ILAC. See International Laboratory Accreditation Cooperation Image analysis, 161, 165–166, 168–169 Implied requirements, safe cosmetics. See also Safe cosmetics cycle counting, 110–111 integrated into work activity, 109–110 leveraging, 113–115 process-batch enterprise resource planning, 105 5S, Lean manufacturing, 105–108 satisfiying, 102–113 stock room, factory operations, 110 transactional reporting easier, 108–109 validation, datasecurity, 109 Importer, 24, 27–28 In use test, 158 In vitro studies, 161, 163 INCI. See International Nomenclature of Cosmetic Ingredients

259

Inclusion criteria, 159 India, 217–224 Cosmetic Regulations, 219–223 Indian Cosmetic Market, 217–218 Indian Cosmetic Trade Association (ISTMA), 222 Information Network of Departments of Dermatology (IVDK), 68, 71–72, 74 Informed consent, 172 Infringement, 241–242, 245, 249 INPI. See National Industrial Property Institute (INPI) Instrumental methods, 157–158, 163 Integrated State Automated Information System (ISAIS), 232 Intellectual Property (IP), 51, 235 International Fragrance Association (IFRA), 62, 67, 70 International Laboratory Accreditation Cooperation (ILAC), 210 International Nomenclature of Cosmetic Ingredients (INCI), 36, 179–180, 183, 195, 204, 207, 212 Invasive techniques, 172 Invention, 236–238, 246 Inventory, 103, 113, 116–117 Inventory turnover, 116 IP. See Intellectual Property IPEC-PQG GMP Guide, 86 vs. EFfCI GMP Guide, 90–91 for pharmaceutical excipients, 90–91 ISAIS. See Integrated State Automated Information System (ISAIS) ISO 22000, 98

260

ISO 22716, 79–80, 92 ISO 9001, 86–90, 98 Isoeugenol, 58–60, 62–64, 68, 72 ISTMA. See Indian Cosmetic Trade Association (ISTMA) IUPAC Name, 60 IVDK. See Information Network of Departments of Dermatology Japan, 35, 53n2, 177, 179–180 Japanese Cosmetic Ingredient Dictionary (JCID), 36 JCID. See Japanese Cosmetic Ingredient Dictionary Jeneil Biosurfactant Company, 13 Keratinocytes, 161 Korea, 35, 50, 170–171, 179–180 Korean FDA (KFDA), 170 Labeling, 184–186 Language, 177, 180 Lean Manufacturing, 98, 104–108, 112 Legal requirements, cosmetic ingredients, 32–36 other countries, 35 downstream user, 36 Europe, 33 supplier, 32–33 USA, 33–35 Less hazardous synthesis, 5–7 Lilial, 61, 64, 69 Limonene, 65 Linalool, 58, 61, 64, 69, 73 Linalool hydroperoxide, 70 London agreement, 250n1 Lot declaration, 41, 47 Lot trace, 102, 105 Lot trace history, 97 Lyral®, 61, 69, 71, 74

Index

Manufacturer, 20, 24, 26 Marketing&Use Directive, 33–34 Master Production Schedule (MPS), 114 Material Requirements Planning (MRP), 105 Material Safety Data Sheets (MSDS), 18, 33 MED. See Minimum erythematic dosis Melanocytes, 161 MERCOSUR, 201–202, 204 3-Methyl-4-(2,6,6-trimethyl-2cyclohexen-1-yl)-3 buten-2-one, 64 Methylheptincarbonate, 69 Mexameter®, 167 Microbial contamination, 88 Minimum erythematic dosis (MED), 171 Moisturemeter®, 163 Monographs, 36–37, 43, 53n5, 187 MPS. See Master Production Schedule MRP. See Material Requirements Planning MRP2, 105 MSDS. See Material Safety Data Sheet Mustard glycosides, 65 Mutual recognition arrangement (MRA), 210 NAC. See National Advertising Council NAD. See National Advertising Division NAFTA. See North American Free Trade Agreement (NAFTA) Nail lacquer, 8–9, 12

Index

NARB. See National Advertising Review Board National Advertising Council (NAC), 156 National Advertising Division (NAD), 137 NAD actions, 142–145 National Advertising Review Board (NARB), 142–143 National Coordinating Committee on Therapeutic Goods (NCCTG), 196 National Industrial Chemicals Notification and Assessment Scheme (NICNAS), 35, 190–195 National Industrial Property Institute (INPI), 206 National Organic Program (NOP), 184 National Phase, 244, 246, 248 Natural, 31, 38, 42–43, 45–46 Natural Health Product Directorate, 130 Natural Health Product Regulation, 213 Natural Health Products (NHP), 179 Nature Works™ PLA, 6 NCCTG. See National Coordinating Committee on Therapeutic Goods (NCCTG) NDSL. See Nondomestic Substance List NHP. See Natural Health Products Nickel allergy, 59, 71 NICNAS. See National Industrial Chemicals Notification and Assessment Scheme NIR spectroscopy, 163 NOC. See Non-Objections Certificate (NOC)

261

Noncovalent derivatization, 11 Nondomestic Substance List (NDSL), 35 Non-Objections Certificate (NOC), 220–221 NOP. See National Organic Program North American Free Trade Agreement (NAFTA), 214–215 Novelty, 239, 241–243, 245 Nutraceuticals, 98–99 Oak moss, 64, 68, 71, 76 Oak moss Extract, 58–59, 61–62, 64, 73 Obviousness, 239 Ökotest, 71, 74 downgrading system, 68–69 Only Representative, 23–28 On-time delivery, 116–117 OOS. See Out-of-Specification Oral hygiene, 194 Order (batch) splitting, 117–118 Organic legislation, 184, 200 OTC. See Over the counter Out-of-Specification (OOS), 89 Over-regulation, 70 Over-the-counter (OTC), 122, 130–132, 143, 168, 170, 178, 186–187, 199, 205, 213 Packaging and Packaging Waste Directive, 184 Packaging, global regulation impact, 175–188 elements for, 177–186 additional labeling, 184–186 cosmetic vs. drug, 178–179 ingredients on labels, 179–180

262

innovation, package, 180–181 primary&secondary components, 181–184 global packaging trend, issues, 176–177 importance, 176 sunscreen product, See Sunscreen product Panelist, 158, 162–163, 171–172 PAO. See Period After Opening Paraguay, 201, 202, 204 Pareto Law, 111 PAT. See Process Analytical Technology Patent and Trademark Offices (PTO), 239, 242–246 Patent Cooperation Treaty (PCT), 244–245, 247–248, 250n1 Patentability, 240 Patents, 236–237, 246, 250 PCAR. See Perfumery and Cosmetics Association of Russia (PCAR) PCPC. See Personal Care Products Council PCT. See Patent Cooperation Treaty PDP. See Principal Display Panel Pedigree Law, 95 Perfume allergy, 55 Perfumery and Cosmetics Association of Russia (PCAR), 231 Period After Opening (PAO), 183 Personal Care Products Council (PCPC), 38, 93 Peru balsam, 74 Pharmaceuticals, 80, 82, 85, 90 Pharmaceutical Affairs Law, 129, 148

Index

Pharmacopeia, 32, 43 Phase-in, 19–20 Phorbolester, 65 Phototrichogram, 168 PLA. See Polylactic acid Plant extract, 10 Pollution prevention, 4 real-time analysis for, 13–14 Polylactic acid, 6–7 Precautionary principle, 39, 44, 70 Preparation, 19, 25–26, 29 Preregistration, 18–20, 22–23, 25–26 Presidential Green Chemistry Challenge Awards, 2, 6 Primary component, 181 Principal Display Panel (PDP), 181–182, 186–187 Prior art, 239, 243, 245 Priority date, 243–244 Process Analytical Technology (PAT), 13–14 Profilometry, 163, 166 Proposition 65, 50 PTO. See Patent and Trademark Offices Public domain, 250 Puffery, 141–142 QA. See Quality Assurance QSAR. See Quantitative structure-activity relationship Quality Assurance (QA), 102, 104, 109–110 Quantitative structure-activity relationship (QSAR), 23 Quarantine Act, 211 Quasi Drug, 179 Quasidrug, 39, 50, 53n2, 129, 131, 168, 170

Index

Quebec, 187 Questionnaires, 37, 39–41, 43, 50, 52 Radio Frequency Identification Device (RFID), 95–96 Raw Material Information Form (RMIF), 38, 53n6 REACH IT, 23 REACH. See Registration Evaluation Authorization and Restriction of Chemicals Records Maintenance, 97 Registration Evaluation Authorization and Restriction of Chemicals (REACH), 17–30, 33, 41, 46, 50, 177 European union life in and outside the, 17–30 industry trends, 25–29 phasing and facing REACH, 21–23 principle steps, 18–21 authorization, 21 preregistration, 20 product assessment, 19–20 registration, 20–21 restriction, 21 supply chain affection, 17–30 supply chain options, 25–29 Registration, 20–21 Regulatory compliance. See also Safe cosmetics, Implied requirements Renewable resources, 11, 13, 15 Research Institute for Fragrance Materials (RIFM), 62, 70 Restrictions, 21 Retest, 89 Return on Investment (ROI), 94, 115–120

263

RevTech, Inc., 9 RFID. See Radio Frequency Identification Device Rhamnolipid, 13 RIFM. See Research Institute for Fragrance Materials Risk, 81–83, 88 Risk and Policy Analysis report, 75 Risk assessment, 32, 34, 48–49, 80 RMIF. See Raw Material Information Form ROI. See Return on Investment Russia, 224–232 certifications, 228–230 of imported ingredients for the beauty industry, 231 cosmetic market, 224–225 Cosmetic Regulations, 225–228 5S, 105–108, 112 Safe cosmetics. See also Implied requirements biotoxin attack simulation, 100–101 from burden to opportunity, 93–120 food and beverage safety aspect in, 96–98 and regulatory compliance, 93–120 future possible catalysts for, 99 implied requirements, 102–113. See also individual entry nutraceuticals, 98–99 pharmaceutical, 94–96 in related industries, 94–100 return on investment, 115–119 Safer chemical products, 7 Safety Data Sheets (SDS), 22

264

Safety (Hygienic) Certification, 226 SCCNFP/0017/98, 59, 63 SCCP. See Scientific Committee for Consumer Products Scientific Committee for Consumer Products (SCCP), 47–49, 56 SDS. See Safety Data Sheets Sebumeter®, 164 Sebutape®, 164–166 SECEX, 210 Secondary component, 181–184 Self assessment, 158 Sensorial analysis, 158 Shelf impact, 176, 188 SISCOMEX, 210 Six Sigma, 105, 108 Skin Care, 123, 136–137, 144, 192–194, 200, 214, 224–226 Skin firmness, 166 Skin physiology, 161 SOA. See Statutory Order about Aerosols SOI. See Statement of Identity Soleau, 238, 246 Solvents organic solvents, 6, 8–9 safer solvent, auxiliaries, 7–9 Specification, 240, 245, 248, 250n1 SPF. See Sun protection factor Standardized Raw Material Information Form, 38, 53n6 Statement of Identity (SOI), 181–182 Statistical significance, 162 Statutory Order about Aerosols (SOA), 185 Structure/Function Claims, 138–139

Index

Substance, 18–20, 25 Substances of Very High Concern (SVHC), 19, 21–22 Suction blister, 171 Sun Alert, 187 Sun protection factor (SPF), 171, 180, 186–187, 198–199 Sunscreen products 192–193, 198–199, 207, 209, 221 for Canada, 186–187 for the EU, 186 for US, 187 Supplier, 26–28, 32–33, 40 Supply chain, 17–30, 96–97, 100 Surfactant, 10, 13 synthetic surfactant, 13 Sustainability, 1, 14–15 SVHC. See Substances of Very High Concern 3T3, 161 TEGEWA, 37, 52 2-(4-Tert-Butylbenzyl) propionaldehyde, 58–59, 61, 69, 73 Tewameter®, 163 TGA. See Therapeutic Goods Administration Therapeutic Goods Act, 191, 196 Therapeutic Goods Administration (TGA), 198–199 Therapeutic Product Directorate (TPD), 130, 213–214 Total Quality, 105, 108 Toxic Substances Control Act (TSCA), 33 Toxicology, 20 TPD. See Therapeutic Product Directorate Trademarks, 236, 244, 246–247

265

Index

Treemoss, 64, 68, 71, 74, 76 Treemoss extract, 58, 61, 73 Trost, Barry, M., 5 TSCA. See Toxic Substances Control Act Twelve Principles, 4–14 atom economy, 4–5 catalysis, 11–12 design for degradation, 12–13 energy efficiency, 9–10 inherently safer chemistry for accident prevention, 14 less hazardous synthesis, 5–7 pollution prevention, 4 real-time analysis for pollution prevention, 13–14 reduce derivatives, 11 renewable feedstocks, 10–11 safer auxiliaries, 7–9 safer chemical products, 7 safer solvents, 7–9 Twistometer®, 166 Type size, 182–183, 187 Unfair or deceptive business practices, 139 Uruguay, 201–204 Urushiol, 65 USDA, 184

UVA, 186–187 UVB, 186–187 UV filters, 195, 201, 205 Value Stream Mapping (VSM), 98, 107–108 VCRP. See Voluntary Cosmetic Registration Program Venezuela, 202, 204 VISIA® system, 164 VOC. See Volatile organic compounds Volatile organic compounds (VOC), 10, 216–217 Voluntary Cosmetic Registration Program (VCRP), 123–124 Voluntary self-regulation, 143 VSM. See Value Stream Mapping Warner Babcock Institute, 7–8, 11 Warnings, 182–183, 185 Weight claim, 182, 185 World Trade Organization (WTO), 221–223, 232 Wrinkle treatment, 170 Wrinkles, 122, 132–133, 139, 144–145 WTO. See World Trade Organisation (WTO)

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