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Global Regulatory Issues for the Cosmetics Industry

Global Regulatory Issues for the Cosmetics Industry

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Global Regulatory Issues for the Cosmetics Industry

1/5 (1 valutazione)
422 pagine
Feb 20, 2009


This volume examines regulatory issues of ingredients, manufacturing, and finished products, as well as claim substantiation, packaging, and advertising. A chapter on Chinese regulations will be one of the first about this country to be published in book form.

• Includes a regulatory map of India and China
• Global IP protection strategies
• REACH and European Regulatory standards
• "Green chemistry" in relation to cosmetics and regulation

* Simplifies global regulations for anyone exporting cosmetics.
* Excellent reference not only for manufacturing and marketing, but for legal departments and packaging as well.
* Describes how to develop a global regulatory strategy.
Feb 20, 2009

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Global Regulatory Issues for the Cosmetics Industry - Karl Lintner



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

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 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.


Karl Lintner, PhD

November 2008

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 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?) 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.

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 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 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.

Green Chemistry: Foundations in Cosmetic Sciences

Amy S. Cannon ¹ , John C. Warner ²

¹ Beyond Benign, Woburn, MA, USA

² 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.

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

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