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Current Date: October 13, 2004
Release Date: October 13, 2004
Europe Leads the Way in Cosmetic Product Safety

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: Europe Leads the Way in Cosmetic Product Safety
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Chicago, IL á60612 á October 13, 2004
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Three years ago, the European Union (EU) announced precedential new initiatives to ensure the safety of cosmetics. Known as the Seventh Amendment (of the Cosmetics Directive), this law will become effective in March 2005.

The Seventh Amendment bans the continued use of three major classes of toxic ingredients. First, those which pose risks of cancer, such as lead acetate and mineral spirits. Second, those which cause hormonal or reproductive disturbances, notably dibutyl phthalate. Third, those which cause genetic damage.

This new law will have a profound impact on global cosmetic companies. It will increase the competitiveness of responsible companies who are already in compliance with the law, as reflected by labeling practices. The law will also increase the competitiveness of other companies actively involved in research and development to ensure compliance in the near future. Notable exceptions will be less responsible companies who opt for the dual strategy of marketing safe new products in Europe, while continuing to supply U.S. and Asiatic markets with unsafe old products.

Besides this new safety law, the Seventh Amendment requires the labeling of 26 fragrance ingredients which may cause allergic reactions, contact dermatitis and even asthma, in sensitive users. While this requirement is most welcome, it is too broad brush in failing to recognize critical distinctions between allergenic ingredients in natural and modern synthetic fragrances.

Natural fragrances, which have been used since time immemorial, are based on relatively few essential oils distilled from plants. Allergenic ingredients are less common in natural than synthetic fragrances. Furthermore, there is strong historical evidence that the same allergens in natural fragrances pose less risks than in their synthetic counterparts. Additionally, there is recent evidence (Journal of Applied Physics, April 2004) that there are critical differences between natural versus synthetic ingredients.

Modern synthetic fragrances are based on mixes of hundreds of inexpensive synthetic chemicals, some of which are allergenic. In addition, some synthetic fragrances contain "aroma boosters," which may be potent irritants and highly toxic.

It should, however, be emphasized that responsible global companies identify and characterize all ingredients in modern fragrances, and virtually eliminate allergens, by skin patch testing of human volunteers (the Repeated Insult Patch Test), and also skin irritants, and other toxics. However, less responsible companies have failed, and still fail, to take these basic precautions. This is well exemplified by the results of a 1999 analysis of Calvin Klein's Eternity Eau de Parfum, by an industry laboratory specializing in fragrance chemistry, commissioned by the Environmental Health Network of California, in response to complaints by its members of allergic contact dermatitis and asthma following use of Eternity. The analysis identified 41 ingredients, including allergens, skin irritants, lung and reproductive toxics, and carcinogens. Furthermore, toxicity data were unavailable on several ingredients, while data on others were inadequate.

Concerns on modern synthetic fragrances are further reinforced by recent U.S. and Danish surveys. These have shown that the incidence of allergic dermatitis has increased by approximately 10 percent over the last decade.

Apart from the Seventh Amendment, less well recognized by cosmetic companies, are proposed new regulations on the manufacture of industrial chemicals. These laws, now pending approval by the European Parliament, are based on a complex known as REACH—Registration, Evaluation, and Authorization of CHemicals. These initiatives are designed to phase out the production and use of industrial chemicals which are highly toxic, and responsible for persistent environmental pollution. As importantly, these regulations are designed to stimulate the manufacture and use of safe alternative chemicals, which are becoming increasingly available and used by some major industries, and also major retailers.

The pending European regulations on cosmetic product safety are in sharp contrast to the Food and Drug Administration's longstanding regulatory abdication, in spite of the specific requirements of the Food, Drug and Cosmetic, and Fair Packaging and Labeling Acts. FDA Regulations (21 CFR Sec. 740/10) stipulate: "Each ingredient used in a cosmetic products and each finished cosmetic product shall be adequately substantiated for safety prior to marketing. Any such ingredient or product whose safety is not adequately substantiated prior to marketing is misbranded unless it contains the following conspicuous statement on the principal display panel: Warning: the safety of this product has not been determined."

Clearly, corrective legislation is urgent, and well overdue, to ensure consumer safety. Consumers also have an unarguable, and explicit right to know of all hazardous ingredients in their cosmetics and toiletries, and their risks.



Samuel S. Epstein, M.D., Chairman, Cancer Prevention Coalition, professor emeritus Environmental & Occupational Medicine, University of Illinois at Chicago School of Public Health, MC 922, 2121 West Taylor Street, Chicago, IL 60612. phone 312-996-2297; fax 312-413-9898; e-mail epstein@uic.edu; web www.preventcancer.com.
á
Samuel S. Epstein, M.D. (epstein@uic.edu)
Chairman
Cancer Prevention Coalition
UIC School of Public Health, MC 922
Chicago, IL á 60612
Phone : 312-996-2297
Fax : 312-413-9898
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