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
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
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
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 email@example.com;
Samuel S. Epstein, M.D. (firstname.lastname@example.org) Chairman Cancer Prevention Coalition UIC School of Public Health, MC 922
Chicago, IL 60612 Phone : 312-996-2297 Fax : 312-413-9898
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