(WOMENSENEWS)--It's the beauty industry's ugly secret.

For decades, cosmetic companies have made products containing chemical compounds that have been linked to reproductive birth defects and cancer. The compounds are phthalates (pronounced THA-laytes) and they help cosmetics adhere without smudging.

The European Union has banned phthalates from all cosmetics and now a coalition of advocacy groups has given U.S. companies a deadline of Monday, May 3 to support a ban.

Three environmentally-conscious manufacturers (Body Shop International, Urban Decay Cosmetics and Aveda Corporation) have already volunteered to remove phthalates from all their products. But New York-based Estee Lauder Companies, Inc. (which has annual revenues of $4.7 billion) and Cincinnati-based Procter and Gamble Company (which has annual revenues of $40.2 billion) are the only large, multinational companies to follow suit--and they have done so by removing phthalates from one product, nail polish.

Representatives of the $29 billion cosmetics industry (which is not subject to regulatory approval before putting its products on the market and which does not have to list phthalates on ingredient labels) are balking at the proposed ban.

Industry insiders say levels of the substance are safe and the outcry is all based on tests of animal subjects that do not translate into human risks. They argue that there is no need for them to reformulate their U.S. products and use substitutes for phthalates, as they will for all products sold in Europe starting in September 2004.

On April 19, Estee Lauder pledged to eliminate the chemicals from its MAC and Clinique nail polish lines, while on the same day, Procter and Gamble promised to remove them from its Max Factor and Cover Girl nail polish lines.

"This is a much bigger issue than nail polish or phthalates," says Barbara Brenner, the executive director of the San-Francisco-based Breast Cancer Action, one of the advocacy groups putting pressure on the cosmetics industry. "It could be the beginning of a revolution in consumer safety. People need to know that some cosmetics contain toxic chemicals and they need to demand that safer ingredients be used."

Industry Minimizes Risks

For their part, many cosmetic industry representatives insist that phthalate levels in makeup do not pose a hazard to human health. "Science clearly supports the continued safe use of these ingredients," says Gerald McEwan, vice president for science at the Cosmetic, Toiletry, and Fragrance Association, a Washington-based trade group. He invokes studies done by independent researchers and by the cosmetics companies themselves.

Health advocates, however, say a growing body of research indicates that the ingredient is not worth the risk.

A 2000 study at the University of Puerto Rico in San Juan linked phthalates (which are also used to soften plastic) to early puberty in girls. Studies conducted at Harvard University in Cambridge in 2002 and 2003 linked the chemicals to decreased sperm counts in men. Researchers from several different environmental groups say that phthalates, which disrupt hormone function, may contribute to the rising incidence of uterine problems in women, testicular cancer in men and infertility in both sexes.

In May 2002, the Environmental Working Group, a Washington-based advocacy organization, tested 72 cosmetics and found measurable levels of phthalates in three-quarters of them. Though the levels were minimal, scientists warned that their combined effect could pose health problems. They pointed to a 2000 study by the Atlanta-based Centers for Disease Control and Prevention, which found that phthalate levels in young women (who represent the bulk of cosmetics consumers) may be 20 times higher than average. The group's researchers called on the scientific community to study phthalates in more depth and to reassess exposure levels that are considered safe.

Intensifying Campaign

The decision to remove phthalates from nail polish comes in the wake of intense lobbying from health and environmental groups.

In March, Breast Cancer Action and 60 other organizations sent a letter to Estee Lauder Companies Inc., the Procter and Gamble Company, Avon Products Inc., Revlon Consumer Products Corporation, Unilever, and the L'Oreal Group demanding that these companies comply with European regulations banning "carcinogens, mutagens and reproductive toxins." The chemicals they're targeting include di-n-butyl phthalate (DBP, commonly found in nail polish) and di(2-ehtylhexyl) phthalate (DEHP, found in perfumes).

The Cosmetic, Toiletry, and Fragrance Association calls the European regulation "unnecessary" and dismisses research on phthalates for two reasons: because Phthalate levels in cosmetics are well within U.S. safety standards and because most studies on the chemicals' ill effects have been conducted on animals and not humans.

Some Human Effects Reported

While it's true that most phthalate studies have been done on mice and rats, adverse effects in humans have been reported.

When Olivia James gave birth to her son Darren seven years ago, she learned he had bright eyes and a dimple on his right cheek. She also learned he had hypospadias, a birth defect in which the urethra fails to extend the whole length of the penis.

Repeated surgeries have corrected Darren's problem. But his mother, now 40 and living in Princeton, N.J., still can't shake the horror she felt when learned about phthalates and realized her son's condition could be linked to the chemicals in the makeup and hair products she used during her 15 years as a professional model.

Every day of her career, James slathered on foundation, eye shadow, lipstick and mascara containing phthalates. In addition to wearing heavy makeup, James also had her hair straightened once a month. Like many hair products aimed at African Americans, the straightener she used contained a high concentration of phthalates.

"American manufacturers argue that no single product has been proven to have a detrimental effect," says James, 40, of Princeton, N. J. "But when you're using 10 or 20 of these products each day, the cumulative exposure does add up."

The cosmetic industry's defense--that it follows safety standards--is coming under fire.

Federal authorities have set the safety level for phthalate exposure at 2,800 milligrams of phthalates per kilogram of body weight per day--a threshold the critics say is too high.

"This standard is based on old studies," says Stacy Malkan, a spokesperson for Health Care Without Harm, an environmental advocacy group based in Washington, D.C. "Information is not only incomplete, but conflicting. The National Toxicology Program lists some phthalates as carcinogens, but other government agencies do not."

Putting Risks on Labels

Health advocates are urging authorities to reform labeling practices and study cosmetic ingredients in more depth.

The federal Food and Drug Administration takes a hands-off approach to cosmetics. Instead of testing products before they hit the market, the FDA regulates these products only after they are sold, investigating health complaints when and if complaints are filed.

"The FDA says there is no harm until harm is proven," says Malkan. "U.S. cosmetic companies are not required by law to mention phthalates or many other chemical compounds on their labels. Nail polish is actually one of the few products for which phthalates must be listed."

With the nail polish victory behind them, health advocates are demanding that U.S. cosmetics manufacturers starting using the same formulations they use in Europe, where cosmetics are made in factories separate those sold in the United States. In addition, they're calling for further study of other suspect ingredients: parabens (which are in face creams and lotions and have been found in human breast tumors) and formaldehyde (which is found in nail polish and blush and has been linked to cancer).

Health advocates have made some headway in California, where regulators have added the phthalate DEHP to the list of chemicals known to cause birth defects. Later this year, California legislators plan to vote on a bill requiring more detailed labeling of cosmetics and banning all ingredients that fail to meet standards for "safe use."

"Chemicals linked to birth defects and infertility don't belong in cosmetics," says Bryony Schwan, a spokesperson for the Montana-based advocacy group Women's Voices for the Earth. "We demand that manufacturers act responsibly and immediately remove them from the products that we use every day."

Molly M. Ginty is a freelance writer based in New York City.

For more information:

Breast Cancer Action--
think before you pink:
http://www.thinkbeforeyoupink.org

Environmental Working Group--
"Are Common Chemical Ingredients in Cosmetics
Posing Risks to Human Health?":
http://www.ewg.org/issues/cosmetics/index.php

Because We’re Worth It! The Campaign for Safe Cosmetics:
http://www.safecosmetics.org

Cosmetic, Toiletry, and Fragrance Association--
"Cosmetics Containing Phthalates are Safe":
http://ctfa.activematter.com/Content/ContentGroups/News/ Latest_Statements/Cosmetics_Containing_Phthalates_are_Safe.htm