Chemical Soup and Federal Loopholes

Phthalates, the chemicals used in some cosmetics, may keep your nail polish hard and shiny and your tresses thick and glossy, but in animal tests they cause birth defects, disrupt hormone systems and lead to reproductive problems. Those are just a few of the reasons the European Union recently banned them. Now, despite a huge outcry from the $35 billion cosmetics industry, some California lawmakers are trying to ban phthalates in the U.S.

California Assemblywoman Judy Chu has introduced a bill that would ban the same two types of phthalates as the EU did. In part because the FDA does not conduct pre-market health testing of cosmetics ingredients (nor require cosmetics makers to do so), Chu was moved to present a similar bill last year that would have banned phthalates and other chemicals blacklisted by entities like the International Agency for Research on Cancer, the European Union and the Environmental Protection Agency.

Those efforts were defeated. But if passed this session, Chu's Phthalates Ban Bill (AB 908), would be the first ever phthalate ban in the United States.

"After three decades of extensive studies [on] carcinogens and reproductive toxins, the EU banned two phthalates and those are the two that I am proposing to ban," Chu said in a recent telephone interview. "It is outrageous that American women aren't give the same protections that European women are. How can a whole continent of women be protected yet Americans ignore this?"

Chu says she would also like to make companies list any phthalates on product labels but has set aside that politically more difficult task (the industry argues that rejigging its labeling process presents huge economic burdens and could infringe on trade secrets).

During last year's legislative session, Chu's original bill (AB 2012), would have prohibited phthalates and forced cosmetics manufacturers to disclose to state officials any hazardous chemicals on their products. That bill failed to pass the Assembly Health Committee after intense industry opposition.

"They probably spent millions lobbying against it," says Chu. "They flew people in from New York and spent days and days lobbying members." Supporters of the bill, ranging from the United Food and Commercial Workers to the Breast Cancer Fund were no match.

This time round, the cosmetics industry plans to mount the same kind of campaign.

"We intend to vigorously oppose any similar legislation this year," says Irene Malbin, a spokeswoman for the Cosmetics, Toiletry and Fragrance Association, a trade association in Washington representing 600 companies such as Revlon and Mary Kay.

Growing Uneasiness

The bills come amidst growing public uneasiness over cosmetics ingredients, especially after the EU ban, enacted in 2003 and implemented in September 2004, prohibited the use of chemicals, including phthalates, known or suspected of being toxins, mutagens and reproductive toxins.

Activists say the ban, the bills and the issue of phthalates all tell a tale of regulatory lapses, flawed scientific argument, and negligence from a powerful industry that, oddly enough, is the nation's primary arbiter over the safety of cosmetics ingredients. Jeanne Rizzo, director of the Breast Cancer Fund and director of the Campaign for Safe Cosmetics, hopes the European ban will help give cosmetic safety – long buried in the environmentalist's in-box – its overdue day.

"Cosmetics makers who sell their product in Europe will have to reformulate their products and we are arguing that they use those reformulations here," she said in a telephone interview from her home in California. By forcing companies to find safer chemical formulations, and by boosting consumer awareness, optimists say the ban could shift corporate behavior in American markets and stoke political will to regulate.

That could well be true, says Chu. "Last year it was difficult to get attention on this issue because nobody had heard of phthalates," Chu said, adding that Europe's momentum has helped raise awareness among lawmakers.

Already, the EU ban has pushed some companies to change their ways. Responding to the ban and activist pressure, L'Oreal and Revlon said in letters to the Campaign for Safe Cosmetics that they are in conformity with the new law. In a letter dated Dec. 21, a L'Oreal senior vice president wrote that the company's products are in compliance with the EU cosmetics directive "no matter where they are sold around the world." And a Revlon spokesperson penned a letter on Dec. 20 stating that "all products sold by Revlon are currently in full compliance" with EU directives.

Poisonous Poster Child

The story of phthalates is one of an industry on the loose, thanks to failed environmental and health legislation.

According to the Centers for Disease Control, different phthalates have different abilities to produce in animal studies effects such as testicular injury, liver injury and liver cancer, among other things. But the agency says human impacts "have not been well-studied" even though a 2002 CDC study reported that every one of 289 persons tested for a study on the plasticizer dibutyl phthalate (DBP) had the compound in their bodies.

Despite this, the FDA, by law, can do little. In the agency's own words, "a cosmetic manufacturer may use almost any raw material as a cosmetic ingredient and market the product without an approval from FDA." Neither it nor any other government agency can require safety tests before chemicals are put in personal care products.

The Environmental Working Group, a frequently cited watchdog organization, sums up the issue:

Phthalates are recognized as toxic substances under environmental law, but companies are free to use unlimited amounts in cosmetics. An environmental release of just 10 pounds of DBP must be reported to environmental authorities under the Superfund law. The cosmetics industry, in contrast, puts hundreds of thousands of pounds of DBP into nail polish each year, with no requirements for safety testing or reporting to anyone.
Foxes Guarding the Henhouse

Until states or the federal government exert more regulation, the principal arbiter of cosmetic safety will continue to be the industry itself, in the form of a panel of scientists funded by CTFA, the industry trade group. The Cosmetics Industry Review panel, or CIR, is staffed by scientists and two non-voting members, one from FDA and one from the Consumer Federation of America. The panel is paid by CTFA to pass safety verdicts on chemicals used by its corporate members.

In 2002, for the second time, the CIR ruled that diethyl (DEP), dimethyl (DMP), and dibutyl (DBP) phthalates were safe. And the level for human risk was found to be 36,000 times lower than the amount that caused no effect level in animals, says Dr. Gerald McEwen, CTFA's vice president of science.

Dr. McEwen, contacted in his office in Washington, stressed that CIR adheres to the same conflict-of-interest standards as the FDA and is staffed by only top scientists who produce peer-reviewed reports. Recent European Union regulations, he claimed, are political in nature, tacked together under public pressure without solid scientific proof. The industry's safety procedures are healthy, he says, and have worked for decades to balance protection and reasonable innovation. He also said the panel has reviewed some 1,200 ingredients used in cosmetics and determined that nine were unsafe for use and taken off the market.

The National Environmental Trust, another watchdog group, is less sanguine.

"Because the FDA does no pre-market health testing of chemical ingredients in cosmetics, for industry to claim considerable safe use over many years is to wholly neglect the fact that we have no publicly verifiable way of knowing such a claim is true," says Nick Guroff, the group's California organizer.

His sentiments are echoed in a report by the Environmental Working Group. After analyzing CIR documents, the group reported that the panel hasn't determined the amounts of DBP that are absorbed in people's bodies from cosmetics. Nor has it determined the full range of products DBP is used in. What's more, the group says only 11 percent of 10,500 personal-care product ingredients have been publicly assessed for safety.

CTFA's McEwan says cosmetic safety is proven by the rarity of hospital admissions.

"One of the indices of safety is a surveillance of emergency rooms called the Electronic Injury Surveillance," he says. "If you look at emergency room admissions, you'll find that cosmetics are less hazardous than, say, pillows and mattress."

Behind the Mask

Activists chaff at such arguments, considering them ethically-flawed extensions of the "dose makes the poison theory" that says toxic chemicals which fail to reach susceptible biological systems in sufficient numbers (in high enough doses) cause no harm. That people don't stagger into emergency rooms with acute cosmetics poisoning has nothing to do with it. The debate is about the long-term effects of a low-dosage soup of chemicals and, more broadly, lack of control over the industry.

"There is not the kind of precautionary review to determine long-term effect of low-doses from multiple exposures," says Rizzo. "We don't have exposures to one lipstick or deodorant. Every day we face multiple exposure to these things and there is not regulation that looks at that. These are known mutagens, carcinogens and known reproductive toxins, and there is no reason we should take that risk when we have data on long-term low-dose multiple exposure of these chemicals.

"Ask yourself, if these chemicals aren't dangerous, why do salon workers wear masks?"
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