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Phthalates What?

The latest and maybe the greatest concern on the personal care product market maybe in every market today is phthalates. Huh? Its confusing to spell and appears impossible to pronounce and who has ever heard of these chemicals before and why are we hearing about them now?

Phthalates (pronounced "thal-ates") are chemical liquids used as "plasticisers", or substances that alter the physical properties of materials. Phthalates resemble vegetable oil, are odorless, and belong to a family of ubiquitous chemicals that apparently have been in use for over 50 years. Phthalates are created by the reaction of alcohols with phthalic anhydride and then the elimination of any water content. Commonly used to soften polyvinyl chloride (PVC), making it more pliable, Phthalates are found in almost everything we use. A larger-molecule type is used to give flexibility to vinyl flooring and children's toys. A smaller-molecule type is used as a fixative for perfumes to slow evaporation and help the scent last longer, and in nail polishes to increase flexibility.

The issues of this common chemical and its derivatives are complex and have as many supporters as detractors. Greenpeace, Health Care Without Harm, and other watchdog groups have suggested that phthalates pose a threat to our health by exposure through medical and consumer products and should be banned. Yet other groups, such as a task force headed by former U.S. Surgeon General C. Everett Koop, argue that the risk posed by these chemicals is minimal. Human dosage levels are significantly lower than those exposures tested on animals and unlikely to cause harm.

But five percent of the 20 to 40 year-old women tested by the US Centers for Disease Control and Prevention (CDC) are receiving in their normal daily routines up to 45 times more phthalates than previously believed. These women are clearly at levels of concern. And even more disturbing was that while the CDC found evidence of phthalates in virtually every one of the Americans tested, evidence of the highest levels of exposure to the phthalate DBP (dibutyl phthalate) was found in women of childbearing age. DBP. This is especially disturbing because several studies indicate that modest fetal exposure to one or more of several phthalates can cause reproductive birth defects including deformed genitalia on male babies.

Yet again, several research groups have shown that few humans, if any, are exposed to a dose of phthalates proven to cause even minor harm in animal tests when administered over a lifetime. With the exception of short-term, life-saving medical procedures, safety margins for typical human exposure to phthalates are substantial. Human exposures stemming from medical procedures are well below those shown to cause harm in animal tests.

In answer to the question, do phthalates affect human health, the FDA states:
It's not clear what effect, if any, phthalates have on health. An expert panel convened from 1998 to 2000 by the National Toxicology Program (NTP), part of the National Institutes of Health, concluded that reproductive risks from exposure to phthalate esters were minimal to negligible in most cases.

In 2002, the Cosmetic Ingredient Review (CIR) reaffirmed its original conclusion (reached in 1985) that DBP, DMP, and DEP are safe as used in cosmetic products. The panel concluded that exposures to phthalates from cosmetics are low compared to levels that would cause adverse effects in animals. (The CIR is an industry-sponsored organization that reviews cosmetic ingredient safety and publishes its results in open, peer-reviewed literature.)

FDA reviewed safety and toxicity data (including the CDC data) for phthalates in 2001 and 2002 as well as CIR conclusions that were based on reviews of the data in 1985 and 2003. FDA noted that the CDC survey report in 2001 was not intended to make an association between the presence of environmental chemicals in human urine and disease, but rather to learn more about the extent of human exposure to industrial chemicals. While the CDC report noted elevated levels of phthalates excreted by women of child-bearing age, neither it nor the other data reviewed by FDA established an association between the use of phthalates in cosmetic products and a health risk. As a result, FDA determined that there was insufficient evidence upon which to take regulatory action.

The European Union has banned phthalates from all cosmetics. What do they know that our FDA apparently does not? Here in the US in March, 2004, 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 targeted include di-n-butyl phthalate (DBP, commonly found in nail polish) and di(2-ehtylhexyl) phthalate (DEHP, found in perfumes). 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."

So which opinions are true? All of the above? None of the above? Common sense dictates that where there is smoke, there is fire. If there is cause for concern enough to spawn study after study, and if those studies continue to be inconclusive, the answer is always to proceed with caution. Do not expose yourself or your loved ones to excessive levels of phthalates unnecessarily. I say unnecessarily because there are medical applications where the use of phthalates is truly beneficial to patients. A simple example is that whole blood stored in a PVC bag remains viable for 42 days, compared to only 21 days for other containers. According to America's Blood Centers, more than 23 million blood components are made from about 14 million whole blood donations stored in PVC bags yearly.

What can we do? We can't protect ourselves unless we can get manufacturers and our government to make changes. We need public policies that recognize how exposures from the many products that contain toxic chemicals are accumulating in our systems. Cosmetic, food-packaging and medical products that contain phthalates should be clearly labeled and manufacturers should publicly pledge to voluntarily remove phthalates as quickly as possible.

Meanwhile, pay attention. Read your labels. Watch for products that may contain phthalates, like plastic bottles, plastic toys, and PVC products of all kinds. Limit your exposure to these chemicals while we try to affect a change. Write to your members of Congress, write to the FDA, write to your friends and family.

Spread the word. Become aware. Be healthy. Go to for more information or to ask a question.

About the Author: Steve Reed is Senior Partner at Vashon Organics, an online distributor of organic and natural personal care products. He is also the author of PEBBLING THE WALK; SURVIVING CANCER CAREGIVING, a book for caregivers. Reeds experience includes technical writing, healthcare writing, non-fiction, novels, and journalism.

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