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Of the many phthalates used in different ways today, three in particular -- DMP, DEP, and DBP -- are used in cosmetics and personal care products because they deliver benefits that are difficult to otherwise achieve. For example, the addition of a small amount of DBP provides just enough "give" to make nail polish chip-resistant. When perfume fragrances are dissolved in either DEP or DMP, they evaporate more slowly, making the scent linger longer. They also find other niche applications in products such as adhesives and as solvents.
The Centers for Disease Control and Prevention has issued extensive reports on the presence of natural or man-made substances in the blood or urine of representative samples from the U.S. population. Three reports have been issued, the most recent in 2005, covering a total of more than 5,000 test subjects and 148 elements and compounds.
Phthalate exposure levels of all study participants derived from the CDC data showed that the levels of exposure to each phthalate used in personal care products were well within the safety levels set by the Environmental Protection Agency -- levels that already incorporate a number of conservative safety margins.
Some pressure groups have been saying the CDC data show that women of childbearing age show higher exposures to DBP than other women do. That statement is based on a very early test run of the CDC data involving 289 subjects. The authors of this preliminary report warned that the demographics of the 289 people were different from that of the general population, and not to draw any conclusions from such a small and unrepresentative sample. Nevertheless, some pressure groups built an entire campaign, called Not Too Pretty, around the preliminary data – data that, as the CDC itself warned, indeed turned out to have significant limitations. CDC researchers subsequently published an update correcting the earlier report. Nevertheless, the obsolete information remains prominently displayed on some pressure group Web sites. Read more here.
The Food and Drug Administration, which has regulatory authority over cosmetics, studied the CDC’s biomonitoring data in 2001 and said it found "no reason for consumers to be alarmed at the use of cosmetics containing phthalates." It continues to evaluate available data and is in the middle of surveying the presence of phthalates in cosmetics. The FDA has not seen data that has led it to take any further steps, although it will conduct risk assessments if the data warrant.
That’s what the Cosmetic Ingredient Review (CIR) Expert Panel said in 2002 about phthalates in cosmetics. The CIR is an FDA-sanctioned independent body of toxicologists and dermatologists that regularly reviews compounds used in cosmetics and personal care products, and in 2002 it completed an extensive review of all the literature on DMP, DEP and DBP.
The recent European Union ban on the use of DBP in cosmetics results from a two-part regulatory framework. EU law bans substances from cosmetics even if no actual risk to users of the product has been demonstrated; just showing that high doses of a substance have caused health problems in rodents is enough to ban a substance. DBP (along with many other chemicals) has been banned for that reason alone – there has never been a health risk shown from DBP in cosmetics to justify a ban. (In the European regulation that created this ban, the CDC data, as well as what other assessments of risk show, are irrelevant).
A second part of the EU system does evaluate risk. In 2006, the EU published its final risk assessment of DBP and concluded that there was "no concern for consumers using nail polish containing DBP." Some major cosmetics companies have nevertheless chosen to change their formulations on a global basis rather than endure the inefficiencies of having different formulations for different parts of the world. In a news report, a Proctor & Gamble spokesperson was quoted as saying that his company's decision to stop using DBP "was not based on any concern about the safety of the chemical. We and other outside groups have done numerous risk assessments on phthalates. There are no health hazards associated with their use in cosmetics."
From time to time, special interest groups have tried to create a stir about DEP in their war against cosmetics, but it is difficult to understand why they bother. DEP has a very strong safety profile, according to reviews by agencies in the United States and in Europe. Europe’s Scientific Committee on Cosmetic Products reviewed DEP in 2002 and gave it a margin of safety of 15,000 when used as a fragrance solvent at concentrations up to 50 percent of the fragrance mix (or less than 2% of the total perfume product). In the United States, the National Toxicology Program did not even bother to review DEP in its examination of chemicals for possible reproductive and developmental effects.
In their long history of use in consumer products, there has never been any reliable evidence that the phthalates found in nail polish, or in any other cosmetics, have ever caused anyone any harm. Using estimates of the average amounts of DBP found in nail polish, if a person were to absorb all the DBP in almost five bottles of nail polish, or all the DEP in two quarts of perfume, every day, the resultant exposure would still be a level at which no effect is seen in laboratory animals.
Last Updated: June 6, 2006

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