Phthalate Safety in Cosmetics
General Background of Phthalates
Although you never see them, phthalates (pronounced 'thal-ates' often misspelled as "pthalates" or "thalates") play an important part in making everyday life more convenient, colorful, and fun. Thanks to their varying characteristics, this family of workhorse ingredients makes a wide range of consumer and industrial products work better for us. Dozens of phthalates have been developed over the years, and some have been in use for nearly a century. The dozen or so types in general use today have some traits in common - they are clear liquids resembling common vegetable oil, have little or no smell, and do not readily evaporate. They all break down rapidly in the environment and in living organisms.

But the similarities end when it comes to the diverse jobs they do. The larger-molecule phthalates are used primarily to make vinyl plastic flexible, in everything from your child's toys to your kitchen floor. They make possible the color-fast, durable, low-maintenance qualities that make vinyl so valuable and so widely used in building materials, autos, toys, and even medical devices. The smaller-molecule phthalates do many different jobs. Some act as fixatives for perfume, slowing down evaporation and making the scent linger longer. Consumer and industrial applications range from making cosmetic nail polish flexible and screwdriver handles less brittle to helping make the time-release coatings on numerous pharmaceutical products. In addition, phthalates help make lubricants, adhesives, weather stripping, and safety glass. The list of products or materials containing phthalates is long.

Phthalates are some of the most heavily studied chemicals in existence. Recent thorough reviews of the health effects of phthalates support their safe use. These include risk assessments by the European Union (EU) and exhaustive reviews by the U.S. National Toxicology Program (NTP), which can be found at http://cerhr.niehs.nih.gov/reports/index.html. Phthalates have established a very strong safety profile over the 50 years in which they have been in general use. There is no reliable evidence that any phthalate has ever caused a health problem for a human from its intended use.
Phthalate Use in Cosmetics and Personal Care Products
Of the many phthalates used in different ways today, two in particular (Diethyl Phthalate, and Dibutyl Phthalate) 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 (dibutyl phthalate) provides just enough "give" to make nail polish chip-resistant. When perfume fragrances are dissolved in DEP (diethyl phthalate), they evaporate more slowly, making the scent linger longer. They also find other niche applications in products such as adhesives and as solvents.
The Issue
Events on both sides of the Atlantic have raised issues in recent years about the use of certain phthalates in cosmetics. In late 2000, the U.S. Centers for Disease Control and Prevention (CDC) announced the results of its study on the presence of a number of compounds, including phthalates in 289 human urine samples (the CDC actually measured the breakdown products of phthalates, called metabolites). Publicity surrounding this report indicated that the phthalate levels were "higher than expected" and that the levels of one phthalate, DBP, were higher in women of childbearing age than in other women.

Despite a cautionary note from the study authors that the size of the sample set was small and not representative of the general population, special interest groups used it to anchor a campaign attacking the use of DBP in cosmetics and personal care products. Alarmist statements in the campaign alleged that fetuses of pregnant women could be in danger from concentrations that "may be" greater than the average exposures of the general population. This supposition was apparently based on separate research showing that male laboratory rats fed very high doses of DBP over a period of time experienced effects in their reproductive systems, but the campaign produced no evidence that human exposures are even remotely close to those levels.
The Evidence
Since its initial small study in 2000, the CDC has issued more extensive reports on the presence of natural or man-made substances in the blood or urine of representative samples from the U.S. population. The most recent report was issued in 2003 and reported on the presence of 116 substances in samples from approximately 2,500 people, including the original 289. Phthalate exposure levels of all 2,500 study participants derived from the CDC data undermined the anti-cosmetics campaign's initial interpretation. They showed that the levels of exposure to each phthalate were not only within predicted levels but also well within the safety levels set by the Environmental Protection Agency -- levels that already incorporate a number of conservative safety margins. In fact, the data showed that average exposure levels for DBP remained more than 100 times below government safety levels. In addition, the exposure levels indicated for DBP (dibutyl phthalate) and DEP (diethyl phthalate) were about half of what had been indicated in the smaller sample from the initial study in 2000.

And what about the activists' assertions about exposures to women of childbearing age? It turns out that toward the end of 2003, CDC researchers separated out and published the data on all women aged 20 to 39 in the entire sample of 2,500 people. The data indicated that their levels of exposure to DBP were slightly lower than for other women, not higher! (Health Perspectives Article)

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.

In addition, in 2002, the Cosmetic Ingredient Review (CIR) Expert Panel, an independent body of toxicologists and dermatologists that regularly reviews compounds used in cosmetics and personal care products, completed an extensive review of all the literature on DEP and DBP and found them to be "safe as used" in cosmetics. (CIR Phthalate Review)

The recent European Union ban on the use of DBP in cosmetics results from a two-part regulatory framework. The EU permits substances in products to be banned 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 can be enough to support a ban of that substance. DBP has been banned for that reason alone - there has never been any actual risk shown from the DBP in cosmetics. (In the European regulation that created this ban, the CDC data, as well as what other assessments of risk show, is irrelevant).

A second part of the EU system does evaluate risk - and in fact a draft risk assessment recently completed for DBP states that there is "no concern" for consumers from DBP as it is currently used. This inconsistent regulatory framework is being challenged, but some major cosmetics companies have chosen to change their formulations on a global basis rather than endure the inefficiencies of needing different formulations for different parts of the world. In a news report, a P&G spokesperson was quoted as saying that our 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."

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 every day, the resultant exposure would still be a level at which no effect is seen in laboratory animals.
P&G Beauty's Position on Phthalates
P&G Beauty has eliminated the phthalate ingredient DBP (dibutyl phthalate) from all of our products globally. As discussed above, this decision was not based upon any concern over safety, but on a commitment to comply with new European regulations. All tests and safety reviews conducted to date have shown there is no safety concern with this ingredient when used in cosmetics and personal care products.

The only other phthalates present at trace levels in some P&G Beauty products (usually as a component of the fragrance) are DEP (diethyl phthalate) and DMP (dimethyl phthalate). DEP has been confirmed as safe for use in cosmetics by EU and US expert panels, including the EU's own Scientific Advisory Panel convened to review proposed phthalate bans. Both DEP and DMP have been reviewed and confirmed as safe for use in cosmetics by the Cosmetic Ingredient Reveiw Expert Panel.
©2005 Procter&Gamble