Dibutyl Phthalate and Cosmetics

July 27, 2004

Introduction: Dibutyl phthalate (DBP), a phthalate used in some personal care products, most notably nail polish, has recently been unfairly attacked as unsafe by special interest groups. However, various government agencies here and in Europe have reviewed the toxicity and exposure data on DBP and have found it to pose little or no risk to humans as it is used today in these products.

In the United States

Safety data: Data from biomonitoring studies conducted by the Centers for Disease Control and Prevention (CDC) show that average human exposures to DBP are more than 100 times below the safety level set by the Environmental Protection Agency (EPA). Average exposure in humans is less than one microgram per kilogram of body weight per day (ug/kg/day). The safety level, called a reference dose, or RfD, is 100 ug/kg/day and is based on a dose level that produced no adverse health effects in rodents, divided by a safety factor of 1000. The RfD, initially established in the 1980’s, is being updated by EPA, with the expectation that it will remain the same or be even higher if the same methodology is used.

Although a preliminary report in October 2002, by the CDC indicated that women of childbearing age had higher concentrations of DBP than other women, this finding has been shown to be incorrect. The initial finding was based on a survey of urine samples from 289 subjects. However, when the data from the entire sample of 2,500 adults and children from across the nation were analyzed, it was found that women of childbearing age had exposure levels slightly lower than other female age groups.

In November of 2002, after an extensive review of the scientific literature, a panel of scientists found DBP “safe as used” in personal care products. The Cosmetics Ingredient Review (CIR) Expert Panel comprised of seven dermatologists and toxicologists plus representatives of the Food and Drug Administration, the Consumer Federation of America, and the Cosmetic, Toiletries and Fragrances Association, the industry’s trade association that funds the panel. The scientists on the panel must adhere to federal conflict-of-interest requirements.

Regulatory actions: There are no federal regulations restricting the use of DBP in personal care products in the United States. The State of California is considering listing DBP as causing reproductive toxicity based on rodent data. If DBP is listed, its use will not be restricted, but warning labels or signage will be required for products that expose consumers to an amount that exceeds a “maximum allowable daily limit.” That limit is yet to be set, but is expected to be higher than exposure levels from most or all products currently in commerce, based on the methodologies used by California with other listed chemicals.

In Europe

Safety data: The European Union's (EU) Joint Research Centre has conducted risk assessments on a number of phthalates. The final risk assessment on DBP, published in the spring of 2006, finds "no concern for consumers using nail polish containing DBP". The review panel also found "no concern for breast-fed babies."

Regulatory actions: In Europe any substance known or suspected to be carcinogenic, mutagenic, or to cause reproductive effects in laboratory animals at any dose cannot be used in cosmetics after implementing legislation comes into force (perhaps mid-2006). This includes DBP. Interestingly, the EU draft risk assessment for DBP, which presently finds “no concern” for current human exposure, when finalized will have no effect on the provisions of the law. In the EU, to ban the use of DBP or other chemicals in cosmetics, actual risk to humans does not have to be demonstrated and exposure levels are irrelevant, as is the larger question of whether effects seen in rodents are relevant to humans. The law, which is “hazard-based” not risk-based, has induced some American cosmetics companies to stop using DBP to avoid the inefficiency of marketing different formulations for different continents.

In a news report, a Procter & 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."

Special interest group activities: In June, 2004, a coalition of special interest groups led by the Environmental Working Group launched a “Campaign for Safe Cosmetics.” A petition filed with the Food and Drug Administration calls for bans or warning labels on products containing any of 356 ingredients that, according of the Cosmetics Ingredient Review, (1) ”lack sufficient data to support their safe use,” (2) contain any one of nine “toxic ingredients,” and/or (3) are among 20 cosmetics products that contain ingredients “that may cause harm.” None-- not one--of these lists names any phthalate, nor are phthalates mentioned anywhere in the petition. Nevertheless, DBP is included elsewhere in a list of “Product Ingredients of Concern,” based on adverse health effects seen in male rodents from high doses of DBP. As indicated above, human exposures are far below the doses that cause effects in rodents.

A similar coalition tested personal care products in 2002 and found an average concentration of 5 percent DBP in two-thirds of the nail polishes tested. Based on those analyses, a user would have to absorb all of the DBP in four and a half bottles of nail polish a day, every day, for a lifetime in order to reach the exposure level that shows no effect in rodents.

Breast Cancer Action (BCA) has run a newspaper advertisement that names phthalates and another chemical as possible factors in breast cancer. The Phthalates Esters Panel has written letters to BCA detailing the lack of scientific support for this claim with regard to phthalates. The exchange of letters may be viewed at http://www.phthalates.org/pdfs/letter_exhange.pdf.

For further information, please see the following links: http://www.phthalates.org/yourhealth/personal_care.asp
http://www.phthalates.org/mediacenter/panelstatement.asp?ID=52
http://www.phthalates.org/mediacenter/pep_2002_7_19.asp