Dibutyl Phthalate (DBP) and Cosmetics

Dibutyl phthalate (DBP) has been found to be safe and effective for use in making nail polish flexible and resistant to chipping. Restrictions on its use in nail polish and other cosmetics in Europe have caused many manufacturers to eliminate the use of DBP in nail products both in Europe and North America. Numerous reviews in the United States and Europe suggest, however, that exposure to DBP through regular use of nail polish products poses little or no risk to humans.

Inhalation exposure to DBP used in nail polish is minimal, since the substance does not evaporate quickly. The primary source of exposure is assumed to be absorption through the nail surface. Exposure estimates from nail polish use have assumed 5 percent dermal absorption, although actual absorption is likely to be less.

In the United States

In November 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 was comprised of seven dermatologists and toxicologists, plus representatives of the Food and Drug Administration (FDA), the Consumer Federation of America, and the cosmetics industry’s trade association (now called the Personal Care Products Council).

Since DBP exposure may result from other, non-cosmetic sources as well, expert reviews also have used the results from biomonitoring studies to estimate total exposures. The most recent 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 safe level (Reference Dose, or RfD) set by the Environmental Protection Agency (EPA). According to EPA, the RfD is the estimate of a daily oral exposure to the human population, including sensitive subgroups such as children, that is “not likely to cause harmful effects during a lifetime."

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 was not verified in a subsequent CDC analysis. The initial finding was based on a survey of urine samples from 289 subjects. However, when the data from a larger sample of 2,500 adults and children from across the nation was analyzed, it was found that women of childbearing age had exposure levels slightly lower than other female age groups.

FDA has reviewed the safety and toxicity data for DBP and other phthalates, including the CDC data and the CIR conclusions, and determined in 2008 that “neither [the CDC data] 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. In its review, FDA focused on women of childbearing age.

There are no federal regulations restricting the use of DBP in personal care products in the United States. The state of California listed DBP as a reproductive toxin in 2005, based on rodent data. As a result, personal care and other products containing DBP are subject to labeling requirements in the state.

In Europe

The European Chemical Bureau (ECB) concluded in its 2004 risk assessment on DBP that there was “no need for further information or testing or risk reduction measures” related to consumers using nail polish containing DBP. The European assessment further concluded that there was "no concern for breast-fed babies" based on the highest levels of DBP found in breast milk samples collected by the World Health Organization.

Despite the ECB’s conclusions, DBP was prohibited for use in cosmetics and personal care products under the European Commission’s Cosmetics Directive in 2006. The commission’s decision was based on the testing results in laboratory animals, and did not consider the EBC’s conclusions about exposure or risk to DBP in cosmetics and personal care products. While it only applies to products sold in Europe, the European Commission’s directive induced 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."

For further information, please see the following links:

New Study of CDC Data Undermines Activist Campaign Against the Use of Phthalates in Cosmetics

Not a Pretty Site! Activist Coalition Web Site Provides Strong Support for Use of Phthalates In Beauty Products