Phthalates are used in a variety of cosmetics and personal care products. Phthalates are chemical compounds developed in the last century that are used to make plastics more durable. These colorless, odorless, oily liquids also referred to as “plasticizers” based on their most common uses. They do not evaporate easily and do not permanently bind to plastic surfaces to which they are applied. Phthalates also function as solvents and stabilizers in perfumes and other fragrance preparations. Cosmetics that may contain phthalates include nail polishes, hair sprays, aftershave lotions, cleansers, and shampoos.
How to Know if Phthalates are in the Cosmetics You Use
Historically, the primary phthalates used in cosmetic products have been dibutylphthalate (DBP), used as a plasticizer in products such as nail polishes (to reduce cracking by making them less brittle); dimethylphthalate (DMP), used in hair sprays (to help avoid stiffness by allowing them to form a flexible film on the hair); and diethylphthalate (DEP), used as a solvent and fixative in fragrances. According to the FDA's latest survey of cosmetics, conducted in 2010, however, DBP and DMP are used rarely. DEP appears to be the only phthalate still commonly used in cosmetics.
Under the authority of the Fair Packaging and Labeling Act (FPLA), the FDA requires an ingredient declaration on cosmetic products sold at the retail level to consumers. Consumers can tell whether some products contain phthalates by reading the ingredient declaration on the labels of such products.
However, the regulations do not require the listing of the individual fragrance or flavor, or their specific ingredients. Fragrance or flavor may be listed as such. As a result, a consumer may not be able to determine from the ingredient declaration on the label if phthalates are present in a fragrance or a flavor used in the product. Based on currently available safety information, the FDA does not have safety concerns with the use of DEP as currently used in cosmetics and fragrances. Consumers who nevertheless do not want to purchase cosmetics containing DEP may wish to choose products that do not include "Fragrance" or “Flavor” in the ingredient declaration.
Possible Health Effects of Phthalates in Cosmetics
The FDA considers all available scientific literature on the safety of phthalates in cosmetics published by the scientific community.
In 2002, the Cosmetic Ingredient Review (CIR) Expert Panel, an industry-sponsored organization that reviews cosmetic ingredient safety and publishes its results in open, peer-reviewed literature, reaffirmed its original conclusion (reached in 1985), finding that DBP, DMP, and DEP were safe as used in cosmetic products. (See “Annual Review of Cosmetic Ingredient Safety Assessments 2002/2003,” International Journal of Toxicology (Supplement 1), 1-102, 2005.) Looking at maximum known concentrations of these ingredients in cosmetics, the panel evaluated phthalate exposure and toxicity data, and conducted a safety assessment for DBP in cosmetic products. The panel found that levels of exposures to phthalates from cosmetics were low compared to levels that may cause adverse effects in animals.
The Centers for Disease Control and Prevention (CDC) released a report on March 21, 2001, titled "National Report on Human Exposure to Environmental Chemicals." The report described a survey of a small segment of the U.S. population for environmental chemicals in urine to learn more about the extent of human exposure to industrial chemicals. One group of chemicals surveyed was phthalates. While the CDC report noted elevated levels of phthalates excreted by women of child-bearing age, neither this report nor the other data reviewed by the FDA established an association between the use of phthalates in cosmetic products and a health risk. Based on this information, the FDA determined that there wasn’t a sound, scientific basis to support taking regulatory action against cosmetics containing phthalates.
An expert panel convened by the National Toxicology Program, part of the National Institute of Environmental Health Sciences, from 1998 to 2000, concluded that reproductive risks from exposure to phthalates were minimal.
As the FDA continues to follow the ongoing scientific discussions, we will consider additional actions as needed.
The FDA's Role in Regulating Phthalates in Cosmetics
Under the law, cosmetic products and ingredients, with the exception of color additives, are not subject to FDA approval before they go on the market. Cosmetics must be safe under the labeled or customary conditions of use, and the FDA can take action against cosmetics on the market that do not comply with the law.
At the present time, the FDA does not have evidence that phthalates as used in cosmetics pose a safety risk. If we determine that a health hazard exists, we will advise the industry and the public, and will take action to protect consumers within the scope of our authority under the Federal Food, Drug, and Cosmetic Act. For related information, see FDA Authority Over Cosmetics.
The FDA’s Continued Evaluation of Phthalates in Cosmetics
The FDA continues to monitor levels of phthalates in cosmetic products. We have developed an analytical method for determining the levels of phthalates in a survey of marketed cosmetic products.
The FDA published this analytical method and results of our 2004 survey in the article, “Analysis of Consumer Cosmetic Products for Phthalate Esters,” (J.C. Hubinger and D.C. Havery, Journal of Cosmetic Science, 2006, vol. 57, pp. 127-137). We conducted a second survey in 2006. Results were published in the article, “A Survey of Phthalate Esters in Consumer Cosmetic Products," (PDF 488 KB) (J.C. Hubinger, Journal of Cosmetic Science, 2010, vol. 61, no. 6, pp. 457-465). Results of a third survey, concluded in 2010, are shown below in the table, 2010 Survey of Cosmetics for Phthalate Content. We learned from these surveys that use of phthalates in cosmetics decreased considerably from 2004 to 2010.
Infant Exposure to Phthalates in Personal Care Products
Infants, like all consumers, are exposed daily to phthalates from a number of sources, including air, drugs, food (including breast milk), plastics, water, and cosmetics. The American Academy of Pediatrics published an article stating that infants exposed to infant care products, specifically baby shampoos, baby lotions, and baby powder, showed increased levels of phthalate metabolites in their urine (see “Baby Care Products: Possible Sources of Infant Phthalate Exposure,” S. Sathyanarayana, Pediatrics, 2008, vol. 121, pp. 260-268). This biomonitoring study was not designed to establish an association between these findings and any adverse health effects. In addition, levels of phthalates, if any, in the infant care products were not determined in this study.
In its survey that was completed in 2006, the FDA included 24 children’s products intended for infants and children, and included nearly 50 products for infants and children in the survey we completed in 2010. We learned that the use of phthalates in cosmetics intended for people of all ages, including infants and children, has decreased considerably since our surveys began in 2004.
Results of the FDA's 2010 Survey of Cosmetics for Phthalate Content
The products listed below represent a sample of cosmetics on the market at the time the survey was conducted, and products may have been reformulated since then. This survey was intended to monitor trends in the use of phthalates in cosmetics, not as a comprehensive analysis of all cosmetics on the market. The law does not require cosmetic firms to file their formulations with the FDA. Also, please note that some so-called "personal care products," such as diaper creams and nipple creams, are regulated as drugs, or in some cases both cosmetics and drugs. (See "Is It a Cosmetic, a Drug, or Both? (Or Is It Soap?)")
2010 Survey of Cosmetics for Phthalate Content