Phthalates
What are phthalates? Phthalates are a group of chemicals used in hundreds of products, such as toys, vinyl flooring and wall covering, detergents, lubricating oils, food packaging, pharmaceuticals, blood bags and tubing, and personal care products, such as nail polish, hair sprays, soaps, and shampoos.
What phthalates are used in cosmetics? The principal phthalates used in cosmetic products are dibutylphthalate (DBP), dimethylphthalate (DMP), and diethylphthalate (DEP). They are used primarily at concentrations of less than 10% as plasticizers in products such as nail polishes (to reduce cracking by making them less brittle) and hair sprays (to help avoid stiffness by allowing them to form a flexible film on the hair) and as solvents and perfume fixatives in various other products.
Do phthalates affect human health? It's not clear what effect, if any, phthalates have on health. An expert panel convened from 1998 to 2000 by the National Toxicology Program (NTP), part of the National Institutes of Health, concluded that reproductive risks from exposure to phthalate esters were minimal to negligible in most cases. . In addition, the Centers for Disease Control (CDC) released a report on March 21, 2001, entitled "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. One of the chemicals surveyed was phthalates.
In 2002, the Cosmetic Ingredient Review (CIR) reaffirmed its original conclusion (reached in 1985) that DBP, DMP, and DEP are safe as used in cosmetic products. The panel evaluated phthalate exposure and toxicity data and conducted a risk assessment for dibutyl phthalate in cosmetic products. The panel concluded that exposures to phthalates from cosmetics are low compared to levels that would cause adverse effects in animals. (The CIR is an industry-sponsored organization that reviews cosmetic ingredient safety and publishes its results in open, peer-reviewed literature.) (See “Annual Review of Cosmetic Ingredient Safety Assessments 2002/2003,” International Journal of Toxicology (Supplement 1), 1-102, 2005.)
Do phthalates affect human health? It's not clear what effect, if any, phthalates have on health. An expert panel convened from 1998 to 2000 by the National Toxicology Program (NTP), part of the National Institutes of Health, concluded that reproductive risks from exposure to phthalate esters were minimal to negligible in most cases. . In addition, the Centers for Disease Control (CDC) released a report on March 21, 2001, entitled "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. One of the chemicals surveyed was phthalates.
What does FDA currently know about infant exposure to phthalates? Infants, like all consumers, are exposed daily to phthalates from a number of sources, including air, drugs, food, plastics, water, and cosmetics. We are currently beginning a survey of infant/children cosmetic products to determine the levels of phthalates so we can more accurately assess infant exposure.
The American Academy of Pediatrics has 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). Like the CDC report, this study did not establish an association between these findings and any health effects. In addition, levels of phthalates (if any) in the infant care products were not determined. Source: "U.S. Food and Drug Administration, CFSAN/Office of Cosmetics and Colors."