What are Phthalates and Are They Bad for You, According to the FDA?

Another great article in fda.gov

References and Images:

https://www.fda.gov/cosmetics/cosmetic-ingredients/phthalates

FDA has received a number of inquiries on the safety of phthalates, which are used in a variety of cosmetics as well as other consumer products. Here are answers to questions consumers often ask about these ingredients.

• What are phthalates?
• How phthalates have been used in cosmetics
• Phthalates and human health
• How FDA has followed up
• What we know about infant exposure to phthalates
• How to know if there are phthalates in the cosmetics you use
• FDA's role
• Results of FDA's 2010 Survey of Cosmetics for Phthalate Content

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, aftershave lotions, soaps, shampoos, perfumes and other fragrance preparations.

How phthalates have been used in cosmetics

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 FDA's latest survey of cosmetics, conducted in 2010, however, DBP and DMP are now used rarely. DEP is the only phthalate still commonly used in cosmetics.

Phthalates and human health

It's not clear what effect, if any, phthalates have on human health. An expert panel convened from 1998 to 2000 by the National Toxicology Program (NTP), part of the National Institute for Environmental Safety and Health, concluded that reproductive risks from exposure to phthalates were minimal to negligible in most cases.

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. One group of chemicals surveyed was phthalates. However, the CDC survey was not intended to make an association between the presence of environmental chemicals in human urine and disease, but rather to learn more about the extent of human exposure to industrial chemicals.

In 2002, the Cosmetic Ingredient Review (CIR) Expert Panel 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 dibutylphthalate in cosmetic products. The panel found that exposures to phthalates from cosmetics were 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. FDA participates in CIR on a non-voting basis and may or may not accept CIR findings.)

FDA reviewed the safety and toxicity data for phthalates, including the CDC data from 2001, as well as the CIR conclusions based on reviews in 1985 and 2002. 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 FDA established an association between the use of phthalates in cosmetic products and a health risk. Based on this information, FDA determined that there wasn’t a sound, scientific basis to support taking regulatory action against cosmetics containing phthalates.

How FDA has followed up

FDA continues to monitor levels of phthalates in cosmetic products. We have developed an analytical method for determining the levels of phthalates in cosmetic products and conducted surveys of products to determine these levels in cosmetics on the market.

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, Laboratory Survey of Cosmetics Products for Phthalate Esters. We learned from these surveys that use of phthalates in cosmetics decreased considerably from 2004 to 2010.

What we 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.

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,”External Link Disclaimer 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.

FDA included 24 children’s products intended for infants and children in the survey we completed in 2006, and nearly 50 products for infants and children in the survey we completed in 2010. What we learned was 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.

How to know if there are phthalates in the cosmetics you use

Under the authority of the Fair Packaging and Labeling Act (FPLA), 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 ingredients; therefore, the consumer will not be able to determine from the ingredient declaration if phthalates are present in a fragrance. Also, because the FPLA does not apply to products used exclusively by professionals--for example, in salons--the requirement for an ingredient declaration does not apply to these products. Based on available safety information, DEP does not pose known risks for human health as it is 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" in the ingredient listing.

FDA's role

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. FDA can take action against unsafe cosmetics that are on the market, but only if we have dependable scientific evidence showing that a product or ingredient is unsafe for consumers under labeled or customary conditions of use.

At the present time, 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 within the scope of our authority under the Federal Food, Drug, and Cosmetic Act in protecting the health and welfare of consumers.

For related information, see FDA Authority Over Cosmetics and How FDA Evaluates Regulated Products: CosmeticsExternal Link Disclaimer.

Results of 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 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?)")

EPILYNX SKINCARE TIP: We have chosen not to have phthalates in your products but it is true that phthalates can always 'creep in' even though they were never put there initially.

2010 Survey of Cosmetics for Phthalate Content