U. S. Food and Drug Administration
Center for Food Safety and Applied Nutrition
Office of Cosmetics and Colors Fact Sheet
April 19, 2001


Phthalates and Cosmetic Products

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 group of chemicals the survey identified was phthalates. The following is intended to answer questions on the subject of phthalates in cosmetics.

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?

We don't know. 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 1985, the Cosmetic Ingredient Review (CIR) Expert Panel, a group of scientists that reviews the safety of cosmetic raw materials, reviewed the safety of phthalates in cosmetics and concluded they were safe as used.

How do I know if there are phthalates in the cosmetics I use?

Under the authority of the Fair Packaging and Labeling Act (FPLA), FDA requires an ingredient declaration on the 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.

What is FDA's role?

FDA believes that at the present time there is no reason for consumers to be alarmed at the use of cosmetics containing phthalates. However, the agency is in the process of evaluating the study data to determine whether the levels described in the CDC report are a health concern.

If FDA determines that a health hazard exists, the agency will advise the industry and the public, and will consider its legal options under the authority of the Food, Drug and Cosmetic Act in protecting the health and welfare of consumers.


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