News Coverage
Europe Considers Phthalates Ban; FDA Rejects Labeling Petition
Published May 6, 2003
Cosmetics makers are feeling the heat from opponents of some ingredients used in product formulations. The European Union (EU) has proposed banning dibutyl phthalate (DBP), used as a plasticizer in nail polish and other products; and lead acetate, which is used in hair dyes. The EU has not yet decided what action should be taken for two other phthalates: di-n-octyl phthalate and dimethyl phthalate. Diethyl phthalate (DEP) has been approved by the EU for use in cosmetics. FDA, however, rejected a petition filed by environmental groups late last year that had lobbied for mandatory labeling for three phthalates commonly found in cosmetics. FDA found that dibutyl, diethyl, and dimethyl phthalates pose no health risk at typical exposure levels.
U.S. cosmetics producers are concerned about the EU restrictions because it will require reformulations for products exported to the EU. Business groups say the proposed EU restrictions are unnecessary because they regulate phthalates that may never come into contact with consumers. "The concept of risk as we understand it no longer holds in Europe," says Gerald McEwen, v.p./science for the Cosmetics, Toiletry, and Fragrance Association (Washington). To the EU "it doesn't matter if there is no risk of exposure, you still can't use it in a product." The U.S., however, allows products to contain phthalates if the risk of exposure is low enough, he says.
Environmental groups say phthalates have been linked to reproductive problems in some laboratory animals, and that the high levels found in women of childbearing age warrants restrictions on their use in personal care products. Women aged 20-40 have higher levels of phthalates in their systems than other population groups, according to a Centers fro Disease Control and Prevention (CDC; Atlanta) study (CW, Sept. 20, 2000, p. 16).
Environmental groups have challenged FDA's findings that phthalates pose no health risk at exposure levels commonly found in the U.S. population. "Phthalates are strongly linked to birth defects in animal studies, but they are perfectly legal to use in cosmetics," says Environmental Working Group (EWG) v.p./research Jane Houlihan. FDA should consider that many people use a a lot of cosmetics at one time, and therefore the agency should look at the possible health effects of multiple exposures, Houlihan says.
Industry says the concentrations found in humans are nowhere near what regulators would view as "levels of concern." Human exposure to phthalates through cosmetics is "very very low," says Marian Stanley, manager of ACC's phthalate esters panel. A person could use five bottles of nail polish per day, every day for her entire life, and still not come close to the levels of phthalates that would cause an observable health effect in laboratory animals, Stanley says.
CDC released a landmark biomonitoring report in 2001 measuring the concentrations of 24 chemicals commonly found in humans. That report showed the highest concentration of DEP was under 100 micrograms per kilogram per day. EPA has found that the dosage needed to cause an observable health effect from DEP is 800 micrograms per kilogram per day, Stanley says.
Environmental groups say the FDA has allowed industry's scientists to set policy. FDA has "rubber stamped" industry's findings without conducting its own scientific assessment of exposure and risk, Houlihan says. In light of FDA's decision not to regulate phthalates in cosmetics, EWG says it is focusing on encouraging companies to introduce phthalate-free products. Aveda, The Body Shop, New Wave, and Urban Decay have each introduced reformulated, phthalate-free products, she says