Phthalates Face Increased Scrutiny

Mass & Toxic Tort Update

Date: November 21, 2007


With Governor Schwarzenegger’s signing of Assembly Bill 1108 in October, California became the first state to ban the use of certain phthalates in toys and child-care products for children under the age of three. The European Union and the city of San Francisco already passed similar bans of certain phthalates; however, California's law is broader than those previous bans. California's action on phthalates is but one of a number of recent measures to limit, if not ban, the use of phthalates.

Phthalates (pronounced "thallates") are ubiquitous; they are used in everything from toys to medical devices to cars to air fresheners. Phthalates are a family of compounds made from alcohols and phthalic anhydride. They are oily, colorless, odorless liquids that do not evaporate readily and are most often used to make polyvinyl chloride soft and flexible. The compounds also are used to enhance fragrances in sprays and candles.

Regulation of Phthalates on the Increase

A 2003 U.S. Consumer Product Safety Commission (CPSC) study reportedly concluded that few children are at risk from phthalates because the amount (or dose) that a child could potentially ingest does not reach a level that would be harmful. Nevertheless, consumer protection groups are relying on various laboratory animal studies to argue that phthalates could interfere with hormonal systems, disrupt testosterone production and cause malformed sex organs. Now it appears that, at least in California, the regulation of phthalates is outpacing the science.

Under Assembly Bill 1108, California became the first state to ban the use of certain phthalates in toys and child-care products for children under three. Beginning in 2009, the new law will forbid the sale, manufacture or distribution of any toy or child care article with concentrations of certain phthalates exceeding 0.1 percent. Similar proposed bans in Washington and Oregon were unsuccessful over the past year. The California ban is particularly significant because California represents nearly 30 percent of the North American toy market.

The European Union was first to regulate phthalates when it imposed a temporary ban on the use of phthalates in children’s toys and pacifiers in 1999. In September 2004, the European Council of Ministers voted unanimously for a permanent ban on the use of six specific phthalate plasticizers in toys and child-care items intended for use by children under the age of three. In the summer of 2005, the European Parliament unanimously voted in favor of adopting the ban.

NRDC Seeks Regulation of Air Fresheners

In search of national regulations in the United States, the Natural Resources Defense Council (NRDC) recently issued a warning that phthalates in household air fresheners could impact hormones and reproductive development, mostly in babies. The NRDC tested 14 different brands of common household air fresheners and reports that 12 contained phthalates. Yet none of the air fresheners listed phthalates in their ingredients. Two of the air fresheners having the highest level of phthalates were sold under the name of a retailer that has already pulled those products off shelves and pledged to replace them with phthalate-free products.

On September 19, the NRDC, along with the Sierra Club, the Alliance for Healthy Homes and the National Center for Healthy Housing, filed a petition with the Environmental Protection Agency and the CPSC requesting comprehensive testing for all air freshener products on the market.

Apple Faces Lawsuit Over Phthalates

The Center for Environmental Health has taken initial steps to sue Apple in response to a Greenpeace report stating that the levels of phthalates in the iPhone's earphone wires exceed those allowed by California's Proposition 65. Proposition 65 stipulates that products that expose consumers to a specific list of chemicals that are reproductive toxins or carcinogens must carry a warning label or be taken off the market. At least six phthalates appear on Proposition 65's list of chemicals.

American Medical Association Urges Labeling

The American Medical Association recently urged the Food and Drug Administration to require labeling of all medical products containing phthalates to protect newborns in hospitals. In fact, more than 100 hospitals have already begun to voluntarily remove such products from neonatal nurseries out of concern for the health of baby boys.

For More Information

As the science behind the potential health effects of exposure to phthalates continues to be hotly debated, there is no question that the plastics industry faces a continuously evolving and complex regulatory landscape. Thompson Hine's lawyers have years of experience representing the plastics industry, including trade associations, manufacturers and fabricators, in mass and toxic tort litigation. That experience, combined with our access to world-renowned experts in the fields of epidemiology, industrial hygiene, oncology, rheumatology, internal medicine, pathology, toxicology and environmental consulting, enables us to help our clients in the plastics industry navigate the regulatory complexities they face.