Greater Oversight for Cosmetic Ingredients Expected

Momentum has been building for greater oversight of the chemicals in cosmetics with the European Union and California taking the lead in imposing new rules for monitoring what is in perfumes, creams, nail polish and hair sprays. The California Safe Cosmetics Act, which took effect on Jan. 1, requires cosmetics companies to tell state health authorities if a product contains any chemical on several government lists covering possible cancer-causing agents or substances that may harm the reproductive system.

Americans spent about $50 billion last year on cosmetics and toiletries, according to market research firm Euromonitor International. The cosmetics industry is already taking steps to heighten self-monitoring, though representatives said the ingredients that the California law regulates pose no risk to human health when used topically in the small quantities found in some cosmetics.

Although no large-scale clinical trials have been conducted indicating that cosmetics trigger major diseases in humans, there are reports published in medical journals suggest that a few substances used in cosmetics may affect hormone function in humans. Scientists are particularly interested in a group of chemicals called phthalates — used in some nail polishes, fragrances, medical devices and shower curtains — some of which have had an effect on the reproductive systems of lab animals and can be absorbed and excreted by the human body.

But some environmentalists are pressing for a deeper analysis of the possible long-term effects of exposure to these chemicals. Some have formed a group called the Campaign for Safe Cosmetics to publicize their concerns, using the Internet to highlight ingredients and manufacturers. Their efforts have raised the possibility that the cosmetics industry eventually could be subject to greater government regulation, with perhaps mandatory testing and product approval.

Since 1938, when Congress gave the Food and Drug Administration limited authority over beauty products, cosmetics has been a largely self-regulating industry. Prescription and over-the-counter drugs must submit safety data to the agency before it approves them for sale to the public. But cosmetics do not need agency approval because they are defined as topical products (like moisturizer or mascara) that alter neither the structure nor the function of the skin.

Beauty manufacturers are required to ensure the safety of their cosmetics before they go on sale, but the federal agency has never defined safety, according to an agency spokeswoman. That has left it to the beauty industry to settle on a definition, with the overall standard being that products are safe for use if they do not irritate the skin when applied as directed.

But some health groups have raised questions about the possible long-term or cumulative effects of exposure to all the chemicals in everyday products. In response to their concerns, the European Union imposed new regulations on the industry in 2004, banning more than 600 chemicals from use in cosmetics. In 2005, it went further to require more package information on product shelf life and allergenic ingredients.

Later this year, the European Union will take its oversight another step, instituting a policy called the Registration, Evaluation and Authorization of Chemicals (REACH), which will require companies — including cosmetics firms — that produce chemicals or use them in their products, packaging or manufacturing, to collect comprehensive data on the possible risks of the substances to human health and to the environment. The European Commission has estimated that the new law will cost the chemical industry as much as $6.7 billion over the next decade, but that it could save up to $70 billion in health costs over the next 30 years.

The industry has employed lobbyists to counter legislation and has argued that the new regulations are prompted by unsubstantiated fears rather than by hard science Industry representatives said their goal is increased self-regulation, not government oversight. Toward that aim, the Cosmetic, Toiletry and Fragrance Association, an industry trade group, last month began to offer companies a voluntary program to make their safety data available to the F.D.A. and to report adverse reactions to the agency. They also said manufacturers would be more accountable to the guidance of an industry panel that reviews the safety of cosmetic ingredients.

John Bailey, executive vice president for science of the cosmetics industry trade group, said that each beauty company conducts its own safety assessment of ingredients and final products. This typically includes a review of scientific literature to ensure that chemicals used in formulas don't cause toxic reactions or cell mutations in the body; patch tests on volunteers to make sure finished products won't irritate; and bacterial tests to make sure products won't spoil.