In a rare move to toughen safety regulations for personal care products, the U.S. Food and Drug Administration on Monday proposed a new rule to require makers of antibacterial soap to prove their products are safe and effective, a first step toward mandatory limitations on hormone disrupting chemicals used in cleaners and cosmetics.

The proposal challenges claims by antibacterial soap makers about the effectiveness of their products, and aims to limit the use of the chemical triclosan, which has been linked to changes in hormone levels and increased risk of cancer, and is a common ingredient in most soaps and anti-bacterial hand gels.

"Due to consumers' extensive exposure to the ingredients in antibacterial soaps, we believe there should be a clearly demonstrated benefit from using antibacterial soap to balance any potential risk," said Janet Woodcock, director of the FDA's Center for Drug Evaluation and Research.

Under the FDA proposal, companies that make antibacterial soap such as Dial, Softsoap and Lever would be required to prove their products are safe for long-term daily use and more effective than plain soap and water in preventing illness and the spread of certain infections.

Calls placed to Henkel, which makes Dial soap, and Colgate-Palmolive, which makes several antibacterial products including Softsoap, were not immediately returned Monday.

Health advocates and environmental groups have for years warned of the potentially hazardous effects of triclosan, which also has been linked to adverse impacts on brain development. But the FDA only recently changed its position on triclosan. In October, the agency told this newspaper that "Triclosan is not currently known to be hazardous to humans."

On Monday, FDA spokeswoman Andrea Fischer said that while the agency "does not currently have any evidence" that ingredients in antibacterial products are unsafe, it has "potential concerns about the effects of repeated daily human exposure to antibacterial ingredients such as triclosan."

The proposal stemmed from a settlement of a lawsuit filed in 2010 by the National Resources Defense Council, which called on the FDA to finalize regulations for antibacterial soaps that have hung in limbo for about 35 years. Monday's announcement was the first substantial action the FDA has taken to pass tougher regulations for antibacterial soaps and washes.

"We're baffled as to why it's taken so long," said Janet Nudelman, program director at the Breast Cancer Fund in San Francisco and leader of the Campaign for Safe Cosmetics, which has pushed manufacturers and retailers to limit triclosan in beauty products. "It really begs the question of whether the FDA is asleep at the wheel."

The FDA said the proposed change is part of a larger, ongoing review of antibacterial products -- triclosan is in everything from body washes to shave gel, face wash, deodorant, mascara, blush, eye shadow, hand and foot cream, and toothpaste. In a 2004 study of human exposure to environmental chemicals, the Centers for Disease Control found triclosan in the urine of 75 percent of Americans tested. The FDA said it will next review ingredients of antibacterial soaps used in hospitals and health care offices, and hand sanitizers. "They don't work, and you can use an alternative -- which is soap -- which does not have an active ingredient that could adversely impact thyroid hormone level, which could impact brain development," said Tracey Woodruff, director of the Program on Reproductive Health and the Environment at UC San Francisco, who is leading a study on triclosan.

The proposed FDA regulation must go through a public comment period before a final rule is submitted in 2016, and soap manufacturers will then have one year to prove their products are safe and as effective as they claim, or reformulate them without the triclosan or relabel them.

But some manufacturers and retailers are moving more quickly than the FDA to rid their products of chemicals, pressured by groups such as the Campaign for Safe Cosmetics and growing consumer awareness of the toxicity in many everyday cleaning and beauty products.

Target unveiled in October a new safety standard that will assess more than 7,500 household cleaners and beauty supplies, and calls on manufacturers to remove unnecessary and potentially harmful chemicals from their products. Wal-Mart announced in September a new chemical policy requiring that, beginning in January, suppliers reduce or eliminate about 10 chemicals commonly used in beauty products, household cleaners and cosmetics. Also in September, Procter & Gamble, one of the largest consumer goods manufacturers, announced the elimination of some phthalates and triclosan from its products.

"A lot of manufacturers are starting to see the writing on the wall," said Mae Wu, a lawyer for the National Resources Defense Council. "They're all starting to see that the end of triclosan is near."

Contact Heather Somerville at 510-208-6413. Follow her at Twitter.com/heathersomervil.

triclosan
Concern: Linked to changes in hormone levels and increased risk of cancer, especially breast and prostate cancers.
Use: Preservative
Where: Antibacterial soap, body wash, shave gel, face wash, deodorant, mascara, blush, eye shadow, hand and foot cream and about 17 types of Colgate toothpaste. Procter & Gamble, manufacturer of more than 50 beauty brands, pledged to remove triclosan from products by 2014.