Environmental Health Perspectives  [Printer-friendly version]
July 1, 2006


[Rachel's introduction: "Although the new act applies only in
California, its effects are likely to reverberate nationwide.
Consumer advocates predict that manufacturers seeking to avoid
negative publicity will remove, rather than report, suspect

By Cynthia Washam

Californians frustrated with what they consider the FDA's loose
control over cosmetic safety have taken matters into their own hands
with the country's first state cosmetics regulatory act, which takes
effect in January 2007. The California Safe Cosmetics Act of 2005 [SB
484] will require manufacturers to report the use of potentially
hazardous ingredients to the state Department of Health Services
(DHS), which in turn will alert consumers. The DHS has the authority
to investigate whether the product could be toxic under normal use and
to require that manufacturers submit health effects data.
Manufacturers that continue marketing products deemed unsafe in
California could face legal action.

"The legislation's sponsors believe that the basis of the law is the
public's right to know," says Kevin Reilly, DHS deputy director of
prevention services. The new law uses the list of toxicants drawn up
under California's Proposition 65, which mandates that the governor
publish a list, updated at least yearly, of chemicals that are known
to the state of California to cause cancer, birth defects, or other
reproductive harm.

Although the new act applies only in California, its effects are
likely to reverberate nationwide. Consumer advocates predict that
manufacturers seeking to avoid negative publicity will remove, rather
than report, suspect ingredients. Those formulas would then be
marketed coast to coast.

Impetus for the law stems from consumers' concerns over long-term
exposure to certain cosmetic ingredients. Cosmetic use has not been
linked to chronic illnesses, but some products do contain carcinogens
(such as formaldehyde, used in nail treatments), teratogens (such as
lead acetate, used in two hair dyes), and other reproductive toxicants
(such as di-n-butyl phthalate, used in nail treatments and dandruff

Studies in recent years have shown that humans absorb and inhale
sometimes surprisingly high levels of toiletry ingredients. In the
November 2005 issue of EHP, a team led by Susan M. Duty of the
Harvard School of Public Health demonstrated that urine concentrations
of phthalate metabolites increased by 33% with each personal care
product-hair gel or spray, lotion, deodorant, cologne, aftershave-that
subjects used.

Historically, cosmetics safety has been in the hands of manufacturers;
the FDA requires no premarket testing. Each year, an expert panel
convened by the industry-funded Cosmetic Ingredient Review (CIR)
identifies priority ingredients for which it conducts literature
reviews and analyses to determine safety. The panel-made up of
independent academic researchers and representatives from industry,
consumer interests, and the FDA-has declared 9 of the 1,286
ingredients reviewed since 1976 unsafe for normal cosmetic use. But
manufacturers are not obligated to eliminate any ingredients-at least
one ingredient identified as unsafe by CIR, hydroxyanisole, is still

Safety advocates see evidence of any harm in any use as reason enough
for a ban. "Ingredients suspected of causing cancer shouldn't be used
in cosmetics," says spokesman Kevin Donegan of the Breast Cancer Fund,
a San Francisco-based nonprofit that promoted the California bill.

F. Alan Andersen, director and scientific coordinator of CIR, counters
that the dose creates the danger. "We don't subscribe to the notion
that if there's ever an adverse effect, [a chemical] must not be in a
product people use," he says. "It doesn't make sense to us to apply
the precautionary principle. Instead, we use a risk assessment
approach, and the wide margins of safety that we have found for
chemicals such as phthalates using this approach assure us that actual
use of cosmetics is safe."

The law drew fierce opposition from individual companies and the
Cosmetic, Toiletry, and Fragrance Association (CTFA) as it worked its
way through the California legislature. "CTFA supports strong federal
regulation by the FDA," says Kathleen Dezio, executive vice president
of public affairs and communications for the association. "For this
reason, CTFA has generally opposed state-specific legislation that
would undermine this national approach and lead to an unworkable
state-by-state patchwork of rules... or unjustified, extreme
requirements that are well beyond those placed on any other category
of food, beverages, drugs, or consumer products." She adds that CTFA
has met with the DHS and "pledged our cooperation in accomplishing the
requirements" of the law.

Some manufacturers have already ceded to public pleas for safer
products. In the past two years, almost 350 of them signed a pledge
promoted by the Campaign for Safe Cosmetics, a coalition of health
and environmental groups, to use no chemicals linked to cancer or
birth defects. Industry leaders L'Oreal and Revlon broke new ground
last year when they promised that products they sold in the United
States would meet more stringent European Union standards. In 2004
Europe enacted a ban on suspected carcinogens, mutagens, and
reproductive toxicants in personal care products.

"We're definitely seeing a shift in the attitude of manufacturers,"
Donegan says. "They're starting to see the benefits of removing
anything that could cause cancer."