[Pharmwaste] Skin Deep - Should You Trust Your Makeup?

[DeBiasi,Deborah]

http://www.nytimes.com/2007/02/15/fashion/15skin.html?th&emc=th

February 15, 2007

Skin Deep   Should You Trust Your Makeup? 

By NATASHA SINGER

FOR decades, companies that make everything from after-shave to lip
gloss have conducted safety testing on grooming products and shipped the
cosmetics to stores to be sold to consumers, all with very little
government involvement. And over the years, there have been few health
or safety problems associated with the myriad grooming products and
cosmetics on the market.

Nonetheless, momentum has been building for greater oversight of the
chemicals in everyday products, with the European Union and California
taking the lead in imposing new rules for monitoring what is in the
perfumes, creams, nail polish and hair sprays that are sold. 

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. 

State Senator Carole Migden, Democrat of San Francisco, said that such
chemicals, even in trace amounts, should be removed from beauty products
because they have been found to cause cancer or hormonal changes in lab
animals. 

"The bill mandates that manufacturers reveal potentially poisonous
ingredients," said Senator Migden, the bill's author. "I hope that the
bill will lead manufacturers to voluntarily eliminate suspect
ingredients from cosmetics."

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.

Indeed, no rigorous large-scale clinical trials have been conducted that
would indicate that cosmetics trigger major diseases in humans. But some
small case 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. 

Although the cosmetics industry considers the phthalates used in its
products to be safe, some companies have voluntarily removed dibutyl
phthalate, which California considers harmful to the reproductive
system, from their nail polishes.

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.

Diana Zuckerman, president of the National Research Center for Women and
Families in Washington, said that activists are singling out cosmetics
because, unlike medical devices, they are optional purchases.

"If you are looking for chemical exposures that everyone can relate to,
it's not medical devices like IV bags," Dr. Zuckerman said. "It's
shampoos and creams that are ubiquitous, that men, women and children
are using every day."

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.

By that standard, the industry has a long record of safety, with about
six billion products manufactured annually worldwide, and only rare
reports of problems like allergic reactions. Americans spent about $50
billion last year on cosmetics and toiletries, according to Euromonitor
International, a market research firm. 

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.

Part of the push for greater oversight stems from concerns about health
trends, like increased reports of early puberty, asthma and allergies.
Some scientists and health groups want to know if there is any
connection to the aggregate exposure to chemicals.

A handful of small case studies and anecdotal reports, published in
medical journals, suggest that a few ingredients used in some cosmetics
could potentially have a hormonal or allergenic affect on humans.

A report published Feb. 1 in the New England Journal of Medicine
described the cases of three preteenage boys who each used shampoo, hair
gel or body products that contained either lavender oil or tea tree oil
and who each grew breast tissue; the tissue receded after the boys
stopped using the products. The researchers said their findings, though
far from conclusive, suggest that repeated exposure to these oils has
the potential to affect hormones. 

On Feb. 2, BMJ (formerly known as the British Medical Journal) published
an editorial from doctors in which they cited reports of a marked
increase in allergic reactions to hair dyes. The editorial called for
increased scrutiny of hair dyes.

California has done the most of any state to address the issue of
chemicals in cosmetics. Legislators in a few other states have discussed
similar measures. 

The cosmetics industry has not been resistant to greater disclosure. It
has embraced the new European regulations, and it is working with
California regulators to institute the new law.

But 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.

At the same time, though, 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.

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, he said.

Dr. Bailey added that substances being singled out by regulators and
environmental groups are present in such small amounts in such a limited
number of cosmetics that they pose no threat to human health. He
compared them to salt in cooking.

"A little salt on your peas or tomatoes can be good," Dr. Bailey said.
"But a lot of salt can have adverse health effects on your blood
pressure, and too much can be fatal."

But some say the possible cumulative effect is exactly the point.

"They test in the short term for immediate reactions to make sure the
product doesn't cause your skin to itch, get red or fall off," said
Jeanne Rizzo, executive director of the Breast Cancer Fund, a nonprofit
group in San Francisco that was one of the sponsors of the new
California law. "But we don't know the long-term effect of multiple
exposures to chemicals in cosmetics that can get absorbed in your skin
and end up in your urine or your bloodstream."

Antonia M. Calafat, lead researcher at the National Center for
Environmental Health at the Centers for Disease Control and Prevention
in Atlanta, said the body's absorption and excretion of chemicals do not
necessarily indicate an impact on human health.

"All we can say at the moment is that humans are exposed to these
chemicals, but the presence of a chemical in the body does not
necessarily constitute a negative effect," said Dr. Calafat, who added,
"There need to be comprehensive, well-designed studies to understand
whether indeed these compounds are harmful for humans."

The chemicals that must be reported to health officials under the
California law include lead acetate, found in some hair dyes;
formaldehyde, which can be used as a cosmetic preservative; and toluene,
a solvent used in some nail products. 

"The law only requires that a cosmetic manufacturer with a product that
contains a toxicant report it," said Kevin Reilly, deputy director of
prevention services of the state's public health program. "But it will
be interesting to see whether this bill drives reformulation of
products."


Deborah L. DeBiasi
Email:   dldebiasi at deq.virginia.gov
WEB site address:  www.deq.virginia.gov
Virginia Department of Environmental Quality
Office of Water Permit Programs
Industrial Pretreatment/Toxics Management Program
Mail:          P.O. Box 1105, Richmond, VA  23218 (NEW!)
Location:  629 E. Main Street, Richmond, VA  23219
PH:         804-698-4028
FAX:      804-698-4032