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New York Times
February 15, 2007
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.''Looking
at the Bottle and What's In It
CONCERNS about chemicals in cosmetics have prompted some consumer groups and
researchers to conduct their own lab tests on beauty products.
Last month, Consumer Reports ShopSmart magazine published a report about eight
consumer fragrances the company had tested for the presence of phthalates, a
group of chemicals used as plasticizers in many consumer products. A few of
these chemicals have been found to have a hormonal effect on lab animals; one
chemical, DEHP, is banned from cosmetics in European Union nations.
The magazine reported that each scent, tested by an outside lab, contained DEHP,
but it did not disclose how much of the chemical was present.
John Bailey, executive vice president for science of the Cosmetic, Toiletry and
Fragrance Association, an industry trade group, said that cosmetic companies do
not use DEHP in their perfume formulas. The chemical may have leached into the
scents from their plastic containers, he said.
Researchers from the Food and Drug Administration, in a study published last
year in the Journal of Cosmetic Science, said there is not enough data to
conclude that exposure to phthalates from cosmetics constitutes a hazard to
human health.
Another lab test published last week, commissioned by David Steinman, an
environmental writer who has a new book out, examined 15 popular baby shampoos
and bubble baths for the presence of dioxane, a chemical that has caused cancer
in lab animals. An independent lab hired to conduct the tests detected trace
amounts of dioxane in each product.
Dr. Bailey said that cosmetics companies do not use dioxane in formulas, but it
can be a manufacturing byproduct. ''Suppliers and manufacturers are doing their
best to reduce this,'' he said, noting that dioxane levels in cosmetics have
declined markedly in the last decade.
The F.D.A. has not established a limit for dioxane in cosmetics, according to an
agency official. The agency has tested cosmetics and determined that dioxane
evaporated so quickly during use of products that the amounts available to
absorb through the skin were very low, a spokeswoman said. NATASHA SINGER
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