From NY Times
February 15, 2007 Skin Deep
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
''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
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
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
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
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
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
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
''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
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.
It IS the
combinations of chemicals, states UC
Professor Tyrone Hayes in Oakland Tribune article about pesticides.
It IS the
environment states Breast
Cancer Action and Breast Cancer Fund in an Oakland Tribune article about breast cancer.
It IS the
combination of fragrance chemicals, as well
as individual petrochemically derived chemicals,
Betty Bridges, RN (FPIN) and Barb Wilkie (EHN) since
petitioning the FDA May 11, 1999.
the FDA . . . tell them to protect your health by
regulating the flavors and fragrance industry.
Docket Number 99P-1340 on your subject line.