26 November 2002
Coverup? A Cosmetic Ingredient Is Linked to Animal Defects.
Its Human Risks Are Less Clear
chemical substances that make plastic more flexible without reducing
its strength, are an all-but-inescapable part of life in the 21st
century. They're used in toys, garden hoses, shower curtains and
medical devices. They're also common ingredients in beauty products,
making nail polish chip-resistant and making hair spray keep a bouffant
a small coalition of consumer groups, led by Environmental Working
Group and Health Care Without Harm, has cried foul, claiming the
chemicals' risk to millions of cosmetic-wearing women has been underestimated.
Over the past months, citing animals studies that have linked the
additives (pronounced THAY-lates) to birth defects, including liver
and kidney damage and malformation of the testes, the anti-phthalates
groups have run ads in The Washington Post and the New York Times
warning of toxic chemicals lurking in perfumes and hair mousse.
week the Cosmetic Ingredient Review (CIR), a scientific panel that
monitors the safety of substances in U.S. cosmetics, weighed in
on the matter and came away unswayed by the activists. The CIR,
which claims to operate independently of the Cosmetic, Toiletry
and Fragrance Association that funds it, said there's no new evidence
to suggest that phthalates in cosmetics pose any health risk to
women or their offspring.
used, phthalates are safe. The concentrations at which phthalates
are used in cosmetics are low compared to the levels known to toxic
in animal tests," said Alan Anderson, the director and scientific
coordinator for the panel, who said the panel found the products
had "a wide margin of safety."
CIR's decision, however, is not likely to end debate on the matter.
And that's not just because the environmental activists are voicing
disatisfaction with the ruling. It's also because the government
concedes there just isn't enough human science on the issue to disconnect
rodent ills from human risk.
animal data definitely show an effect [injurious to health],"
says Jim Pirkle, the deputy director of science for the environmental
health lab at the Centers for Disease Control and Prevention, "but
that effect is dependent on the dose. We're not able to say right
now" what the safe human dose is, he said. "There's uncertainly
in the area, so that people on one side the issue grab that for
one reason and people on the other side grab it for another reason."
the time being at least, the Food and Drug Administration (FDA),
which regulates cosmetics, sees no new cause for concern over the
chemicals, which have been a part of life for the better part of
still think that phthalates are safe in cosmetics," said Monica
Revelle, an agency spokeswoman. "There's no new safety information
that would cause us to open up the record at the present time."
at a Price?
are just the latest battleground over phthalates, which have aroused
safety concerns for decades. In 1984 the CIR first declared phthalates
safe in cosmetics. It stuck to that position even after data were
released suggesting that the chemicals affected the hormones of
the mid-1990s, groups such as Greenpeace have taken up the anti-phthalate
cause, raising questions about whether plastic IV bags expose patients
to unreasonable risks and whether certain phthalate-containing plastic
toys harm children.
FDA has recommended that doctors performing certain procedures,
such as dialysis in pregnant women and newborn boys, should look
for alternatives to phthalate-containing devices, which leach the
chemicals at far higher rates than cosmetics do.
Consumer Product Safety Commission (CPSC) has deemed that toys made
with the chemical are generally safe but recommended that, as a
precaution, phthalates should be removed from baby rattles and teethers.
1998, several toy makers yielded to marketplace fears and agreed
to follow the CPSC recommendation to search for phthalate replacements.
In 1999 the medical product maker Baxter announced it, too, would
seek phthalate alternatives. Some cosmetic makers are already following
the same pattern: Last week The Body Shop, the U.K.-based beauty
products retailer, said it would phase out phthalate-containing
study done over the summer by an independent Chicago lab found that
phthalate-containing cosmetics are the rule, not the exception,
with more than 70 percent of products tested -- from Eternity perfume
to Degree deodorant -- coming up positive for the chemicals. Phthalates
are not listed on product labels, however -- nor is there any requirement
that they be listed -- so consumers can't easily identify or avoid
products that contain them. A Web site posted by the anti-phthalate
activists, www.nottoopretty.org, lists several dozen U.S. beauty
products said to contain the chemicals; no manufacturer responses
the cosmetics debate, some facts are known. Studies have shown clear
evidence of harm in laboratory animals given high doses of phthalates
in food and liquids. And there is growing evidence that humans are
exposed to the chemicals at higher rates than had been previously
thought. The chemicals are circulating in the body of nearly every
American, the CDC has found. Still, because widespread testing has
just begun, it's not known if the concentration is on the rise --
or anywhere remotely near a level that can cause human harm.
some researchers and industry officials argue that the animal data
and human blood levels should not justify tagging nail polish with
a skull and crossbones and warning consumers to apply deodorant
at their own risk. The difference between the level where animals
start to show ill effects and the largest doses humans are likely
to receive is still large enough, said Gerald McEwan, the vice president
of science with the Cosmetic, Toiletry and Fragrance Association,
to suggest that even the vainest consumer of beauty products runs
little health risk.
said that the highest dose rodents can tolerate without getting
sick -- known as the no-adverse-effect level -- is more than a thousand
times higher than the phthalate kick that could be expected by a
heavy user of cosmetics. And that, he said, is a conservative estimate.
makers, he said, calculate a risky dose to humans at more than 36,000
times higher than the expected phthalate dose from cosmetics. Policymakers
usually look for a margin of safety of 100 times the expected dose.
taking the worst case, we still have a margin of safety over 1,500.
It gives us a sense of security that the use of these in cosmetic
products is not going to cause any harm," McEwan said. He rejected
calls to err on the side of safety and push for replacement chemicals.
"The scientific answer is: If it's safe, it's safe. It's not
a matter of something being safer."
there are other chemicals that can fill the same role as phthalates,
most of them don't have a long history of use, and McEwan said that
there's little reason to switch to an alternative.
opponents say that stance obscures recent science on the topic.
Everyday exposures can be higher than the Environmental Protection
Agency's safety limit, 100 micrograms per kilogram of body weight
a day, according to a memo to the CIR panel by the anti-phthalate
coalition. (Industry sources argue that the EPA figure is conservative
and that higher doses still don't have the potential to cause harm.)
The memo notes that researchers haven't yet found a dose so low
that it won't cause male birth defects in rodents. Adding to the
concern is the general lack of information about what, if anything,
the chemical does in the human body.
we're all exposed to phthalates every day, there has not been a
human study," said Jane Houlihan, the vice president for research
at Environmental Working Group. "No one has the answers yet,
and certainly this panel didn't come up with the answers."
preliminary work has been done to assess phthalate levels in humans,
there's been no move yet to try to compare those levels to health
profiles. That, said Pirkle, will come later, as researchers uncover
more information about exposure.
too, said Houlihan, is the growing number of products that may cause
exposure in humans. While a single spritz of perfume may be of negligible
impact, she conceded, added exposure from a variety of medical and
household products could tip the balance from safety to danger.
least one new piece of evidence may help resolve the debate shortly:
Next year, the CDC is expected to release much-more-detailed information
on phthalates and other chemicals, drawn directly from human urine
and blood measurements. That, said Pirkle, should allow scientists
to draw better conclusions about the nature of the risks, if any,
that phthalates pose.•
Reid is a regular contributor to the Health section.