Jane Houlihan Sean Gray Timothy Kropp, Ph.D. Chris Campbell

Transcription

Jane Houlihan
Sean Gray
Timothy Kropp, Ph.D.
Chris Campbell
Acknowledgements
Authors:
Jane Houlihan
Sean Gray
Timothy Kropp, Ph.D.
Chris Campbell
Reviewers: Richard Wiles, Ken Cook
This report was made possible by grants from the
Heinz Family Foundation, Beldon Fund, and the John
Merck Fund. The opinions expressed in this report are
those of the authors and editors and do not necessarily
reflect the views of our supporters. EWG is responsible
for any errors of fact or interpretation contained in this
report.
Personal care product use surveys collected by
The Breast Cancer Fund, Womenʼs Voices for the
Earth, Health Care Without Harm, the Massachusetts
Breast Cancer Coalition, Clean Water Action, and the
Environmental Working Group.
EWG is a nonprofit research organization with offices in
Washington, DC and Oakland, CA. EWG uses the power of
information to educate the public and decision-makers about
a wide range of environmental issues, especially those
affecting public health.
Kenneth A. Cook, President
Richard Wiles, Senior Vice President
Mike Casey, Vice President for Public Affairs
Jane Houlihan, Vice President for Research
Bill Walker, Vice President/West Coast
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Executive Summary
FDA cannot require companies to do safety testing of their
cosmetic products before marketing.
— FDA Office of Cosmetics and Colors (FDA 1995)
Most consumers would be surprised to learn that the government
does not require health studies or pre-market testing for cosmetics
and other personal care products before they are sold. According
to the government agency that regulates cosmetics, the FDA’s
Office of Cosmetics and Colors, “...a cosmetic manufacturer may
use almost any raw material as a cosmetic ingredient and market
the product without an approval from FDA” (FDA 1999).
The toxicity of product ingredients is scrutinized almost
exclusively by a self-policing industry safety committee, the
Cosmetic Ingredient Review (CIR) panel. Because testing is
voluntary and controlled by the manufacturers, many ingredients
in cosmetics products are not safety tested at all. Environmental
Working Group’s analysis of industry and government sources
shows that:
• Eighty-nine (89) percent of 10,500 ingredients used in
personal care products have not been evaluated for safety by the
CIR or anyone else (FDA 2000, CIR 2003).
The absence of government oversight for this $35 billion industry
leads to companies routinely marketing products with ingredients
that are poorly studied, not studied at all, or worse, known to
pose potentially serious health risks.
The Environmental Working Group’s (EWG’s) six-month computer
investigation into the health and safety assessments on more
than 10,000 personal care product ingredients found major gaps
in the regulatory safety net for these products. To help people use
what we learned we developed an online rating system that ranks
products on their potential health risks and the absence of basic
safety evaluations. The core of the analysis compares ingredients
in 7,500 personal care products against government, industry, and
academic lists of known and suspected chemical health hazards.
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Our analysis shows that ingredients in cosmetics range from
essentially harmless components like table salt and oatmeal,
to chemicals known to cause cancer in humans. Notably,
natural ingredients are no more likely to have been assessed
for safety than synthetic chemicals. Individual ingredients vary
tremendously in their ability to soak through the skin. Some
absorb in only miniscule amounts, while others can quite easily
penetrate the skin to the blood vessels below. Few individual
ingredients pose excessive risks, but most people use many
products in the course of a day, so it well may be that these risks
are adding up. A survey of 2,300 people conducted as part of this
research effort shows that the average adult uses 9 personal care
products each day, with 126 unique chemical ingredients. More
than a quarter of all women and one of every 100 men use at
least 15 products daily.
Little research is available to document the safety or health risks
of low-dose repeated exposures to chemical mixtures like those
in personal care products, but the absence of data should never
be mistaken for proof of safety. The more we study low dose
exposures, the more we understand that they can cause adverse
effects ranging from the subtle and reversible, to effects that are
more serious and permanent.
Overall, our investigation of product safety shows cause for
concern, not alarm. Much more study is needed to understand the
contribution of exposures from personal care products to current
human health trends.
Findings. Our safety assessment of 7,500 personal care product
labels, documented in this web-based review, shows that:
• Just 28 of the 7,500 products we analyzed have been
fully assessed for safety by the cosmetic industry’s selfregulating panel, the Cosmetic Ingredient Review (CIR).
All other products — 99.6 percent of those examined
— contain one or more ingredients never assessed for
potential health impacts by the CIR. This panel, run and
funded by the cosmetic industry’s trade association, is
billed as the organization that “thoroughly reviews and
assesses the safety of ingredients used in cosmetics”
on behalf of the industry (CIR 2004). The government
does not systematically review the safety of personal
care products and has banned or restricted just nine of
the more than 10,000 ingredients used in personal care
products.
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• One of every 100 products on the market contains
ingredients certified by government authorities as known
or probable human carcinogens, including shampoos,
lotions, make-up foundations, and lip balms manufactured
by Almay, Neutrogena, Grecian Formula, and others. An
astonishing one-third of all products contain one or more
ingredients classified as possible human carcinogens.
• Seventy-one hair dye products contain ingredients
derived from carcinogenic coal tar. These products have
all been granted a specific exemption from federal
rules that deem products to be adulterated when they
contain ingredients that can harm human health. Coal tar
containing products include dyes made by Clairol, Revlon,
L’Oreal, and others. Coal tar hair dyes are one of the few
products for which FDA has issued consumer advice on
the benefits of reducing use, in this case as a way to
potentially “reduce the risk of cancer” (FDA 1993).
• Fifty-five percent of all products assessed contain
“penetration enhancers,” ingredients that can increase
a product’s penetration through the skin and into the
bloodstream, increasing consumers’ exposures to other
ingredients as well. We found 50 products containing
penetration enhancers in combination with known or
probable human carcinogens.
• Nearly 70 percent of all products contain ingredients
that can be contaminated with impurities linked to cancer
and other health problems. Studies by FDA and European
agencies show that these impurities are common, in some
cases occurring in nearly half of all products tested (FDA
1996, DTI 1998). Some manufacturers buy ingredients
certified by an independent organization called United
States Pharmacopeia (USP). These ingredients may
contain lower levels of harmful impurities, but the criteria
for certification are not public. There are no federal
standards for ingredient purity. While it seems likely
that some companies purchase or manufacture refined,
purified ingredients, it is equally likely that many do not.
Consumers and government health officials have no way to
know.
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• Fifty-four products violate recommendations for
safe use set by the industry’s self-regulating Cosmetic
Ingredient Review board. Most of these products contain
ingredients found unsafe for the intended use of the
product they are found in. Examples include ingredients
found unsafe for use in baby products but used in diaper
cream, ingredients found unsafe for use on injured or
damaged skin contained in products marketed specifically
for use on chapped and injured skin, and ingredients not
safe for sprays but found in spray products. Brand name
products found in violation of industry recommendations
include Neutrogena, Destin, Herbal Essences, and Rite Aid.
• In its 67-year history of monitoring cosmetic safety,
FDA has banned or restricted just nine personal care
product ingredients (FDA 2000). In its review of 1,175
ingredients, the industry’s safety panel has found just nine
ingredients (a different nine) unsafe for use in cosmetics
(CIR 2003). By contrast, 450 ingredients are banned
for use in cosmetics in the European Union, although
the vast majority of these have never been used by the
industry. The regulatory vacuum in the U.S. gives cosmetic
companies tremendous leeway in selecting ingredients,
while it transfers potentially significant and largely
unnecessary health risks to the users of the products.
Recommendations.
Because the FDA has no legal authority to require safety
assessments of cosmetics, products safety is by default the
responsibility of the industry and its own appointed Cosmetic
Ingredient Review panel. This voluntary policing arrangement
has been a failure. EWG’s analysis of 7,500 personal care
product labels found that some cosmetic companies use
known human carcinogens in products, manufacture scores of
products containing ingredients in direct contraindication of
industry hazard assessments, widely use chemicals that are
likely to be contaminated with harmful impurities, and add to
thousands of products ingredients that industry assessments
show lack basic information needed to support their safety.
To improve the safety of personal care products EWG recommends
that manufacturers:
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Table 1. Many leading cosmetics companies may have failed to formulate their products with customer health as a top concern. According to an EWG Safety Assessment Rating for personal care products,
the products with the highest health concerns in 25 different product
categories contain ingredients linked to cancer, pregnancy problems,
and other potential health issues (scores range from 0 to 10, with 10
being of highest health concern):
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• Remove from products all chemicals classified as
known or possible human carcinogens, reproductive toxins,
and developmental toxins. Manufacturers are currently
reformulating products in Europe to comply with this
restriction.
• Certify that ingredients do not have impurities
classified as known or probable human carcinogens,
reproductive toxins, or developmental toxins.
• Conform with the recommendations of the CIR and
reformulate products to eliminate ingredients that are
deemed unsafe for the intended use of the product.
In addition to these actions by industry we also strongly
recommend that:
• Congress amend the Federal Food Drug and Cosmetic
Act to provide FDA with clear and unencumbered authority
to request any and all safety studies that it deems
necessary to assess the safety of cosmetics and other
personal care products.
References
Cosmetics Ingredient Review (CIR) (2003). 2003 CIR Compendium,
containing abstracts, discussions, and conclusions of CIR cosmetic
ingredient safety assessments. Washington DC.
Cosmetics Ingredient Review (CIR) (2004). CIR information
available at http://www.cir-safety.org, accessed May 6 2004.
Department of Trade and Industry, UK (DTI) (1998). A survey
of cosmetic and certain other skin-contact products for nnitrosamines.
Food and Drug Administration (FDA) (1993). Hair Dye Dilemmas.
FDA Consumer. April 1993. Accessed online May 6 2004 at http:
//vm.cfsan.fda.gov/~dms/cos-818.html.
Food and Drug Administration (FDA) (1995). FDA Authority over
Cosmetics. Center for Food Safety and Applied Nutrition. Office of
Cosmetics and Colors Fact Sheet. February 3 1995. Accessed online
May 6 2004 at http://www.cfsan.fda.gov/~dms/cos-206.html.
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Food and Drug Administration (FDA) (1996). Are nitrosamines in
cosmetics a health hazard? Accessed online May 6 2004 at http://
vm.cfsan.fda.gov/~dms/qa-cos25.html. Updated November 1996.
Food and Drug Administration (FDA) (1999). Diethanolamine and
Cosmetic Products. Office of Cosmetics and Colors Fact Sheet. Dec
9, 1999. Accessed online May 6 2004 at http://vm.cfsan.fda.gov/
~dms/cos-dea.html.
Food and Drug Administration (FDA) (2000). Prohibited
Ingredients and Related Safety Issues. Office of Cosmetics and
Colors Fact Sheet. March 30, 2000. Accessed online May 20 2004
at http://www.cfsan.fda.gov/~dms/cos-210.html.
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12
Part 1: Carcinogens in
personal care products
Consumers believe that ’if it’s on the market, it can’t hurt
me.’ And this belief is sometimes wrong.
– Director of FDA’s Office of Cosmetics and Colors (FDA
1998)
Known and probable human carcinogens in cosmetics
In a systematic comparison of ingredients in 7,500 personal care
products against government lists of cancer-causing chemicals,
the Environmental Working Group has found that one of every
100 products on the market contains a known or probable human
carcinogen (Table 1), and an astonishing one-third of all products
contain one or more ingredients with at least some evidence of
carcinogencity in laboratory studies or investigations of human
populations (Table 2).
Seventy-seven products, one of every 100 products assessed,
contain ingredients certified by government authorities as
known or probable human carcinogens, including shampoos,
lotions, foundations, and lip balms manufactured by Almay,
Neutrogena, Grecian Formula, and others (Table 1). The cancercausing ingredients range from coal tar in shampoo to quartz
crystals contained in powders and linked to lung cancer. Federal
law does not prohibit the use of carcinogens in cosmetics. FDA
can take legal action through the Department of Justice to
remove poisonous (adulterated) cosmetics from the market, but
the legal costs and the high burden of proof of health harms
the agency faces under the law discourage such actions. As a
result, legal action is rare, and cosmetics that pose potential
cancer risks remain on the market. Many impurities common to
cosmetics are also linked to cancer. ÊImpurity levels in cosmetics
are largely unrestricted, in spite of the potentially serious
health consequences. EWG’s assessment of product ingredient
labels and data on cancer-causing chemicals identified three
common impurities in personal care products that are linked to
mammary tumors in animal studies - ethylene oxide, PAHs, and
1,3-butadiene. The ingredients for which these impurities are of
concern are used in one of every four personal care products on
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the market and are discussed further in the “Impurities” section
of this investigation. Among the known and probable human
carcinogens used in cosmetics are the eight ingredients discussed
below.
Coal tar. Coal tar is a known human carcinogen (NTP 2004,
IARC 2004). It is also used in four shampoos from Neutrogena
and Ionil designed to control itching and eczema, including
Neutrogena T-Gel Shampoo. None of the products note
potential cancer risks on their labels. All four products
contain penetration enhancers, ingredients that may increase
the absorption of coal tar through the scalp and into the
blood vessels below.
Benzyl violet 4B. Benzyl violet 4B, also known as violet 2,
is considered a carcinogen by the State of California and the
International Agency for Research on Carcinogens (OEHHA
2004, IARC 2004). An EWG analysis of ingredient labels
found benzyl violet 4B in 25 products, including an Alberto
VO5 shampoo, a Caress moisturizing body bar, and Almay nail
treatments.
Formaldehyde. Formaldehyde is a probable human carcinogen
(IARC 2004, OEHHA 2004, NTP 2002). From an inspection of
product labels, we identified formaldehyde in two OPI nail
treatment products and in a lotion designed to protect against
jellyfish stings bearing the brand name “SafeSea.”
Lead acetate. Although the most notorious health hazard
associated with lead acetate is potential harm to a developing
brain in babies and young children, it is also considered a
carcinogen by the E.U. and the U.S. government’s National
Toxicology Program (NTP 2002, UNECE 2004). Lead acetate is
an ingredient in Grecian Formula 16 hair dye.
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Progesterone. Progesterone is a probable human carcinogen,
linked in animal studies to tumors of the mammary gland and
abnormal growth of reproductive tissues (NTP 2002, OEHHA
2004). It is produced naturally by all mammals and is an
approved drug used for treatment of abnormal menstruation
and other reproductive problems. It is also an ingredient in
23 cosmetic products in EWG’s product database, including
ten “menopause creams”, hair thinning serums, and two
sunscreens. According to the National Toxicology Program’s
review of progesterone, “FDA regulates progesterone under
the Food, Drug, and Cosmetic Act (FD&CA) as a prescription
drug approved for human use. FDA has ruled that progesterone
must carry a warning label for patients and physicians
concerning use, risks, and contraindications. FDA also requires
that no residues of progesterone be found in the uncooked
edible tissues of lamb and steer” (NTP 2002). Given its
status as a regulated drug, it is not clear why progesterone
appears in non-prescription cosmetic products. On labels it
is listed as both progesterone and lutein, a common synonym
(ChemFinder 2004).
Selenium sulfide. Both the U.S. National Toxicology program
and the State of California classify selenium sulfide as a
carcinogen (NTP 2002, OEHHA 2004). It is used in one
product, Head & Shoulders Dandruff Shampoo, Intensive
Treatment, according to an EWG analysis of 7,500 product
labels.
Nitrofurazone. Nitrofurazone is classified as a carcinogen
by the State of California and the International Agency for
Research on Carcinogens, and is a mammary carcinogen
according to the U.S. government’s National Toxicology
Program (OEHHA 2004, IARC 2004, NTP 2004). It is an
ingredient in a tanning product called Total Skin Care Sunless
Tanner, For All Skin Types, listed on the ingredient label as
“NF,” a common synonym (ChemFinder 2004).
Silica. Crystalline silica is a known human carcinogen (IARC
2004). Silica in cosmetics may be in the form of tiny particles
of glass (Merck 2004), sand or bits of ground quartz from
mining operations (NIOSH 2002) — the crystalline form
of silica, or even an extract from horsetail plants (see, for
example, www.wholehealthmd.com, 2004). Of these, the
sand or quartz material is the crystalline form known to be
carcinogenic.
Other forms of silica — glass, for instance — are not considered
known human carcinogens. In sales materials, the chemical
giant Merck describes the company’s technology breakthrough in
producing of “tiny glass beads” that are now used in namebrand
toothpastes and sunscreens (Merck 2004), and a company called
SCHOTT promotes the use of a material called bioactive glass
powder for cosmetic applications (SCHOTT 2004). The State of
New Jersey cites “limited evidence that fibrous glass implanted
into animals” causes cancer (NJDHHS 2004), but the glass form of
silica is not classified as a human carcinogen.
A consumer has no way to know if the “silica” listed on the
ingredient label of a product is a respirable, carcinogenic,
crystalline silica or another form of silica that may not pose
cancer risks through inhalation. Through ingredient label
searches, EWG identified some form of silica in one of every nine
products (862 products altogether), including 14 products in
powder or aerosol form for which inhalation is likely. Regardless of
the cancer risk, consumers may want to avoid the use of powders,
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Table 1. Products that contain known or probable human
carcinogens.
77 (1.0%) products contain known or probable carcinogens. Showing top 20 product categories, ranked by
prevalence.
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Source: EWG analysis of ingredient labels from 7,494 products compared against government,
industry, and academic lists of known and suspected chemical health hazards.
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Table 2. Products that contain possible carcinogens.
2,451 (32.7%) products contain possible human
carcinogens. Showing top 20 product categories, ranked by
prevalence. See all categories. List all products.
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Source: EWG analysis of ingredient labels from 7,494 products compared against government,
industry, and academic lists of known and suspected chemical health hazards.
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even those that do not contain silica, because of potential risks
for other kinds of lung damage. In consumer education materials,
FDA notes that “powders may cause lung damage if inhaled
regularly” (FDA 2000a).
Coal tar hair dyes, bladder cancer, and
non-Hodgkin’s lymphoma
...women who used permanent hair dyes at least once
a month experienced a 2.1-fold risk of bladder cancer
relative to non-users... We estimate that 19% of bladder
cancers in women in Los Angeles County, California, may
be attributed to permanent hair-dye use. (Gago-Dominguez
et al. 2001)
The use of hair color products appears to increase the risk
of non-Hodgkin’s lymphona... If these results represent
a causal association, use of hair coloring products would
account for 35% of non-Hodgkin’s lymphoma cases in
exposed women and 20% in all women. (Zahm et al. 1992)
Seventy-one hair dye products contain ingredients derived
from carcinogenic coal tar and specifically exempt from federal
authority over adulterated products that can harm health. These
include dyes made by Clairol, Revlon, L’Oreal, and others. Coal tar
hair dyes are one of the few products for which FDA has issued
consumer advice on the benefits of reducing use, in this case as a
way to potentially “reduce the risk of cancer” (FDA 1993).
Coal tars and coal tar pitches are known human carcinogens (IARC
1987). The specific components of coal tar used in hair dyes —
aromatic amines — have been shown to mutate DNA (IARC 1993),
and to cause cancer in animals (Sontag 1981). An increasing
number of studies of humans link long-time hair dye use with
cancer, including bladder cancer, non-Hodgkin’s lymphoma, and
multiple myeloma.
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Much of the evidence linking hair dyes with bladder cancer
comes from studies of hairdressers. In seven of 10 populations
studied (from the US, Norway, Sweden, Finland, Denmark, Japan),
scientists found elevated incidence of bladder cancer among
hairdressers, barbers, beauticians and cosmetologists exposed to
hair dyes — 40 percent higher, on average, than population-wide
risks. Hair dye exposure was also linked to bladder cancer in seven
of 12 case-control studies focused specifically on occupational
history among bladder cancer victims (Gago-Dominguez et al.
2001).
In 1993 the International Agency for Research on Cancer found
that “occupation as a hairdresser or barber entails exposures that
are probably carcinogenic” (IARC 1993), and a recent study by
scientists from the University of Southern California’s School of
Medicine shows that hairdressers and barbers with more than 10
years on the job face a five-fold increase in bladder cancer risk
compared to people not exposed to hair dye (Gago-Dominguez et
al. 2001).
Is cancer a risk outside the beauty industry, for consumers who
dye their hair? In 1982 the National Bladder Cancer Study failed
to find a relationship between hair dye use and bladder cancer
risk among 3,000 bladder cancer victims. While this study has
long provided assurance of low risks from hair dye exposure
among people outside the beauty industry, a growing number of
more sensitive, focused studies are heightening concerns that
long-time or frequent hair dye use does, in fact, substantially
increase cancer risks. These findings have been catalyzed by more
sophisticated research techniques that include the collection
of detailed information on the type of hair dye used, and the
inclusion of factors that account for an individual’s genetic
susceptibility to cancer.
In 2001 researchers from the University of Southern California’s
(USC) School of Medicine found that women using permanent hair
dye at least once a month more than double their risk of bladder
cancer (Gago-Dominguez et al. 2001). Earlier studies had failed
to segregate the use of permanent dye from semi-permanent
and temporary dyes; the USC study showed this may be a critical
distinction. The authors estimate that “19% of bladder cancers
in women in Los Angeles County, California, may be attributed
to permanent hair-dye use” (Gago-Dominguez et al. 2001). This
study is to date the largest and most scientifically rigorous on
permanent hair dye and bladder cancer incidence.
USC researchers also found that women who are genetically
vulerable to bladder cancer (so-called “slow acetylators” who
are exposed to some carcinogens for longer periods of time)
more than quadruple their risk of bladder cancer with long-time
or frequent use of permanent hair dye (Gago-Dominguez et al.
2001). These associations see further confirmation in a study
performed by researchers at Dartmouth Medical School that also
found links between permanent hair dye use and bladder cancer
(Andrew et al. 2004).
New studies have identified the particular chemicals in hair
dye thought to be linked to bladder cancer as aromatic amines,
chemicals derived from coal tar but best known as potent bladder
carcinogens in cigarette smoke (Yu et al. 2002). Association
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of permanent hair dyes with non-Hodgkin’s lymphoma,
mutiple myeloma, colorectal adenocarcinoma, lung and upper
aerodigestive tract cancers has been studied but associations have
been both positive and negative, or only preliminarily studied
(Czene et al. 2003; Skov and Lynge 1994; Zahm et al. 1992;
Brown et al. 1992; Grodstein et al. 1994; Herrinton et al. 1994;
Holly et al. 1998; Robinson and Walker 1999). Among the stronger
findings from these studies are those from the National Cancer
Institute, where researchers found that 20 percent of all cases of
non-Hodgkin’s lymphoma may be linked to hair dye use (Zahm et
al. 1992).
Alpha Hydroxy Acids (AHAs), Beta Hydroxy Acids
(BHAs), and skin cancer
Very little about the process restricts their sale. And
it’s a somewhat alarming idea to put acids on the skin.
It raises obvious safety questions. — Dr. John Bailey,
Table 3. Products that contain coal tar dyes.
71 hair dye products contain coal tar dyes.
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Source: EWG analysis of product ingredient labels against CIR identifications of coal tar dyes (CIR 2003).
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Director of FDA’s Office of Cosmetics and Color, on the use
of alpha hydroxy acids (AHAs) in cosmetics (FDA 1999)
After four weeks of AHA application, volunteers’
sensitivity to skin reddening produced by UV increased by
18%. Similarly, the volunteers’ sensitivity to UV-induced
cellular damage doubled, on average, with considerable
differences among individuals. — FDA’s Office of Cosmetics
and Color, on new AHA safety studies (FDA 2000b)
On May 21, 1992 FDA issued a consumer warning that commercial
“skin peel” products, advertised to remove wrinkles, blemishes,
blotches and acne scars, could destroy the upper layers of the
skin, causing severe burns, swelling, and pain. FDA describes
the following progression: “The skin initially reddens, as with
a sunburn, then darkens and finally peels away revealing what
manufacturers claim will be “new skin.” Treatments may be painful
and leave permanent scars” (FDA 1992).
Since these initial warnings, the use of the active skin peel
ingredients — alpha and beta hydroxy acids (AHAs and BHAs)
— has grown dramatically in the cosmetic industry. According
to EWG’s assessment of ingredient labels for 7,500 personal care
products, these acids are now added to one of every 17 products
on the market, including nearly 10 percent of all moisturizers and
six percent of all sunscreens (Table 4). The acids are commonly
used in products promoted as enhancing the youthful appearance
of skin.
Beginning with its initial burn warnings, FDA has now studied
the safety of AHAs and BHAs for 14 years, driven in part by
the increasing use of these acids in cosmetics, as well as by
the agency’s estimate that AHAs and BHAs injure 1,000 people
nationwide each year (FDA 1999). Most recently, FDA’s Office
of Women’s Health sponsored studies that have linked these
ingredients to UV-induced skin damage and potential increased
risks of skin cancer. The studies identified a doubling of UV
damage to skin among people using AHA-containing products
(FDA 2000b).
According to the Environmental Protection Agency, skin cancer in
the U.S. has reached “epidemic proportions,” with more than one
million new cases occurring each year. At current rates one in five
Americans is expected to develop skin cancer over their lifetime,
and one American dies every hour from the disease (EPA 2004).
The use of acids in cosmetics may be contributing to current skin
cancer rates. The use of these acids in sunscreens, where they
appear in six percent of all products we assessed, is perplexing
21
and counterintuitive, and may detract from the cancer protection
sunscreen products normally provide.
FDA’s 14-year review process has culminated with the Agency
issuing guidance on the need for product manufacturers to include
sunburn warnings on their products (FDA 2002). The guidance is
draft, set to be finalized in 2004, and is voluntary, highlighting
the agency’s lack of meaningful authority over cosmetics, even on
an issue that the Director of FDA’s Office of Cosmetics and Color
found “alarming” (FDA 1999). The suggested warnings, a rare
request from an agency that has in its history tackled only a few
cosmetic safety issues in such depth, include language advising
consumers to “Use a sunscreen and limit sun exposure while using
this product and for a week afterwards” (FDA 2002).
The cosmetic industry’s efforts to preserve the use of these
acids in products began with an industry-sponsored study that
showed increased UV-induced skin damage for product testers.
The cosmetic trade association CTFA presented this study to the
industry’s safety panel in 1996. According to FDA, the panel
approved the use of AHAs in cosmetics in June 1997 in spite
of the study results and “in spite of serious safety questions
submitted by a consumer group and a major manufacturer” (FDA
1997).
The industry panel found that AHAs are “safe for use in cosmetic
products at concentrations less than or equal to 10 percent,
at final formulation pHs greater than or equal to 3.5, when
formulated to avoid increasing the skin’s sensitivity to the
sun, or when directions for use include the daily use of sun
protection.” For salon use, the panel found AHAs “safe for use
at concentrations less than or equal to 30 percent, at final
formulation pHs greater than or equal to 3.0, in products designed
for brief, discontinuous use followed by thorough rinsing from the
skin, when applied by trained professionals, and when application
is accompanied by directions for the daily use of sun protection”
(CIR 2003).
In their critique of industry panel recommendations, FDA implies
that the safety panel’s admonition to industry is less than useful
to consumers, since “AHA concentration and pH are generally
not noted on all products. (FDA does not require it.)” The agency
notes that consumers can request the information from the
manufacturer (FDA 1997).
22
Comments on AHAs from FDA’s Director of the Office of Cosmetics
and Color Dr. John Bailey, coming several years prior to the
agency’s issuance of suggested, voluntary warning language for
cosmetic manufacturers, illustrate the problem inherent in a
regulatory system that does not require premarket safety testing:
Table 4. Products that contain AHAs and BHAs.
494 (6.6%) products contain alpha and beta hydroxy acids.
Showing top 20 product categories, ranked by prevalence.
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Source: EWG analysis or product ingredient labels against listings of AHAs and BHAs from FDA and
CIR (2003). Analysis excludes salts and esters classified as AHAs and BHAs.
There are 9 of these products that contain 3 or more alpha and beta hydroxy acids.
“There are many unanswered questions in front of us... AHAs are
unlike anything else ever introduced onto the cosmetic market on
such a wide scale. They are not your traditional cosmetics” (FDA
1999).
23
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27
28
Part 2: Pregnancy Concerns
Therefore, based on demonstrated reproductive and
developmental toxicity associated with dermal and other
exposures, these ingredients are considered unsafe for use
in cosmetic formulations.
— Cosmetic industry safety panel’s findings on
ethoxyethanol acetate (CIR 2003), an ingredient that
continues to be used in Anna Sui nail color 105
The personal care product industry’s self-regulating health and
safety body, the Cosmetic Ingredient Review panel, has found
more than 99 percent of all chemicals reviewed safe for use in
cosmetics. Of the nine ingredients rejected by the panel, two
were found unsafe based on potential risks posed to a developing
child. With these exceptions, for the vast majority of ingredients
reviewed, the panel found little of concern with respect to
developmental and reproductive toxicity. But an assessment of
CIR ingredient review summaries, compared with data on known
and probable reproductive toxins from government sources, shows
that the panel routinely approves ingredients that show evidence
of impairing reproduction or harming development in the womb.
Established reproductive toxins are used in scores of personal care
products:
• At least four ingredients listed as known or probable
developmental and reproductive toxins by government
agencies are used in personal care products, nearly all of
them nail care products, according to EWG’s assessment of
7,500 product ingredient labels: dibutyl phthalate (used
in 95 nail polishes and other nail care products), toluene
(used in 60 nail polishes and other nail care products),
lead acetate (used in Grecian Formula 16 hair dye), and
ethoxyethanol acetate (used in Anna Sui nail color 105).
• One of every ten ingredients approved for use by The
Cosmetic Ingredient Review panel shows some evidence of
reproductive toxicity in laboratory studies, according to
EWG’s assessment of CIR review summaries (CIR 2003), and
is approved for use in cosmetics in spite of these studies.
Approximately the same fraction of approved ingredients
is linked to birth defects and other developmental harms
in laboratory studies. For many of the ingredients in CIR
29
(2003), the panel’s review represents the only available
comprehensive information on the chemical, given the
dearth of government assessments of personal care product
ingredients. Because so many of the ingredients reviewed
by the CIR show at least some evidence of reproductive
and developmental toxicity, it is likely that the accounting
of products we describe below is an underestimate of
products that may pose concerns for reproduction or a
developing child in the womb.
Summary of known and probable human reproductive
and developmental toxins
Dibutyl phthalate (DBP) is an industrial plasticizer and wellestablished reproductive toxin that targets the male reproductive
system. DBP has been approved for use in cosmetics by the CIR,
first in 1985 and again upon reassessment in 2002 (CIR 2003).
DBP will be banned for use in cosmetics in the EU by September
2004. DBP is widely used in nail polishes to impart flexibility to
the polish film as it dries on the nail.
Toluene is considered a reproductive toxin by the State of
California (OEHHA 2004) and the EU (UNECE 2004). In its
establishment of a public health goal for toluene in drinking
water, California’s Office of Environmental Health Hazard
Assessment found that “Studies in animals have shown a clear
association of toluene exposure with developmental toxicity”
(OEHHA 1999), including reduced fetal weight, and bone growth
deficiencies and deformities.
Lead acetate is used in progressive hair dye products applied over
a period of days for gradual coloring (FDA 2002). Lead acetate
dyes continue to be used in Grecian Formula 16 despite the
widely acknowledged fact that lead lodges in the brain, causes
permanent brain damage, and lingers in the body for decades
(e.g., Rice 1995). Most of the evidence for harm centers on the
developing brain of a child, with IQ deficits being the most
familiar outcome from a large body of literature on lead toxicity.
Increasingly, lead is postulated to play a role in diseases of aging,
such as Parkinsons, although few studies have been conducted to
date (e.g., Gorell et al. 2004). Research shows that lead residues
can be spread throughout a home after normal use of the hair dye
products (Mielke et al. 1997)
30
In 2002 the CIR concluded that ethoxyethanol acetate was unsafe
for use in cosmetics, finding that “numerous reproductive and
developmental toxicity studies, across several species, involving
various routes of administration, indicate that... Ethoxyethanol
Acetate [is a] reproductive toxicant and teratogen [causes birth
defects]” (CIR 2003). This ingredient is used in Anna Sui nail
color 105.
More information on the toxicity of two of these ingredients,
dibutyl phthalate and lead acetate, and discussion of their
prevalence in personal care products is provided below.
Phthalates. Phthalates are industrial plasticizers widely used
in personal care products to moisturize and soften skin, to
dissolve and coalsesce ingredients, and to impart flexibility to
nail polish after it dries. More than two decades ago, scientists
began building a body of work indicating that phthalates are
reproductive and developmental toxicants in laboratory animals,
particularly in males. Early studies focused on phthalates’ ability
to cause testicular atrophy (e.g., Gray and Buttersworth 1980),
but phthalates are now known to cause a broad range of birth
defects and lifelong reproductive impairments in laboratory
animals exposed in-utero and shortly after birth targeting every
organ in the male reproductive system (e.g., Ema et al 1998,
Marsman 1995, Mylchreest et al 1998, 1999, and 2000, Gray et al
1999, Wine et al 1997).
In September 2000 scientists from the Centers for Disease Control
and Prevention (CDC) reported finding phthalates in every one
of 289 people tested, at surprisingly high levels. These tests,
considered the first accurate measurements of human phthalate
exposures, led to authors to conclude that “from a public
health perspective, these data provide evidence that phthalate
exposure is both higher and more common than previously
suspected” (Blount et al. 2000). The tests showed higher levels
of phthalates in women of reproductive age than any other group.
CDC postulated that this difference could derive from personal
care product exposures, which might vary by gender more than
exposures from other common consumer products laden with
phthalates (plastic, food wrap, and pharmaceuticals, for example).
Since the publication of CDC’s findings, the Environmental
Working Group (EWG) has conducted two investigations on the
prevalence and levels of phthalates in personal care products.
The first, a study titled Beauty Secrets (EWG 2000), reported on
the widespread use of dibutyl phthalate in nail polish, at levels
up to five percent of product weight. The second, instigated by
Healthcare Without Harm in partnership with Women’s Voices for
the Earth and EWG, detailed results of a product testing program
that found phthalates in nearly three-quarters of a wide range of
products tested, despite the fact that none listed the phthalate
ingredient on the label (Not Too Pretty, EWG et al. 2002). As
these groups documented the common use of phthalates in
personal care products, CDC published new results of phthalate
31
testing in more than 2,500 people ages six and above, confirming
their original findings: phthalate exposures are widespread across
the population, and women are exposed at higher levels than men
(with exposures expressed as “creatinine-adjusted,” corrected for
urine concentration) (CDC 2003).
Cosmetic labelling requirements state that all cosmetics produced
or distributed for retail sale to consumers for their personal
care bear a list of ingredients, ordered by prevalence (21 CFR
701.3). Cosmetic labeling requirements apply to all cosmetics
marketed in the U.S., whether manufactured here or abroad.
But industry can use phthalates as components of fragrances or
chemical mixtures that are considered “trade secrets,” both of
which are exempt from labelling requirents. Industry sources have
indicated that phthalates do not appear on the vast majority of
products containing them simply because they are components of
fragrance and thus exempt from labelling requirements. This gives
consumers little power to avoid phthalates in their purchases of
personal care products.
After the publication of product testing results in Not Too Pretty
(EWG et al. 2002), the industry safety panel, the CIR, reviewed
available toxicity data for DBP and other phthalates. These
ingredients had last been reviewed by the panel in 1985, since
which time scientists had conducted the bulk of the research
demonstrating phthalates’ reproductive toxicity. At the same time
that the E.U. was banning phthalates from use in personal care
products (DBP and DEHP), the CIR again found phthalates “safe
for use in cosmetic formulations in the present practices of use
and concentration” (CIR 2003).
The panel made this finding based in part on an exposure
estimate proposed by the cosmetic trade association, CTFA, that
relied on phthalate testing results for 72 products conducted
by public health and environmental groups (EWG et al. 2002).
Although CTFA claims as its members 600 companies (CTFA 2004),
the organization could find no more comprehensive source of data
on phthalate levels in products than that provided by testing
paid for by public interest groups, targeting 72 of the presumably
thousands of products manufactured by their members. If the
industry wishes to retain what FDA calls their “well-established
self regulation” (FDA 1995), they might do well to implement an
industry-sponsored data collection program instead of relying on
others for such data.
32
The industry panel’s assessment fell far short of standard scientific
practice. Among other shortcomings, the panel failed to consider
the fact that consumers using phthalate-laden cosmetics have
a background burden of phthalates in their bodies from other
sources of exposure; failed to incorporate in its estimates the
significant fraction of women exposed to phthalates at levels
exceeding the government’s safe dose, according to CDC’s testing
programs (Kohn et al. 2000); failed to collect data on measured
concentrations of phthalates in air, particularly in nail salons
and rooms with poor ventilation, where inhalation may be a
significant source of phrthalate exposure; and failed to consider
the ability of penetration enhancers, used in more than half of all
personal care products, to increase the absorption of phthalates
through the skin.
FDA has not produced an independent, public review of the
safety of phthalates in cosmetics. Instead the agency has
advised consumers that there is “no reason... to be alarmed.” The
agency notes that it is conducting its own review to determine
if phthalate exposures from cosmetics are a health concern, and
that if this review shows “that a health hazard exists, the agency
will advise the industry and the public, and will consider its legal
options under the authority of the Food, Drug and Cosmetic Act in
protecting the health and welfare of consumers” (FDA 2001).
Although the industry’s trade group and safety panel have not
recommended that phthalates be phased out of cosmetics, many
companies have taken the step on their own. Acknowledging
requests made by a coalition of public health and environmental
groups concerned about reproductive toxins in cosmetics, fifteen
companies have now indicated their plans to produce products
free of two widely-used phthalates (dibutyl phthalate, or DBP,
and diethylhexyl phthalate, or DEHP). This decision is consistent
with E.U.-wide reformulation requirements banning their use in
cosmetics set to take effect in September 2004. [read more]
Health impacts of phthalates. Scientists have shown that
phthalates can damage the female reproductive system, but
it is the male reproductive system that appears to be more
sensitive. Phthalate exposures damage the testes, prostate gland,
epididymis, penis, and seminal vesicles in laboratory animals (see,
for example, Mylchreest et al. 1998). Most of these effects persist
throughout the animal’s life, and include, specifically:
• Testicular atrophy — a defect that leads to reduced
capacity to form sperm and male sex hormones;
• Hypospadias — a defect of the penis in which the
opening occurs on the bottom of the penis instead of the
tip;
• Undescended testicles — a condition in which
the testes fail to descend into the scrotal sac during
pregnancy;
33
• Ectopic testes — a condition in which testes are
grown outside the scrotal sac;
• Absent testes — testes are not formed at all;
• Absent prostate gland — the prostate gland
contributes liquid secretions to semen;
• Absent or small seminal vesicles — these structures,
like the prostate gland, contribute liquid secretions to
semen;
• Reduced sperm count — leads to reduced fertility;
• Malformed or absent epididymis — the epididymis is
the structure where sperm mature and are stored.
Trends in human male reproductive health include many of the
same effects seen in lab animals dosed with phthalates. Although
a cause and effect relationship has not been established, the
ubiquity of phthalates in the human population validates the
notion that phthalates may be contributing to these problems.
Until proven safe, phthalates should be considered as potential
contributors to the following human health effects:
• Declining sperm count — An analysis of 101 studies
(1934-1996) by Dr. Shanna Swan of the University of
Missouri confirms results of previous studies: average
sperm counts in industrialized countries are declining at a
rate of about one percent each year (Swan et al 2000).
• Hypospadias — Data from the Centers for Disease
Control show that rates of hypospadias in the U.S. began
climbing in about 1970, and continued this increase
through the 1980s. This condition is a physical deformity
of the penis in which the opening of the urethra occurs on
the bottom of the penis instead of the tip. Currently the
occurrence of hypospadias appears to be stable, at about
30 to 40 cases per 10,000 births (Paulozzi 1999).
• Undescended testicles — This birth defect, where
testicles fail to completely descend into the scrotum
during pregnancy, occurs in two to five percent of full-term
boys in Western countries. Rates of the defect increased
in the U.S. in the 1970s and 1980s. Men born with this
defect are at higher risk for testicular cancer and breast
cancer (Paulozzi 1999).
34
• Testicular cancer — This is the most common cancer
of young men in many countries, including the U.S. Its
incidence continues to increase at a rate of about two
to four percent each year in industrialized countries,
although rates appear to have stabilized in the U.S. after
a 20-year increase. Men with hypospadias, infertility,
and undescended testicles — the same constellation
of conditions seen in lab animals exposed to certain
phthalates — are at greater risk for developing testicular
cancer (Toppari et al 1996 and Moline et al. 2000).
Lead acetate in hair dye products. Lead acetate is not banned
from use in cosmetics by FDA. Instead it is an approved color
additive for hair dyes based on an FDA decision rendered in 1980.
The CIR has not reviewed lead acetate. We identified lead acetate
Table 1. Products that contain parabens.
4,292 (57.3%) products contain parabens. Showing top 20 product
categories, ranked by prevalence.
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in Grecian Formula 16 for men. We did not find lead acetate on
the label of hair dye products marketed to women, but nothing
disallows it use in women’s products, and we assessed just a
fraction of hair dye products on the market. Residual lead on an
adult’s hands after using the hair dye, and the potential transfer
of that lead to children in the household, is a concern regardless
of gender.
FDA approved lead acetate on the basis of human trials that
showed no evidence of significant increases in body lead levels
after hair dye use. In its guidance on assessing dermal absorption
of lead, the State of California recommends the use of data from
a 1980 hair dye absorption study showing that 0.06 percent of
radioactive lead in hair dye absorbed into the body after use,
based on a “whole body counting” technique, a study now nearly
a quarter of a century old. For lead acetate in hair dye, however,
research indicates that absorption through the scalp may not be
the main route of exposure.
In 1997 researchers from Xavier University published a study
showing that the use of lead acetate hair dyes results in small
amounts of lead being dispersed throughout the house. Lead wipe
samples collected after hair dye use found residual lead on the
Table 2. Products that contain alkylphenols and alkylphenol ethoxylates.
117 (1.6%) products contain alkylphenols and alkylphenol ethoxylates.
36
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forehead and hands of the test subject, throughout the bathroom
and even on the telephone. Lead was easily wiped from the
surface of dry hair after dyeing (Mielke et al. 1997). A subsequent
legal challenged filed under California’s Proposition 65 resulted in
the manufacturers of Grecian Formula 16 agreeing to reduce lead
levels in their product by 50 percent (CEH 2004).
Even small amounts of lead absorbed into the body might be a
concern, given that lead lodges in the brain and remains in the
body for decades (ORNL 1994). Exposures would be of particular
concern for those using lead acetate hair dyes regularly over
periods of years, and are likely a concern for everyone in the
household given the evidence that normal use of the product may
result in lead being spread throughout the home.
Because of concerns about effects of lead exposures for children,
FDA requires that lead acetate hair dyes bear the following
warning (FDA 2002):
Caution: Contains lead acetate. For external use
only. Keep this product out of children’s reach. Do not
use on cut or abraded scalp. If skin irritation develops,
discontinue use. Do not use to color mustaches, eyelashes,
eyebrows, or hair on parts of the body other than the
scalp. Do not get in eyes. Follow instructions carefully and
wash hands thoroughly after use.
Ingredients that may harm health by affecting the hormone
system. Many common ingredients used in personal care products
have the potential to disrupt hormone signaling, the body’s
communication system for growth and repair, with potential risks
ranging from impaired fertility to cancers of the reproductive
system to altered development of a child or a baby in the womb.
Much of the evidence for harms from hormonally active chemicals
comes from studies of wildlife, or from work conducted in
laboratories, but an increasing number of studies raise concerns
with respect to human health.
A recent study of 168 men found a correlation between reduced
sperm motility and sperm concentration with exposures to two
phthalate plasticizers used in a range of consumer products,
including personal care products (Duty et al. 2003). These
plasticizers are potent reproductive toxins in the laboratory.
Phthalates are used in an estimated three quarters of all personal
care products, raising concerns with respect to potential effects to
human reproduction (EWG et al. 2002).
37
Parabens are common preservatives in personal care products,
and can mimic estrogen in the body. The potential health risks
raised in relation to estrogenic chemicals include breast cancer
and altered pregnancy outcomes. Although such links have not
yet been studied in human populationssome, these relationships
are firmly borne out in laboratory studies. EWG’s assessment of
product ingredient labels identified parabens in 57.3 percent
of 7,500 products (Table 1). By this assessment, parabens are
used in more personal care products than any other synthetic
ingredient, and are second only to water in their overall
prevalence in products. Despite the cosmetic industry’s contention
that parabens are quickly metabolized and excreted from the body
(CIR 2003), a recent study identified parabens in human breast
cancer tissue, raising obvious questions about the influence these
estrogenic chemicals might have on human breast cancer risk
(Darbre et al. 2004).
Although the cosmetic industry’s self-policing safety panel has
not raised concerns with respect the the hormone activity of
synthetic ingredients, it has raised such concerns with wild yam
root: “One of the primary safety concerns with this plant extract
is the possible metabolic/endocrine activity, e.g., estrogen-like
or progesterone-like activity as a result of the presence of small
amounts of plant phytosterols such as diosgenin” (CIR 2003).
Other personal care product ingredients with the potential to
disrupt the hormone system include common surfactants known
as alkylphenols, and active ingredients in sunscreen that mimic
estrogen (Schlumpf et al. 2001) (Tables 2 and 3).
Although studies of human populations are few, and have yet
to firmly link most hormone disrupting chemicals with health
harms, many of the health trends in the population are consistent
with the spectrum of effects associated with these widely used
ingredients in laboratory studies, including recent declines in
sperm quality and recent increases in certain cancers of the
reproductive system (see discussion of phthalate toxicity above
for more detail). In light of these broad human health trends,
consumers may wish to avoid hormone disrupting ingredients in
the products they purchase.
References
Blount BC, MJ Silva, SP Caudill, LL Needham, JL Pirkle, EJ
Sampson, GW Lucier, RJ Jackson, JW Brock. (2000). Levels
of seven urinary phthalate metabolites in a human reference
population. Environmental Health Perspectives. 108(10):979-982.
38
Table 3. Products that contain sunscreens that mimic estrogen.
155 (2.1%) products contain sunscreens that mimic estrogen. Showing
top 10 product categories, ranked by prevalence.
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California Department of Toxic Substances and Control (Cal DTSC).
(1992). Supplemental Guidance for Human Health Multimedia Risk
Assessments of Hazardous Waste Sites and Permitted Facilities.
Chapter 7: Assessment of Health Risks from Inorganic Lead in
Soil. Accessed online May 10 2004 at http://www.dtsc.ca.gov/
ScienceTechnology/ Supplemental_Guidance.html#contents.
Center for Environmental Health (CEH) (2004). Consumer products.
Working with Proposition 65. Accessed online May 20 2004 at
http://www.cehca.org/consumer.htm.
Centers for Disease Control and Prevention (CDC) (2003). Second
National Report on Human Exposure to Environmental Chemicals.
Available online at http://www.cdc.gov/exposurereport/2nd/.
Cosmetics, Toiletry and Fragrance Association (CTFA) (2004).
About CTFA. Accessed online May 25 2004 at http://www.ctfa.org/
39
Content/NavigationMenu /About_CTFA/Overview_of_CTFA/About_
CTFA.htm.
Duty SM, Silva MJ, Barr DB, Brock JW, Ryan L, Chen Z, Herrick RF,
Christiani DC, Hauser R. (2003). Phthalate exposure and human
semen parameters. Epidemiology. 2003 May;14(3):269-77.
Darbre PD, Aljarrah A, Miller WR, Coldham NG, Sauer MJ, Pope GS.
(2004). Concentrations of parabens in human breast tumours. J
Appl Toxicol. 2004 Jan-Feb;24(1):5-13.
Ema M, Amano H, Ogawa Y. (1994). Characterization of the
developmental toxicity of di-n-butyl phthalate in rats. Toxicology
86:163-174.
Ema M, Kurosaka R, Amano H, Ogawa Y. (1995). Comparative
developmental toxicity of n-butyl benzyl phthalate and di-n-butyl
phthalate in rats. Arch Environ Contam Toxicol 28:223-228(1995).
Ema M, Miyawaki E, Kawashima K. (1998). Further evaluation
of developmental toxicity of di-n-butyl phthalate following
administration during late pregnancy in rats. Toxicol Lett:8793(1998).
Environmental Protection Agency (EPA). (1990). Integrated Risk
Information System. Dibutyl phthalate, CASRN 84-74-2. October
1990. Available online at http://www.epa.gov/ngispgm3/iris/
Environmental Working Group (EWG) (2000). Beauty Secrets. Does
a common chemical in nail polish pose risks to human health?
November 2000. Available online at http://www.ewg.org/reports/
beautysecrets/pr.html.
Environmental Working Group (EWG), Healthcare Without Harm,
and Womens Voices for the Earth (Houlihan, Brody, and Schwan)
(2002). Not Too Pretty. Phthalates, beauty products, and the
FDA. July 2002. Available online at http://www.ewg.org/issues/
cosmetics and http://www.safecosmetics.org.
Food and Drug Administration (FDA). (2002). Lead acetate in hair
dye products. Office of Cosmetics and Colors Fact Sheet. January 9
2002. Accessed online May 10 2004 at http://www.cfsan.fda.gov/
~dms/cos-lead.html.
Food and Drug Administration (FDA). (2001). Phthalates
and cosmetic products. Office of Cosmetics and Colors Fact
Sheet. April 19 2001. Accessed online May 10 2004 at http://
www.cfsan.fda.gov/~dms/cos-phth.html.
40
Food and Drug Administration (FDA) (1995). Cosmetic Ingredients:
Understanding the Puffery. FDA Consumer magazine. Originally
published May 1992, modified February 1995. Accessed May 18
2004 at http://www.fda.gov/fdac/reprints/puffery.html.
Foster PM, BG Lake, LV Thomas, MW Cook, SD Gangolli. (1981).
Studies on the testicular effects and zinc excretion produced by
various isomers of monobutyl-o-phthalate in the rat. Chem Biol
Interact 1981 Mar 1;34(2):233-8.
Gorell JM, Peterson EL, Rybicki BA, Johnson CC. (2004). Multiple
risk factors for Parkinson’s disease. J Neurol Sci. 2004 Feb
15;217(2):169-74.
Gray LE, Jr, Wolf C, Lambright C, Mann P, Price M, Cooper RL,
Ostby J. (1999). Administration of potentially antiandrogenic
pesticides (procymidone, linuron, iprodione, chlozolinate,
p,p’-DDE, and ketoconazole and toxic substance (dibutyland diethylhexyl phthalate, PCB 169, and ethane dimethane
sulphonate) during sexual differentiation produces diverse profiles
of reproductive malformations in the male rat. Toxicol Ind Health
15:94-118(1999).
Gray TJ and Butterworth KR (1980). Testicular atrophy produced
by phthalate esters. Arch. Toxicol. Suppl. 1980;4:452-5
Kohn MC, Parham F, Masten SA, Portier CJ, Shelby MD, Brock JW,
Needham LL. (2000). Human Exposure Estimates for Phthalates.
Environmental Health Perspectives 108(10).
Marsman DS. (1995). NTP technical report on toxicity studies of
dibutyl phthalate (CAS No. 84-74-2) administered in feed to F344
rats and B6C3F1 mice. NIH Publication 95-3353. Research Triangle
Park: National Toxicology Program.
Mielke HW, Taylor MD, Gonzales CR, Smith MK, Daniels PV Buckner
A (1997). Lead Based Hair Products: Too Hazardous for Household
Use. Some hair coloring products sold in pharmacies contain more
lead than paint, making them a public health hazard. Journal
of American Pharmaceutical Association (NS37, Jan/Feb 1997:
85-89). Available online at http://www.uwsp.edu/geo/courses/
geog100/MielkeHairLead1.htm.
Moline JM, Golden A, Bar-Chama N, Smith E, Rauch M, Chapin R,
Perreault S, Schrader S, Suk W, Landrigan P. September (2000).
Exposure to hazardous substances ad male reproductive health: a
research framework. Environmental Health Perspectives. 108(9).
Moore, M. R., P. A. Meridith, W. S. Watson, D. J. Summer, M. K.
Taylor, and A. Goldberg. (1980). The percutaneous absorption
41
of lead-203 in humans from cosmetic preparations containing
lead acetate, as assessed by whole-body counting and other
techniques. Food Cosmet. Toxicol. 18: 636.
Mylchreest E, Cattley RC, Foster PM. (1998). Male reproductive
tract malformations in rats following gestational and lactational
exposure to di(n-butyl) phthalate: An antiandrogenic mechanism?
Toxicol Sci 43:47-60(1998).
Mylchreest E, Sar M, Cattley RC, Foster PMD. (1999). Disruption of
androgen-regulated male reproductive development by di(n-butyl)
phthalate during late gestation in rats is different from flutamide.
Toxicol Appl Pharmacol 156:81-95(1999).
Mylchreest E, Wallace DG, Cattley RC, Foster P. (2000). Dosedependent alternations in androgen-regulated male reproductive
development in rats exposed to di(n-butyl) phthalate during late
gestation. Toxicol Sci(2000).
Oak Ridge National Laboratory (ORNL) (1994). Toxicity
Profiles. Toxicity Summary for Lead. Available online at http://
risk.lsd.ornl.gov/tox/profiles/lead_c.shtml.
Office of Environmental Health Hazard Assessment (OEHHA)
(1999). Public Health Goal for Toluene In Drinking Water. Prepared
by Office of Environmental Health Hazard Assessment. California
Environmental Protection Agency. Pesticide and Environmental
Toxicology Section. February 1999. Accessed online May 20 at
http://www.oehha.ca.gov/water/phg/allphgs.html.
Paulozzi LJ (1999). International trends in rates of hypospadias
and cryptorchidism. Environmental Health Perspectives. 107(4).
April 1999.
Rice, Deborah (1995). Neurotoxicity of Lead, Methylmercury, and
PCBs in Relation to the Great Lakes. Environ Health Perspect.
1995 Dec;103 Suppl 9:71-87.
Schlumpf M, Cotton B, Conscience M, Haller V, Steinmann B,
Lichtensteiger W. (2001). In vitro and in vivo estrogenicity of UV
screens. Environ Health Perspect. 2001 Mar;109(3):239-44.
Swan SH, Elkin EP, Fenster L. (2000). The question of declining
sperm density revisited: An analysis of 101 studies published
1934-1996. Environmental Health Perspectives. 108(10). October
2000.
42
Toppari, J, Larsen JC, Christiansen P, Giwercman A, Grandjean
P, Guillette Lj Jr, Jegou B, Jensen, TK, Jouannet P, Keiding N,
Leffers H, McLachlan JA, Meyer O, Muller J, Meyts, E R-D, Scheike
T, Sharpe R, Sumpter J, Skakkebaek NE. (1996). Male reproductive
health and environmental xenoestrogens. Environmental Health
Perspectives. 104. Supplement 4.
Wine R, Li LH, Barnes LH, Gulati DK, Chapin RE. (1997).
Reproductive toxicity of di-n-butyl phthalate in a continuous
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105:102-107 91997).
43
44
Part 3: Safety
Recommendations Ignored
The cosmetic industry is sensitive to the image of an
uncontrolled market where anything goes... They counter
this image with well-established self-regulation programs.
Part of the incentive for such industry policy is to avoid
increased regulatory authority.
– Director of FDA’s Office of Cosmetics and Colors (FDA
1995)
In a systematic comparison of recommendations from the personal
care product industry’s self-regulatory health and safety panel, the
CIR, with ingredient uses in 7,500 personal care products, EWG
has found that the industry routinely ignores the advice of its
own panel:
• One of every 140 products (54 products) violates
industry panel safety recommendations, including products
by Neutrogena, Desitin, Herbal Essences, and Rite Aid
(Table 1).
• Industry violations encompass 16 ingredients in 54
products found unsafe by the CIR, including ingredients
found safe only in products rinsed off the skin but used in
lotion and acne treatments, and ingredients found unsafe
for use on infant skin found in diaper creams (Table 2).
The safety violations each involve an ingredient contained in
products used in ways the CIR recommends against. The 17
violating ingredients fall in the following categories in CIR
assessments, and are contained in products intended for these
same “unsafe” purposes: unsafe in any cosmetic product (found in
nail polish and face masks), unsafe for use on skin (found in acne
treatment), safe only in products rinsed off of skin immediately
after use (found in moisturizers and skin depigmenting products),
unsafe for use on infant skin (found in diaper cream and baby
lotions), unsafe for use on injured or damaged skin (found in
lotions for chapped and dry skin), unsafe in products that are
aerosolized (found in spray products), and contains ingredients
45
Table 1. 54 products violate recommendations of industry’s self regulating health and
safety panel
Some products appear in multiple safety violation categories.
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that combine to form carcinogenic nitosamines (found in
moisturizer) (Table 2). Two ingredients are discussed below.
46
The Cosmetic Ingredient Review (CIR) panel, funded by the
industry’s trade association (the Cosmetic Toiletry and Fragrance
Association), is the only body in the U.S. that systematically
considers the safety of cosmetic ingredients. They fill a void
typically occupied by government toxicologists for other major
sources of human exposures to industrial chemicals, including
contaminants in food, air, and water. According to FDA’s Director
of the Office of Cosmetics and Colors, “In the absence of the CIR
program, there would be no systematic examination of the safety
of individual cosmetic ingredients” (FDA 1995).
The cosmetic industry safety panel has found more than 99
percent of all reviewed ingredients safe for use in cosmetics.
An assessment of the panel’s ingredient review compendium
(CIR 2003) shows that this decision is sometimes rendered in
the absence of basic toxicity data and other times in spite of
the availability of studies suggesting the potential for serious
health outcomes — evidence of increased risks for cancer or birth
defects, for example. The panel routinely considers evidence on
skin reactions to the near exclusion of other effects in forming its
conclusions.
The high rate at which the panel approves ingredients may be
driven in part by shortcomings in the scientific rigor of reviews,
or by the inherent conflict in panel members being paid by the
industry whose products they are reviewing. But given what
appears to be the relative laxity of many safety reviews, it is all
the more surprising that the cosmetics industry routinely violates
the recommendations of the panel. Examples of ingredients used
in violation of panel recommendations are discussed below.
Boric acid and sodium borate. Boric acid and sodium borate
are used in diaper creams and baby lotions, including Balmex
and Desitin products. The CIR determined these ingredients
should not be used on infant skin because “...in rare instances,
the application of Boric Acid powder to a diaper rash has been
reported to cause fatality” (CIR 2003). It may be that the baby
products EWG identified (Table 1) contain very low concentrations
of these ingredients. It does not seem likely that these products
could be causing fatalities that have gone unreported and
unnoticed by the government. Nevertheless, it may be desirable
for the companies using these ingredients to reformulate,
considering the panel’s standing recommendations and the
severity of the reported risks.
Hydroquinone. The CIR determined that hydroquinone should not
be used in non-drug cosmetic products that are left on the skin
and not immediately rinsed off. The panel drew this conclusion
based on studies linking hydroquinone to cancer and immune
system damage that targets bone marrow. This review constitutes
one of the few cases for which effects other than skin reactions
informed the panel’s conclusions. EWG identified hydroquinone on
ingredients lists of 18 products left on the skin, most designed
as depigmenters or skin lighteners. Based on the listing of
hydroquinone as an “active ingredient” on ingredient labels, a
requirement for drugs sold in the U.S., it appears that 15 of these
products are sold as drugs, falling outside the purview of the
CIR recommendations. Three products containing hydroquinone
appear to be sold as cosmetics, not drugs, and therefore violate
CIR recommendations (Table 1). The potential risks posed by
47
either the “drug” or “cosmetic” versions of these products would
be driven by the amounts of hydroquinone in the product, and by
how readily hydroquinone is absorbed through the skin, a factor
that varies based on product formulation and that is higher for
products that contain alcohol (CIR 2003).
References
Food and Drug Administration (FDA) (1995). Cosmetic Ingredients:
Understanding the Puffery. FDA Consumer magazine. Originally
published May 1992, modified February 1995. Accessed May 18
2004 at http://www.fda.gov/fdac/reprints/puffery.html.
48
Table 2. 16 ingredients are used in products that violate safety standards
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50
Part 4: Impurities of concern
in personal care products
Indeed, it has been demonstrated that nitrosamines
are carcinogenic in more animal species than any other
category of chemical carcinogen. (DTI 1998)
Clearly, it appears that [nitrosamines] can be formed
during storage, once a product has been opened.
— U.K. Department of Trade and Industry, Cosmetic
contamination study (DTI 1998)
In a 1998 personal care product testing program, a European
government agency found carcinogenic impurities in 43 percent
of 128 products tested (DTI 1998), including baby lotion and
shampoo, sunscreen, and liquid soap. This study, focused on the
family of carcinogenic chemicals called N-nitrosamines, joins
other government and industry studies showing that harmful
impurities can commonly contaminate cosmetic products (see, for
example, CIR 2003 and FDA 2000a,b).
Government and industry sources reveal 24 industrial chemicals
or groups of chemicals identified as potential impurities in a
wide range of products, with health concerns spanning cancer,
neurotoxicity, and reproductive problems (CIR 2003, FDA 2000a,b,
UNECE 2004). The certainty of these impurities’ presence in
cosmetics ranges widely, from speculation — reflected in the
industry safety panel setting limits on residues of arsenic,
mercury, PCBs and pesticides in cottonseed acid, for example
— to complete confirmation, such as the established presence
of carcinogenic nitrosamines in a wide range of personal care
products.
An EWG analysis of government and industry sources (CIR 2003,
FDA 2000a,b, UNECE 2004) shows that at least 146 cosmetic
ingredients may contain harmful impurities linked to cancer and
other serious health impacts (Tables 1 and 2), including 3 of the
top 20 most commonly used cosmetic ingredients (Table 3). Our
analysis of ingredients in 7,500 personal care products shows
that because some of these ingredients are used so widely, the
vast majority of products on the market have the potential to
51
be contaminated with impurities. None of these impurities is
regulated by the federal government:
• Nearly seventy percent of all products assessed
contain ingredients that can be contaminated with
impurities linked to cancer and other health problems,
including more than 80 percent of all lip balms and baby
bath products (Table 1).
• Many common impurities readily absorb through the
skin. FDA notes that the carcinogenic cosmetic impurity
acrylamide is “rapidly absorbed through the skin” (FDA
2004a); that dioxane, a potential impurity in a wide range
of ethoxylated cosmetic ingredients, “readily penetrates
animal and human skin” (FDA 2000); and that the common
family of impurities called nitrosamines also “penetrate
the skin” (FDA 2000a).
Sources and prevalence of impurities. Unwanted impurities in
cosmetic products can be manufacturing residuals, breakdown
products from cosmetic ingredients, environmental contaminants
in the case of plant-derived ingredients, or what are called
“unreacted monomers,” the small building blocks of the large
polymer ingredients common in cosmetics. Potential health harms
associated with impurities can dwarf those linked to the product
ingredients themselves, but are mitigated by the typically low
levels of impurities in the products.
In their cosmetic ingredient review summaries, the industry safety
panel notes concerns over potential impurities for about one of
every 10 ingredients assessed. Likewise, in 10 percent of cases
for which the panel has recommended concentration limits for
chemicals in cosmetics, the limits have been set for impurities,
not for the ingredient under review (CIR 2003). Of the four
product concerns for which FDA explicitly requests direct contact
from imported cosmetic inspectors, three are related to harmful
impurities in the products (FDA 2000b).
Cosmetic industry polices the purity of its own products. Some
manufacturers buy ingredients certified by an independent
organization called United States Pharmacopeia (USP). These
ingredients may contain lower levels of harmful impurities, but
the criteria for certification are not public. There are no federal
standards for ingredient purity. While is seems likely that some
companies purchase or manufacture refined, purified ingredients,
it is equally likely that many do not. Consumers and government
health officials have no way to know.
52
Because the purity of cosmetic ingredients is not regulated by
federal law, product purity has become a business decision.
Companies can weigh the cost of purchasing purified or certified
ingredients against the potential liability of selling products that
may contain carcinogenic impurities. Liabilities are low: cancer
typically has a long latency period, and a doctor can rarely trace
the disease back to particular exposures. Although some studies
show evidence that actions taken by industry have reduced levels
of some impurities over the past 25 years (Matyska et al. 2000),
recent testing programs undertaken by FDA and European agencies
show that the use of impure ingredients by the industry is still
common (FDA 1996, DTI 1998).
Table 1. Products that may be contaminated with impurities.
5,205 (69.5%) products may be contaminated with impurities.
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Table 2. Products that may be contaminated with
impurities, by impurity type.
54
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It is clear from a review of ingredient assessment summaries
published by the Cosmetic Ingredient Review that the industry
panel routinely approves ingredients in the absence of impurity
data. In a review of a large class of surfactants called ceteareths,
for example, the panel stressed “the importance of purification
procedures to remove... impurities” noting that “...in the
absence of impurities data, the Panel caution[s] that a Ceteareth
preparation should not contain 1,4-dioxane or ethylene oxide
which are possible oxidation products” (CIR 2003). In another
case the panel assumed industry would limit levels of acrylic acid
and methacrylic acid impurities in acrylate polymer ingredients
after learning that the impurities smell bad, an incentive for
industry to keep levels low (CIR 2003).
Two of the impurities commonly found in cosmetic ingredients are
discussed below.
1,4-dioxane. The Environmental Protection Agency considers 1,4dioxane a probable human carcinogen, based of the “induction
of nasal cavity and liver carcinomas in multiple strains of rats,
liver carcinomas in mice, and gall bladder carcinomas in guinea
pigs” (EPA, 2003). In a review conducted in 1982, the Cosmetic
Ingredient Review panel noted that the cosmetic industry was
“aware of the problem” of the presence of the 1,4-dioxane in
cosmetics and was “making an effort to lower or remove 1,4dioxane in cosmetics” (CIR 2003, review of choleth-24). But 18
years later, FDA expressed continuing concerns about 1,4-dioxane,
noting its potential to contaminate a wide range of products, its
ready penetration through the skin, and the evidence linking it to
systemic cancer in a skin painting study (FDA 2000). FDA notes
that 1,4-dioxane can be removed “by means of vacuum stripping
at the end of the polymerization process without an unreasonable
increase in raw material cost” (FDA 2000), but such treatment
would be voluntary on the part of industry.
A consumer could identify products with potential 1,4-dioxane
contamination by scanning product labels for the common
ethoxylated surfactants that may contain the impurity, which
according to FDA are identifiable by the prefix, or by the
designations, of ‘PEG,’ ‘Polyethylene,’ ‘Polyethylene glycol’
‘Polyoxyethylene,’ ‘–eth–,’ or ‘–oxynol–’ (FDA, 2000).
Nitrosamines. FDA began analyzing personal care products for
the carcinogenic impurities known as nitrosamines as early as
1979. In tests of 300 products between 1979 and 1980 the
agency identified a nitrosamine called N-nitrosoethanolamine
(NDELA) at levels up to 150 parts per million (ppm). The agency
published a notice in the Federal Register of April 10, 1979 (44 FR
21365) warning the cosmetics industry that products containing
55
nitrosamines may be considered adulterated and subject to
enforcement action. In a testing program 12 years later, the
agency found that maximum levels had dropped 50-fold, to three
ppm (Matyksa et al. 2000). And in a European agency study
published in 1998, maximum levels of total N-nitroso compounds,
including NDELA and related chemicals, had fallen to less than
one ppm (DTI 1998).
Despite the apparent reduction in nitrosamine levels achieved by
industry over the past quarter century, FDA remains concerned
about nitrosamine impurities, because of the solid evidence
linking these chemicals to cancer, and because of their ready
absorption through the skin:
FDA has urged cosmetic manufacturers to voluntarily
remove from cosmetics any ingredient which may combine
with others to form NDELA and to conduct additional
testing to determine why cosmetics become contaminated
with NDELA.
–– USFDA Office of Cosmetics and Colors, 1996
According to scientists from San Jose University, the common
nitrosamine impurity NDELA “is readily absorbed through the
skin and accumulates in organs, such as the liver, bladder, etc.
where it induces chronic toxic effects” (Matyska et al. 2000).
The International Agency for Research on Carcinogens has found
that nitrosamines are carcinogenic in all animal species studied,
including primates. No other carcinogen has been found to be
carcinogenic in as many species as nitrosamines. (IARC, 1978;
1982; 1985; 1987).
It may be the case that industry has developed methods to lower
nitrosamine levels in newly-manufactured products, but recent
studies suggest that industry’s persistence in using nitrosamine
precursors in a wide range of products guarantees that the
products will become contamined with nitrosamines during a
period of normal use, as the precursors react with other chemicals
to form nitrosamines. Our analysis shows that one of every 10
products on the market contains ingredients that can combine
with other chemicals to form nitrosamines. Notably, a study
sponsed by the U.K. Department of Trade and Industry found that
nitrosamine levels in some products had more than doubled four
months after the product was opened, and increased by more than
four-fold over 17 months (DTI 1998).
56
Breast cancer and impurities. EWG’s assessment of product
ingredient labels and data on cancer-causing chemicals identified
three common impurities in personal care products that are linked
to mammary tumors in animal studies — ethylene oxide, PAHs,
Table 3. Top 10 ingredients with impurity concerns, by prevalence of use.
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and 1,3-butadiene. The ingredients for which these impurities are
of concern are used in one of every four personal care products on
the market (Table 4).
Among girls born today, one in eight is expected to get breast
cancer and one in 30 is expected to die from it (NCI 1996, 1997,
2000). A review by scientists from Lawrence Berkeley National
Laboratory shows that as many as one of every five chemical
carcinogens causes mammary tumors in laboratory studies,
indicating that the breast is more sensitive to carcinogens than
almost any other tissue in the body (Gold et al. 1991). EWG’s
identification of three impurities linked to breast cancer does
not represent a full accounting of possible mammary carcinogens
in personal care products. Instead, it is a partial accounting
based on the National Toxicology Program’s assessment of
mammary carcinogens (NTP 2000) and other sources in the peerreviewed literature. Further study would likely identify additional
ingredients in personal care products that raise concerns with
respect to breast cancer.
•
PAHs. PAHs, or polycyclic aromatic hydrocarbons,
are common contaminants in petrolatum, also called
petroleum jelly and sold under well-known brand names
57
Table 4. Products that
might contain impurities
linked to breast cancer.
1,974 (26.3%) products
might contain impurities
linked to breast cancer.
Showing top 20 product
categories, ranked by
prevalence.
58
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like Vaseline. Petrolatum is found in one of every 14
products on the market (7.1 percent of the products
assessed by EWG), including 15 percent of all lipstick
and 40 percent of al baby lotions and oils. FDA restricts
petrolatum in food to no more than 10 parts per million,
and requires petrolatum used in food packaging or drugs
to meet impurity restrictions for PAHs (21 CFR 178, 21 CFR
172.880). But the agency allows any amount of petrolatum
of any purity in personal care products, many of which are
applied directly to the lips and swallowed. Manufacturers
would find no legal impediments to using the same
unregulated petrolatum in personal care products as can
be used in shoe polish.
Among the studies linking the petrolatum impurity
PAHs to breast cancer is a Columbia University study in
which researchers found that the breast tissue of women
with breast cancer was 2.6 times more likely to contain
elevated levels of PAHs bound to DNA (called DNA
adducts) than the breast tissue of women without breast
cancer (Rundle et al. 2000). The National Toxicology
Programs finds that some PAHs are reasonable anticipated
to be human carcinogens, and the State of California lists
a number of PAHs as carcinogens in its Proposition 65
program (NTP 2002, OEHHA 2004).
Petrolatum is listed as a probable human carcinogen
in the European Union’s Dangerous Substances Directive
(UNECE 2004), and its use in cosmetics will be banned
by September 2004 with the following caveat: “The
classification as a carcinogen need not apply if the full
refining history is known and it can be shown that the
substance from which it is produced is not a carcinogen.”
Chemical industry sources have interpreted this clause
to mean that petrolatum will continue to be allowed in
cosmetics in the EU if it is refined and meets PAH purity
standards for food set by FDA (Faust and Casserly 2003).
Even this purity standard does not set direct limits on PAH
content, but instead relies on a light absorption test as an
indirect indicator of contamination.
In the U.S. no requirement for refinement applies for
petrolatum in personal care products. Some manufacturers
likely choose refined petrolatum low in PAHs, but
perhaps some do not. Product labels do not uniformly
show the “USP” certification on the petrolatum listing
59
in EWG’s ingredient label database, and in any event,
the certification criteria for a USP listing are not public.
Some product labels include the term “skin protectant”
in parentheses after the petrolatum listing, an indication
that the petrolatum has been refined and meets FDA
requirements for drug applications. But in most cases a
consumer buying a product containing petrolatum has no
way to know if the ingredient is low in carcinogenic PAHs
or not.
•
Ethylene oxide. Ethylene oxide can be an impurity
in one of every four personal care products on the market,
judging from the prevalence of the common ingredients
associated with ethylene oxide impurities (ethoxylated
surfactants). Ethylene oxide shows “clear evidence” of
carcinogenicity in the mammary glands of both male and
female test animals, according to the National Toxicology
Program (NTP 2000).
Ethylene oxide would be expected to occur in tandem
with the carcinogenic impurity 1,4-dioxane, also a residual
contaminant in common personal care product surfactants.
According to FDA, a consumer could identify products
with these potential contaminants by scanning product
labels for the common ethoxylated surfactants that may
contain the impurity, identifiable by the prefix, or by the
designations, of ‘PEG,’ ‘Polyethylene,’ ‘Polyethylene glycol’
‘Polyoxyethylene,’ ‘–eth–,’ or ‘–oxynol–’ (FDA, 2000).
The industry’s safety panel, the CIR, routinely raises
the spectre of ethylene oxide impurities in its safety
reviews, but in nearly every case lacks the data that would
allow for an assessment of health concerns. In their review
of product ingredients known as oleths, the panel merely
noted its concerns about ethylene oxide in its review
findings: “Of concern was the possible presence of 1,4dioxane and ethylene oxide impurities. The importance
of using the necessary purification procedures to remove
these impurities was stressed” (CIR 2003).
60
In another case, the CIR was provided data from
industry showing that ethylene oxide levels in cosmetic
ingredients called nonoxynols range up to 12.2 parts per
million. The panel compared the dose of ethylene oxide
estimated from cosmetics exposures against allowable
daily doses for people exposed to the same chemical as a
residue on medical equipment, from a private standardsetting body called the International Organization
for Standardization. Finding the estimated dose from
cosmetics to be lower than the allowable dose from
medical equipment, the panel then determined that “the
use of a cosmetic product only in excessive amounts could
yield [the] level of exposure” found to be of concern for
medical devices (CIR 2003). This, the panel’s most rigorous
assessment of ethylene oxide occurrence in cosmetics,
relies on safe doses derived from a private organization
setting voluntary standards for medical equipment.
Ethylene oxide is fairly volatile and might be easily
stripped from ingredients in purification processes. FDA
notes that its companion impurity 1,4-dioxane “may be
removed from ethoxylated compounds by means of vacuum
stripping at the end of the polymerization process without
an unreasonable increase in raw material cost” (FDA 2000).
Such a process would also likely removed ethylene oxide,
but no such treatment is required for personal care product
ingredients. Levels of ethylene oxide are not restricted in
products, so consumers have no ability to know if they are
purchasing items free of ethylene oxide or not.
•
1.3-butadiene. 1,3-Butadiene is a potential
impurity in butane (also called n-butane), a propellant
used in aerosol personal care products (CIR 2003). CIR’s
safety review of butane in personal care products fails to
mention the potential for 1,3-butadiene impurities, but
in the EU, butane will be banned from use is cosmetics
by September 2004 if impurity levels exceed 0.1 percent.
1,3-Butadiene shows “clear evidence” of carcinogenicity
in the mammary glands of both male and female test
animals, according to the National Toxicology Program
(NTP 2000), and is listed as an ingredient in 198 personal
care products assessed by EWG.
61
References
Department of Trade and Industry, UK (DTI) (1998). A survey
of cosmetic and certain other skin-contact products for nnitrosamines.
Environmental Protection Agency (2003). 1,4-Dioxane (CASRN
123-91-1). Integrated Risk Information System. Available
online at http://www.epa.gov/IRIS/subst/0326.htm Updated on
November 7th, 2003.
Faust HR and EW Casserly (2003). Petrolatum and Regulatory
Requirements. Penreco. NPRA International Lubricants & Waxes
Meeting, November 13-14, 2003, Houston, TX. Accessed online
May 17 2004 at www.penreco.com/newsevents/tradearticles/
NPRA2003_Pet_Regulations.pdf.
Food and Drug Administration (FDA) (1996). Are nitrosamines in
cosmetics a health hazard? Office of Cosmetics and Colors, FDA/
CSFAN. Accessed online May 6 2004 at http://vm.cfsan.fda.gov/
~dms/qa-cos25.html Updated November 1996.
Food and Drug Administration (FDA) (2000). Prohibited
Ingredients and Related Safety Issues. Office of Cosmetics and
Colors Fact Sheet. March 30, 2000. Accessed online May 20 2004
at http://www.cfsan.fda.gov/~dms/cos-210.html.
Food and Drug Administration (FDA) (2000a). Office of Cosmetics
and Colors. Prohibited Ingredients and Related Safety Issues.
March 30 2000. Accessed online May 12 2004 at http://
www.cfsan.fda.gov/~dms/cos-210.html
Food and Drug Administration (FDA) (2000b). Center for Food
Safety Applied Nutrition. Cosmetics Compliance Program.
Imported Cosmetics Program. Issued December 8, 2000. Chapter
29 — Cosmetics and Color Technology. Accessed online May 12
2004 at http://vm.cfsan.fda.gov/~comm/cp29002.html.
Food and Drug Administration (FDA) (2004). In Vitro Percutaneous
Absorption of Acrylamide and Styrene in Human Skin From
Cosmetic Vehicles M. E. Kraeling, R. L. Bronaugh, Office of
Cosmetics and Colors, USFDA, Laurel, MD. 2004 FDA Science
Forum. Abstract available online at http://www.cfsan.fda.gov/
~frf/forum04/D-20.htm.
62
Gold LS, Slone TH, Manley NB, Garfinkel GB, Hudes ES, Rohrbach
L, Ames BN. (1991). The Carcinogenic Potency Database: analyses
of 4000 chronic animal cancer experiments published in the
general literature and by the U.S. National Cancer Institute/
National Toxicology Program. Environ Health Perspect. 1991
Dec;96:11-5.
Havery, D.C. and Chou, H.J. (1994a) N-nitrosamines in cosmetic
products. Cosmetics and Toiletries 109, 53.
Havery, D.C. and Chou, H.J. (1994b) Nitrosamines in sunscreens
and cosmetic products: occurrence, formation and trends. In
Nitrosamines and related N-nitroso compounds (Loeppky, R.N. and
Michejda, D.J., Eds) ACS Symposium Series 553. Washington, DC.
Hecht, S.S. (1998) N-Nitrosamines In Environmental and
Occupational Medicine, 3rd Ed. (Rom, W.N., Ed) Lippincott-Raven
Publishers, Philadelphia.
International Agency for Research on Carcinogens (IARC) (1978).
IARC Monograph. The evaluation of the carcinogenic risk of
chemicals to humans Some N-Nitroso compounds.
N-Nitroso compounds: occurrence and biological effect. Sci. Publ.
No. 41.
IARC Monograph. The evaluation of the carcinogenic risk of
chemicals to humans Tobacco habits other than smoking, betelquid, areca-nut chewing and some related nitrosamines.
The relevance of N-nitroso compounds to human cancer: exposure
and mechanisms. Sci. Publ. No. 84.
Matyska MT, Pesek JJ, Yang L. (2000). Screening method for
determining the presence of N-nitrosodiethanolamine in cosmetics
by open-tubular capillary electrochromatography. J Chromatogr A.
2000 Jul 28;887(1-2):497-503.
National Cancer Institute (NCI) (1996). SEER Cancer
Statistics Review. 1973-1996. Available online at http://
www.seer.ims.nci.nih.gov/Publications/CSR1973_1996/.
National Cancer Institute (NCI) (1997). SEER Cancer
Statistics Review. 1973-1997. Available online at http://
www.seer.ims.nci.nih.gov/Publications/CSR1973_1997/.
63
National Cancer Institute (NCI) (2000). Overview of the SEER
Cancer Statistics Review, 1973-1999 (overview in a single PDF
file). Available online at http://seer.cancer.gov/csr/1973_1999/
sections.html#overview.
National Toxicology Program (2002). Report on Carcinogens, Tenth
Edition; U.S. Department of Health and Human Services, Public
Health Service, National Toxicology Program, December 2002.
Available online at http://ehp.niehs.nih.gov/roc/toc10.html.
National Toxicology Program (2004). Chemicals Associated with
Site-Specific Tumor Induction in Mammary Gland. Available online
at http://ntp-server.niehs.nih.gov/htdocs/Sites/MAMM.Html.
Office of Environmental Health Hazard Assessment (OEHAA)
(2004). State of California Environmental Protection Agency.
Chemicals known to the state to cause cancer or reproductive
toxicity. http://www.oehha.ca.gov/prop65/prop65_list/files/
41604list.html.
Rundle A, Tang D, Hibshoosh H, Estabrook A, Schnabel F, Cao W,
Grumet S, Perera FP. (2000). The relationship between genetic
damage from polycyclic aromatic hydrocarbons in breast tissue
and breast cancer. Carcinogenesis. 2000 Jul;21(7):1281-9.
64
65
66
Part 5: Penetration Enhancers
One long-standing approach for improving [absorption
through skin] uses penetration enhancers (also called
sorption promoters or accelerants) which penetrate into
skin to reversibly decrease the barrier resistance.
— Scientists with the School of Pharmacy, University of
Bradford, UK (Williams and Barry 2004)
...Bisabolol is a penetration enhancer... Noting that
Bisabolol is used in baby lotions the Panel cautioned
formulators to the possibility of increased absorption
of other ingredients also contained in the formulation,
especially those ingredients whose safety is based on their
lack of dermal absorption.
– Cosmetic industry safety panel, the Cosmetic Ingredient
Review (CIR 2003)
For more than 20 years drug companies have used penetration
enhancing chemicals to deliver patch drugs like birth control and
nicotine deeper and faster through the skin and into the blood
vessels below. In some cases penetration enhancers increase
absorption of a drug by 100-fold relative to absorption without
the enhancer (Karande et al. 2004).
Although not necessarily added to cosmetics for the purpose
of enhancing penetration, many ingredients used in cosmetics
happen to have that property. A recent review of penetration
enhancers by scientists at the Drug Delivery Group at the
University of Bradford, West Yorkshire, UK, notes common
cosmetic chemicals that are used in drug delivery applications
(propylene glycol and sodium lauryl sulfate, for example)
(Williams and Barry 2004). The cosmetic industry’s safety panel
has acknowledged the use of penetration enhancers in cosmetics,
and warns the industry to consider their effect in combination
with ingredients the panel deemed safe based on an assumption
of low absorption.
67
Table 1. Penetration
enhancers are found in
products that contain
known or probable
carcinogens.
50 (0.7%) products contain
penetration enhancers in
combination with known or
probable carcinogens. There
are also 71 hair dye
products contain
penetration enhancers
in combination with
coal tar dyes.
68
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enhnacers are found in
products that contain known
or probable reproductive
toxins.
7 products contain
penetration enhancers in
combination with known
or probable reproductive
toxins.
Health concerns with penetration enhancers do not necessarily
revolve around the toxicity of the enhancer itself, but instead
with what it brings with it as it opens the skin up for greater
absorption. In our assessment of 7,500 personal care products, we
found that penetration enhancers are used in products that also
contain ingredients with significant potential health concerns:
• Fifty-six percent of 7,500 products examined contain
ingredients that are penetration enhancers, according to
data presented in CIR (2003) and peer-reviewed sources.
• 50 products contain penetration enhancers in
combination with known or probable human carcinogens
(Table 1).
combination with known or probable reproductive toxins
(Table 2).
combination with chemicals considered safe for use in
cosmetics in part because of assumed low absorption
through the skin (Table 3).
69
References
Karande Pankay, A. Jain, S. Mitragotri (2004). Discovery of
transdermal penetration enhancers by high-throughput screening.
Nature Biotechnology 22(2). February 2004.
Williams, A.C. and Barry, B.W. (2004). Penetration Enhancers. Adv.
Drug Deliv. Rev. 56, 603-618.
70
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enhancers are found in
products containing
ingredients deemed safe
for use in cosmetics (CIR
2003) in part because of
an assumption of low
absorption through the
skin.
1.6% (120) products
contain penetration
enhancers in combination
with ingredients deemed
safe for use in cosmetics in
part because of an
assumption of low
absorption through
the skin.
71
72
Part 6: Unstudied Ingredients
The Expert Panel noted the marked absence of
safety data specifically on Isostearamide DEA and MEA,
Myristamide DEA and MEA, and Stearamide DEA and MEA.
– Industry safety panel, the Cosmetic Industry Review,
commenting on the lack of data available for all six
chemicals under review before finding them all “safe for
use” in cosmetics (CIR 2003)
Since its inception in 1976, the cosmetic industry’s self-regulating
safety panel, the Cosmetic Ingredient Review (CIR), has met an
estimated 112 times and reviewed 1,175 cosmetic ingredients
(CIR 2004a, CTFA 2004, CIR 2003). Despite the notably prodigious
output of the panel, the reviews fall far short in both quantity and
quality relative to what would be needed for an industry striving
to ensure a high degree of health protection for consumers. An
analysis of industry safety panel meeting schedules, summary
panel review documents, and statistics on ingredient use in the
cosmetic industry from FDA shows:
• The CIR has assessed at most just 11 percent of the
10,500 ingredients found by FDA to be used in cosmetics
(FDA 2000, CTFA 2004).
• The CIR has spent an average of one hour and ten
minutes deliberating the use, toxicity, and safety of each
ingredient reviewed over its three decade history. [see
note 1]
• The CIR has found just nine of 1,175 ingredients
unsafe for use in cosmetics. EWG identified two of these
nine ingredients in products currently on the market.
• Just 28 of the 7,494 products we analyzed list only
ingredients that have been fully assessed for safety by
the cosmetic industry’s self-regulating panel, the Cosmetic
Ingredient Review (CIR) [link]. All other products — 99.6
percent of those examined — contain one or more
ingredients never assessed for potential health impacts by
the CIR.
A further analysis of the panel’s reviews in relation to ingredients
73
Table 1: 17 of the 50 most
prevalent ingredients in
cosmetics have not been
studied by the industry’s
safety panel.
74
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in 7,500 products from EWG’s ingredient label database shows that
the CIR has failed to review one-third of the top 50 ingredients
used in cosmetics (Table 1). These range from ingredients of
little health concern for cosmetic uses (common table salt, for
instance) to chemicals posing potential cancer risks (talc and
silica).
Our analysis of product labels also shows that of the 1,175
ingredients reviewed by the industry panel, half are not used in
cosmetics. Clearly, consumers will see health benefits from safer
products only if the panel reviews ingredients currently used by
the industry.
In FDA’s own words, the agency “cannot require companies to
do safety testing of their cosmetic products before marketing”
(FDA 1995). The government’s lack of authority to require testing
makes the reviews of the industry safety panel critical for ensuring
that cosmetic products are not harming health. That the industry
panel has reviewed so few of the ingredients used in cosmetics
raises obvious questions about the safety of products used by
millions daily.
For many of the ingredients the CIR has chosen to review, the
cosmetic industry has failed to conduct even the most basic
toxicity tests, and the panel has been unable to assess the
ingredients’ safety:
• For one of every 10 ingredients reviewed the CIR was
unable to determine if the ingredient was safe for use
in cosmetics or not (CIR 2003) and rendered a finding of
“insufficient data.”
• Nearly one of every 20 products (4.7 percent)
contains one or more ingredients that the CIR found
had insufficient testing data to support the ingredients’
safe use in cosmetics (Table 2). Under federal law if the
safety of a cosmetic product has not been substantiated,
the product’s label must read: “WARNING: The safety of
this product has not been determined” (FDA 1995). A
partial analysis of product labels did not identify any such
warnings on the products in EWG’s database containing
ingredients with insufficient data. Unless they have
conducted or uncovered studies that fill the data gaps
identified by the CIR, and these studies show the product
is safe, the manufacturers of these products may be in
violation of federal law.
The following data were not available for [six Carbomers]:
(1) exact structural composition; (2) details of manufacturing
process; (3) analytical methods; (4) potential interactions with
75
other ingredients; (5) absorption; (6) metabolism; (7) excretion;
(8) terateogenesis; (9) mutagenesis; and (10) carcinogenesis. ––
Industry safety panel, the Cosmetic Industry Review, noting nearly
complete lack of data for six cosmetic ingredients before finding
them “safe as used” based on skin irritation and allergy data (CIR
2003)
Ingredients approved with little consideration of cancer or
reproductive risks. In a detailed assessment of ingredient review
findings in CIR’s 2003 Compendium (CIR 2003), EWG determined
that the panel fails in whole to discuss any available data with
respect to cancer and mutagenicity, birth defects, and other
reproductive risks, for more than half of all ingredients approved
by the panel (642 of 1,166 ingredients approved). This may
indicate that the panel approved these chemicals in the complete
absence of such data, or it may reflect the fact that issues of skin
irritation and sensitization (allergic reactions) dominate panel
discussions and findings, a health endpoint that directly impacts
product sales. (A detailed survey of approximately one-third of
the panel’s ingredient reviews in CIR (2003) shows that CIR has
chosen sensitization and the related effect of irritation as the
basis for approximately 80% of its safety decisions, to the near
total exclusion of other health impacts.)
Unfortunately, detailed CIR scientific literature review documents
that underpin panel decisions are only available for a fee, making
difficult the task of understanding in full the data gaps faced by
the panel. According to publication listings available on the CIR
website, the panel has published 336 unique scientific literature
reviews for cosmetic ingredients, each available for purchase
at $80 (CIR 2004b). At a cost of about $27,000, then, one
would have the capacity to understand in full the data gaps for
ingredients in personal care products. This prohibitive fee stands
in stark contrast to the open access granted the public for safety
assessments of consumer products regulated by the government
and not industry, including assessments of pesticides in food
and contaminants in drinking water freely available from the
Environmental Protection Agency.
Regardless, it is clear from the review summaries published
by the panel in the open scientific literature that basic safety
data are often lacking. For instance, in their review of glycol
distearate, the panel explicitly noted a lack of subchronic testing
in lab animals and the lack of human data at levels greater than
four percent (based on product weight) before approving the
ingredient “safe as used” in cosmetics at levels up to 10 percent
(CIR 2003).
76
Note 1: According to CIR’s website, the industry-funded panel
meets four times a year in Washington DC, in meetings that last
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Table 2. Products that
contain ingredients that
the cosmetic industry safety
panel found had insufficient
testing data to support
the ingredients’ safe use in
cosmetics.
356 (4.8%) products
contain ingredients that
the cosmetic industry safety
panel found had insufficient
testing data to support
the ingredients’ safe use in
cosmetics. Showing top 20
product categories, ranked by
prevalence.
1.5 days and that are open to the public. Assuming this rate
of meetings has been constant through the 28 years since the
panel’s inception, the panel met 112 times by the end of 2003,
for a total of about 1344 hours. During these years the panel
reviewed 1,175 ingredients (CTFA 2004). An analysis of these
statistics shows that for each ingredient the panel has studied
and deliberated for an average of one hour and ten minutes.
77
References
Cosmetic Ingredient Review (CIR) (2004a). General information.
How does CIR work? Accessed online May 2004 at http://www.cirsafety.org/info.html.
Cosmetic Ingredient Review (CIR). (2004b). Publications. Accessed
online May 2004 at http://www.cir-safety.org/publication.shtml.
Cosmetics Toiletry and Fragrance Association (CTFA) (2004).
Product information: 2004 CIR Compendium. Accessed May 6 2004
through online bookstore at www.ctfa.org.
Food and Drug Administration (FDA) (1995). FDA Authority over
Cosmetics. Center for Food Safety and Applied Nutrition. Office of
Cosmetics and Colors Fact Sheet. February 3 1995. Accessed online
May 6 2004 at http://www.cfsan.fda.gov/~dms/cos-206.html.
Food Drug Administration (FDA) (2000). Center for Food
Safety and Applied Nutrition, Cosmetics Compliance Program,
Domestic Cosmetics Program, Issued July 31, 2000, Chapter 29
- Cosmetics and color technology. Accessed May 10 2004 at http:
//vm.cfsan.fda.gov/~comm/cp29001.html.
78
79
80
Part 7: Allergic Reactions
(Sensitization)
In the Expert Panel’s review of the effects of
Chlorhexidine on the mucous membrane, there was concern
about its implication in cases of anaphylactic shock
reaction... –– Industry safety panel, the Cosmetic Industry
Review, before discounting all but one case of anaphylactic
shock and finding the cosmetic ingredient chlorhexidine
“safe for use” in cosmetics (CIR 2003)
The cosmetic industry’s self-regulating safety panel, the Cosmetic
Ingredient Review (CIR), considers allergic reactions the top
health issue with cosmetics, judging from the weight placed on
the topic in panel discussions and subsequent written reviews.
The reactions can be severe, swift, and in rare cases even
life-threatening — including asthma attacks, for example, or
anaphylactic shock — or can appear as symptoms like hives,
swelling, or blistering that can begin to heal when exposures end.
Once sensitized, a person can remain so for a lifetime, enduring
allergic reactions with every subsequent exposure.
A survey of approximately one-third of the reviews in CIR (2003)
shows that the panel has chosen sensitization and the related
effect of irritation as the basis for approximately 80% of its safety
decisions, to the near total exclusion of other health impacts. Our
analysis shows that of the ingredients approved by CIR for use in
cosmetics based on irritation and sensitization data, 14 percent
also had some data indicating cancer risks, yet the panel still
chose sensitization as the health endpoint of concern, and the
basis for recommended safe levels of use.
Sensitization affects product sales. Once a consumer develops an
allergic response to a cosmetic ingredient, he or she can no longer
use that product and will no longer buy it. And the sales impact
of a consumer’s sensitization can extend beyond the original
product that elicited the reaction. Based on their experience in
treating people sensitized to cosmetics, the American Academy
of Dermatology recommends that sensitized patients use only
fragrance-free products, and avoid all perfumes, colognes, aftershaves, fingernail care products, and hair spray (AAD 2000).
81
Despite the potential financial impacts of sensitization to
the cosmetic industry, our review of product labels shows
that ingredients linked to sensitization are routinely used
by the industry, dominated by fragrances, a leading cause of
sensitization worldwide. EWG’s analysis of potentially sensitizing
ingredients in cosmetics shows that:
• Skin sensitizing ingredients are found in 76 products
that can contact the skin and that are not always rinsed
off, including between five and 25 percent of all antiaging creams, lip balms, acne treatments, anti-aging
treatments, and nail polish remover (Table 1).
• Lung sensitizing chemicals that can trigger asthsma
attacks are found in one aerosolized product, the hair
styling product Nexxus Retexxtur Curl Rejuvenating
Treatment. The sensitizer, or allergen, in this product is
an ingredient called papain, an enzyme that the E.U. has
identified as an allergen via inhalation (UNECE, 2004; EU
Directive 67/548/EEC).
Table 1. The occurence of
skin sensitizers in products
that contact the skin and
are not always rinsed off.
1.0% (76) products that
contact the skin and are
not always rinsed off also
contain skin sensitizers.
82
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• Forty-six percent of all products examined list the
word “fragrance” on the label, including more than threequarters of all body washes, conditioners, antiperspirants
and deodorants, hair styling products, baby bath wash,
mousse, nail polish remover, and hair spray (Table 2).
Fragrances are considered to be among the top five known
allergens (deGroot and Frosch 1997, cited in Jansson
and Loden 2001). In a subset of asthmatics, attacks are
specifically triggered by, and only by, cosmetic fragrances.
This indicates that fragrances may not only be a trigger
but also a cause of asthma in some cases, although more
research is needed on this subject (Norback et al. 1995;
Milqvist et al. 1996).
Sensitization reactions are common, protection for consumers is
scant. The American Academy of Dermatologists suggests that
up to 10 percent of the population will have an adverse reaction
to a cosmetic product over the course of their lifetime (AAD
2000), and a recent review of fragrance allergies by the EU’s
Scientific Committee on Cosmetic Products and Non-food Products
estimated that as many as one of every 50 people is sensitized to
fragrances (SCCNFP 1998). In 2003 an estimated three-quarters
of all cosmetic injuries reported by consumers to FDA included
symptoms consistent with sensitization — rash, redness, swelling,
blisters, sores, lumps, inflammation, irritation, dryness, peeling,
splitting, cracking, scars, choking, coughing, sneezing, shortness
of breath, and wheezing (EWG analysis of FDA 2004).
Despite the importance of minimizing allergy potential to the
financial health of the cosmetic industry, the industry’s safety
panel places little to no margin of safety between safe levels of
use for sensitizing ingredients in cosmetics, and levels shown
to elicit allergic reactions in studies. A detailed survey of
approximately one-third of the panel’s ingredient reviews in CIR
(2003) shows that CIR has incorporated a safety margin into
just 14 percent of its recommended safe values, and in one of
every five cases endorsed limits of use higher than the safe levels
determined in clinical studies. The industry panel places undue
weight on sensitization to the exclusion of nearly every other
effect, but they do it with little scientific rigor and inadequate
safety margins for consumers. Their decisions may contribute
to the high rates of allergic reactions to cosmetics across the
population.
The primary trade association for the fragrance industry, the
International Fragrance Association (IFRA), is also willing
to publish questionable science that could ultimately place
consumers at risk. For instance, the Code of Practice of the
83
frgrance association recommends that the common fragrance
compound isoeugenol be restricted to 200 ppm (parts per
million) in products. But studies show that 20 percent of persons
sensitized to this compound will react to isoeugenol at half that
level (Jansson and Loden, 2001; Johansen et al., 1996).
Consumers should report allergic reactions and other injuries
from cosmetics use to FDA. A more comprehensive accounting
of reactions will give the agency a more complete picture of the
scope of harm, and may ultimately result in safer products. FDA
requests that consumers “send reports about adverse reactions to
cosmetics, as well as problems such as filth, decomposition, or
spoilage, to: FDA, Office of Cosmetics and Colors (HFS-106), 5100
Paint Branch Parkway, College Park, MD 20740-3835” (FDA 2004).
References
American Academy of Dermatology (AAD) (2000). Allergies: The
Culprit Could Be Hiding In Your Cosmetic Bag. Accessed online
May 6 2004 at http://www.aad.org/PressReleases/allergies.html.
de Groot AC, Frosch PJ (1997). Adverse reactions to fragrances. A
clinical review. Contact Dermatitis 36:57-86, 1997.
EU chemical directive (2004). EU directive on classification
and labeling of dangerous substances (Directive 67/548/EEC).
Annex 1. Chemical compendium at http://europa.eu.int/comm/
enterprise/chemicals/legislation/ markrestr/cmrlist.pdf.
Food and Drug Administration (FDA) (2004). How to Report
Problems With Products Regulated by FDA. Accessed online
May 6 2004 at http://www.fda.gov/opacom/backgrounders/
problem.html#cosmetics.
Food and Drug Administration (FDA) (2004). Consumer Complaints
About Cosmetic Products. Accessed online May 6 2004 at http:
//www.cfsan.fda.gov/~dms/cos-comp.html.
Jansson, T. and Loden, M. (2001) Strategy to decrease the risk of
adverse effects of fragrance ingredients in cosmetic products. Am.
J. Contact Dermatitis 12, 166-169.
84
Johansen, J.D., Andersen, K.E., Menne, T. (1996) Quantitative
aspect of isoeugenol contact allergy assessed by use and patch
tests. Contact Derm. 34, 414-418.
Norback D, Bjornsson E, Janson C, Widstrom J, Boman G.
(1995) Asthmatic symptoms and volatile organic compounds,
formaldehyde, and carbon dioxide in dwellings. Occup Environ
Med. 52, 388-395.
Millqvist E, Lowhagen O. (1996) Placebo-controlled challenges
with perfume in patients with asthma-like symptoms. Allergy 51,
434-439.
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Table 2. Fragrances
are routinely used in
cosmetics and are also
commonly linked to allergic
reactions (sensitization).
46.0% (3,447) products
list “fragrance” on the
ingredient label. Showing
top 20 product categories,
ranked by prevalence.
85
86
Part 8: Questions and Answers
Are my personal care products harmful? Should I stop
using them?
You should continue to use cosmetics and other personal care
products if they are part of the routine you are comfortable with.
Our investigation of their safety shows cause for concern, not
alarm. That said, some products pose higher potential risks than
others, and given that the average adult uses 10 products a day
with 146 unique chemical ingredients, it well may be that these
risks are adding up. Some simple tips to reduce your exposures
include:
* Use fewer products. Is there something you can
cut from your daily routine, or a product you can use
less often? By cutting down on the number of chemicals
contacting your skin every day, you will reduce any
potential health risks associated with your products.
* Shop smart. Use the “Custom Report” feature of our
online investigation to customize your shopping list. Your
custom report will give suggestions for products to buy
that have fewer potential health issues.
* Avoid products containing ingredients that are known
carcinogens or that are linked to birth defects and other
reproductive problems. See our investigations on “Cancer”
and “Pregnancy Concerns” to learn more and to see lists of
products you may want to avoid.
* Use milder soaps. Soap removes dirt and grease from
the surface of your skin, but it also strips away your body’s
own natural skin oils. Choosing a milder soap may reduce
skin dryness and your need for moisturizers to replace oils
your skin can provide naturally.
* Minimize your use of dark hair dyes. Many contain
coal tar ingredients that have been linked to cancer in
some studies.
* Can you shampoo less often? Shampoos strip natural
oils from the scalp that can make hair shine and prevent it
87
from becoming dry and brittle. You might find you can cut
down on your need for conditioner and styling products
simply by shampooing less frequently.
* Cut down on your use of powders; avoid the use
of baby powder on newborns and infants. A number of
ingredients common in powder have been linked to cancer
and other lung problems when they are inhaled. FDA warns
that powders may cause lung damage if inhaled regularly.
* Choose products that are fragrance free when you
can. Fragrances can cause allergic reactions. Products that
claim to be “fragrance free” on the packaging may not
be. They could contain masking fragrances that give off a
neutral odor. Read the ingredient label - in products truly
free of fragrance, the word “fragrance” will not appear
there.
* Reduce your use of nail polish. It’s one of the few
types of products that routinely contains ingredients
linked to birth defects. Can you paint your nails less often,
or paint just your toenails and skip the fingernails? Paint
nails in a well-ventilated room, or outside. Browse our
interactive product guide for advice on nail polishes that
contain fewer ingredients of concern.
Should I be concerned about chemicals in my
cosmetics products? If they were in my food, I’d
understand the concern, but I’m only putting them
on my hair and my skin.
Very few of the ingredients used in cosmetics are legal to add
to food. It’s a good thing, then, that the skin serves as a partial
barrier, cutting down on the amounts of chemical cosmetic
ingredients that can soak through the skin and enter the blood
vessels below. Individual ingredients vary tremendously in their
ability to soak through the skin. Some absorb in only miniscule
amounts, while others can quite easily penetrate the skin. Some
areas of the body absorb chemicals much more readily than others
- the lips, and the skin under the arms and around the eyes.
88
Many ingredients are approved for use in cosmetics by industry’s
self-regulating panel not because the ingredient is thought to be
inherently safe, but simply because not much of it is expected to
absorb through the skin. It is a concern, then, that more than
half of all products contain penetration enhancers, ingredients
that alter skin structure and allow other ingredients to penetrate
more deeply and more quickly through the skin.
The average adult uses 9 personal care products each day, with
126 unique chemical ingredients. More than a quarter of all
women and one of every 100 men use at least 15 products daily.
Little research is available to document the safety or health
risks of low-dose repeated exposures to chemical mixtures like
those in personal care products, but the absence of data should
never be mistaken as proof of safety. The more that science tells
us about the effects of low dose exposures, from the subtle and
reversible to effects that are serious and permanent, the more
we understand that low doses can be harmful. But much more
study is needed to understand the contribution of exposures from
personal care products to current human health trends. In the
meantime, you can choose to purchase products that have fewer
potential health concerns by using the interactive product guide
in this report.
Can I trust what I read on the label? Fragrance free,
hypoallergenic, natural, no animal testing - what am
I really getting?
According to FDA, many claims on personal care product
packaging have considerable marketing value, but little scientific
meaning. The terms can mean anything or nothing at all,. The
attempts FDA has made to regulate the use of “natural” and
“hypoallergenic” claims were thrown out in court. Here is what
FDA says about some of the marketing terms commonly made on
personal care products (excerpted from FDA Consumer, “Clearing
up Cosmetic Confusion,” May-June 1998, last modified August
2000):
* Natural: implies that ingredients are extracted
directly from plants or animal products as opposed to
being produced synthetically. There is no basis in fact
or scientific legitimacy to the notion that products
containing natural ingredients are good for the skin.
* Hypoallergenic: implies that products making this
claim are less likely to cause allergic reactions. There are
no prescribed scientific studies required to substantiate
this claim. Likewise, the terms “dermatologist-tested,”
“sensitivity tested,” “allergy tested,” or “nonirritating”
carry no guarantee that they won’t cause skin reactions.
* Fragrance Free: implies that a cosmetic product so
labeled has no perceptible odor. Fragrance ingredients
may be added to a fragrance-free cosmetic to mask any
89
offensive odor originating from the raw materials used, but
in a smaller amount than is needed to impart a noticeable
scent.
* Cruelty Free: implies that products have not been
tested on animals. Most ingredients used in cosmetics
have at some point been tested on animals so consumers
may want to look for “no new animal testing,” to get a
more accurate indication.
Are “organic” personal care products safer?
Not necessarily, but they have other benefits you should consider.
“Organic” has no official meaning in the regulatory arena, but
generally manufacturers use the term to mean one of three things:
1. The product contains natural ingredients (typically
derived from plants) as opposed to petroleum products and
other industrial chemicals.
2. The product contains ingredients derived from plants
that were grown according to the U.S. Department of
Agriculture’s organic standards, free of pesticides and
artificial fertilizers.
3. The personal care product itself has been certified
as organic, meeting USDA’s standards for organic food
products and containing only organic plant materials and
additives approved for organic processed food.
Many ingredients derived from plants have not been safety tested.
But the same is true for industrial chemicals. Your shopping
choices ultimately support the industries that manufacture the
ingredients. Buying “natural” products made with plant materials
supports farming over the petroleum or industrial chemical
industries that manufacturer the alternatives. Buying products
with organically grown, pesticide-free plant ingredients supports
the organic farming industry, and is a contribution (albeit small)
to reducing our society’s reliance on pesticides. Products made
with organically grown plants likely contain fewer pesticide
residues than those made from plants grown conventionally.
Although FDA says there is no basis in fact or scientific legitimacy
to the notion that products containing natural ingredients are
good for the skin, your personal convictions on issues bigger than
your skin may lead you to choose them anyway.
90
What about animal testing? Shouldn’t we all be
purchasing cosmetics not tested on animals?
The “no animal testing” claim on a product may mean that the
manufacturer doesn’t test its ingredients or finished products
on animals, but it doesn’t mean the chemicals in the product
have never been tested on animals. Many of the ingredients in
cosmetics come from the petroleum and chemical industries, are
used in other types of consumer products, and have seen their
share of animal studies.
Ingredients in our products that truly have never been tested on
animals are, in essence, being tested on us, although no one is
collecting the data.
EWG advocates for safe cosmetics. We advocate for personal care
product manufacturers to transition to ingredients inherently
safer than those used now. And we advocate for pre-market
health and safety testing for ingredients that ultimately end up
in our products. For some health endpoints scientists have not
yet developed reliable alternatives to animal studies. In these
cases we support continuing research to develop reliable tests
- computer models, or “in vitro” tests done in laboratory dishes
- that do not rely on animals. But we acknowledge that current
state-of-the-art toxicology relies on animal studies as integral
to understanding how to use a chemical safely. We support tests
that are necessary to prove safety, that are relevant, and that
do not unnecessarily repeat tests already conducted by others.
Ultimately, we advocate for personal care products proven safe
before they go on the market. In some cases this requires animal
studies, although our hope is that this will not always be the
case.
I am sensitized to some ingredients in personal care
products. What kinds of products should I look for?
First, you should seek the advice of a medical professional on
product lines less likely to induce allergies. The interactive
product guide on this website can guide you to products that
don’t contain allergens identified by the industry’s self-regulating
health and safety panel, but many of the ingredients in cosmetics
have not yet been studied for their potential to cause allergic
reactions. In a survey conducted in 1994, FDA scientists found
that nearly one-quarter of the people questioned responded “yes”
to having suffered an allergic reaction to personal care products,
91
including moisturizers, foundations, and eye shadows, indicating
that many people have this problem in common with you.
The term “hypoallergenic” on product labels might not be
reliable guidance for safe shopping, as it has no official
meaning. A federal court struck down FDA’s efforts to regulate
the use of the term in 1978, and “hypoallergenic” has remained
an unsubstantiated claim ever since. It might mean that the
manufacturer has avoided the use of well-established allergens,
but it could just as easily mean nothing at all. Bottom line - if
you experience allergic reactions to personal care products, seek
the advice of a doctor and report your injuries to FDA’s voluntary
consumer injury report system. FDA requests that consumers
send reports about adverse reactions to cosmetics to: FDA, Office
of Cosmetics and Colors (HFS-106), 5100 Paint Branch Parkway,
College Park, MD 20740-3835.
92
93
94
Part 9: Interactive Website
Visit http://www.ewg.org/reports/skindeep/ for an
interactive report where you can find out about the
products you use.
95

Jane Houlihan Sean Gray Timothy Kropp, Ph.D. Chris Campbell

Transcription

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