Allowable Levels of Lead in Cosmetics

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LEAD: An Introduction
Although lead is an element found naturally on Earth, human activity such as mining, burning fossil fuels and
manufacturing has caused its vast spread. It is used as a coloring element in ceramic glazes, and in wicks of
candles. It is the traditional base metal for water pipes. Previously, lead was used in gasoline but this was recently
phased out. Due to contamination of soil by lead paints and corroded pipes, food such as fruit, vegetables, meats,
grains, seafood, soft drinks and wine may contain significant amounts of lead. Since pipes were originally made of
lead, their corrosion can lead to contamination of drinking water especially when water is slightly acidic.
Lead is basically taken up by ingestion. It can enter the human body through uptake of food (65%), water (20%)
and air (15%). Lead poisoning occurs when lead builds up in the body, often over a period of months or years. The
significant level of lead is about 10 microgram/dL since at this level, damage starts to arise, especially in children.
At higher levels, ~25 micrograms/dL, there is high possibility of damage to kidneys and nervous system in both
children and adults. Very high lead levels may cause seizures, unconsciousness and possibly death.
Signs and symptoms usually don't appear until dangerous amounts have accumulated. Exposure to amounts of
lead too low to cause symptoms in the short term may increase the risk of high blood pressure and future risk for
mental decline. Symptoms may include:
1.
2.
3.
4.
5.
6.
7.
8.
9.
Pain, numbness or tingling of the extremities
Muscular weakness
Headache
Abdominal pain
Memory loss
Mood disorders
Reduced sperm count, abnormal sperm
Miscarriage or premature birth in pregnant women
Fatigue
The mission to identify other commercially available products with significant lead content started about 3 years
ago. In August 2007, toy company Mattel recalled more than 18 million products after high lead content was found
in their toys that were subcontracted in China. Furthermore, in October 2007, Campaign for Safe Cosmetics
released a report which revealed trace amounts of lead among commercially-available lipstick brands. The group
reported these brands as having lead levels exceeding USFDA’s upper limit for candy, 0.1ppm. This news alarmed
many, particularly the media, as the companies involved are top cosmetic companies in the United States.
This leads us to our research question:
Is there a significant amount of lead among commercially available lipstick brands that can pose health risks?
The following are the objectives:
a.
To identify the allowable levels of lead according to drug authorities such as FDA
b.
To identify commercial brands of lipstick with significant lead content
c.
To compare the relative lead content in lipsticks with lead
d.
To determine if the use of the said products has already caused hazard to human health
http://www.usatoday.com/money/industries/retail/2007-09-18-lead_N.htm
http://www.lenntech.com/periodic/elements/pb.htm#ixzz15LlLh9jN
http://safecosmetics.org/downloads/A%20Poison%20Kiss_report.pdf
News Articles
10.12.2007 12:00 am
Lead Found in Lipstick
Top Brands of Lipstick Have Lead; Industry Denies Danger
Read more: http://www.thedailygreen.com/environmental-news/latest/7798#ixzz15PSOZw7h
More than half of the 33 brand-name lipsticks tested by a non-profit advocacy group had lead
in them, though none listed lead as an ingredient. Some of the reddest of the reds have high
lead content, at least in those brands that have lead at all.
The Campaign for Safe Cosmetics had an independent laboratory test the products, one-third of
which had more lead than is allowed in candy -- though the Food and Drug Administration has
set no limit for lead in cosmetics. The group claims lead applied to the lips is ingested just as
candy is, making them equivalent dangers.
Cost was no indicator of safety, with some less-expensive brands like Revlon containing no lead,
and more expensive brands like Dior Addict having high levels, relative to other brands.
These were the brands that tested with the most lead content. PPM means parts per million
and is a measure of the concentration of a substance. The FDA limit for lead in candy is 0.1
ppm.




L’Oreal Colour Riche “True Red” – 0.65 ppm
L’Oreal Colour Riche “Classic Wine” – 0.58 ppm
Cover Girl Incredifull Lipcolor “Maximum Red” – 0.56 ppm
Dior Addict “Positive Red” – 0.21 ppm
Lead is a proven neurotoxin that can cause learning, language and behavioral problems such as
lowered IQ, reduced school performance and increased aggression. Pregnant women and
young children are particularly vulnerable to lead exposure. Lead easily crosses the placenta
and enters the fetal brain where it can interfere with normal development.
The Campaign for Safe Cosmetics is calling on the industry to reformulate products to remove
lead, to require suppliers to guarantee that raw materials are free of lead and other
contaminants, and to join the campaign in demanding that the FDA more strictly regulate
personal care products.
The full report, “A Poison Kiss: The Problem of Lead in Lipstick,” including complete test results,
is posted at www.SafeCosmetics.org.
An industry group, the Cosmetic Toiletry and Fragrance Association, released this statement in
response to the allegations:
"Despite continuous allegations over the years, lead is not intentionally added to cosmetics.
Lead is a naturally occurring element that is found everywhere in the environment. Consumers
are exposed daily to lead when they eat, drink water and breathe the air. The average amount
of lead a woman would be exposed to when using cosmetics is 1,000 times less than the
amount she would get from eating, breathing, and drinking water that meets Environmental
Protection Agency (EPA) drinking water standards.
"The U.S. Food and Drug Administration (FDA) has set daily safe levels for lead exposure for
adults, children and pregnant women. The agency also has set strict limits for lead levels
allowed in the colors used in lipsticks, and actually analyze most of these to ensure they are
followed. The products identified in the Campaign for Safe Cosmetics (CSC) report meet these
standards. In fact, all the products tested in the CSC report meet the California standards for
safety established under their Prop 65 process.
"Despite the negligible levels of lead found in some lipsticks, cosmetic companies are
committed to reducing that level even further. For decades, cosmetic companies have worked
to minimize all product contamination, including lead. They actively and continually review all
raw materials to ensure that they contain the lowest levels of impurities possible. Cosmetic
companies have some of the world's leading chemists, toxicologists, and biologists to evaluate
all the safety information."
Don't Pucker Up: Lead In Lipstick
From the Department Store to the Drugstore: Lead on Your Lips
Oct. 12, 2007
You might want to think twice before touching up your lipstick.
According to a new report, some lipsticks are contaminated with lead, from drugstore brands to
designer labels.
The Campaign for Safe Cosmetics randomly purchased more than 30 lipsticks in four cities and
sent them to a lab for lead testing. More than half came back with levels of lead.
"It's unconscionable that women should have to worry about lead in lipstick," said Stacy Malkan
of the Campaign for Safe Cosmetics.
The coalition's report found that 20 of the 33 lipsticks it sent to be tested contained lead.
Higher levels were found in products made by L'Oreal, Cover Girl and Christian Dior.
Because there is no federal standard for lead in cosmetics, the advocacy group used the Food
and Drug Administration's limits for lead in candy as a yardstick.
"We want the companies to immediately reformulate their products to get the lead out and …
ultimately, really we need to change the laws and force these companies to be accountable to
women's health," Malkan said.
But the trade group representing the cosmetics industry said the report is nothing new and, not
surprisingly, the findings are not cause for worry.
"I think the levels are actually quite low — trace levels — really not something that would
present a cause for concern," said John Bailey of the Cosmetic, Toiletry, and Fragrance
Association.
Experts say pregnant women should be extra aware when it comes to lead-tainted products.
"Lead is a proven neurotoxin. It can cause learning disabilities. It's also linked to miscarriage and
infertility," Malkan said.
Bailey advises that all pregnant women consult their physician before choosing their cosmetics.
L'Oreal told ABC News that all its products are in compliance with FDA regulations and that it
upholds the highest standards of safety for its customers. Proctor and Gamble, maker of Cover
Girl, said that it stands behind the safety of its products and that all its products go through
rigorous testing procedures.
LVMH, the company that makes Dior products, said it does not use lead products in its
cosmetics. Trace amounts of lead exist in natural pigments, but the company considers those
levels harmless.
FDA Finds Lead in All Lipsticks Tested
Tuesday, June 29, 2010 by: Kim Evans, citizen journalist
(NaturalNews) According to a report from Florida's Department of Health there's no amount of
lead in the blood that's safe. Yet last year, the FDA tested for lead in 22 brands of lipstick and
found lead in every single one of them. It's estimated that the average woman inadvertently
consumes four pounds of lipstick in her lifetime and even low levels of lead in the body have
been linked to developmental delays, aggression, hyperactivity, irreversible brain damage,
being antisocial, and having attention and learning problems. Newborns are regularly found to
have lead in their umbilical cord blood, so this neurotoxin is affecting them long before their
blood brain barrier has even formed. All this, and the FDA says the lead in lipstick isn't a
problem.
One study found that children with higher levels of lead in their blood were more apt to be
arrested later in life. This is because having lead in the body regularly makes people violent and
aggressive. But who'd think that by applying lipstick each day while you're pregnant you'd be
even slightly increasing the chances that your child will behave aggressively with playmates - or
increasing the chances that your child will end up behind bars later in life? It sounds farfetched,
but if you connect the dots, it's really not.
To be fair, lead in lipstick is far from the only source of lead that most people are exposed to.
Lead is found in paints, plastics, PVC, inks, dyes, building materials, fishing tackle, and consumer
products - and it also makes its way into our bodies from these sources. But, lipstick is a product
that women apply directly to their lips and our lips are porous. In fact, our lips may be more
porous than our skin. So, in addition to the four pounds of lipstick that most women
inadvertently consume, they're likely absorbing much more. And if you're absorbing lead into
your body before becoming pregnant or while pregnant, you're exposing your child to this
known poison at a critical stage in his/her development.
The lipstick with the highest level of lead had 34 times more lead than the lipstick with the
lowest level - and the highest lead levels came from common, well-known brands that are often
purchased at drugstores. Lead is known to build in the body with time and some of it is
incorporated into our bones. Because it's stored in our bones, blood lead levels have been
found to be higher in pregnant women because their bodies are breaking down the calcium in
their bones to provide it to their children. But at the same time, pregnant women are also
releasing their stored lead.
It's interesting to watch the FDA's position on lead when it's in toys from China and how it flips
dramatically when it's brought to us from U.S. companies. But the truth is: A poison is a poison,
no matter who's manufacturing it.
from: http://www.naturalnews.com/029093_lipstick_lead.html
Lead Easily
-
Interesting Snopes.com article. Disabled yata ‘yung pagcopy ng text, basahin niyo na
lang sa site mismo.
http://www.snopes.com/medical/toxins/lipstick.asp
Objective 1: To identify the allowable levels of lead according to drug authorities such as FDA
The USFDA is a body of the United States Department of Health and Human Services concerned with the
regulation of cosmetic safety under the authority of the Federal Food, Drug and Cosmetic Act. Currently, the FDA
has not set a limit for lead as a contaminant in cosmetics. However, there are specifications set for impurities in
color additives used in cosmetics. The limit of lead levels in color additives approved for use in cosmetics is set at
20 ppm. In a study conducted by Al-Saleh et.al., all of the 26 brands consisting of 72 lipstick samples from China,
USA, France, Italy, Taiwan and Germany turned out to be positive for lead. Lead levels range from 0.27-3760 ppm.
These levels however have 3 outliers. Exclusion of these three outliers would drop the upper value of the range
from 3760 ppm to 36.90 ppm, with only two values above the limit set by the USFDA. Since there are no valid
reasons to exclude the outliers, ultimately, 4 brands are recognized as having levels beyond the 20 ppm limit.
These lipstick samples were obtained from China.
At present, the Campaign for Safe Cosmetics group set the limit to 0.1 ppm in the absence of a legislative
regulation for lead levels in cosmetics particularly lipsticks. This value was adapted based on the permissible limit
of lead in candies following the assumption that lipsticks can be ingested. This will put all tested samples in this
study as having lead content beyond the permissible level of lead the FDA set for candies. However, there has
been an argument that 0.1 ppm is not valid as a limit level for lipsticks since they are not intended for ingestion
and consumption on a regular basis and that the amount taken by the body is small.
The results of lead levels in this study are higher than the lead levels found in a study in US involving 33
brands with a range of 0.03-0.65 ppm. Another unpublished study consisting of 7 expensive brands have results
(0.36-1.07ppm) comparable to the latter study in US. This simply shows the usual amount of lead present in this
type of cosmetics. The FDA stated that trace amount of lead is unavoidable under good manufacturing practice.
Lead is not an ingredient of lipsticks but it can be present as component of a dye. The natural dyes are extracted
from herbs and vegetables and mineral based pigments include iron oxide, aluminum oxide, etc. The USFDA
exempts these natural colors from batch certification. Thus, it is possible that these natural components might
contain trace amounts of lead. Therefore, the US FDA has established a limit for lead that gets into the cosmetics
as an ingredient of dye, that is, 20ppm.
In this study, shimmering colored lipsticks have the highest lead content with a range of 0.33– 3760 ppm.
The glittery and metallic shimmering look in these lipsticks might come from Mica which is a group of silicate
minerals that are widely used in cosmetics industry. This is a naturally occurring mineral found in various types of
rocks. Therefore, Mica may contain traces of heavy metals, and thus, lead.
The Bureau of Food and Drugs in the Philippines, currently known as the FDA on the other hand, has
issued a circular (No. 2006-012) issuing a statement that the maximum allowable limit of lead in cosmetics is 20
ppm. This statement was made after the consolidation of data from other ASEAN member countries.
Objectives 2 and 3: To identify commercial brands of lipstick with significant lead content; To compare the
relative lead content in lipsticks with lead
In the USFDA website, results regarding lead content analysis in a selection of lipsticks were obtained by
scientists at the U.S. Food and Drug Administration (FDA) and reported in the Journal of Cosmetic Science. FDA
purchased lipsticks from retail stores between October and December 2007. In this study done by Hepp, Mindak
and Cheng (2009), 20 lipsticks of varying brands were found to have lead levels ranging from 0.09-3.06 ppm.
Among the 20 lipsticks, it is Cover Girl who has the highest level of lead, with 3.06 ppm. Avon has the lowest level
of lead, on the other hand, with 0.09 ppm. On the average, lipsticks included in this study had a lead level of 1.07
ppm
Objective 4: To determine if the use of the said products has already caused hazard to human health
As discussed in the study by Al-Saleh et.al.,lead in lipsticks might not cause an immediate health problem.
However, it can accumulate due to repeated application and may result in cumulative toxicity. This is also
dependent on the frequency of application which varies from one woman to another. The consequences of these
products can only be properly verified by conducting population risk assessment exposure study.
Currently, however, the FDA has assessed that the lead available in the lipsticks they have tested are safe
and should not be a cause for concern. Their statement is based on the premise that lipstick is for topical use only
and that majority of them are below the recommended limit given by public health officials (Health Canada, 2009),
which is 10ppm.
SUMMARY OF RESULTS
Allowable Levels of Lead in Cosmetics
Currently, the US Food and Drug Administration (FDA) has not set a limit for lead as a
contaminant in cosmetics, particularly lipsticks. A private group (Campaign for Safe Cosmetics, 2007),
however, has set out to evaluate the lead content of several lipsticks based on the acceptable FDA limit
of lead in candy, which is 0.01 PPM. The results of their study show that one-third of lipsticks in the
market have levels of lead exceeding those of the allowable limit for candy (0.03-0.65ppm). A new study
by the FDA (Hepp, Mindak and Cheng, (2009) also showed that the levels in the CSC study were
underestimated and that the levels of lead in some lipsticks range from 0.09ppm to 3.06ppm.
Comparing the levels of lead in lipsticks is not practical, however, according to the FDA, as lipsticks are
not meant for ingestion, unlike candies (Al-Saleh, Al-Enazi & Shinwari, 2009), and are only applied
topically.
While the FDA has no limit on lipsticks, it has however, imposed a specific limit for lead content
as an impurity in the color additives used in lipsticks or cosmetics in general. Color additives that have a
lead content of 10-20 ppm, according to the article by Al-Saleh et al (2009), are safe and acceptable by
FDA standards.
The Bureau of Food and Drugs in the Philippines, on the other hand, has issued a circular (No.
2006-012) issuing a statement that the maximum allowable limit of lead in cosmetics is 20 ppm. This
statement was made after the consolidation of data from other ASEAN member countries.
Comparison of Commercial Brands of Lipsticks with Significant Lead Content
In the study done by Hepp, Mindak and Cheng (2009), 20 lipsticks of varying brands were found
to have lead levels ranging from 0.09-3.06 ppm. Among the 20 lipsticks, it is Cover Girl who has the
highest level of lead, with 3.06 ppm. Avon has the lowest level of lead, on the other hand, with 0.09
ppm. On the average, lipsticks included in this study had a lead level of 1.07 ppm. Below is a table of the
different brands.
BRAND NAME
PARENT COMPANY
LIPSTICK LINE
AND SHADEA
COVER GIRL
PROCTER & GAMBLE
REVLON
COVER GIRL
REVLON, INC.
PROCTER & GAMBLE
LOT NUMBERSB
LEAD (PB)C
(PPM)D
INCREDIFUL LIPCOLOR
964 MAXIMUM RED
7241S1
3.06
5188S1
3.05
COLORSTAY LIPCOLOR
345 RED VELVET
COMPOSITEE
2.91F
07298
2.38
QUEEN COLLECTION
7136
2.24
Q580 RUBY REMIX
BODY SHOP
L'OREAL
LIP COLOUR
22 GARNET
C274EA
1.79
COVER GIRL
PROCTER & GAMBLE
CONTINUOUS COLOR
435 CHERRY BRANDY
7228
1.76
L'OREAL
L'OREAL
COLOUR RICHE
315 TRUE RED
FD261
1.47
REVLON
REVLON, INC.
SUPER LUSTROUS
660 BED OF ROSES
07208 1508 53
1.37
MAYBELLINE
L'OREAL
MOISTURE EXTREME
F315 COCOA PLUM
WD2891
1.21
REVLON
REVLON, INC.
SUPER LUSTROUS
725 LOVE THAT RED
07284 1508 59
1.04
0.79
L'OREAL
COLOUR RICHE
752 CLASSIC WINE
FD064
L'OREAL
FD234
0.67
CLINIQUE
ESTEE LAUDER COMPANIES INC.
LONG LAST
FJ MERLOT
AA7
0.55
CLINIQUE
ESTEE LAUDER COMPANIES INC.
LONG LAST
F9 PAPRIKA
A87
0.48
ESTEE LAUDER
ESTEE LAUDER COMPANIES INC.
PURE COLOR
1A3 MARASCHINO
B55
0.43
BURT'S BEES
CLOROX COMPANY
LIP SHIMMER
MERLOTG
1840701
0.33
MAYBELLINE
L'OREAL
MOISTURE EXTREME
E215 MIDNIGHT RED
WD3041
0.23
PEACEKEEPER
PEACEKEEPER
PAINT ME COMPASSIONATEG
H
0.17
DIOR
LVMH
REPLENISHING LIPCOLOR
752 RED PREMIERE
7A01
0.15
DIOR
LVMH
ADDICT ULTRA-SHINE
750 SHINIEST SEXINESS
7D01
0.12
MAC
ESTEE LAUDER COMPANIES INC.
MATTE LIPSTICK
VIVA GLAM I
A67
0.10
AVON
AVON
ULTRA COLOR RICH
U250 CHERRY JUBILEE
H
0.09
AVERAGE
1.07
In the study by Al-Saleh, Al-Enazi & Shinwari (2009), 48 lipsticks from 26 brands were bought
from a 2-riyals store and analyzed. Analysis of their raw data showed that the levels of lead in their
lipstick samples ranged from 0.27 to 3760 PPM. Removal of three outliers, however, adjusted the range
to 0.27–36.90 PPM, with only two brands exhibiting lead levels above 20 PPM or the FDA limit for lead
as an impurity. These two brands were noted to have originated from China as well as the other three
outliers that exhibited lead levels as high as 3760 ppm. Lipsticks with shimmers were also noted to have
high levels of lead in them (0.33–3760 PPM). All lipsticks included in the study, however, also exceeded
the 0.1 PPM US FDA permissible lead level in candy, which was the standard used by the CSC in their
study.
Effects of Cosmetics with Lead to Human Health
According to article by the Inter-organization Programme for the Sound Management of
Chemicals (1998), the allowable blood levels of lead are limited to <20 µg/dl in the general population.
In the United States, the allowable level for children is <10 µg/dl as this amount can already lead to a
2.5-point decrease in intelligence quotient of IQ.
The following blood lead levels can affect certain organs in adults:
Nervous system: overt clinical encephalopathy
Kidney: atrophy and interstitial nephritis
Gastrointestinal: colic
Formation of blood cells: anemia
Reporudctive system: hypospermia, testicular
atrophy
Nervous system: IQ/learning disruption, sensory
system deficits
Heart and Blood Vessels: Hypertension
Formation of blood cells: biochemical (enzyme
changes)
100-120 µg/dl
40-100
40-60
50
40-50
40
<7
3-30
The article mentions, however, that there is no exposure level below which lead appears to be
safe and that children are more susceptible to the toxic effects of lead due to their behavior and stage of
development. According to the American Academy of Child and Adolescent Psychiatry (2006), almost all
children in the United States have been exposed to lead, commonly from paint, water, or soil. The
Center for Disease Control (CDC) states that about 6 percent of children aged 1-2 years old have toxic
blood lead levels. As mentioned, blood lead level in children as low as less than 10 µg/dl can hamper
blood cell formation and affect one’s IQ or cause some form of learning disruption. Similar to adults,
however, higher levels may cause colic, encephalopathy, renal atrophy, and interstitial nephritis as well.
As women predominantly use lipsticks, lead exposure during pregnancy is also a viable concern.
Lead in the body are mainly stored in the bone and these stores may be mobilized due to hormonal
effects in pregnancy. Lead also readily crosses the placental barrier and may affect the fetus. Thus
childhood exposure of women may not manifest in them specifically but could affect their future
children via prenatal exposure.
Currently, however, the FDA has assessed that the lead available in the lipsticks they have tested
are safe and should not be a cause for concern. Their statement is based on the premise that lipstick is
for topical use only and that majority of them are below the recommended limit given by public health
officials (Health Canada, 2009), which is 10ppm.
The same cannot be said for other cosmetics such as kohl, however. In a study by Al-Ashban,
Aslam, and Shah (2002), it was found that the blood analyses of regular kohl users revealed a high lead
concentration and relatively low hemoglobin levels. Kohl, in the study, was also estimated to have lead
levels as high as 52.3%. For blood lead levels, the control group had a mean value of 0.9µg/dl ± 0.43
while the Kohl users group had a mean of 17.65µg/dl ±2.29. As for the hemoglobin levels, the control
group had a mean of 14.02g/dl ± 0.21 while the Kohl users group had a lower mean at 12.22g/dl ± 0.37.
The article by Al-Saleh et al (1999) also supports the findings made by Al-Ashban et al (2002),
particularly for blood lead levels.
REFERENCES
CSC, the Campaign for Safe Cosmetics (2007). A Poison Kiss: The Problem of Lead in Lipsticks. Available
from: <http://www.safecosmetics.org/about/reports.cfm>
Hepp, N.M., Mindak, W.R., and Cheng, J. (2009). Determination of total lead in lipstick: Development
and validation of a microwave-assisted digestion, inductively coupled plasma–mass spectrometric
method. Journal of Cosmetic Science, 60, 405-414.
Al-Saleh, I, Al-Enazi, S. and Shinwari, N. (2009). Assessment of lead in cosmetic products. Regulatory
Toxicology and Pharmacology, 54, 105-133.
Bureau of Food and Drugs (2006). Bureau circular 2006-012, Maximum allowable limits of heavy metals
for cosmetic products. Retrieved from www.bfad.gov.ph/oldsite/BC/bc%202006-012.pdf
Health Canada (2009), Draft Guidance on Heavy Metal Impurities in Cosmetics.
Al-Saleh I, Nester M, DeVol E, et al (1999). Determinants of blood lead levels in Saudi Arabian schoolgirls.
International Journal of Occupational Environmental Health 5,107-14.
Inter-organization Programme for the Sound Management of Chemicals (1999). Global opportunities for
reducing the use of leaded gasoline. Available from: http://www.chem.unep.ch/pops/pdf/lead/toc.htm
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