Assessment of lead in cosmetic products

Iman Al-Saleh
*
, Sami Al-Enazi, Neptune Shinwari
Environmental Health Section, Biological & Medical Research Department, King Faisal Specialist Hospital & Research Centre, P.O. Box 3354, Riyadh 11211, Saudi Arabia
a r t i c l e i n f o
Article history:
Received 19 August 2008
Available online 27 February 2009
Keywords:
Lead exposure
Lipsticks
Eye shadow
Cosmetics
Saudi Arabia
a b s t r a c t
There have been a number of recent reports in the media and on the internet about the presence of lead in
brand-names lipsticks. This has drawn our attention to assess the safety of various cheap brands of cos-
metics sold at 2-riyals stores in Saudi market that are imported from countries where safety regulations
are poorly enforced as well as they lack perfect conditions for manufacturing. Lead contents were deter-
mined in 26 and eight different brands of lipsticks and eye shadows using the Zeeman atomic absorption
spectrophotometer coupled to graphite tube atomizer after an acid digestion procedure. Lead was
detected in all the studied samples. The median (25th75th percentile) lead content in 72 lipsticks sam-
ples was 0.73 (0.491.793) PPM wet wt. in the range of 0.273760 PPM wet wt. There were four brands of
lipsticks with lead content above the FDA lead limit as impurities in color additives (20 PPM). The FDA
does not set a limit for lead in lipstick. Three of them were extremely high points and considered outliers.
The median (25th75th percentile) lead contents in pressed powder eye shadow was 1.38 (0.9441.854)
PPM wet wt. (n = 22) in the range of 0.4258.7 PPM wet wt. One brand was above 20 PPM the US FDAs
lead limit as impurities. The overall results indicate that lead in lipsticks and eye shadows are below the
FDA lead limit as impurities and, thus, probably have no signicant toxicological effects. Nevertheless,
few brands had lead content above 20 PPM that might put consumers at the risk of lead poisoning. Lead
is a cumulative, and applying lead-containing cosmetics several times a day or every day, can potentially
add up to signicant exposure levels. Pregnant and nursing mothers are vulnerable population because
lead passes through placenta and human milk and affect fetus or infants developments. Our ndings call
for an immediate mandatory regular testing program to check lead and other toxic metals in lipsticks and
other cosmetic products imported to Saudi Arabia in order to curtail their excess and safeguard consumer
health.
2009 Elsevier Inc. All rights reserved.
1. Introduction
Lead is a naturally occurring element in the earths crust. It is
widely distributed through the environment because it has been
extensively used worldwide in gasoline, consumer products, recy-
cling old products and manufacturing processes (CDC, 1991).
Although important measures have been implemented in a num-
ber of countries to decrease environmental lead exposure such as
the use of unleaded gasoline, removal of lead from paint, solder
of canned foods and glazed ceramics used for storage and prepara-
tion of food, it is still a major environmental health problem in spe-
cic communities and targeted high-risk populations. Lead affects
virtually every system in the body such as the reproductive, neuro-
logical, hematopoietic, hepatic, and renal systems (Meyer et al.,
2008). More than 90% of the lead body burden is localized in bone
with an average half-life of more than 20 years (WHO, 1995). Bone
releases lead during periods of increased bone turnover in wo-
mens lives, such as pregnancy, lactation, and menopause (Gulson
et al., 1998; Vahter et al., 2004; Ettinger et al., 2007). It is well
established that lead can cross the placenta during pregnancy
and has been associated with intrauterine fetal death, premature
delivery and low birth weight (Papanikolaou et al., 2005). Maternal
blood lead levels of approximately 10 lg/dl have been linked to in-
creased risks of pregnancy hypertension, spontaneous abortion,
and reduced offspring neurobehavioral development (Bellinger,
2005). Furthermore, the consequences of accelerated bone loss
during menopause due to decrease in estrogen production may
place women at increased risk for elevated lead levels (Vahter
et al., 2007).
There are numerous reports and research papers on other po-
tential sources for lead exposure that are hidden and need to be ad-
dressed. These include ethnic folk remedies and cosmetics,
Mexican terra cotta pottery, toys and certain imported candies
and spices (Al-Saleh et al., 1996; Baer et al., 1998; Lekouch et al.,
2001; CDC, 2002, 2004; Ernst, 2002a, b; CDC, 2004; Woolf and
Woolf, 2005; Kales et al., 2007; Meyer et al., 2008). Recently, the
Campaign for Safe Cosmetics in the United States raised another
0273-2300/$ - see front matter 2009 Elsevier Inc. All rights reserved.
doi:10.1016/j.yrtph.2009.02.005
* Corresponding author.
E-mail address: iman@kfshrc.edu.sa (I. Al-Saleh).
Regulatory Toxicology and Pharmacology 54 (2009) 105113
Contents lists available at ScienceDirect
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j our nal homepage: www. el sevi er . com/ l ocat e/ yr t ph
concern about the presence of lead in lipsticks. They found that
more than half of the tested 33 brand-name red lipsticks (61%)
contained detectable lead in the range of 0.030.65 PPM (CSC,
2007). Since the US Food and Drug Administration has not set a
limit for lead in lipsticks, the CSCs results was evaluated based
on the acceptable FDA limit of lead in candy assuming that lipstick
can be ingested like candy. They found that one third of the tested
lipsticks had lead levels exceeded 0.1 PPM FDAs lead limit in candy
(US FDA, 2006a). According to the FDA, this is not a fair comparison
because candy is intended for ingestion and which may be con-
sumed on a regular basis. While lead levels in lipstick, a product in-
tended for topical use and which is ingested in much smaller
quantities than candy (US FDA, 2007a).
Eye cosmetics could be another source of heavy metals expo-
sure. For example, various colors are used in manufacturing eye
shadows and the US FDA has allowed the use of some natural col-
ors or inorganic pigments such as iron oxide, carmine, Mica, tita-
nium dioxide, copper powder, bronze powder, aluminum
powder, manganese violet etc. (US FDA, 2007b). Though the US
FDA has not set a specic limit for lead content but has set a limit
for its content that is considered to be safe in color additives which
is typically between 10 and 20 PPM. There have been several re-
ports on the presence of lead and other metals in traditional eye
cosmetics such as Kohl and Surma (Al-Saleh, 1998; Hardy et al.,
2004, 2006; Lekouch et al., 2001; Al-Ashban et al., 2004). While
Kohl is allowed in a number of countries, the Federal Food, Drug,
and Cosmetic Act (FD&C Act) dened it as a color additive and
there is no regulation permitting its use in a cosmetic or in any
other FDA-regulated product (US FDA, 2006b). On the other hand,
there are hardly studies on metal contents in eye cosmetics apart
from the study of Sainio et al.s (2000). They screened various
brands of eye shadows for heavy metals and found the levels of
lead and arsenic were less than 20 PPM, but higher levels of cobalt
and nickel were detected. Authors recommended that good manu-
facturing practice of cosmetic products should be applied in order
to ensure the absence of harmful levels of impurities in the
ingredients.
Though, the European Union (EU) laws for cosmetics banned
lead and lead compounds in cosmetics since 1976 (Council Direc-
tive 76/768/EEC, 1976), trace amounts of lead are unavoidable un-
der conditions of good manufacturing practice. Cosmetic products
and ingredients are not subject to the US FDA pre-market approval
authority, with the exception of color additives (US FDA, 2007a).
However, the Federal Food, Drug, and Cosmetic Act (FD&C Act) col-
lects samples for examination and analysis as part of its plant
inspections, import inspections, and follow-up to complaints of ad-
verse reactions. They may also conduct research on cosmetic prod-
ucts and ingredients to address safety concerns (US FDA, 2005).
Therefore, the US FDA lays the responsibility on the cosmetic rms
for checking the safety of their products and ingredients before
introducing it into the market. Most of developing countries lack
safety regulations for cosmetics and other products that comply
with the US FDAs requirement such as labeling violations, the ille-
gal use of color additives, and the presence of poisonous or delete-
rious substances, such as pathogenic microorganisms (US FDA,
2002b, 2006c).
There have been various reports in the media and on the inter-
net discussing whether lipsticks with lead levels ranging from 0.03
to 0.65 PPM reported by the CSC in 2007 should be of concern. The
claims that these levels are well below the FDA limit for lead as
impurities in color additives (20 PPM). Reports about lead in lip-
sticks are not new and in the 1990s, the FDA checked a similar
claim from a commercial testing laboratory and found no action
was necessary because the laboratory used an un-validated and
inappropriate testing method. Such periodic allegations have urged
the FDA to establish an intramural research program that is con-
ducted by researchers of the Center for Food Safety and Applied
Nutrition (CFSAN). They are currently working on developing and
validating a method for measuring the amount of lead in lipsticks.
The method will permit FDA to make an independent evaluation of
the hazard suggested by media reports (US FDA 2007a, 2008). An
enforcement action will be taken if health hazard is found.
Nevertheless, the CSCs reported results should be taken seri-
ously until the results are scientically veried by the FDA for
two reasons. First lead is not an ingredient in lipstick but found
as impurities in the raw materials or be acquired during the man-
ufacturing process. Second most of the latest studies emphasize
that there is no safe level of lead exposure (Bellinger, 2008).
Lead exposure assessments were always based on its intake
from food, water, or air. Depending on the source, the concentra-
tion of lead and its bioavailability, the relative contribution of each
source may vary considerably (WHO, 1995). WHO (1995) esti-
mated a range of 14.428 lg/day total daily lead intake from air,
food dust, and water in adults. The major source of lead for non-
occupationally exposed adults is food and drink. For example, total
lead intakes from food by adults in the range of 26282 lg/day
from various countries as estimated by WHO (1995). ORourke et
al. (1999) assessed lead exposure from multi-pathway (air, soil,
house dust, food, beverage, and water) in the US adult population
and found daily exposure of 36 lg/day (range: 11-107 lg/day).
Lead in lipsticks represents a very minor source of lead exposure
compared to other sources because the amount of lipstick that
one applies daily is actually very small compare to the amount of
water, food or air one takes. Nonetheless, one should not exclude
the fact that lead accumulates in the body over time and repetitive
lead-containing lipstick application can lead to signicant expo-
sure levels. However, the consequences of these products can only
be properly veried by conducting population risk assessment
exposure study.
The CSCs ndings raised a concern about the safety of cheap
priced lipsticks that are sold widely in 2-riyals stores around
Riyadh City. Most of their products are imported from countries
where there is a lack of regulatory inspection as well as perfect
conditions for manufacturing. The absence of regulations relevant
to the import of cosmetics in Saudi Arabia allows the sell of prod-
ucts with harmful ingredients that jeopardizes consumer health.
Saudi Arabia remains the main market for cosmetic and beauty
products in the region. In 2005, sales of cosmetics and toiletries
was SR 5 billion (USD 1.3 billion; EUR 1.04 billion) representing a
6% increase over the previous year. This growth is partly explained
by the blooming economy and the increase in the number of
hypermarkets and specialist shops (www.beauty-on-line.com,
2006). Furthermore, the demographic nature of the country where
58% of the populations are under the age of 24, accompanied by
dramatic changes in lifestyles and increasing numbers of Saudis
joining the workforce, also played an important role in driving
sales of such products (http://www.euromonitor.com/Cosmet-
ics_And_Toiletries_in_Saudi_Arabia, 2007).
In the present study, we determined lead content in different
brands of lipstick and eye shadow samples which were collected
from various 2-riyals stores in Riyadh market in order to check
their safety.
2. Materials and methods
2.1. Samples and reagents
Like dollar stores in America, there are many 2-riyals shops in
Riyadh and other parts of Saudi Arabia where most items in these
stores are sold for 2-riyals (1 riyal 0.26 US dollar). At these shops,
one can buy anything from cooking utensils, cloths, ofce supplies,
106 I. Al-Saleh et al. / Regulatory Toxicology and Pharmacology 54 (2009) 105113
cosmetics. They are very popular and most of its products are im-
ported mainly from developing countries where no quality control
measures are applied. We purchased all the 26 different lipsticks
and eight pressed powder eye shadows brands that were available
in these stores at the time of the study. Each brand has a manufac-
turing LOT number which represents either one or more color/
shade. In this study, we collected also all the available different
LOT numbers for each brand. Total LOT numbers for lipsticks and
pressed powder eye shadows were 48 and 22, respectively. We col-
lected 38 and 15 different colors or shades of lipsticks and eye
shadows, respectively. Two to four batches per each brand of lip-
stick or eye shadow with the same LOT number were selected.
Selection of LOT number and batches were based on their availabil-
ity in stores at the time of study. Based on the brands label, coun-
try of origin was specied. Lipsticks were imported from seven
different countries (China, Thailand, Taiwan, USA, France, Italy,
and Germany). Two brands were of unknown origin. Fig. 1 shows
few samples of the studied lipsticks. On the other hand, the se-
lected eye shadows were imported from China, France, and USA
as written on the label. Most of the tested products were either
un-labeled or inadequately labeled.
Lead reference solution (1000 PPM) and 30% hydrogen peroxide
(H
2
O
2
) were obtained from Fisher ChemAlert Guide, Fisher Scien-
tic Co. Trace metal free selectipur nitric acid and ammonium
dihydrogen phosphate modier were obtained from E. Merck, D-
6100 Darmstaot, Frankfurter Strasse 250 Germany.
2.2. Sample treatment
A weighed sample of 0.2 g lipstick was placed into a Teon ves-
sel and reacted with 4 ml concentrated nitric acid, left at room
temperature for 4 h then placed in the oven overnight at 85 C.
After digestion, the sample was allowed to cool to room tempera-
ture. Furthermore, after adding 1 ml of 30% hydrogen peroxide, the
sample solutions were heated at 85 C for another hour. The clear
supernatant was transferred to polypropylene tubes and diluted to
10 ml with deionized water. Metal contents were expressed as part
per million wet weight (PPM wet wt.).
2.3. Instrumentation
Lead analysis was performed using a Varian AA-280 Zeeman
atomic absorption spectrophotometer with a hollow cathode lamp
and a deuterium lamp for background correction, coupled to GTA-
120 electrothermal atomizer and a programmable sample dis-
penser (Varian Techtron PTY. Ltd., Australia). The optimized heat-
ing programs followed for the analysis of lead were that
described by the instrument manufacturer. Lead was analyzed by
mixing one volume of digest (usually 3 ll) with an equal volume
of 1% (w/v) ammonium dihydrogen phosphate modier. Injection
volume was 6 ll. Quadruplicate determinations were made on all
samples. Methods detection limit was 0.25 PPM wet wt. The
detection limit was calculated as the mean plus 3 times the SD
of the blank sample.
Calibration lead standards were prepared each day using a man-
ual standard addition procedure where lipstick or eye shadow
samples were divided into six equal portions. Known amounts of
aqueous lead solutions were added to these to give nal concentra-
tions in the range of 0.254.0 PPM. There was a good linear relation
between absorbance and standard concentration of lead. Linearity
was evaluated by calculating the linear correlation coefcients (r)
for 7 runs of spiked lipsticks, which was 0.999 0.0001 and 2 runs
for spiked eye shadow (r = 0.999).
Due to the unavailability of certied material for lipstick or eye
shadow analysis, the accuracy of the method was determined by
measuring the recovery of lead added to either matrix. These
spiked samples were run with the test samples using the same
analytical procedure. The analytical recovery for seven spiked lip-
stick samples with 0.4, 0.8, and 1.6 PPM lead were 99.7 6.22%,
104.9 5.71%, and 103.8 1.66%, respectively. The recovery of
two sets of spiked eye shadows with 0.4, 0.8, and 1.6 PPM lead
were 109.3%, 103.9%, and 104.5%, respectively. The results for coef-
cient of variation (CV) of within-day precision for 0.3 and 0.6 PPM
wet wt. concentrations of lead were 6.8% and 3.9%, respectively.
2.4. Data analysis
Results of similar LOT numbers for each brand of the lipstick or
eye shadow were pooled and reported as average lead content in
PPM wet wt. Values in the text are presented as means SD and
median (with the 25th and the 75th percentiles). For health risk
assessment, Loretz et al.s (2005) calculated the daily usage of lip-
sticks by 360 women, ages 1865 years based on 2.35 number of
application per day. The means of lipstick usage per day was
24 mg. Based on Loretzs assumptions; we calculated the weekly
lead exposure from lipsticks. Spearmans rank correlation coef-
Fig. 1. Few samples of the tested lipsticks.
I. Al-Saleh et al. / Regulatory Toxicology and Pharmacology 54 (2009) 105113 107
Table 1
Lead contents (PPM wet wt.) in various lipstick samples.
Brand # Country of
origin
LOT NO. Color Lead content (PPM wet wt.) Mean lead content
(PPM wet wt.)
Batch # 1 Batch # 2
1 China 14 Rose 1.67 2.93 2.30
17 Bright rose 1.69 1.47 1.58
08 Shimmering beige 0.54 0.87 0.70
23 Shimmering mauve 2.69 3.46 3.08
2 China 17 Mocha 0.53 0.82 0.67
16 Red brown 0.59 0.91 0.75
06 Copper 0.47 0.62 0.54
02 Shimmering violet 0.23 0.43 0.33
01 Mocha 0.53 1.06 0.80
3 Unknown 04 Shimmering pink 0.37 0.78 0.57
11 Shimmering orange 0.33 0.79 0.56
03 Chocolate/Shimmering pink 1.09 1.34 1.21
04 Shimmering pink/peach 1.49 1.55 1.52
4 China 63 Shimmering beige 1985.0 2070.0 2027.50
81 Rose 1.97 1.55 1.76
5 China 02 Light mocha 0.39 0.36 0.38
03 Mocha 0.52 1.33 0.92
05 Red 0.24 0.31 0.28
08 Shimmering beige 1.81 2.43 2.12
07 Light rose 0.55 0.78 0.66
19 Shimmering beige 0.40 0.57 0.48
05 Rose 0.66 0.74 0.70
12 Chocolate 39.80 34.0 36.90
03 Red 1.04 0.18 0.61
12 Dark Rose 0.36 0.24 0.30
01 Shimmering peach 0.41
10 Shimmering rose 0.50 0.50 0.50
08 Shimmering bronze 1.68 1.95 1.82
07 Green 0.57 0.49 0.53
6 Taiwan 33 Light pink 0.26 0.48 0.37
7 China 501 Ruby red 0.34 0.60 0.47
515 Shimmering mocha 0.75 1.23 0.99
526 Chocolate 1.66 1.83 1.74
535 Dark rose 1.54 2.07 1.81
532 Light rose 0.45 0.66 0.55
509 Dark red 0.54 0.55 0.55
8 Unknown 08 Shimmering violet 0.76 0.63 0.69
9 China 952 Rose 2.17 2.06 2.11
822 Light mocha 12.35 20.80 16.58
10 China 22 Shimmering mocha 3.44 3.38 3.41
13 Red 0.90 0.99 0.94
18 Shimmering mocha 0.94 1.55 1.24
21 Shimmering pink 0.75 0.77 0.76
11 China 46 Dark mauve 1.13 0.97 1.05
37 Dark rose 3.12 2.52 2.82
30 Mocha 2780.0 2265.0 2522.50
04 Red 2.44 2.44
40 Brown 1.97 2.91 2.44
12 China 01 Shimmering dark mocha 0.59 2.03 1.31
13 China 804 Red brown 0.71 0.55 0.63
14 Taiwan 03 Dark mocha 0.64 0.61 0.63
05 Dark rose 0.46 0.57 0.52
08 Chocolate 0.50 0.47 0.49
15 Thailand 30 Shimmering red brown 0.68 0.62 0.65
121 Shimmering beige 0.46 0.56 0.51
197 Shimmering beige 0.33 0.40 0.36
16 Germany 11 Red brown 1.00 1.38 1.19
60 Mocha 2.97 2.64 2.80
17 China 10 Bright rose 24.40 16.45 20.43
09 Shimmering beige 3740.0 3780.0 3760.0
18 USA 29 Cinnamon 0.23 0.32 0.28
12 Pink 0.30 0.24 0.27
19 Taiwan 12 Orange 0.33 0.30 0.31
27 Light violet 0.40 0.37 0.39
28 Copper 0.35 0.37 0.36
108 I. Al-Saleh et al. / Regulatory Toxicology and Pharmacology 54 (2009) 105113
cient was employed to provide an estimate of relationship between
different batches of brand with similar LOT number. The data were
evaluated using the SPSS for Windows (Version 13.0, SPSS Chicago,
IL). Values were considered signicant at P < 0.05.
3. Results
3.1. Lead contents in lipsticks
Table 1 lists the results of lead analysis in the 26 brands of lip-
sticks. The mean value of lead in 72 lipstick samples as an aver-
age of two batches with the same LOT number was
117.40 576.80 PPM wet wt. The rule is always that any value
more than three standard deviations from the mean should be
considered as an outlier. In this study, three data points with ex-
tremely high lead concentration were found in different lipstick
brands. The acid digestion of these samples was repeated three
times and the results were consistent. As for the possibility of
matrix interferences, our recovery results is an indication of
how efcient our analytical procedure. Since we do not have spe-
cial cause for this unusual deviation and it is also not advisable to
delete these points because they might be representing true
observations, we decided to keep the suspected outliers. How-
ever, our lead data was presented as median (25th75th percen-
tile). The median is less sensitive to outliers and better measure
than the mean for highly skewed distributions. Our median
(25th75th percentile) values for lead levels as an average of
the two batches of lipstick were 0.73 (0.4891.793) PPM wet
wt. in the range of 0.273760 PPM wet wt. There was consistency
in the lead contents of the two different batches of the same
brand (r = 0.87, P = 0). When we looked at the lead contents
according to the color of lipsticks (Fig. 2), it seems the highest
lead content was found in shimmering colored lipsticks in the
range: 0.333760 PPM wet wt.
3.2. Lead contents in eye shadow
In the eight different brands of pressed powder eye shadows
that we analyzed in this study, our median (25th75th percentile)
values for lead levels as an average of two to four batches of eye
shadows were 1.38 (0.9441.854) PPM wet wt. in the range of
0.4258.7 PPM wet wt. Only single product gave lead content high-
er than 20 PPM (FDAs set specication for impurities). As indicated
in Table 2, the lead content in the various batches of the same
brand and LOT number were consistent. Correlation test gave r-va-
lue of 0.79 (P = 0).
3.3. Weekly lead intake
Based on Loretz et al.s data and the assumption in 2005 that
lipstick can be ingested; we calculated our results in terms of the
weekly lead exposure. Based on median value, the weekly lead
exposure is 0.12 lg/week in the range of 0.045631.68 lg/week.
4. Discussion
Lead was detected in all tested lipstick samples in the range of
0.273760 PPM wet wt. If we exclude the three questionable out-
liers, the mean lead contents in lipsticks dropped from 117.40 to
2.07 PPM wet wt. (range: 0.2736.90 PPM wet wt.) with only
two brands with lead content above 20 PPM the FDA limit for lead
as impurities in color additives used in cosmetics (US FDA, 2002a).
Since there was no valid reason to remove these values, we found
four brands of lipsticks with lead contents around or above 20
PPM. In the absence of legislative regulation concerning the limit
of lead in lipstick, the CSC used the 0.1 PPM US FDA permissible
lead level in candy (CSC, 2007) assuming that lipstick can be di-
rectly ingested. Using this benchmark, all tested lipstick samples
contained lead content much higher than the FDAs permissible
lead limit in candy. However, there is still some a debate that this
is not a valid limit because candy is intended for ingestion and
which may be consumed on a regular basis, while lipstick, is used
topically and might be ingested in much smaller quantities (US
FDA, 2007a). Indeed, the results of this study are much higher than
lead contents in the 33 brand-name lipsticks tested in the USA
with lead levels ranging from 0.03 to 0.65 PPM (CSC, 2007). Com-
parable to the CSC results, we found lead in seven expensive
brand-names lipsticks in the range of 0.361.07 PPM wet wt.
(unpublished result) as shown in Table 3 which reinforces their
ndings. The primary ingredients found in lipstick are wax, oil,
alcohol, and dye. Though, lead is not an ingredient of the lipsticks,
it might be present as impurities in the color additives. According
to the US FDA, trace amount of lead in cosmetics is unavoidable un-
der conditions of good manufacturing practice. Therefore, the US
FDA has established a limit for lead that gets into the cosmetics
as an ingredient of dye. For example, lead in D&C Red No. 6 dye
should not be more than 20 PPM (US FDA, 2002a). In the USA,
any cosmetics contain a color additive, they should adhere to the
FDAs requirements: (1) approval. Any color additives used in cos-
metics must be approved by FDA where a clear regulation speci-
cally addressing a substances use as a color additive,
specications, and restrictions; (2) certication. A number of color
additives must be batch certied by FDA if they are to be used in
cosmetics marketed in the US; (3) identity and specications. All
color additives must meet the requirements for identity and
specications stated in the Code of Federal Regulations (CFR);
and (4) use and restrictions. Color additives may be used only for
the intended uses stated in the regulations that pertain to them.
The regulations also specify other restrictions for certain colors,
such as the maximum permissible concentration in the nished
product (US FDA, 2007c). These regulations are applied also on im-
ported cosmetics (US FDA, 2006c). Color additives can be natural or
Table 1 (continued)
Brand # Country of
origin
LOT NO. Color Lead content (PPM wet wt.) Mean lead content
(PPM wet wt.)
Batch # 1 Batch # 2
20 USA C12 Shimmering pink 1.00 1.94 1.47
C04 Shimmering light beige 0.43 0.51 0.47
21 Italy 11 Dark mocha 0.91 0.61 0.76
22 China 20 Black 3.49 2.43 2.96
23 France 94 Dark rose 0.24 0.29 0.27
24 Taiwan 10 Mocha 0.18 0.49 0.33
25 China 04 Dark rose 0.75 0.89 0.82
07 Dark rose 3.68 2.74 3.21
26 Taiwan A9 Mauve 0.49 0.45 0.47
*
LOT NO. It means any number written on the product from which the complete history of the manufacture, control, packaging and distribution of a batch can be determined.
I. Al-Saleh et al. / Regulatory Toxicology and Pharmacology 54 (2009) 105113 109
synthetic. Natural dyes are those extracted from natural herbs and
vegetables such b-carotene, caramel, henna etc., while mineral
based pigments include iron oxide, aluminum oxide, titanium
oxide etc. The US FDA exempts natural color additives from batch
certication (US FDA, 2007b). Hence they might contain traces of
lead or mercury or arsenic. In this study, the highest lead content
was found in shimmering colored lipsticks in the range of 0.33
3760 PPM wet wt. 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. Because it is
naturally occurring earths minerals, they are distributed in various
types of rocks. Therefore, Mica may contain traces of heavy metals
(MSD, 2002). The US FDA approved the use of Mica in amounts
consistent with good manufacturing practice with lead content
should not exceed 4 PPM in food and ingested drugs while in exter-
nal used drugs, dentifrices, and cosmetics should be not more than
20 PPM (US FDA, 2002c, 2007b). If Mica or any color additives of
mineral origin is an ingredient of our tested lipsticks, then one
should not dismiss the presence of other toxic metals such as ar-
senic, mercury etc. (Sainio et al., 2000; Nnorom et al., 2005).
Pressed powder eye shadows are the most popular eye cosmet-
ics and usually applied to the eyelid by lightly stroking a soft
sponge-tipped applicator across the skin. Their main ingredients
are talc with pigments and zinc or magnesium stearate used as a
6.76%
16.22%
6.76%
33.78%
36.49%
Red colors 1.81
0.72
*
(0.27-20.43)
Shimmering
colors
242.18
0.87
*
(0.33-3760)
Light colors 0.37
0.37
*
(0.27-0.53)
Brown
colors
212.18
0.72
*
(0.33-2522.5)
Dark colors 8.90
2.44
*
(0.49-36.90)
Fig. 2. Lead contents (PPM wet wt.) in 26 brands lipsticks categorized according to colors. Vales with asterisk () are the median.
110 I. Al-Saleh et al. / Regulatory Toxicology and Pharmacology 54 (2009) 105113
binder (Draelos, 2001). Looking at the lead contents in the eight
different brands of pressed powder eye shadows, only brand # 1
had one product with 58.70 PPM wet wt. lead contents above 20
PPM the US FDAs permissible limit for lead as impurities in dye
for externally used cosmetics under good manufacturing practice
(US FDA, 2007b). On the other hand, the rest of samples were in
the range of 0.4217.68 PPM (Fig. 3). Tsankov et al. (1982) deter-
mined lead contents in various cosmetic products such as creams,
cleansing milk, shampoos, hair dyes, eye shadows, rouge, lipsticks,
powders, fond de teint, tooth pastes. The majority of their cosmetic
products contained lead 2.08 PPM. However, in only some deco-
rative cosmetic, lead content was considerably high (41.1 PPM).
Authors related to an inadequate purication of the initial raw
materials. Based on sub-acute dermal toxicity study on albino rats,
Tsankov et al. (1982) proposed that the maximum allowable con-
centration of lead should be 10 PPM. If we follow his proposed
permissible level, only two of our tested eye shadows had lead con-
tents >10 PPM. Another study by Sainio et al. (2000), reported lead
content (<20 PPM) in 49 eye shadow products.
In this study, China is the major manufacturer of our tested lip-
sticks and eye shadows. There have been a number of recent inci-
dents where imported products from China to the US markets
such as toys, jewelry, bibs, and lunch boxes were found to have dan-
gerously high lead contents. In 2007, the US Consumer Product
Safety Commission (CPSC) signed an agreement with the Chinese
authorities to introduce safety checks on products such as toys, cig-
arettes, electrics and re-works before imported to the US (CPSC,
2007). Of course regulation might be enforced by the requirement
of the importing countries. As for cosmetics, there were a series
of recalls when chromium and neodymium were found in nine
SK-II products (http://www.bpfk.gov.my/pdfworddownload/
skII.pdf) as well as ten Chinese cosmetics had dexamethasone,
chloramphenicol and metronidazole (http://www.chinaretail-
news.com/2007/11/27/931-ministry-of-health-recalls-ten-chi-
nese-cosmetics/). Since then there were few announcements to
tighten the safety of cosmetics in order to be in compliance with
international regulatory standards (http://www.export.gov/china/
exporting_to_china/cosmetics.asp, 2007). There should be always
certicate export with each cosmetic to assure that it complies with
regulations in the destination country. Signicant differences in
regulations exist among different countries. There have been two
incidents where imported products from China such as toothpaste
and toys because of diethylene glycol and lead content, respec-
tively, were removed from the Saudi markets (http://www.reu-
ters.com/article/newsOne/idUSL2372574020070823, 2007; http://
www.iht.com/articles/ap/2007/08/25/africa/ME-GEN-Saudi-China-
Toy-Recall.php, 2007). The Saudi ofcials have introduced a routine
check on Chinese toothpaste before going on the market.
Though lead in lipsticks might not cause an immediate health
problem but its cumulative effect due to repeated application can-
Table 2
Lead contents (PPM wet wt) in various eye shadows.
Brands # Country of origin LOT NO. Color Lead content (PPM wet wt) Mean Lead (PPM wet wt.)
Batch # 1 Batch # 2 Batch # 3 Batch # 4
1 China 1.00 Dark gray 1.60 1.50 1.55
2.00 Shimmering pink 93.50 23.90 58.70
3.00 Shimmering beige 2.73 2.73
6.00 Shimmering beige 2.36 2.76 3.24 2.58 2.73
2 China 3.00 Purple 0.96 1.09 1.15 1.15 2.17
2.00 Shimmering dark blue 1.29 1.40 1.34
4.00 Shimmering gray 0.47 0.76 0.62
3 China 3.00 Shimmering light blue 1.39 1.23 1.39
5.00 Brown 1.69 1.59 1.82 1.90 1.75
4 China 5.00 Brown 1.07 1.07
5.00 Light green 0.42 0.42
4.00 Shimmering green 0.75 1.83 1.84 1.47
3.00 Shimmering rose 1.00 0.50 0.75
5.00 Pink 1.21 1.27 1.24
France 1.00 Rose 1.31 1.31
4.00 Shimmering rose 0.61 0.42 0.52
4.00 Shimmering green 0.84 0.87 0.81 0.86
5 USA 13.00 Dark gray 1.53 1.67 1.60
1.00 Brown 1.66 1.58 1.62
6 France 40.00 Shimmering peach 17.93 17.43 17.68
7 China 2.00 Pink 1.02 0.99 1.00 0.90 0.97
8 1.00 Shimmering gray 1.33 1.29 1.48 1.38 1.37
Table 3
Lead contents (PPM wet wt.) in seven expensive red colored lipstick brands.
Brand # Country of origin LOT NO. Lead levels (PPM wet wt.) Mean lead levels (PPM wet wt.)
Batch # 1 Batch # 2
1 Belgium 140 1.11 1.03 1.07
2 Japan SL7 0.77 0.75 0.76
3 Belgium 30 0.90 0.90 0.90
4 France 15 0.89 0.77 0.83
5 France 282 0.44 0.46 0.45
6 France 168 0.36 0.36 0.36
7 France 18 0.44 0.41 0.42
I. Al-Saleh et al. / Regulatory Toxicology and Pharmacology 54 (2009) 105113 111
not be ruled out. As we know, lead builds up in the body over time
and lead-containing lipstick whether applied a number of times a
day or on daily basis can contribute to signicant lead exposure
levels. Nevertheless, the use of lipsticks varies from one woman
to another. When we compared our results to the provisional tol-
erable weekly intake (PTWI) proposed by the FAO/WHO Joint Ex-
pert Committee on Food Additives and Contaminants to assess
the risk of lead exposure to human health (WHO, 2000), only three
lipstick samples exceeded the PTWI of 25 lg/Kg body weight. Un-
like lipsticks, eye shadows are applied externally and previous
studies reported insignicant skin absorption of lead (WHO,
1995). Furthermore, Lilley et al. (1988) suggested that lead ab-
sorbed through the skin may be eliminated via sweat and other
extracellular uids, and hence not be as great a health hazard as in-
gested lead. There are few studies on lead dermal absorption.
Gorter et al. (2005) revealed that no toxic risk was observed when
commonly prescribed lead-containing ointment Plumbum metalli-
cum 0.4% in humans was applied on skin. The highest lead content
(0.006%) found in our tested eye shadows was much lower than the
cream used in Gorter et al.s study. Therefore, we do not expect sig-
nicant systematic toxicological effects.
Pregnant women and young children are particularly vulnerable
to lead exposure. The use of lead contaminated lipstick or eye
shadows by pregnant or /and lactating women could expose the fe-
tus and infants to the risk of lead poisoning. Latest studies show
there is no safe level of lead exposure (Bellinger, 2008). Gilbert
and Weiss (2006) emphasized the importance of lowering the
CDC blood lead action limit to 2 lg/dl arguing that there is now
sufcient and compelling scientic evidence showing that blood
lead levels below 10 lg/dl may impair neurobehavioral develop-
ment in children. Lead has also been linked to infertility and mis-
carriage. A recent review article by Mendola et al. (2008)
examined published studies and research reports from 1999 to
2007 indexed in PubMed and found that exposure to lead is the
strongest environmental contaminant that interferes with healthy
reproductive function in adult females.
As it is known, lead is a dangerous heavy metal that we are
not supposed to have it in our body. In addition to the primary
sources of lead exposure that we are likely expose to, there
seems to be many recent studies and reports revealing the
presence of lead in numerous other products such as toys, jew-
elry, herbal remedies, candy etc. that put the vulnerable popu-
lation at risk of lead poisoning (Medlin, 2004; US CPSC, 2005;
Weidenhamer and Clement, 2007). To be exposed to lead from
cosmetics raise another concern. Scientists and health care
workers are aware of the long-term health effect of lead expo-
sure. It is asymptomatic that builds up in the body giving the
chance of developing different health problems such as high
blood pressure, kidney damage, anemia, infertility, and neurobe-
havioral/learning disabilities. The overall results indicate that
lead in lipsticks and eye shadows are below lead limit as impu-
rities and, thus, probably have no signicant toxicological ef-
fects. Nevertheless, few brands had lead content above 20
PPM the US FDAs lead limit as impurities. These might put
consumers at the risk of lead poisoning. Our ndings call for
an immediate mandatory regular testing program to check lead
and other toxic metals in lipsticks and other cosmetic products
imported to Saudi Arabia in order to curtail their excess and
safeguard consumer health.
References
Al-Ashban, R.M., Aslam, M., Shah, A.H., 2004. Kohl (surma): a toxic traditional eye
cosmetic study in Saudi Arabia. Public Health 118, 292298.
8
7
6
5
4
3
2
1
Brand#
16.43
1.57
1.61
17.68
0.97
1.37
1.38
0.95
Fig. 3. Lead contents (PPM wet wt.) in eight different brands of eye shadows.
112 I. Al-Saleh et al. / Regulatory Toxicology and Pharmacology 54 (2009) 105113
Al-Saleh, I., Mustafa, A., Dufour, L., Taylor, A., Hiton, R., 1996. Lead exposure in the
city of Arar, Saudi Arabia. Arch. Environ. Health 51, 7382.
Al-Saleh, I., 1998. Sources of lead in Saudi Arabia: a review. J. Environ. Pathol.
Toxicol. Oncol. 17, 1735.
Baer, R.D., Garcia de Alba, J., Leal, R.M., Plascencia Campos, A.R., Goslin, N., 1998.
Mexican use of lead in the treatment of empacho: community, clinic, and
longitudinal patterns. Soc. Sci. Med. 47, 12631266.
Bellinger, DC., 2005. Teratogen update: lead and pregnancy. Birth Defects Res. A
Clin. Mol. Teratol. 73, 409420.
Bellinger, D.C., 2008. Very low lead exposures and childrens neurodevelopment.
Curr. Opin. Pediatr. 20, 172177.
CDC, Center for Disease Control and Prevention, 1991. Preventing Lead Poisoning in
Young Children: A Statement by the Center for Disease Control. US Department
of Health and Human Service/Public Health Service/Center for Disease Control,
Atlanta.
CDC, Centers for Disease Control and Prevention, 2002. Childhood lead poisoning
associated with tamarind candy and folk remediesCalifornia, 19992000.
MMWR 51, 684686.
CDC, Centers for Disease Control and Prevention, 2004. Lead poisoning associated
with ayurvedic medicationsve states, 20002003. MMWR 53, 582584.
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>.
Council Directive of 27 July 1976 on the approximation of the laws of the Member
States relating to cosmetic products (76/768/EEC). OJEC L 26227.9.1976, p. 169.
Draelos, Z.D., 2001. Special considerations in eye cosmetics. Clin. Dermatol. 19, 424430.
Ernst, E., 2002a. Heavy metals in traditional Indian remedies. Eur. J. Clin. Pharmacol.
57, 891896.
Ernst, E., 2002b. Toxic heavy metals and undeclared drugs in Asian herbal
medicines. Trends Pharmacol. Sci. 23, 136139.
Ettinger, A.S., Hu, H., Hernandez-Avila, M., 2007. Dietary calciumsupplementation to
lower bloodlead levels inpregnancy and lactation. J. Nutr. Biochem. 18, 172178.
Gilbert, S.G., Weiss, B., 2006. A rationale for lowering the blood lead action level
from 10 to 2 mg/dL. Neurotoxicology 27, 693701.
Gorter, R.W., Butorac, M., Cobian, E.P., 2005. Cutaneous resorption of lead after
external use of lead-containing ointments in volunteers with healthy skin. Am.
J. Ther. 12, 1721.
Gulson, B.L., Mahaffey, K.R., Jameson, C.W., Mizon, K.J., Korsch, M.J., Cameron, M.A.,
Eisman, J.A., 1998. Mobilization of lead from the skeleton during the postnatal
period is larger than during pregnancy. J. Lab. Clin. Med. 131, 324329.
Hardy, A., Walton, R., Vaishnav, R., 2004. Composition of eye cosmetics (kohls) used
in Cairo. Int. J. Environ. Health Res. 14, 8391.
Hardy, A.D., Walton, R.I., Myers, K.A., Vaishnav, R., 2006. Availability and chemical
composition of traditional eye cosmetics (kohls) used in the United Arab
Emirates of Dubai, Sharjah, Ajman, Umm Al-Quwain, Ras Al-Khaimah, and
Fujairah. J. Cosmet. Sci. 57, 107125.
Kales, S.N., Christophi, C.A., Saper, R.B., 2007. Hematopoietic toxicity from lead-
containing ayurvedic medications. Med. Sci. Monit. 13, CR295CR298.
Lekouch, N., Sedki, A., Nejmeddine, A., Gamon, S., 2001. Lead and traditional
Moroccan pharmacopoeia. Sci. Total Environ. 280, 3943.
Lilley, S.G., Florence, T.M., Stauber, J.L., 1988. The use of sweat to monitor lead
absorption through the skin. Sci. Total Environ. 76, 267278.
Loretz, L.J., Api, A.M., Barraj, L.M., Burdick, J., Dressler, W.E., Gettings, S.D., Han Hsu,
H., Pan, Y.H.L., Re, T.A., Renskers, K.J., Rothenstein, A., Scrafford, C.G., Sewall, C.,
2005. Exposure data for cosmetic products: lipstick, body lotion, and face
cream. Fd. Chem. Toxicol. 43, 279291.
Medlin, J., 2004. Sweet candy, bitter poison. Environ. Health Perspect. 112, A803.
Mendola, P., Messer, L.C., Rappazzo, K., 2008. Science linking environmental
contaminant exposures with fertility and reproductive health impacts in the
adult female. Fertil. Steril. 89, e81e94.
Meyer, P.A., Brown, M.J., Falk, H., 2008. Global approach to reducing lead exposure
and poisoning. Mutat. Res. 659, 166175.
MSD, Material safety data sheet. Kings Mountain Mica, 2002. Available from:
<http://www.dar-techinc.com/docs/MicaMSDS.pdf>.
Nnorom, I.C., Igwe, J.C., Oji-Nnoromc, 2005. Trace metal contents of facial (make-up)
cosmetics commonly used in Nigeria. Afr. J. Biotechnol. 4, 11331138.
ORourke, M.K., Van de Water, P.K., Jin S. Rogan, S.P., Weiss, A.D., Gordon, S.M.
Moschandreas, D.M., Lebowitz, M.D., 1999. Evaluations of primary metals from
NHEXAS Arizona: distributions and preliminary exposures. National Human
Exposure Assessment Survey. J. Exp. Anal. Environ. Epidemiol. 9, 435445.
Papanikolaou, N.C., Hatzidaki, E.G., Belivanis, S., Tzanakakis, G.N., Tsatsakis, A.M.,
2005. Lead toxicity update. A brief review. Med. Sci. Monit. 11, RA329RA336.
Sainio, E.L., Jolanki, R., Hakala, E., Kanerva, L., 2000. Metals and arsenic in eye
shadows. Contact Dermatitis 42, 510.
Tsankov, Iu., Iordanova, I., Lolova, D., Uzunova, S., Dinoeva, S., 1982. Hygienic
evaluation of the content of heavy metals (lead and copper) in cosmetic
products. Probl. Khig. 7, 127136.
US CPSC, US Consumer Product Safety Commission, 2005. Interim enforcement
policy for childrens metal jewelry containing lead2/3/2005. Available from:
<http://www.cpsc.gov/BUSINFO/pbjewelgd.pdf>.
US CPSC, US Consumer Product Safety Commission, 2007. International consumer
product safety program 2007 China Program Plan. Available from: <http://
www.cpsc.gov/BUSINFO/china.pdf>.
US FDA, United States Food and Drug Authorities, 2002a. Title 21Food and Drugs.
Chapter IFood and Drug Administration, Department of Health and Human
Services. Part 74Listing of Color Additives Subject to Certication/Ofce of
Cosmetics and Colors. Sec. 74.1306 D&C Red No. 6. Available from: <http://
www.cfsan.fda.gov/lrd/cf741306.html>.
US FDA, United States Food and Drug Authorities. Center for Food Safety and
Applied Nutrition (CFSAN), 2002b. FDA-Issued/Supported Export Certicates for
Foods. Available from: <http://www.cfsan.fda.gov/lrd/certi3.html>.
US FDA, United States Food and Drug Authorities, 2002c. Title 21Food and Drugs.
Chapter IFood and Drug Administration, Department of Health and Human
Services. Part 73Listing of color additives exempt from certication. FSAN/
Ofce of Cosmetics and Colors. Sec. 73.2496 Mica. Available from: <http://
www.cfsan.fda.gov/lrd/cf732496.html>.
US FDA, United States Food and Drug Authorities Guidance for Industry. Center for
Food Safety and Applied Nutrition (CFSAN), 2005. FDA Authority over
Cosmetics. Available from: <http://www.cfsan.fda.gov/dms/cos-206.html>.
US FDA, United States Food and Drug Authorities Guidance for Industry. Center for
Food Safety and Applied Nutrition (CFSAN), Ofce of Plant and Dairy Foods,
HFS-300, 2006a. Lead in Candy Likely To Be Consumed Frequently by Small
Children: Recommended Maximum Level and Enforcement Policy. http://
www.cfsan.fda.gov/dms/pbguid3.html.
US FDA, United States Food and Drug Authorities. Center for Food Safety and
Applied Nutrition (CFSAN), Ofce of Cosmetics and Colors. Kohl, Kajal, Al-Kahl,
or Surma: By Any Name, Beware of Lead Poisoning, 2006b. Available from:
<http://www.cfsan.fda.gov/dms/cos-kohl.html>.
US FDA, United States Food and Drug Authorities. Center for Food Safety and
Applied Nutrition (CFSAN), Ofce of Cosmetics and Colors. Imported Cosmetics,
2006c. Available from: <http://www.cfsan.fda.gov/dms/cos-imp.html>.
US FDA, United States Food and Drug Authorities. Center for Food Safety and
Applied Nutrition (CFSAN), Ofce of Cosmetics and Colors, 2007a. Lipstick and
Lead: Questions and Answers. Available from: <http://www.cfsan.fda.gov/dms/
cos-pb.html>.
US FDA, Summary of Color Additives Listed for Use in the United States in Food,
Drugs, Cosmetics, and Medical Devices, 2007b. Color Additives Approved for
Use in Cosmetics Part 73, Subpart C: Color Additives Exempt from Batch
Certication. Available from: <http://www.cfsan.fda.gov/dms/opa-col2.html>.
US FDA, United States Food and Drug Authorities. Center for Food Safety and
Applied Nutrition (CFSAN), Ofce of Cosmetics and Colors, 2007c. Color
Additives and Cosmetics. Available from: <http://www.cfsan.fda.gov/dms/cos-
col.html>.
US FDA, United States Food and Drug Authorities. Center for Food Safety and
Applied Nutrition (CFSAN), Ofce of Cosmetics and Colors, 2008. Intramural
Research Portfolio. Available from: <http://www.cfsan.fda.gov/dms/
cfsres08.html>.
Vahter, M., Berglund, M., Akesson, A., 2004. Toxic metals and the menopause. J. Brit.
Menopause Soc. 10, 6064.
Vahter, M., kesson, A., Lidn, C., Ceccatelli, S., Berglund, M., 2007. Gender
differences in the disposition and toxicity of metals. Environ. Res. 104, 8595.
Weidenhamer, J.D., Clement, ML., 2007. Evidence of recycling of lead battery waste
into highly leaded jewelry. Chemosphere 69, 16701672.
WHO, World Health Organization, International Programme on Chemical Safety,
2000. Safety evaluation of certain food additives and contaminants. WHO Food
Additives Series: 44 Prepared by the 53rd meeting of the Joint FAO/WHO Expert
Committee on Food Additives (JECFA). World Health Organization, Geneva.
WHO, World Health Organization, 1995. Environmental Health Criteria 165:
Inorganic Lead, Geneva: International Programme on Chemical Safety. World
Health Organization, Geneva.
Woolf, A.D., Woolf, N.T., 2005. Childhood lead poisoning in 2 families associated
with spices used in food preparation. Pediatrics 116, e314e318.
I. Al-Saleh et al. / Regulatory Toxicology and Pharmacology 54 (2009) 105113 113