Lead in Cosmetics
Summary of RRL
Allowable Levels of Lead in Cosmetics
• Currently no lead content limit set by FDA
• Campaign for Safe Cosmetics, 2007
– FDA limit of lead in candy: 0.01 PPM
– 1/3 of lipsticks in the market: 0.03-0.65 PPM
• FDA study in 2009
– Lipsticks in the market: 0.09-3.06 PPM
– Lipsticks should not be compared to candies
because they are not ingested.
Allowable Levels of Lead in Cosmetics
• FDA has set a lead content limit as an impurity
in the color additives used in cosmetics
– 10-20 PPM: safe and acceptable
• BFAD statement
– Maximal allowable lead limit in cosmetics: 20 PPM
– Based on consolidation of data from other ASEAN
countries
Comparison of Commercial Brands of
Lipsticks with Significant Lead Content
• FDA study in 2009
– 20 lipsticks of varying brands
– Highest: Cover Girl brand, 3.06 PPM
– Lowest: Avon brand, 0.09 PPM
– Average level: 1.07 PPM
PARENT COMPANY
LIPSTICK LINE
AND SHADEA
LOT NUMBERSB
PROCTER & GAMBLE
INCREDIFUL LIPCOLOR
964 MAXIMUM RED
7241S1
5188S1
REVLON
REVLON, INC.
COLORSTAY LIPCOLOR
345 RED VELVET
COMPOSITEE
07298
LEAD
(PB)C
(PPM)D
3.06
3.05
2.91F
2.38
COVER GIRL
PROCTER & GAMBLE
QUEEN COLLECTION
Q580 RUBY REMIX
7136
2.24
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
BRAND NAME
COVER GIRL
L'OREAL
L'OREAL
CLINIQUE
ESTEE LAUDER COMPANIES INC.
CLINIQUE
ESTEE LAUDER COMPANIES INC.
ESTEE LAUDER
ESTEE LAUDER COMPANIES INC.
BURT'S BEES
CLOROX COMPANY
MAYBELLINE
L'OREAL
PEACEKEEPER
PEACEKEEPER
DIOR
LVMH
DIOR
LVMH
MAC
ESTEE LAUDER COMPANIES INC.
AVON
AVON
COLOUR RICHE
752 CLASSIC WINE
LONG LAST
FJ MERLOT
LONG LAST
F9 PAPRIKA
PURE COLOR
1A3 MARASCHINO
LIP SHIMMER
MERLOTG
MOISTURE EXTREME
E215 MIDNIGHT RED
PAINT ME COMPASSIONATEG
REPLENISHING LIPCOLOR
752 RED PREMIERE
ADDICT ULTRA-SHINE
750 SHINIEST SEXINESS
MATTE LIPSTICK
VIVA GLAM I
ULTRA COLOR RICH
U250 CHERRY JUBILEE
FD064
FD234
0.79
0.67
AA7
0.55
A87
0.48
B55
0.43
1840701
0.33
WD3041
0.23
H
0.17
7A01
0.15
7D01
0.12
A67
0.10
H
0.09
AVERAGE
1.07
Comparison of Commercial Brands of
Lipsticks with Significant Lead Content
• Study by Al-Saleh et al, 2009
– 48 lipsticks from 26 brands
– Lead content range: 0.27-3760 PPM
• There were 3 outliers in the data
– Without outliers: 0.27-36.90 PPM
• Only 2 brands above the 20 PPM limit
– All 5 lipsticks that exceeded the limit: from China
– Lipsticks with shimmers: 0.33-3760 PPM
– All exceeded the 0.1 PPM limit in candy
Effect of Cosmetics with Lead to
Human Health
• Inter-organization Programme for the Sound
Management of Chemicals, 1998
– Allowable blood levels of lead: <20 µg/dl
– Allowable levels for children: <10 µg/dl
• This amount can already lead to a 2.5-point decrease in
intelligence quotient of IQ
Nervous system: overt clinical encephalopathy
100-120 µg/dl
Kidney: atrophy and interstitial nephritis
40-100
Gastrointestinal: colic
40-60
Formation of blood cells: anemia
50
Reporudctive system: hypospermia, testicular
atrophy
Nervous system: IQ/learning disruption, sensory
system deficits
40-50
Heart and Blood Vessels: Hypertension
<7
Formation of blood cells: biochemical (enzyme
changes)
3-30
40
Effect of Cosmetics with Lead to
Human Health
• Inter-organization Programme for the Sound
Management of Chemicals, 1998
– There is no exposure level below which lead appears
to be safe
– Children are more susceptible to the toxic effects of
lead due to their behavior and stage of development
– Blood lead levels as low as 10 µg/dl can hamper blood
cell formation and affect one’s IQ or cause some form
of learning disruption
– Higher levels may cause colic, encephalopathy, renal
atrophy, and interstitial nephritis
Effect of Cosmetics with Lead to
Human Health
• American Academy of Child and Adolescent
Psychiatry, 2006
– Lead exposure to children: paint, water, soil
• Center for Disease Control
– About 6 percent of children aged 1-2 years old
have toxic blood lead levels
Effect of Cosmetics with Lead to
Human Health
• Lead exposure during pregnancy
– Lead in the body are mainly stored in the bone
– These stores may be mobilized due to hormonal
effects in pregnancy
– Lead readily crosses the placental barrier and may
affect the fetus
– Pregnant women may not manifest symptoms but
their future children could be affected via prenatal
exposure
Effect of Cosmetics with Lead to
Human Health
• Currently FDA assessment of lipsticks tested
– Lead content levels are safe, not a concern
– Based on the premise that lipstick is for topical
use only
– Majority are below the recommended limit given
by public health officials, 10 PPM
Effect of Cosmetics with Lead to
Human Health
• Study by Al-Ashban et al, 2002
– Blood analyses of regular kohl users revealed a
high lead concentration and relatively low
hemoglobin levels
– Kohl was also estimated to have lead levels as high
as 52.3%
Effect of Cosmetics with Lead to
Human Health
• Study by Al-Ashban et al, 2002
– Blood lead levels
• Control group mean value: 0.9µg/dl ± 0.43
• Kohl users group mean value: 17.65µg/dl ±2.29
– Hemoglobin levels
• Control group mean value: 14.02g/dl ± 0.21
• Kohl users group mean value: 12.22g/dl ± 0.37
• The study by Al-Saleh et al (1999) supports the
findings made by Al-Ashban et al (2002).
References
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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
American Academy of Child and Adolescent Psychiatry (2006). Lead exposure in children affects
brain and behavior. Retrieved from
http://www.aacap.org/cs/root/facts_for_families/lead_exposure_in_children_affects_brain_and_b
ehavior.