PML/PR-45/2014
Heavy Metals in Cosmetics
Investigators
Mr. Ramakant Sahu
Ms. Poornima Saxena
Dr. Sapna Johnson
Advisors
Prof. H. B. Mathur
Prof. H. C. Agarwal
Date
January 2014
Centre for Science and Environment
41, Tughlakabad Institutional Area, New Delhi 110062
website: www.cseindia.org; e-mail: [email protected]
Pollution Monitoring Laboratory
Core 6A, Fourth Floor, India Habitat Centre,
Lodhi Road, New Delhi – 110003
1
Contents
1. About PML
3
2. Introduction
3
3. Literature Review
5
4. Health Impact of Heavy Metals in Cosmetics
7
5. Regulations for Cosmetics
8
6. Objectives of the Study
12
7. Material and Methods
12
8. Results and Discussions
13
9. Conclusions
17
2
1.
About PML
The Centre for Science and Environment (CSE), one of India’s leading non-governmental organization
based in New Delhi, has set up the Pollution Monitoring Laboratory (PML) to monitor environmental
pollution and food contamination. PML is an ISO 9001:2008 certified laboratory accredited by SWISO,
CH-5610, Wohlen, Switzerland, conducting Pollution Monitoring and Scientific Studies on
Environmental and food Samples. The Lab has qualified and experienced staff that exercise Analytical
Quality Control (AQC) and follow Good Laboratory Practices (GLP). It is equipped with state-of-art
equipment for monitoring and analysis of air, water and food contamination, including Gas
Chromatograph with Mass Spectrometer (GC-MS), Gas Chromatograph (GC) with ECD, NPD, FID
and other detectors, High Performance Liquid Chromatograph (HPLC), Atomic Absorption
Spectrometer, UV-VIS Spectrophotometer, Mercury Analyzer, Respirable Dust Sampler, TS-EMF, etc.
Its main aim is to undertake scientific studies to generate public awareness about environmental
pollution and toxins in food and other commodities. It provides scientific services at nominal cost to
communities that cannot obtain scientific evidence against polluters in their area. The lab and its work
are directed to use science to achieve environmentally sound and socially relevant public policy.
2. Introduction
Cosmetic is defined as “Any article intended to be rubbed, poured, sprinkled or sprayed on, or
introduced into, or otherwise applied to, the human body or any part thereof for cleansing, beautifying,
promoting attractiveness, or altering the appearance, and includes any article intended for use as a
component of cosmetic”1. Cosmetic products are regulated for health and safety. There are concerns
regarding the presence of harmful chemicals, including heavy metals, in these products. There has not
been many studies on presence of heavy metals in cosmetics in India. To assess the levels of heavy
metals, PML conducted a study on commonly available lipsticks, fairness creams, lip balms and antiaging creams.
1
Section 3 aaa) . Drug and Cosmetic Act, 1940 available at
http://cdsco.nic.in/html/copy%20of%201.%20d&cact121.pdf
3
3.
Literature Review
A study published in Contact Dermatitis found that in 88 eye shadow colours from 49 different
products, 75% of the eye shadow colours contained >5 ppm of at least one of the following: lead,
cobalt, nickel, chromium, and arsenic. And 100% contained >1 ppm of at least one of the above
substances2.
Test conducted in the United States by the Campaign for Safe Cosmetics revealed that 61% of the 33
brands of lipsticks contained lead, with levels of upto 0.65 ppm3. The United States Food and Drug
Administration also found lead in all the samples of lipstick that it tested, with levels ranging from 0.09
to 3.06 ppm4. Health Canada found that 81% of the samples of lipstick that it tested for lead had levels
ranging from 0.079 to 0.84 ppm, and that one lipstick contained 6.3 ppm5. This is despite many metals
being banned as intentional ingredients in cosmetics in Canada6. They are not banned as product
impurities since their presence as such is considered unavoidable7. An impurity is a substance not
intentionally added to a product, but rather is either a by-product of the manufacturing process, formed
by the breakdown of ingredients or an environmental contaminant of raw ingredients8. The latter is the
case for heavy metals, as their persistence in the environment and their natural presence in rocks, soil
and water lead to their presence in pigments and other raw materials used in various industries,
including cosmetics9.
Environmental Working Group found that the average women use 12 products containing a total of 168
unique ingredients every day. Their study “Exposures Add Up” also showed that through using these
products on a daily basis, one in 13 women are exposed to ingredients that are known or probable
human carcinogens and one in 24 women are exposed to ingredients that are known or probable
2
Sainio, E.-L., Jolanki, R., Hakala, E., & Kanerva, L. Metals and arsenic in eye shadows. Contact Dermatitis,
2001; 42(1): 5-10
3
Lead in Lipstick. Retrieved October 28, 2010, from http://www.safecosmetics.org/article.php?id=223
4
Lipstick and Lead: Questions and Answers. Retrieved October 28, 2010, from
http://www.fda.gov/Cosmetics/ProductandIngredientSafety/ProductInformation/ucm137224.htm
5
Tories won’t list leaded lipsticks. Canada.com. Retrieved from
http://www.canada.com/topics/news/national/story.html?id=4b8f58b0-c225-4925-8e6e-3b41a3687626
6
Cosmetic Ingredient Hotlist - June 2010. Retrieved October 28, 2010, from http://www.hc-sc.gc.ca/cpsspc/alt_formats/hecs-sesc/pdf/person/cosmet/info-ind-prof/_hot-list-critique/hotlist-liste_2010-eng.pdf
7
Draft Guidance on Heavy Metal Impurities in Cosmetics. Retrieved November 5, 2010, from http://www.hcsc.gc.ca/cps-spc/legislation/consultation/_cosmet/metal-metauxconsulteng.php
8
Impurities of Concern in Personal Care Products. Retrieved October 30, 2010, from
http://www.ewg.org/skindeep/2007/02/04/impurities-of-concern-in-personalcareproducts
9
Draft Guidance on Heavy Metal Impurities in Cosmetics. Retrieved November 5, 2010, from http://www.hcsc.gc.ca/cps-spc/legislation/consultation/_cosmet/metalmetauxconsulteng.php
4
reproductive and developmental toxins, linked to impaired fertility or developmental harm for a baby in
the womb or a child10.
Shen et al. analysed 15 kinds of samples, including hair sprays, perfumes, deodorants, cream, lotion,
etc. for seven kinds of phthalates, i.e. DEP, DPP, DBP, BBP, DCHP, DEHP, DOP, and four parabens,
i.e. MPB, EPB, PPB, BPB, and found that only one of the 15 examined samples was free from
phthalates and parabens. The remaining 14 samples were found to contain at least three or more of these
phthalates and/or parabens. The predominant phthalates and parabens detected in the studied samples
were MPB, PPB, DEP, DBP, DCHP, and DEHP. The residue level was 1.22–5289 ppm11.
A recent assessment by WHO reported that mercury in skin lightening creams and soaps that are
commonly used in Asian and Central African nations is potentially dangerous as they have serious side
effects and can be fatal. Mercury present in fairness creams can cause anxiety, depression, nerve
damage, reduces skin resistance to infections, can cause seizures, numbness and even memory loss12.
Researchers in California recently found that most of the tested lip products (32) contained high
concentrations of titanium and aluminium. All examined products had detectable manganese. Lead was
detected in 75% samples tested. Approximately half (47%) of the samples contained Lead at
concentrations higher than the FDA-recommended maximum level of 0.1 ppm for Lead in candy likely
to be consumed frequently by small children. Chromium and Nickel were found in almost all samples.
Highest concentration of Chromium was 9.72 ppm and Nickel was 9.73 ppm. 13
4.
Health Impact of Heavy Metals in Cosmetics
A variety of chemicals are used in cosmetics as ingredients and some are used as preservatives. These
chemicals have different health effects.
Hexavallent Chromium (Cr+6) is corrosive and allergic to the skin. Cr+6 compounds are enlisted as
carcinogens by the International Agency for Research on Cancer (IARC). Adverse effects of the Cr+6 on
the skin may include ulcerations, dermatitis, and allergic skin reactions. Inhalation of Cr+6 compounds
can result in ulceration and perforation of the mucous membranes of the nasal septum, irritation of the
10
Exposures Add Up - Survey Results. Retrieved October 28, 2010, from
http://www.cosmeticsdatabase.com/research/exposures.php
11
Shen HY, Jiang HL, Mao HL, Pan G, Zhou Lu, Cao YF; J. Sep. Sci.; 2007, 30, 48–54
12
Mercury in skin lightening products: http://www.who.int/ipcs/assessment/public_health/mercury_flyer.pdf
13
Liu S., Hammond S. K., Rojas-Cheatham A.; Concentrations and Potential Health Risks of Metals in Lip
Products. Environmental Health Perspectives 2013; 121(6): 705 - 710
5
pharynx and larynx, asthmatic bronchitis, bronchospasms and edema. Respiratory symptoms may
include coughing and wheezing, shortness of breath, and nasal itch.
Nickel can cause allergic reaction when it comes in contact with the skin. Studies on animals show that
if consumed in high amounts, it affects kidneys, stomach and liver.
Mercury is used in cosmetic products such as skin whitening creams. Mercury is a neurotoxin. Mercury
has been used by many names such as “mercurous chloride”, calomel, mercuric, mercurio or mercury.
The prolonged use of products containing mercury can lead to inflammation of the liver, kidneys and
urinary tract. Presence of mercury in Skin Creams has become a global public health problem. Mercury
compounds are readily absorbed through the skin on topical application and have the tendency to
accumulate in the body. They may cause allergic reactions, skin irritation or neurotoxic
manifestations14. Mercury intoxication from cosmetics has been featured in numerous news stories in
recent years. There is evidence suggesting children who had been exposed in-utero from their mothers
experienced developmental issues. These children were affected with a range of symptoms including
motor difficulties, sensory problems and mental retardation15.
Distribution of mercury-containing creams and soaps is banned in the European Union16. A European
Union Directive specifies that mercury and mercury compounds are not allowed as ingredients in
cosmetics (including soaps, lotions, shampoos and skin bleaching products). However, phenyl mercuric
salts for use as a preservative in eye makeup and eye makeup removal products are allowed at
concentrations equal to or less than 0.007% by weight.
The California Department of Public Health (CDPH) is investigating several cases of mercury
poisoning due to an unlabeled face cream from Mexico used for lightening the skin, fading freckles and
age spots, and treating acne. The cream contained very high levels of mercury: 56,000 parts per million
(ppm) or 5.6%.17
14
Regulations on the use of toxins in cosmetics: http://www.health-report.co.uk/cosmetic-regulations.htm
The Danger Of Mercury In Beauty Products: http://meliatop.com/the-danger-of-mercury-in-beauty products.html
16
IPCS (1991). Mercury-containing cream and soap. In: Inorganic mercury. Geneva, World Health
Organization, International Programme on Chemical Safety (Environmental Health Criteria 118;
http://www.inchem.org/documents/ehc/ehc/ehc118.htm#SectionNumber:3.5).
15
17
California Department of Public Health, Health Alert, Mercury Poisoning Linked to Use of Face Lightening
Cream: http://www.ehib.org/papers/CDPH_Mecury_Health_Alert_Skin_Cream.pdf
6
5.
Regulations for Cosmetics
India
Cosmetics products in India are regulated under the Drugs and cosmetics Act 1940 and Rules 1945 and
Labeling Declarations by Bureau of Indian Standards (BIS). BIS sets the standards for cosmetics for the
products listed under Schedule ‘S’ of the Drugs and cosmetics Rules 194518.
Bureau of Indian Standards (BIS) has provided the specification for Skin Creams and Lipstick in the
Indian Standards (IS) 6608:2004 and 9875:1990 respectively. IS 6608:2004 says that if all the raw
materials requiring test for heavy metals have been so tested and comply with the requirements, then
the manufacturer may not test the finished cosmetic for heavy metals and arsenic.
The Dyes colors (pigments lakes) if used in the manufacture of skin creams and lipstick shall comply
with IS 4707 (Part I) subject to the provision of Schedule Q of Drugs and Cosmetics Act and Rules,
issued by the Government of India, and as amended from time to time. Other ingredients shall comply
with the provisions of IS 4707 (Part 2).
Rule 134 of Drugs and Cosmetics Rules has laid down restrictions on use of cosmetics containing Dyes,
Colors and Pigments other than those specified by the Bureau of Indian Standards (IS: 4707 Part 1 as
amended) and Schedule Q. The permitted Synthetic Organic Colors and Natural Organic Colors used in
the Cosmetic shall not contain more than:
• 2 ppm (parts per million) of Arsenic calculated as Arsenic Trioxide.
• 20 ppm of lead calculated as lead.
• 100 ppm of heavy metals other than lead calculated as the total of the respective metals.
These coloring agents are generally recognized as safe (GRAS). For some of these, purity requirements
are mentioned as laid down in the EEC directive of 1962. Maximum concentration in finished products
is mentioned in some.
Rule 145 of the Drugs and Cosmetics Rules prohibits use of lead and arsenic compounds in cosmetics
for the purpose of coloring. Rule 135 prohibits import of cosmetics in which a lead or arsenic
compound has been used for the coloring purpose. Rule 145 D and 135 A prohibits manufacture and
import respectively of cosmetics containing mercury compounds.
18
The Drugs and Cosmetics act and rules: The manufacture of cosmetics for sale or distribution, Part XIV, rules
138
7
Table 1: Limits for Heavy Metals in Cosmetics in India
Regulatory
Body
Mercury
Other than
Eye Area
Products
India (BIS)
Prohibited
for
intentional
use.
Eye Area
Products
≤ 0.007% by
weight
Lead
Cadmium
Arsenic
Total
Heavy
Metals
Through permitted Synthetic Organic Colors and
Natural Organic Colors
20 ppm of
lead
calculated as
lead
---
2 ppm of
Arsenic
calculated
as
Arsenic
Trioxide
100 ppm
other than
lead.
Calculated
as total of
respective
metals
European Union
EU cosmetic legislations are based on Council Directive 76/768/EEC of 27 July 1976 on the
approximation of the laws of the Member States relating to cosmetic products (Cosmetics Directive)19.
Manufacturers are responsible for ensuring that cosmetic products comply with the law before they are
marketed. The manufacturer or importer of cosmetics is responsible for demonstrating that the product
is safe for its intended use. Regulations are enforced at the national level, and each country in the EU
has an authoritative body that is responsible for upholding compliance. EU has banned about 1,328
chemicals in cosmetics. The chemicals prohibited in cosmetic products are listed in Annexure II of
Cosmetic Regulations. Arsenic, Lead cyanide, human tissue etc. are prohibited in cosmetics
USA
In the US, cosmetics are regulated by Federal Food, Drug and Cosmetic Act (FD&C Act)20. It is the
role of the FDA to oversee the compliance with these regulations. However, as opposed to drugs,
cosmetic products and ingredients are not subject to FDA premarket approval with the exception to
color additives. The regulations published by the Food and Drug Administration (FDA) are all codified
in Title 21, Code of Federal Regulations (21 CFR) applicable to Cosmetics4 stated at 21 CFR, parts 700
to 740 (21 CFR 700 to 740) defines ingredients as “Any single chemical entity or mixture used as a
component in the manufacture of a cosmetic product.”
19
EU legislations: The rules governing cosmetic products in the European Union, Council Directive 76/768/EEC.
Vol.1 cosmetic legislations (1999), article 7a (d).
20
http://www.fda.gov/regulatoryinformation/legislation/federalfooddrugandcosmeticactfdcact/default.htm
8
The FD&C Act prohibits any product or ingredient that is a “poisonous or deleterious substance which
may render [the product] injurious to users under the conditions of use prescribed in the labeling.”
FDA addresses the presence of trace impurities in cosmetics on a case-by-case basis. Requirements for
specific cosmetics are listed in 21 CFR part 700. For heavy metals, FDA has set a limit of 1 ppm
mercury in most cosmetics under 21 CFR 700.13 (a limit of 65 ppm is permitted in certain eye area
cosmetics) and prohibits the use of zirconium in aerosol cosmetics under 21 CFR 700.16. In addition,
FDA has established specifications for lead, arsenic, and mercury in most color additives. A few more
heavy metal specifications have been established for certain color additives.
Health Canada
The Canadian Food and Drugs Act (F&DA) stipulates that “No person shall sell any cosmetic that:
a) has in or on it any substance that may cause injury to the health of the user when the cosmetic is
used,
b) consists in whole or in part of any filthy or decomposed substance or of any foreign matter; or
c) was manufactured, prepared, preserved, packaged or stored under unsanitary conditions.”
In December 2008, Health Canada released a Draft Guidance on Heavy Metal Impurities in Cosmetics
for lead, arsenic, cadmium, mercury, and antimony21.
6.
Objectives of the Study
Use of cosmetic products is increasing rapidly in India and various chemicals including the heavy
metals are used in the cosmetics which pose health risk to consumers. The present study was conducted
to determine heavy metals - lead, cadmium, chromium and nickel in lipsticks, lip-balm and anti-ageing
creams and mercury in fairness creams available in the Delhi market. The results were compared with
the available standards.
21
Health Canada (2011). Heavy metals in cosmetics—fact sheet. Ottawa, Ontario, Health Canada (http://www.hcsc.gc.ca/cps-spc/pubs/indust/heavy_metals-metaux_lourds/index-eng.php).
9
7.
Material and Methods
Sampling Methodology
30 samples of lipsticks, 32 samples of fairness creams, 8 samples of lip-balm and 3 samples of antiageing creams were purchased from local market of Delhi. The details of the samples are presented in
Table 2 and Table 3.
Equipment: Atomic Absorption Spectrometer (Thermo) Solar M-6 Series, equipped with Flame and
Flameless techniques was used for analysis.
Glassware: All the glassware were cleaned with detergent and 10% nitric acid and rinsed thoroughly
with distilled water before use.
Chemicals: All the chemicals used were purchased from E Merck. The water used in all the
experiments was ultrapure water obtained from Elga water purification system.
Sample preparation for Lead, Cadmium, Chromium and Nickel Determination
Lipstick, lip-balm and anti-ageing creams were analyzed for lead, cadmium, chromium and nickel.
Sample preparation for the determination of Lead, Cadmium, Chromium and Nickel was done
following the method of Chauhan et al22.
About 1.0 g of each sample was digested in 5.0 mL mixture of concentrated acid HNO3:HCLO4 (3:1)
for 2-3 hours on a hot plate at 900C. Then 3.0 mL of acid mixture was again added and then again
heated for 2-3 hours to complete the digestion. The above digested samples were cooled and about 5.0
mL ultra pure water was added mixed well and volume made upto 25 mL in volumetric flask. The
solution was then finally filtered through Whatman filter paper (Number 41). The clear solution was
used for metal quantification.
Sample preparation for Mercury Determination
Fairness creams were analyzed for mercury. Application note provided by Clark et. al. of CETAC
Technologies of USA was used for the sample preparation for mercury estimation23. The samples were
weighed (~0.2g) into the beaker. The samples were predigested with 2 mL of H2SO4 and 2 mL HNO3
for 1.5 hours at 800C. This initial predigest step dissolved/dispersed the samples and then allowed to
cool to room temperature. Then 7.0 mL of 5% KMnO4 and 5 mL 3% HCl were added to each beaker
22
Chauhan AS, Bhadauria R, Singh AK, Lodhi SS, Chaturvedi DK, Tomar VS. Determination of Lead and
Cadmium in cosmetic products. J. Chem. Pharm. Res., 2010, 2(6):92-97
23
David H. Clarke, Jeffrey A. Forsberg, and John L. McQuatters; Mercury Determination in Cosmetics, Using
the CETAC QuickTrace™ M-7500 CVAAS; CETAC Technologies, Omaha, NE 10
and then heated at 950C for 2 hours. After again cooling to room temperature, 3.0 mL of 12%
hydroxylamine solution was added to reduce the KMnO4. The beakers were swirled to assure complete
reaction with the excess KMnO4. They were then brought up to a final volume of 25 mL with 3% HCl
with thorough mixing prior to instrument analysis of the samples.
Sample analysis for Lead, Cadmium, Chromium and Nickel Determination
Lead, Cadmium, Chromium and Nickel were determined using flame atomic absorption spectrometry.
Air-acetylene flame was used for Lead, Cadmium and Nickel while air-acetylene-nitrous oxide flame
was used for Chromium determination. Standard solutions were prepared in five different
concentrations for each metal separately to obtain calibration curve for quantitative analysis. All the
measurements were run in triplicate for the samples and standard solutions. Deuterium lamp was used
for background correction.
Sample analysis for Mercury Determination
Digested samples were analyzed for Mercury using flameless atomic absorption spectrometry. Standard
solutions were prepared in five different concentrations to obtain calibration curve for quantitative
analysis. All the measurements were run in triplicate for the samples and standard solutions. Deuterium
lamp was used for background correction.
Recovery test was performed for all the metals. Recovery was found to be more than 90% in all the
cases.
11
8.
Results and Discussions
A total of 30 lipsticks, 8 lip-balms and 3 anti-ageing creams were tested for lead, cadmium, total
chromium and nickel and 32 samples of fairness creams (26 for women and 6 for men) for mercury.
a. Lipstick
Chromium: Total chromium was detected in 50% (15 out of 30) samples in the range of 0.45 ppm to
17.83 ppm (Table 4).
Total Cr detected in lipstick samples was compared with Average Daily Intake (ADI) of Cr+6.
Recognizing the need for extra precaution, all Cr has been assumed as Cr+6. This assumption is made by
most health regulators, including the USEPA while setting standards. 24
The ADI value of 0.0001 mg/day for a 50 kg woman for Cr+6 derived by Liu et. al. (2013) was used for
estimating exposure risk25. This ADI value is derived based on the cancer risk posed by Cr+6. An
average use of 24 mg/day and high use of 87 mg/day of lipstick suggested by Loretz et. al. (2005)26
were used for estimating the exposure risk.
In case of average use of 24 mg/day of lipstick, the estimated intake was in the range of 10.8% to
427.9% of ADI in 15 samples detected with chromium and was more than 100% in 4 samples (Table
5). While considering the high use of 87 mg/day of lipstick, it was in the range of 39.2% to 1551.2% of
ADI and was more than 100% in case of 13 samples out of 15 samples detected with chromium (Table
5).
The highest concentration of 17.83 ppm of total chromium was found in Hearts & Tarts (080V) shade
of ColorBar lipstick which was 427.9% of ADI in case of average use of lipstick and 1551.2% in case
of high use. The second highest concentration - 13.9 ppm was found in Labsolu Nu-204 shade of
Lancome lipstick which was 333.6% of ADI in case of average use of lipstick and 1209.3% in case of
high use (Table 5).
The toxicity of chromium compounds depends on the oxidation state of the metal. Hexavalent form is
more toxic than trivalent form. Hexavalent chromium is recognized as a human carcinogen when it is
24
USEPA, Chromium in Drinking Water:
http://water.epa.gov/drink/info/chromium/index.cfm?utm_source=feedburner&utm_medium=feed&utm_campaig
n=Feed%3A+Region3_WaterNews+(U.S.+EPA%3A+Mid+Atlantic+Region+Water+News+)
25
Liu S., Hammond S. K., Rojas-Cheatham A.; Concentrations and Potential Health Risks of Metals in Lip
Products. Environmental Health Perspectives 2013; 121(6): 705 - 710
26
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. Exposure data for cosmetic products: lipstick, body
lotion, and face cream. Food and Chemical Toxicology 2005; 43: 279–291 12
inhaled. Chronic inhalation of Hexavalent chromium has been shown to increase risk of lung cancer and
may also damage the small capillaries in kidneys and intestines. Other adverse health effects associated
with Hexavalent chromium exposure, according to the National Institute for Occupational Safety and
Health (NIOSH), include skin irritation or ulceration, allergic contact dermatitis, occupational asthma,
nasal irritation and ulceration, perforated nasal septa, rhinitis, nosebleed, respiratory irritation, nasal
cancer, sinus cancer, eye irritation and damage, perforated eardrums, kidney damage, liver damage,
pulmonary congestion and edema, epigastric pain and erosion and discoloration of teeth27.
Nickel: It was detected in 43.3% (13 out of 30) samples in the range of 0.57 ppm to 9.18 ppm. The
highest concentration of 9.18 ppm was found in Labsolu Nu-204 shade of Lancome lipstick. The
second highest concentration of 5.47 ppm was found in Hearts & Tarts (080V) shade of ColorBar
lipstick (Table 4).
High levels of Nickel exposure can lead to health effects depending on route and the kind of nickel
exposed to28. Certain types of nickel (oxidic, sulphidic, and soluble nickel) were considered to be toxic
because of concern to health due to carcinogenicity29. Metallic nickel and alloys have been classified as
possibly carcinogenic to humans30. Allergy to nickel is common and it can cause severe contact
dermatitis31. The first case of nickel allergy caused by eye shadow was reported twelve years ago and it
has been reported that even 1 ppm may trigger a pre-existing allergy32.
Lead and Cadmium were not detected in any of the samples.
b. Lip-balm and Anti-ageing Creams: None of the heavy metals tested were detected in lip-balm and
anti-ageing creams.
27
http://environment.about.com/od/healthenvironment/f/Hexavalent-Chromium-Health-Risks.htm
Report on Human Biomonitoring of Environmental Chemicals in Canada: Results of the Canadian Health
Measures Survey Cycle 1 (2007–2009). Ottawa.
29
http://www.hc-sc.gc.ca/ewh-semt/alt_formats/hecs-sesc/pdf/pubs/contaminants/psl1lsp1/compounds_nickel_composes/nickel-eng.pdf
30
Agents Classified by the IARC Monographs, Volumes 1–100. Retrieved November 3, 2010, from
http://monographs.iarc.fr/ENG/Classification/index.php
31
Report on Human Biomonitoring of Environmental Chemicals in Canada: Results of the Canadian Health
Measures Survey Cycle 1 (2007–2009). Ottawa.
32
Sainio, E.L., Jolanki, R., Hakala, E., & Kanerva, L. (2001). Metals and arsenic in eye shadows. Contact
Dermatitis, 42(1), 5-10.
28
13
c. Mercury in Fairness (Skin Whitening) Creams
Mercury was detected in about 44% (14 of 32) samples in the range of 0.10 ppm to 1.97 ppm as total
mercury (Table 6). According to the Drugs and Cosmetic Act, mercury in Fairness creams is prohibited.
Therefore 14 samples that contained mercury violated the Act.
The concentration of total mercury detected in the skin whitening creams were converted to
concentration of mercuric chloride (HgCl2) because skin whitening creams commonly use inorganic
mercury in the form of ammoniated mercuric chloride and mercuric iodide (Table 6). Conversion of
total Hg to HgCl2 is done by considering the molecular weight of Hg as 200.592 and that of HgCl2 as
271.496. It is assumed that all mercury (Total Hg) in the skin whitening creams is HgCl2.
Oral Reference Dose (RfD) of HgCl2 set by USEPA is 0.0003 mg/kg-day which translates into an
Average Daily Intake (ADI) for a 50 kg person as 0.015 mg. Loretz et. al. (2005) has estimated that the
average use of creams is 2.05 g/day and high use is 3.99 g/day33. Considering 100% dermal absorption
the amount of HgCl2 obtained after conversion was compared as percentage the above ADI of HgCl2
(0.015 mg for a 50 kg person) (Table 6).
Aroma Magic Fair Lotion had the highest mercury concentration of 1.97 ppm as total mercury (2.67
ppm equivalent HgCl2) which is 36.4% of ADI for average use of cream (2.05 g/day) and considering
the high use (3.99 g/day) it is 70.9% of ADI (Table 6). Fair and Lovely Ayurvedic Care had the lowest
concentration 0.10 ppm as total mercury and 0.14 ppm as HgCl2 which is 1.8% of ADI for average use
of cream (2.05 g/day) and considering the high use (3.99 g/day) it is 3.6% of ADI.
Out of 6 Fairness Creams for men, mercury was detected in only one sample (Garnier Men Power
Light) at a level of 0.24 ppm as total mercury.
According to the FDA, the permissible limit for mercury in Cosmetics other than eye products is 1 ppm.
Out of 32 samples tested three samples (10.7%) exceeded the limit of 1 ppm given by FDA (Table 6).
Repeated application of these skin whitening creams could cause cumulative effect of prolonged low
level mercury exposure, which could lead to nephritic syndrome Mercury can also be transferred from
33
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. Exposure data for cosmetic products: lipstick, body
lotion, and face cream. Food and Chemical Toxicology 2005; 43: 279–291 14
the mother to the fetus during pregnancy34. Mercury from soap and cream has been reported to be
readily absorbed through the skin and via inhalation.
9.
Conclusions
In 50% of the lipsticks (15 of 30) Chromium was found with highest being 17.83 ppm in Hearts & Tarts
(080V) shade of ColorBar lipstick.
The estimated intake of chromium from lipsticks was in the range of 10.8% to 427.9% of ADI in 15
samples detected with chromium in case of average use of 24 mg/day of lipstick, and was more than
100% in 4 samples. While considering the high use of 87 mg/day of lipstick, it was more than 100% in
case of 13 samples out of 15 samples in the range of 39.2% to 1551.2% of ADI.
Nickel was detected in 43.3% (13 of 30) lipsticks. Highest concentration of 9.18 ppm was detected in
Labsolu Nu shade-204 of Lancome lipstick.
Hearts & Tarts (080V) shade of ColorBar lipstick contained highest amount of Chromium and also 5.47
ppm Nickel. Similarly Lancome (Labsolu Nu-204) lipstick contained 13.9 and 9.18 ppm of Chromium
and Nickel.
No other heavy metals tested (Lead and Cadmium) were detected in the lipstick samples tested.
Mercury concentration in the fairness creams analyzed ranged from 0 - 1.97 ppm. About 44% of the
samples had mercury above the Indian permissible limit, which is zero.
Three samples (10.7%) were above the threshold limit of 1 ppm set by the USFDA.
None of the heavy metals tested were detected in lip-balm and anti-ageing creams.
34
Rosenman KD, Valciukas JA, Glickman L, Meyers BR, Cinotti A. Sensitive indicators of inorganic mercury
toxicity. Arch Environ Health.1986 Jul-Aug; 41(4):208-15.
15
Table 2: Cosmetic Samples Purchased from Markets in Delhi
S.
Sample
No.
Code
Lipstick
Brand
Color
Batch
No.
Manufactured By
Ruby Sparkle
(12)
Rouge
Plump+ (RP+
746)
Extreme Pink
(19)
A Different
Grape
Burnt Orange
(017)
XJ802CD
Made in Italy
--A 10
COPARCOS S.A, Rue de
Bains, 33, 1211, Geneva 8,
Switzerland
Made in USA
A 21
Made in USA
AKA12
Aero Pharma Pvt. Ltd., W –
34(B), TTC Industrial Area,
MIDC Rabel, Navi Mumbai 400701
Aero Pharma Pvt. Ltd., W –
34(B), TTC Industrial Area,
MIDC Rabel, Navi Mumbai 400701
Viva Cosmetics, Asangaon,
Thane - 421601
1
LS 01
Body Shop
2
LS 02
Chambor
3
LS 03
Clinique
4
LS 04
Clinique
5
LS 05
ColorBar
6
LS 06
ColorBar
Bitter
Chocolate
(028)
ALA12
7
LS 07
ColorBar
Hearts & Tarts
(080V)
116
8
LS 08
Dior
(Rouge Dior)
Mazette (028)
Parfums Christian Dior Orient
FZCO
9
LS 09
Dior
(Dior Addict
Extreme)
Fireworks
(756)
Parfums Christian Dior Orient
FZCO
10
LS 10
Estee Lauder
Fuchsia Fever
(60)
AA2
Estee Lauder, Dist. New York,
N. Y. 10022
16
Imported &/or
Marketed By
The Body Shop
Use
Before
07/2015
11/2015
Remark
Reference No.
826975
SPF 15,
Reference 2910
SPF 15
ColorBar Cosmetics Pvt.
Ltd., 4, Community Centre,
New Friends Colony, New
Delhi - 110025
ColorBar Cosmetics Pvt.
Ltd., 4, Community Centre,
New Friends Colony, New
Delhi - 110025
ColorBar Cosmetics Pvt.
Ltd., 4, Community Centre,
New Friends Colony, New
Delhi - 110025
TARZ Distribution Pvt. Ltd.,
201, Ackruti Star, MIDC,
Andheri (E), Mumbai 400093
TARZ Distribution Pvt. Ltd.,
201, Ackruti Star, MIDC,
Andheri (E), Mumbai 400093
ELCA Cosmetics Pvt. Ltd.,
202-206, Tolstoy House, 15
08/2015
SPF 15
09/2015
SPF 15
11/2015
01/2015
09/2015
10/2015
Made in
Belgium
Tolstoy Road, New Delhi –
110001
11
LS 11
Estee Lauder
Scarlet Siren
(73)
A92
Estee Lauder, Dist. New York,
N. Y. 10022
12
LS 12
Red Hot (43)
094E12
13
LS 13
Lakme
(Absolute
Matte)
Lakme
Bridal Dream
(44)
226J12
14
LS 14
Lakme
Pink Romance
(206)
160012
15
LS 15
Lakme
Enrich Satins
(352)
Not
Readable
16
LS 16
Lancome
L’ABSOLU
NU (204)
62H803
Hindustan Unilever Ltd., Unit
– 4, I. Industrial Estate,
Haridwar - 249403
Hindustan Unilever Ltd., Unit
– 4, I. Industrial Estate,
Haridwar - 249403
Hindustan Unilever Ltd., Unit
– 4, I. Industrial Estate,
Haridwar - 249403
Hindustan Unilever Ltd., Unit
– 4, I. Industrial Estate,
Haridwar - 249403
Lancome Luxury Products
LLC, New York, NY 10017
Dist. Lancome Canada,
Montreal, H4T1K5
17
LS 17
L’Oreal (Paris)
Intense Plum
(374)
16J800
18
LS 18
MAC (Satin
Lipstick)
Paramount
(A52)
M3EW
19
LS 19
MAC
(Lustre
Plumful (A62)
M31A
Estee Lauder, Dist. New York,
N. Y. 10022
Dist. By – Make-up Art
Cosmetics, Toronto, Ontario,
Canada M5VIR7
Estee Lauder, Dist. New York,
N. Y. 10022
17
ELCA Cosmetics Pvt. Ltd.,
202-206, Tolstoy House, 15
Tolstoy Road, New Delhi 110001
Hindustan Unilever Ltd.,
Unit – 4, I. Industrial Estate,
Haridwar - 249403
Hindustan Unilever Ltd.,
Unit – 4, I. Industrial Estate,
Haridwar - 249403
Hindustan Unilever Ltd.,
Unit – 4, I. Industrial Estate,
Haridwar - 249403
Hindustan Unilever Ltd.,
Unit – 4, I. Industrial Estate,
Haridwar - 249403
L’Oreal India Pvt. Ltd., AWing, 8th Floor, Marathon
Futurex Building, N. M.
Joshi Road, Lower Parel,
Mumbai - 400013
L’Oreal India Pvt. Ltd., AWing, 8th Floor, Marathon
Futurex Building, N. M.
Joshi Road, Lower Parel,
Mumbai - 400013
Elca Cosmetics Pvt. Ltd.,
202-206, Tolstoy House, 15
Tolstoy Road, New Delhi 110001
09/2015
Made in
Belgium
05/2015
Made in
Canada
Elca Cosmetics Pvt. Ltd.,
202-206, Tolstoy House, 15
06/2015
Made in
Canada
Use before
24 months
from Pkd
Use before
24 months
from Pkd
Use before
24 months
from Pkd
09/2015
03/2015
Made in France
05/2015
Lipstick)
20
LS 20
MAC
(Lustre
Lipstick)
Cockney
(A82)
M31A
21
LS 21
MAC
(Matte
Lipstick)
So Chaud
(A82)
M2LP
22
LS 22
Maxfactor
Pomegranate
(665)
2137
23
LS 23
Maybelline
(Colorsensation
al)
Hooked On
Pink (065)
20J701
Dist. By – Make-up Art
Cosmetics, Toronto, Ontario,
Canada M5VIR7
Estee Lauder, Dist. New York,
N. Y. 10022. Dist. By – Makeup Art Cosmetics, Toronto,
Ontario, Canada M5VIR7
Estee Lauder, Dist. New York,
N. Y. 10022
Dist. By – Make-up Art
Cosmetics, Toronto, Ontario,
Canada M5VIR7
Proctor & Gamble UK, KT13
OXP, UK
CH – 1213, Petit Lancy 1
Maybelline LLC, New York,
N. Y. 10017
Dist. – Maybelline Canada,
Montreal - H4T TK5
24
LS 24
Maybelline
(Colorsensation
al)
Fatal Red
(530)
16J802
25
LS 25
Maybelline
(Super Stay)
Endless Raisin
(090)
20J401
26
LS 26
Revlon
(Color Burst)
Ruby (85)
122651
Maybelline LLC, New York,
N. Y. 10017
Dist. – Maybelline Canada,
Montreal - H4T TK5
G. S. Pharmabutor Pvt. Ltd.,
(Unit – II), Plot No. 58,59, 66
& 67, Sector-3, I. I. E.,
Pantnagar, Rudrapur,
Uttrakhand - 263153
18
Tolstoy Road, New Delhi 110001
Elca Cosmetics Pvt. Ltd.,
202-206, Tolstoy House, 15
Tolstoy Road, New Delhi 110001
Elca Cosmetics Pvt. Ltd.,
202-206, Tolstoy House, 15
Tolstoy Road, New Delhi 110001
L’Oreal India Pvt. Ltd., AWing, 8th Floor, Marathon
Futurex Building, N. M.
Joshi Road, Lower Parel,
Mumbai - 400013
L’Oreal India Pvt. Ltd., AWing, 8th Floor, Marathon
Futurex Building, N. M.
Joshi Road, Lower Parel,
Mumbai - 400013
L’Oreal India Pvt. Ltd., AWing, 8th Floor, Marathon
Futurex Building, N. M.
Joshi Road, Lower Parel,
Mumbai - 400013
Modi-Revlon Pvt. Ltd,
(Umesh Modi Group
Company), New Delhi 110019
08/2015
Made in
Canada
08/2015
Made in
Canada
10/2015
Made in Ireland
03/2015
Made in USA
04/2015
03/2015
08/2015
Made in USA
27
LS 27
Revlon (Super
Lustrous)
Frost Grape
Juice (164)
Not
Readable
G. S. Pharmabutor Pvt. Ltd.,
(Unit – II), Plot No. 58,59, 66
& 67, Sector-3, I. I. E.,
Pantnagar, Rudrapur,
Uttrakhand - 263153
G. S. Pharmabutor Pvt. Ltd.,
(Unit – II), Plot No. 58,59, 66
& 67, Sector-3, I. I. E.,
Pantnagar, Rudrapur,
Uttrakhand – 263153
Modi-Revlon Pvt. Ltd,
(Umesh Modi Group
Company), New Delhi 110019
06/2015
28
LS 28
Revlon (Super
Lustrous)
Frost Copper
Glow Berry
(311)
Not
Readable
Modi-Revlon Pvt. Ltd,
(Umesh Modi Group
Company), New Delhi 110019
09/2014
29
LS 29
Yves Saint
Laurent (YSL)
(Lip Twins)
7DC
Yves Saint Laurent Parfums,
92512, NEUILLY, Codex
France
No
information
SPF 8 Made in
France
30
LS 30
Yves Saint
Laurent (YSL)
(Pure Color)
Satin/Shine
Cassis Rose
Black Current
Rose (10)
Rose Libertin
Satiny
Radiance (26)
0KCA
Yves Saint Laurent Parfums,
92512, NEUILLY, Codex
France
No
information
Made in France
24200833
R
The Himalaya Drug Company,
Plot No. C-15, MIDC, Five
Star Industrial Area, Shendra,
Aurangabad (M. S.) - 431201
Lotus Herbals Color
Cosmetics, 80-B, Jharmajri,
Baddi, Distt. Solan, H. P.
Lotus Herbals Color
Cosmetics, 80-B, Jharmajri,
Baddi, Distt. Solan, H. P.
Made in China
11/2015
Lip Balm
1
LB 01
The Body Shop
2
LB 02
The Body Shop
3
LB 03
Himalaya
Lip Care SPF
15
Born Lippy
Plum Lip
Balm
Lip Balm
4
LB 04
Lotus
Fresh Mint
B 01
5
LB 05
Lotus
Velvety Rose
B 04
6
LB 06
Maybelline
New York
Enriched with
Centella
6J130
19
Lotus Herbals Ltd., B-9,
Sector 58, Noida, U. P. 201301
Lotus Herbals Ltd., B-9,
Sector 58, Noida, U. P. 201301
L’Oreal India Pvt. Ltd.,
Peninsula Towers, Lower
04/2015
SPF 15
10/2015
SPF 15
12/2014
SPF 20
7
LB 07
8
LB 08
(Baby Lips)
Maybelline
New York
(Baby Lips
Color)
Essence
Berry Crush
fJ257M
Made in Thailand
Nivea
Essential Care
22419810
Beiersdorf AG,
Troplowitzstrasse 10, 22529
Hamburg, Germany
Youth Code
(Rejuvenating
Anti-wrinkle
Day Cream)
Total Effects
(7 in one,
Anti-aging
Night Firming
Treatment)
Age Miracle
(Cell ReGEN
Day Cream)
28J302
Parel, Mumbai - 400013
L’Oreal India Pvt. Ltd.,
A-wing, 8th Floor, Marathon
Futurex Building, N. M.
Joshi Road, Lower Parel,
Mumbai - 400013
NIVEA India Pvt. Ltd., Hyde
Park, 301, Saki Vihar Road,
Andheri (E), Mumbai 400072
03/2015
SPF 16
11/2014
Made in
Germany
Anti Ageing Cream
1
AAC 01
L’Oreal (Paris)
2
AAC 02
Olay
3
AAC 03
Ponds
Made in
Germany
2184PRF
Distr. By – Proctor & Gamble,
Cincinnati, OH - 45202
Imported for – Proctor &
Gamble INC., Toronto, ON
M5W 1C5
Not
mentioned
B040
Hindustan Unilever Ltd., Unit
– 4, I. Industrial Estate,
Haridwar - 249403
Hindustan Unilever Ltd.,
165/166, Backbay
Reclamation, Mumbai 400020
06/2014
20
SPF 15 PA++
Table 3: Fairness Creams Analyzed for Mercury
S. No. Code No. Name
Fairness Creams for Men
Manufactured By
4
Emami Fair
Handsome
2
3
Fair
&
Lovely
MAXFairness
For
MEN
3
25
Vaseline MENface
4
7
5
5
L'Oreal Men Expert
Garnier Men Power
Light
29
Nivea
For Men
Advance Whitening
1
6
and
Fairness Creams for Women
Garnier Skin
7
6
Naturals, Light
Fairever
Cream
Fairness
Date of Mfg.
Emami Limited, College Nagar,
Abhoypur, North Guwahati,
Assam - 781031
Hindustan Unilever Ltd., Unit –
8, Plot No. 1-(1-H), Sec 1A,
Sidcul Ranipur, Haridwar 249403
Aero Pharma (Silvassa), Preeti
Indl. Estate, Survey No. 127/1,
Amli , Silvassa - 396230
L’Oreal India Private Ltd.
L'Oreal India Private Ltd.,
Chakan, Pune - 410501
Beiersdorf (Thailand) Co. Ltd.,
163 Bangplee Industrial Estate,
Samutprakarn 10540, Thailand
L'Oreal India Private Ltd.,
Chakan, Pune - 410501
CavinKare Pvt. Ltd., Plot No. 16
& 17, Sec – 04, IIE, Sidcul,
Haridwar - 249403
Aero Pharma (Silvassa), Preeti
Industrial. Estate, Survey No.
127/1, Amli , Silvassa - 396230
8
2
9
14
10
27
Lakme Perfect
Radiance
Lotus Micro
Emulsion
11
8
L'Oreal Pearl Perfect
Kanidi Cosmeceuticals
L'Oreal India Private
Chakan, Pune - 410501
12
1
Fair & Lovely
Hindustan Unilever Ltd., Unit –
Marketed by
Use before
Batch No.
AP785
Mar - 2012
August - 2014
08/07/2012
24 Months from
Pkd.
B91
Nov - 2012
Mar - 2012
L'OREAL
Singapore Pte Ltd.
Hindustan
Unilever Ltd.
L'OREAL
Philippines
24 Months from
Pkd.
B008
FJ090
36 Months from
Pkd.
18/04/2012
B534937
21171577
Mar - 2012
Nivea India Pvt.
Nivea India Pvt.
August - 2014
36 Months from
Pkd.
11/05/2012
B536527
U. B. 09
CavinKare Pvt.
Ltd.
24 Months from
Pkd.
Hindustan
Unilever Ltd.
Lotus Herbals
Ltd.
04/07/2012
24 Months from
Pkd.
36 Months from
Pkd.
36 Months from
Pkd.
06/07/2012
24 Months from
Apr - 2012
Aug - 2012
Dec - 2011
Ltd.,
21
Imported by
B 034
B 12
B540605
Advanced Multi
Vitamin Daily
Fairness Expert
13
14
15
21
Biotique, Bio
Coconut, Whitening
and Brightening
Cream
18
Lotus Cocofair
Cream
20
Nivea Visage,
Sparkling Glow
28
Lotus Herbals Fair
Gel
1, Tinsukia, Assam - 786151
Bio Veda Action Research
Company, Khasra No. 439/42,
441/43
526/442/43,
Mauja
Rampur Ghat, Tehsil Paonta
Sahib, Dist. – Sirmour, H. P. 173025
Kanidi Cosmeceuticals, 80C,
Jharmajri, Baddi, Distt. Solan,
H. P.
Beiersdorf (Thailand) Co. Ltd.,
163, Bang Plee Industrial Estate,
Bangna Trad Rd, Km 24,
Samutprakarn – 10540, Thailand
19
24
Blossom Kochhar
Aroma Magic
Kanidi Cosmeceuticals, 80C,
Jharmajri, Baddi, Distt. Solan,
H. P.
VLCC Personal Care Ltd., Plot
No. – 11 & 12, Sec 6A, Sidcul,
IIE, Hardwar, Uttarakhgand 246403
Procter & Gamble Home
Products Ltd., Plot No. 01,
Industrial Area, Katha, P. O.
Baddi, Solan, H. P. - 173205
Blossom
Kochhar
Beauty
Products Pvt. Ltd., Plot No. –
90A, Khasra No – 68, Shiv
Ganga Industrial Estate, Village
– Lakeshri, Post – Bhagwanpur,
Tehsil – Roorkee, Dist.–
Haridwar, Uttarakhand - 247667
20
19
Lotus Whiteglow Gel
Kanidi
16
17
18
23
22
VLCC Enbrighten
Olay Natural White
Cosmeceuticals,
80C,
Pkd.
12-005
Bio
Veda
Action Research
Company
Mar - 2012
36 Months from
Pkd.
B 03
Lotus
Ltd.
Herbals
Jan - 2015
10350277
Jan - 2011
Nivea India Pvt.
Nivea India Pvt.
Lotus Herbals
Ltd., B-9, Sec –
58, Noida, UP 201301
June - 2013
B 02
April - 2015
12002
Mar - 2012
36 Months from
Pkd.
Aug - 2012
36 Months from
Pkd.
B6911
FALR-13/12
24 Months from
Pkd.
Sep - 2012
Batch No –
22
B07D
Lotus
Herbals
October 2014
Cream
21
11
Fair & Lovely Anti
Marks
22
16
Emami Malai Keshar
Cold Cream
15
Shahnaz Husain Fair
One
10
Fair & Lovely
Ayurvedic Care
17
Neutrogena, Fine
Fairness
26
9
Fair & Lovely Winter
Fairness
27
13
Ponds White Beauty
28
12
Vivel Active Fair
29
26
Lakme
30
Himalaya
Herbals
Fairness Cream
23
24
25
30
Jharmajri, Baddi, Distt. Solan,
H. P.
Hindustan Unilever Ltd., Unit –
8, Plot No. 1-(1-H), Sec 1A,
Sidcul Ranipur, Haridwar 249403
Emami Limited, College Nagar,
Abhoypur, North Guwahati,
Assam - 781031
Elder Pharmaceuticals Ltd., Plot
No. – 103, Gondpur Industrial
Area, Paonta Sahib, Dist. –
Sirmour, H. P. 173025
Hindustan Unilever Ltd., Unit –
8, Plot No. 1-(1-H), Sec 1A,
Sidcul Ranipur, Haridwar 249403
Johnson & Johnson Korea Ltd.,
140-20, Song Jeong Dong,
Heung Duck Ku, Cheong Ju
City, Chung Buk, Korea
Hindustan Unilever Ltd., Unit –
8, Plot No. 1-(1-H), Sec 1A,
Sidcul Ranipur, Haridwar 249403
L. B. C. P., Unit – II, Haridwar 249403
ITC Ltd., Plot No 01, Sec – 11,
IIE, Ranipur Haridwar - 249403
Aero Pharma
The Himalaya Drug Company,
182,
Village
Gurumajra,
Kishanpura, Tehsil Nalagarh,
Distt. Solan, H. P. - 174101
B-48
Ltd.
B 05
20/03/2012
24 Months from
Pkd.
Sep - 2011
24 Months from
Pkd.
May - 2011
24 Months from
Pkd.
28/05/2012
24 Months from
Pkd.
AU 043
BPAX1018
B 34
Not mentioned
10/04/2012
Johnson
Johnson Ltd.
&
Johnson
&
Johnson Ltd.
24 Months from
Pkd.
B 33
24 Months from
Pkd.
24 Months from
Pkd.
03/10/2012
25/05/2012
B 067
B162A 22
Nov - 2011
Jul - 2012
Hindustan
Unilever Ltd.
April - 2013
24 Months from
Pkd.
16200408M
May - 2012
23
B 48
April - 2015
31
31
32
32
Revlon Touch &
Glow
Jovees
Pearl
Whitening
Face
Cream
G. S. Pharmbutor Pvt. Ltd., Unit
– II, Plot No. – 58, 59, 66 & 67,
Sec – 03, I. I. E. Pantnagar,
Rudrapur, Uttrakhand - 263153
Jovees Herbal Care, Plot No. –
16, Sector 03, I. I. E., Pant
Nagar, 263146, Uttarakhand
IN123001
Oct - 2012
Mar - 2012
24
Modi-Revlon
Pvt.Ltd.
36 Months from
Pkd.
36 Months from
Pkd.
1618
Table 4: Heavy Metals in Lipstick, Lip-balm and Anti-aging Creams (ppm)
S.
Sample
No
Lipstick
1 Bodyshop (Ruby Sparkle - 12)
2 Chambor (Rouge Plump - 746)
3 Clinique (Extreme Pink - 19)
4 Clinique (Different Grape)
5 ColorBar (Burnt Orange - 017)
6 ColorBar (Bitter Chocolate - 028)
7 ColorBar (Hearts & Tarts 080V)
8 Dior (Mazette - 028)
9 Dior (Fireworks - 756)
10 Estee Lauder (Fuchsia Fever 60)
11 Estee Lauder (Scarlet Siren - 73)
12 Lakme (Red Hot - 43)
13 Lakme (Bridal Dream - 44)
14 Lakme (Pink Romance - 206)
15 Lakme (Enrich Satin - 352)
16 Lancome (Labsolu Nu - 204)
17 L’Oreal (Intense Plum - 374)
18 MAC (Paramount - A52)
19 MAC (Plumful - A62)
20 MAC (Cockney - A82)
21 MAC (So chaud - A82)
22 Maxfactor (Pomegranate - 665)
23 Maybelline (Hooked Pink - 065)
24 Maybelline (Fatal Red - 530)
25 Maybelline (Endless Raisin -090)
26 Revlon (Ruby - 85)
27 Revlon (Frost Grape Juice - 164)
28 Revlon (Copper Glow Berry-311)
29 YSL (Current Rose - 10)
30 YSL (Satiny Radiance - 26)
Lip-balm
1 The Body Shop (Lip Care)
2 The Body Shop (Plum Lip-balm)
3 Himalaya (Lip-balm)
4 Lotus (Fresh mint)
5 Lotus (Velvety Rose)
6 Maybelline (Baby Lips)
7 Maybelline (Baby Lips Color)
8 Nivea (Essential Care)
Anti Ageing Creams
1 L’Oreal (Youth Code)
2 Olay (Total Effects)
3 Ponds (Age Miracle)
Sample
Code
Lead
Cadmium
Chromium
Nickel
LS 01
LS 02
LS 03
LS 04
LS 05
LS 06
LS 07
ND
ND
ND
ND
ND
ND
ND
ND
ND
ND
ND
ND
ND
ND
2.91
ND
ND
ND
1.62
2.55
17.83
1.65
ND
ND
ND
ND
ND
5.47
LS 08
LS 09
LS 10
ND
ND
ND
ND
ND
ND
ND
ND
ND
ND
ND
0.99
LS 11
LS 12
LS 13
LS 14
LS 15
LS 16
LS 17
LS 18
LS 19
LS 20
LS 21
LS 22
LS 23
LS 24
LS 25
LS 26
LS 27
LS 28
LS 29
LS 30
ND
ND
ND
ND
ND
ND
ND
ND
ND
ND
ND
ND
ND
ND
ND
ND
ND
ND
ND
ND
ND
ND
ND
ND
ND
ND
ND
ND
ND
ND
ND
ND
ND
ND
ND
ND
ND
ND
ND
ND
1.34
0.45
1.39
ND
ND
13.90
ND
1.14
1.22
2.32
5.75
1.59
5.27
ND
ND
ND
ND
2.43
ND
ND
2.36
2.47
0.57
ND
1.09
9.18
ND
2.19
ND
ND
3.42
ND
2.21
ND
ND
ND
ND
2.18
0.99
ND
LB 01
LB 02
LB 03
LB 04
LB 05
LB 06
LB 07
LB 08
ND
ND
ND
ND
ND
ND
ND
ND
ND
ND
ND
ND
ND
ND
ND
ND
ND
ND
ND
ND
ND
ND
ND
ND
ND
ND
ND
ND
ND
ND
ND
ND
AAC 01
AAC 02
AAC 03
ND
ND
ND
ND
ND
ND
ND
ND
ND
ND
ND
ND
25
Table 5: Lipstick Samples Detected with Chromium (Compared as Percentage of ADI)
S.
No.
Sample
Code
1
2
3
4
5
6
7
8
9
10
11
12
13
14
15
LS 01
LS 05
LS 06
LS 07
LS 11
LS 12
LS 13
LS 16
LS 18
LS 19
LS 20
LS 21
LS 22
LS 23
LS 28
Lipstick Samples Detected with
Chromium
Bodyshop (Ruby Sparkle – 12)
ColorBar (Burnt Orange – 017)
ColorBar (Bitter Chocolate – 028)
ColorBar (Hearts & Tarts – 080V)
Estee Lauder (Scarlet Siren – 73)
Lakme (Red Hot – 43)
Lakme (Bridal Dream – 44)
Lancome (Labsolu Nu – 204)
MAC (Paramount – A52)
MAC (Plumful – A62)
MAC (Cockney – A82)
MAC (So Chaud – A82)
Maxfactor (Pomegranate – 665)
Maybelline (Hooked Pink – 065)
Revlon (Copper Glow Berry – 311)
Total
Chromium
(ppm)
%age of
ADI for
Average Use
of 24
mg/day
%age of
ADI for
High Use of
87 mg/day
2.91
1.62
2.55
17.83
1.34
0.45
1.39
13.90
1.14
1.22
2.32
5.75
1.59
5.27
2.43
69.8
38.9
61.2
427.9
32.2
10.8
33.4
333.6
27.4
29.3
55.7
138.0
38.2
126.5
58.3
253.2
140.9
221.9
1551.2
116.6
39.9
120.9
1209.3
99.2
106.1
201.8
500.3
138.3
458.5
211.4
Note: Comparison of total Cr Detected in Lipsticks with Average Daily Intake (ADI) of Cr+6
•
The ADI value of 0.0001 mg/day for a 50 kg woman for Cr+6 derived by Liu et. al. (2013) was used
for estimating exposure risk35. This ADI value is derived based on the cancer risk posed by Cr+6.
•
CSE tested total Cr and not Cr+6 in lipsticks. Recognizing the need for extra precaution, all Cr has
been assumed as Cr+6. This assumption is made by most health regulators, including the USEPA
while setting standards.
•
An average use of 24 mg/day and high use of 87 mg/day of lipstick suggested by Loretz et. al.
(2005) were used for estimating the exposure risk.
35
Liu S., Hammond S. K., Rojas-Cheatham A.; Concentrations and Potential Health Risks of Metals in Lip Products.
Environmental Health Perspectives 2013; 121(6): 705 - 710
26
Table 6: Mercury in Fairness (Skin Whitening) Creams
S.
No.
Code
No.
Name
Manufacturer
Total
Mercury
(ppm)
Mercury
as HgCl2
(ppm)
%age of
ADI for
Average
Use*
%age of
ADI for
High
Use*
-----
-----
Fairness Creams for Women
Fair & Lovely multi Vitamin
1
1
daily fairness cream
Hindustan Unilever Ltd.
ND
2
2
Fairever
CavinKare Pvt. Ltd.
ND
-----
3
6
Garnier Skin Naturals, Light
L'Oreal India Private Ltd.
ND
---
---
---
4
8
L'Oreal Pearl Effect
L'Oreal India Private Ltd.
0.70
0.95
12.9
25.2
5
9
Fair & Lovely Winter Fairness
Hindustan Unilever Ltd.
ND
---
---
---
1.8
3.6
6
10
Fair & Lovely Ayurvedic Care
Hindustan Unilever Ltd.
0.10
0.14
7
11
Fair & Lovely Anti Marks
Hindustan Unilever Ltd.
0.73
0.99
13.5
26.3
8
12
Vivel Active Fair
ITC Ltd.
0.23
0.31
4.3
8.3
9
13
Ponds White Beauty
Hindustan Unilever Ltd.
1.36
1.84
25.2
49.0
10
14
Lakme Perfect Radiance
Aero Pharma
0.19
0.26
3.5
6.8
11
15
Elder Pharmaceuticals Ltd.
ND
---
---
---
0.22
0.30
4.1
7.9
ND
--15.0
--29.2
12
16
Fair One Shahnaz Husain
Emami Malai Keshar
Cream
13
17
Neutrogena Fine Fairness
Emami Limited
Johnson & Johnson Corea
Ltd.
14
18
Lotus Cocofair Cream
Kanidi Cosmeceuticals
0.81
--1.10
15
19
Lotus White Glow
ND
---
---
---
16
20
Nivea Sparkling Glow
ND
---
---
---
17
21
Biotique Bio Coconut
0.24
0.32
4.4
8.6
18
22
Olay Natural White
Kanidi Cosmeceuticals
Beiersdorf
(Thailand)
Co.Ltd.
Bio Veda Action Research
Company
Procter & Gamble Home
Products Ltd.
1.79
2.42
33.1
64.4
19
23
VLCC Enbrighten (Sun Defence)
0.11
0.15
2.0
4.0
20
24
Aroma Magic Fair Lotion
VLCC Personal Care Ltd.
Blossom Kochhar Beauty
Products Pvt. Ltd.
1.97
21
26
Lakme
Aero Pharma
ND
2.67
---
36.4
---
70.9
---
22
27
Lotus Micro emulsion
Kanidi Cosmeceuticals
ND
---
---
---
23
28
Kanidi Cosmeceuticals
ND
---
---
---
24
30
Lotus Fair Gel
Himalaya
Herbals
Cream
Himalya Drug Company
ND
25
31
Revlon Touch and Glow
Jovees Pearl Whitening Face
26
32
Cream
Fairness Creams for Men
G.S. Pharmbutor Pvt Ltd.
0.25
--0.34
--4.6
--9.0
Jovees Herbal Care.
ND
---
---
---
27
3
Fair & Lovely Max Fairness
Hindustan Unilever Ltd.
ND
---
---
---
28
4
Emami Fair and Handsome
Emami Limited
ND
---
---
---
4.4
8.6
Cold
Fairness
29
5
Garnier Men Power Light
L'Oreal India Private Ltd.
0.24
0.32
30
7
L'Oreal Men Expert
L'Oreal India Private Ltd.
ND
---
---
---
31
25
Vaseline Men Face
Aero Pharma
ND
---
---
---
27
32
29
Nivea Advance Whitening For
Men
Beiersdorf (Thailand) Co.
Ltd.
ND
---
---
Note: Conversion of total Hg to HgCl2 is done by considering the Molecular Weight of Hg as 200.592 and
that of HgCl2 as: 271.496.
•
Comparison of Hg detected in Fairness Creams with Average Daily Intake (ADI) of
HgCl2:
•
Skin whitening creams commonly use inorganic mercury in the form of ammoniated mercuric
chloride and mercuric iodide.
•
Loretz et. al. (2005) have estimated that the average use of creams is 2.05 g/day and high use is
3.99 g/day36.
•
100% dermal absorption is considered.
•
Calculation of ADI is based on USEPA oral Reference Dose (RfD) of 0.0003 mg/kg-day of HgCl2
which translates into an ADI for a 50 kg person as 0.015 mg.
36
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. Exposure data for cosmetic products: lipstick, body lotion,
and face cream. Food and Chemical Toxicology 2005; 43: 279–291
28
---