Heavy Metals in Cosmetics

1

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

2

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

3

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 anti-

aging creams.

1 Section 3 aaa) . Drug and Cosmetic Act, 1940 available at http://cdsco.nic.in/html/copy%20of%201.%20d&cact121.pdf

4

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/cps-spc/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.hc-sc.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.hc-sc.gc.ca/cps-spc/legislation/consultation/_cosmet/metalmetauxconsulteng.php

5

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

6

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 15 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). 17California 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

7

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

8

Table 1: Limits for Heavy Metals in Cosmetics in India

Regulatory Body

Mercury Lead Cadmium Arsenic Total Heavy Metals

Other than Eye Area Products

Eye Area Products

Through permitted Synthetic Organic Colors and

Natural Organic Colors

India (BIS) Prohibited for intentional use.

≤ 0.007% by weight

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

9

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.hc-sc.gc.ca/cps-spc/pubs/indust/heavy_metals-metaux_lourds/index-eng.php).

10

7. Material and Methods

Sampling Methodology

30 samples of lipsticks, 32 samples of fairness creams, 8 samples of lip-balm and 3 samples of anti-

ageing 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

11

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.

12

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

24USEPA, Chromium in Drinking Water: http://water.epa.gov/drink/info/chromium/index.cfm?utm_source=feedburner&utm_medium=feed&utm_campaign=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

13

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 28 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/psl1-lsp1/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.

14

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

15

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.

16

Table 2: Cosmetic Samples Purchased from Markets in Delhi S.

No. Sample Code

Brand Color Batch No.

Manufactured By Imported &/or Marketed By

Use Before

Remark

Lipstick 1 LS 01 Body Shop Ruby Sparkle

(12) XJ802CD Made in Italy The Body Shop 07/2015 Reference No.

826975 2 LS 02 Chambor Rouge

Plump+ (RP+ 746)

--- COPARCOS S.A, Rue de Bains, 33, 1211, Geneva 8, Switzerland

11/2015 SPF 15, Reference 2910

3 LS 03 Clinique Extreme Pink (19)

A 10 Made in USA SPF 15

4 LS 04 Clinique A Different Grape

A 21 Made in USA

5 LS 05 ColorBar Burnt Orange (017)

AKA12 Aero Pharma Pvt. Ltd., W – 34(B), TTC Industrial Area, MIDC Rabel, Navi Mumbai - 400701

ColorBar Cosmetics Pvt. Ltd., 4, Community Centre, New Friends Colony, New Delhi - 110025

08/2015 SPF 15

6 LS 06 ColorBar Bitter Chocolate (028)

ALA12 Aero Pharma Pvt. Ltd., W – 34(B), TTC Industrial Area, MIDC Rabel, Navi Mumbai - 400701


09/2015 SPF 15

7 LS 07 ColorBar Hearts & Tarts (080V)

116 Viva Cosmetics, Asangaon, Thane - 421601


11/2015

8 LS 08 Dior (Rouge Dior)

Mazette (028) Parfums Christian Dior Orient FZCO

TARZ Distribution Pvt. Ltd., 201, Ackruti Star, MIDC, Andheri (E), Mumbai - 400093

01/2015

9 LS 09 Dior (Dior Addict Extreme)

Fireworks (756)

Parfums Christian Dior Orient FZCO

TARZ Distribution Pvt. Ltd., 201, Ackruti Star, MIDC, Andheri (E), Mumbai - 400093

09/2015

10 LS 10 Estee Lauder Fuchsia Fever (60)

AA2 Estee Lauder, Dist. New York, N. Y. 10022

ELCA Cosmetics Pvt. Ltd., 202-206, Tolstoy House, 15

10/2015 Made in Belgium

17

Tolstoy Road, New Delhi – 110001

11 LS 11 Estee Lauder Scarlet Siren (73)

A92 Estee Lauder, Dist. New York, N. Y. 10022

ELCA Cosmetics Pvt. Ltd., 202-206, Tolstoy House, 15 Tolstoy Road, New Delhi - 110001

09/2015 Made in Belgium

12 LS 12 Lakme (Absolute Matte)

Red Hot (43) 094E12 Hindustan Unilever Ltd., Unit – 4, I. Industrial Estate, Haridwar - 249403

Hindustan Unilever Ltd., Unit – 4, I. Industrial Estate, Haridwar - 249403

Use before 24 months from Pkd

13 LS 13 Lakme Bridal Dream (44)

226J12 Hindustan Unilever Ltd., Unit – 4, I. Industrial Estate, Haridwar - 249403



14 LS 14 Lakme Pink Romance (206)

160012 Hindustan Unilever Ltd., Unit – 4, I. Industrial Estate, Haridwar - 249403



15 LS 15 Lakme Enrich Satins (352)

Not Readable



09/2015

16 LS 16 Lancome L’ABSOLU NU (204)

62H803 Lancome Luxury Products LLC, New York, NY 10017 Dist. Lancome Canada, Montreal, H4T1K5

L’Oreal India Pvt. Ltd., A-Wing, 8th Floor, Marathon Futurex Building, N. M. Joshi Road, Lower Parel, Mumbai - 400013

03/2015 Made in France

17 LS 17 L’Oreal (Paris) Intense Plum (374)

16J800 L’Oreal India Pvt. Ltd., A-Wing, 8th Floor, Marathon Futurex Building, N. M. Joshi Road, Lower Parel, Mumbai - 400013

05/2015

18 LS 18 MAC (Satin Lipstick)

Paramount (A52)

M3EW Estee Lauder, Dist. New York, N. Y. 10022 Dist. By – Make-up Art Cosmetics, Toronto, Ontario, Canada M5VIR7

Elca Cosmetics Pvt. Ltd., 202-206, Tolstoy House, 15 Tolstoy Road, New Delhi - 110001

05/2015 Made in Canada

19 LS 19 MAC (Lustre

Plumful (A62) M31A Estee Lauder, Dist. New York, N. Y. 10022

Elca Cosmetics Pvt. Ltd., 202-206, Tolstoy House, 15


18

Lipstick) Dist. By – Make-up Art Cosmetics, Toronto, Ontario, Canada M5VIR7

Tolstoy Road, New Delhi - 110001

20 LS 20 MAC (Lustre Lipstick)

Cockney (A82)

M31A Estee Lauder, Dist. New York, N. Y. 10022. Dist. By – Make-up Art Cosmetics, Toronto, Ontario, Canada M5VIR7



21 LS 21 MAC (Matte Lipstick)

So Chaud (A82)

M2LP Estee Lauder, Dist. New York, N. Y. 10022 Dist. By – Make-up Art Cosmetics, Toronto, Ontario, Canada M5VIR7



22 LS 22 Maxfactor Pomegranate (665)

2137 Proctor & Gamble UK, KT13 OXP, UK CH – 1213, Petit Lancy 1

10/2015 Made in Ireland

23 LS 23 Maybelline (Colorsensational)

Hooked On Pink (065)

20J701 Maybelline LLC, New York, N. Y. 10017 Dist. – Maybelline Canada, Montreal - H4T TK5


03/2015 Made in USA

24 LS 24 Maybelline (Colorsensational)

Fatal Red (530)

16J802 L’Oreal India Pvt. Ltd., A-Wing, 8th Floor, Marathon Futurex Building, N. M. Joshi Road, Lower Parel, Mumbai - 400013

04/2015

25 LS 25 Maybelline (Super Stay)

Endless Raisin (090)

20J401 Maybelline LLC, New York, N. Y. 10017 Dist. – Maybelline Canada, Montreal - H4T TK5


03/2015 Made in USA

26 LS 26 Revlon (Color Burst)

Ruby (85) 122651 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

08/2015

19

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


06/2015

28 LS 28 Revlon (Super Lustrous)

Frost Copper Glow Berry (311)

Not Readable

G. S. Pharmabutor Pvt. Ltd., (Unit – II), Plot No. 58,59, 66 & 67, Sector-3, I. I. E., Pantnagar, Rudrapur, Uttrakhand – 263153


09/2014

29 LS 29 Yves Saint Laurent (YSL) (Lip Twins)

Satin/Shine Cassis Rose Black Current Rose (10)

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)

Rose Libertin Satiny Radiance (26)

0KCA Yves Saint Laurent Parfums, 92512, NEUILLY, Codex France

No information

Made in France

Lip Balm 1 LB 01 The Body Shop Lip Care SPF

15

2 LB 02 The Body Shop Born Lippy Plum Lip Balm

3 LB 03 Himalaya Lip Balm 24200833R

The Himalaya Drug Company, Plot No. C-15, MIDC, Five Star Industrial Area, Shendra, Aurangabad (M. S.) - 431201

11/2015

4 LB 04 Lotus Fresh Mint B 01 Lotus Herbals Color Cosmetics, 80-B, Jharmajri, Baddi, Distt. Solan, H. P.

Lotus Herbals Ltd., B-9, Sector 58, Noida, U. P. - 201301

04/2015 SPF 15

5 LB 05 Lotus Velvety Rose B 04 Lotus Herbals Color Cosmetics, 80-B, Jharmajri, Baddi, Distt. Solan, H. P.

Lotus Herbals Ltd., B-9, Sector 58, Noida, U. P. - 201301

10/2015 SPF 15

6 LB 06 Maybelline New York

Enriched with Centella

6J130 Made in China L’Oreal India Pvt. Ltd., Peninsula Towers, Lower

12/2014 SPF 20

20

(Baby Lips) Essence Parel, Mumbai - 400013 7 LB 07 Maybelline

New York (Baby Lips Color)

Berry Crush fJ257M Made in Thailand L’Oreal India Pvt. Ltd., A-wing, 8th Floor, Marathon Futurex Building, N. M. Joshi Road, Lower Parel, Mumbai - 400013

03/2015 SPF 16

8 LB 08 Nivea Essential Care 22419810 Beiersdorf AG, Troplowitzstrasse 10, 22529 Hamburg, Germany

NIVEA India Pvt. Ltd., Hyde Park, 301, Saki Vihar Road, Andheri (E), Mumbai - 400072

11/2014 Made in Germany

Anti Ageing Cream 1 AAC 01 L’Oreal (Paris) Youth Code

(Rejuvenating Anti-wrinkle Day Cream)

28J302 Made in Germany

2 AAC 02 Olay Total Effects (7 in one, Anti-aging Night Firming Treatment)

2184PRF Distr. By – Proctor & Gamble, Cincinnati, OH - 45202

Imported for – Proctor & Gamble INC., Toronto, ON M5W 1C5

Not mentioned

3 AAC 03 Ponds Age Miracle (Cell ReGEN Day Cream)

B040 Hindustan Unilever Ltd., Unit – 4, I. Industrial Estate, Haridwar - 249403

Hindustan Unilever Ltd., 165/166, Backbay Reclamation, Mumbai - 400020

06/2014 SPF 15 PA++

21

Table 3: Fairness Creams Analyzed for Mercury

S. No. Code No. Name Manufactured By Date of Mfg. Imported by Marketed by Use before Batch No.

Fairness Creams for Men

1 4 Emami Fair and Handsome

Emami Limited, College Nagar, Abhoypur, North Guwahati, Assam - 781031 Mar - 2012 August - 2014

AP785

2 3

Fair & Lovely MAXFairness For MEN

Hindustan Unilever Ltd., Unit – 8, Plot No. 1-(1-H), Sec 1A, Sidcul Ranipur, Haridwar - 249403 08/07/2012

24 Months from Pkd.

B91

3 25 Vaseline MENface

Aero Pharma (Silvassa), Preeti Indl. Estate, Survey No. 127/1, Amli , Silvassa - 396230 Nov - 2012

Hindustan Unilever Ltd.

24 Months from Pkd.

B008

4 7 L'Oreal Men Expert L’Oreal India Private Ltd. Mar - 2012 L'OREAL Singapore Pte Ltd.

L'OREAL Philippines

FJ090

5 5 Garnier Men Power Light

L'Oreal India Private Ltd., Chakan, Pune - 410501 18/04/2012

36 Months from Pkd.

B534937

6 29 Nivea For Men Advance Whitening

Beiersdorf (Thailand) Co. Ltd., 163 Bangplee Industrial Estate, Samutprakarn 10540, Thailand Mar - 2012 Nivea India Pvt. Nivea India Pvt. August - 2014

21171577

Fairness Creams for Women

7 6 Garnier Skin Naturals, Light

L'Oreal India Private Ltd., Chakan, Pune - 410501 11/05/2012

36 Months from Pkd.

B536527

8 2 Fairever Fairness Cream

CavinKare Pvt. Ltd., Plot No. 16 & 17, Sec – 04, IIE, Sidcul, Haridwar - 249403 Apr - 2012

CavinKare Pvt. Ltd.

24 Months from Pkd.

U. B. 09

9 14 Lakme Perfect Radiance

Aero Pharma (Silvassa), Preeti Industrial. Estate, Survey No. 127/1, Amli , Silvassa - 396230 Aug - 2012

Hindustan Unilever Ltd.

24 Months from Pkd.

B 034

10 27 Lotus Micro Emulsion Kanidi Cosmeceuticals Dec - 2011

Lotus Herbals Ltd.

36 Months from Pkd.

B 12

11 8 L'Oreal Pearl Perfect L'Oreal India Private Ltd., Chakan, Pune - 410501 04/07/2012

36 Months from Pkd.

B540605

12 1 Fair & Lovely Hindustan Unilever Ltd., Unit – 06/07/2012 24 Months from

22

Advanced Multi Vitamin Daily Fairness Expert

1, Tinsukia, Assam - 786151 Pkd. B07D

13 21

Biotique, Bio Coconut, Whitening and Brightening Cream

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 Mar - 2012

Bio Veda Action Research Company

36 Months from Pkd.

12-005

14 18 Lotus Cocofair Cream

Kanidi Cosmeceuticals, 80C, Jharmajri, Baddi, Distt. Solan, H. P.

Lotus Herbals Ltd. Jan - 2015

B 03

15 20 Nivea Visage, Sparkling Glow

Beiersdorf (Thailand) Co. Ltd., 163, Bang Plee Industrial Estate, Bangna Trad Rd, Km 24, Samutprakarn – 10540, Thailand Jan - 2011 Nivea India Pvt. Nivea India Pvt. June - 2013

10350277

16 28 Lotus Herbals Fair Gel

Kanidi Cosmeceuticals, 80C, Jharmajri, Baddi, Distt. Solan, H. P.

Lotus Herbals Ltd., B-9, Sec – 58, Noida, UP - 201301 April - 2015

B 02

17 23 VLCC Enbrighten

VLCC Personal Care Ltd., Plot No. – 11 & 12, Sec 6A, Sidcul, IIE, Hardwar, Uttarakhgand - 246403 Mar - 2012

36 Months from Pkd.

12002

18 22 Olay Natural White

Procter & Gamble Home Products Ltd., Plot No. 01, Industrial Area, Katha, P. O. Baddi, Solan, H. P. - 173205 Aug - 2012

36 Months from Pkd.

B6911

19 24 Blossom Kochhar Aroma Magic

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 Sep - 2012

24 Months from Pkd.

FALR-13/12

20 19 Lotus Whiteglow Gel Kanidi Cosmeceuticals, 80C, Batch No – Lotus Herbals October 2014

23

Cream Jharmajri, Baddi, Distt. Solan, H. P.

B-48 Ltd. B 48

21 11 Fair & Lovely Anti Marks


24 Months from Pkd.

B 05

22 16 Emami Malai Keshar Cold Cream

Emami Limited, College Nagar, Abhoypur, North Guwahati, Assam - 781031 Sep - 2011

24 Months from Pkd.

AU 043

23 15 Shahnaz Husain Fair One

Elder Pharmaceuticals Ltd., Plot No. – 103, Gondpur Industrial Area, Paonta Sahib, Dist. – Sirmour, H. P. 173025 May - 2011

24 Months from Pkd.

BPAX1018

24 10 Fair & Lovely Ayurvedic Care


24 Months from Pkd.

B 34

25 17 Neutrogena, Fine Fairness

Johnson & Johnson Korea Ltd., 140-20, Song Jeong Dong, Heung Duck Ku, Cheong Ju City, Chung Buk, Korea 10/04/2012

Johnson & Johnson Ltd.

Johnson & Johnson Ltd.

24 Months from Pkd.

Not mentioned

26 9 Fair & Lovely Winter Fairness


24 Months from Pkd.

B 33

27 13 Ponds White Beauty L. B. C. P., Unit – II, Haridwar - 249403 25/05/2012

24 Months from Pkd.

B 067

28 12 Vivel Active Fair ITC Ltd., Plot No 01, Sec – 11, IIE, Ranipur Haridwar - 249403 Nov - 2011 April - 2013

B162A 22

29 26 Lakme Aero Pharma Jul - 2012 Hindustan Unilever Ltd.

24 Months from Pkd.

30 30 Himalaya Herbals Fairness Cream

The Himalaya Drug Company, 182, Village Gurumajra, Kishanpura, Tehsil Nalagarh, Distt. Solan, H. P. - 174101 May - 2012 April - 2015

16200408M

24

31 31 Revlon Touch & Glow

G. S. Pharmbutor Pvt. Ltd., Unit – II, Plot No. – 58, 59, 66 & 67, Sec – 03, I. I. E. Pantnagar, Rudrapur, Uttrakhand - 263153 Oct - 2012

Modi-Revlon Pvt.Ltd.

36 Months from Pkd.

IN123001

32 32

Jovees Pearl Whitening Face Cream

Jovees Herbal Care, Plot No. – 16, Sector 03, I. I. E., Pant Nagar, 263146, Uttarakhand Mar - 2012

36 Months from Pkd.

1618

25

Table 4: Heavy Metals in Lipstick, Lip-balm and Anti-aging Creams (ppm)

S. No

Sample Sample Code

Lead

Cadmium

Chromium

Nickel

Lipstick 1 Bodyshop (Ruby Sparkle - 12) LS 01 ND ND 2.91 1.65 2 Chambor (Rouge Plump - 746) LS 02 ND ND ND ND 3 Clinique (Extreme Pink - 19) LS 03 ND ND ND ND 4 Clinique (Different Grape) LS 04 ND ND ND ND 5 ColorBar (Burnt Orange - 017) LS 05 ND ND 1.62 ND 6 ColorBar (Bitter Chocolate - 028) LS 06 ND ND 2.55 ND 7 ColorBar (Hearts & Tarts -

080V) LS 07 ND ND 17.83 5.47

8 Dior (Mazette - 028) LS 08 ND ND ND ND 9 Dior (Fireworks - 756) LS 09 ND ND ND ND

10 Estee Lauder (Fuchsia Fever - 60)

LS 10 ND ND ND 0.99

11 Estee Lauder (Scarlet Siren - 73) LS 11 ND ND 1.34 2.36 12 Lakme (Red Hot - 43) LS 12 ND ND 0.45 2.47 13 Lakme (Bridal Dream - 44) LS 13 ND ND 1.39 0.57 14 Lakme (Pink Romance - 206) LS 14 ND ND ND ND 15 Lakme (Enrich Satin - 352) LS 15 ND ND ND 1.09 16 Lancome (Labsolu Nu - 204) LS 16 ND ND 13.90 9.18 17 L’Oreal (Intense Plum - 374) LS 17 ND ND ND ND 18 MAC (Paramount - A52) LS 18 ND ND 1.14 2.19 19 MAC (Plumful - A62) LS 19 ND ND 1.22 ND 20 MAC (Cockney - A82) LS 20 ND ND 2.32 ND 21 MAC (So chaud - A82) LS 21 ND ND 5.75 3.42 22 Maxfactor (Pomegranate - 665) LS 22 ND ND 1.59 ND 23 Maybelline (Hooked Pink - 065) LS 23 ND ND 5.27 2.21 24 Maybelline (Fatal Red - 530) LS 24 ND ND ND ND 25 Maybelline (Endless Raisin -090) LS 25 ND ND ND ND 26 Revlon (Ruby - 85) LS 26 ND ND ND ND 27 Revlon (Frost Grape Juice - 164) LS 27 ND ND ND ND 28 Revlon (Copper Glow Berry-311) LS 28 ND ND 2.43 2.18 29 YSL (Current Rose - 10) LS 29 ND ND ND 0.99 30 YSL (Satiny Radiance - 26) LS 30 ND ND ND ND Lip-balm 1 The Body Shop (Lip Care) LB 01 ND ND ND ND 2 The Body Shop (Plum Lip-balm) LB 02 ND ND ND ND 3 Himalaya (Lip-balm) LB 03 ND ND ND ND 4 Lotus (Fresh mint) LB 04 ND ND ND ND 5 Lotus (Velvety Rose) LB 05 ND ND ND ND 6 Maybelline (Baby Lips) LB 06 ND ND ND ND 7 Maybelline (Baby Lips Color) LB 07 ND ND ND ND 8 Nivea (Essential Care) LB 08 ND ND ND ND

Anti Ageing Creams 1 L’Oreal (Youth Code) AAC 01 ND ND ND ND 2 Olay (Total Effects) AAC 02 ND ND ND ND 3 Ponds (Age Miracle) AAC 03 ND ND ND ND

26

Table 5: Lipstick Samples Detected with Chromium (Compared as Percentage of ADI)

S. No.

Sample Code

Lipstick Samples Detected with Chromium

Total Chromium

(ppm)

%age of ADI for

Average Use of 24

mg/day

%age of ADI for

High Use of 87 mg/day

1 LS 01 Bodyshop (Ruby Sparkle – 12) 2.91 69.8 253.2 2 LS 05 ColorBar (Burnt Orange – 017) 1.62 38.9 140.9 3 LS 06 ColorBar (Bitter Chocolate – 028) 2.55 61.2 221.9 4 LS 07 ColorBar (Hearts & Tarts – 080V) 17.83 427.9 1551.2 5 LS 11 Estee Lauder (Scarlet Siren – 73) 1.34 32.2 116.6 6 LS 12 Lakme (Red Hot – 43) 0.45 10.8 39.9 7 LS 13 Lakme (Bridal Dream – 44) 1.39 33.4 120.9 8 LS 16 Lancome (Labsolu Nu – 204) 13.90 333.6 1209.3 9 LS 18 MAC (Paramount – A52) 1.14 27.4 99.2

10 LS 19 MAC (Plumful – A62) 1.22 29.3 106.1 11 LS 20 MAC (Cockney – A82) 2.32 55.7 201.8 12 LS 21 MAC (So Chaud – A82) 5.75 138.0 500.3 13 LS 22 Maxfactor (Pomegranate – 665) 1.59 38.2 138.3 14 LS 23 Maybelline (Hooked Pink – 065) 5.27 126.5 458.5 15 LS 28 Revlon (Copper Glow Berry – 311) 2.43 58.3 211.4

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

27

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

1 1 Fair & Lovely multi Vitamin 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 --- --- ---

6 10 Fair & Lovely Ayurvedic Care Hindustan Unilever Ltd. 0.10 0.14 1.8 3.6

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 Fair One Shahnaz Husain Elder Pharmaceuticals Ltd. ND

---

---

---

12 16 Emami Malai Keshar Cold Cream Emami Limited 0.22

0.30

4.1

7.9

13 17 Neutrogena Fine Fairness Johnson & Johnson Corea Ltd. ND

---

---

---

14 18 Lotus Cocofair Cream Kanidi Cosmeceuticals 0.81 1.10 15.0 29.2

15 19 Lotus White Glow Kanidi Cosmeceuticals ND --- --- ---

16 20 Nivea Sparkling Glow Beiersdorf (Thailand) Co.Ltd. ND

---

---

---

17 21 Biotique Bio Coconut Bio Veda Action Research Company 0.24

0.32

4.4

8.6

18 22 Olay Natural White Procter & Gamble Home Products Ltd. 1.79

2.42

33.1

64.4

19 23 VLCC Enbrighten (Sun Defence) VLCC Personal Care Ltd. 0.11

0.15

2.0

4.0

20 24 Aroma Magic Fair Lotion Blossom Kochhar Beauty Products Pvt. Ltd. 1.97

2.67

36.4

70.9

21 26 Lakme Aero Pharma ND --- --- ---

22 27 Lotus Micro emulsion Kanidi Cosmeceuticals ND --- --- ---

23 28 Lotus Fair Gel Kanidi Cosmeceuticals ND --- --- ---

24 30 Himalaya Herbals Fairness Cream Himalya Drug Company ND

---

---

---

25 31 Revlon Touch and Glow G.S. Pharmbutor Pvt Ltd. 0.25 0.34 4.6 9.0

26 32 Jovees Pearl Whitening Face Cream Jovees Herbal Care. ND

---

---

---

Fairness Creams for Men

27 3 Fair & Lovely Max Fairness Hindustan Unilever Ltd. ND --- --- ---

28 4 Emami Fair and Handsome Emami Limited ND --- --- ---

29 5 Garnier Men Power Light L'Oreal India Private Ltd. 0.24 0.32 4.4 8.6

30 7 L'Oreal Men Expert L'Oreal India Private Ltd. ND --- --- ---

31 25 Vaseline Men Face Aero Pharma ND --- --- ---

28

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

32 29 Nivea Advance Whitening For Men

Beiersdorf (Thailand) Co. Ltd. ND

---

---

---

Education

Heavy Metals in Cosmetics