Healthy Skin is Beauty NOT The Complexion

Transcription

1 Healthy Skin is Beauty NOT The Complexion Assessment of Prevalence of Health Complications and Skin Diseases due to Mercury Containing Skin Whitening Creams (SWCs) Use among the Population at Selected Cities of Pakistan S. Waqar Ali and Dr. Mahmood A. Khwaja Sustainable Development Policy Institute (SDPI) Islamabad Pakistan October,

2 Assessment of Prevalence of Health Complications and Skin Diseases due to Mercury Containing Skin Whitening Creams (SWCs) Use among the Population at Selected Cities of Pakistan S. Waqar Ali and Dr. Mahmood A. Khwaja Sustainable Development Policy Institute (SDPI) Islamabad Pakistan October,

3 Table of Contents Executive summary...1 Acronyms Introduction Obsession for skin whitening creams: Mercury Pathways and impacts on skin complexion Skin whitening creams (SWCs) use and their effects on skin and health Reported Cases of Mercury toxicity Earlier studies on mercury content in SWCs Objectives of the present study Materials and Methods Sampling and mercury content analysis of skin whitening creams (SWCs) Survey/Interviews with Dermatologists and Skin Specialists Results and discussion Comparison of mercury content in (ppm) SWC brands in different countries Mercury containing SWC (% samples) in different countries SDPI study on SWCs use in Pakistan SDPI study: Part 1. Total mercury content in studied skin whitening creams (SWCs) SDPI study: Part 2. Survey at skin care centers in selected cities Conclusion and Recommendations References...38 Annex A: Laboratory Reports of Sample Analysis...44 Annex B: Survey Performa/Questionnaire for Dermatologists & Skin Specialists in Islamabad, Rawalpindi and Peshawar...47 Annex 1: Details of SWCs Studied...48 Annex 2: Reported Hg containing Pakistani SWCs available in global market Annex 3: List of Hg containing SWCs reported in Asia...52 Annex 4: Hg containing SWCs in different countries Annex 5: List of Dermatologists...63 Annex 6: Summarized survey findings in Islamabad...67 Annex 7: Summarized survey findings in Rawalpindi...68 Annex 8: Summarized survey findings in Peshawar...69 Annex 9: Overall survey findings in Islamabad, Rawalpindi and Peshawar...70

4 Executive summary The use of mercury (3rd most hazardous chemical) in various cosmetic products, particularly for its skin whitening effects, has been in practice since the nineteenth century and such products continue to be easily accessible in open markets and are most commonly used all around the world including many developing countries. The obsession for fair skin in the subcontinent is believed to have emerged with the introduction of the cast system according to which fair complexion was considered as the domain of the upper ruling class, whereas dark complexion was associated with the lower working class. It is also suggested that the migration of Aryans who were much fairer than the local population may also have influenced the dark skinned population s desire for fair complexion. Living under the regime of various colonial legacies for more than two centuries could have further influenced the local population to perceive white skin as a sign of power and superiority. Presently, preference for a fair skin has also been intensified by the fairness cream industries through extensive electronic & print media campaigns. The most unfortunate exaggerations in some advertisements can even reach to the extent that they project fair skin as an essential prerequisite for success in both professional and personal matters. Very few investigations on mercury added products and their use by consumers have been carried out in South Asia, including Pakistan. This brief report (full report with details would soon be accessible at focuses on the findings of our recently completed study, to investigate the health threats and challenges due to the use of Skin Whitening Creams (SWCs) in some selected main cities (Peshawar, Islamabad Rawalpindi) of Pakistan. The study was carried out in two parts. First, the sampling and analyses was carried out for the determination of total mercury contents in SWCs, sold and purchased by the consumers from the open market. In the second part, contacts were made, in person, with 50 dermatologists/skin specialists (male & female) in 29 hospitals and 14 private clinics of the three cities and through a questionnaire, their opinion/recommendations on SWCs related issues were sought. Samples of 20 SWCs different brands were purchased from the retail shops in the open markets in the three selected main cities. For SWCs assay, acidic digestion of the homogenized SWCs samples was followed by total mercury content measurements by flow injection mercury system - FIMS-CVAAS. In the 20 SWCs brands analyzed, total mercury content was found to be in the range ,500 ppm. Mercury content in one sample seems to be less than 0.1ppm. Eight samples showed mercury content less than 1ppm (requirement of Minamata Convention on Mercury). On the basis of the observed total mercury content in the studied samples and the health risk due to mercury exposure, the studied SWCs brands were categorized in four major groups as (a) most hazardous with Hg content > 10,000 ppm (5 samples), (b) highly hazardous Hg content > 5000 ppm (4 samples), (c) moderately hazardous Hg contet < 5000 ppm (3 samples) and (d) least hazardous with Hg content < 1ppm (8 samples). It is evident from the above these analytical results that SWCs users are exposed to alarmingly high levels of mercury in SWCs which may result in mercury being absorbed, inhaled or ingested, thus causing adverse health impacts (to consumers health directly and children s indirectly) which are well known and established. These include effects on neurological development, growing brain, nervous system, lungs and kidneys. The summarized overall findings, from the survey/interviews with the dermatologists/skin specialists (n=50) in Peshawar, Rawalpindi & Islamabad, regarding SWCs users reasons for changing complexion, their level of awareness about SWCs, number, frequency of visiting patients, their age & gender and other mercury/swcs related issues, are given below: Among various factors considered for an individual s reason to go for complexion change, according to the majority of dermatologists (78%) interviewed in the 3 main cities, seems to be social and not at all professional (91%). (51%) of the dermatologists thought, it could also be personnel. As a result, people use products such as SWCs to lighten their skin tone and thus put their health in significant 1

5 risk. These social pressures for acquiring fair complexion are mostly directed through advertisements and TV shows that strongly suggest the viewers with exaggerated benefits of having a fair skin tone. There is consensus among all respondents that such advertisements and programs (including morning shows) should be banned immediately. One of the reasons for the extensive use of SWCs in Pakistani population is due to the lack of awareness of the hazardous contents/ingredients of SWCs and their possible health risks among the public, as agreed by all respondents. However all the dermatologists claim that they very strongly caution their patients about the adverse health effects of these products such as SWCs that may contain high levels of toxic chemicals such as mercury.the overall flow of patients with skin disease has been found to be high as more than 70% dermatologists informed, they received more than 50 patients per week. This indicates the prevalence of skin related issues among the population of the 3 selected cities of Pakistan. The current study reveals that 23% of the patients received by dermatologists are male the remaining 77% patients females. Majority of patients (45%) visiting skin care centers are of age between years. There s unanimous support (100%) of all dermatologists interviewed for awareness raising, regulating the manufacturing and sale of SWCs and display of full information regarding the ingredients and their amounts in the products, on labels of SWCs products. 91% support the review and revision of current MBBS curriculum/syllabus and to include mercury related information. (98%) support banning the manufacturing and sale of SWCs with mercury content higher than 1ppm, as pointed out in Minamata convention on mercury. Additional information/comments received from the visited dermatologists in Islamabad, Rawalpindi and Peshawar, regarding health effects, popular SWCs brands and alternatives for skin care are summarized below: According to dermatologists/skin specialists regarding the types of health conditions/ailments commonly observed among the patients who have a history of SWC use, are, formation of wrinkles, rosacea, melanosis, acne, telangiectasia, aczema rash, scaring, webbing, hypersensitivity and sometimes, dermatitis, erythema, ocronosis, skin abscess, hirsutism and even fungal infections & allergy. In addition to this almost all dermatologists pointed out that SWCs users also develop conditions such as skin sensitivity, thinning, peeling & atropy, acne formation, hyperpigmentation, including melasma, dark spots and freckles. SWCs that are most commonly used among the patients are Fair and lovely, Due whitening cream, Faiza beauty cream, Golden pearl, Stillman s freckle cream, Arche cream, Face fresh, Gipsy Amazing cream and also Betnovate. Some alternative treatments are also prescribed by the dermatologists for skin lightening effects, such as vitamins (C D & E), zalic acid, Derma glow, betnogenotic, Sefraderm, 1% hydrocortizone, and other hydroquinone and kojic acid based products. On patients demand, a few dermatologists also administer Glutathione injections. Patients are also advised larger intake of dietary supplements such as fruits & vegetables, avoiding excessive sun exposure, wearing proper clothing and using umbrella/sunblock when going out in the sun. From the literature survey, results of analyses of 20samples of SWCs and the opinions expressed by 50 dermatologists/skin specialists, it is very evident that with the continued use of mercury containing SWCs, the skin is affected, becomes unhealthy and ugly looking. Besides, mercury absorbed through the skin, causes adverse health problem to human health. Such SWCs brand need not be used at all. There is dire need of public awareness raising (through social, print & electronic media), regarding the high level of hazardous mercury & other chemicals contents in SWCs and their effects both to the skin and human health. People need to understand that Healthy skin is beauty, not its Complexion and people should not hunt for SWCs which use lead to unhealthy and ugly 2

6 looking skin. At present, there does not seem to be an effective check and balance in place for the direly needed assessment of chemicals in consumer products. Ministry of Health/health department, Pakistan medical & dental council (PMDC), Pakistan national accreditation Council (PNAC) through joint efforts by Specific regulations need to be developed and implemented, especially regarding standards for chemicals content in consumer products, including cosmetics/swcs. All products need to be have proper labels (Mandatory), clearly indicating the amount of the chemicals added to the products, with updated contacts/address of the manufacturer. Consumer products, containing excessive amount of chemicals be banned for use/sale/manufacturing. EPAs may also be involved in view of environmental pollution caused by chemicals use and resulting releases/wastes. It is also recommended that higher education commission (HEC) looks into MBBS syllabus/curriculum for the needed additional information about cosmetics, especially SWCs, to be included for dermatology specialization. WE strongly recommend ban on the production/use of skin lightening creams with total mercury content above one ppm as per the requirement of Minamata convention on Mercury. 3

7 Acronyms ATSDR AWHHE BEP CVAS DNA EPA FAO FDA GB GDOH GoP HCL HEC Hg HNO3 KPK MDL ME NIH PKR ppm RAPEX REL Rfc SA SDPI SEA TCs UNEP UVR WHO Agency for Toxic Substances and Disease Registry Armenian Women for Health and Healthy Environment Best Environmental Practices Cold Vapour Absorption Spectrophotometry Deoxyribonucleic Acid Environmental Protection Agency Food And Agriculture Organization Food and Drug Authority Gilgit Baltistan Governmentt Department of Health Government of Pakistan Hydrochloric Acid Higher Education Commission Mercury Nitric Acid Khyber Pukhtunkhawa Minimum Detection Limit Middle East National Institute of Health Pakistani Rupees Parts per million Rapid Alert System for Non-Food Consumer Products (EU) Recommended Exposure Limit Reference concentration South Asia Sustainable Development Policy Institute, Islamabad South East Asia Tropical Corticosteroids United Nations Environment Program Ultra-violet Rays World Health Organization 4

8 Assessment of Prevalence of Health Complications and Skin Diseases due to Mercury Containing Skin Whitening Creams Use among the Population at Selected Cities of Pakistan 1. Introduction The use of mercury in various cosmetic products particularly for its skin whitening effects has been in practice since the nineteenth century and still commonly used in many developing countries (US NIH, 1996; Hong Kong GDOH, 2002; Olumide YM et al, 2008; Barr RD et al, 1973). Despite the fact that mercury and mercury salts, including mercurous chloride and mercurous oxide because of their high toxicity and their obvious harmful health effects are prohibited for use as skin-lightening agents, their production and continued use is now a serious global public health concern (Soo Y.O et al, 2003; FDA; Chan TY, 2011). Before the consumers products are introduced to the marker, the US FDA as well as the national drug regulatory authorities make it mandatory to check their safety and ingredients. However most of the developing countries including Pakistan lack national safety regulations to comply with or implement the US FDA s requirements such as, products proper labeling, no use of color additives and toxic chemicals such as mercury and other heavy metals in cosmetics, including skin whitening creams - SWCs (Al-Saleh, 1997). WHO report claims Pakistan among the countries that manufacture mercury containing whitening creams (WHO, 2013). In one of the study conducted by European Commission, very high levels of toxic mercury were detected in most of the SWCs from Pakistan which had no warnings labels on the product (RAPEX 2011, RAPEX Report). Recently, Pakistan signed Minamata convention on Mercury and ratification process for the same in in progress. According to the convention, all cosmetic products (including SWCs) having mercury content more than 1ppm would be phased out and banned. However, presently, these products are openly available in the markets across the country and reaching the consumers, without any prior assessment for their hazardous chemicals contents and thus the general public, using these products, is exposed to significant health risks Obsession for skin whitening creams: Historically the obsession for fair skin in the subcontinent is believed to have emerged with the introduction of the cast system according to which fair complexion was considered as the domain of the upper ruling class whereas dark complexion was associated with the lower working class. (Islam KS et al, 2006). It has been observed that the migration of Aryans who were much fairer than the local population may also have influenced the dark skinned population s desire for fair complexion. Living under the regime of various colonial legacies for more than two centuries could have further influenced the local population to perceive white skin as a sign of power and superiority (Shankar PR and Subish P, 2007; Goon P and Craven A, 2003). The prevalence of SWCs in the Pakistani market has been studied earlier by Askari et al, 2013 who reported that the use of skin lightening products among the population in Lahore is 59% and the most used SWC product is Fair n Lovely by Unilever Pakistan, followed by others. In another study conducted in Pakistan to determine the extent of SWC use, 50% of the studied population was using fairness creams along with Tropical Corticosteroids (TCs) while 17% were exclusively using only fairness creams. Most popular brands used are Fair & Lovely cream followed by Golden Pearl cream, Stillman s Bleach cream, Archie cream, Face 5

9 Fresh cream and Faiza Beauty cream (Chohan et al, 2014). Similar consumers demand has also been also observed in India, where 61% of the dermatological market consists of skin lightening products containing toxic ingredients (Ladizinski, 2011). Fair & Lovely cream reported to be the most popular brand in India, where its total market share is estimated 76% (Sangeeta, 2012). It also indicates the magnitude of fairness obsession and brand consciousness among the consumers. Study carried out on SWCs in Korea revealed that about 40% of Korean females used skin lighteners (UNEP, 20 08). The obsession for skin whitening creams has also rapidly spread among dark skinned population in Malaysia, Egypt, Nigeria and other African countries. (The Muslim News, 2002 ; Ngunjiri 2006). While the use of SWCs is mostly practiced by women (Chu, et al, 1977; Sun, 1987; Harada et al, 2001), it has also been getting popular among male population. Frequent advertisements nowadays are promoting skin lightening products among males. The high demand of SWCs in the local markets indicates the intensity of obsession for fair complexion, especially in a society where most of the population has dark skin. In Pakistan, complexion does matter in certain aspects. For instance fair complexion becomes a prime criterion in marriage prospects, as it represents higher socioeconomic status in the society. 70.5% of the population studied by Askari, (2013) in Lahore, Pakistan, agreed that lighter skin tone increases a women s chance of getting married. 82% of them also believed that men consider women with lighter skin tone more beautiful (Askari, 2013). Preference for a fair skin has also been intensified by the fairness cream industries through extensive media campaigns. Promoting the notion that fairness is an object of desire especially in a country where large proportion of the population is dark skinned. Such promotional campaigns through media ( especially TV) help boost their business and resulting in substantial profit to the fairness cream industry (Shankar et al, 2006). The exaggerations in few advertisements can even reach to the extent that they project fair skin an essential prerequisite for success, both in professional and personal matters (Shankar and Subish, 2007). According to a study conducted by Askari (2013), 90.2% respondents in Lahore Pakistan agreed that television commercials of skin lightening products may change females perception of women regarding complexion which may result in eventually driving a much larger population towards using SWCs to acquire fair complexion. Another significant influence comes from the western media which for decades has been portraying beauty as possession of flawless, fair skin. Even in the post-colonial era, the amount of glamour and sensation in the western media acted as a source of role model for Asian population, with their profound penetration and influence in the Asian society (Verma SB, 2010) Mercury Pathways and impacts on skin complexion The melanocytes in the epidermis determine the type of skin color of a person. Although the number of melanocytes is the same in both fair and dark skinned people, production of melanin is partly determined by ones genetics and partly by the environment in which the individual is living (Swerdlow, 2002). Moreover the type and amount of melanin synthesized by the melanocyte, and its distribution pattern in the surrounding keratinocytes also determine the actual color of the skin. (Parvez et al, 2006). T he pigmentation of the skin provides protection to the body by preventing UVR exposure that can cause direct and indirect oxidative damage to the DNA (Cleaver & Crowley 2002, Kielbassa et al. 1997, Shea & Panish 1991). People living near the tropics or at higher elevation where UVR indexes are comparatively more high, tend to have dark complexion to protect them from potentially harmful UV rays (Karnani, 2007; Norton, et al., 2007; Shankar PR and Subish P, 2007). At the molecular level, mercury performs its skin lightening action by competing with copper in tyrosinase enzyme and thus suppressing tyrosinase activity which is a rate-limiting enzyme 6

10 in the melanin production pathway (Engler, 2005). This cause s decrease production of melanin, thus the skin complexion appears lighter (Olumide et al, 2008; Vámos, 1981). Mercury s ability to get absorbed through the skin across the epidermis makes it more hazardous since it may then cause different health complications once it is inside the body. The absorbing ability of through the skin was studied earlier by Rothman (1954) who found traces of mercury in intercellular spaces of the epidermis after topical application of mercury. Another study by Garza-Ocanas (1997) also indicated that percutaneous absorption of mercury could occur easily as users of a SWC containing mercury, showed increased urinary mercury excretion and the presence of related symptoms. Percutaneous absorption of mercury enhances since mercury containing SWCs, on times, are used for long duration as well as on a large body surface area under hot humid conditions, (Olumide et al, 2008) therefore significantly increasing the risk of mercury toxicity in the body. The rate of dermal absorption also depends on factors such as amount of mercury in the SWCs brand, prior hydration of the skin (Palmer et al, 2000) skin integrity and lipid solubility (Garza- Ocanas, 1997). Absorption of mercury could occur via sweat glands, sebaceous glands, and hair follicles (Chan, 2011), while ingestion may also occur after topical application around the mouth and hand-to-mouth contact. After absorption, inorganic mercury is distributed widely in the body tissues (ATSDR, 1999) where it may cause a wide range of health complications. (Chan, 2011) 1.3. Skin whitening creams (SWCs) use and their effects on skin and health While it is established that mercury can cause cutaneous complications such as allergic contact dermatitis, flushing, purpura and erythroderma (Engler, 2005, Cuadra, 1993), skin diseases and other medical conditions can make the skin more vulnerable to mercury containing skin lightening creams. The intensity of damage also depends on toxicity, concentration, duration of use; number of products used at one time and skin sensitivity (Faye O et al, 2005; Pitché P et al, 2005). Factors such as person s lifestyle and exposure to aggressive environmental conditions should also be considered since these can augment the effects of the damage cause by SWCs. Chronic use of mercurial skin lighteners can cause a paradoxic hyperpigmentation which might be caused by dermal deposition of mercury-containing granules (Goeckermann, 1975). The use of skin whitening creams containing mercury can also cause, among others, facial burns and discoloration, (Weldon M.M et al, 2000; Soo, et al, 2003). Children exposure to inorganic mercury has been associated with acrodynia (Engler, 2005). Skin damage such as skin atrophy, thinning & breaking causing keloidal scarring, payroll dermatitis, contact allergic & irritant dermatitis, acneiform eruptions, striae, hypertrichosis, telangiectasias, fungal infections (Candida, dermatophyte) and bacterial infection (pyoderma, folliculitis, furuncles, impetiginous lesions, erysipelas) (Faye et al, 2005; Pitché et al, 2005; Ajose, 2005) have also been reported for SWC use but these symptoms may also occur due the presence of other SWC contents such as steroids, since most of the skin lightening products contain more than one lightening agent. Mercury and their derivatives may cause neurotoxicity, mercury-induced nephropathy and immune toxicity in the human body (Ntambwe, 2006). Since early 20th century, there have been investigations on the health effects related to the use of topically applied products, containing mercury which have documented renal, (Barr et al, 1972; Kibukamusoke et al, 1974; Turk et al, 1968) neurologic, (Kern 1991; Dyall-Smith and Scurry, 1990) and dermal (Warkany and Hubbard, 1953; Dyall-Smith and Scurry, 1990; Goeckermann,1922) effects of mercury containing products. 7

11 Nephrotoxicity is one of the major complications related to use of mercury containing cosmetic products (Tang, 2006; Soo, 2003; Oliveira, 1987). The kidneys particularly within renal tubules are the major sites of inorganic mercury deposition and can cause renal damages including reversible proteinuria, acute tubular necrosis and nephrotic syndrome (Soo et al, 2003). The extent of kidney damage depends on the form of mercury in the product and the rate of its administration (Oliveira, 1987) whereas the type of renal damage depends upon the length of exposure of the individual, (a) with acute exposure usually causing tubular injury (acute tubular necrosis) and (b) chronic exposure usually causing glomerular injury (membranous nephropathy, immune complex mediated glomerulonephritis, minimal change disease) (Tang, 2006; Soo, 2003; Oliveira, 1987; Barr, 1972; Kibukamusoke, 1974; Tubbs, 1982) Moreover gastrointestinal symptoms such as metallic taste, gingivostomatitis, nausea and hypersalivation (Soo et al, 2003) as a result of mercury toxicity from the use of mercury containing lightening products have also been reported. Mercury can also interfere with the function of the nervous system and can cause neuropsychiatric toxicities that are indicated by symptoms such as metallic taste, tremor, peripheral neuropathy, erethrism, memory loss, anxiety, depression, and psychosis (Engler, 2005; Saffer, 1976). Although mercury s ability to penetrate the blood brain barrier is low, prolonged exposure can result in neurotoxicity as well as its accumulation in the central nervous system (CNS) (Soo et al, 2003) Reported Cases of Mercury toxicity A number of cases related to renal, neuro, dermal and other toxicities from the use of skinlightening products have been reported from several countries including Africa, Europe, US, Mexico, Australia, and China. Such cases provide a much clear understanding of the health effects/complications caused by the use of mercury containing SWCs. According to one report (Tang et al in 2006) a 34-year old Chinese woman developed nephritic syndrome after using a SWCs. Soo et al in 2003 reported about an Indonesian domestic helper who was suffering with nephrotic syndrome (secondary to membranous nephropathy) due to regular use of a SWC cream containing mercury (almost 2,000 times above the allowable limit of 1ppm). Her blood and urinary mercury levels, both were elevated but her symptoms improved after the SWC use was stopped. 50% of young women in Kenya who used mercury-containing SWCs developed glomerular lesions (Barr, 1972). (Kibukamusoke et al 1974) reported about a 21-year-old African woman who developed membranous nephropathy after using mercury containing, Bustone Extra-Strong Night Cream for 2 years. Oliveira et al reported about a Pakistani female who developed membranous nephropathy following the use of a SWC that was imported from Saudi Arabia. According to a recent report, in Hong Kong about one hundred women were suspected of mercury poisoning due to use of SWCs, imported from China (Hong Kong GDOH, 2002; Li et al 2000; Chan et al, 2001). Most of the reported cases showed neurologic symptoms including lassitude, headache, finger tingling, burning sensations, and hand tremor. In Mexico, a 30-year-old women developed malar rash, erythema on the palms and soles, hypersalivation, intention tremor, emotional lability, weakness, and insomnia (with a high mercury level in urine and blood) after using a cosmetic cream for 5 years (Tlacuilo-Parra et al, 2001). According to Weldon (2000) i n the some states of America (Arizona, California, New Mexico, and Texas), 317 females who used Crema de Belleza-Manning, reported a high prevalence of symptoms associated with mercury poisoning, inducing fatigue, nervousness and/or irritability, severe headaches, insomnia, memory loss, loss of strength in the legs, tingling or burning sensations, tremors or shaking of the hands, depression, and a metallic taste in the mouth (with a high level of mercury in the urine). Benz et al ( 2011) reported 8

12 about a 4-year-old girl who showed hyper intense lesions in brain MRI following the use of a mercuric chloride containing skin whitening cream Earlier studies on mercury content in SWCs. A number of studies on mercury contents in different brands of SWCs have been carried out and reported in many countries and are summarized in Table 1 3. Table 1: Reported Mercury content of skin whitening creams (SWC) brands available and studied in different countries Hg Content(ppm) SN Brand name Banglad esh (ESDO, 2012) Mexico (Peregrino C, 2011) Saudi Arabia (Al- Saleh/Aldoush.1997 ) Sri Lanka (CEJ, 2013) Nepal (CEPHD, 2012) UK (Rapex, ) Denmar k (Rapex, ) Pak-LCWU (Chaudhry A, 2014) Pak-PU (Gul N, 2012) SDPI Study () 1 PONDS NR 1.27 NR NR NR 2 Olay 3603 NR NR NR NR NR NR 3 Fair & lovely Ayurvedic 4004 NR NR NR NR NR 0.42 NR NR 4 Fair & lovely Max fairness 4175 NR NR NR NR NR NR NR 5 Garnier 4643 NR NR < NR NR , NR NR 6 Fair & Handsome (Emami) 4133, 3566 NR NR <0.01 NR NR NR NR NR 7 Tibbat 3752 NR 0.37 NR NR NR NR NR NR 8 ARCHE (Formula A.A. Melasma Cream) NR NR 0.74 NR NR NR NR 1.96 NR L'Oreal NR NR NR ND NR NR NR NR Faiza No.1 Beauty Cream NR NR NR NR NR 5430 and 5940 NR NR NR Stillmann s NR NR NR NR NR 12000,42000, 3.1 % NR Due Whitening Cream NR NR NR NR NR NR NR NR Brido whitening cream NR NR NR NR NR NR NR NR White face NR NR NR NR NR NR NR NR Golden Pearl NR NR NR NR NR NR NR NR NR= Not reported ND= Not Detected 9

13 The reported mercury contents of 15 different brands of SWCs available in markets of eight countries (including two earlier & SDPI studies in Pakistan) are given in Table 1. Samples of SWC brands at SN 1-7, available in Bangladesh, indicated alarmingly high mercury content in the range ppm (permissible limit under Minamata Convention = 1ppm). Samples of brands at S.No.9-11, available in UK also indicated mercury content in the range ppm. Sample/s of SWC brand at S. No. 11 available in Denmark also indicated mercury content = ppm. Results of mercury content analyses of samples of 79 SWC brands from another 11 countries are given in Table 2. Sri Lankan research report revealed presence of mercury in 25 out of 46 studied samples of SWCs (Rubesinghe and Withanage, 2013). A study in Nepal (CEPHD, 2012) also reported presence of mercury in SWCs. In Bangladesh, 56% of the products, revealed high content = 4004 ppm in Fair & Lovely Ayurvedic and 4174 ppm in Fair & Lovely Max Fairness cream (Country situation report, 2012). Table 2: Mercury content of SWCs (n=79) in different countries SN Reporting Country No of SWC products studied Mercury Content Range(ppm) References 1 Mexico 16 MDL Peregrino C, UK % by weight Rapex, 3 Norway Rapex, Germany %-5.0% by weight Rapex, Denmark Rapex, The Netherlands Austria 1 1% by weight Rapex, Rapex, USA (New York) McKelvey, Wendy, et 8 62,200-41,600 al Armenia, Belarus, Georgia AWHHE, 2011 A number of SWCs claimed to be manufactured in Pakistan have been analyzed for their mercury content ( Al-Saleh et al, 1997; Rapex Report, 2011) and reported with mercury content as high as 38,800 ppm mercury in a few studied products. Studies conducted in Pakistan have also indicated mercury contents in a few SWC brand exceeding the permissible limit of 1 ppm (Tables 1 & 3) 10

14 Table 3: Reported range of Mercury content in skin whitening creams products (n=169) SN Reporting Country No. of products studied Mercury Content Range (ppm) References 1 Bangladesh ESDO, Saudi Arabia Al-Saleh and Aldoush Sri Lanka 39 MDL CEJ, Nepal CEPHD, Philippines ,200 TOXIC ALERT, 6 Pakistan(LCWU) Chaudhry A, Pakistan (PU) Gul N, SDPI study Method detection limit= <0.01 ppm Apart from the Pakistani products, Al-Saleh et al, (1997) also analyzed several types of SWCs available in markets of many countries. Some of the studied SWC brands contained alarmingly high content of mercury. The products were claimed to be manufactured in Thailand, Lebanon and England. Uram et al, 2010 analyzed mercury content of cosmetics made in Mexico. Some of the studied products had the description of the ingredients on the label and others did not even have labels. Other studies have also detected and reported mercury content of very high levels in SWCs (Peregrino, Moreno, Miranda, Rubio, & Leal, 2011). rugs Administration, 2011). In one study the mercury content of SWCs ranged from 660 to 57,000 ppm (Sin andtsang, 2003). 2. Objectives of the present study The main objectives of the present study are to: (i) (ii) examine levels of mercury content in SWCs, available in the local markets of a few selected main cities of Pakistan and to assess & highlight the health complications arising/prevailing among mercury containing SWCs users, through interviewing dermatologists/skin specialists in private clinics, teaching institutions and general hospitals of the same selected cities. The study also aims to identify factors that are influencing the public s opinion regarding their skin complexion and enhancing an obsession for a fair complexion. In the light of the findings, as inferred from the analytical data and survey, recommendations would be developed, specially to raise awareness among youth/students & general public, regarding health hazards resulting from using mercury containing SWCs and encourage them to realize that healthy skin is beauty, not the complexion accept. Use of mercury containing SWCs be avoided which results in unhealthy skin and ugly looks. 11

15 3. Materials and Methods 3.1. Sampling and mercury content analysis of skin whitening creams (SWCs) A list of all purchased SWC products and their purchase points is given in annexes. SWCs were mostly purchased from retail shops located in Karachi (Sindh), Lahore (Punjab), Islamabad (capital territory), Peshawar (KPK) and Haripur (KPK) and preference for products selection was generally based on popularity of the brand. Only products which were labeled as whitening, lightening or fairness creams were selected for this study and preference was also given to products that were manufactured locally. Apart from the locally manufactured products, a few SWCs products imported from USA, Switzerland, UK and Thailand were also included for the study. Prices of the SWC products mostly ranged between PK.Rs Locally manufactured products were comparatively cheaper than the imported ones. Table 4. List of purchased skin whitening creams (SWCs) Sn. City Outlet Name Date Of Purchase 1 Karachi Bin Hashim Address SB-C1 Block 14 Gulshan-E-Jauhar Near Dar-Ul- Sahar, Karachi Items Purchased Total Cost 11 2,975 2 Lahore Khalid Pharmacy T-Block, DHA Lahore Lahore General Store Upper Mall Scheme Lahore Lahore Paradise Store Haripur Fashion For Fashion Boutique 6 Islamabad Lucky Chemist Islamabad 8 Peshawar 9 Peshawar Hi Choice cash and carry Prime medicos and general store Blue bells cosmetics 2-S, Commercial Area, Phase 2, DHA Lahore D-Stop GT Road Haripur Shop 7-8, AAA Plaza, G-10 Markaz Islamabad G-10 markaz islamabad tel: /3/ Shop 5, cantt medical center, dabgari garden Peshawar /3/ Abdara chowk, university road Peshawar A total of 50 different SWC bands were purchased (between December, 2015 January, ) and are described in Table 4. Out of these 20 (Karachi = 11 and 3 each from Haripur, Lahore & Islamabad) were taken for chemical analyses to find out their total mercury content (Table 5). Before proceeding to the sample preparation, details of each product such as its color, physical state, manufacturing date, expiry date, details of manufacturers were recorded. Information regarding their brand, color, dates of production and expiry, sampling location/city and manufacturer, as provided by the respective manufacture, are also provided in Table 5. Six samples did not have any information regarding, neither their date of production nor date of expiry. The purchased samples with tight lids and in plastic shopping bags were placed in bigger cloth bags and kept in wooden cupboard at room temperatures, prior to sending the same to laboratory for their mercury content analyses. 12

16 Table 5. List (n = 20) of skin whitening creams (SWCs) for Mercury content analyses SN Brand Manufacturer Date of production Date of expiry Sampling City/Location Sample color 1 Arche Cream Pearl NG 22-Aug-15 NG Gulistan e Jauhar Karachi Off white 2 Brido Whitening Cream CPHL Mingora, Swat- Pakistan. NG NG Gulistan e Jauhar Karachi Shiny Off White 3 Faiza Beauty Cream Poonia Brothers Pakistan 23-Nov Nov-18 Gulistan e Jauhar Karachi Off white 4 Golden Pearl Beauty Cream NG 30-Nov Dec-17 Gulistan e Jauhar Karachi Off white 5 Lookfresh Whitening Cream CPHL Mingora, Swat- Pakistan. NG NG Gulistan e Jauhar Karachi Light green 6 Parley Whitening Cream Khyber Chemicals Pvt Ltd LHR Pak 20-Sep Sep-18 Gulistan e Jauhar Karachi Light green 7 Samrah Whitening Cream Poonia Brothers Pakistan 16-Dec Dec-17 Gulistan e Jauhar Karachi Light brown 8 Skin White Gold Beauty Cream Skincare Company Pakistan NG NG Gulistan e Jauhar Karachi Peach 9 Stillman's Bleach Cream Stillman Company Inc. USA Dec-15 Dec-18 Gulistan e Jauhar Karachi Shiny White 10 Kojic Acid Whitening Facewash The Vitamin Company, USA 1-May-17 May-17 Gulistan e Jauhar Karachi Transparent 11 Loreal Cream 16, Place Vendome Paris Mar-15 Mar-18 Gulistan e Jauhar Karachi Shiny White 12 Skin White Cold Cream(With Honey) Skin Care Company Pakistan NG NG D stop GT Road Haripur Shiny White 13 Skin White Whitening Cream Skincare Company Pakistan Apr-14 Apr-17 D stop GT Road Haripur Shiny White 14 Whitening Crème Bleach Golden Girl Cosmetics USA Aug-15 Aug-18 D stop GT Road Haripur Light Pink 15 Yoko Whitening Cream SIAM YOKO CO.Ltd Thailand Sep-15 Sep-20 G10 Markaz ISB Off white 16 BLESSO Whitening Cream HCL London NG NG G10 Markaz ISB Shiny White Yoko Whitening Cream (Ginseng And Pearl) White Face Whitening Cream SIAM YOKO CO.Ltd Aug-13 Aug-18 NG NG NG G10 Markaz ISB Upper mall Scheme Lahore Off white Apple White 19 Pure White Beauty Whitening Cream Pure white Cosmetics pak July 1st, 2015 July 1st,2018 Upper mall Scheme Lahore Off White 20 Due Whitening Cream Kreative Cosmetics.Ltd 1-Dec-14 1-Dec-17 Upper mall Scheme Lahore Parrot Green NG: Not given/provided by the manufacturer 13

17 During sample preparation for transportation to the designated laboratory, safety gloves were used in order to avoid personal exposure to the contents of the products. Samples were then carefully unpacked and transferred into airtight bags using separate plastic spatulas. All the airtight bags were then labeled with a series of alphanumerical codes and were then further sealed in non-transparent bags. A list of the sample codes (samples IDs) was generated and dispatched with the samples for further analysis. The samples were prepared and delivered personally by SDPI researchers, after a thorough inspection and briefing from the laboratory administration. Chemical analyses was carried out by Tt international testing laboratory, a division of Total Testing Solutions Inc. ( ISO/IEC accredited Lab, ISO/IEC Accredited inspection body and CPSC accredited. Acid digestion standard method was used to convert total mercury content of SWCs into a solution form (tti ) and analyzed by Flow injection Mercury System (FMS -CVAAS). Method detection limit (MDL) = 0.05 mg mercury/kg Twenty (20) SWCs samples (Sample IDs KC-1 to KC-11; HC-12 to HC-14; IC-15 to IC-17 and LC- 18 to LC-20) were received by Tti Lab on January 14, and the analytical report (Reference No R dated February 03, ) was directly sent to SDPI (Annex A; Table No. = 7) 3.2. Survey/Interviews with Dermatologists and Skin Specialists As the analysis of the mercury containing SWCs in this study revealed hazardous levels of mercury, it became necessary to seek opinions of dermatologists and skin specialists on the SMCs use and also assess the prevalence of health complications of SWCs use among their growing number of patients. 14

18 A questionnaire was developed (Annex B) comprising 18 close and open ended questions that were mainly focused on assessing the disease pattern among the SWC users, reasons for SWC use, male to female ratio, age group, contents regarding SWCs in teaching curriculum, legislation for content display and ban on SWC production. Dermatologists from Islamabad, Rawalpindi, Peshawar and Gilgit were visited for interview and the data was recorded on the questionnaire at the spot. Only qualified/certified dermatologists working at both private clinics and general hospitals (private/public) were included in this study. The inflow of patients was observed to be different in both cases. a. Private Clinics Surveys were conducted between February and April of. Due to the unavailability of any official list of dermatologists, a list was prepared from the accessible information on the internet. During survey work problems were faced in finding their clinics, resulting in undesirable waste of time. Initially 24 clinics were identified in Islamabad of which 16 were located in F sector, 4 in G sector and 4 in H sector. However dermatologists from 5 out of 24 clinics could be interviewed. In Rawalpindi 13 clinics were identified but 3 dermatologists were interviewed. In Peshawar city, the total dermatologists clinics identified were 26, out of which only 6 were visited. Only one clinic could be located in Gilgit city and interview was held with the dermatologist in-charge (Table 6). b. Hospitals Apart from the private clinics, dermatologists were also interviewed in private and general hospitals of the selected cities. In Islamabad 27 public and private general hospitals were identified from which 4 were located in Sector F, 13 in Sector G, 4 in Sector H, 2 in Sector I, 2 in Table 6: List of Visited Hospitals and Clinics in selected main cities SN Hospitals (29) Clinics (15) City No. Dermatologists Professional experience City No. Dermatologists Professional experience 1 Islamabad Islamabad Rawalpindi Rawalpindi Peshawar Peshawar Gilgit Gilgit Reference: Annex 5 Sector E, and 2 were located in the other areas. However, out of these, interviews with dermatologists could only be held at 11 hospitals. In Peshawar the total identified general hospitals were 33 of which dermatologists in 5 hospitals were interviewed. In Rawalpindi the total identified general hospitals were 15 out of which 11 were visited and dermatologists there were interviewed. Situation in Gilgit were contrastingly the 2 general hospitals were visited and interview with dermatologists were held at both the hospitals (Table 6). Fifty (50) dermatologists were interviewed in this study of which 19 were located in Islamabad, 17 in Rawalpindi, 12 in Peshawar and 2 were located in Gilgit city. Their personal details were recorded for future correspondence and information sharing about further developments. 15

19 Since the nature of this study was descriptive, the results were analyzed by descriptive statistics. Graphs and tables were prepared using Microsoft Excel. 4. Results and discussion 4.1. Comparison of mercury content in (ppm) SWC brands in different countries Comparative data of eight SWC brands, available for sale in open market, as reported in earlier studies carried out in Denmark, Saudi Arabia, UK and also by three institutions in Pakistan is shown in Figure 3. Summarized data of earlier has also been already described in Tables 1 3 & 7 (SDPI study) in preceding pages. For Arche brand, Saudi Arabia study showed lower mercury content (0.74 ppm) compared to the two studies (2.04 & 1.96 ppm) in Pakistan. For L Oreal, the reported mercury content is almost same. However, mercury content reported by SDPI in Faiza Beauty Cream (7680 ppm) is higher compare to UK values. Whereas samples of Stillman s SWC brands analyzed in UK & Denmark indicated mercury content above 30, 000 ppm, SDPI study showed less than 30,000 ppm (Figure 3). All study reports showed alarmingly high mercury content in Stillman s SWC samples analyzed. Results of analytical measurements of mercury content, as reported by SDPI for Due, Brido & White Face SWC brands are higher as compare to other reports but for Goldern Pearl SWC brand, it is lower (Figure 2). Figure.3. Comparison of mercury content of the same SWC brands in different countries Saudi Arabia Pak-LCWU SDPI Study Pak-LCWU SDPI Study UK UK SDPI Study UK UK UK Denmark Pak-PU SDPI Study UK SDPI Study Pak-LCWU SDPI Study Pak-PU SDPI Study Pak-PU SDPI Study Arche Cream L'Oreal Faiza No.1 Beauty Cream Stillmann s Due Whitening Cream Brido whitening cream White face Golden Pearl By comparing the mercury levels in local SWC brands with those imported, it was revealed that 8 out of the 20 brands manufactured outside Pakistan had mercury levels between ppm except Stillman s which had the highest observed mercury levels of 26,500 ppm. On the contrary, 4 out of the 12 local SWC brands were having mercury levels that ranged between ppm whereas mercury levels in the rest were found to be alarmingly high and were in the range of ppm. The presence of such high levels of mercury in the local brands is an indication of a significant health risk from their use among the local population. 16

20 4.2. Mercury containing SWC (% samples) in different countries The issue of hazardous mercury exposure from the use of SWCs is not a recent, as a number of studies have been previously conducted around the globe. SWCs (% samples) containing mercury as well as total number of SWCs studied in 21 countries are given in Table 9 A & B. All samples (100%) studied in 8 countries (S.N. 1-6/Table 9A & 6,8/Table 9B) showed presence of mercury. Highest content (39,000 & 40,000 ppm) were observed in two samples in Denmark, followed by SWC samples ( ppm) of Bangladesh (Table 9B). Of 549 SWCs samples studied in USA (S.No.11/Table 9A), only 33 samples (6%) showed presence of mercury. SN Table 9 A: Mercury containing SWCs (% samples) in different countries. Reporting Country SWCs with Hg presence/total SWCs studied (%) Hg Content Range(ppm) References 1 UK 17/17 (100%) % by weight Rapex,( ) 2 Norway 16/16 (100%) ibid- 3 Germany 2/2 (100%) 2.56%-5.0% by weight -ibid- 4 Denmark 2/2 (100%) 39000, ibid- 5 The Netherlands 1/1 (100%) 1% by weight -ibid- 6 Austria 2/2 (100%) 16400, ibid Armenia, Belarus, Georgia 15/21 (71%) AWHHE, 2011 South Africa 12/29 (41.4%) Maneli et al. () Somali 11/27 (40.7%) 1.07 to 33,000 Adawe and Oberg (2013) New York, USA 8/17 (47.1%) ,600 McKelvey et al. (2011) USA 33/549 (6%) ,622 Hamann et al. (2014) Mexico 6/16 (37.5%) ,824 Peregrino et al. (2011) More than 50% samples studied, containing mercury have been observed for SWCs in Armenia, Belarus, Georgia, Philippines, Oman, Pakistan and Sri Lanka. Studies showed 50-10% of SWCs samples containing mercury in 8 countries (S.No. 8-10,12/Table 9A & S.No. 2,3,5,9/Table 9B). Only SWCs samples studied in USA showed less than 10% samples containing mercury (Table 9A). 17

21 Reference: as given in Table 9 A & B Furthermore the findings of other studies also highlight the need for addressing the issue of mercury in SWCs on urgent basis. A number of reports on Hg containing SWCs from African and North American countries indicate the prevalence of SWC use for complexion change among the dark skinned individuals in such population and also signifies the extent of health risks posed from their use. Similar conditions prevail in the African countries where studies have detected mercury levels as high as 33,000 ppm in few SWCs (Maneli et al, ; Adawe and Oberg, 2013). Also a study conducted in Mexico has analyzed SWCs for mercury content and detected as high as 35,824 ppm mercury in few samples ( Peregrino C, 2011). Few studies such as those reported from USA indicate the trend of obsession for fair skin among the dark skinned population of the country. A couple of studies conducted in USA by McKelvey et al, 2011and Hamann et al, 2014 have detected high levels of mercury (45,622 ppm) in few SWCs. Table 9 B: Mercury containing SWCs (% samples)) in different countries SN Reporting Country SWC with Hg presence/total SWCs studied (%) Hg Content Range(ppm) Reference 1 Philippines 10/20 (50%) ,200 TOXIC ALERT, () 2 Thailand 10/47 (21.3%) to 99,070 EARTH, (2003) 3 Cambodia 13/60 (21.7%) 2022, highest 6305 Murphy et al. (2015) 4 Oman 25/40 (62.5%) 0.02 to 25.7 Naser and Kirm (2012) 18

22 5 Alqadami et al. (2013), Al- Saleh et al. (2011a), Al- Ashban et al. (2006), Al-Saleh and Al-Doush (1997) Saudi Arabia 71/188 (38.7%) Bangladesh 12/12 (100%) ESDO, (2012) 7 Sri Lanka 25/46 (54%) CEJ, (2013) 8 Nepal 7/7 (100%) CEPHD, (2012) 9 India 14/32 (43.8%) Travasso, (2014) 10 Pakistan 56/57 (95%) Chaudhry A,( 2014), SDPI (), Gul N, (2012) In the Middle Eastern countries including Saudi Arabia and Oman reports show mercury levels as high as 314, ppm in few products from Saudi Arabia (Naser and Kirm, 2012: Alqadami et al., 2013; Al-Saleh et al., 2011a; Al-Ashban et al., 2006; Al-Saleh and Al-Doush, 1997) which is the highest ever recorded mercury content among all the studies on SWCs described in this report. SWCs studied by Naser and Kirm (2012) in Oman indicated relatively lower mercury contents that ranged from 0.02 to 25.7 ppm. A number of reports from South Asian, South East Asian and Middle Eastern countries have also highlighted the issue of mercury and its use in SWCs in the region. Since these regions lay in the tropical zone, exposure to high index UVR is expected to be increased, resulting in enhancing the process of melanin production and causing darker complexion of majority of the population. Reports from Asian countries including Philippines, Thailand and Cambodia show contrastingly high levels of mercury in the SWCs analyzed. Although the Philippines Food and Drug Regulatory Authority has already identified and banned a number of SWCs that contain more than 1ppm mercury, yet their manufacturing and sale is still continuing.("doh- FDA Advisory No A; "FDA Advisory No ). According to one study presence of mercury has been reported in 50% of the SWCs tested, some of the samples contained more than 60,000 ppm of mercury content (TOXIC ALERT, ). Another study from Cambodia detected as high as 6305 ppm of mercury in SWCs available in the market (Murphy et al, 2015). Study in Thailand has reported 99,070 ppm mercury in SWCs available in the local market. These high levels of mercury are extremely hazardous for the human health and may cause a range of acute as well as chronic toxicity in humans. Studies in the south Asian region have reported high levels of mercury contents in a number of SWCs and and have also provided information regarding the extent of SWCs use in this part of the world. A country report for Bangladesh by ESDO in 2012 revealed presence of mercury in all studied samples, mercury content ranged from ppm. Similarly a report from Sri Lanka indicated presence of mercury in more than 50% of the studied SWCs and mercury levels were observed as high as ppm (CEJ, 2013). However SWCs studied in Nepal had mercury levels less than the permissible limit of 1 ppm and were in the range of ppm (CEPHD, 2012). M arket for fairness cream is enormous in India, however, there are a few reported studies on SWCs in the country. Study by Travasso in 2014 analyzed 32 SWCs and presence of mercury has been reported in 14 of the studied samples. 19

23 4.3. SDPI study on SWCs use in Pakistan A few studies on SWCs use in Pakistan have also been reported. The use of SWC to achieve fair complexion is considered to be effective tool, as agreed by majority of women (59%) in one study conducted in Pakistan, also agreeing that lighter skin tone is more beautiful and the use of skin lightening products are strongly associated with achieving fair complexion (Askari, 2013). Chaudhry A, in 2014 analyzed 27 samples of SWCs and found the presence of mercury in all studied samples, in the range 0.42 to ppm. Another study by Gul, in 2012 reported mercury in 9 out of 10 studied SWCs and mercury content in the range 8 to 63.2 ppm. With the presence of such high content of mercury in the SWCs available in the open market in Pakistan, the population s health is at significant risk, as supported earlier studies. Majority of patients suffer with multiple adverse effects, as observed in majority of the SWCs users (Chohan, 2014). Majority of the SWC users are reported to be unaware of not only the hazardous ingredients of the SWCs but also about the adverse effects resulting from their use. (Chohan, 2014). According to the findings of the study in Pakistan by Askari (2014), 88.9% of SWCs users agreed that Skin lightening creams may cause undesirable health effects, yet this has not affected their continued use of SWCs in the country. In the following pages, study carried out by SDPI is described in two parts. In the first part, the study examines the levels of mercury content in 20 SWCs, available in the local markets of a few selected main cities of Pakistan and in the second part the study assessed & highlight the health complications arising/prevailing among mercury containing SWCs users, through interviewing dermatologists/skin specialists in private clinics, teaching institutions and general hospitals of the same selected cities.. Factors that are influencing the public s opinion regarding their skin complexion and enhancing an obsession for a fair complexion have also been identified and discussed SDPI study: Part 1. Total mercury content in studied skin whitening creams (SWCs) The results of mercury analyses of the studied SWCs samples (20) are given in Table 7 and Figure 1. Some relevant information about these samples has already been provided in Table 5, in the preceding pages. Most of the samples were jelly like semi-solids and white in color. Table 7: Mercury content (ppm) in studied SWCs Sample ID Product Name Hg Content (ppm) Sampling City/Location Date of purchase KC-1 Arche Cream Pearl Thailand 2.04 Karachi 3-Jan-16 KC-2 Brido Whitening Cream 6610 Karachi 3-Jan-16 KC-3 Faiza Beauty Cream 7680 Karachi 3-Jan-16 KC-4 Golden Pearl Beauty Cream 0.69 Karachi 3-Jan-16 KC-5 Lookfresh Whitening Cream Karachi 3-Jan-16 KC-6 Parley Whitening Cream Karachi 3-Jan-16 KC-7 Samrah Whitening Cream 9900 Karachi 3-Jan-16 KC-8 Skin White Gold Beauty Cream 0.39 Karachi 3-Jan-16 KC-9 Stillman's Bleach Cream Karachi 3-Jan-16 KC-10 Kojic Acid Whitening Facewash <0.05 Karachi 3-Jan-16 20

24 KC-11 Loreal Cream 0.18 Karachi 3-Jan-16 HC-12 Skin White Cold Cream(With Honey) 0.31 Haripur 1-5 dec 2015 HC-13 Skin White Whitening Cream 0.13 Haripur 1-5 dec HC-14 Whitening Crème Bleach 0.57 Haripur 1-5 dec 2017 IC-15 Yoko Whitening Cream 0.19 Islamabad 6-Jan-16 IC-16 BLESSO Whitening Cream 11.4 Islamabad 6-Jan-16 IC-17 Yoko Whitening Cream (Ginseng And Pearl) 3.76 Islamabad 6-Jan-16 LC-18 White Face Whitening Cream Lahore jan LC-19 Pure White Beauty Whitening Cream 7060 Lahore jan 2017 LC-20 Due Whitening Cream Lahore jan 2018 SWC samples received for analysis by lab: Jan 14, Results received by SDPI from lab: Feb 03, Figure 1: Mercury content (ppm) in studied samples of SWCs Hg Content (ppm) KC-1 KC-2 KC-3 KC-4 KC-5 KC-6 KC-7 KC-8 KC-9 KC-10 KC-11 HC-12 HC-13 HC-14 IC-15 IC-16 IC-17 LC-18 LC-19 LC-20 Sample ID Mercury content were found to be in the rang 0.13 (HC-13) - 26,500 ppm (KC-9). Mercury content of one sample (KC-10) seems to be less than 0.1ppm. Eight samples (KC-4, KC-8 & KC , HC & IC-15) showed (Figure 1) mercury content less than 1ppm (requirement of Minamata Convention on Mercury). On the basis of the observed total mercury content in the studied samples and the health risk due to mercury exposure, the studied SWCs may be categorized in four major groups (Table 8; Figure 2) as most hazardous Hg content > 10,000 ppm (5 samples), h ighly hazardous Hg content > 5000 ppm (4 samples), moderately hazardous Hg contet < 5000 ppm (3 samples) and least hazardous - Hg content < 1ppm (8 samples). 21

25 Table 8 Categorization of Studied Mercury Containing Hazardous SWCs Levels of Hazardousness Most Hazardous (25%)* Highly Hazardous (45%)* Moderately Hazardous (15%)* Least Hazardous (40%)* SN ( Hg >10000 ppm) (Hg >5000 ppm) (Hg <5000 ppm) (Hg <1 ppm) *% SWCs. Lookfresh Whitening Cream (KC-5) Parley Whitening Cream (KC-6) Stillman's Bleach Cream (KC-9) White face whitening cream (LC-18) Due Whitening Cream (LC-20) Brido Whitening Cream (KC-2) Faiza Beauty Cream (KC-3) Samrah Whitening Cream (KC-7) Pure White Beauty Whitening Cream (LC- 19) Arche Cream Pearl Thailand (KC-1) BLESSO Whitening Cream (IC- 16) Yoko Whitening Cream (Ginseng And Pearl) (IC-17) Figure: 2. Mercury containing SWCs Hazardousness levels. Golden Pearl Beauty Cream (KC-4) Skin White Gold Beauty Cream (KC- 8) Kojic Acid Whitening Facewash (KC-10) Loreal Cream (KC- 11) Skin White Cold Cream(With Honey) (HC-12) Skin White Whitening Cream (HC-13) Whitening Crème Bleach (HC-14) Yoko Whitening Cream (IC-15) 45% 40% 25% 15% Most Hazardous ( Highly Hazardous Hg >10000 ppm) (Hg >5000 ppm) Moderately Hazardous (Hg <5000 ppm) Least Hazardous (Hg <1 ppm) The table shows the highest level of mercury in Stillman's Bleach Cream sample, Due Whitening Cream, Lookfresh Whitening Cream, Parley Whitening Cream and White face Whitening Cream. Interestingly all the samples containing more than 10,000 ppm mercury were purchased from either Karachi or Lahore, whereas samples brought from other sites were comparatively having less than 10,000 ppm mercury. Moreover the same trend was observed in the highly hazardous category where all the samples were purchased from Karachi (3) and Lahore (1). Moderately hazardous category contained one sample (KC -1) from Karachi along with 2 samples each from Islamabad. A few SWCs from Karachi were also having less than 1ppm mercury and were placed in the least hazardous category along with 22

26 samples from Haripur and Islamabad. All samples of SWCs (HC12 HC13) purchased from Haripur showed lowest mercury content ( ppm), as compared to the samples purchased from other cities. The contrasting difference in mercury levels of products purchased from different locations might suggest the excessive demand/usage of SWCs in different cities especially in cities like Karachi, where most of the population have comparatively darker complexion and demand for SWCs with higher mercury content, to give effective and desirable complexion change, immediately. It is also possible that despite the same brand label, the SWCs products may have been manufactured by more than one manufacturer (inside/outside the country), with varying composition/amou nt of the ingredients, including mercury content. Mercury content in SWCs, exceeding the permissible limit (1ppm) should be considered potential risk to human health and protection from the resulting mercury exposure is strongly advised. Skin specialist survey SDPI study: Part 2. Survey at skin care centers in selected cities The presence of mercury in 95% SWC samples studied and alarmingly very high mercury content in some most commonly used SWC samples, led to the 2nd part of SDPI study and it was considered worthwhile to also conduct a survey at skin care centers in few selected main cities in the country for thoughts-sharing and to know the views/experiences of the dermatologists/skin specialists on the use of SWCs in the country and some related major issues. According to an earlier study 85.7% of users of a section of Pakistan population were practicing skin lightening for social purpose (Askari, 2013). In the Pakistani society, skin tone has become a prime criterion especially during marriage prospects. According to a survey carried out in Pakistan, 82% of the female respondents believe that men consider women with lighter skin tone, more beautiful (Askari, 2013) which seems to be a significant contributing factor in the usage of skin lightening products among the local population The study revealed (Askari, 2013) that 63.9% of the respondendts of a section of population in in Pakistan did not know the product s ingredients, as also observed by Chohan et al ( 2014), who highlighted the lack of knowledge among the respondents regarding contents of the SWCs in use. As a result, the public remains unaware of the hazardous chemical contents of the products and thus become exposed to health risks. It has also been reported that the SWC users in Pakistan suffered more than one adverse effect in (Chohan, 2014). Meetings/interview with the dermatologists/skin specialists were held through a questionnaire, (18 questions) developed at SDPI. Close and open ended questions mainly focused on assessing the disease pattern among the SWC users, reasons for SWC use, male to female ratio, age group, contents regarding SWCs in teaching curriculum, legislation for content display and ban on mercury containing SWCs production. It is essential to raise awareness and advise caution among the local population regarding Hg exposure and their possible health effects. There is also a dire need for the support on legislation, advocacy and ban on Hg containing SWCs available in the market. Educating the masses would in turn help reduce the burden of health costs on both the individuals as well as the government. Among others, the main focus of this survey being identifying factors that are influencing people to change their complexion, labeling of SWCs and health risks from the use of such creams (which contain extremely high level of mercury).the health adversities from the use of such SWCs can be well understood by studying the cases/patients received by dermatologists/skin specialists in hospitals and skin care clinics in 23

27 some selected cities of Pakistan. The findings are described and discussed in the following pages Survey at skin care centers in Islamabad Results of the survey in Islamabad is summarized in (Figs. 3 A - E) and Annexes 6. Full questions may be seen in the sample questionnaire (Annex B). Reasons for changing complexion: We asked the skin specialists working in Islamabad whether factors such as personal needs; professional requirements and social pressure could be the reasons for people to change their complexion. According to 47% of them, the decision for changing complexion is mostly driven by personal needs, whereas 89% dermatologists/skin specialists refuted the idea that professional requirements influence the decision of people to change their complexion. 79% of the respondents agreed that social pressure has the most influence on individuals regarding how they perceive their skin complexion (Figure 3A). All visited dermatologists/skin specialists were of the opinion that electronic/print media advertisements & TV morning shows creating an obsession for fair skin and are making people conscious about their skin tone. Respondents considered these advertisement misleading and unanimously recommended ban on the same Awareness and precaution regarding Hg exposure We also ascertained the level of awareness of the patients regarding the SWC products they use to change their complexion (Figure 3B). Almost all the dermatologists were of the opinion that majority of the patients who have used SWCs were unaware of its contents, including mercury. All respondents also indicated lack of awareness among the patients regarding the possible health effects, resulting from the use of mercury containing SWCs. The extent to which SWCs are so excessively used by a segment of the general public, may be attributed to their lack of awareness about harmful contents of SWCs, such as mercury which eventually affect their skins & health. Regarding recommending SWCs use to patients, 79% responded in affirmative but added only medicated SWCs are recommended to patients, in case of genuine need with caution to be used only for recommended specific time period. All respondents cautioned their patients about the adverse health effects caused by the SWCs use. Visiting patients To assess the frequency of patients reporting various health complications from the SWC use, we assessed the number of patients/week visiting skin specialists both in the general hospitals as well as in private clinics. In Islamabad 95% of the visited dermatologists receive more than 50 patients with skin problems per week (Figure 3C). 47% respondents receive more than 50 patients/ week with skin health issues specifically related to SWC use. 53% of the visiting patients have skin problems both on their face and hands, whereas 47% develop skin conditions particularly on their face (Figure 3C). 42 % dermatologists in Islamabad are visited by > 50 patients/week, with request for change of complexion. Gender and age of SWCs Users It was somewhat surprising to know from the visited dermatologists in Islamabad that 40% of their patients were male (Figure 3-D), as generally, the complexion issue is considered to be female specific. Mostly patients visiting skin care centers were between years of age (58%), followed by tho se having age between below 25 years (26%). However, there were also patients with above 40 years age (16%). 24

28 Mercury related policy issues Dermatologists in Islamabad were asked whether the MBBS curriculum sufficiently covers topics related to Hg exposure and their health effects. 84% respondents did not think (Figure 3E) so and mentioned there was lack of sufficient information and recommended the need for its inclusion in the MBBS curriculum. However 11% dermatologists declined to comment due to their lack of knowledge/fresh memory on the topic. All respondents (100%) supported legislation and regularization of all types of SWC products and their brands available in the market, complete information on the product labels regarding ingredients of SWCs and their amount, awareness raising among general public about health impacts due to mercury exposure among mercury containing SWCs users and ban on the manufacturing of all mercury containing SWCs with mercury content above the permissible limit (Figure 3E). Figure 3: Summarized survey findings for Islamabad Figure3-A Reasons for changing complexion Yes No Yes No Yes No Yes No (Personal/Q8) (Professional/Q8) (Social/8) (Ads and TV shows/q16) Figure 3-B Awareness and precaution regarding Hg exposure Yes No Yes No Yes No Yes No (SWCs content/q9) (Hg health effects/q10 (Recommending SWC/Q6) (Cautioning SWC use/q11) 25

29 Figure 3 -C Visiting patients < to 50 (Total cases reported/week) Q1 >50 <10 10 to 50 (Cases of SWC use/week) Q3 >50 Face Hands and Face (Affected body part)q2 Others < to 50 >50 (Complexion change requests/week) Q5 Figure 3-D Gender (M:F) and age of SWC users Male Female Below yrs Above 40 yrs (Male/Female)Q17 (Age of patients/q18) Figure 3-E Hg related policy issues Yes No Don t Know Yes No Yes No (SWCs in MBBS curriculum/q12) (Legislation support, advocacy, SWC contents disclosure/q13) (Ban on Hg in SWCs/Q14) 26

30 Survey at skin care centers in Rawalpindi Results for the interviews of 17 dermatologists during survey of skin caring centers of Rawalpindi are given in Figure 4A-E and Annex 7. Reasons for changing complexion According to the dermatologists interviewed in Rawalpindi, 59% attributed personal choice as one of the main reason, due to which people choose to change their complexion (Figure 4A). 82% respondents agreed it could also be due to professional requirements of individuals. Social pressure could also be playing a significant part in this regard, as suggested by 71% of the respondents (Figure 4A). Nonetheless, as was the consensus among dermatologists in Islamabad, all Rawalpindi respondents also agreed the influence of the press & electronic media and TV morning shows in promoting complexion change and use of SWCs. Awareness and precaution regarding Hg exposure When asked if the patients are aware of the hazardous contents of the SWCs and their adverse health impacts, almost all the dermatologists (100%)agreed their patients were unaware of the same and thought it was due to no information or lack of information on the SWCs product labels (Figure 4B). As most of the patients were unaware of the health consequences of mercury containing SWCs, they continue using the products beyond the recommended period of time which leads to significant health risks to the SWCs users. 82% of the dermatologists in Rawalpindi prescribe medicated SWCs of different brands/companies to the patients and also caution them about the health hazards of using unbranded product for prolong period (Figure 4B). Visiting patients Situation in Rawalpindi differs from Islamabad in terms of the number of patients visiting the dermatologists. It was observed that 71% of the dermatologists in Rawalpindi (Figure 4C) receive more than 50 patients per week, which was relatively less than that observed in Islamabad (95%). However 65% of the total dermatologists in Rawalpindi received 10 to 50 patients who have skin problems related to SWC use. The remaining 35% dermatologists receive more than 50 patients per week with skin complications subsequent to SWC use. According to 47% of the dermatologists in Rawalpindi, most of the patients developed skin problems both on their hands and face, whereas only 24% visited dermatologists informed most of their patients had skin problems only on their faces, as a results of SWC use (Figure 4C). The attitude for changing complexion was observed to be lesser in Rawalpindi residents, compared to Islamabad s (42%), as only 29% of the dermatologists received more than 50 patients per week who desired change of their complexion. Gender and age of SWC users Majority of the patients according to the dermatologists in Rawalpindi comprise of 80% female and 20% male (Figure 4D). It was observed that the trend of SWCs use among men in Islamabad is twice compare to Rawalpindi, where it was 40% male among all SWCs users (Figure 3D). However, the number of SWCs users below 25 years of age is much higher in Rawalpindi (47%) compared to Islamabad (26%). As was also observed for Islamabad, majority of SWCs users of Rawalpindi are also in the age group between years. The SWCs users above 40 years are not many in Rawalpindi (6%), whereas, in Is lamabad it is more than double (16%). 27

31 Figure 4: Summarized survey findings for Rawalpindi Figure4-F Reasons for changing complexion Yes No Yes No Yes No Yes No Personal Professional Social Ads and TV shows 0 Figure 4-G Awareness and precaution regarding Hg exposure Yes No Yes No Yes No Yes No (SWCs content/q9) (Hg health effects/q10 (Recommending SWC/Q6) (Cautioning SWC use/q11) 28

32 Figure 4 -H Visiting patients < to 50 >50 <10 10 to 50 >50 Face Hands and Face Others < to 50 >50 (Total cases reported/week) Q1 (Cases of SWC use/week) Q3 (Affected body part)q2 Figure 4-I Gender and age of SWC users. (Complexion change Male Female Below yrs Above 40 yrs (Male/Female)Q17 (Age of patients/q18) Figure 4-J Hg related policy issues Yes No Don t Know Yes No Yes No (SWCs in MBBS curriculum/q12) (Legislation support, advocacy, SWC contents disclosure/q13) (Ban on Hg in SWCs/Q14) 29

33 Mercury related policy issues The revision of MBBS dermatology curriculum was strongly endorsed by dermatologists of Rawalpindi as 88% said there was insufficient information in the current curriculum on mercury related issues, including mercury exposure and its health impacts (Figure 4E). All the dermatologists were also strongly favor regulating SWCs manufacturing and sale in the open markets and display of complete information with the amount of SWCs ingredients. According to the visited dermatologists in Rawalpindi, SWCs products that contain hazardous chemicals such as mercury should be banned immediately. Respondents were also unanimous (100%) in pointing out the dire need for advocacy and campaigns for raising awareness about the health hazards of mercury exposure from the use of mercury containing SWCs (Figure 4E) Survey at skin care centers in Peshawar A total of 12 skin specialists in Peshawar were interviewed during the survey. Summarized results are provided in Fig.5A-E and Annex 8 Reasons for changing complexion Skin specialists were asked whether the choice of changing ones complexion is driven by personal needs, to which 64% of respondents agreed and said that mostly people want to change their complexion when they are about to get married (Figure 5A). However 36% dermatologists did not agree to it. When asked if people tend to change their complexion due to professional requirements, none of them considered it as a significant factor, especially here in Pakistan. Regarding the effects of social pressure on the use of SWCs for complexion change, 86% believed it as one of the major reasons due to which people are dissatisfied with their skin tone and go for use of SWCs for immediate results. All visited dermatologists/skin specialists agreed regarding negative influence of advertisements about SWCs in print & electronic media and TV morning shows and supported ban on the same (Figure 5A). Awareness and precaution regarding Hg exposure All dermatologists in Peshawar agreed that most of people lacked the awareness regarding adverse health effects of SWCs as well as information regarding their ingredients of the SWCs brands in their use (Figure 5B). 90% of the interviewed dermatologists prescribed SWCs to their patients. Despite caution by the dermatologists, most of the SWCs users continued SWCs use, beyond the period recommended (Figure 5B). Visiting patients Although the total number of visiting patients with skin complications is high in Peshawar (50% respondents received more than 50 patients/week) but the number of patients having skin problems due to SWC use is relatively less as 71% of the visited dermatologists receive less than 10 such patients/week (Figure 5C). 30

34 Figure5-K: Reasons for changing complexion Yes No Yes No Yes No Yes No (Personal/Q8) (Professional/Q8) (Social/8) (Ads and TV shows/q16) Figure 5-L: Awareness and precaution regarding Hg exposure Yes No Yes No Yes No Yes No (SWCs content/q9) (Hg health effects/q10 (Recommending SWC/Q6) (Cautioning SWC use/q11) Figure 5 -M: Visiting patients < to 50 (Total cases reported/week) Q1 >50 <10 10 to 50 (Cases of SWC use/week) Q3 >50 Face Hands Others < 10 and Face (Affected body part)q2 10 to 50 >50 (Complexion change requests/week) Q5 31

35 Figure 5-N: Gender and age of SWC users Male Female Below yrs Above 40 yrs (Male/Female)Q17 (Age of patients/q18) Figure 5-O: Hg related issues and key recommendations Yes No Don t Know Yes No Yes No (SWCs in MBBS curriculum/q12) (Legislation support, advocacy, SWC contents disclosure/q13) (Ban on Hg in SWCs/Q14) Figure 5: Summarized survey findings for Peshawar 79% dermatologists (Figure 5C) said most of the patients with a history of SWC use have problem only on their faces. A few also have problems both on their hands as well as faces. The number of requests for complexion change is contrastingly less in Peshawar, where most of the dermatologists receive less than 10 patients per week with such requests. This could be due to the fact that majority of the population in Peshawar have fair complexion as compared to those from other parts of the country. Gender and age of SWC users Almost 90% of the patients visiting dermatologists in Peshawar are female, whereas males make up only 10% of the total visiting patients. Age of majority of the visiting patients as reported during the interviews was below 25 43% respondents), to the observations of 29% dermatologists, it was between the age 25 and 40 years (Figure 5D). 29% respondents informed that they received majority of patients of 40 years age. According to the 32

36 dermatologists, the reason for the use of SWC among the elderly females for treating melisma, developed during pregnancy and persists for some time after that. Mercury related policy issues All visited dermatologists in Peshawar were of the opinion that the current MBBS curriculum did not sufficiently cover mercury related issues (including exposure & the resulting health impacts and therefore needs to be revised at the earliest (Figure 5E). They also supported mercury specific legislation for regulating SWCs manufacturing and open sale and suggested proper monitoring of the contents of products available in the market. All the dermatologists interviewed in Peshawar raised the need for extensive campaign and advocacy to spread awareness, regarding the harmful effects of mercury containing SWCs to public health. In this regard, they emphasized that media can play a very effective role in spreading the awareness and educating people. The visited dermatologists also pointed out the lack of information on the SWCs products labels by the manufacturers and emphasized on making the content display on product labels compulsory and imposing fines on those who do not comply with such official notifications. 93% of the respondents fully supported imposing a ban on the SWCs products that Figure 6: Overall survey findings for Islamabad, Rawalpindi & Peshawar (n = 50) Figure 6-P: Reasons for changing complexion Yes No Yes No Yes No Yes No (Personal/Q8) (Professional/Q8) (Social/8) (Ads and TV shows/q16) Figure 6-Q: Awareness and precaution regarding Hg exposure Yes No Yes No Yes No Yes No (SWCs content/q9) (Hg health effects/q10 (Recommending SWC/Q6) (Cautioning SWC use/q11) 33

37 Figure 6 -R: Visiting patients < to 50 >50 <10 10 to 50 >50 Face Hands and Face Others < to 50 >50 (Total cases reported/week) Q1 (Cases of SWC use/week) Q3 (Affected body part)q2 (Complexion change requests/week) Q5 Figure 1-S: Gender and age of SWC users Male Female Below yrs Above 40 yrs (Male/Female)Q17 (Age of patients/q18) Figure 6-T: Hg related policy issues Yes No Don t Know Yes No Yes No (SWCs in MBBS curriculum/q12) (Legislation support, advocacy, SWC contents disclosure/q13) (Ban on Hg in SWCs/Q14) contain high levels of mercury (more than 1 ppm), to avoid mercury exposure and health risks to the users of the mercury containing SWCs. 7% thought that the ban may be imposed after easy accessibility of affordable non-mercury based products in the open local markets (Figure 5E). 34

38 Overall Survey findings in Islamabad, Rawalpindi and Peshawar The overall results for all the respondents (n=50) 50 are summarized in Fig 6A-E and Annex 9. In Fig 6F, overall findings of only a few selected mercury related issues are highlighted. Figure 6 F: Overall survey findings of Selected mercury related issues Reasons for changing complexion Among various factors considered for an individual s reason to go for complexion change, according to the majority of dermatologists (78%) interviewed in the 3 main cities, seems to be social and not at all professional (91%). (51%) of the dermatologists thought, it could also be personnel ((Figure6A). As a result, people use products such as SWCs to lighten their skin tone and thus put their health in significant risk. These social pressures for acquiring fair complexion are mostly directed through advertisements and TV shows that strongly suggest the viewers with exaggerated benefits of having a fair skin tone. There is consensus among all respondents that such advertisements and programs (including morning shows) should be banned immediately. Awareness and precaution regarding mercury exposure One of the reasons for the extensive use of SWCs in Pakistani population is due to the lack of awareness of the hazardous contents/ingredients of SWCs and their possible health risks among the public, as agreed by all respondents (Figure 6B). Since SWCs users are unaware of the contents of SWCs and their health impacts, the application of SWCs continues for selfmedicated extended period of time. 85% were recommending SWCs to patients whereas 15% did not recommend any SWC at all. However all the dermatologists claim that they very strongly caution their patients about the adverse health effects of these products such as SWCs that may contain high levels of toxic chemicals such as mercury (Figure 6B). Visiting patients The overall flow of patients with skin disease has been found to be high as more than 70% dermatologists informed, they received more than 50 patients per week (Figure 6C). This 111indicates the prevalence of skin related issues among the population of the 3 selected cities of Pakistan. However the numbers of patients who develop skin condition particularly from the use of SWCs are between patients per week, as conveyed by 42% of the respondents. 32% dermatologists receive more than 50 patients per week and the remaining 26% less than 10 patients/week, with skin problems developed from the use of SWCs. 35