Beauty and the beast

Beauty and the beast

Pallavi Saxena, 21, is an aspiring model in Delhi who must look fair and glamorous all the time. Every day, in the morning and evening, she gently massages a fairness cream to enhance her complexion. She never steps out of the house without makeup. “I always carry a lipstick in my purse for reapplying in between my shows, meetings and dinners,” Pallavi says. Linda Pannei also swears by cosmetics. She works at a showroom of leading cosmetic brand, ColorBar, in Delhi. To make sure that the lip colour does not fade, she applies lipstick three to four times during the working hours. “It helps convince customers about the company’s latest products, while making me feel beautiful and confident,” says Linda. Both Pallavi and Linda use branded products that come with high price tags. “Branded cosmetics are safe,” says Linda who spends about Rs 5,000 a month on the products. So feel millions of people, both men and women, who are increasingly relying on cosmetics to look their best.

The cosmetic industry is one of the fastest growing in India. In 2011, the industry registered impressive sales worth Rs 26,410 crore, according to the latest study by RNCOS, a business consultancy service in the US. With rising purchasing power and growing fashion consciousness, RNCOS estimates that the industry would expand at about 17 per cent a year between 2013 and 2015. Cosmetic giants are leaving no stone unturned to cash in on this opportunity and are roping in Bollywood superstars as advocates of their products. In one of the advertisements of Emami’s Fair and Handsome, Shah Rukh Khan throws the skin whitening cream towards a young man to use and become fairer. The implicit message is: whiter the skin, the more attractive and successful one is (see ‘Outrage over commercials’). While no one can say for sure that using cosmetics makes one look beautiful, what is confirmed is that they have adverse health effects.

Neena Khanna, professor of dermatology at the All India Institute of Medical Sciences (AIIMS), Delhi, says there has been a sharp increase in skin problems associated with cosmetics in the past few years. Hema Jerajani Shukanje, former head of the dermatology department at Sion Hospital, Mumbai, agrees. “Women complain of change in skin pigmentation or itching around the lips because of use of lipstick. Even children report similar skin problems as they also use cosmetics,” she adds.

While skin problems are visible, cosmetics could have other hazardous impacts on health. Consider this. Last year, California researchers tested lipsticks of 32 brands available in the US market and found high levels of heavy metals such as titanium, manganese, aluminium, cadmium and chromium. Lead was found in 75 per cent of the lipsticks tested. These heavy metals are known health hazards. While lead is a neurotoxin, long-term exposure to the others can harm body organs like the liver and kidneys and cause cancer.

It is estimated that nearly all of the applied lipstick is ingested by the user and the metals find their way into the body. On an average a woman applies lipstick about 2.5 times daily and uses 24 milligrams (mg) of it. Those who slather it on could be using as high as 87 mg of lipstick a day. The California researchers found that women who use lipsticks could be ingesting a significant amount of aluminium, cadmium, chromium and manganese. In case of average use, the estimated intakes of the metals were more than 20 per cent of their accepted daily intake (ADI) limits. ADI is the maximum amount of a toxin that a person can be exposed to without any appreciable health risk. Thirty-one per cent samples exceeded the ADI for chromium in case of average use (24 mg a day) and 68 per cent were above the ADI values when high use (87 mg a day) was considered. “Cosmetics’ safety should be assessed not only by the presence of hazardous contents, but also by comparing estimated exposures with health-based standards,” the researchers advised in the scientific journal Environmental Health Perspective in June 2013.

The study is not the first one to demonstrate the presence of heavy metals in cosmetics. In 2007, Campaign for Safe Cosmetics, a US-based coalition against unhealthy ingredients used in cosmetics, tested lipsticks of 33 popular brands and found 61 per cent of them containing lead in the range of 0.03 to 0.65 parts per million (ppm). One-third of the lipsticks had more than 0.1 ppm of lead, the standard set by the US Food and Drug Administration (USFDA) for candies to protect children from ingesting lead. To corroborate the results USFDA tested lipsticks available in the market and found lead in almost all the samples. Some brands contained much more lead than previously reported by Campaign for Safe Cosmetics. Maybelline Color Sensation by L’Oreal USA had 10 times more lead than earlier. The findings were published in the July-August 2009 issue of the Journal of Cosmetic Science.

Such high levels of heavy metals in cosmetics have also been reported elsewhere in the world. In 2012, a research in Nigeria reported heavy metals, such as arsenic, cadmium, lead, mercury and nickel, in almost all cosmetics available in the country. This was published in the African Journal of Biotechnology. That year, Center for Public Health and Environmental Development (CEPHED), a non-profit in Nepal, tested lipsticks for heavy metals and found that the average lead content in the samples was over 900 times the USFDA standard of 0.1 ppm. CEPHED also tested skin whitening creams available in the country for mercury. Of the seven samples collected, two contained mercury levels above the USFDA standard. Garnier Skin Naturals had the highest—0.521 ppm—levels of mercury. In Sri Lanka, non-profit Centre for Environmental Justice also found high levels of mercury in 25 of the 46 skin whitening products available in the country. Pai Mei, a whitening spot cream imported from China, contained a whopping 30,167 ppm of mercury. In the absence of any comprehensive studies in India, Delhi non-profit Centre for Science and Environment (CSE) recently analysed lipsticks and fairness creams for the presence of heavy metals. It tested 32 fairness creams (26 for women and six for men) for mercury and 30 lipsticks for lead, cadmium, chromium and nickel. The samples included Indian and international cosmetic brands along with a few herbal products. The results were startling.

Mercury, which is prohibited for use in cosmetics in India, except for eye care products, was found in 44 per cent of fairness creams. Of the lipstick samples tested, 50 per cent contained chromium and more than 43 per cent had nickel. While chromium is prohibited for use in cosmetics in the US, the EU and India with certain exceptions, a few nickel compounds find mention in the prohibitory list of India, the EU and the US. Lead and cadmium were not found in the samples tested.

Mercury was present in the fairness creams tested by CSE in the range of 0.10 ppm to 1.97 ppm. Three creams contained this toxic heavy metal in excess of 1 ppm—the maximum limit applicable in the US. Aroma Magic Fair Lotion, a product of Blossom Kochhar Beauty Products Pvt Ltd, had the highest mercury level at 1.97 ppm, followed by Olay Natural White, a product of Procter and Gamble, India, and Ponds White Beauty of Hindustan Unilever Ltd (see ‘Fairness creams with high mercury content’).

The potential harm caused by these creams can be gauged by comparing their mercury content with the ADI limit for the metal. Since India has not set limits for ADI, CSE compared the amount of mercury in fairness creams with the ADI set by the US Environmental Protection Agency (USEPA). The results show whitening creams may contribute up to 71 per cent of the ADI for mercury, depending upon the product, amount used and duration of application (see ‘Proportion of mercury in...’). This is a very high level of exposure to mercury from just one product. People are regularly exposed to the heavy metal from natural sources such as food, water and air. With whitening cream accounting for over 50 per cent of the ADI for mercury, chances are high that a person using these products may exceed the ADI limit for mercury. Health risks associated with mercury would increase proportionally.

In lipsticks, chromium was present in the range of 0.45 to 17.83 ppm. Hearts & Tarts (080V) shade of ColorBar had the highest concentration of the metal. Chromium is prohibited in India. Only two of its compounds—chromium oxide and chromium hydroxide—are permitted in cosmetic colourants. Though the US allows these colourants in cosmetics, it prohibits their use in lipsticks. But there is no such exception in India. There is also no standards to limit its use. The levels of chromium found in lipsticks by CSE was anything between 10 per cent and 1,550 per cent of the ADI limits (see ‘Lipsticks with high chromium and nickel content’ on p25). CrVI, one of the forms in which the metal is present, is known to cause cancer in humans. When inhaled, it can cause lung cancer. Oral exposure through drinking water has been linked to increased stomach tumours. Such high levels of chromium in lipsticks demand urgent attention from regulators and the industry.

Nickel was in the range of 0.57 to 9.18 ppm, with Labsolu Nu-204 of Lancome containing the highest concentration. India bans some of its compounds (such as nickel sulphate, nickel carbonate, nickel monoxide) for use in cosmetics. While it is known what is not allowed, there is no clarity on what is allowed. Though the amount of nickel found in lipsticks were quite low compared to its ADI—the contribution of lipsticks to the ADI for nickel was less than 1 per cent—nickel was found in 10 of the 15 lipstick samples that had chromium. Such collective presence of heavy metals in lipstick is worrisome.

People are unknowingly consuming heavy metals from different sources like drugs, vegetables and water, says K K Das, professor of physiology at BLDE College in Karnataka who has published study papers on adverse health effects of nickel. Heavy metals in cosmetics, which can enter the body either through the skin or mouth, add to the body burden, he adds. “There is an accumulative health effect of these heavy metals,” says Y K Gupta, head of the department of pharmacology at AIIMS.

CSE shared its findings with the respective companies to find out the reasons for the presence of such high levels of heavy metals in cosmetics. “We hoped that this would help find ways to limit the presence of heavy metals in cosmetics,” say CSE researchers. After several months of correspondence about batch details, testing methodology and follow-ups, only seven companies responded—The Body Shop India, Lakme of Hindustan Unilever Ltd, Hindustan Unilever Ltd, Emami Ltd, ELCA Cosmetics Pvt Ltd (Estee lauder), Modi Revlon Pvt Ltd and ITC Ltd.

A few companies responded comprehensively. For instance, Lakme and Emami backed up their responses through internal and third party safety assessments and testing. Some also replied briefly addressing only partial set of queries but few cared to own up their responsibility. There was something common to almost all the responses: the presence of heavy metals in the products was not intended.

“We do not add mercury as ingredients into finished cosmetic products. Our products fully comply with the applicable regulations and standards,” said the spokesperson of Hindustan Unilever Ltd when asked about the presence of heavy metals in Ponds and Fair and Lovely creams. “However, heavy metals like mercury are naturally occurring, present in the environment and can make their way in trace quantities into raw materials despite all possible precautions and good manufacturing practice,” he said. Referring to lipsticks from Estee Lauder, ELCA Cosmetics Private Limited said, “Governmental authorities in the US, Asia, and the EU agree that there is no safety or health risk associated with the presence of trace amounts of such naturally occurring elements in cosmetic products that meet established regulatory standards.” Spokesperson of Lakme of Hindustan Unilever, while referring to lipsticks, said, “Due to the ubiquitous nature of the trace metals, regulations world over do not prohibit the presence of or lay down any limits upon the presence of such trace metals in finished products.” These responses show that cosmetic companies are taking refuge in the concept of unavoidable “trace” presence of prohibited substances.

It is clear from the industry’s response that stringent regulations are the only way to ensure safety of cosmetics. But a look at the Drugs and Cosmetics Act of India, 1940 shows that cosmetics are one of the most unregulated products under the law.

Under the law, the Drugs Controller General of India (DCGI) is responsible for ensuring that cosmetics sold in the country are safe. But the assessment is done on the basis of documents provided by the manufacturer or the company importing the product. A company can import cosmetics by registering the brand for just US $250 and providing details of product specification, testing protocols and documents that establish that the cosmetics do not include toxic products banned in India. Indian cosmetic manufacturer also need to provide similar documents for seeking licence from the state drugs authority. Nowhere during the approval processes do DGCI officials evaluate the safety of the products as claimed by the companies. The companies are expected to follow the good manufacturing practice and standards set by the Bureau of Indian Standards (BIS). While this is voluntary, even BIS has standards for very few heavy metals present in colour additives.

Depending upon the colour and brand, colourants make up 10-15 per cent of the weight of a lipstick. Colourant is one of the sources of heavy metals, which are either present as impurities or as part of its composition. For instance, Blue 1 lake, a permitted organic colourant, is found to have chromium as an impurity. Ferrous ferrocyanide, an inorganic colour additive permitted in India and the US, contains nickel as impurity, while another inorganic colourant, iron oxide, may have arsenic, lead and mercury as impurities. These colourants were mentioned on the labels of certain lipsticks CSE tested.

BIS does not have limits for heavy metals in colourants that are inorganic in nature. Though it allows 100 ppm of heavy metals in organic colourants and sets aside an additional 20 ppm limit for lead, it does not specify limits for individual metals, except for arsenic which is allowed up to 2 ppm. In 40 per cent of the 10 lipstick samples that contained both chromium and nickel, the two heavy metals ate up the entire quota of 100 ppm allowed through colourants, shows a calculation by CSE (see ‘Breaching Indian standards’). Of these, two had over 3.5 times the allowed limit. In the absence of heavy metal standards in finished products, this provides a regulatory loophole that manufacturers can exploit.

Another regulatory loophole results in high quantities of banned metals like mercury finding their way in cosmetic products. Manufacturers often get away on the pretext that toxic metals are present in trace levels. Since Indian regulators do not acknowledge the concept of “trace”, there is no maximum limit set for the metals in finished products. Trace presence of heavy metals are recognised by both the US and the EU. The US and Germany allow a maximum of 1 ppm mercury, provided it is technically unavoidable in good manufacturing practice and does not cause damage to human health.

It is important for policy makers to set limits for trace presence. Since monitoring sourcing of colourants is cumbersome and manufacturers often put the onus of heavy metal contamination on suppliers of colourants, setting standards for finished products is a better alternative, suggest CSE researchers. This would also help account for trace presence of heavy metals through all possible sources, other than colourants. The companies also need to ensure that such “trace” presence is really unavoidable.

Despite heavy metal concerns in ayurvedic formulations, there are no separate limits for herbal cosmetics. BIS should set standards for allowed and prohibited raw materials, colourants and preservative used in herbal cosmetics. While regulators should ensure that companies adhere to good manufacturing practices more often than not it is assumed that manufacturers follow BIS standards. “We check samples at various levels, such as while giving licence and after it is on the shelves,” says H G Koshia, Gujarat drugs controller. “We send the cosmetic samples to our laboratory in Baroda. But we usually look for spurious products and manufacturers falsely using the name of big brands during inspection,” he adds. In Maharashtra, joint commissioner of Food and Drugs Administration, O S Sadhavani, says his officials check ingredients before giving licence by picking up samples from market. But instead of quality issues, they too end up dealing with cases of spurious products.

Talking to Down To Earth, Drugs Controller General India G N Singh assured that he is working towards increasing monitoring of cosmetics in market. Since April 2013, he has made registration compulsory for cosmetic products. The government plans to set up a Rs 3,000 crore laboratory in Chennai for checking samples of cosmetics, medical equipment and drugs. A significant number of staff will be recruited for the laboratory. “The authority is serious about monitoring the ingredients used in cosmetics and forcing manufacturers to abide by the country’s standards,” Singh says.

Lab study by Ramakant Sahu, Sapna Johnson and Poornima Saxena. See full lab report