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Jane Houlihan Sean Gray Timothy Kropp, Ph.D. Chris Campbell Acknowledgements Authors: Jane Houlihan Sean Gray Timothy Kropp, Ph.D. Chris Campbell Reviewers: Richard Wiles, Ken Cook This report was made possible by grants from the Heinz Family Foundation, Beldon Fund, and the John Merck Fund. The opinions expressed in this report are those of the authors and editors and do not necessarily reflect the views of our supporters. EWG is responsible for any errors of fact or interpretation contained in this report. Personal care product use surveys collected by The Breast Cancer Fund, Womenʼs Voices for the Earth, Health Care Without Harm, the Massachusetts Breast Cancer Coalition, Clean Water Action, and the Environmental Working Group. EWG is a nonprofit research organization with offices in Washington, DC and Oakland, CA. EWG uses the power of information to educate the public and decision-makers about a wide range of environmental issues, especially those affecting public health. Kenneth A. Cook, President Richard Wiles, Senior Vice President Mike Casey, Vice President for Public Affairs Jane Houlihan, Vice President for Research Bill Walker, Vice President/West Coast 4 Executive Summary FDA cannot require companies to do safety testing of their cosmetic products before marketing. — FDA Office of Cosmetics and Colors (FDA 1995) Most consumers would be surprised to learn that the government does not require health studies or pre-market testing for cosmetics and other personal care products before they are sold. According to the government agency that regulates cosmetics, the FDA’s Office of Cosmetics and Colors, “...a cosmetic manufacturer may use almost any raw material as a cosmetic ingredient and market the product without an approval from FDA” (FDA 1999). The toxicity of product ingredients is scrutinized almost exclusively by a self-policing industry safety committee, the Cosmetic Ingredient Review (CIR) panel. Because testing is voluntary and controlled by the manufacturers, many ingredients in cosmetics products are not safety tested at all. Environmental Working Group’s analysis of industry and government sources shows that: • Eighty-nine (89) percent of 10,500 ingredients used in personal care products have not been evaluated for safety by the CIR or anyone else (FDA 2000, CIR 2003). The absence of government oversight for this $35 billion industry leads to companies routinely marketing products with ingredients that are poorly studied, not studied at all, or worse, known to pose potentially serious health risks. The Environmental Working Group’s (EWG’s) six-month computer investigation into the health and safety assessments on more than 10,000 personal care product ingredients found major gaps in the regulatory safety net for these products. To help people use what we learned we developed an online rating system that ranks products on their potential health risks and the absence of basic safety evaluations. The core of the analysis compares ingredients in 7,500 personal care products against government, industry, and academic lists of known and suspected chemical health hazards. 5 Our analysis shows that ingredients in cosmetics range from essentially harmless components like table salt and oatmeal, to chemicals known to cause cancer in humans. Notably, natural ingredients are no more likely to have been assessed for safety than synthetic chemicals. Individual ingredients vary tremendously in their ability to soak through the skin. Some absorb in only miniscule amounts, while others can quite easily penetrate the skin to the blood vessels below. Few individual ingredients pose excessive risks, but most people use many products in the course of a day, so it well may be that these risks are adding up. A survey of 2,300 people conducted as part of this research effort shows that the average adult uses 9 personal care products each day, with 126 unique chemical ingredients. More than a quarter of all women and one of every 100 men use at least 15 products daily. Little research is available to document the safety or health risks of low-dose repeated exposures to chemical mixtures like those in personal care products, but the absence of data should never be mistaken for proof of safety. The more we study low dose exposures, the more we understand that they can cause adverse effects ranging from the subtle and reversible, to effects that are more serious and permanent. Overall, our investigation of product safety shows cause for concern, not alarm. Much more study is needed to understand the contribution of exposures from personal care products to current human health trends. Findings. Our safety assessment of 7,500 personal care product labels, documented in this web-based review, shows that: • Just 28 of the 7,500 products we analyzed have been fully assessed for safety by the cosmetic industry’s selfregulating panel, the Cosmetic Ingredient Review (CIR). All other products — 99.6 percent of those examined — contain one or more ingredients never assessed for potential health impacts by the CIR. This panel, run and funded by the cosmetic industry’s trade association, is billed as the organization that “thoroughly reviews and assesses the safety of ingredients used in cosmetics” on behalf of the industry (CIR 2004). The government does not systematically review the safety of personal care products and has banned or restricted just nine of the more than 10,000 ingredients used in personal care products. 6 • One of every 100 products on the market contains ingredients certified by government authorities as known or probable human carcinogens, including shampoos, lotions, make-up foundations, and lip balms manufactured by Almay, Neutrogena, Grecian Formula, and others. An astonishing one-third of all products contain one or more ingredients classified as possible human carcinogens. • Seventy-one hair dye products contain ingredients derived from carcinogenic coal tar. These products have all been granted a specific exemption from federal rules that deem products to be adulterated when they contain ingredients that can harm human health. Coal tar containing products include dyes made by Clairol, Revlon, L’Oreal, and others. Coal tar hair dyes are one of the few products for which FDA has issued consumer advice on the benefits of reducing use, in this case as a way to potentially “reduce the risk of cancer” (FDA 1993). • Fifty-five percent of all products assessed contain “penetration enhancers,” ingredients that can increase a product’s penetration through the skin and into the bloodstream, increasing consumers’ exposures to other ingredients as well. We found 50 products containing penetration enhancers in combination with known or probable human carcinogens. • Nearly 70 percent of all products contain ingredients that can be contaminated with impurities linked to cancer and other health problems. Studies by FDA and European agencies show that these impurities are common, in some cases occurring in nearly half of all products tested (FDA 1996, DTI 1998). Some manufacturers buy ingredients certified by an independent organization called United States Pharmacopeia (USP). These ingredients may contain lower levels of harmful impurities, but the criteria for certification are not public. There are no federal standards for ingredient purity. While it seems likely that some companies purchase or manufacture refined, purified ingredients, it is equally likely that many do not. Consumers and government health officials have no way to know. 7 • Fifty-four products violate recommendations for safe use set by the industry’s self-regulating Cosmetic Ingredient Review board. Most of these products contain ingredients found unsafe for the intended use of the product they are found in. Examples include ingredients found unsafe for use in baby products but used in diaper cream, ingredients found unsafe for use on injured or damaged skin contained in products marketed specifically for use on chapped and injured skin, and ingredients not safe for sprays but found in spray products. Brand name products found in violation of industry recommendations include Neutrogena, Destin, Herbal Essences, and Rite Aid. • In its 67-year history of monitoring cosmetic safety, FDA has banned or restricted just nine personal care product ingredients (FDA 2000). In its review of 1,175 ingredients, the industry’s safety panel has found just nine ingredients (a different nine) unsafe for use in cosmetics (CIR 2003). By contrast, 450 ingredients are banned for use in cosmetics in the European Union, although the vast majority of these have never been used by the industry. The regulatory vacuum in the U.S. gives cosmetic companies tremendous leeway in selecting ingredients, while it transfers potentially significant and largely unnecessary health risks to the users of the products. Recommendations. Because the FDA has no legal authority to require safety assessments of cosmetics, products safety is by default the responsibility of the industry and its own appointed Cosmetic Ingredient Review panel. This voluntary policing arrangement has been a failure. EWG’s analysis of 7,500 personal care product labels found that some cosmetic companies use known human carcinogens in products, manufacture scores of products containing ingredients in direct contraindication of industry hazard assessments, widely use chemicals that are likely to be contaminated with harmful impurities, and add to thousands of products ingredients that industry assessments show lack basic information needed to support their safety. To improve the safety of personal care products EWG recommends that manufacturers: 8 Table 1. Many leading cosmetics companies may have failed to formulate their products with customer health as a top concern. According to an EWG Safety Assessment Rating for personal care products, the products with the highest health concerns in 25 different product categories contain ingredients linked to cancer, pregnancy problems, and other potential health issues (scores range from 0 to 10, with 10 being of highest health concern): �� 9 • Remove from products all chemicals classified as known or possible human carcinogens, reproductive toxins, and developmental toxins. Manufacturers are currently reformulating products in Europe to comply with this restriction. • Certify that ingredients do not have impurities classified as known or probable human carcinogens, reproductive toxins, or developmental toxins. • Conform with the recommendations of the CIR and reformulate products to eliminate ingredients that are deemed unsafe for the intended use of the product. In addition to these actions by industry we also strongly recommend that: • Congress amend the Federal Food Drug and Cosmetic Act to provide FDA with clear and unencumbered authority to request any and all safety studies that it deems necessary to assess the safety of cosmetics and other personal care products. References Cosmetics Ingredient Review (CIR) (2003). 2003 CIR Compendium, containing abstracts, discussions, and conclusions of CIR cosmetic ingredient safety assessments. Washington DC. Cosmetics Ingredient Review (CIR) (2004). CIR information available at http://www.cir-safety.org, accessed May 6 2004. Department of Trade and Industry, UK (DTI) (1998). A survey of cosmetic and certain other skin-contact products for nnitrosamines. Food and Drug Administration (FDA) (1993). Hair Dye Dilemmas. FDA Consumer. April 1993. Accessed online May 6 2004 at http: //vm.cfsan.fda.gov/~dms/cos-818.html. Food and Drug Administration (FDA) (1995). FDA Authority over Cosmetics. Center for Food Safety and Applied Nutrition. Office of Cosmetics and Colors Fact Sheet. February 3 1995. Accessed online May 6 2004 at http://www.cfsan.fda.gov/~dms/cos-206.html. 10 Food and Drug Administration (FDA) (1996). Are nitrosamines in cosmetics a health hazard? Accessed online May 6 2004 at http:// vm.cfsan.fda.gov/~dms/qa-cos25.html. Updated November 1996. Food and Drug Administration (FDA) (1999). Diethanolamine and Cosmetic Products. Office of Cosmetics and Colors Fact Sheet. Dec 9, 1999. Accessed online May 6 2004 at http://vm.cfsan.fda.gov/ ~dms/cos-dea.html. Food and Drug Administration (FDA) (2000). Prohibited Ingredients and Related Safety Issues. Office of Cosmetics and Colors Fact Sheet. March 30, 2000. Accessed online May 20 2004 at http://www.cfsan.fda.gov/~dms/cos-210.html. 11 12 Part 1: Carcinogens in personal care products Consumers believe that ’if it’s on the market, it can’t hurt me.’ And this belief is sometimes wrong. – Director of FDA’s Office of Cosmetics and Colors (FDA 1998) Known and probable human carcinogens in cosmetics In a systematic comparison of ingredients in 7,500 personal care products against government lists of cancer-causing chemicals, the Environmental Working Group has found that one of every 100 products on the market contains a known or probable human carcinogen (Table 1), and an astonishing one-third of all products contain one or more ingredients with at least some evidence of carcinogencity in laboratory studies or investigations of human populations (Table 2). Seventy-seven products, one of every 100 products assessed, contain ingredients certified by government authorities as known or probable human carcinogens, including shampoos, lotions, foundations, and lip balms manufactured by Almay, Neutrogena, Grecian Formula, and others (Table 1). The cancercausing ingredients range from coal tar in shampoo to quartz crystals contained in powders and linked to lung cancer. Federal law does not prohibit the use of carcinogens in cosmetics. FDA can take legal action through the Department of Justice to remove poisonous (adulterated) cosmetics from the market, but the legal costs and the high burden of proof of health harms the agency faces under the law discourage such actions. As a result, legal action is rare, and cosmetics that pose potential cancer risks remain on the market. Many impurities common to cosmetics are also linked to cancer. ÊImpurity levels in cosmetics are largely unrestricted, in spite of the potentially serious health consequences. EWG’s assessment of product ingredient labels and data on cancer-causing chemicals identified three common impurities in personal care products that are linked to mammary tumors in animal studies - ethylene oxide, PAHs, and 1,3-butadiene. The ingredients for which these impurities are of concern are used in one of every four personal care products on 13 the market and are discussed further in the “Impurities” section of this investigation. Among the known and probable human carcinogens used in cosmetics are the eight ingredients discussed below. Coal tar. Coal tar is a known human carcinogen (NTP 2004, IARC 2004). It is also used in four shampoos from Neutrogena and Ionil designed to control itching and eczema, including Neutrogena T-Gel Shampoo. None of the products note potential cancer risks on their labels. All four products contain penetration enhancers, ingredients that may increase the absorption of coal tar through the scalp and into the blood vessels below. Benzyl violet 4B. Benzyl violet 4B, also known as violet 2, is considered a carcinogen by the State of California and the International Agency for Research on Carcinogens (OEHHA 2004, IARC 2004). An EWG analysis of ingredient labels found benzyl violet 4B in 25 products, including an Alberto VO5 shampoo, a Caress moisturizing body bar, and Almay nail treatments. Formaldehyde. Formaldehyde is a probable human carcinogen (IARC 2004, OEHHA 2004, NTP 2002). From an inspection of product labels, we identified formaldehyde in two OPI nail treatment products and in a lotion designed to protect against jellyfish stings bearing the brand name “SafeSea.” Lead acetate. Although the most notorious health hazard associated with lead acetate is potential harm to a developing brain in babies and young children, it is also considered a carcinogen by the E.U. and the U.S. government’s National Toxicology Program (NTP 2002, UNECE 2004). Lead acetate is an ingredient in Grecian Formula 16 hair dye. 14 Progesterone. Progesterone is a probable human carcinogen, linked in animal studies to tumors of the mammary gland and abnormal growth of reproductive tissues (NTP 2002, OEHHA 2004). It is produced naturally by all mammals and is an approved drug used for treatment of abnormal menstruation and other reproductive problems. It is also an ingredient in 23 cosmetic products in EWG’s product database, including ten “menopause creams”, hair thinning serums, and two sunscreens. According to the National Toxicology Program’s review of progesterone, “FDA regulates progesterone under the Food, Drug, and Cosmetic Act (FD&CA) as a prescription drug approved for human use. FDA has ruled that progesterone must carry a warning label for patients and physicians concerning use, risks, and contraindications. FDA also requires that no residues of progesterone be found in the uncooked edible tissues of lamb and steer” (NTP 2002). Given its status as a regulated drug, it is not clear why progesterone appears in non-prescription cosmetic products. On labels it is listed as both progesterone and lutein, a common synonym (ChemFinder 2004). Selenium sulfide. Both the U.S. National Toxicology program and the State of California classify selenium sulfide as a carcinogen (NTP 2002, OEHHA 2004). It is used in one product, Head & Shoulders Dandruff Shampoo, Intensive Treatment, according to an EWG analysis of 7,500 product labels. Nitrofurazone. Nitrofurazone is classified as a carcinogen by the State of California and the International Agency for Research on Carcinogens, and is a mammary carcinogen according to the U.S. government’s National Toxicology Program (OEHHA 2004, IARC 2004, NTP 2004). It is an ingredient in a tanning product called Total Skin Care Sunless Tanner, For All Skin Types, listed on the ingredient label as “NF,” a common synonym (ChemFinder 2004). Silica. Crystalline silica is a known human carcinogen (IARC 2004). Silica in cosmetics may be in the form of tiny particles of glass (Merck 2004), sand or bits of ground quartz from mining operations (NIOSH 2002) — the crystalline form of silica, or even an extract from horsetail plants (see, for example, www.wholehealthmd.com, 2004). Of these, the sand or quartz material is the crystalline form known to be carcinogenic. Other forms of silica — glass, for instance — are not considered known human carcinogens. In sales materials, the chemical giant Merck describes the company’s technology breakthrough in producing of “tiny glass beads” that are now used in namebrand toothpastes and sunscreens (Merck 2004), and a company called SCHOTT promotes the use of a material called bioactive glass powder for cosmetic applications (SCHOTT 2004). The State of New Jersey cites “limited evidence that fibrous glass implanted into animals” causes cancer (NJDHHS 2004), but the glass form of silica is not classified as a human carcinogen. A consumer has no way to know if the “silica” listed on the ingredient label of a product is a respirable, carcinogenic, crystalline silica or another form of silica that may not pose cancer risks through inhalation. Through ingredient label searches, EWG identified some form of silica in one of every nine products (862 products altogether), including 14 products in powder or aerosol form for which inhalation is likely. Regardless of the cancer risk, consumers may want to avoid the use of powders, 15 Table 1. Products that contain known or probable human carcinogens. 77 (1.0%) products contain known or probable carcinogens. Showing top 20 product categories, ranked by prevalence. �� Source: EWG analysis of ingredient labels from 7,494 products compared against government, industry, and academic lists of known and suspected chemical health hazards. 16 Table 2. Products that contain possible carcinogens. 2,451 (32.7%) products contain possible human carcinogens. Showing top 20 product categories, ranked by prevalence. See all categories. List all products. �� Source: EWG analysis of ingredient labels from 7,494 products compared against government, industry, and academic lists of known and suspected chemical health hazards. 17 even those that do not contain silica, because of potential risks for other kinds of lung damage. In consumer education materials, FDA notes that “powders may cause lung damage if inhaled regularly” (FDA 2000a). Coal tar hair dyes, bladder cancer, and non-Hodgkin’s lymphoma ...women who used permanent hair dyes at least once a month experienced a 2.1-fold risk of bladder cancer relative to non-users... We estimate that 19% of bladder cancers in women in Los Angeles County, California, may be attributed to permanent hair-dye use. (Gago-Dominguez et al. 2001) The use of hair color products appears to increase the risk of non-Hodgkin’s lymphona... If these results represent a causal association, use of hair coloring products would account for 35% of non-Hodgkin’s lymphoma cases in exposed women and 20% in all women. (Zahm et al. 1992) Seventy-one hair dye products contain ingredients derived from carcinogenic coal tar and specifically exempt from federal authority over adulterated products that can harm health. These include dyes made by Clairol, Revlon, L’Oreal, and others. Coal tar hair dyes are one of the few products for which FDA has issued consumer advice on the benefits of reducing use, in this case as a way to potentially “reduce the risk of cancer” (FDA 1993). Coal tars and coal tar pitches are known human carcinogens (IARC 1987). The specific components of coal tar used in hair dyes — aromatic amines — have been shown to mutate DNA (IARC 1993), and to cause cancer in animals (Sontag 1981). An increasing number of studies of humans link long-time hair dye use with cancer, including bladder cancer, non-Hodgkin’s lymphoma, and multiple myeloma. 18 Much of the evidence linking hair dyes with bladder cancer comes from studies of hairdressers. In seven of 10 populations studied (from the US, Norway, Sweden, Finland, Denmark, Japan), scientists found elevated incidence of bladder cancer among hairdressers, barbers, beauticians and cosmetologists exposed to hair dyes — 40 percent higher, on average, than population-wide risks. Hair dye exposure was also linked to bladder cancer in seven of 12 case-control studies focused specifically on occupational history among bladder cancer victims (Gago-Dominguez et al. 2001). In 1993 the International Agency for Research on Cancer found that “occupation as a hairdresser or barber entails exposures that are probably carcinogenic” (IARC 1993), and a recent study by scientists from the University of Southern California’s School of Medicine shows that hairdressers and barbers with more than 10 years on the job face a five-fold increase in bladder cancer risk compared to people not exposed to hair dye (Gago-Dominguez et al. 2001). Is cancer a risk outside the beauty industry, for consumers who dye their hair? In 1982 the National Bladder Cancer Study failed to find a relationship between hair dye use and bladder cancer risk among 3,000 bladder cancer victims. While this study has long provided assurance of low risks from hair dye exposure among people outside the beauty industry, a growing number of more sensitive, focused studies are heightening concerns that long-time or frequent hair dye use does, in fact, substantially increase cancer risks. These findings have been catalyzed by more sophisticated research techniques that include the collection of detailed information on the type of hair dye used, and the inclusion of factors that account for an individual’s genetic susceptibility to cancer. In 2001 researchers from the University of Southern California’s (USC) School of Medicine found that women using permanent hair dye at least once a month more than double their risk of bladder cancer (Gago-Dominguez et al. 2001). Earlier studies had failed to segregate the use of permanent dye from semi-permanent and temporary dyes; the USC study showed this may be a critical distinction. The authors estimate that “19% of bladder cancers in women in Los Angeles County, California, may be attributed to permanent hair-dye use” (Gago-Dominguez et al. 2001). This study is to date the largest and most scientifically rigorous on permanent hair dye and bladder cancer incidence. USC researchers also found that women who are genetically vulerable to bladder cancer (so-called “slow acetylators” who are exposed to some carcinogens for longer periods of time) more than quadruple their risk of bladder cancer with long-time or frequent use of permanent hair dye (Gago-Dominguez et al. 2001). These associations see further confirmation in a study performed by researchers at Dartmouth Medical School that also found links between permanent hair dye use and bladder cancer (Andrew et al. 2004). New studies have identified the particular chemicals in hair dye thought to be linked to bladder cancer as aromatic amines, chemicals derived from coal tar but best known as potent bladder carcinogens in cigarette smoke (Yu et al. 2002). Association 19 of permanent hair dyes with non-Hodgkin’s lymphoma, mutiple myeloma, colorectal adenocarcinoma, lung and upper aerodigestive tract cancers has been studied but associations have been both positive and negative, or only preliminarily studied (Czene et al. 2003; Skov and Lynge 1994; Zahm et al. 1992; Brown et al. 1992; Grodstein et al. 1994; Herrinton et al. 1994; Holly et al. 1998; Robinson and Walker 1999). Among the stronger findings from these studies are those from the National Cancer Institute, where researchers found that 20 percent of all cases of non-Hodgkin’s lymphoma may be linked to hair dye use (Zahm et al. 1992). Alpha Hydroxy Acids (AHAs), Beta Hydroxy Acids (BHAs), and skin cancer Very little about the process restricts their sale. And it’s a somewhat alarming idea to put acids on the skin. It raises obvious safety questions. — Dr. John Bailey, Table 3. Products that contain coal tar dyes. 71 hair dye products contain coal tar dyes. �� Source: EWG analysis of product ingredient labels against CIR identifications of coal tar dyes (CIR 2003). 20 Director of FDA’s Office of Cosmetics and Color, on the use of alpha hydroxy acids (AHAs) in cosmetics (FDA 1999) After four weeks of AHA application, volunteers’ sensitivity to skin reddening produced by UV increased by 18%. Similarly, the volunteers’ sensitivity to UV-induced cellular damage doubled, on average, with considerable differences among individuals. — FDA’s Office of Cosmetics and Color, on new AHA safety studies (FDA 2000b) On May 21, 1992 FDA issued a consumer warning that commercial “skin peel” products, advertised to remove wrinkles, blemishes, blotches and acne scars, could destroy the upper layers of the skin, causing severe burns, swelling, and pain. FDA describes the following progression: “The skin initially reddens, as with a sunburn, then darkens and finally peels away revealing what manufacturers claim will be “new skin.” Treatments may be painful and leave permanent scars” (FDA 1992). Since these initial warnings, the use of the active skin peel ingredients — alpha and beta hydroxy acids (AHAs and BHAs) — has grown dramatically in the cosmetic industry. According to EWG’s assessment of ingredient labels for 7,500 personal care products, these acids are now added to one of every 17 products on the market, including nearly 10 percent of all moisturizers and six percent of all sunscreens (Table 4). The acids are commonly used in products promoted as enhancing the youthful appearance of skin. Beginning with its initial burn warnings, FDA has now studied the safety of AHAs and BHAs for 14 years, driven in part by the increasing use of these acids in cosmetics, as well as by the agency’s estimate that AHAs and BHAs injure 1,000 people nationwide each year (FDA 1999). Most recently, FDA’s Office of Women’s Health sponsored studies that have linked these ingredients to UV-induced skin damage and potential increased risks of skin cancer. The studies identified a doubling of UV damage to skin among people using AHA-containing products (FDA 2000b). According to the Environmental Protection Agency, skin cancer in the U.S. has reached “epidemic proportions,” with more than one million new cases occurring each year. At current rates one in five Americans is expected to develop skin cancer over their lifetime, and one American dies every hour from the disease (EPA 2004). The use of acids in cosmetics may be contributing to current skin cancer rates. The use of these acids in sunscreens, where they appear in six percent of all products we assessed, is perplexing 21 and counterintuitive, and may detract from the cancer protection sunscreen products normally provide. FDA’s 14-year review process has culminated with the Agency issuing guidance on the need for product manufacturers to include sunburn warnings on their products (FDA 2002). The guidance is draft, set to be finalized in 2004, and is voluntary, highlighting the agency’s lack of meaningful authority over cosmetics, even on an issue that the Director of FDA’s Office of Cosmetics and Color found “alarming” (FDA 1999). The suggested warnings, a rare request from an agency that has in its history tackled only a few cosmetic safety issues in such depth, include language advising consumers to “Use a sunscreen and limit sun exposure while using this product and for a week afterwards” (FDA 2002). The cosmetic industry’s efforts to preserve the use of these acids in products began with an industry-sponsored study that showed increased UV-induced skin damage for product testers. The cosmetic trade association CTFA presented this study to the industry’s safety panel in 1996. According to FDA, the panel approved the use of AHAs in cosmetics in June 1997 in spite of the study results and “in spite of serious safety questions submitted by a consumer group and a major manufacturer” (FDA 1997). The industry panel found that AHAs are “safe for use in cosmetic products at concentrations less than or equal to 10 percent, at final formulation pHs greater than or equal to 3.5, when formulated to avoid increasing the skin’s sensitivity to the sun, or when directions for use include the daily use of sun protection.” For salon use, the panel found AHAs “safe for use at concentrations less than or equal to 30 percent, at final formulation pHs greater than or equal to 3.0, in products designed for brief, discontinuous use followed by thorough rinsing from the skin, when applied by trained professionals, and when application is accompanied by directions for the daily use of sun protection” (CIR 2003). In their critique of industry panel recommendations, FDA implies that the safety panel’s admonition to industry is less than useful to consumers, since “AHA concentration and pH are generally not noted on all products. (FDA does not require it.)” The agency notes that consumers can request the information from the manufacturer (FDA 1997). 22 Comments on AHAs from FDA’s Director of the Office of Cosmetics and Color Dr. John Bailey, coming several years prior to the agency’s issuance of suggested, voluntary warning language for cosmetic manufacturers, illustrate the problem inherent in a regulatory system that does not require premarket safety testing: Table 4. Products that contain AHAs and BHAs. 494 (6.6%) products contain alpha and beta hydroxy acids. Showing top 20 product categories, ranked by prevalence. �� Source: EWG analysis or product ingredient labels against listings of AHAs and BHAs from FDA and CIR (2003). Analysis excludes salts and esters classified as AHAs and BHAs. There are 9 of these products that contain 3 or more alpha and beta hydroxy acids. “There are many unanswered questions in front of us... AHAs are unlike anything else ever introduced onto the cosmetic market on such a wide scale. They are not your traditional cosmetics” (FDA 1999). 23 References Alexeff (1999). Expedited evaluation of risk assessment for tertiary butyl alcohol in drinking water. Memorandum to Dr. David Spath, Chief, Division of Drinking Water and Environmental Management, Department of Health Services from Dr. George Alexeff, Deputy Director for Scientific Affairs. June 2 1999. Available online at http://www.oehha.ca.gov/water/pals/ tba.html. Andrew, A.S., Schned, A.R., Heaney, J.A., Karagas, M.R. (2004). Bladder cancer risk and personal hair dye use. Int. J. Cancer 109, 581-586. Agency for Toxic Substances and Disease Registry (ATSDR), Public Health Service, US Department of Health and Human Services. (2002). Toxicological profile of wood creosote, coal tar creosote, coal tar, coal tar pitch and coal tar pitch volatiles. Brown, L.M., Everett, G.D., Burmeister, L.F., Blair, A. (1992). Hair dye use and multiple myeloma in white men. Am. J. Public Health 82, 1673-1674. ChemFinder (2004). Cambridge Soft ChemFinder.com Database and Internet Searching. Available online at http://chemfinder.cambrid gesoft.com/result.asp. Cosmetics Ingredient Review (CIR) (2003). 2003 CIR Compendium, containing abstracts, discussions, and conclusions of CIR cosmetic ingredient safety assessments. Washington DC. Czene, K., Tiikkaja, S., Hemminki, K (2003). Cancer risks in hairdressers: Assessment of carcinogenicity of hair dyes and gels. Int. J. Cancer 105, 108-112. Environmental Protection Agency (EPA) (2004). Health effects of overexposure to the sun. Accessed online May 10 2004 at http: //www.epa.gov/sunwise/uvandhealth.html. Food and Drug Administration (FDA) (1992). Skin Peelers. HHS News. P92-13: May 21, 1992. Ohline May 26 2004 at http:// vm.cfsan.fda.gov/~dms/cos-824.html. Food and Drug Administration (FDA) (1993). Hair Dye Dilemmas. FDA Consumer. April 1993. Accessed online May 6 2004 at http: //vm.cfsan.fda.gov/~dms/cos-818.html. 24 Food and Drug Administration (FDA) (1997). Alpha Hydroxy Acids in Cosmetics. FDA Backgrounder July3 1997. Accessed online May 26 2004 http://vm.cfsan.fda.gov/~dms/cos-aha.html. Food and Drug Administration (FDA) (1998). Clearing up cosmetic confusion. FDA Consumer. May-Jun 1998. Accessed online May 10 2004 http://www.fda.gov/fdac/features/1998/398_cosm.html. Food and Drug Administration (FDA) (1999). Alpha hydroxy acids for skin care; Smooth sailing or rough seas? Office of Cosmetics and Color Fact Sheet. Revised May 1999. Accessed online May 10, 2004 at http://www.cfsan.fda.gov/~dms/fdacaha.html. Food and Drug Administration (FDA) (2000a). Clearing up Cosmetic Confusion. FDA Consumer. May-June 1998; Revised May 1998 and August 2000. Accessed online May 12 2004 at http:// www.cfsan.fda.gov/~dms/fdconfus.html. Food and Drug Administration (FDA) (2000b). AHAs and UV sensitivity: Results of new FDA-sponsored studies. Office of Cosmetics and Color Fact Sheet. March 2, 2000. Accessed online May 10, 2004 at http://www.cfsan.fda.gov/~dms/cosahauv.html. Food and Drug Administration (FDA) (2002). Guidance for industry. Labeling for topically applied cosmetic products containing alpha hydroxyl acids as ingredients. FDA Center for Food Safety and Applied Nutrition. December 2, 2002. Accessed online May 10, 2004 at http://www.cfsan.fda.gov/~dms/ ahaguide.html. Food and Drug Administration (FDA) (2004). Food, Nutrition, and Cosmetics Questions & Answers: Are hair dyes safe? http:// www.cfsan.fda.gov/~dms/qa-top.html Updated January, 2003. Gago-Dominguez, M., Catelao, J.E., Yuan, J., Yu, M.C., Ross, R.K. (2001). Use of permanent hair dyes and bladder-cancer risk. Int. J. Cancer 91, 575-579. Grodstein, F., Hennekens, C.H., Colditz, G.A., Hunter, D.J., Stampfer, M.J. (1994). A prospective study of permanent hairdye use and hematopoietic cancer. J. Natl. Cancer Inst. 86, 14661470. Hartge P., Hoover R., Altman R., Austin D.F., Cantor K.P., Child M.A., Key C.R., Mason T.J., Marrett L.D., Myers M.H., Narayana A.S., Silverman D.T., Sullivan J.W., Swanson G.M., Thomas D.B., West D.W. (1982) Use of hair dyes and risk of bladder cancer. Cancer Risk 42, 4784-4787. Herrinton, L.J., Weiss, N.S., Koepsell, T.D., Daling, J.R., Taylor, J.W., Lyon, J.L., Swanson, G.M., Greenberg, R.S. (1994). Exposure to hair-coloring products and the risk of multiple myeloma. Am. J. Public Health 84, 1142-1144. 25 Holly, E.A., Lele, C., Bracci, P.M. (1998). Hair-color products and risk for non-hodgkin’s Lymphoma: A population-based study in the San Francisco bay area. Am. J. Public Health 88, 1767-1773. International Agency for Research on Cancer (IARC) (1987). Overall evaluations of carcinogenicity. IARC Monographs on the evaluation of carcinogenic risks to humans. Suppl 7 International Agency for Research on Cancer (IARC) (1993). Occupational exposures of hair dressers and barbers and personal use of hair colourants: some hair dyes, cosmetic colourants, industrial dyestuffs and aromatic amines. IARC Monographs on the evaluation of carcinogenic risks to humans. 57 International Agency for Research on Cancer (IARC) (2004). IARC Monographs on the Evaluation of Carcinogenic Risks to Humans and their Supplements: A complete list. Available online at http: //monographs.iarc.fr/monoeval/allmonos.html. Merck (2004). Technology with high potential - the glass beads. Available online at http://www.pigments.merck.de/servlet/PB/ menu/1064100/. National Institute for Occupational Safety and Health (NIOSH) (2002). Health Effects of Occupational Exposure to Respirable Crystalline Silica. NIOSH Hazard Review. Department of Health and Human Services. Centers for Disease Control and Prevention. National Institute for Occupational Safety and Health. DHHS (NIOSH) Publication No. 2002-129. April 2002. Accessed online May 11 2004 at http://www.cdc.gov/niosh/02-129A.html. National Toxicology Program (NTP) (2002). Report on Carcinogens, Tenth Edition; U.S. Department of Health and Human Services, Public Health Service, National Toxicology Program, December 2002. Available online at http://ehp.niehs.nih.gov/roc/ toc10.html. National Toxicology Program (NTP) (2004). Chemicals Associated with Site-Specific Tumor Induction in Mammary Gland. Available online at http://ntp-server.niehs.nih.gov/htdocs/Sites/ MAMM.Html. New Jersey Department of Health and Senior Services (NJDHHS) (2004). Fibrous glass (dust). Hazardous Substances Fact Sheet. Accessed online May 12 2004 at http://www.state.nj.us/health/ eoh/rtkweb/0933.pdf. 26 Office of Environmental Health Hazard Assessment (OEHHA) (2004). State of California Environmental Protection Agency. Chemicals known to the state to cause cancer or reproductive toxicity. http://www.oehha.ca.gov/prop65/prop65_list/files/ 41604list.html. Robinson, C.F. and Walker, J.T. (1999). Cancer mortality among women employed in fast-growing U.S. occupations. Am. J. Ind. Med. 36, 186-192. SCHOTT (2004). Cosmetics — Bioactive Glass Powder in Cosmetic Applications. Available online at http://www.us.schott.com/ bioactive/english/products/cosmetics.html. Skov, T. and Lynge, E. (1994). Cancer risk and exposures to carcinogens in hairdressers. Skin Pharmacol. 7, 94-100. Sontag, J.M. (1981). Carcinogenicity of substitutedbenzenediamines (phenylenediamines) in rats and mice. J. Natl. Cancer Inst. 66, 591-602. Thun, M.J., Altekruse, S.F., Namboodiri, M.M., Calle, E.E., Myers, D.G., and Heath, C.W. (1994). Hair dye use and risk of fatal cancers in U.S. women. J. Natl. Cancer Inst. 86, 210-215. United Nations Economic Commission for Europe (UNECE) (2004). The Globally Harmonized System of Classification and Labelling of Chemicals (GHS). http://www.unece.org/trans/danger/publi/ghs/ officialtext.html. (Part 3: Health and Environmental Hazards) wholehealthmd.com (2004) at http://www.wholehealthmd.com/ refshelf/ substances_view/1,1525,10105,00.html. Yu MC, Skipper PL, Tannenbaum SR, Chan KK, Ross RK. (2002). Arylamine exposures and bladder cancer risk. Mutat Res. 2002 Sep 30;506-507:21-8. Zahm, S.H., Weisenburger, D.D., Babbitt, P.A., Sall, R.C., Vaught, J.B., Blair, A. (1992). Use of hair coloring products and the risk of lymphoma, multiple myeloma, and chronic lymphocytic leukemia. Am. J. Public Health 82, 990- 27 28 Part 2: Pregnancy Concerns Therefore, based on demonstrated reproductive and developmental toxicity associated with dermal and other exposures, these ingredients are considered unsafe for use in cosmetic formulations. — Cosmetic industry safety panel’s findings on ethoxyethanol acetate (CIR 2003), an ingredient that continues to be used in Anna Sui nail color 105 The personal care product industry’s self-regulating health and safety body, the Cosmetic Ingredient Review panel, has found more than 99 percent of all chemicals reviewed safe for use in cosmetics. Of the nine ingredients rejected by the panel, two were found unsafe based on potential risks posed to a developing child. With these exceptions, for the vast majority of ingredients reviewed, the panel found little of concern with respect to developmental and reproductive toxicity. But an assessment of CIR ingredient review summaries, compared with data on known and probable reproductive toxins from government sources, shows that the panel routinely approves ingredients that show evidence of impairing reproduction or harming development in the womb. Established reproductive toxins are used in scores of personal care products: • At least four ingredients listed as known or probable developmental and reproductive toxins by government agencies are used in personal care products, nearly all of them nail care products, according to EWG’s assessment of 7,500 product ingredient labels: dibutyl phthalate (used in 95 nail polishes and other nail care products), toluene (used in 60 nail polishes and other nail care products), lead acetate (used in Grecian Formula 16 hair dye), and ethoxyethanol acetate (used in Anna Sui nail color 105). • One of every ten ingredients approved for use by The Cosmetic Ingredient Review panel shows some evidence of reproductive toxicity in laboratory studies, according to EWG’s assessment of CIR review summaries (CIR 2003), and is approved for use in cosmetics in spite of these studies. Approximately the same fraction of approved ingredients is linked to birth defects and other developmental harms in laboratory studies. For many of the ingredients in CIR 29 (2003), the panel’s review represents the only available comprehensive information on the chemical, given the dearth of government assessments of personal care product ingredients. Because so many of the ingredients reviewed by the CIR show at least some evidence of reproductive and developmental toxicity, it is likely that the accounting of products we describe below is an underestimate of products that may pose concerns for reproduction or a developing child in the womb. Summary of known and probable human reproductive and developmental toxins Dibutyl phthalate (DBP) is an industrial plasticizer and wellestablished reproductive toxin that targets the male reproductive system. DBP has been approved for use in cosmetics by the CIR, first in 1985 and again upon reassessment in 2002 (CIR 2003). DBP will be banned for use in cosmetics in the EU by September 2004. DBP is widely used in nail polishes to impart flexibility to the polish film as it dries on the nail. Toluene is considered a reproductive toxin by the State of California (OEHHA 2004) and the EU (UNECE 2004). In its establishment of a public health goal for toluene in drinking water, California’s Office of Environmental Health Hazard Assessment found that “Studies in animals have shown a clear association of toluene exposure with developmental toxicity” (OEHHA 1999), including reduced fetal weight, and bone growth deficiencies and deformities. Lead acetate is used in progressive hair dye products applied over a period of days for gradual coloring (FDA 2002). Lead acetate dyes continue to be used in Grecian Formula 16 despite the widely acknowledged fact that lead lodges in the brain, causes permanent brain damage, and lingers in the body for decades (e.g., Rice 1995). Most of the evidence for harm centers on the developing brain of a child, with IQ deficits being the most familiar outcome from a large body of literature on lead toxicity. Increasingly, lead is postulated to play a role in diseases of aging, such as Parkinsons, although few studies have been conducted to date (e.g., Gorell et al. 2004). Research shows that lead residues can be spread throughout a home after normal use of the hair dye products (Mielke et al. 1997) 30 In 2002 the CIR concluded that ethoxyethanol acetate was unsafe for use in cosmetics, finding that “numerous reproductive and developmental toxicity studies, across several species, involving various routes of administration, indicate that... Ethoxyethanol Acetate [is a] reproductive toxicant and teratogen [causes birth defects]” (CIR 2003). This ingredient is used in Anna Sui nail color 105. More information on the toxicity of two of these ingredients, dibutyl phthalate and lead acetate, and discussion of their prevalence in personal care products is provided below. Phthalates. Phthalates are industrial plasticizers widely used in personal care products to moisturize and soften skin, to dissolve and coalsesce ingredients, and to impart flexibility to nail polish after it dries. More than two decades ago, scientists began building a body of work indicating that phthalates are reproductive and developmental toxicants in laboratory animals, particularly in males. Early studies focused on phthalates’ ability to cause testicular atrophy (e.g., Gray and Buttersworth 1980), but phthalates are now known to cause a broad range of birth defects and lifelong reproductive impairments in laboratory animals exposed in-utero and shortly after birth targeting every organ in the male reproductive system (e.g., Ema et al 1998, Marsman 1995, Mylchreest et al 1998, 1999, and 2000, Gray et al 1999, Wine et al 1997). In September 2000 scientists from the Centers for Disease Control and Prevention (CDC) reported finding phthalates in every one of 289 people tested, at surprisingly high levels. These tests, considered the first accurate measurements of human phthalate exposures, led to authors to conclude that “from a public health perspective, these data provide evidence that phthalate exposure is both higher and more common than previously suspected” (Blount et al. 2000). The tests showed higher levels of phthalates in women of reproductive age than any other group. CDC postulated that this difference could derive from personal care product exposures, which might vary by gender more than exposures from other common consumer products laden with phthalates (plastic, food wrap, and pharmaceuticals, for example). Since the publication of CDC’s findings, the Environmental Working Group (EWG) has conducted two investigations on the prevalence and levels of phthalates in personal care products. The first, a study titled Beauty Secrets (EWG 2000), reported on the widespread use of dibutyl phthalate in nail polish, at levels up to five percent of product weight. The second, instigated by Healthcare Without Harm in partnership with Women’s Voices for the Earth and EWG, detailed results of a product testing program that found phthalates in nearly three-quarters of a wide range of products tested, despite the fact that none listed the phthalate ingredient on the label (Not Too Pretty, EWG et al. 2002). As these groups documented the common use of phthalates in personal care products, CDC published new results of phthalate 31 testing in more than 2,500 people ages six and above, confirming their original findings: phthalate exposures are widespread across the population, and women are exposed at higher levels than men (with exposures expressed as “creatinine-adjusted,” corrected for urine concentration) (CDC 2003). Cosmetic labelling requirements state that all cosmetics produced or distributed for retail sale to consumers for their personal care bear a list of ingredients, ordered by prevalence (21 CFR 701.3). Cosmetic labeling requirements apply to all cosmetics marketed in the U.S., whether manufactured here or abroad. But industry can use phthalates as components of fragrances or chemical mixtures that are considered “trade secrets,” both of which are exempt from labelling requirents. Industry sources have indicated that phthalates do not appear on the vast majority of products containing them simply because they are components of fragrance and thus exempt from labelling requirements. This gives consumers little power to avoid phthalates in their purchases of personal care products. After the publication of product testing results in Not Too Pretty (EWG et al. 2002), the industry safety panel, the CIR, reviewed available toxicity data for DBP and other phthalates. These ingredients had last been reviewed by the panel in 1985, since which time scientists had conducted the bulk of the research demonstrating phthalates’ reproductive toxicity. At the same time that the E.U. was banning phthalates from use in personal care products (DBP and DEHP), the CIR again found phthalates “safe for use in cosmetic formulations in the present practices of use and concentration” (CIR 2003). The panel made this finding based in part on an exposure estimate proposed by the cosmetic trade association, CTFA, that relied on phthalate testing results for 72 products conducted by public health and environmental groups (EWG et al. 2002). Although CTFA claims as its members 600 companies (CTFA 2004), the organization could find no more comprehensive source of data on phthalate levels in products than that provided by testing paid for by public interest groups, targeting 72 of the presumably thousands of products manufactured by their members. If the industry wishes to retain what FDA calls their “well-established self regulation” (FDA 1995), they might do well to implement an industry-sponsored data collection program instead of relying on others for such data. 32 The industry panel’s assessment fell far short of standard scientific practice. Among other shortcomings, the panel failed to consider the fact that consumers using phthalate-laden cosmetics have a background burden of phthalates in their bodies from other sources of exposure; failed to incorporate in its estimates the significant fraction of women exposed to phthalates at levels exceeding the government’s safe dose, according to CDC’s testing programs (Kohn et al. 2000); failed to collect data on measured concentrations of phthalates in air, particularly in nail salons and rooms with poor ventilation, where inhalation may be a significant source of phrthalate exposure; and failed to consider the ability of penetration enhancers, used in more than half of all personal care products, to increase the absorption of phthalates through the skin. FDA has not produced an independent, public review of the safety of phthalates in cosmetics. Instead the agency has advised consumers that there is “no reason... to be alarmed.” The agency notes that it is conducting its own review to determine if phthalate exposures from cosmetics are a health concern, and that if this review shows “that a health hazard exists, the agency will advise the industry and the public, and will consider its legal options under the authority of the Food, Drug and Cosmetic Act in protecting the health and welfare of consumers” (FDA 2001). Although the industry’s trade group and safety panel have not recommended that phthalates be phased out of cosmetics, many companies have taken the step on their own. Acknowledging requests made by a coalition of public health and environmental groups concerned about reproductive toxins in cosmetics, fifteen companies have now indicated their plans to produce products free of two widely-used phthalates (dibutyl phthalate, or DBP, and diethylhexyl phthalate, or DEHP). This decision is consistent with E.U.-wide reformulation requirements banning their use in cosmetics set to take effect in September 2004. [read more] Health impacts of phthalates. Scientists have shown that phthalates can damage the female reproductive system, but it is the male reproductive system that appears to be more sensitive. Phthalate exposures damage the testes, prostate gland, epididymis, penis, and seminal vesicles in laboratory animals (see, for example, Mylchreest et al. 1998). Most of these effects persist throughout the animal’s life, and include, specifically: • Testicular atrophy — a defect that leads to reduced capacity to form sperm and male sex hormones; • Hypospadias — a defect of the penis in which the opening occurs on the bottom of the penis instead of the tip; • Undescended testicles — a condition in which the testes fail to descend into the scrotal sac during pregnancy; 33 • Ectopic testes — a condition in which testes are grown outside the scrotal sac; • Absent testes — testes are not formed at all; • Absent prostate gland — the prostate gland contributes liquid secretions to semen; • Absent or small seminal vesicles — these structures, like the prostate gland, contribute liquid secretions to semen; • Reduced sperm count — leads to reduced fertility; • Malformed or absent epididymis — the epididymis is the structure where sperm mature and are stored. Trends in human male reproductive health include many of the same effects seen in lab animals dosed with phthalates. Although a cause and effect relationship has not been established, the ubiquity of phthalates in the human population validates the notion that phthalates may be contributing to these problems. Until proven safe, phthalates should be considered as potential contributors to the following human health effects: • Declining sperm count — An analysis of 101 studies (1934-1996) by Dr. Shanna Swan of the University of Missouri confirms results of previous studies: average sperm counts in industrialized countries are declining at a rate of about one percent each year (Swan et al 2000). • Hypospadias — Data from the Centers for Disease Control show that rates of hypospadias in the U.S. began climbing in about 1970, and continued this increase through the 1980s. This condition is a physical deformity of the penis in which the opening of the urethra occurs on the bottom of the penis instead of the tip. Currently the occurrence of hypospadias appears to be stable, at about 30 to 40 cases per 10,000 births (Paulozzi 1999). • Undescended testicles — This birth defect, where testicles fail to completely descend into the scrotum during pregnancy, occurs in two to five percent of full-term boys in Western countries. Rates of the defect increased in the U.S. in the 1970s and 1980s. Men born with this defect are at higher risk for testicular cancer and breast cancer (Paulozzi 1999). 34 • Testicular cancer — This is the most common cancer of young men in many countries, including the U.S. Its incidence continues to increase at a rate of about two to four percent each year in industrialized countries, although rates appear to have stabilized in the U.S. after a 20-year increase. Men with hypospadias, infertility, and undescended testicles — the same constellation of conditions seen in lab animals exposed to certain phthalates — are at greater risk for developing testicular cancer (Toppari et al 1996 and Moline et al. 2000). Lead acetate in hair dye products. Lead acetate is not banned from use in cosmetics by FDA. Instead it is an approved color additive for hair dyes based on an FDA decision rendered in 1980. The CIR has not reviewed lead acetate. We identified lead acetate Table 1. Products that contain parabens. 4,292 (57.3%) products contain parabens. Showing top 20 product categories, ranked by prevalence. �� 35 in Grecian Formula 16 for men. We did not find lead acetate on the label of hair dye products marketed to women, but nothing disallows it use in women’s products, and we assessed just a fraction of hair dye products on the market. Residual lead on an adult’s hands after using the hair dye, and the potential transfer of that lead to children in the household, is a concern regardless of gender. FDA approved lead acetate on the basis of human trials that showed no evidence of significant increases in body lead levels after hair dye use. In its guidance on assessing dermal absorption of lead, the State of California recommends the use of data from a 1980 hair dye absorption study showing that 0.06 percent of radioactive lead in hair dye absorbed into the body after use, based on a “whole body counting” technique, a study now nearly a quarter of a century old. For lead acetate in hair dye, however, research indicates that absorption through the scalp may not be the main route of exposure. In 1997 researchers from Xavier University published a study showing that the use of lead acetate hair dyes results in small amounts of lead being dispersed throughout the house. Lead wipe samples collected after hair dye use found residual lead on the Table 2. Products that contain alkylphenols and alkylphenol ethoxylates. 117 (1.6%) products contain alkylphenols and alkylphenol ethoxylates. Showing top 10 product categories, ranked by prevalence. 36 �� forehead and hands of the test subject, throughout the bathroom and even on the telephone. Lead was easily wiped from the surface of dry hair after dyeing (Mielke et al. 1997). A subsequent legal challenged filed under California’s Proposition 65 resulted in the manufacturers of Grecian Formula 16 agreeing to reduce lead levels in their product by 50 percent (CEH 2004). Even small amounts of lead absorbed into the body might be a concern, given that lead lodges in the brain and remains in the body for decades (ORNL 1994). Exposures would be of particular concern for those using lead acetate hair dyes regularly over periods of years, and are likely a concern for everyone in the household given the evidence that normal use of the product may result in lead being spread throughout the home. Because of concerns about effects of lead exposures for children, FDA requires that lead acetate hair dyes bear the following warning (FDA 2002): Caution: Contains lead acetate. For external use only. Keep this product out of children’s reach. Do not use on cut or abraded scalp. If skin irritation develops, discontinue use. Do not use to color mustaches, eyelashes, eyebrows, or hair on parts of the body other than the scalp. Do not get in eyes. Follow instructions carefully and wash hands thoroughly after use. Ingredients that may harm health by affecting the hormone system. Many common ingredients used in personal care products have the potential to disrupt hormone signaling, the body’s communication system for growth and repair, with potential risks ranging from impaired fertility to cancers of the reproductive system to altered development of a child or a baby in the womb. Much of the evidence for harms from hormonally active chemicals comes from studies of wildlife, or from work conducted in laboratories, but an increasing number of studies raise concerns with respect to human health. A recent study of 168 men found a correlation between reduced sperm motility and sperm concentration with exposures to two phthalate plasticizers used in a range of consumer products, including personal care products (Duty et al. 2003). These plasticizers are potent reproductive toxins in the laboratory. Phthalates are used in an estimated three quarters of all personal care products, raising concerns with respect to potential effects to human reproduction (EWG et al. 2002). 37 Parabens are common preservatives in personal care products, and can mimic estrogen in the body. The potential health risks raised in relation to estrogenic chemicals include breast cancer and altered pregnancy outcomes. Although such links have not yet been studied in human populationssome, these relationships are firmly borne out in laboratory studies. EWG’s assessment of product ingredient labels identified parabens in 57.3 percent of 7,500 products (Table 1). By this assessment, parabens are used in more personal care products than any other synthetic ingredient, and are second only to water in their overall prevalence in products. Despite the cosmetic industry’s contention that parabens are quickly metabolized and excreted from the body (CIR 2003), a recent study identified parabens in human breast cancer tissue, raising obvious questions about the influence these estrogenic chemicals might have on human breast cancer risk (Darbre et al. 2004). Although the cosmetic industry’s self-policing safety panel has not raised concerns with respect the the hormone activity of synthetic ingredients, it has raised such concerns with wild yam root: “One of the primary safety concerns with this plant extract is the possible metabolic/endocrine activity, e.g., estrogen-like or progesterone-like activity as a result of the presence of small amounts of plant phytosterols such as diosgenin” (CIR 2003). Other personal care product ingredients with the potential to disrupt the hormone system include common surfactants known as alkylphenols, and active ingredients in sunscreen that mimic estrogen (Schlumpf et al. 2001) (Tables 2 and 3). Although studies of human populations are few, and have yet to firmly link most hormone disrupting chemicals with health harms, many of the health trends in the population are consistent with the spectrum of effects associated with these widely used ingredients in laboratory studies, including recent declines in sperm quality and recent increases in certain cancers of the reproductive system (see discussion of phthalate toxicity above for more detail). In light of these broad human health trends, consumers may wish to avoid hormone disrupting ingredients in the products they purchase. References Blount BC, MJ Silva, SP Caudill, LL Needham, JL Pirkle, EJ Sampson, GW Lucier, RJ Jackson, JW Brock. (2000). Levels of seven urinary phthalate metabolites in a human reference population. Environmental Health Perspectives. 108(10):979-982. 38 Table 3. Products that contain sunscreens that mimic estrogen. 155 (2.1%) products contain sunscreens that mimic estrogen. Showing top 10 product categories, ranked by prevalence. �� California Department of Toxic Substances and Control (Cal DTSC). (1992). Supplemental Guidance for Human Health Multimedia Risk Assessments of Hazardous Waste Sites and Permitted Facilities. Chapter 7: Assessment of Health Risks from Inorganic Lead in Soil. Accessed online May 10 2004 at http://www.dtsc.ca.gov/ ScienceTechnology/ Supplemental_Guidance.html#contents. Center for Environmental Health (CEH) (2004). Consumer products. Working with Proposition 65. Accessed online May 20 2004 at http://www.cehca.org/consumer.htm. Centers for Disease Control and Prevention (CDC) (2003). Second National Report on Human Exposure to Environmental Chemicals. Available online at http://www.cdc.gov/exposurereport/2nd/. Cosmetics Ingredient Review (CIR) (2003). 2003 CIR Compendium, containing abstracts, discussions, and conclusions of CIR cosmetic ingredient safety assessments. Washington DC. Cosmetics, Toiletry and Fragrance Association (CTFA) (2004). About CTFA. Accessed online May 25 2004 at http://www.ctfa.org/ 39 Content/NavigationMenu /About_CTFA/Overview_of_CTFA/About_ CTFA.htm. Duty SM, Silva MJ, Barr DB, Brock JW, Ryan L, Chen Z, Herrick RF, Christiani DC, Hauser R. (2003). Phthalate exposure and human semen parameters. Epidemiology. 2003 May;14(3):269-77. Darbre PD, Aljarrah A, Miller WR, Coldham NG, Sauer MJ, Pope GS. (2004). Concentrations of parabens in human breast tumours. J Appl Toxicol. 2004 Jan-Feb;24(1):5-13. Ema M, Amano H, Ogawa Y. (1994). Characterization of the developmental toxicity of di-n-butyl phthalate in rats. Toxicology 86:163-174. Ema M, Kurosaka R, Amano H, Ogawa Y. (1995). Comparative developmental toxicity of n-butyl benzyl phthalate and di-n-butyl phthalate in rats. Arch Environ Contam Toxicol 28:223-228(1995). Ema M, Miyawaki E, Kawashima K. (1998). Further evaluation of developmental toxicity of di-n-butyl phthalate following administration during late pregnancy in rats. Toxicol Lett:8793(1998). Environmental Protection Agency (EPA). (1990). Integrated Risk Information System. Dibutyl phthalate, CASRN 84-74-2. October 1990. Available online at http://www.epa.gov/ngispgm3/iris/ Environmental Working Group (EWG) (2000). Beauty Secrets. Does a common chemical in nail polish pose risks to human health? November 2000. Available online at http://www.ewg.org/reports/ beautysecrets/pr.html. Environmental Working Group (EWG), Healthcare Without Harm, and Womens Voices for the Earth (Houlihan, Brody, and Schwan) (2002). Not Too Pretty. Phthalates, beauty products, and the FDA. July 2002. Available online at http://www.ewg.org/issues/ cosmetics and http://www.safecosmetics.org. Food and Drug Administration (FDA). (2002). Lead acetate in hair dye products. Office of Cosmetics and Colors Fact Sheet. January 9 2002. Accessed online May 10 2004 at http://www.cfsan.fda.gov/ ~dms/cos-lead.html. Food and Drug Administration (FDA). (2001). Phthalates and cosmetic products. Office of Cosmetics and Colors Fact Sheet. April 19 2001. Accessed online May 10 2004 at http:// www.cfsan.fda.gov/~dms/cos-phth.html. 40 Food and Drug Administration (FDA) (1995). Cosmetic Ingredients: Understanding the Puffery. FDA Consumer magazine. Originally published May 1992, modified February 1995. Accessed May 18 2004 at http://www.fda.gov/fdac/reprints/puffery.html. Foster PM, BG Lake, LV Thomas, MW Cook, SD Gangolli. (1981). Studies on the testicular effects and zinc excretion produced by various isomers of monobutyl-o-phthalate in the rat. Chem Biol Interact 1981 Mar 1;34(2):233-8. Gorell JM, Peterson EL, Rybicki BA, Johnson CC. (2004). Multiple risk factors for Parkinson’s disease. J Neurol Sci. 2004 Feb 15;217(2):169-74. Gray LE, Jr, Wolf C, Lambright C, Mann P, Price M, Cooper RL, Ostby J. (1999). Administration of potentially antiandrogenic pesticides (procymidone, linuron, iprodione, chlozolinate, p,p’-DDE, and ketoconazole and toxic substance (dibutyland diethylhexyl phthalate, PCB 169, and ethane dimethane sulphonate) during sexual differentiation produces diverse profiles of reproductive malformations in the male rat. Toxicol Ind Health 15:94-118(1999). Gray TJ and Butterworth KR (1980). Testicular atrophy produced by phthalate esters. Arch. Toxicol. Suppl. 1980;4:452-5 Kohn MC, Parham F, Masten SA, Portier CJ, Shelby MD, Brock JW, Needham LL. (2000). Human Exposure Estimates for Phthalates. Environmental Health Perspectives 108(10). Marsman DS. (1995). NTP technical report on toxicity studies of dibutyl phthalate (CAS No. 84-74-2) administered in feed to F344 rats and B6C3F1 mice. NIH Publication 95-3353. Research Triangle Park: National Toxicology Program. Mielke HW, Taylor MD, Gonzales CR, Smith MK, Daniels PV Buckner A (1997). Lead Based Hair Products: Too Hazardous for Household Use. Some hair coloring products sold in pharmacies contain more lead than paint, making them a public health hazard. Journal of American Pharmaceutical Association (NS37, Jan/Feb 1997: 85-89). Available online at http://www.uwsp.edu/geo/courses/ geog100/MielkeHairLead1.htm. Moline JM, Golden A, Bar-Chama N, Smith E, Rauch M, Chapin R, Perreault S, Schrader S, Suk W, Landrigan P. September (2000). Exposure to hazardous substances ad male reproductive health: a research framework. Environmental Health Perspectives. 108(9). Moore, M. R., P. A. Meridith, W. S. Watson, D. J. Summer, M. K. Taylor, and A. Goldberg. (1980). The percutaneous absorption 41 of lead-203 in humans from cosmetic preparations containing lead acetate, as assessed by whole-body counting and other techniques. Food Cosmet. Toxicol. 18: 636. Mylchreest E, Cattley RC, Foster PM. (1998). Male reproductive tract malformations in rats following gestational and lactational exposure to di(n-butyl) phthalate: An antiandrogenic mechanism? Toxicol Sci 43:47-60(1998). Mylchreest E, Sar M, Cattley RC, Foster PMD. (1999). Disruption of androgen-regulated male reproductive development by di(n-butyl) phthalate during late gestation in rats is different from flutamide. Toxicol Appl Pharmacol 156:81-95(1999). Mylchreest E, Wallace DG, Cattley RC, Foster P. (2000). Dosedependent alternations in androgen-regulated male reproductive development in rats exposed to di(n-butyl) phthalate during late gestation. Toxicol Sci(2000). Oak Ridge National Laboratory (ORNL) (1994). Toxicity Profiles. Toxicity Summary for Lead. Available online at http:// risk.lsd.ornl.gov/tox/profiles/lead_c.shtml. Office of Environmental Health Hazard Assessment (OEHHA) (1999). Public Health Goal for Toluene In Drinking Water. Prepared by Office of Environmental Health Hazard Assessment. California Environmental Protection Agency. Pesticide and Environmental Toxicology Section. February 1999. Accessed online May 20 at http://www.oehha.ca.gov/water/phg/allphgs.html. Paulozzi LJ (1999). International trends in rates of hypospadias and cryptorchidism. Environmental Health Perspectives. 107(4). April 1999. Rice, Deborah (1995). Neurotoxicity of Lead, Methylmercury, and PCBs in Relation to the Great Lakes. Environ Health Perspect. 1995 Dec;103 Suppl 9:71-87. Schlumpf M, Cotton B, Conscience M, Haller V, Steinmann B, Lichtensteiger W. (2001). In vitro and in vivo estrogenicity of UV screens. Environ Health Perspect. 2001 Mar;109(3):239-44. Swan SH, Elkin EP, Fenster L. (2000). The question of declining sperm density revisited: An analysis of 101 studies published 1934-1996. Environmental Health Perspectives. 108(10). October 2000. 42 Toppari, J, Larsen JC, Christiansen P, Giwercman A, Grandjean P, Guillette Lj Jr, Jegou B, Jensen, TK, Jouannet P, Keiding N, Leffers H, McLachlan JA, Meyer O, Muller J, Meyts, E R-D, Scheike T, Sharpe R, Sumpter J, Skakkebaek NE. (1996). Male reproductive health and environmental xenoestrogens. Environmental Health Perspectives. 104. Supplement 4. United Nations Economic Commission for Europe (UNECE) (2004). The Globally Harmonized System of Classification and Labelling of Chemicals (GHS). http://www.unece.org/trans/danger/publi/ghs/ officialtext.html. (Part 3: Health and Environmental Hazards) Wine R, Li LH, Barnes LH, Gulati DK, Chapin RE. (1997). Reproductive toxicity of di-n-butyl phthalate in a continuous breeding protocol in Sprague-Dawley rats. Environ Health Perspect 105:102-107 91997). 43 44 Part 3: Safety Recommendations Ignored The cosmetic industry is sensitive to the image of an uncontrolled market where anything goes... They counter this image with well-established self-regulation programs. Part of the incentive for such industry policy is to avoid increased regulatory authority. – Director of FDA’s Office of Cosmetics and Colors (FDA 1995) In a systematic comparison of recommendations from the personal care product industry’s self-regulatory health and safety panel, the CIR, with ingredient uses in 7,500 personal care products, EWG has found that the industry routinely ignores the advice of its own panel: • One of every 140 products (54 products) violates industry panel safety recommendations, including products by Neutrogena, Desitin, Herbal Essences, and Rite Aid (Table 1). • Industry violations encompass 16 ingredients in 54 products found unsafe by the CIR, including ingredients found safe only in products rinsed off the skin but used in lotion and acne treatments, and ingredients found unsafe for use on infant skin found in diaper creams (Table 2). The safety violations each involve an ingredient contained in products used in ways the CIR recommends against. The 17 violating ingredients fall in the following categories in CIR assessments, and are contained in products intended for these same “unsafe” purposes: unsafe in any cosmetic product (found in nail polish and face masks), unsafe for use on skin (found in acne treatment), safe only in products rinsed off of skin immediately after use (found in moisturizers and skin depigmenting products), unsafe for use on infant skin (found in diaper cream and baby lotions), unsafe for use on injured or damaged skin (found in lotions for chapped and dry skin), unsafe in products that are aerosolized (found in spray products), and contains ingredients 45 Table 1. 54 products violate recommendations of industry’s self regulating health and safety panel Some products appear in multiple safety violation categories. �� that combine to form carcinogenic nitosamines (found in moisturizer) (Table 2). Two ingredients are discussed below. 46 The Cosmetic Ingredient Review (CIR) panel, funded by the industry’s trade association (the Cosmetic Toiletry and Fragrance Association), is the only body in the U.S. that systematically considers the safety of cosmetic ingredients. They fill a void typically occupied by government toxicologists for other major sources of human exposures to industrial chemicals, including contaminants in food, air, and water. According to FDA’s Director of the Office of Cosmetics and Colors, “In the absence of the CIR program, there would be no systematic examination of the safety of individual cosmetic ingredients” (FDA 1995). The cosmetic industry safety panel has found more than 99 percent of all reviewed ingredients safe for use in cosmetics. An assessment of the panel’s ingredient review compendium (CIR 2003) shows that this decision is sometimes rendered in the absence of basic toxicity data and other times in spite of the availability of studies suggesting the potential for serious health outcomes — evidence of increased risks for cancer or birth defects, for example. The panel routinely considers evidence on skin reactions to the near exclusion of other effects in forming its conclusions. The high rate at which the panel approves ingredients may be driven in part by shortcomings in the scientific rigor of reviews, or by the inherent conflict in panel members being paid by the industry whose products they are reviewing. But given what appears to be the relative laxity of many safety reviews, it is all the more surprising that the cosmetics industry routinely violates the recommendations of the panel. Examples of ingredients used in violation of panel recommendations are discussed below. Boric acid and sodium borate. Boric acid and sodium borate are used in diaper creams and baby lotions, including Balmex and Desitin products. The CIR determined these ingredients should not be used on infant skin because “...in rare instances, the application of Boric Acid powder to a diaper rash has been reported to cause fatality” (CIR 2003). It may be that the baby products EWG identified (Table 1) contain very low concentrations of these ingredients. It does not seem likely that these products could be causing fatalities that have gone unreported and unnoticed by the government. Nevertheless, it may be desirable for the companies using these ingredients to reformulate, considering the panel’s standing recommendations and the severity of the reported risks. Hydroquinone. The CIR determined that hydroquinone should not be used in non-drug cosmetic products that are left on the skin and not immediately rinsed off. The panel drew this conclusion based on studies linking hydroquinone to cancer and immune system damage that targets bone marrow. This review constitutes one of the few cases for which effects other than skin reactions informed the panel’s conclusions. EWG identified hydroquinone on ingredients lists of 18 products left on the skin, most designed as depigmenters or skin lighteners. Based on the listing of hydroquinone as an “active ingredient” on ingredient labels, a requirement for drugs sold in the U.S., it appears that 15 of these products are sold as drugs, falling outside the purview of the CIR recommendations. Three products containing hydroquinone appear to be sold as cosmetics, not drugs, and therefore violate CIR recommendations (Table 1). The potential risks posed by 47 either the “drug” or “cosmetic” versions of these products would be driven by the amounts of hydroquinone in the product, and by how readily hydroquinone is absorbed through the skin, a factor that varies based on product formulation and that is higher for products that contain alcohol (CIR 2003). References Cosmetics Ingredient Review (CIR) (2003). 2003 CIR Compendium, containing abstracts, discussions, and conclusions of CIR cosmetic ingredient safety assessments. Washington DC. Food and Drug Administration (FDA) (1995). Cosmetic Ingredients: Understanding the Puffery. FDA Consumer magazine. Originally published May 1992, modified February 1995. Accessed May 18 2004 at http://www.fda.gov/fdac/reprints/puffery.html. 48 Table 2. 16 ingredients are used in products that violate safety standards �� 49 50 Part 4: Impurities of concern in personal care products Indeed, it has been demonstrated that nitrosamines are carcinogenic in more animal species than any other category of chemical carcinogen. (DTI 1998) Clearly, it appears that [nitrosamines] can be formed during storage, once a product has been opened. — U.K. Department of Trade and Industry, Cosmetic contamination study (DTI 1998) In a 1998 personal care product testing program, a European government agency found carcinogenic impurities in 43 percent of 128 products tested (DTI 1998), including baby lotion and shampoo, sunscreen, and liquid soap. This study, focused on the family of carcinogenic chemicals called N-nitrosamines, joins other government and industry studies showing that harmful impurities can commonly contaminate cosmetic products (see, for example, CIR 2003 and FDA 2000a,b). Government and industry sources reveal 24 industrial chemicals or groups of chemicals identified as potential impurities in a wide range of products, with health concerns spanning cancer, neurotoxicity, and reproductive problems (CIR 2003, FDA 2000a,b, UNECE 2004). The certainty of these impurities’ presence in cosmetics ranges widely, from speculation — reflected in the industry safety panel setting limits on residues of arsenic, mercury, PCBs and pesticides in cottonseed acid, for example — to complete confirmation, such as the established presence of carcinogenic nitrosamines in a wide range of personal care products. An EWG analysis of government and industry sources (CIR 2003, FDA 2000a,b, UNECE 2004) shows that at least 146 cosmetic ingredients may contain harmful impurities linked to cancer and other serious health impacts (Tables 1 and 2), including 3 of the top 20 most commonly used cosmetic ingredients (Table 3). Our analysis of ingredients in 7,500 personal care products shows that because some of these ingredients are used so widely, the vast majority of products on the market have the potential to 51 be contaminated with impurities. None of these impurities is regulated by the federal government: • Nearly seventy percent of all products assessed contain ingredients that can be contaminated with impurities linked to cancer and other health problems, including more than 80 percent of all lip balms and baby bath products (Table 1). • Many common impurities readily absorb through the skin. FDA notes that the carcinogenic cosmetic impurity acrylamide is “rapidly absorbed through the skin” (FDA 2004a); that dioxane, a potential impurity in a wide range of ethoxylated cosmetic ingredients, “readily penetrates animal and human skin” (FDA 2000); and that the common family of impurities called nitrosamines also “penetrate the skin” (FDA 2000a). Sources and prevalence of impurities. Unwanted impurities in cosmetic products can be manufacturing residuals, breakdown products from cosmetic ingredients, environmental contaminants in the case of plant-derived ingredients, or what are called “unreacted monomers,” the small building blocks of the large polymer ingredients common in cosmetics. Potential health harms associated with impurities can dwarf those linked to the product ingredients themselves, but are mitigated by the typically low levels of impurities in the products. In their cosmetic ingredient review summaries, the industry safety panel notes concerns over potential impurities for about one of every 10 ingredients assessed. Likewise, in 10 percent of cases for which the panel has recommended concentration limits for chemicals in cosmetics, the limits have been set for impurities, not for the ingredient under review (CIR 2003). Of the four product concerns for which FDA explicitly requests direct contact from imported cosmetic inspectors, three are related to harmful impurities in the products (FDA 2000b). Cosmetic industry polices the purity of its own products. Some manufacturers buy ingredients certified by an independent organization called United States Pharmacopeia (USP). These ingredients may contain lower levels of harmful impurities, but the criteria for certification are not public. There are no federal standards for ingredient purity. While is seems likely that some companies purchase or manufacture refined, purified ingredients, it is equally likely that many do not. Consumers and government health officials have no way to know. 52 Because the purity of cosmetic ingredients is not regulated by federal law, product purity has become a business decision. Companies can weigh the cost of purchasing purified or certified ingredients against the potential liability of selling products that may contain carcinogenic impurities. Liabilities are low: cancer typically has a long latency period, and a doctor can rarely trace the disease back to particular exposures. Although some studies show evidence that actions taken by industry have reduced levels of some impurities over the past 25 years (Matyska et al. 2000), recent testing programs undertaken by FDA and European agencies show that the use of impure ingredients by the industry is still common (FDA 1996, DTI 1998). Table 1. Products that may be contaminated with impurities. 5,205 (69.5%) products may be contaminated with impurities. Showing top 20 product categories, ranked by prevalence. �� 53 Table 2. Products that may be contaminated with impurities, by impurity type. 54 �� It is clear from a review of ingredient assessment summaries published by the Cosmetic Ingredient Review that the industry panel routinely approves ingredients in the absence of impurity data. In a review of a large class of surfactants called ceteareths, for example, the panel stressed “the importance of purification procedures to remove... impurities” noting that “...in the absence of impurities data, the Panel caution[s] that a Ceteareth preparation should not contain 1,4-dioxane or ethylene oxide which are possible oxidation products” (CIR 2003). In another case the panel assumed industry would limit levels of acrylic acid and methacrylic acid impurities in acrylate polymer ingredients after learning that the impurities smell bad, an incentive for industry to keep levels low (CIR 2003). Two of the impurities commonly found in cosmetic ingredients are discussed below. 1,4-dioxane. The Environmental Protection Agency considers 1,4dioxane a probable human carcinogen, based of the “induction of nasal cavity and liver carcinomas in multiple strains of rats, liver carcinomas in mice, and gall bladder carcinomas in guinea pigs” (EPA, 2003). In a review conducted in 1982, the Cosmetic Ingredient Review panel noted that the cosmetic industry was “aware of the problem” of the presence of the 1,4-dioxane in cosmetics and was “making an effort to lower or remove 1,4dioxane in cosmetics” (CIR 2003, review of choleth-24). But 18 years later, FDA expressed continuing concerns about 1,4-dioxane, noting its potential to contaminate a wide range of products, its ready penetration through the skin, and the evidence linking it to systemic cancer in a skin painting study (FDA 2000). FDA notes that 1,4-dioxane can be removed “by means of vacuum stripping at the end of the polymerization process without an unreasonable increase in raw material cost” (FDA 2000), but such treatment would be voluntary on the part of industry. A consumer could identify products with potential 1,4-dioxane contamination by scanning product labels for the common ethoxylated surfactants that may contain the impurity, which according to FDA are identifiable by the prefix, or by the designations, of ‘PEG,’ ‘Polyethylene,’ ‘Polyethylene glycol’ ‘Polyoxyethylene,’ ‘–eth–,’ or ‘–oxynol–’ (FDA, 2000). Nitrosamines. FDA began analyzing personal care products for the carcinogenic impurities known as nitrosamines as early as 1979. In tests of 300 products between 1979 and 1980 the agency identified a nitrosamine called N-nitrosoethanolamine (NDELA) at levels up to 150 parts per million (ppm). The agency published a notice in the Federal Register of April 10, 1979 (44 FR 21365) warning the cosmetics industry that products containing 55 nitrosamines may be considered adulterated and subject to enforcement action. In a testing program 12 years later, the agency found that maximum levels had dropped 50-fold, to three ppm (Matyksa et al. 2000). And in a European agency study published in 1998, maximum levels of total N-nitroso compounds, including NDELA and related chemicals, had fallen to less than one ppm (DTI 1998). Despite the apparent reduction in nitrosamine levels achieved by industry over the past quarter century, FDA remains concerned about nitrosamine impurities, because of the solid evidence linking these chemicals to cancer, and because of their ready absorption through the skin: FDA has urged cosmetic manufacturers to voluntarily remove from cosmetics any ingredient which may combine with others to form NDELA and to conduct additional testing to determine why cosmetics become contaminated with NDELA. –– USFDA Office of Cosmetics and Colors, 1996 According to scientists from San Jose University, the common nitrosamine impurity NDELA “is readily absorbed through the skin and accumulates in organs, such as the liver, bladder, etc. where it induces chronic toxic effects” (Matyska et al. 2000). The International Agency for Research on Carcinogens has found that nitrosamines are carcinogenic in all animal species studied, including primates. No other carcinogen has been found to be carcinogenic in as many species as nitrosamines. (IARC, 1978; 1982; 1985; 1987). It may be the case that industry has developed methods to lower nitrosamine levels in newly-manufactured products, but recent studies suggest that industry’s persistence in using nitrosamine precursors in a wide range of products guarantees that the products will become contamined with nitrosamines during a period of normal use, as the precursors react with other chemicals to form nitrosamines. Our analysis shows that one of every 10 products on the market contains ingredients that can combine with other chemicals to form nitrosamines. Notably, a study sponsed by the U.K. Department of Trade and Industry found that nitrosamine levels in some products had more than doubled four months after the product was opened, and increased by more than four-fold over 17 months (DTI 1998). 56 Breast cancer and impurities. EWG’s assessment of product ingredient labels and data on cancer-causing chemicals identified three common impurities in personal care products that are linked to mammary tumors in animal studies — ethylene oxide, PAHs, Table 3. Top 10 ingredients with impurity concerns, by prevalence of use. �� and 1,3-butadiene. The ingredients for which these impurities are of concern are used in one of every four personal care products on the market (Table 4). Among girls born today, one in eight is expected to get breast cancer and one in 30 is expected to die from it (NCI 1996, 1997, 2000). A review by scientists from Lawrence Berkeley National Laboratory shows that as many as one of every five chemical carcinogens causes mammary tumors in laboratory studies, indicating that the breast is more sensitive to carcinogens than almost any other tissue in the body (Gold et al. 1991). EWG’s identification of three impurities linked to breast cancer does not represent a full accounting of possible mammary carcinogens in personal care products. Instead, it is a partial accounting based on the National Toxicology Program’s assessment of mammary carcinogens (NTP 2000) and other sources in the peerreviewed literature. Further study would likely identify additional ingredients in personal care products that raise concerns with respect to breast cancer. • PAHs. PAHs, or polycyclic aromatic hydrocarbons, are common contaminants in petrolatum, also called petroleum jelly and sold under well-known brand names 57 Table 4. Products that might contain impurities linked to breast cancer. 1,974 (26.3%) products might contain impurities linked to breast cancer. Showing top 20 product categories, ranked by prevalence. 58 �� like Vaseline. Petrolatum is found in one of every 14 products on the market (7.1 percent of the products assessed by EWG), including 15 percent of all lipstick and 40 percent of al baby lotions and oils. FDA restricts petrolatum in food to no more than 10 parts per million, and requires petrolatum used in food packaging or drugs to meet impurity restrictions for PAHs (21 CFR 178, 21 CFR 172.880). But the agency allows any amount of petrolatum of any purity in personal care products, many of which are applied directly to the lips and swallowed. Manufacturers would find no legal impediments to using the same unregulated petrolatum in personal care products as can be used in shoe polish. Among the studies linking the petrolatum impurity PAHs to breast cancer is a Columbia University study in which researchers found that the breast tissue of women with breast cancer was 2.6 times more likely to contain elevated levels of PAHs bound to DNA (called DNA adducts) than the breast tissue of women without breast cancer (Rundle et al. 2000). The National Toxicology Programs finds that some PAHs are reasonable anticipated to be human carcinogens, and the State of California lists a number of PAHs as carcinogens in its Proposition 65 program (NTP 2002, OEHHA 2004). Petrolatum is listed as a probable human carcinogen in the European Union’s Dangerous Substances Directive (UNECE 2004), and its use in cosmetics will be banned by September 2004 with the following caveat: “The classification as a carcinogen need not apply if the full refining history is known and it can be shown that the substance from which it is produced is not a carcinogen.” Chemical industry sources have interpreted this clause to mean that petrolatum will continue to be allowed in cosmetics in the EU if it is refined and meets PAH purity standards for food set by FDA (Faust and Casserly 2003). Even this purity standard does not set direct limits on PAH content, but instead relies on a light absorption test as an indirect indicator of contamination. In the U.S. no requirement for refinement applies for petrolatum in personal care products. Some manufacturers likely choose refined petrolatum low in PAHs, but perhaps some do not. Product labels do not uniformly show the “USP” certification on the petrolatum listing 59 in EWG’s ingredient label database, and in any event, the certification criteria for a USP listing are not public. Some product labels include the term “skin protectant” in parentheses after the petrolatum listing, an indication that the petrolatum has been refined and meets FDA requirements for drug applications. But in most cases a consumer buying a product containing petrolatum has no way to know if the ingredient is low in carcinogenic PAHs or not. • Ethylene oxide. Ethylene oxide can be an impurity in one of every four personal care products on the market, judging from the prevalence of the common ingredients associated with ethylene oxide impurities (ethoxylated surfactants). Ethylene oxide shows “clear evidence” of carcinogenicity in the mammary glands of both male and female test animals, according to the National Toxicology Program (NTP 2000). Ethylene oxide would be expected to occur in tandem with the carcinogenic impurity 1,4-dioxane, also a residual contaminant in common personal care product surfactants. According to FDA, a consumer could identify products with these potential contaminants by scanning product labels for the common ethoxylated surfactants that may contain the impurity, identifiable by the prefix, or by the designations, of ‘PEG,’ ‘Polyethylene,’ ‘Polyethylene glycol’ ‘Polyoxyethylene,’ ‘–eth–,’ or ‘–oxynol–’ (FDA, 2000). The industry’s safety panel, the CIR, routinely raises the spectre of ethylene oxide impurities in its safety reviews, but in nearly every case lacks the data that would allow for an assessment of health concerns. In their review of product ingredients known as oleths, the panel merely noted its concerns about ethylene oxide in its review findings: “Of concern was the possible presence of 1,4dioxane and ethylene oxide impurities. The importance of using the necessary purification procedures to remove these impurities was stressed” (CIR 2003). 60 In another case, the CIR was provided data from industry showing that ethylene oxide levels in cosmetic ingredients called nonoxynols range up to 12.2 parts per million. The panel compared the dose of ethylene oxide estimated from cosmetics exposures against allowable daily doses for people exposed to the same chemical as a residue on medical equipment, from a private standardsetting body called the International Organization for Standardization. Finding the estimated dose from cosmetics to be lower than the allowable dose from medical equipment, the panel then determined that “the use of a cosmetic product only in excessive amounts could yield [the] level of exposure” found to be of concern for medical devices (CIR 2003). This, the panel’s most rigorous assessment of ethylene oxide occurrence in cosmetics, relies on safe doses derived from a private organization setting voluntary standards for medical equipment. Ethylene oxide is fairly volatile and might be easily stripped from ingredients in purification processes. FDA notes that its companion impurity 1,4-dioxane “may be removed from ethoxylated compounds by means of vacuum stripping at the end of the polymerization process without an unreasonable increase in raw material cost” (FDA 2000). Such a process would also likely removed ethylene oxide, but no such treatment is required for personal care product ingredients. Levels of ethylene oxide are not restricted in products, so consumers have no ability to know if they are purchasing items free of ethylene oxide or not. • 1.3-butadiene. 1,3-Butadiene is a potential impurity in butane (also called n-butane), a propellant used in aerosol personal care products (CIR 2003). CIR’s safety review of butane in personal care products fails to mention the potential for 1,3-butadiene impurities, but in the EU, butane will be banned from use is cosmetics by September 2004 if impurity levels exceed 0.1 percent. 1,3-Butadiene shows “clear evidence” of carcinogenicity in the mammary glands of both male and female test animals, according to the National Toxicology Program (NTP 2000), and is listed as an ingredient in 198 personal care products assessed by EWG. 61 References Cosmetics Ingredient Review (CIR) (2003). 2003 CIR Compendium, containing abstracts, discussions, and conclusions of CIR cosmetic ingredient safety assessments. Washington DC. Department of Trade and Industry, UK (DTI) (1998). A survey of cosmetic and certain other skin-contact products for nnitrosamines. Environmental Protection Agency (2003). 1,4-Dioxane (CASRN 123-91-1). Integrated Risk Information System. Available online at http://www.epa.gov/IRIS/subst/0326.htm Updated on November 7th, 2003. Faust HR and EW Casserly (2003). Petrolatum and Regulatory Requirements. Penreco. NPRA International Lubricants & Waxes Meeting, November 13-14, 2003, Houston, TX. Accessed online May 17 2004 at www.penreco.com/newsevents/tradearticles/ NPRA2003_Pet_Regulations.pdf. Food and Drug Administration (FDA) (1996). Are nitrosamines in cosmetics a health hazard? Office of Cosmetics and Colors, FDA/ CSFAN. Accessed online May 6 2004 at http://vm.cfsan.fda.gov/ ~dms/qa-cos25.html Updated November 1996. Food and Drug Administration (FDA) (2000). Prohibited Ingredients and Related Safety Issues. Office of Cosmetics and Colors Fact Sheet. March 30, 2000. Accessed online May 20 2004 at http://www.cfsan.fda.gov/~dms/cos-210.html. Food and Drug Administration (FDA) (2000a). Office of Cosmetics and Colors. Prohibited Ingredients and Related Safety Issues. March 30 2000. Accessed online May 12 2004 at http:// www.cfsan.fda.gov/~dms/cos-210.html Food and Drug Administration (FDA) (2000b). Center for Food Safety Applied Nutrition. Cosmetics Compliance Program. Imported Cosmetics Program. Issued December 8, 2000. Chapter 29 — Cosmetics and Color Technology. Accessed online May 12 2004 at http://vm.cfsan.fda.gov/~comm/cp29002.html. Food and Drug Administration (FDA) (2004). In Vitro Percutaneous Absorption of Acrylamide and Styrene in Human Skin From Cosmetic Vehicles M. E. Kraeling, R. L. Bronaugh, Office of Cosmetics and Colors, USFDA, Laurel, MD. 2004 FDA Science Forum. Abstract available online at http://www.cfsan.fda.gov/ ~frf/forum04/D-20.htm. 62 Gold LS, Slone TH, Manley NB, Garfinkel GB, Hudes ES, Rohrbach L, Ames BN. (1991). The Carcinogenic Potency Database: analyses of 4000 chronic animal cancer experiments published in the general literature and by the U.S. National Cancer Institute/ National Toxicology Program. Environ Health Perspect. 1991 Dec;96:11-5. Havery, D.C. and Chou, H.J. (1994a) N-nitrosamines in cosmetic products. Cosmetics and Toiletries 109, 53. Havery, D.C. and Chou, H.J. (1994b) Nitrosamines in sunscreens and cosmetic products: occurrence, formation and trends. In Nitrosamines and related N-nitroso compounds (Loeppky, R.N. and Michejda, D.J., Eds) ACS Symposium Series 553. Washington, DC. Hecht, S.S. (1998) N-Nitrosamines In Environmental and Occupational Medicine, 3rd Ed. (Rom, W.N., Ed) Lippincott-Raven Publishers, Philadelphia. International Agency for Research on Carcinogens (IARC) (1978). IARC Monograph. The evaluation of the carcinogenic risk of chemicals to humans Some N-Nitroso compounds. International Agency for Research on Carcinogens (IARC) (1982). N-Nitroso compounds: occurrence and biological effect. Sci. Publ. No. 41. International Agency for Research on Carcinogens (IARC) (1985). IARC Monograph. The evaluation of the carcinogenic risk of chemicals to humans Tobacco habits other than smoking, betelquid, areca-nut chewing and some related nitrosamines. International Agency for Research on Carcinogens (IARC) (1987). The relevance of N-nitroso compounds to human cancer: exposure and mechanisms. Sci. Publ. No. 84. Matyska MT, Pesek JJ, Yang L. (2000). Screening method for determining the presence of N-nitrosodiethanolamine in cosmetics by open-tubular capillary electrochromatography. J Chromatogr A. 2000 Jul 28;887(1-2):497-503. National Cancer Institute (NCI) (1996). SEER Cancer Statistics Review. 1973-1996. Available online at http:// www.seer.ims.nci.nih.gov/Publications/CSR1973_1996/. National Cancer Institute (NCI) (1997). SEER Cancer Statistics Review. 1973-1997. Available online at http:// www.seer.ims.nci.nih.gov/Publications/CSR1973_1997/. 63 National Cancer Institute (NCI) (2000). Overview of the SEER Cancer Statistics Review, 1973-1999 (overview in a single PDF file). Available online at http://seer.cancer.gov/csr/1973_1999/ sections.html#overview. National Toxicology Program (2002). Report on Carcinogens, Tenth Edition; U.S. Department of Health and Human Services, Public Health Service, National Toxicology Program, December 2002. Available online at http://ehp.niehs.nih.gov/roc/toc10.html. National Toxicology Program (2004). Chemicals Associated with Site-Specific Tumor Induction in Mammary Gland. Available online at http://ntp-server.niehs.nih.gov/htdocs/Sites/MAMM.Html. Office of Environmental Health Hazard Assessment (OEHAA) (2004). State of California Environmental Protection Agency. Chemicals known to the state to cause cancer or reproductive toxicity. http://www.oehha.ca.gov/prop65/prop65_list/files/ 41604list.html. Rundle A, Tang D, Hibshoosh H, Estabrook A, Schnabel F, Cao W, Grumet S, Perera FP. (2000). The relationship between genetic damage from polycyclic aromatic hydrocarbons in breast tissue and breast cancer. Carcinogenesis. 2000 Jul;21(7):1281-9. United Nations Economic Commission for Europe (UNECE) (2004). The Globally Harmonized System of Classification and Labelling of Chemicals (GHS). http://www.unece.org/trans/danger/publi/ghs/ officialtext.html. (Part 3: Health and Environmental Hazards) 64 65 66 Part 5: Penetration Enhancers One long-standing approach for improving [absorption through skin] uses penetration enhancers (also called sorption promoters or accelerants) which penetrate into skin to reversibly decrease the barrier resistance. — Scientists with the School of Pharmacy, University of Bradford, UK (Williams and Barry 2004) ...Bisabolol is a penetration enhancer... Noting that Bisabolol is used in baby lotions the Panel cautioned formulators to the possibility of increased absorption of other ingredients also contained in the formulation, especially those ingredients whose safety is based on their lack of dermal absorption. – Cosmetic industry safety panel, the Cosmetic Ingredient Review (CIR 2003) For more than 20 years drug companies have used penetration enhancing chemicals to deliver patch drugs like birth control and nicotine deeper and faster through the skin and into the blood vessels below. In some cases penetration enhancers increase absorption of a drug by 100-fold relative to absorption without the enhancer (Karande et al. 2004). Although not necessarily added to cosmetics for the purpose of enhancing penetration, many ingredients used in cosmetics happen to have that property. A recent review of penetration enhancers by scientists at the Drug Delivery Group at the University of Bradford, West Yorkshire, UK, notes common cosmetic chemicals that are used in drug delivery applications (propylene glycol and sodium lauryl sulfate, for example) (Williams and Barry 2004). The cosmetic industry’s safety panel has acknowledged the use of penetration enhancers in cosmetics, and warns the industry to consider their effect in combination with ingredients the panel deemed safe based on an assumption of low absorption. 67 Table 1. Penetration enhancers are found in products that contain known or probable carcinogens. 50 (0.7%) products contain penetration enhancers in combination with known or probable carcinogens. There are also 71 hair dye products contain penetration enhancers in combination with coal tar dyes. 68 �� Table 2. Penetration enhnacers are found in products that contain known or probable reproductive toxins. 7 products contain penetration enhancers in combination with known or probable reproductive toxins. Health concerns with penetration enhancers do not necessarily revolve around the toxicity of the enhancer itself, but instead with what it brings with it as it opens the skin up for greater absorption. In our assessment of 7,500 personal care products, we found that penetration enhancers are used in products that also contain ingredients with significant potential health concerns: • Fifty-six percent of 7,500 products examined contain ingredients that are penetration enhancers, according to data presented in CIR (2003) and peer-reviewed sources. • 50 products contain penetration enhancers in combination with known or probable human carcinogens (Table 1). • 7 products contain penetration enhancers in combination with known or probable reproductive toxins (Table 2). • 120 products contain penetration enhancers in combination with chemicals considered safe for use in cosmetics in part because of assumed low absorption through the skin (Table 3). 69 References Cosmetics Ingredient Review (CIR) (2003). 2003 CIR Compendium, containing abstracts, discussions, and conclusions of CIR cosmetic ingredient safety assessments. Washington DC. Karande Pankay, A. Jain, S. Mitragotri (2004). Discovery of transdermal penetration enhancers by high-throughput screening. Nature Biotechnology 22(2). February 2004. Williams, A.C. and Barry, B.W. (2004). Penetration Enhancers. Adv. Drug Deliv. Rev. 56, 603-618. 70 �� Table 3. Penetration enhancers are found in products containing ingredients deemed safe for use in cosmetics (CIR 2003) in part because of an assumption of low absorption through the skin. 1.6% (120) products contain penetration enhancers in combination with ingredients deemed safe for use in cosmetics in part because of an assumption of low absorption through the skin. 71 72 Part 6: Unstudied Ingredients The Expert Panel noted the marked absence of safety data specifically on Isostearamide DEA and MEA, Myristamide DEA and MEA, and Stearamide DEA and MEA. – Industry safety panel, the Cosmetic Industry Review, commenting on the lack of data available for all six chemicals under review before finding them all “safe for use” in cosmetics (CIR 2003) Since its inception in 1976, the cosmetic industry’s self-regulating safety panel, the Cosmetic Ingredient Review (CIR), has met an estimated 112 times and reviewed 1,175 cosmetic ingredients (CIR 2004a, CTFA 2004, CIR 2003). Despite the notably prodigious output of the panel, the reviews fall far short in both quantity and quality relative to what would be needed for an industry striving to ensure a high degree of health protection for consumers. An analysis of industry safety panel meeting schedules, summary panel review documents, and statistics on ingredient use in the cosmetic industry from FDA shows: • The CIR has assessed at most just 11 percent of the 10,500 ingredients found by FDA to be used in cosmetics (FDA 2000, CTFA 2004). • The CIR has spent an average of one hour and ten minutes deliberating the use, toxicity, and safety of each ingredient reviewed over its three decade history. [see note 1] • The CIR has found just nine of 1,175 ingredients unsafe for use in cosmetics. EWG identified two of these nine ingredients in products currently on the market. • Just 28 of the 7,494 products we analyzed list only ingredients that have been fully assessed for safety by the cosmetic industry’s self-regulating panel, the Cosmetic Ingredient Review (CIR) [link]. All other products — 99.6 percent of those examined — contain one or more ingredients never assessed for potential health impacts by the CIR. A further analysis of the panel’s reviews in relation to ingredients 73 Table 1: 17 of the 50 most prevalent ingredients in cosmetics have not been studied by the industry’s safety panel. 74 �� in 7,500 products from EWG’s ingredient label database shows that the CIR has failed to review one-third of the top 50 ingredients used in cosmetics (Table 1). These range from ingredients of little health concern for cosmetic uses (common table salt, for instance) to chemicals posing potential cancer risks (talc and silica). Our analysis of product labels also shows that of the 1,175 ingredients reviewed by the industry panel, half are not used in cosmetics. Clearly, consumers will see health benefits from safer products only if the panel reviews ingredients currently used by the industry. In FDA’s own words, the agency “cannot require companies to do safety testing of their cosmetic products before marketing” (FDA 1995). The government’s lack of authority to require testing makes the reviews of the industry safety panel critical for ensuring that cosmetic products are not harming health. That the industry panel has reviewed so few of the ingredients used in cosmetics raises obvious questions about the safety of products used by millions daily. For many of the ingredients the CIR has chosen to review, the cosmetic industry has failed to conduct even the most basic toxicity tests, and the panel has been unable to assess the ingredients’ safety: • For one of every 10 ingredients reviewed the CIR was unable to determine if the ingredient was safe for use in cosmetics or not (CIR 2003) and rendered a finding of “insufficient data.” • Nearly one of every 20 products (4.7 percent) contains one or more ingredients that the CIR found had insufficient testing data to support the ingredients’ safe use in cosmetics (Table 2). Under federal law if the safety of a cosmetic product has not been substantiated, the product’s label must read: “WARNING: The safety of this product has not been determined” (FDA 1995). A partial analysis of product labels did not identify any such warnings on the products in EWG’s database containing ingredients with insufficient data. Unless they have conducted or uncovered studies that fill the data gaps identified by the CIR, and these studies show the product is safe, the manufacturers of these products may be in violation of federal law. The following data were not available for [six Carbomers]: (1) exact structural composition; (2) details of manufacturing process; (3) analytical methods; (4) potential interactions with 75 other ingredients; (5) absorption; (6) metabolism; (7) excretion; (8) terateogenesis; (9) mutagenesis; and (10) carcinogenesis. –– Industry safety panel, the Cosmetic Industry Review, noting nearly complete lack of data for six cosmetic ingredients before finding them “safe as used” based on skin irritation and allergy data (CIR 2003) Ingredients approved with little consideration of cancer or reproductive risks. In a detailed assessment of ingredient review findings in CIR’s 2003 Compendium (CIR 2003), EWG determined that the panel fails in whole to discuss any available data with respect to cancer and mutagenicity, birth defects, and other reproductive risks, for more than half of all ingredients approved by the panel (642 of 1,166 ingredients approved). This may indicate that the panel approved these chemicals in the complete absence of such data, or it may reflect the fact that issues of skin irritation and sensitization (allergic reactions) dominate panel discussions and findings, a health endpoint that directly impacts product sales. (A detailed survey of approximately one-third of the panel’s ingredient reviews in CIR (2003) shows that CIR has chosen sensitization and the related effect of irritation as the basis for approximately 80% of its safety decisions, to the near total exclusion of other health impacts.) Unfortunately, detailed CIR scientific literature review documents that underpin panel decisions are only available for a fee, making difficult the task of understanding in full the data gaps faced by the panel. According to publication listings available on the CIR website, the panel has published 336 unique scientific literature reviews for cosmetic ingredients, each available for purchase at $80 (CIR 2004b). At a cost of about $27,000, then, one would have the capacity to understand in full the data gaps for ingredients in personal care products. This prohibitive fee stands in stark contrast to the open access granted the public for safety assessments of consumer products regulated by the government and not industry, including assessments of pesticides in food and contaminants in drinking water freely available from the Environmental Protection Agency. Regardless, it is clear from the review summaries published by the panel in the open scientific literature that basic safety data are often lacking. For instance, in their review of glycol distearate, the panel explicitly noted a lack of subchronic testing in lab animals and the lack of human data at levels greater than four percent (based on product weight) before approving the ingredient “safe as used” in cosmetics at levels up to 10 percent (CIR 2003). 76 Note 1: According to CIR’s website, the industry-funded panel meets four times a year in Washington DC, in meetings that last �� Table 2. Products that contain ingredients that the cosmetic industry safety panel found had insufficient testing data to support the ingredients’ safe use in cosmetics. 356 (4.8%) products contain ingredients that the cosmetic industry safety panel found had insufficient testing data to support the ingredients’ safe use in cosmetics. Showing top 20 product categories, ranked by prevalence. 1.5 days and that are open to the public. Assuming this rate of meetings has been constant through the 28 years since the panel’s inception, the panel met 112 times by the end of 2003, for a total of about 1344 hours. During these years the panel reviewed 1,175 ingredients (CTFA 2004). An analysis of these statistics shows that for each ingredient the panel has studied and deliberated for an average of one hour and ten minutes. 77 References Cosmetics Ingredient Review (CIR) (2003). 2003 CIR Compendium, containing abstracts, discussions, and conclusions of CIR cosmetic ingredient safety assessments. Washington DC. Cosmetic Ingredient Review (CIR) (2004a). General information. How does CIR work? Accessed online May 2004 at http://www.cirsafety.org/info.html. Cosmetic Ingredient Review (CIR). (2004b). Publications. Accessed online May 2004 at http://www.cir-safety.org/publication.shtml. Cosmetics Toiletry and Fragrance Association (CTFA) (2004). Product information: 2004 CIR Compendium. Accessed May 6 2004 through online bookstore at www.ctfa.org. Food and Drug Administration (FDA) (1995). FDA Authority over Cosmetics. Center for Food Safety and Applied Nutrition. Office of Cosmetics and Colors Fact Sheet. February 3 1995. Accessed online May 6 2004 at http://www.cfsan.fda.gov/~dms/cos-206.html. Food Drug Administration (FDA) (2000). Center for Food Safety and Applied Nutrition, Cosmetics Compliance Program, Domestic Cosmetics Program, Issued July 31, 2000, Chapter 29 - Cosmetics and color technology. Accessed May 10 2004 at http: //vm.cfsan.fda.gov/~comm/cp29001.html. 78 79 80 Part 7: Allergic Reactions (Sensitization) In the Expert Panel’s review of the effects of Chlorhexidine on the mucous membrane, there was concern about its implication in cases of anaphylactic shock reaction... –– Industry safety panel, the Cosmetic Industry Review, before discounting all but one case of anaphylactic shock and finding the cosmetic ingredient chlorhexidine “safe for use” in cosmetics (CIR 2003) The cosmetic industry’s self-regulating safety panel, the Cosmetic Ingredient Review (CIR), considers allergic reactions the top health issue with cosmetics, judging from the weight placed on the topic in panel discussions and subsequent written reviews. The reactions can be severe, swift, and in rare cases even life-threatening — including asthma attacks, for example, or anaphylactic shock — or can appear as symptoms like hives, swelling, or blistering that can begin to heal when exposures end. Once sensitized, a person can remain so for a lifetime, enduring allergic reactions with every subsequent exposure. A survey of approximately one-third of the reviews in CIR (2003) shows that the panel has chosen sensitization and the related effect of irritation as the basis for approximately 80% of its safety decisions, to the near total exclusion of other health impacts. Our analysis shows that of the ingredients approved by CIR for use in cosmetics based on irritation and sensitization data, 14 percent also had some data indicating cancer risks, yet the panel still chose sensitization as the health endpoint of concern, and the basis for recommended safe levels of use. Sensitization affects product sales. Once a consumer develops an allergic response to a cosmetic ingredient, he or she can no longer use that product and will no longer buy it. And the sales impact of a consumer’s sensitization can extend beyond the original product that elicited the reaction. Based on their experience in treating people sensitized to cosmetics, the American Academy of Dermatology recommends that sensitized patients use only fragrance-free products, and avoid all perfumes, colognes, aftershaves, fingernail care products, and hair spray (AAD 2000). 81 Despite the potential financial impacts of sensitization to the cosmetic industry, our review of product labels shows that ingredients linked to sensitization are routinely used by the industry, dominated by fragrances, a leading cause of sensitization worldwide. EWG’s analysis of potentially sensitizing ingredients in cosmetics shows that: • Skin sensitizing ingredients are found in 76 products that can contact the skin and that are not always rinsed off, including between five and 25 percent of all antiaging creams, lip balms, acne treatments, anti-aging treatments, and nail polish remover (Table 1). • Lung sensitizing chemicals that can trigger asthsma attacks are found in one aerosolized product, the hair styling product Nexxus Retexxtur Curl Rejuvenating Treatment. The sensitizer, or allergen, in this product is an ingredient called papain, an enzyme that the E.U. has identified as an allergen via inhalation (UNECE, 2004; EU Directive 67/548/EEC). Table 1. The occurence of skin sensitizers in products that contact the skin and are not always rinsed off. 1.0% (76) products that contact the skin and are not always rinsed off also contain skin sensitizers. 82 �� • Forty-six percent of all products examined list the word “fragrance” on the label, including more than threequarters of all body washes, conditioners, antiperspirants and deodorants, hair styling products, baby bath wash, mousse, nail polish remover, and hair spray (Table 2). Fragrances are considered to be among the top five known allergens (deGroot and Frosch 1997, cited in Jansson and Loden 2001). In a subset of asthmatics, attacks are specifically triggered by, and only by, cosmetic fragrances. This indicates that fragrances may not only be a trigger but also a cause of asthma in some cases, although more research is needed on this subject (Norback et al. 1995; Milqvist et al. 1996). Sensitization reactions are common, protection for consumers is scant. The American Academy of Dermatologists suggests that up to 10 percent of the population will have an adverse reaction to a cosmetic product over the course of their lifetime (AAD 2000), and a recent review of fragrance allergies by the EU’s Scientific Committee on Cosmetic Products and Non-food Products estimated that as many as one of every 50 people is sensitized to fragrances (SCCNFP 1998). In 2003 an estimated three-quarters of all cosmetic injuries reported by consumers to FDA included symptoms consistent with sensitization — rash, redness, swelling, blisters, sores, lumps, inflammation, irritation, dryness, peeling, splitting, cracking, scars, choking, coughing, sneezing, shortness of breath, and wheezing (EWG analysis of FDA 2004). Despite the importance of minimizing allergy potential to the financial health of the cosmetic industry, the industry’s safety panel places little to no margin of safety between safe levels of use for sensitizing ingredients in cosmetics, and levels shown to elicit allergic reactions in studies. A detailed survey of approximately one-third of the panel’s ingredient reviews in CIR (2003) shows that CIR has incorporated a safety margin into just 14 percent of its recommended safe values, and in one of every five cases endorsed limits of use higher than the safe levels determined in clinical studies. The industry panel places undue weight on sensitization to the exclusion of nearly every other effect, but they do it with little scientific rigor and inadequate safety margins for consumers. Their decisions may contribute to the high rates of allergic reactions to cosmetics across the population. The primary trade association for the fragrance industry, the International Fragrance Association (IFRA), is also willing to publish questionable science that could ultimately place consumers at risk. For instance, the Code of Practice of the 83 frgrance association recommends that the common fragrance compound isoeugenol be restricted to 200 ppm (parts per million) in products. But studies show that 20 percent of persons sensitized to this compound will react to isoeugenol at half that level (Jansson and Loden, 2001; Johansen et al., 1996). Consumers should report allergic reactions and other injuries from cosmetics use to FDA. A more comprehensive accounting of reactions will give the agency a more complete picture of the scope of harm, and may ultimately result in safer products. FDA requests that consumers “send reports about adverse reactions to cosmetics, as well as problems such as filth, decomposition, or spoilage, to: FDA, Office of Cosmetics and Colors (HFS-106), 5100 Paint Branch Parkway, College Park, MD 20740-3835” (FDA 2004). References American Academy of Dermatology (AAD) (2000). Allergies: The Culprit Could Be Hiding In Your Cosmetic Bag. Accessed online May 6 2004 at http://www.aad.org/PressReleases/allergies.html. Cosmetics Ingredient Review (CIR) (2003). 2003 CIR Compendium, containing abstracts, discussions, and conclusions of CIR cosmetic ingredient safety assessments. Washington DC. de Groot AC, Frosch PJ (1997). Adverse reactions to fragrances. A clinical review. Contact Dermatitis 36:57-86, 1997. EU chemical directive (2004). EU directive on classification and labeling of dangerous substances (Directive 67/548/EEC). Annex 1. Chemical compendium at http://europa.eu.int/comm/ enterprise/chemicals/legislation/ markrestr/cmrlist.pdf. Food and Drug Administration (FDA) (2004). How to Report Problems With Products Regulated by FDA. Accessed online May 6 2004 at http://www.fda.gov/opacom/backgrounders/ problem.html#cosmetics. Food and Drug Administration (FDA) (2004). Consumer Complaints About Cosmetic Products. Accessed online May 6 2004 at http: //www.cfsan.fda.gov/~dms/cos-comp.html. Jansson, T. and Loden, M. (2001) Strategy to decrease the risk of adverse effects of fragrance ingredients in cosmetic products. Am. J. Contact Dermatitis 12, 166-169. 84 Johansen, J.D., Andersen, K.E., Menne, T. (1996) Quantitative aspect of isoeugenol contact allergy assessed by use and patch tests. Contact Derm. 34, 414-418. Norback D, Bjornsson E, Janson C, Widstrom J, Boman G. (1995) Asthmatic symptoms and volatile organic compounds, formaldehyde, and carbon dioxide in dwellings. Occup Environ Med. 52, 388-395. Millqvist E, Lowhagen O. (1996) Placebo-controlled challenges with perfume in patients with asthma-like symptoms. Allergy 51, 434-439. United Nations Economic Commission for Europe (UNECE) (2004). The Globally Harmonized System of Classification and Labelling of Chemicals (GHS). http://www.unece.org/trans/danger/publi/ghs/ officialtext.html. (Part 3: Health and Environmental Hazards) �� Table 2. Fragrances are routinely used in cosmetics and are also commonly linked to allergic reactions (sensitization). 46.0% (3,447) products list “fragrance” on the ingredient label. Showing top 20 product categories, ranked by prevalence. 85 86 Part 8: Questions and Answers Are my personal care products harmful? Should I stop using them? You should continue to use cosmetics and other personal care products if they are part of the routine you are comfortable with. Our investigation of their safety shows cause for concern, not alarm. That said, some products pose higher potential risks than others, and given that the average adult uses 10 products a day with 146 unique chemical ingredients, it well may be that these risks are adding up. Some simple tips to reduce your exposures include: * Use fewer products. Is there something you can cut from your daily routine, or a product you can use less often? By cutting down on the number of chemicals contacting your skin every day, you will reduce any potential health risks associated with your products. * Shop smart. Use the “Custom Report” feature of our online investigation to customize your shopping list. Your custom report will give suggestions for products to buy that have fewer potential health issues. * Avoid products containing ingredients that are known carcinogens or that are linked to birth defects and other reproductive problems. See our investigations on “Cancer” and “Pregnancy Concerns” to learn more and to see lists of products you may want to avoid. * Use milder soaps. Soap removes dirt and grease from the surface of your skin, but it also strips away your body’s own natural skin oils. Choosing a milder soap may reduce skin dryness and your need for moisturizers to replace oils your skin can provide naturally. * Minimize your use of dark hair dyes. Many contain coal tar ingredients that have been linked to cancer in some studies. * Can you shampoo less often? Shampoos strip natural oils from the scalp that can make hair shine and prevent it 87 from becoming dry and brittle. You might find you can cut down on your need for conditioner and styling products simply by shampooing less frequently. * Cut down on your use of powders; avoid the use of baby powder on newborns and infants. A number of ingredients common in powder have been linked to cancer and other lung problems when they are inhaled. FDA warns that powders may cause lung damage if inhaled regularly. * Choose products that are fragrance free when you can. Fragrances can cause allergic reactions. Products that claim to be “fragrance free” on the packaging may not be. They could contain masking fragrances that give off a neutral odor. Read the ingredient label - in products truly free of fragrance, the word “fragrance” will not appear there. * Reduce your use of nail polish. It’s one of the few types of products that routinely contains ingredients linked to birth defects. Can you paint your nails less often, or paint just your toenails and skip the fingernails? Paint nails in a well-ventilated room, or outside. Browse our interactive product guide for advice on nail polishes that contain fewer ingredients of concern. Should I be concerned about chemicals in my cosmetics products? If they were in my food, I’d understand the concern, but I’m only putting them on my hair and my skin. Very few of the ingredients used in cosmetics are legal to add to food. It’s a good thing, then, that the skin serves as a partial barrier, cutting down on the amounts of chemical cosmetic ingredients that can soak through the skin and enter the blood vessels below. Individual ingredients vary tremendously in their ability to soak through the skin. Some absorb in only miniscule amounts, while others can quite easily penetrate the skin. Some areas of the body absorb chemicals much more readily than others - the lips, and the skin under the arms and around the eyes. 88 Many ingredients are approved for use in cosmetics by industry’s self-regulating panel not because the ingredient is thought to be inherently safe, but simply because not much of it is expected to absorb through the skin. It is a concern, then, that more than half of all products contain penetration enhancers, ingredients that alter skin structure and allow other ingredients to penetrate more deeply and more quickly through the skin. The average adult uses 9 personal care products each day, with 126 unique chemical ingredients. More than a quarter of all women and one of every 100 men use at least 15 products daily. Little research is available to document the safety or health risks of low-dose repeated exposures to chemical mixtures like those in personal care products, but the absence of data should never be mistaken as proof of safety. The more that science tells us about the effects of low dose exposures, from the subtle and reversible to effects that are serious and permanent, the more we understand that low doses can be harmful. But much more study is needed to understand the contribution of exposures from personal care products to current human health trends. In the meantime, you can choose to purchase products that have fewer potential health concerns by using the interactive product guide in this report. Can I trust what I read on the label? Fragrance free, hypoallergenic, natural, no animal testing - what am I really getting? According to FDA, many claims on personal care product packaging have considerable marketing value, but little scientific meaning. The terms can mean anything or nothing at all,. The attempts FDA has made to regulate the use of “natural” and “hypoallergenic” claims were thrown out in court. Here is what FDA says about some of the marketing terms commonly made on personal care products (excerpted from FDA Consumer, “Clearing up Cosmetic Confusion,” May-June 1998, last modified August 2000): * Natural: implies that ingredients are extracted directly from plants or animal products as opposed to being produced synthetically. There is no basis in fact or scientific legitimacy to the notion that products containing natural ingredients are good for the skin. * Hypoallergenic: implies that products making this claim are less likely to cause allergic reactions. There are no prescribed scientific studies required to substantiate this claim. Likewise, the terms “dermatologist-tested,” “sensitivity tested,” “allergy tested,” or “nonirritating” carry no guarantee that they won’t cause skin reactions. * Fragrance Free: implies that a cosmetic product so labeled has no perceptible odor. Fragrance ingredients may be added to a fragrance-free cosmetic to mask any 89 offensive odor originating from the raw materials used, but in a smaller amount than is needed to impart a noticeable scent. * Cruelty Free: implies that products have not been tested on animals. Most ingredients used in cosmetics have at some point been tested on animals so consumers may want to look for “no new animal testing,” to get a more accurate indication. Are “organic” personal care products safer? Not necessarily, but they have other benefits you should consider. “Organic” has no official meaning in the regulatory arena, but generally manufacturers use the term to mean one of three things: 1. The product contains natural ingredients (typically derived from plants) as opposed to petroleum products and other industrial chemicals. 2. The product contains ingredients derived from plants that were grown according to the U.S. Department of Agriculture’s organic standards, free of pesticides and artificial fertilizers. 3. The personal care product itself has been certified as organic, meeting USDA’s standards for organic food products and containing only organic plant materials and additives approved for organic processed food. Many ingredients derived from plants have not been safety tested. But the same is true for industrial chemicals. Your shopping choices ultimately support the industries that manufacture the ingredients. Buying “natural” products made with plant materials supports farming over the petroleum or industrial chemical industries that manufacturer the alternatives. Buying products with organically grown, pesticide-free plant ingredients supports the organic farming industry, and is a contribution (albeit small) to reducing our society’s reliance on pesticides. Products made with organically grown plants likely contain fewer pesticide residues than those made from plants grown conventionally. Although FDA says there is no basis in fact or scientific legitimacy to the notion that products containing natural ingredients are good for the skin, your personal convictions on issues bigger than your skin may lead you to choose them anyway. 90 What about animal testing? Shouldn’t we all be purchasing cosmetics not tested on animals? The “no animal testing” claim on a product may mean that the manufacturer doesn’t test its ingredients or finished products on animals, but it doesn’t mean the chemicals in the product have never been tested on animals. Many of the ingredients in cosmetics come from the petroleum and chemical industries, are used in other types of consumer products, and have seen their share of animal studies. Ingredients in our products that truly have never been tested on animals are, in essence, being tested on us, although no one is collecting the data. EWG advocates for safe cosmetics. We advocate for personal care product manufacturers to transition to ingredients inherently safer than those used now. And we advocate for pre-market health and safety testing for ingredients that ultimately end up in our products. For some health endpoints scientists have not yet developed reliable alternatives to animal studies. In these cases we support continuing research to develop reliable tests - computer models, or “in vitro” tests done in laboratory dishes - that do not rely on animals. But we acknowledge that current state-of-the-art toxicology relies on animal studies as integral to understanding how to use a chemical safely. We support tests that are necessary to prove safety, that are relevant, and that do not unnecessarily repeat tests already conducted by others. Ultimately, we advocate for personal care products proven safe before they go on the market. In some cases this requires animal studies, although our hope is that this will not always be the case. I am sensitized to some ingredients in personal care products. What kinds of products should I look for? First, you should seek the advice of a medical professional on product lines less likely to induce allergies. The interactive product guide on this website can guide you to products that don’t contain allergens identified by the industry’s self-regulating health and safety panel, but many of the ingredients in cosmetics have not yet been studied for their potential to cause allergic reactions. In a survey conducted in 1994, FDA scientists found that nearly one-quarter of the people questioned responded “yes” to having suffered an allergic reaction to personal care products, 91 including moisturizers, foundations, and eye shadows, indicating that many people have this problem in common with you. The term “hypoallergenic” on product labels might not be reliable guidance for safe shopping, as it has no official meaning. A federal court struck down FDA’s efforts to regulate the use of the term in 1978, and “hypoallergenic” has remained an unsubstantiated claim ever since. It might mean that the manufacturer has avoided the use of well-established allergens, but it could just as easily mean nothing at all. Bottom line - if you experience allergic reactions to personal care products, seek the advice of a doctor and report your injuries to FDA’s voluntary consumer injury report system. FDA requests that consumers send reports about adverse reactions to cosmetics to: FDA, Office of Cosmetics and Colors (HFS-106), 5100 Paint Branch Parkway, College Park, MD 20740-3835. 92 93 94 Part 9: Interactive Website Visit http://www.ewg.org/reports/skindeep/ for an interactive report where you can find out about the products you use. 95

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