Welcome to our collection of articles relating to organics, wellness, nutrion, toxic free living, alternative parenting and ethical business. Explore our main Miessence Organic Home Page here . Alternatively explore our Organic Health Blog here.

Cosmetic Safety

Compiled by Narelle Chenery
(Creator of Miessence Certified Organic Products and co founder and director of ONE Group)

Chemicals linked to cancer and birth defects do not belong in cosmetics. However, some common brands of shampoo, deodorant, face cream and other everyday products contain these dangerous chemicals - including phthalates, acrylamide, formaldehyde and ethylene oxide - which are listed by USA Environmental Protection Agency as carcinogens or reproductive toxins.   Many of these chemicals have entered our bodies, our breast milk and our children.

The chemicals in any one consumer product alone are unlikely to cause harm. But unfortunately, we are repeatedly exposed to industrial chemicals from many different sources on a daily basis. 

The Campaign for Safe Cosmetics is a coalition of a number of environmental and consumer groups. Their mission is to protect the health of consumers and workers by requiring the health and beauty industry to phase out the use of chemicals that are known or suspected to cause cancer, genetic mutation or reproductive harm. www.safecosmetics.org

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 1995).

FDA cannot require companies to do safety testing of their cosmetic products before marketing. -- FDA Office of Cosmetics and Colors (FDA 1995)

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 (www.ewg.org) analysis of industry and government sources shows that eighty-nine (89) percent of the 10,500 ingredients FDA has determined are used in personal care products (FDA 2000) have not been evaluated for safety by the CIR, the FDA, or any other publicly accountable institution (FDA 2000, CIR 2003).

The absence of government oversight for the US$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 they learned they developed an online rating system that ranks products on their potential health risks and the absence of basic safety evaluations; called Skin Deep, ( www.ewg.org/reports/skindeep/ ) 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.

Their analysis shows that ingredients in cosmetics range from essentially harmless components like table salt and oatmeal, to chemicals known to cause cancer in humans. 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. ( www.ewg.org/reports/bodyburden/ )

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.

Overall, the EWG's investigation of product safety shows cause for concern. Much more study is needed to understand the contribution of exposures from personal care products to current human health trends.

Personal care safety review findings

The EWG's safety assessment of 7,500 personal care product labels, documented in their web-based review, shows that:

• Just 28 of the 7,500 products we analysed have been fully assessed for safety. All other products -- 99.6 percent of those examined -- contain one or more ingredients never assessed for potential health impacts.
• One of every 120 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. 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.  
• 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. They 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.
• Fifty-four products violate recommendations for safe use set by the industry's self-regulating Cosmetic Ingredient Review board. 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.  

Product ingredients of concern

1. Known and probable human carcinogens in cosmetics

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)

Sixty-two products assessed by the EWG, list ingredients certified by US government authorities as known or probable human carcinogens , including shampoos, lotions, foundations, and lip balms. The cancer-causing 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. The US 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.

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 lists on the label a known or probable human carcinogen, and an astonishing one-third of all products contain one or more ingredients with at least some evidence of carcinogenicity in laboratory studies or investigations of human populations.

Coal tar. Coal tar is a known human carcinogen (NTP 2004, IARC 2004). It is also used in four shampoos designed to control itching and eczema. 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.

Formaldehyde. Formaldehyde is a probable human carcinogen (IARC 2004, OEHHA 2004, NTP 2002). From an inspection of product labels, the EWG identified formaldehyde in two nail treatment products and in a lotion designed to protect against jellyfish stings.

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 a men hair colour restorer.

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.

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).   Of these, the sand or quartz material is the crystalline form known to be carcinogenic.

2. 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.

...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)

Many impurities common to cosmetics are also linked to cancer. Impurity 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 25% of personal care products on the market.

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, including 3 of the top 20 most commonly used cosmetic ingredients. The EWG 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 be contaminated with impurities. None of these impurities is regulated by the federal government:

• Nearly 70 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.
• 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).

The EWG states, 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 have an unpleasant odor, 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 1,4-dioxane 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 1,4-dioxane in cosmetics (CIR 2003, review of choleth-24). But 18 years later, the USFDA 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). USFDA 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.

Ethylene oxide. Ethylene oxide can be an impurity in 25 percent of 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).

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 1,4-dioxane and ethylene oxide impurities. The importance of using the necessary purification procedures to remove these impurities was stressed" (CIR 2003).

A consumer can identify products with potential ethylene oxide and 1,4-dioxane contamination by scanning product labels for the common ethoxylated surfactants that may contain the impurity, which according to USFDA are identifiable by the prefix, or by the designations, of 'PEG,' 'Polyethylene,' 'Polyethylene glycol' 'Polyoxyethylene,' '-eth-,' or '-oxynol-' (FDA, 2000).

Nitrosamines. 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).

FDA has urged cosmetic manufacturers to voluntarily remove from cosmetics any ingredient that 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

The EWG 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 sponsored 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).

PAHs. PAHs, or polycyclic aromatic hydrocarbons, are common contaminants in petrolatum, also called petroleum jelly and sold under well-known brand names 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.

USFDA 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).

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.

3. Unassessed 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 18 of the 7,500 products we analysed list only ingredients that have been fully assessed for safety by the cosmetic industry's self-regulating 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.

A further analysis of the panel's reviews in relation to ingredients 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 . 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).

The EWG 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 USFDA'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."

Because the USFDA 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:

• 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 to the recommendations of the CIR and reformulate products to eliminate ingredients that are deemed unsafe for the intended use of the product.

Until this happens, the only way to ensure your products do not contain potentially harmful chemicals is to use products that are certified to organic food standards.

Acknowledgements and Resources

AUTHORS: Jane Houlihan, Sean Gray, Timothy Kropp, Ph.D., Chris Campbell.

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 n-nitrosamines.
• 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.
• 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). Cosmetics Compliance Program. Domestic Cosmetics Program. July 31, 2000. Accessed online May 20 2004 at http://www.cfsan.fda.gov/~comm/cp29001.html.

Find Out About Our Organic Home Business Opportunity

Work from home Support Wellness & the Environment Spend as little as 5 hours / week Low start up costs Join a booming and ethical industry An education culture with no "hard sell" Support & tailored solutions from a successful and friendly team View our ORGANIC HOME BUSINESS OPPORTUNITY OVERVIEW or listen to a five minute audio presentation about ONE Group, Miessence and our organic business opportunity (the second link opens in a new window).

x