Why aren’t all products safe?

Adolescence is a time of experimentation and the first steps toward independence. Girls entering adolescence have often begun a lifelong exploration of their own individual styles, which may be expressed in part through the beauty and body care products they use. Like most Americans, teens assume that personal care products readily available on store shelves do not contain ingredients or impurities known or suspected of causing lasting damage to human health.

In fact, the Food and Drug Administration (FDA) has no authority to require testing of personal care product ingredients for safety before they are sold. Instead, FDA states that the manufacturers of these products, with few exceptions, “may use essentially any raw material as a cosmetic ingredient and market the product without an approval from FDA” (FDA 1995). While the required ingredient list on body care products provides consumers, including teens, with some information, this list does not document the presence of impurities – contaminants formed when a raw material is manufactured, or when it breaks down within a product – many of which are commonly found in cosmetics. Worse, FDA does not have the power to require the recall of a harmful product – recalls are voluntary company actions, and the mere act of FDA suggesting a recall requires that the Agency have firm evidence of potential human harm.

In place of government authority to ensure safety, the personal care products industry polices itself through an industry panel called the Cosmetic Ingredient Review (CIR). This industry-funded panel of scientists has reviewed just 11% of all ingredients in cosmetics, including many no longer in regular use. An EWG investigation found that the panel chooses criteria regarding sensitivity and irritation for 80% of its safety recommendations, ignoring more serious health concerns such as cancer, birth defects, and hormone disruption, and as a result finds more than 99% of ingredients reviewed safe as used. What’s more, companies are not bound by the panel’s restrictions or recommendations – compliance is entirely voluntary.

As it stands, it’s up to individual cosmetic companies to make decisions about safety – for adults and teens alike. Some companies make body care products safe enough to eat; others make products using ingredients with documented links to birth defects in humans, or ingredients laced with cancer-causing impurities.

Companies are also free to represent their products in any way they choose - marketing claims for body care products are entirely unregulated. FDA tried establishing official definitions for terms like “natural” and “hypoallergenic,” but these protections were overturned in court. As a result, manufacturers can use marketing claims “to mean anything or nothing at all” (FDA 2000). According to FDA, “Image is what the cosmetics industry sells through its products, and it’s up to the consumer to believe the claims or not” (FDA 2000). While FDA has taken pains to research and account for the still-maturing decision-making abilities of teens using over-the-counter medications (FDA 2007b), they have made no attempt to protect teens from the deceptive marketing practices used in the cosmetics industry.

Body care products provide an appalling example of the inadequacy of current chemical regulations in the U.S. The Federal Food, Drug, and Cosmetic Act, the law governing cosmetics safety, does not require companies to test products for safety before they are sold. The Toxic Substances Control Act, the law that regulates all industrial chemicals in the United States, was created over 3 decades ago, and assumes chemicals in everyday products are innocent until proven guilty. The products we and our children use each day can contain thousands of ingredients that have never been tested for safety.

We cannot continue to allow a self-regulating industry to make decisions about the health of young women and men throughout America. Health protective reform of chemical standards must include:

• Premarket testing of products and their ingredients for safety.
• Protective purity standards for ingredients.
• Attention to the effects of mixtures of chemicals on human health.
• Safety standards that acknowledge critical developmental “windows of vulnerability” to chemical exposures, including the period of adolescence.

Cosmetics chemicals of concern

Teen participants were tested for chemicals from 4 chemical families commonly used in body care products.

Phthalates
Triclosan
Musks
Parabens
Table: Cosmetics chemicals can alter the hormone systemPhthalates

What are phthalates?

The widely-used group of chemicals called phthalates (pronounced THA-lates) can interfere with hormones in the body, posing potential risks to the reproductive and thyroid systems (Duty 2003, 2004, 2005; Swan 2005; Main 2006; Hauser 2007; Huang 2007; Meeker 2007). Preliminary studies also link phthalates to diabetes risk and asthma (Bornehag 2004; Stahlhut 2007; Jaakkola 2008; Kolarik 2008). Phthalates are detected in nearly every American, from babies to adults (CDC 2005). According to a large national survey conducted by the Centers for Disease Control and Prevention (CDC), levels of phthalates in some U.S. women of childbearing age exceed the government’s safe levels (Kohn 2000). Phthalates are widespread contaminants in the environment and in wildlife as well (Kolpin 2002; Rudel 2003).

How are we exposed to them?

Though not always listed on labels, phthalates are common ingredients in cosmetics and body care products. Dibutyl phthalate may be found in nail polish. Phthalates are also used to moisturize and to help chemicals absorb into the skin. The most common use of phthalates is as an ingredient in “fragrance” mixtures added to body care products. Companies are not required to reveal the ingredients making up fragrance mixtures on the labels of products. EWG product testing found phthalates in nearly three-quarters of 72 name-brand products, though none of them listed phthalates as ingredients (EWG/HCWH/WVE 2002).

Phthalates also soften plastic used in a wide range of ordinary products, from food wraps and toys to building materials and medical equipment. Currently, the chemical industry produces billions of pounds of these chemicals each year. People are exposed to phthalates daily through contact with everyday products and via food, indoor air, and even house dust (CDC 2005).

What are the potential health effects?

Studies of ordinary people suggest exposures to phthalates increase the risk of reproductive system birth defects and hormonal changes in baby boys (Swan 2005; Main 2006). In adult men they are linked to reduced sperm motility and concentration, increased damage to sperm DNA, and hormonal changes (Duty 2003, 2004, 2005; Hauser 2007). Phthalate exposures are linked to obesity and insulin resistance in men (Stahlhut 2007), conditions that can lead to Type 2 diabetes. They are also linked to thyroid irregularities in both men and women (Huang 2007; Meeker 2007), and to asthma and skin allergies in children (Bornehag 2004; Jaakkola 2008; Kolarik 2008). Animal studies indicate exposure to phthalates can trigger miscarriage or cause infertility in females, and can cause birth defects in male and female offspring of animals exposed during pregnancy (e.g., Marsman 1995; Wine 1997; Ema 1998; Mylchreest 1998, 1999, 2000; Gray 1999, 2000; CERHR 2000).

Have these chemicals been regulated?

Phthalates are considered hazardous waste and are regulated as pollutants in air and water. One phthalate, DEHP, is regulated in drinking water. DEHP was allegedly removed voluntarily from children’s toys over a decade ago. However, 2 recent studies detected DEHP in toys on the market today (Purvis 2005; Kay 2006). Bans on specific phthalates in children’s products were passed recently, first in California, and then nationwide. Phthalates are unregulated in food, cosmetics, and medical products in the U.S. In contrast, the European Union restricts use of some phthalates.

How can we prevent future exposures?

Because phthalates are found in many everyday products, some exposure may be unavoidable. One way to reduce exposure is to switch to phthalate-free cosmetics and body care products. Choose products that do not list “fragrance” as an ingredient, and nail polish that does not contain dibutyl phthalate. You can also choose fragrance-free detergents and cleaning products, eat less food packaged in plastic, and not microwave food in plastic containers.

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Triclosan

What is triclosan?

Triclosan is an artificial antimicrobial chemical used to kill bacteria on the skin and other surfaces. Triclosan is used in a variety of cosmetics and everyday products. Recent studies suggest this chemical may disrupt thyroid function (Veldhoen 2006), and can form toxic byproducts in tap water and in the environment (Adolfsson-Erici 2002; Lindstrom 2002; Lores 2005; Fiss 2007). A scientific advisory panel to the U.S. Food and Drug Administration (FDA) determined that “antibacterial” soaps, like those containing triclosan, were no better than regular soap and water at killing germs or reducing the spread of infection (FDA 2005). The American Medical Association recommends that triclosan and other “antibacterial” products not be used in the home, as they may encourage bacterial resistance to antibiotics (Tan 2002). Despite this advice, widespread use has led to detection of triclosan in the breast milk, blood, and urine of ordinary people (Adolfsson-Erici 2002; TNO 2005; Allmyr 2006a, 2006b; Dayan 2007; Calafat 2008). CDC’s national survey indicates that triclosan contaminates the bodies of 75% of the American population (Calafat 2008).

How are we exposed to triclosan?

Triclosan is the most common active ingredient in “antibacterial” liquid hand soaps, and is also found in toothpastes, deodorants, face and body washes, and acne treatments, among others. Besides cosmetics, triclosan is found in an increasing number of everyday items, such as dishwashing detergent, kitchen tools, toys, trash bags, bedding, bathmats, socks, and footwear (EWG 2008). Triclosan also contaminates household dust (Canosa 2007).

What are the potential health effects?

Triclosan accumulates in fat and can build up in the bodies of people and animals over time (Samsøe-Petersen 2003). An animal study indicates tadpoles exposed to tiny amounts of triclosan experience disruption of the thyroid system (Veldhoen 2006). Triclosan increased the effect of thyroid hormones when it was present in water at levels below 1 part per billion. Such low levels are commonly measured in people, and in rivers and streams, due to widespread use of triclosan (Kolpin 2002; Calafat 2008). The thyroid hormone system is similar in frogs and humans, suggesting that triclosan may disrupt the human thyroid system. Thyroid hormones are critical for normal growth and development of humans as well; the developing brain of a child is particularly vulnerable to damage caused by disruption of the thyroid system.

Triclosan may also disrupt other critical hormone systems. A recent lab study found the chemical to exert both estrogenic and androgenic effects on human breast cancer cells (Gee 2008). Studies of fish suggest that triclosan may have weak androgenic (Foran 2000) or anti-estrogenic effects (Matsumura 2005), while a metabolite of triclosan may have estrogenic effects (Ishibashi 2004). Other animal studies link triclosan to inhalation and liver toxicity and cancer (EWG 2008).

Triclosan can react with chlorine in tap water to form chloroform, a suspected cancer-causing chemical (Fiss 2007). It can also degrade into a type of dioxin (Lores 2005), part of a group of highly toxic chemicals, and a compound called methyl triclosan that is toxic to aquatic life (Adolfsson-Erici 2002; Lindstrom 2002; Farré 2008). Triclosan may also promote antibiotic resistance in bacteria, because while repeated use kills most bacteria, this can allow resistant strains to flourish (Levy 2001; Tan 2002; Aiello 2005).

Has the chemical been regulated?

Triclosan is regulated by FDA when used in cosmetics and for medical applications, by the U.S. Environmental Protection Agency (EPA) when used as an antibacterial pesticide (in products that make “antibacterial” claims), and by the Consumer Product Safety Commission (CPSC) when used in ordinary consumer products that do not make specific “antibacterial” claims. Current regulations do not take into account concerns regarding hormone disruption or formation of toxic byproducts, nor do they fully account for the potential for multiple exposures through the broad variety of triclosan-treated everyday products.

How can we prevent future exposures?

Because triclosan is found in many everyday products, some exposure may be unavoidable. One way to reduce exposure is to switch to triclosan-free cosmetics and body care products. Avoid body care products, especially liquid hand soaps, labeled “antibacterial,” and always check the list of ingredients. Triclosan will be listed as an active ingredient on the product label. If you use a skin disinfectant, use an alcohol hand rub or rinse. Avoid “antibacterial” dishwashing detergents, cleaning products, and other items – there is no evidence that these products protect your health. Triclosan is approved for use in over 140 different types of products, and most of these are not required to have ingredient labels (EWG 2008). Vague claims such as “protection against mold,” “odor-fighting” or “keeps food fresher, longer,” may also indicate the presence of triclosan.

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Musks

What are musks?

Nitro- and polycyclic musks are artificial chemicals used for decades in “fragrance” mixtures added to everyday products. Animal studies indicate musks may disrupt the hormone (endocrine) system (Seinen 1999; Schreurs 2004), and may disturb a natural defense the body uses to protect itself from toxic chemicals (Luckenbach 2005). Laboratory studies also link some musks to cancer (Maekawa 1990; Apostolidis 2002). Widespread use of musks has led to detections in fish and in rivers and lakes (Balk 1999; Fromme 1999, 2001; Gatermann 2002; Peck 2004, 2006; Duedahl-Olesen 2005; Kannan 2005). Musks can accumulate in fat and build up in the human body, and have been detected in people’s breast milk, fat, and blood (Rimkus 1996; Liebl 2000; TNO 2004, 2005; Hutter 2005; Lignell 2008).

How are we exposed to them?

Musks are often used in cosmetics and body care products, like perfume and soap, that contain “fragrance.” Musks are also used in air fresheners, detergents, fabric softeners, cleaning products, cigarettes, and as food additives. Musks can be absorbed through the skin, inhaled, and ingested; skin absorption and inhalation are important routes of exposure through cosmetics. Daily use of body care products containing “fragrance” can result in repeated, direct exposures.

What are the potential health effects?

Some musks irritate the skin, or trigger allergic reactions (Cronin 1984; Parker 1986; Hayakawa 1987, 1991; Menz 1988; Thune 1988; DeLeo 1992; Kanchan 2002). In laboratory studies, certain musks have been linked to cancer (Maekawa 1990; Apostolidis 2002), and others no longer in common use harm the nervous system (Spencer 1984; Ford 1990; Rimkus 1996, 1997). Laboratory studies indicate that some musks can disrupt the hormone system (Seinen 1999; Chou 1999; Bitsch 2002; Gomez 2005; Schreurs 2004, 2005a, 2005b). A study of nitromusks in people suggests that higher levels of some musks may be linked to reproductive problems in women (Eisenhardt 2001).

A recent animal study found that low levels of nitro- and polycyclic musks interfere with the ability of structures in cell walls to keep toxic substances from entering the cell (Luckenbach 2005). By disturbing a cell’s natural ability to fend off toxic chemicals, musks could allow poisons to build up within cells and cause damage. Human cells have the same cell wall structures as those examined in this study, indicating a cause for concern.

Have these chemicals been regulated?

Growing concerns about the health effects of nitromusks led the European Union to ban the use of some of these chemicals in cosmetics and body care products. Many companies have begun to use polycyclic musks in place of nitromusks because they are believed to be less toxic (Daughton 1999; OSPAR 2004). But some studies suggest that polycyclic musks pose some of the same health risks suspected of nitromusks. A nitromusk (musk ambrette) and a polycyclic musk have been removed from the market voluntarily due to health concerns. In the United States, all musk chemicals are unregulated, and safe levels of exposure have not yet been set.

How can we prevent future exposures?

Because musks are found in many everyday products, some exposure may be unavoidable. One way to reduce exposure is to switch to fragrance-free cosmetics and body care products – choose products that do not list “fragrance” as an ingredient. Musks are added to many other products, including laundry detergents, fabric softeners, and household cleaners – choose fragrance-free versions of these products as well. Unfortunately, as there is no requirement for companies to list ingredients on these products, it can be difficult to tell which contain fragrance. Finally, avoid air fresheners, which provide a blast of artificial fragrance to cover up other odors.

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Parabens

What are parabens?

In use since the 1920s, parabens are a group of artificial preservatives commonly found in many different cosmetics and body care products. Parabens are used to prevent the growth of bacteria and mold in a cosmetic product, increasing its shelf life. Laboratory studies suggest parabens can disrupt reproductive hormones (Routledge 1998; Oishi 2001, 2002a, 2002b; Byford 2002; Darbre 2002, 2003; Inui 2003; Gomez 2005; Mikula 2006; Pugazhendhi 2007). In 2006, the Centers for Disease Control (CDC) tested urine samples from a group of 100 adults and found parabens in nearly all samples (Ye 2006). Cosmetics typically contain mixtures of parabens. Of the 6 we measured, 5 are fairly common in cosmetics: methyl-, ethyl-, propyl-, isopropyl-, and butylparaben (measured in combination with isobutylparaben); benzylparaben is less common.

How are we exposed to them?

Parabens are present in a wide variety of cosmetics and body care products, including moisturizers, face and skin cleansers, shampoos, conditioners, sunscreens, deodorants and antiperspirants, shaving gels, toothpastes, makeup, and many others. They are also used as preservatives in food and beverages, and in some medications. Daily use of body care products can result in repeated, direct exposure to parabens. Parabens have also been detected in household dust (Canosa 2007).

What are the potential health effects?

Some parabens can irritate the skin or cause allergic reactions (Schamberg 1967; Nagel 1977; Soni 2001, 2002; CIR 2006). Laboratory studies indicate that parabens are estrogenic, meaning they can mimic the hormone estrogen, disrupting normal function of the hormone system (Routledge 1998; Oishi 2001, 2002a, 2002b; Byford 2002; Darbre 2002, 2003; Inui 2003; Gomez 2005; Mikula 2006; Pugazhendhi 2007). In a recent study, traces of 5 different parabens were found in the breast cancer tumors of 19 of 20 women examined (Darbre 2004); other lab studies also link parabens to cancer (Byford 2002; Darbre 2002, 2003; Pugazhendhi 2007), and to reproductive health problems as well (Oishi 2001, 2002).

When personal care products containing parabens are combined with chlorinated tap water, a number of chlorinated paraben byproducts can form (Canosa 2006). These chlorinated paraben chemicals have not been assessed for safety. Some are persistent, and have been detected in samples of untreated wastewater (Canosa 2006). Parabens are also linked to ecological harm; low levels of butylparaben can kill coral, according to laboratory tests (Danovaro 2008).

Have these chemicals been regulated?

The European Union banned use of sodium methylparaben in fragrance because it can strip skin of pigment (SCCPNFP 1999, 2000). While FDA limits the levels of parabens allowed in foods and beverages, it does not regulate these chemicals in cosmetics and body care products.

How can we prevent future exposures?

Because parabens are found in many everyday products, some exposure may be unavoidable. One way to reduce exposure is to switch to paraben-free cosmetics and body care products.

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Cosmetics chemicals can alter the hormone system

A survey of some of the latest science on cosmetics chemicals shows these widely used ingredients can disrupt the normal function of the hormone system.

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EWG’s shopper’s guide

With no required safety testing, cosmetics companies can use almost any chemical they want, regardless of risks. Read labels before you buy.

 

Study methodology

Introduction

20 dedicated teen volunteers started a morning between April and September 2007 not with classes, sports, or a summer job, but with a 50 mL blood draw at a local clinic. This diverse group of young women shared a common curiosity – the desire to learn about chemical contaminants in their bodies, a pollution they may have absorbed through use of personal care products.

The potential for increased vulnerability during adolescence to hormone disruption and other harmful effects of contaminants, combined with the tendency of teen girls to expose themselves to more, and more varied, cosmetic ingredients through use of body care products, suggests that special attention be directed to assessing chemical exposures for this group. Motivated to fill current data gaps, EWG analyzed blood and urine samples from 20 teens for ingredients commonly found in cosmetics and personal care products – 25 chemicals in total, from 4 chemical classes. To our knowledge this work includes the first reported tests of teens for 17 of these chemicals. Information below describes the components of this new study, detailing the sample collection procedures, sample preparation and analysis methods, the quality assurance and quality control provisions included in the study design, and the analysis of associations between contaminant levels and specific personal care products used. Study design and implementation were approved by an institutional review board that reviewed ethical and data quality considerations of the investigation.

Participants

In collaboration with the Teens for Safe Cosmetics coalition and its umbrella organization, Search for the Cause, EWG recruited 20 teens willing to provide blood and urine samples for analysis. The teens ranged in age from 14 to 19, and came from all over the U.S., representing Northern, Central, and Southern California, Florida, Massachusetts, New Jersey, Oregon, Pennsylvania, Texas, Washington, and Washington DC. The diverse pool of participants included Caucasian (14), African American (3), Asian American (2), and multi-ethnic (1) girls.

Sample collection and storage

Each participant received a sample kit, allowing her to collect her first morning void of urine at home, and then proceed to a local phlebotomy clinic for a 50 mL blood draw. Clinic staff processed the blood to extract the serum, then shipped urine and serum samples to Axys Analytical Services, British Columbia. Axys stored samples at -20 degrees Celsius, and analyzed urine samples for phthalates, triclosan, and parabens. Axys shipped serum samples to TNO Laboratories, The Netherlands, where they were analyzed for musks. Three serum samples were damaged in transit; musk measurements could not be made for these samples.

Analysis of phthalates

Phthalate metabolites were extracted from 1 mL urine samples. Urine samples were first buffered with ammonium acetate, and then spiked with 13C-labeled phthalate monoesters, 13C4-4-methylumbelliferone, and 4-methylumbelliferyl glucuronide. Urine samples were also spiked with beta-glucuronidase enzyme (for deconjugation of glucuronidated forms of the target analytes). The treated samples were incubated to hydrolyze the glucuronides (the completeness of hydrolysis was monitored by the recovery of 4-methylumbelliferone).

Samples were extracted and purified using solid phase extraction (SPE) procedures. Extracts were spiked with labeled recovery standards for phthalate metabolites and analyzed by liquid chromatography tandem mass spectrometry (LC/MS/MS) using a Micromass Quattro Ultima MS/MS coupled with a Waters 2695 HPLC system. The method determined the total of the free and the glucuronidated phthalate metabolites. Analyte concentrations were determined using isotope dilution quantification.

Values are reported in units of micrograms per gram creatinine, a urine protein, to account for variation in the dilution of the urine samples due to different levels of fluid intake by the participants.

Analysis of triclosan

Triclosan metabolites were extracted from 4 mL urine samples. Urine samples were first buffered with ammonium acetate buffer and then spiked with a labeled triclosan standard solution, 13C4-4-methylumbelliferone, and 4-methylumbelliferyl glucuronide, and beta-glucuronidase enzyme (for deconjugation of possible glucuronidated forms of the target analyte). The treated samples were incubated to hydrolyze the glucuronides (the completeness of hydrolysis was monitored by the recovery of 4-methylumbelliferone).

Samples were extracted and purified using SPE procedures employing Waters Oasis Max cartridges. Extracts were spiked with labeled recovery standards and analyzed by LC/MS/MS using Micromass Quattro Ultima MS/MS coupled with a Waters 2695 HPLC system. The method determined the total of the free and the glucuronidated triclosan metabolites. Analyte concentrations were determined using isotope dilution quantification.

Values are reported in units of micrograms per gram creatinine, a urine protein, to account for variation in the dilution of the urine samples due to different levels of fluid intake by the participants.

Analysis of nitro- and polycyclic musks

Serum samples were analyzed by TNO Laboratories, The Netherlands, in compliance with NEN-EN-ISO/IEC 17025 and RvA accreditation no. 54, “The development and application of methods for the determination of organic contaminants in environmental matrices, wastes and material.” TNO Environment and Geosciences Laboratories is listed in the RvA register under no. L 026. RvA is the Dutch Council for Accreditation and is a member of the European cooperation for Accreditation (EA) and the International Laboratory Accreditation Cooperation (ILAC). In addition TNO Environment and Geosciences Laboratories operates in compliance with the Quality System standard ISO 9001.

All glassware used in the analysis for artificial musks was cleaned, rinsed with demineralized water and baked in an oven for 16 hours at 280°C prior to use. All solvents were distilled prior to use to achieve low blank results

For each analysis, a serum sample is placed in a 60 mL clean glass vial. Methanol, 0.1 M HCl and a set of internal standards were added to the sample. The sample was extracted twice with a hexane-diethyl ether mixture and centrifuged after each extraction to separate the organic phase. The combined extracts were washed with a 1% KCl solution and dried with anhydrous sodium sulphate.

The extract was concentrated to a small volume and purified over a glass chromatography column packed with partially deactivated florisil. The fraction containing the artificial musk compounds was collected and concentrated. A syringe standard was added and the final extract was analyzed with gas chromatography coupled with mass spectrometry (GC/MS) in the selected ion monitoring mode (SIM).

The identification of analytes was based on correct retention times and qualifier ion ratios compared to external standards analyzed together with the sample extracts. The quantification was based on a response factor determined from the external standards. The recovery of the added internal standards was used to determine the performance of the method but not to correct the results. Results are expressed in parts per billion parts serum wet weight.

Analysis of parabens

Paraben metabolites were extracted from 2 mL urine samples. Urine samples were spiked with deute-rium labeled quantification standards, 4-methylumbelliferyl glucuronide, 4-methylumbelliferyl sulfate solution, and then buffered with ammonium acetate. Samples were subjected to enzymatic hydrolysis using beta-glucuroni-dase/sulfatase enzyme for deconjugation of conjugated glucuronide and sulfonate forms of the target analytes (the completeness of hydrolysis was monitored by the recovery of 4-methylumbelliferone).

Samples were extracted and purified using SPE procedures employing Waters HLB cartridges. Extracts were spiked with labeled recovery standards and analyzed by LC/MS/MS using a Micromass Quattro Ultima MS/MS coupled with a Waters 2695 HPLC system. The method determined the total of the free and the glucuronidated triclosan metabolites. Analyte concentrations were determined using isotope dilution quantification.

Values are reported in units of micrograms per gram creatinine, a urine protein, to account for variation in the dilution of the urine samples due to different levels of fluid intake by the participants.

Procedures for quality assurance and quality control (QA/QC)

To assess the possibility that air or dust in the home setting could contribute to the levels of contaminants in participants’ urine, some participants were asked to collect “field blank” samples, exposing jars of purified water to the sampling (bathroom) environment simultaneous to collection of the urine sample. EWG staff performed a similar field blank sample collection procedure during collection and processing of serum samples for these participants to assess the hospital environment as a source of additional contamination. A single set of field blanks was analyzed, and no evidence of contamination from home or hospital air was detected.

All urine analyses were conducted in accordance with AXYS’ accredited QA/QC program. Regular participation in international inter-laboratory calibration programs is a component of this program. Each analysis batch included a procedural blank to demonstrate cleanliness, a spiked laboratory control sample to monitor precision and recovery, a batch duplicate to monitor precision and a batch un-spiked matrix (USM) using reference synthetic urine to determine the levels of analytes prior to spiking. The sample results were reviewed and evaluated in relation to the QA/QC samples processed at the same time. The sample surrogate standard recoveries and detection limits, procedural blank data and the laboratory control sample data were evaluated against method criteria to ensure acceptable data quality.

The serum analyses were conducted in accordance with TNO’s ISO-9001 accredited QA/QC program. Upon receipt, the samples were checked for integrity and spiked with isotope labeled internal standards to facilitate compound identification. The recovery of these standards (musk-xylene-d15 and tonalide-d3) is used to determine the performance of the analytical procedure, but not used to correct the results, as these standards are not compound specific.

As part of the QA/QC, control samples were injected and analyzed for each series of real samples. Control samples consisted of a similar matrix or duplicate sample with standard addition of the analytes, or alternatively, the analysis of a duplicate sample. Initial quality control procedures included: assessment of the performance of the instrumental analysis system; assessment of method blank samples and external standards; visual inspection of the chromatograms on peak separation and interferences; identification criteria, e.g. retention time and isotope ratios; quantification criteria, e.g. number of scans/peak, recovery of the internal/surrogate standard, recovery of the standard addition in control samples and minimal signal/noise ratios; and assessment of raw data and calculations by a second technician. The final results of any analysis are validated against the performance criteria of each method before they are reported.

Analysis of personal care products

On the day of the blood draw, participants were asked to complete a questionnaire detailing the personal care products they used, including brand names and other identifying information. Participants were asked how frequently they used the products, and for those products used within the last 48 hours, the number of hours elapsed between their previous 2 uses and the blood draw. 19 of 20 participants provided this information.

EWG researchers linked questionnaire responses to our Skin Deep cosmetics database, an online database of more than 32,000 personal care products, which includes lists of ingredients and associated health concerns. Using this information, we analyzed participants’ body levels of cosmetic chemicals against the ingredients in all products they used, as well as in products used daily or during the 24 hours prior to the blood draw.

50% of all products listed in questionnaire responses were matched exactly to products found in Skin Deep; 91% of products used daily or within 24 hours of sampling were matched exactly. For products that could not be matched to any found in Skin Deep, probabilistic modeling was used to assign products present in the database that were of the same product type (e.g. lotion or sunscreen). 30 iterations of this probabilistic model provided suitable exposure statistics concerning the number of products used containing cosmetic chemicals of concern.

Extensive analysis revealed no statistically significant correlations between participants’ contaminant levels and recent (daily or within 24 hours) or overall product usage for each chemical under study. In addition, no correlations were noted between body levels and exposures for chemical families, or for body levels of musks, phthalates, or diethyl phthalate specifically and exposures to “fragrance” in cosmetics. This lack of correlation is not surprising, given the small number of participants, the lack of information about both the concentrations of each ingredient within body care products and the expected amount of uptake with use, as well as the multiple non-cosmetic sources of exposures to these chemicals that commonly occur.

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Acknowledgments

This report was made possible by the support of The Women’s Foundation of California, Lucy R. Waletzky, M.D., and other funders.

Special thanks to each of the 20 young women who volunteered to participate in this study. The donation of your time and samples will help to further our understanding about our exposures to chemicals of concern in cosmetics and body care products. The information from this study will add to the growing body of science that shows that teens have unique exposures and vulnerabilities to toxic chemicals, and will help to drive national chemicals policy reform that protects our most vulnerable populations.

We are also grateful to Axys Analytical Services and TNO Laboratories for sample analysis and consultations.

Thanks to EWG interns Stefanie Graeter, Marisa Evanouski, and Dan Myers, and volunteers Margaret Sidells and Joshua Mehlman, who assisted this investigation. Tracey Woodruff (University of California at San Francisco) also provided valuable comments on this report.

Finally, EWG thanks the advocacy groups who helped us recruit study participants, including Teens for Safe Cosmetics, a part of Search for the Cause, and Massachusetts Clean Water Action.

Hormone-Altering Cosmetics Chemicals Found in Teenage Girls

OAKLAND, CA – Teenage girls across America are contaminated with hormone-altering chemicals found in cosmetics and body care products, confirms a new study released today by the Environmental Working Group (EWG).

The first-of-its kind study found 16 toxic chemicals in blood and urine samples from 20 teen girls from eight states and the District of Columbia, aged 14-19, including preservatives, fragrance and antimicrobial compounds. Many of these are linked to serious health risks in lab animals, even at low-dose levels.

“Hormone-altering chemicals shouldn’t be in cosmetics, especially in products used by millions of teenage girls,” said Rebecca Sutton, Ph.D, author of the report and Staff Scientist at EWG. “Their bodies are still developing and may be especially vulnerable to risks from these exposures,” added Sutton.

The young women participating in this study were recruited from locations across the U.S. and represent diverse ethnic and cultural backgrounds. They used an average of nearly 17 personal care products per day that contain a total of 174 unique cosmetic ingredients.

The study provides the first data available from teens on levels of synthetic chemical musks, common fragrance ingredients that accumulate in people and act like estrogen in the body, and preservatives called parabens that also mimic estrogen.

“The Teen Body Burden Study is proof that something needs to be done. My results serve as permanent motivation to fight the chemical battle and win,” said Jessica Assaf, one of the teens tested.
Federal health statutes do not require companies to test products or ingredients for safety before they are sold. As a result, nearly all body care products contain ingredients that have not been assessed for safety by any federal agency, and are not required to meet any uniform safety standards.

“Most parents don’t know that the eyeliner, lipstick or shampoo they allow their daughters to use probably contains at least one chemical linked to a number of serious health concerns,” said Sutton. “Teenage girls are at a particularly vulnerable age and these exposures could trigger a subtle sequence of damaging effects that leads to health problems later in life.”

Teenagers and their parents can consult EWG’s Skin Deep online database to help them make informed decisions about their products.

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EWG is a nonprofit research organization based in Washington, DC that uses the power of information to protect human health and the environment.