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Beauty Secrets Does A Common Chemical In Nail Polish Pose Risks To Human Health? W O R K I N G G ROU P TM E N V I R O N M E N T A L Jane Houlihan Richard Wiles

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Page 1: Beauty Secrets - static.ewg.orgstatic.ewg.org/reports/2000/BeautySecrets.pdfLever Brothers Company (New York, NY) deodorant, skin and hair cleansers Maybelline Cosmetics Corporation

Beauty SecretsDoes A Common Chemical In Nail PolishPose Risks To Human Health?

W O R K I N G G R O U P T M

E N V I R O N M E N T A L Jane HoulihanRichard Wiles

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Acknowledgments

This report was written by Jane Houlihan and Richard Wiles of the Environmental Working Group.

This report was made possible by grants from the W. Alton Jones Foundation, the Turner Foundation, Inc., theMitchell Kapor Foundation and the Jenifer Altman Foundation.

Copyright © November 2000 by Environmental Working Group. All rights reserved. Manufactured in theUnited States of America. Printed on recycled paper.

Environmental Working Group

The Environmental Working Group (EWG) is a nonprofit environmental research organization based in Wash-ington, D.C. Through analysis of government and private sector databases, environmental monitoring programs,and scientifically grounded research, EWG develops high-profile publications, computer databases and Internetresources that consistently create public awareness and concern about high priority environmental problems andsolutions.

Kenneth A. Cook, PresidentRichard Wiles, Vice President for ResearchMike Casey, Vice President for Public Affairs

To order a copyCopies of this report may be ordered for $25.00 each (plus 6% sales tax or $1.50 for Washington, DC residents)

and $3.00 for postage and handling. Payment must accompany all orders. Please make checks payable to:

Environmental Working Group1718 Connecticut Avenue, N.W. Suite 600Washington, D.C. 20009(202) 667-6982 (phone)(202) 232-2592 (fax)

www.ewg.org

This and many other EWG publications are available on the World Wide Web at www.ewg.org.

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Contents

Beauty Secrets

Executive Summary ......................................................................... 1

Chapter 1: Chemical industry systematically defeats health protections.............................................. 7

Chapter 2: Phthalates ................................................................... 11

Chapter 3: Phthalates in cosmetics and beauty products .............. 19

References .................................................................................... 25

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1ENVIRONMENTAL WORKING GROUP

Executive Summary

Beauty Secrets

In September 2000, research-ers at the Centers for DiseaseControl and Prevention (CDC)reported that every single one ofthe 289 persons tested for theplasticizer dibutyl phthalate(DBP) had the compound intheir bodies. The finding passedwith little public fanfare, butsurprised government scientists,who just one month earlier hadrated DBP of little health con-cern based on the scientificassumption, which later turnedout to be wrong, that levels inhumans were within safe limits.DBP causes a number of birthdefects in lab animals, primarilyto male offspring, includingtesticular atrophy, reducedsperm count, and defects in thestructure of the penis (CERHR2000).

The most critical population,women of childbearing agewhose fetuses are exposed inthe womb, appear to receive thehighest exposures. Estimatesbased on data published by thesame CDC researchers in Octo-ber 2000, indicate that DBPexposures for 3 million womenof childbearing age may be upto 20 times greater than for theaverage person in the popula-tion. The highest exposure

estimates for these women wereabove the federal safety standard(Blount et al 2000, Kohn et al2000, EPA 1990). EPA rates theiroverall confidence in the safetystandard as “low”, largely be-cause it is based on a studypublished in 1953 that did notexamine the test animals for thebirth defects that concern scien-tists today (EPA 1990).

DBP is just one ingredient inan alphabet soup of pollutantsthat contaminate every person inthe industrialized world. Apatchwork of studies from thefederal government indicates thateveryone in the United Statescarries more than 100 chemicalpollutants, pesticides, and toxicmetals in their bodies. No oneknows exactly where theseexposures come from, and noone has studied the effect ofconstant exposure to this low-level mixture of poisons. Nor isit possible to do so. To test 100chemicals in combinations ofthree for just one health effect(cancer, for example, as opposedto birth defects) would require162,000 new tests. There arecurrently 75,000 chemicals li-censed for use in the UnitedStates. Approximately 15,000 aresold in volumes greater than

DBP is just oneingredient in analphabet soup ofpollutants thatcontaminate everyperson in theindustrialized world.

No one knows exactlywhere these exposurescome from, and noone has studied theeffect of constantexposure to this low-level mixture ofpoisons.

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Table 1. EWG shoppers turned up 37 DBP-containingproducts from 22 companies.

Source: Environmental Working Group.

10,000 pounds per year. Underthe Toxic Substances Control Actthe EPA has regulated just fivechemicals (Roe et al 1997).

Government researchersspeculate that the elevated levelsof DBP among women of child-bearing age come from cosmeticsand beauty products, but no onehas done the studies to test thishypothesis. As a first step indiscovering some major sources,the Environmental WorkingGroup (EWG) shopped at a localRite-Aid, surfed the on-line storeDrugstore.com, and searched theU.S. patent office records forproducts that contain DBP in thepatent application. We found:

§§§§§ DBP in 37 popular nail pol-ishes, top coats, and harden-ers, including products byL’Oréal, Maybelline, Oil ofOlay, and CoverGirl (Table 1).

§§§§§ Patents proposing to use DBPin a broad range of beautyand personal care products,including shampoos andconditioners, lotions, hairgrowth formulations, antiper-spirants, and sunscreen. Evenpatents relating to gum,candy, and pharmaceuticalstaken orally propose DBP asan ingredient.

§§§§§ Many major manufacturerswho propose to use DBP incosmetics and related prod-ucts. Of more than 100patents analyzed by EWG,Procter & Gamble holds themost (37) that propose to useDBP in personal care prod-ucts. Other major companieswith multiple patents areL’Oréal (10), Lever Brothers(4), and Maybelline (3) (Table2).

Name brand Nail care product containing DBP

Black Radiance U.S.A. Black Radiance Nail Color

Bon Bons Bon Bons (nail polish)

Chanel Nail Colour

Christian Dior Nail Enamel

Club Monaco Nail Color

Cosmar Cosmar Press&Go Nails Kit

Cover Girl Cover Girl Nail Slicks

Hard Candy Nail Enamel

Loud Music Nail Enamel

M M Professional Nail Polish

Max Factor Diamond Hard Nail Enamel

Maybelline Express Finish Fast-Dry Nail EnamelUltimate Wear (nail enamel)Salon Finish Nail Enamel)

Nailene Professional Solutions Acrylic Tough Polish ShieldPROfessional Solutions Acrylic Polish ShieldPROfessional Solutions Calcium Growth BuilderNail Paints Art Kit

NARS Nail Polish

Naturistics 90 Second Dry Super Fast Nail Color

Nutra Nail Nutra Nail Maximum StrengthenerNutra Nail Calcium Nail thickenerNutra Nail Iron Shield Nail Hardener

Oil of Olay Nail Lacquer

Orly Orly Salon Nails Nail Color

Tony & Tina Tony & Tina (nail enamel)

Sally Hansen Color Fast! One Coat Fast-Dry EnamelMaximum Support Strengthen & GrowNo More Breaks Restructurizing StrengthenerHard as Nails with NylonTriple Strong Advanced Gel Nail FortifierThicken Up! Strengthening Nail ThickenerUltimate Shield Fortifyng Base & Top CoatHard as NailsInstant Strength Calcium Gel Nail Fortifier

Urban Decay Nail Enamel

Wet 'n' Wild Wet 'n' Wild Nail Color

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Table 2. Major corporations hold patents that propose to use the toxic plasticizer DBP in abroad range of consumer products, from nail polish to hair growth formulations.

Source: Environmental Working Group.

Company holding patentProducts for which DBP is proposed as essential or possible additive

The Procter & Gamble (Cincinnati, OH) lotion, hairspray, mousse, gel, lotion, cream, pomade, hair spray, conditioner, spritz, hair tonic, facial moisturizers, foundations, lipsticks, mascaras, nail polishes, oral pharmaceuticals, hair loss treatments

L'Oreal (Bureau D. A. Casalonga-Josse) hair and nail products

Lever Brothers Company (New York, NY) deodorant, skin and hair cleansers

Maybelline Cosmetics Corporation (Wilmington, DE) nail enamel

Anheuser-Busch, Incorporated (St. Louis, MO) gelled antiperspirant

Chesebrough-Pond's USA Co., Division of Conopco, Inc. (Greenwich, CT)

product to treat or prevent baldness

Colgate Palmolive Company (New York, NY) antiperspirant and deodorant gels

Eastman Chemical Company (Kingsport, TN) nail products

Elizabeth Arden Co., Division of Conopco, Inc. (New York, NY)

skin products

Kraft General Foods, Inc. (Northfield, IL) sunscreen

Revlon Consumer Products (NY, NY) nail enamel

Rhodia Chimie (Courbevoie, FR) hair and skin care products (sprays, tonic lotions, gels, mousses)

Rhone-Poulenc Chimie (Courbevoie Cedex, FR) nail varnishes

Unilever Patent Holding B.V. (Vlaardingen, NL) skin and hair care products, antiperspirants

The Spoils of a Rotten System

Contrary to popular belief,industrial chemicals in consumerproducts are essentially unregu-lated in the United States. Exceptfor chemicals added directly tofood, there is no legal require-ment for health and safetytesting or human exposuremonitoring for any chemical incommerce. The same chemicals,ironically, are often tightlyregulated as pollutants.

For example, phthalates arerecognized as toxic substancesunder environmental law, but

companies are free to use unlim-ited amounts in cosmetics. Anenvironmental release of just 10pounds of DBP must be reportedto environmental authoritiesunder the Superfund law. Thecosmetics industry, in contrast,puts hundreds of thousands ofpounds of DBP into nail polisheach year, with no requirementsfor safety testing or reporting toanyone.

In the 25 years of the ToxicSubstances Control Act, the EPAhas regulated exactly one toxic

Phthalates arerecognized as toxicsubstances underenvironmental law,but companies arefree to use unlimitedamounts in cosmetics.

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substance in a consumer product,lead in paint. This is largelybecause the agency cannotdemand the health and safetytests needed to evaluate achemical’s safety and risk. Indus-try recently agreed to a voluntarytesting program for high produc-tion volume compounds (chemi-cals produced annually inamounts of at least one millionpounds), but this program hasmany shortcomings. Many basictests are not required, such asthose for cancer, nervous systemdamage, and virtually all tests fortoxicity to the developing andimmature animal including devel-opmental neurotoxicity or effectson the immature immune system.About 80 percent of all highproduction volume chemicals arenot covered by the initiative.

Pivotal court decisions imple-menting the 1976 Toxic Sub-stances Control Act (TSCA) haverendered EPA impotent to controltoxic chemicals in commerce.The agency must prove an “un-reasonable risk of injury” tohuman health before it canremove a chemical from themarket. But EPA is powerless tomake that finding because thelaw prohibits the agency fromrequiring safety studies until itproves that “substantial” or “sig-nificant” exposures are occurring.The agency can almost neverprove that substantial or signifi-cant exposures are occurringbecause exposure data are alsoextremely difficult to obtain.

In other words, EPA cannotregulate a chemical until it makes

a finding of risk based on datathat the law virtually prohibits itfrom collecting.

The law also allows industryto manufacture and sell newchemicals without conductingany toxicity studies to determineif the chemicals are safe. After achemical enters the marketplace,there is no requirement forhuman monitoring, even forthose compounds to whichpeople are routinely exposed.

Except for direct food addi-tives, the Federal Food Drug andCosmetic Act (FDC&A) is nobetter (FDA 2000). DBP isallowed in food as an indirectadditive via food packaging, butthis use was grandfathered inand has not been subject tomodern food safety standards.The FDC&A does not requirepre-market safety testing, review,or approval for cosmetics or thecompounds used to make them.While manufacturers might studythe short-term effects in labanimals of the substances thatthey sell, they almost neverstudy long term effects of theirproducts. Industry can and doesput chemicals into widespreadcommercial use without mean-ingful testing for toxicity andwithout any monitoring ofpeople or the environment.

What You Can Do

Researchers are just beginningto discover the names of thehundreds of commercial chemi-cals that contaminate the humanbody. What those chemicals’

Industry can and doesput chemicals intowidespreadcommercial usewithout meaningfultesting for toxicity andwithout anymonitoring of peopleor the environment.

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actual health effects might be arejust beginning to be understood.In the meantime, scores of newchemicals are introduced intocommerce each year, with norequirement that they be shownto be safe.

This situation is the singlebiggest failure in U.S. environ-mental law and is not likely tobe fixed anytime soon. Until itis, people can do a few simplethings to reduce exposure to thecontaminants that we do knowabout.

§ Women who are pregnant,nursing or thinking aboutgetting pregnant should lookfor and avoid all personalcare products with the wordphthalate on the label. Somecommon forms of phthalatesin personal care products aredibutyl phthalate, diethylphthalate, and dimethylphthalate.

§ Urge manufacturers toreformulate their productswith safer alternativechemicals. Go towww.ewg.org for a list ofphone numbers and e-mailaddresses for some majorpersonal care productsmanufacturers.

§ If you use nail products,choose those that containfewer toxins. Use productsfree of DBP and othercommon nail polish toxinslike toluene andformaldehyde. Types of nail

polish that are DBP-, toluene-,and formaldehyde-freeinclude L’Oréal Paris Jet-SetQuick Dry Nail Enamel,Revlon Nail Enamel, GardenBotanika Natural Color NailColor, and Kiss Products KissColors, to name a few.

Policy Recommendations

When it comes to the use ofpotentially toxic chemicals inmanufactured consumer prod-ucts, the official operating prin-ciple is use first, test later, orbetter yet, don’t test at all. Thissituation is disgraceful and com-pletely unacceptable. In the faceof growing evidence that thehuman population is contami-nated with hundreds of poorlytested hazardous industrialchemicals, we recommend thefollowing:

§ The chemical industry mustimmediately and completelyfund a comprehensive humanbiomonitoring initiative inconjunction with the Centersfor Disease Control andPrevention. The initiativewould monitor the humanpopulation for all chemicalsreasonably likely to be foundin human tissue. The studydesign must include highlyexposed and potentiallyvulnerable sub-populations,and must include enoughindividuals to supportstatistically meaningfulconclusions and regulatorydecisions for all sectors of thepopulation, and all chemicals

When it comes to theuse of potentially toxicchemicals inmanufacturedconsumer products,the official operatingprinciple is use first,test later, or betteryet, don’t test at all.

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monitored. All of theinformation gathered must bemade available to the publicafter it is peer reviewed.

• The chemical industry mustexpand its commitment toscreening of high produc-tion volume chemicals toinclude tests for carcinoge-nicity, neurotoxicity,immunotoxicity, and endo-crine system toxicity at alllife stages including gesta-tion, infancy, childhood,adolescence and adulthood.

• The chemical industry andthe personal care productsindustry must immediatelylabel all products contain-ing phthalates and anyother toxic substance towhich there is humanexposure. Labels must beimproved so that they arelegible.

• The current exemption forlabeling requirements thatapplies to non-retail salesof these products to profes-sionals, must be rescinded.

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Administration (OSHA), and wasrepeated with the passage andimplementation of the ToxicSubstances Control Act (TSCA).

The first chemical health stan-dards in the United States wereadopted by OSHA in 1972. Set intheory to protect workers, thesestandards were initially created inthe 1940’s by representatives fromthe chemical industry operatingunder the auspices of the Ameri-can Council of Governmental andIndustrial Hygienists (ACGIH). Atthe time the standards were firstintroduced in 1942, ACGIH issuedmajor caveats regarding theirapplication to human health,stating that: “[they are] not to beconstrued as recommended safeconcentrations” (NCGIH 1942).

Toxicity tests on animals hadbarely been invented at that time,and the standards themselveswere based on rough estimates ofacutely hazardous and lethallevels of exposure. In the wordsof the scientist who devised manyof them, the so-called thresholdlimit values (TLVs) were de-signed, “to provide a handyyardstick to be used as guidancefor the routine control of thesehealth hazards — not that compli-ance with the figures listed would

No pre-market safety testingor approval is required underany federal law for chemicals incosmetics, toys, clothing, car-pets, or construction materials,to name just a few obvioussources of chemical exposure ineveryday life. This little knownfact is the premeditated result ofan orchestrated campaign by thechemical industry to avoidtesting and regulation of theirproducts. It largely explains whyproducts like hair spray, hairdye, pacifiers, stain repellants,glues and children’s toys get onthe market, only to be found tocontain highly toxic compoundsat unsafe levels after decades ofwidespread use. Once theseproducts are on the market,there is no practical legal mecha-nism by which health authoritiescan remove them from com-merce, short of a public healthdisaster or consumer uproar.

OSHA

Since the 1950’s, the chemicalindustry has systematicallyblocked efforts to require safetystudies for the compounds itproduces. This strategy firstplayed out with workplacestandards adopted under theOccupational Safety and Health

Chemical industry systematicallydefeats health protections

Beauty Secrets

Since the 1950’s, thechemical industry hassystematically blockedefforts to requiresafety studies for thecompounds itproduces.

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guarantee protection against illhealth” (Cook, 1945).

This did not stop the chemicalindustry from promoting TLVs aslegitimate health standards, and in1972, OSHA adopted TLVs whole-sale as the nation’s first set ofenforceable health standards forchemicals in the workplace. Inthe process these “handy yard-sticks” took on an aura of respect-ability that belied the fact thatthere was essentially no science tosupport their relevance to humanhealth and safety. The best esti-mates are that basic toxicologicaldata were available for only fivepercent of some 600 industrialchemicals for which OSHA hadadopted standards by 1988(Castleman and Ziem 1994, Roachand Rappaport 1990).

TSCA

This process of faux regulationwas repeated again when thesame chemical industry giantsteamed up to write the nation’smajor toxic chemical law, theToxic Substances Control Act(TSCA). Passed with virtually noregulatory teeth, TSCA has beenan unparalleled failure. Of the62,000 chemicals on the marketwhen TSCA was passed in 1976,EPA has successfully requesteddata for 263 compounds. Of the15,000 chemicals marketed inquantities exceeding 10,000pounds per year, EPA has com-pleted regulatory actions to limituse or exposures on just 5, or 0.03percent (3 one hundredths of onepercent). Four of the five werealready regulated under other

statutes, and only one, lead inpaint, affected a consumerproduct (Roe et al 1997).

TSCA is best thought of as aself-defeating feedback loop.Under the law, all chemicals arepresumed safe, and the burdenof proof is on the EPA to dem-onstrate that a chemical iscausing harm before it can takeany regulatory action. However,the agency cannot require thatindustry conduct the testsneeded to show that a chemicalis causing harm, until theagency has shown that thecompound may present an"unreasonable risk," or thathuman exposure is "substantial"or "significant". Substantialexposures can almost never beproven without additional datafrom industry, and significantexposures cannot be provenwithout information on thechemical’s toxicity. Of course,compelling toxicity data arealmost never available for thecompound in question or EPAwould not be trying to publisha test rule in the first place.

Even if all these hurdles arecleared, which is extremelyunlikely, in order to requestbasic toxicity data on any singlechemical the EPA must issue atest rule through the process ofa rulemaking under administra-tive law. This roadblock isunique to TSCA. Under pesti-cide law, or food safety law,EPA or FDA can request virtu-ally any test that they need toassess the safety of a com-pound.

Passed with virtuallyno regulatory teeth,TSCA has been anunparalleled failure.

Of the 15,000chemicals marketed inquantities exceeding10,000 pounds peryear, EPA hascompleted regulatoryactions to limit use orexposures on just 5, or0.03 percent.

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A defining moment in thecollapse of TSCA occurred in1990 when EPA attempted toissue test rules for the paintthinner cumene. The proposedtest rules were immediatelychallenged by the ChemicalManufacturers Association onthe grounds that EPA had notshown that human exposurewas “substantial,” the basicrequirement under Section 4 ofthe Act. The courts upheld theCMA argument that the burdenof proving “substantial” expo-sure and risk was on the EPAand not the manufacturers(Chemical Manufacturers Ass’n v.EPA, 5th Cir. 1990).

To date EPA has issued rulesrequiring toxicity testing for 0.4percent, or 263, of the 62,000chemicals on the market whenthe law was passed. And evenwhen issued, test rules generallydo not require comprehensivetesting. With barely any datagenerated via test rules theagency cannot support a findingof substantial risk for any chemi-cal, and indeed the agency hastaken only five final actionssince passage of the law (Roe etal 1997).

The final nail in the coffincame in 1991. EPA was trying touse TSCA to regulate asbestos,arguing that it presented an“unreasonable risk of injury” tohuman health. Again the TSCAfeedback loop prevailed, and thecourt ruled that EPA had not metthe burden of providing substan-tial evidence that asbestos pre-sented an unreasonable risk of

injury to human health (Corro-sion Proof Fittings v. EPA, 5th

Cir. 1991). Since this decision,EPA has undertaken no addi-tional major regulatory actionsunder the Act.

Under pressure from environ-mentalists and the Clinton ad-ministration, in 1999 the chemi-cal industry agreed to conductbasic health screening tests forabout 3,000 high productionvolume compounds out of auniverse of more than 75,000chemicals registered for com-mercial use today, 15,000 ofwhich are marketed in quantitiesexceeding 10,000 pounds peryear. This tiny step forward isentirely voluntary and, even if itis completed, it will not provideregulators and public healthauthorities with sufficient infor-mation to fully assess the long-term adverse effects of toxicchemical exposure. Tests nowrecognized as critical to a fullunderstanding of a chemical’stoxicity will not be conducted atall under this initiative. Theseinclude cancer bioassays, studieson the developing nervoussystem, the immune system, theendocrine system, and perhapsmost important, human monitor-ing to determine the extent ofhuman exposure.

This latter element is critical.As discussed below, a string ofrecent discoveries reveal thathuman exposure to commercialchemicals used in commonconsumer products is almostcertainly much more pervasivethan previously thought. Thisnew strata of contamination is in

Tests now recognizedas critical to a fullunderstanding of achemical’s toxicitywill not be conductedat all under thisinitiative.

In 1999 the chemicalindustry agreed toconduct basic healthscreening tests forabout 3,000 highproduction volumecompounds out ofuniverse of more than75,000 chemicalsregistered forcommercial use today.

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addition to the considerable well-known toxic load of pollutants(such as PCBs, dioxin, and DDT)found in the blood and body fatof virtually all people in theindustrialized world.

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new Center for the Evaluation ofRisk to Human Reproduction(CERHR).

At the same time, scientists atthe Centers for Disease Controland Prevention (CDC) wereachieving the first accurate mea-surements of phthalates inpeople. Researchers there weresurprised to find that people havemuch higher levels of somephthalates in their bodies thanpredicted by previous estimates(Blount et al 2000). In October2000, CDC scientists announcedthat levels of some phthalates inwomen of childbearing age,including dibutyl phthalate (DBP)and di(2-ethylhexyl) phthalate(DEHP), exceed the government’ssafe levels set to protect againstbirth defects. Estimates based ondata from this study indicate thatfor more than 3 million heavilyexposed women of childbearingage, exposures to DBP may be 20times greater than the averageexposures in the rest of the popu-lation (Kohn et al 2000).

This report focuses primarilyon DBP, a widely used phthalatethat produces serious reproduc-tive and developmental effects inlaboratory animals. But DBP isnot the only toxic phthalate to

Invented in the 1930’s, theversatile group of commonindustrial chemicals called ph-thalates (pronounced tha-lates)are used as ingredients in adiverse range of consumerproducts from cosmetics to foodwraps, toys and building materi-als. Currently the chemicalindustry produces billions ofpounds of phthalates each year.They are used as plasticizers tosoften plastic, as skin moisturiz-ers and skin penetration enhanc-ers in cosmetics, and as solventsin a wide range of applications.People are exposed to phtha-lates daily through their contactwith consumer products and viafood and indoor air.

In spite of their widespreadpresence in cosmetics and othercommon consumer products,industry has only partially stud-ied the health effects of phtha-lates and has never tested forthe presence of phthalates inhuman bodies. Finally, in April1999, over six decades afterphthalates were first marketed,the federal government’s Na-tional Institute for EnvironmentalHealth Sciences (NIEHS) initi-ated a study of the effects ofphthalates on the human repro-ductive system through their

Phthalates

Beauty Secrets

Currently thechemical industryproduces billions ofpounds of phthalateseach year.

In October 2000, CDCscientists announcedthat levels of somephthalates in womenof childbearing age,including dibutylphthalate (DBP) anddi(2-ethylhexyl)phthalate (DEHP),exceed thegovernment’s safelevels set to protectagainst birth defects.

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12 BEAUTY SECRETS

which people are routinelyexposed. Many other phthalateswidely detected in human urineby the CDC cause the same birthand developmental defects to themale reproductive system asDBP. Absent evidence to thecontrary, it is reasonable toassume that the health effectsfrom exposures to multiplephthalates are additive.

Health effects of dibutylphthalate

At least two decades ago,scientists began building a bodyof work indicating that DBP canbe a powerful reproductive anddevelopmental toxicant in labora-tory animals, particularly formales. Early studies focused onDBP’s ability to cause testicularatrophy (e.g., Gray et al 1980),but DBP is now known to causea broad range of birth defectsand lifelong reproductive impair-ment in male laboratory animalsexposed in-utero and shortlyafter birth (Ema et al 1998,Marsman et al 1995, Mylchreest etal 1998, 1999, and 2000, Gray etal 1999, Wine et al 1997 ).

Scientists believe that theactive toxicant of DBP exposureis its first breakdown product,monobutyl phthalate (MBuP),which has been shown to harmthe male reproductive system.The precise mechanism of actionis not known but the pattern ofreproductive harm is consistentwith other so-called anti-andro-gens or chemicals that interferewith the male hormones calledandrogens.

Effects in immature maleanimals: DBP exposure dam-ages the testes, prostate gland,epididymus, penis, and seminalvesicles in laboratory animals(see, for example, Mylchreest etal, 1998). These effects persistthroughout the animal’s life, andinclude, specifically:

§ Testicular atrophy (the testesproduce sperm and male sexhormones)

§ Hypospadias (a defect of thepenis in which the openingoccurs on the bottom of thepenis instead of the tip)

§ Undescended testicles – acondition in which the testesfail to descend into thescrotal sac during pregnancy.

§ Ectopic testes – a conditionin which testes are grownoutside the scrotal sac

§ Absent testes – testes are notformed at all

§ Absent prostate gland (theprostate gland contributesliquid secretions to semen)

§ Absent or small seminalvesicles (seminal vesicles,like the prostate gland,contribute liquid secretionsto semen)

§ Reduced sperm count(reduced fertility of offspring)

§ Malformed or absentepididymus (the epididymus

At least two decadesago, scientists beganbuilding a body ofwork indicating thatDBP can be apowerful reproductiveand developmentaltoxicant in laboratoryanimals, particularlyfor males.

Early studies focusedon DBP’s ability tocause testicularatrophy.

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is the structure where spermmature and are stored)

Potential health effects ofDBP continue to be significantfor newborn animals who canbe exposed to DBP by breathingphthalate-contaminated air, bytouching things that containphthalates, or by drinking theirmother’s milk, which can con-tain phthalates as a result of herexposures. In young lab ani-mals, DBP has been shown tocause permanent testicularatrophy and reduced spermcounts (Foster et al 1981,Marsman 1995).

In animal tests DBP is also“embryolethal” — causing lossof pregnancy — and preventsimplantation of the fertilizedegg. In lab animals it alsocauses “resorption” of some orall of the fetuses in a litter,where the mother’s body essen-tially dissolves the fetus withoutmiscarriage. DBP also causes arange of skeletal and externalbirth defects for male and femaleoffspring of animals exposedduring pregnancy – includingdeformity of vertebra and ribs,cleft palate, and fused breast-bone (Ema et al 1994 and 1995).

Relevance to people

Broad and disturbing trendsin human male reproductivehealth include many of the sameeffects seen in lab animals dosedwith phthalates. Although acause and effect relationship hasnot been established, the ubiq-uity of phthalates in the human

population creates a biologicallyplausible presumption that phtha-lates may be contributing to theseproblems. Until proven safe,phthalates should be consideredas potential contributors to thefollowing human health effects:

§ Declining sperm count:Recent analysis of 101 studies(1934-1996) by Shanna Swanof the University of Missouriconfirms results of previousstudies: average sperm countsin industrialized countries aredeclining at a rate of about 1percent each year (Swan et al2000).

§ Hypospadias: Data from theCenters for Disease Controlshow that rates ofhypospadias in the U.S. beganclimbing in about 1970, andcontinued this increasethrough the 1980s. Thiscondition is a physicaldeformity of the penis inwhich the opening of theurethra occurs on the bottomof the penis instead of the tip.(Currently the occurrence ofhypospadias appears to bestable, at about 30 to 40 casesper 10,000 births.) (Paulozzi1999)

§ Undescended testicles: Thisbirth defect, where testiclesfail to completely descendinto the scrotum duringpregnancy, occurs in 2-5percent of full-term boys inWestern countries. Rates ofthe defect increased greatly inthe U.S. in the 1970s and

In young lab animals,DBP has been shownto cause permanenttesticular atrophy andreduced sperm counts.

In animal tests DBP isalso “embryolethal” –causing loss ofpregnancy — andprevents implantationof the fertilized egg.

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1980s. Men born with thisdefect are at higher risk fortesticular cancer and breastcancer (Paulozzi 1999).

§ Testicular cancer: This is themost common cancer ofyoung men in manycountries, including the U.S.Its incidence continues toincrease at a rate of about 2to 4 percent each year inindustrialized countries,although rates appear to havestabilized in the U.S. after a20-year increase. Men withhypospadias, infertility, andundescended testicles – thesame constellation ofconditions seen in lab animalsexposed to DBP – are atgreater risk for developingtesticular cancer (Toppari et al1996 and Moline 2000).

History of recent governmentstudies of phthalates

In April 1999, CERHR initiateda review of the reproductive anddevelopmental effects of phtha-lates in humans. The Centerchose seven phthalates for ex-amination, based on consider-ation of production volume,extent of human exposures, usein children’s products, or pub-lished evidence of reproductiveor developmental toxicity.

They addressed the followingthree questions for each phtha-late based on their current under-standing of levels of humanexposure to phthalates:

1. Are young children atrisk for harm to the reproduc-tive system?

2. Is the fetus at risk fordevelopmental effects when themother is exposed?

3. Are adults at risk foreffects to the reproductivesystem?

In their June 2000 reportdraft CERHR assigned low,minimal, or negligible concernto five phthalates, and higherconcern for only one, DEHP.(“Concern” refers to whetherCERHR believes the chemical isa reproductive or developmen-tal toxicant in people at currentlevels of exposure.)

In September 2000, Dr.Brock and his team of CDCscientists published the resultsof the first human testing pro-gram for phthalates (Blount etal 2000). The results turned theCERHR conclusions of minimalconcern on end. They foundphthalates in every persontested, and at surprisingly highlevels in some individuals forsome phthalates. The scientistsconcluded that “from a publichealth perspective, these dataprovide evidence that phthalateexposure is both higher andmore common than previouslysuspected, ” adding that, “Expo-sure data for phthalates is (sic)critically important for humanrisk assessment, especiallyamong potentially susceptiblepopulations.”

In September 2000,CDC scientistspublished the resultsof the first humantesting program forphthalates.

They found phthalatesin every person tested,and at surprisinglyhigh levels in someindividuals.

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Brock and his team measuredlevels of seven phthalate me-tabolites in the urine of 289adults. They found metabolitesfrom two of these in 100 percentof those tested – dibutyl phtha-late, or DBP, and benzylbutylphthalate, or BzBP. A metabo-lite of DBP called monobutylphthalate (MBuP), a potentreproductive toxin in lab ani-mals, was found at significantlyhigher levels in women ofchildbearing age. Six of theeight highest measured levelswere in this group. CDC postu-lates in their paper that highexposures to phthalates inwomen of childbearing age mayarise from the use of cosmeticsand beauty products.

These results caught bothgovernment and industry offguard. Now, government scien-tists are beginning a search foranswers: Are normal body levelsof phthalates safe for infants andpregnant women? How arepeople exposed to phthalates –through which consumer prod-ucts and via what pathway?

Government scientists pub-lished a letter in the Octoberissue of Environmental HealthPerspectives outlining the signifi-cance of the CDC urine study.Their analyses showed that thehighest exposures measured, inwomen of childbearing age, wereabove federal safety levels set toprotect against birth defects.

THE PHTHALATE INDUSTRY LEFT IT UP TO THE GOVERNMENT TO FINALLY DEVELOP A TESTMETHOD THAT GIVES ACCURATE MEASUREMENTS OF PHTHALATES IN PEOPLE.

Historically, phthalate exposure has been difficult to measure precisely because thecompounds are so widely used. Pervasive background contamination during laboratoryanalyses commonly produced test results where true contamination in body fluids couldnot be distinguished from phthalates found in laboratory equipment or in cosmeticsworn by technicians. Until the CDC published its research in September 2000, it wasgenerally assumed that phthalates detected in biological samples in large part reflectedthis background contamination.

As the CERHR study of phthalate risk neared completion, independent work led by Dr.John Brock at the Centers for Disease Control and Prevention (CDC) resulted in a newanalytical method that would, for the first time, allow for the accurate analysis ofphthalates in biological samples free from concerns of background contamination.Brock’s method involves testing urine for human breakdown products, or metabolites,of phthalates. The specific metabolites for which he tests, called the glucaronidatedmonoesters, are not manufactured by industry. With Brock’s innovative method, issuesof background contamination disappear.

The results caughtboth government andindustry off guard.

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Estimates based on these dataindicate that DBP exposures forup to 3 million women of child-bearing age may be 20 timeshigher than for the rest of thepopulation.

In an effort to determine keyroutes of exposure, CDC is be-ginning work on an extensivesurvey to find which products arecausing the high DBP levels inwomen of childbearing age.

Phthalates: regulated as toxicpollutants – but OK in consumerproducts

Phthalates are considered ahazardous waste and are regu-lated as pollutants in air andwater. In contrast, phthalates areessentially unregulated in foodand cosmetics. (One phthalate,DEHP, which was removed fromchildren’s toys more than adecade ago, is regulated in drink-ing water.)

Under various environmentallaws, individual companies arelimited with regards to howmuch DBP they can release tothe environment as pollutioneach year. For example, indus-tries must report any spill orrelease of DBP over 10 pounds,and industries using phthalatesmust keep records of their loca-tion and transportation. But FDAdoes not limit the amount of DBPthat can be used in cosmetics andother beauty products. And theFD&C Act does not require thatcosmetic manufacturers or mar-keters test their products forsafety.

So, by design from the chemi-cal industry, the federal govern-ment treats phthalates with abipolar approach. Phthalates arerecognized as toxic substancesunder environmental law, butcompanies are free to use unlim-ited amounts in cosmetics.Moreover, the labeling require-ments for cosmetics are riddledwith loopholes. If a womanreads the fine print on the backof every cosmetic bottle shepurchases, she might discoverwhether the product containsphthalates. However, she won’tknow the quantiy of phthalatesin the product, or what healtheffects her use of the productcould possibly have on herfetus.

Specifically, FDA’s labelingrequirements state that all cos-metics produced or distributedfor retail sale to consumers fortheir personal care bear a list ofingredients, ordered by preva-lence (21 CFR 701.3). Cosmeticlabeling requirements apply toall cosmetics marketed in theU.S., whether manufactured hereor abroad. But it’s simple forindustry to hide phthalates inconsumer products, as compo-nents of fragrances, flavorings —or chemical mixtures that areconsidered “trade secrets” — allof which are exempt from label-ing requirements.

Remarkably, women whowork in nail and hair salons andpresumably get the highestexposures, are not protectedeven by labeling regulations.Ingredient labeling requirements

If a woman reads thefine print on the backof every cosmeticbottle she purchases,she might discoverwhether the productcontains phthalates.However, she won’tknow how muchphthalates are in theproduct, or whathealth effects her useof the product couldpossibly have on herfetus.

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do not apply to products usedonly by beauty professionals inthe workplace. The 1997 U.S.Economic Census shows thatover 407,000 people are em-ployed in the more than 81,000beauty salons across the country.These employees, primarilywomen including what is likelya large percentage of women ofchildbearing age, are exposed toDBP in beauty products daily,with no knowledge of it and nooption for choosing alternateproducts.

The federal government has“low” confidence in their safedaily dose value for DBP

Ten years ago, using a studypublished in 1953, the Environ-mental Protection Agency (EPA)established a “safe” daily dose ofDBP, called the Reference Dose,or RfD. Even then, the EPAcharacterized this pivotal studyas weak, and their confidence inthe RfD as “low.” Ten yearslater the agency has not revisedthe safe dose, nor required newstudies to strengthen its knowl-edge of DBP toxicity.

The CDC found that high-endDBP exposures in women ofchildbearing age are above thefederal safe daily dose (Kohn etal 2000). If the safe daily dosevalue were brought up to mod-ern standards, even morewomen in the CDC study groupwould fall into the zone ofconcern.

The study supporting the RfDis archaic in design and does not

provide any information on thehealth effects that concern scien-tists today – birth defects in maleoffspring. The study includedonly adult male rats, and deathwas the only health effect stud-ied. Irrespective of the fact thatthe study examined only themost crude endpoint, the resultsare of marginal relevance to realworld human exposures, and donot provide a sufficient scientificbasis to establish a safe exposurelevel under contemporary stan-dards applied to pesticides orfood additives regulated underfederal law. EPA admits that thestudy has many deficiencies. Intheir documentation of the RfDthe agency states “The Oral RfDfor dibutyl phthalate may changein the near future pending theoutcome of a further review nowbeing conducted by the Oral RfDWork Group” (EPA 1990).

Nonetheless, the current RfDis derived from a “safe” dose inthis study of 125 mg of chemicalingested per kilogram of bodyweight (mg/kg) – the dose thatwas shown to induce no addi-tional deaths relative to thecontrol group. A study pub-lished this year (2000) found thatexposures at this level, thoughtpreviously to produce no effects,in fact cause birth defects inmale pups, including extranipples in a third of the pups(Mylchresst et al 2000). Thisstudy found a “safe” dose, calleda no observed adverse effectlevel, or NOAEL, of 50 mg/kg –60 percent lower than the dosethat is currently the basis for theRfD.

Women who work innail and hair salonsand presumably getthe highest exposures,are not protected evenby labelingregulations.

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It is remarkable that such aheavily used chemical, withknown toxicity, can be so poorlyregulated. For example, Procter& Gamble holds a patent whichproposes to add 5 milligrams ofDBP to each dose of an oralpharmaceutical. A woman ofaverage weight (140 pounds)ingesting this tablet would get adaily dose of DBP that is 80percent of her current allowabledaily dose defined by the RfD.She would get double the dosethat would be allowed if the RfDwere updated to protect themale fetus from birth defects,assuming no other exposure toDBP in other products.

The Environmental WorkingGroup conducted a web-basedanalysis to locate consumerproducts, particularly cosmeticsand beauty aids, containingphthalates. We found bothdibutyl phthalate (DBP) anddiethyl phthalate (DEP) in nu-merous products, andbutylbenzyl phthalate (BBP) in asmaller number of products.Ultimately we limited our searchto DBP, because it is a morepotent reproductive and devel-opmental toxin than DEP, and isfound in a greater number ofproducts than BBP.

Phthalates in cosmetics andbeauty products

Several points became clearduring our product search. First,alternatives to phthalates arereadily available to industry, asonly a fraction of any given typeof cosmetic or beauty productcontains phthalates.

Second, women have nopractical way to choose productsthat are phthalate-free. Somecosmetics contain ingredientlabels on the outside of theproduct, but the print is so smallas to be nearly unreadable, and atypical shopper will not knowthat “dibutyl phthalate” is thesame thing as “butyl ester” oreven possibly “plasticizer.” Otherproducts, such as more expen-sive perfumes, contain ingredientlabels inside the packagingwhere they cannot be read untilafter the product is purchased.We found still other products onstore shelves, particularly im-ported products, that lackedingredient labels altogether, indirect violation of federal regula-tions.

Third, with information cur-rently in the public arena, it isnearly impossible to developanything approaching a compre-hensive list of cosmetic andbeauty products that contain

Beauty Secrets

Women have nopractical way tochoose products thatare phthalate-free.

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Table 3. A limited online drugstore label search by EWG found DBP in 37 nail products from22 companies, including Cover Girl, Maybelline, and MaxFactor products.

Source: Environmental Working Group.

phthalates. This would require aproduct-by-product, label-by-label search of every singlecosmetic and personal care boxand bottle sold in the UnitedStates. The results of our analysisonly scratch the surface of whatwill be a daunting task for CDCas they try to define exactlywhere women of childbearingage are being exposed to phtha-lates.

As a first step in discoveringsome of the beauty and personalcare products that contain DBP,

the Environmental WorkingGroup (EWG) shopped at a localRite-Aid, surfed the on-line storeDrugstore.com, and searched theU.S. patent office records forproducts that contain DBP in thepatent application. We foundthat DBP may be used in abroad range of beauty andpersonal care products, includ-ing shampoos and conditioners,lotions, hair growth formula-tions, antiperspirants, and sun-screen. It can even be used ingum, candy and pharmaceuticalstaken orally.

Name brand ProductManufacturer or parent company, and distributor shown in italics Location

Black Radiance U.S.A. Black Radiance Nail Color AM Cosmetics, Inc. North Arlington, NJ 07031Bon Bons Bon Bons (nail polish) Bari Cosmetics, Ltd Greenwich, CT 06831Chanel Nail Colour Chanel, Inc. New York, NY 10019Christian Dior Nail Enamel Parfums Christian Dior Paris, FranceClub Monaco Nail Color Club Monaco Cosmetics Toronto, CanadaCosmar Cosmar Press&Go Nails Kit Cosmar Corporation Huntington Beach, CA 92647Cover Girl Cover Girl Nail Slicks Procter & Gamble Inc. (Noxell Corp ) Hunt Valley, MD 21030Hard Candy Nail Enamel Hard Candy, Inc. Beverly Hills, CA 90211Loud Music Nail Enamel Sel-Leb Marketing Patterson, NJ 07524M M Professional Nail Polish Professional Makeup Company Hollywood, CA 90028Max Factor Diamond Hard Nail Enamel Procter & Gamble Inc. (Max Factor & Co. ) Hunt Valley, MD 21030Maybelline Express Finish Fast-Dry Nail Enamel L'Oréal USA (Maybelline LLC ) New York, NY 10017

Ultimate Wear (nail enamel) L'Oréal USA (Maybelline LLC ) New York, NY 10017Salon Finish Nail Enamel) L'Oréal USA (Maybelline LLC ) New York, NY 10017

Nailene Professional Solutions Acrylic Tough Polish Shield Pacific World Corp. Lake Forest, CA 92630PROfessional Solutions Acrylic Polish Shield Pacific World Corp. Lake Forest, CA 92630PROfessional Solutions Calcium Growth Builder Pacific World Corp. Lake Forest, CA 92630Nail Paints Art Kit Pacific World Corp. Lake Forest, CA 92630

NARS Nail Polish Agora Cosmetics, Inc. New York, NY 10012Naturistics 90 Second Dry Super Fast Nail Color Del Laboratories, Inc (Naturalistics Div. ) Farmingdale, NY 11735Nutra Nail Nutra Nail Maximum Strengthener CCA Industries, Inc. E Rutherford, NJ 07073

Nutra Nail Calcium Nail thickener CCA Industries, Inc. E Rutherford, NJ 07073Nutra Nail Iron Shield Nail Hardener CCA Industries, Inc. E Rutherford, NJ 07073

Oil of Olay Nail Lacquer Procter & Gamble Inc. Hunt Valley, MD 21030Orly Orly Salon Nails Nail Color Orly International Inc. Los Angeles, CA 91311Sally Hansen Color Fast! One Coat Fast-Dry Enamel Del Laboratories, Inc (Sally Hansen Div. ) Farmingdale, NY 11735

Maximum Support Strengthen & Grow Del Laboratories, Inc (Sally Hansen Div. ) Farmingdale, NY 11735No More Breaks Restructurizing Strengthener Del Laboratories, Inc (Sally Hansen Div. ) Farmingdale, NY 11735Hard as Nails with Nylon Del Laboratories, Inc (Sally Hansen Div. ) Farmingdale, NY 11735Triple Strong Advanced Gel Nail Fortifier Del Laboratories, Inc (Sally Hansen Div. ) Farmingdale, NY 11735Thicken Up! Strengthening Nail Thickener Del Laboratories, Inc (Sally Hansen Div. ) Farmingdale, NY 11735Ultimate Shield Fortifyng Base & Top Coat Del Laboratories, Inc (Sally Hansen Div. ) Farmingdale, NY 11735Hard as Nails Del Laboratories, Inc (Sally Hansen Div. ) Farmingdale, NY 11735Instant Strength Calcium Gel Nail Fortifier Del Laboratories, Inc (Sally Hansen Div. ) Farmingdale, NY 11735

Tony & Tina Tony & Tina Nail Enamel Tony & Tina, Inc. New York, NY 10012Urban Decay Nail Enamel Urban Decay Costa Mesa, CA 92627Wet 'n' Wild Wet 'n' Wild Nail Color AM Cosmetics, Inc. North Arlington, NJ 07031

The results of ouranalysis only scratchthe surface of whatwill be a daunting taskfor CDC as they try todefine exactly wherewomen ofchildbearing age arebeing exposed tophthalates.

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Our product label searches inelectronic and real-world drug-stores showed that, for theconsumer, the products mosteasily found that contain DBPare nail enamels and hardeners.In a limited label search of nailproducts on online drugstoreweb sites, EWG found DBP in awide variety of name branditems, including Cover Girl andMaybelline nail enamels (Table3).

The difficulty of compilingcomprehensive lists of phthalate-containing cosmetics, from labelsearches alone, led us to conducta web-based patent search todiscover which companiesclaimed cosmetic-related inven-tions that included phthalates asingredients. As of October 5,2000, the U.S. Patent and Trade-mark Office had records of 309patents related to cosmetics thatincluded DBP as an essential oroptional ingredient, or as aningredient in an example prod-uct formulation. Thirty-eightindividual companies or inven-tors hold 105 recent cosmetic-related patents that propose DBPas an additive (Table 4).

In some patents, companiesgave information on the percentby weight of DBP proposed tobe added to the product. DBPin nail polishes tends to beadded at about five percent byweight (for example, Maybellinenail enamel patent 5972095), butDBP in other products rangedup to 20 percent, in a nightcream invented by the Japanese

Table 4. Proctor and Gamble holds more phthalate-relatedcosmetic patents than any other company (37 of 105patents analyzed).

Source: Environmental Working Group.

AssigneeNumber of

patentsProducts for which DBP is proposed as essential or possible additive

The Procter & Gamble (Cincinnati, OH) 37 lotion, hairspray, mousse, gel, lotion, cream, pomade, hair spray, conditioner, spritz, hair tonic, facial moisturizers, foundations, lipsticks, mascaras, nail polishes, oral pharmaceuticals, hair loss treatments

L'Oréal (Bureau D. A. Casalonga-Josse) 10 hair and nail productsLever Brothers Company (New York, NY) 4 deodorant, skin and hair cleansersLVMH Recherche (FR) 4 nail varnishShiseido Co., Ltd. (Tokyo, JP) 4 skin cream for pharmaceuticals or night

creamKirker Enterprises, Inc. (Paterson, NJ) 3 nail enamelMansouri; Zari (828 Port Walk Pl., Redwood Shores, CA 94065)

3 skin lotions

Maybelline Cosmetics Corporation (Wilmington, DE)

3 nail enamel

Woodward Laboratories, Inc. (Los Alamitos, CA) 3 nail products

Almell, Ltd. (Dallas, TX) 2 nail productsAstra Aktiebolag (Sodertalje, SE) 2 lotions and skin creamsBar-Shalom; Daniel (Rypevaenget 213, DK-2980 Kokkedal, DK); Bukh; Niels (Strandvejen 122, DK-2900 Hellerup, DK)

2 product to treat or prevent baldness

Focal, Inc. (Lexington, MA) 2 in creams, gels, powders, etc applied to skin

Perio Products, Ltd. (Jerusalem, IL); Yissum Research Development Company of the Hebrew University of Jerusalem (Jerusalem, IL)

2 product to treat tooth and gum disease

Akzo Nobel NV (Arnhem, NL) 1 fabric softeners and personal care compositions

Anheuser-Busch, Incorporated (St. Louis, MO) 1 gelled antiperspirantChesebrough-Pond's USA Co., Division of Conopco, Inc. (Greenwich, CT)

1 product to treat or prevent baldness

Colgate Palmolive Company (New York, NY) 1 antiperspirant and deodorant gelsDigestive Care Inc. (Lebanon, NJ) 1 coating ingredient for oral

pharmaceutical

Eastman Chemical Company (Kingsport, TN) 1 nail productsE-L Management Corp. (New York, NY) 1 foundation, blushes, eye shadow, lipstick

Elizabeth Arden Co., Division of Conopco, Inc. (New York, NY)

1 skin products

Goldiner; Arthur (1565 Strand Way, Oceano, CA 93445); Camplese; Linda (1565 Strand Way, Oceano, CA 93445)

1 custom fit teeth

Henkel Kommanditgesellschaft auf Aktien (Duesseldorf, DE)

1 skin care and hair care formulations

Kao Corporation (Tokyo, JP) 1 emulsion for general cosmeticsKao Corporation (Tokyo, JP); Taiyo Kagaku Co., Ltd. (Yokkaichi, JP)

1 hair care products

Kraft General Foods, Inc. (Northfield, IL) 1 sunscreenLaboratoires Virbac (Carros, FR) 1 added to stabilize drugsMinnesota Mining and Manufacturing Company (St. Paul, MN)

1 general cosmetics and personal care products

Mitsui Toatsu Chemicals, Inc. (Tokyo, JP) 1 hair care productsResler; Renee (3046 E. Marlette, Phoenix, AZ 85016)

1 nail products

Revlon Consumer Products (NY, NY) 1 nail enamelRhodia Chimie (Courbevoie, FR) 1 hair and skin care products (sprays, tonic

lotions, gels, mousses)Rhone-Poulenc Chimie (Courbevoie Cedex, FR) 1 nail varnishesUnilever Patent Holding B.V. (Vlaardingen, NL) 1 skin and hair care products,

antiperspirants

Wacker-Chemie GmbH (DE) 1 nail varnishWarner-Lambert Company (Morris Plains, NJ) 1 chewing gum and candy

Witco Corporation (Greenwich, CT) 1 conditioning products for skin and hair

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company Shiseido (patent num-ber 5891846) (Table 5).

Why the cosmetic industry addsphthalates to their products

Multiple chemical properties ofDBP make it a useful additive inmany types of cosmetics. Theseproperties include its ability toimpart flexibility to thin films formascara and nail polish, its oilytexture that makes skin feel soft,and its ability to make lotionspenetrate deeper into the skin(Table 6).

DBP as a plasticizer in nailenamel

The plasticizing and film-formation properties of DBPmake the chemical particularly

DBP in product

Company Product by weight

Procter & Gamble (Cincinnati, OH) long wear nail polish 7%Shiseido Company, Ltd. (Tokyo, JP) oil essence 10%Woodward Laboratories, Inc (Los Alamitos, CA) nail coating 3.4%L'Oreal (France) treatment base for nails 3.8%Procter & Gamble (Cincinnati, OH) pump hair spray 0.2%Kirker Enterprises, Inc (Paterson, NJ) nail enamel 7%Maybelline Cosmetics Corporation (Wilmington, DE) nail enamel 5%Shiseido Company, Ltd. (Tokyo, JP) night cream 5%LVMH Recherche (France) nail enamel 6-8%Shiseido Company, Ltd. (Tokyo, JP) skin cream 20%Wacker-Chemie GmbH (Denmark) nail varnish 2%L'Oreal (France) nail varnish 5%Digestive Care Inc. (Lebanon, NJ) coating for oral drugs 2%Kao Corporation (Tokyo, JP) cosmetic emulsion 7%Procter & Gamble (Cincinnati, OH) oral drugs 5 mg per dosage unitAnheuser-Busch, Incorporated (St. Louis, MO) antiperspirant gel 10%

Table 5. Consumer products ranging from skin cream to oral pharmaceuticals can containup to 20 percent DBP, according to example product formulations given in companypatents.

Source: Environmental Working Group.

useful for nail polish. After nailpolish is applied, some of theingredients volatilize and leavebehind a film that is the coatingover the nail. DBP is one of theingredients left behind, reducingbrittleness and cracking in thepolish.

If the DBP stayed intact in thepolish, women might absorbnegligible amounts of the chemi-cal into their bodies. But agroup of scientists in Hamburg,Germany showed that water-soluble components of thepolish, like DBP, are dissolvedout of the polish each time theycontact water, a conclusion theyreached after measuring theleaching of DBP from nail polishthat had dried for three days. Infact, one of the reasons nail

Scientists in Hamburg,Germany showed thatwater-solublecomponents of thepolish, like DBP, aredissolved out of thepolish each time theycontact water.

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Table 6. DBP is used in cosmetics most often as aplasticizer, to reduce brittleness and cracking, but is alsoused to soften and moisturize skin, and as a penetrationenhancer.

Source: Environmental Working Group.

Function of DBP in cosmetic product

Percent of patents in which DBP serves that

function

Plasticizer 49%Humectant 24%Solvent 16%Coalescent 4%Penetration enhancer 2%Emollient 2%Gastric-acid resistant polymer coating 1%"oily material" 1%

polish eventually chips is that itbecomes brittle as DBP isleached out of the film. Thismeans that every time a womanwashes her hands, DBP iswashed out of her nail polishand contacts her skin. Thescientists conclude that “water-soluble components… attain theskin during extensive but tran-sient contact.” Therefore, awoman wearing nail polish notonly can absorb DBP throughher nail, but also has multipleopportunities to absorb DBPdirectly through her skin.

Since the 1940’s scientistshave known that nail polishcontains allergenic ingredients(Sainio et al 1997). Some com-panies are beginning to studyformulations of nail polish thathave reduced quantities of DBP,because of concerns over aller-gic reactions. The well-knownFrench cosmetics companyL’Oréal, in patent number5,676,935, claims “Nowadays, itis preferable to use plasticizersother than phthalates in var-nishes for reasons of allergy…”In fact, allergic responses toDBP can be severe. In a 1999case study published in thejournal Dermatology, the authorsdescribe a case of anaphylacticshock, a severe allergic reaction,in a patient exposed to DBP inthe coating of an oral pharma-ceutical (Gall et al 1999).

The ability of DBP to causeallergic reactions means that thechemical can induce a state ofhypersensitivity in the immunesystem. Environmental antigens

such as DBP can cause the im-mune system to respond tochemical exposures with immu-nological reactions that are harm-ful, varying from hives to life-threatening responses such asanaphylactic shock, where lowblood pressure and breathingdifficulties can result in death.

L’Oréal USA is still using DBPin their nail products – for ex-ample, in their Maybelline Ex-press Finish Fast-Dry, UltimateWear, and Salon Finish nailenamels that EWG found on theshelves of a Rite-Aid drugstore inWashington DC, in September2000. Even DBP’s well-recog-nized effects on the immunesystem have not been enough tochange manufacturers’ practices.

DBP as a “penetration enhancer”

Both Elizabeth Arden Com-pany (New York, New York) andChesebrough Ponds (Greenwich,

The well-knownFrench cosmeticscompany L’Oréal, inpatent number5,676,935, claims“Nowadays, it ispreferable to useplasticizers other thanphthalates in varnishesfor reasons ofallergy…”

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24 BEAUTY SECRETS

Connecticut) hold patents forcosmetics in which DBP is pro-posed as a penetration enhancer.

Elizabeth Arden proposes DBPas an additive to skin care prod-ucts, where DBP is used to getmore of the product deeper intothe skin: “improving [theproduct’s] delivery through thestratum corneum to its site ofaction in the epidermis.” Simi-larly, Chesebrough Ponds pro-poses that DBP can be added toa hair growth formulation formen to help the formulationpenetrate deeper into the scalp tothe site of action at the hairfollicles.

Research from the chemicalgiant Zeneca gives more evidencethat DBP acts as a penetrationenhancer. Their work shows thatwhen DBP is added to productsfor the skin, allergic reactions aremore severe (in this case, toingredients other than DBP). Thescientists postulate that the en-hanced allergic reactions stemfrom DBP’s ability to deliver thechemicals deeper into the skin(Dearman et al 1996).

The use of DBP as a penetra-tion enhancer stands in directcontrast to CERHR’s assertion that“Dermal contact with productscontaining DBP is possible, butabsorption through the skin ismost likely minimal.” The Centercites a study of DBP migrationthrough rat skin. CDC, on theother hand, upon discovering

high levels of DBP in women ofchildbearing age, postulates thatdermal absorption is playing arole: “Dermal absorption alsooccurs at a significant rate forphthalates with short side chainssuch as …DBP…,” citing thesame rat study as evidence(Blount et al 2000).

Regardless of how variousgovernment agencies are inter-preting the dermal absorptionstudy in rats, industry continuesto use DBP specifically for itsability to absorb deep into theskin.

DBP as a humectant andemollient

DBP is listed as a humectantor emollient in patents fromProcter & Gamble Company(Cincinnati, OH), Lever BrothersCompany Inc (New York, NY),Colgate Palmolive Company(New York, NY), Kraft GeneralFoods (Northfield, IL), Anheuser-Busch, Incorporated (St Louis,MO) and four other companies.Humectants are skin moisturiz-ers; emollients soften the skin.Information in patents fromthese major companies indicatethat DBP is added to skin careproducts because its oily texturegives the impression that theskin itself is soft and moisturized,when in fact it is the DBP resi-due that makes the skin feel thisway.

Industry continues touse DBP specificallyfor its ability to absorbdeep into the skin.

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Blount BC, MJ Silva, SP Caudill, LL Needham, JL Pirkle, EJSampson, GW Lucier, RJ Jackson, JW Brock. October 2000. Levels ofseven urinary phthalate metabolites in a human reference population.Environmental Health Perspectives. 108(10):979-982.

Castleman, BI, and GE Ziem. 1994. American Conference of Gov-ernmental Industrial Hygienists: Low Threshold of Credibility. Ameri-can Journal of Industrial Medicine. 26:133-143.

Center for the Evaluation of Risks to Human Reproduction(CERHR), National Toxicology Program, U.S. Department of Healthand Human Services. October 2000. NTP-CERHR Expert Panel Re-port on Di n Butyl Phthalate. NTP-CERHR-DBP-00.

Dearman RJ, Cumberbatch M, J Hilton, HM Clowes, I Fielding, JRHeylings, I Kimber. 1996. Influence of dibutyl phthalate on dermalsensitization to fluorescien isothiocyanate. Fundam Appl Toxicol 1996Sep;33(1):24-30.

Ema M, Amano H, Ogawa Y. 1994. Characterization of the devel-opmental toxicity of di-n-butyl phthalate in rats. Toxicology 86:163-174.

Ema M, Kurosaka R, Amano H, Ogawa Y. 1995. Comparativedevelopmental toxicity of n-butyl benzyl phthalate and di-n-butylphthalate in rats. Arch Environ Contam Toxicol 28:223-228(1995).

Ema M, Miyawaki E, Kawashima K. 1998. Further evaluation ofdevelopmental toxicity of di-n-butyl phthalate following administrationduring late pregnancy in rats. Toxicol Lett:87-93(1998).

Environmental Protection Agency (EPA). 1990. Integrated RiskInformation System. Dibutyl phthalate, CASRN 84-74-2. October 1990.Available online at http://www.epa.gov/ngispgm3/iris/

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Foster PM, BG Lake, LV Thomas, MW Cook, SD Gangolli. 1981.Studies on the testicular effects and zinc excretion produced by vari-ous isomers of monobutyl-o-phthalate in the rat. Chem Biol Interact1981 Mar 1;34(2):233-8.

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