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Nano Materials in Personal Care Products

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Contact: Lauren Sucher, EWG (202) 667-6982Hundreds of Personal Care Products Contain Poorly Studied Nano-materialsFDA Concerned About Hazards But Lacks Authorityto Require Pre-market Safety Studies (WASHINGTON) — An Environmental Working Group (EWG) computer analysisof 25,000 personal care product labels found that more than 250products on the market today contain one or more of 57 different typesof nano-scale or micronized ingredients identified on product labels.Another 9,500 products contain ingredients that are available innano-form, but were not labeled as either nano-sized orconventional-sized on the label. The absence of a clear governmentdefinition for nano-materials makes quantifying their presence inpersonal care products even more difficult. None of the nano-scale materials identified have been substantiatedfor safety by the Food and Drug Administration (FDA) or the industry'sown Cosmetic Ingredient Review Expert Panel (CIR). In fact, only 11percent of conventional chemical ingredients in cosmetics have beenassessed for safety by the personal care products industry's own CIR. "The industry may have the studies to support the safety of thesenano-materials, but they are not required to make any of thisinformation available to the public," said Jane Houlihan, vicepresident for research at EWG, and author of the EWG assessment."Manufacturers seem to be following the pattern they established withconventional chemical ingredients — put poorly tested chemicals intopersonal care products and do the science later if at all." But with nano-sized materials the stakes could be much higher.Nano-materials are potentially quite hazardous and unpredictablebecause, according to the FDA, their small size and extremely highratio of surface area to volume can produce chemical or physicalproperties that are very different from larger materials. In spite of these potential dangers, FDA cannot require pre-marketsafety studies of nano-materials used in personal care products underthe Federal Food, Drug and Cosmetic Act. While all nano-materials usedpersonal care products must be "substantiated for safety," the FDA hasnot defined safety for nano-materials, and the industry does not haveto disclose the science supporting this claim to the FDA or thepublic. Typically, the industry relies on its own CIR panel to assessingredient safety, but to date the CIR has not assessed a singlenano-material. Before industry is allowed to introduce any more nano-materials intopersonal care products, the FDA must: Define, through a public process, what substantiation of safety meansfor nano-materials.Require industry to make public all of the studies it hassubstantiating the claim that products containing nano-materials aresafe.Identify the presence of nano-materials in all products.Request information on particle size from all personal care productmanufacturers.Please visit ewg.org for a list of nano-materials, micronizedingredients and the products they are found in. ### The Environmental Working Group is a nonprofit research organizationbased in Washington, DC that uses the power of information to protecthuman health and the environment. The Group's research on ingredientsin personal care products is viewable online athttp://www.ewg.org/issues/siteindex/issues.php?issueid=5005. http://ewg.org/issues/cosmetics/20061010/index.php

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