Document MGopKre8agNp5awvaDD2E0Y77

Selected Cosmetic Ingredients > Talc in Cosmetics Page 1 of 6 Home Cosmetics Product and Ingredient Safety Selected Cosmetic Ingredients C o sm etics Talc in Cosmetics Talc is an ingredient used in many cosmetics, from baby powder to blush. From time to time, FDA has received questions about its safety and whether talc contains harmful contaminants, such as asbestos. FDA's authority over cosmetic safety Under the Federal Food, Drug and Cosmetic Act (FD&C Act), cosmetic products and ingredients, with the exception of color additives, do not have to undergo FDA review or approval before they go on the market. Cosmetics must be properly labeled, and they must be safe for use by consumers under labeled or customary conditions of use. Cosmetic companies have a legal responsibility for the safety and labeling of their products and ingredients, but the law does not require them to share their safety information with FDA. FDA monitors for potential safety problems with cosmetic products on the market and takes action when needed to protect public health. Before we can take such action against a cosmetic, we need sound scientific data to show that it is harmful under its intended use. Talc: What it is and how it is used in cosmetics Talc is a naturally occurring mineral, mined from the earth, composed of magnesium, silicon, oxygen, and hydrogen. Chemically, talc is a hydrous magnesium silicate with a chemical formula of Mg3Si4O 10(OH)2. Talc has many uses in cosmetics and other personal care products; in food, such as rice and chewing gum; and in the manufacture of tablets. For example, it may be used to absorb moisture, to prevent caking, to make facial makeup opaque, or to improve the feel of a product. Asbestos: What it is, why it's a concern, and how to prevent its occurrence in cosmetics Asbestos is also a naturally occurring silicate mineral, but with a different crystal structure. Both talc and asbestos are naturally occurring minerals that may be found in close proximity in the earth. Unlike talc, however, asbestos is a known carcinogen. For this reason, FDA considers it unacceptable for cosmetic talc to be contaminated with asbestos. Published scientific literature going back to the 1960s has suggested a possible association between the use of powders containing talc and the incidence of ovarian cancer. However, these studies have not conclusively demonstrated such a link, or if such a link existed, what risk factors might be involved. Nevertheless, questions about the potential contamination of talc with asbestos have been raised since the 1970s. To prevent contamination of talc with asbestos, it is essential to select talc mining sites carefully and take steps to purify the ore sufficiently. How FDA followed up on the latest reports http://www.fda.g0v/C0smetics/Pr0ductandIngredientSafety/SelectedC0srneticIngredients/u... 7/22/2013 Selected Cosmetic Ingredients > Talc in Cosmetics Page 2 of 6 Because safety questions about the possible presence of asbestos in talc are raised periodically, FDA decided to conduct an exploratory survey of currently marketed cosmetic-grade raw material talc, as well as some cosmetic products containing talc. Because FDA's cosmetic laboratories do not have the equipment needed to perform the analyses, we searched for a qualified outside laboratory to do the work. We contracted with AMA Analytical Services, Inc. (AMA) of Lanham, MD to conduct this laboratory survey, based on demonstrated experience with asbestos analysis in complex matrices, appropriate facilities, equipment, personnel, analytical strategy, and budget criteria. The study ran from September 28, 2009 to September 27, 2010. How the survey was conducted The first step was to identify cosmetic talc suppliers and talc-containing cosmetic products. We found seven talc suppliers identified in the 2008 edition of the International Cosmetic Ingredient Dictionary and Handbook and two more by searching online. The contract laboratory contacted each supplier to request samples of its talc. Of the nine suppliers identified, four complied with the request. We found talc-containing cosmetic products to analyze by visiting various retail outlets in the Washington, D.C. metropolitan area. The samples identified for testing included low, medium, and high priced products, along with some from "niche" markets, in order to cover as broad a product range as possible. A total of thirty-four cosmetic products containing talc were selected, including eye shadow, blush, foundation, face powder, and body powder. All cosmetic products were purchased from retail stores in the Washington, D.C. metropolitan area. The contract laboratory analyzed the samples using polarized light microscopy (PLM) and transmission electron microscopy (TEM) methods published by the New York State Department of Health, Environmental Laboratory Approval Program. Each sample was analyzed three times using both methods. The results of FDA's survey and what they mean The survey found no asbestos fibers or structures in any of the samples of cosmetic-grade raw material talc or cosmetic products containing talc. The results were limited, however, by the fact that only four talc suppliers submitted samples and by the number of products tested. For these reasons, while FDA finds these results informative, they do not prove that most or all talc or talccontaining cosmetic products currently marketed in the United States are likely to be free of asbestos contamination. As always, when potential public health concerns are raised, we will continue to monitor for new information and take appropriate actions to protect the public health. The tables below list details for each of the cosmetic-grade raw material talc samples and cosmetic products containing talc that were analyzed in this survey. Limits of detection are shown below the table for each group of samples. Note: "NAD" means "no asbestos detected." Cosmetic-grade raw material talc: Supplier Product Identity Rio Tinto Minerals/Luzenac America Imperial 200 USP Imperial 250 USP Imperial 400 USP Olympic H USP Lot # H10018 H10018 H06049-43 H04018 % Asbestos by PLM NAD NAD NAD NAD % Asbestos by TEM NAD NAD NAD NAD http://www.fda.gOv/Cosmetics/ProductandlngredientSafety/SelectedCosmeticIngredients/u... 7/22/2013 Selected Cosmetic Ingredients > Talc in Cosmetics Page 3 of 6 Supreme H USP Lot 2 H09219-79 NAD Supra H USP H10018 NAD Suprafino H USP H6309-78 NAD PLM average limit of quantitation and limit of detection = 0.23% 0.01 TEM average limit of detection = 0.0000021% 1.26567E-09 TEM average limit of detection = 0.021 ppm 0.001 TEM average limit of quantitation = 0.46% 0.01 NAD NAD NAD Supplier Product Identity Lot # % Asbestos by PLM Presperse Micro Ace P-2 33070516 NAD Micro Ace P-4 37080823 NAD Rose Talc 2008-09 NAD Talc NK-48 017 0306 NAD TalClear BH 070608 NAD TalClear LH 070529 NAD PLM average limit of quantitation and limit of detection = 0.22% 0.01 TEM average limit of detection = 0.0000021% 3.0099E -09 TEM average limit of detection = 0.021 ppm 0.003 TEM average limit of quantitation = 0.43% 0.02 % Asbestos by TEM NAD NAD NAD NAD NAD NAD Supplier Product Identity Lot # % Asbestos % Asbestos by PLM by TEM Sensient Cosmetic 28355 Talc PP W249-06 NAD NAD Technologies 28368 Talc NBSB W080720 NAD NAD 28460 Talc F-MS W053-08 NAD NAD 61631 Talc LCW 26449 NAD NAD R0175 Talc FHC W041397 NAD NAD R0255 Talc SI W05630 NAD NAD R0435 Talc AS W061176 NAD NAD PLM average limit of quantitation and limit of detection = 0.22% 0.01 TEM average limit of detection = 0.0000022% 1.91529E-09 TEM average limit of detection = 0.022 ppm 0.002 TEM average limit of quantitation = 0.43% 0.01 Supplier Product Identity Lot # % Asbestos % Asbestos by PLM by TEM Brenntag Talc IMP BC IMP1886L H01018 NAD NAD Specialties, Inc. Supra H USP BC H10016 NAD NAD (*1718) Imperial 400 USP BC H01017 NAD NAD (*1883) Talcron MP 60-30 USP B8141N1 NAD NAD (1745) Talc IMP BC IMP1820L H07018 NAD NAD Talc Imperial USP BC H10017 NAD NAD IMP1885L Lo-Micron USP BC 2755 B7375N2 NAD NAD PLM average limit of quantitation and limit of detection = 0.23% 0.01 TEM average limit of detection = 0.0000021% 2.10373E-09 TEM average limit of detection = 0.021 ppm 0.002 TEM average limit of quantitation = 0.46% 0.01 Cosmetic products containing talc: http://www.fda.goV/Cosmetics/ProductandIngredientSafety/SelectedCosmeticIngredients/u... 7/22/2013 Selected Cosmetic Ingredients > Talc in Cosmetics Page 4 of 6 Blush: Brand Maybelline New York Expert Wear Blush N.Y.C. New York Color Cheek Glow Powder Blush NARS Blush Shade % Asbestos by PLM Gentle Rose 109EWBR- NAD 30 West Side Wine 652A NAD Torrid 4017 NAD % Asbestos by TEM NAD NAD NAD Eye Shadow: Brand Shade Physician's Formula Hazel Eyes 2222 Shimmer Strips Custom Eye Enhancing Shadow & Liner Black Radiance Retro Chic 8805 Eyeshadow Quartet Stilla Eye Shadow Trio Venus S461-03 Dior 5-Colour Iridescent Petal Shine 809 Eyeshadow % Asbestos by PLM % Asbestos by TEM NAD NAD NAD NAD NAD NAD NAD NAD Foundation: Brand Black Opal True Color Liquid Foundation Laura Mercier Foundation Powder Shade Heavenly Honey Number 2 % Asbestos by PLM % Asbestos by TEM NAD NAD NAD NAD Face Powder: Brand Shade % Asbestos by PLM LA Colors Pressed Nude BPP320 NAD Powder Revlon Color Stay Fair 810 NAD Pressed Powder Cover Girl TruBlend Translucent Fair 405 NAD Mineral Loose Mineral Powder Physician's Formula Moonlight/Light NAD Summer Eclipse Bronzer 3104 Bronzing & Shimmery Face Powder Wet n Wild Bronzer Light/Medium 701 NAD Iman Luxury Pressed Clay Medium Dark NAD Powder Coty Air Spun Loose Translucent 070-24 NAD Face Powder Black Opal Color Fusion Mosaic Raspberry NAD Powder Bronzer Black Radiance Pressed Rich Mahogany Acajou NAD Powder riche 8607B Posner Finishing Touch Honey Beige 53124 NAD % Asbestos by TEM NAD NAD NAD NAD NAD NAD NAD NAD NAD NAD http://www.fda.g0v/Cosmetics/ProductandIngredientSafety/SelectedCosmeticIngredients/u... 7/22/2013 Selected Cosmetic Ingredients > Talc in Cosmetics Page 5 of 6 N.Y.C. New York Color Translucent 741A NAD Loose Face Powder Almay Nearly Naked Light/pale 100 NAD Loose Powder Clinique Stay Matte Invisible Matte 101 NAD Sheer Pressed Powder BeneFit Hello Flawless Me Vain? Champagne NAD Custom Powder Cover- 1B168 Up for Face SPF 15 Smashbox Fusion Soft Baked Stardust DL 106 NAD Lights Intermix Pressed Powder Guerlain Meteorites Mythic Parfait 01 NAD Poudre de Perles Illuminating Perfecting Pressed Powder Urban Decay Baked Gilded NAD Bronzer NAD NAD NAD NAD NAD NAD NAD Body Powder: Brand Shade % Asbestos by PLM Johnson's Baby Powder n/a NAD CVS Brand Baby n/a NAD Powder Rite Aid Baby Powder n/a NAD Anti Monkey Butt n/a NAD Powder Assured Shower & Bath n/a NAD Absorbent Body Powder Angel of Mine Baby n/a NAD Powder Family Dollar Mild Baby n/a NAD Powder Shower to Shower n/a NAD Morning Fresh Absorbent Body Powder PLM average limit of quantitation and limit of detection = 0.19% 0.04 TEM average limit of detection = 0.0000044% 1.76229E-08 TEM average limit of detection = 0.044 ppm 0.018 TEM average limit of quantitation = 0.39% 0.08 % Asbestos by TEM NAD NAD NAD NAD NAD NAD NAD NAD Page Last Updated: 06/05/2013 Note: If you need help accessing information in different file formats, see Instructions for Downloading Viewers and Players. 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