Document nZJr6EDdrnb9vjZzBV6BLLXX

FILE NAME Talc TALC DATE 2016 DOC TALC138 DOCUMENT DESCRIPTION FDA Info on Talc Ingredients > Talc U.S. Food and Drug Administration Protecting and Promoting Your Health 5/28/16 12:12 PM Talc 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 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 a properly labeled and they must be safe for use by consumers under labeled or customary conditions of use Cosmetic companies have 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 Mg3Si4O10 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 a a powders containing talc and the incidence of ovarian cancer However these studies have not conclusively demonstrated such link or if such 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.gov/Cosmetics/Products ucm293184.htm Page 1 of 7 Ingredients > Talc 5/28/16 12:12 PM 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 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 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 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 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 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 containing 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 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 raw material talc Supplier Rio Tinto Luzenac America Rio Tinto Luzenac America Rio Tinto Luzenac America Product Identity Imperial 200 USP Imperial 250 USP Imperial 400 USP Lot # H10018 % Asbestos by PLM NAD H10018 NAD H06049-43 NAD % Asbestos by TEM NAD NAD NAD http://www.fda.gov/Cosmetics/ProductsIngredients/Ingredients/ucm293184.htm Page 2 of 7 Ingredients > Talc 5/28/16 12:12 PM Rio Tinto Minerals America Rio Tinto Minerals America Rio Tinto Minerals America Rio Tinto Minerals America Olympic H USP H04018 NAD Supreme H USP Lot 2 H09219-79 NAD Supra H USP H10018 NAD Suprafino H USP H6309-78 NAD NAD NAD NAD NAD PLM average limit of quantitation and limit of detection = 0.23 -0.01 TEM average limit of detection = 0.0000021 -1.26567E TEM average limit of detection = 0.021 ppm -0.001 TEM average limit of quantitation = 0.46 -0.01 Supplier Presperse Presperse Presperse Presperse Presperse Presperse Product Identity Micro Ace 2 Micro Ace 4 Rose Talc Talc NK TalClear BH TalClear LH Lot # 33070516 37080823 2008-09 017 0306 070608 070529 % Asbestos by PLM NAD NAD NAD NAD NAD NAD % Asbestos by TEM NAD NAD NAD NAD NAD NAD PLM average limit of quantitation and limit of detection = 0.22 -0.01 TEM average limit of detection = 0.0000021 -3.0099E TEM average limit of detection = 0.021 ppm -0.003 TEM average limit of quantitation = 0.43 -0.02 Supplier Sensient Cosmetic Technologies Sensient Cosmetic Technologies Sensient Cosmetic Technologies Sensient Cosmetic Technologies Sensient Cosmetic Technologies Product Identity Lot # % Asbestos by PLM 28355 Talc PP W249-06 NAD 28368 Talc NBSB W080720 NAD 28460 Talc MS W053-08 NAD 61631 Talc LCW 26449 NAD R0175 Talc FHC W041397 NAD % Asbestos by TEM NAD NAD NAD NAD NAD htp:/ww.fda.gov/Cosmetics/ProductsIngredients/Ingredients/ucm293184.htm http://www.fda.gov/Cosmetics/ProductsIngredients/Ingredients/ucm293184.htm htp:/ww.fda.gov/Cosmetics/ProductsIngredients/Ingredients/ucm293184.htm Page 3 of 7 Ingredients > Talc Sensient Cosmetic Technologies Sensient Cosmetic Technologies R0255 Talc SI W05630 NAD R0435 Talc AS W061176 NAD PLM average limit of quantitation and limit of detection = 0.22 -0.01 TEM average limit of detection = 0.0000022 -1.91529E TEM average limit of detection = 0.022 ppm -0.002 TEM average limit of quantitation = 0.43 -0.01 NAD 5/28/16 12:12 PM NAD Supplier Brenntag Specialties Inc. Brenntag Specialties Inc. Brenntag Specialties Inc. Brenntag Specialties Inc. Brenntag Specialties Inc. Brenntag Specialties Inc. Brenntag Specialties Inc. Product Identity Talc IMP BC IMP1886L Lot # % Asbestos by PLM H01018 NAD Supra H USP BC 1718 H10016 NAD Imperial 400 USP BC 1883 H01017 NAD Talcron MP 60-30 USP 1745 B8141N1 NAD Talc IMP BC IMP1820L H07018 NAD Talc Imperial USP BC IMP1885L Micron USP BC 2755 H10017 NAD B7375N2 NAD PLM average limit of quantitation and limit of detection = 0.23 -0.01 TEM average limit of detection = 0.0000021 -2.10373E TEM average limit of detection = 0.021 ppm -0.002 TEM average limit of quantitation = 0.46 -0.01 % Asbestos by TEM NAD NAD NAD NAD NAD NAD NAD Cosmetic products containing talc Blush Brand Shade % Asbestos by PLM % Asbestos by TEM http://www.fda.gov/Cosmetics/Products Page 4 of 7 Ingredients > Talc Maybelline New York Expert Wear Blush Gentle Rose 109EWBR N.Y.C. New York Color Cheek Glow Powder Blush West Side Wine 652A NARS Blush Torrid 4017 NAD NAD NAD 5/28/16 12:12 PM NAD NAD NAD Eye Shadow Brand Physician's Formula Shimmer Strips Custom Eye Enhancing Shadow & Liner Black Radiance Eyeshadow Quartet Stilla Eye Shadow Trio Dior Colour Iridescent Eyeshadow Shade % Asbestos by PLM % Asbestos by TEM Hazel Eyes 2222 NAD NAD Retro Chic 8805 NAD NAD Venus S461-03 NAD NAD Petal Shine 809 NAD NAD Foundation Brand Black Opal True Color Liquid Foundation Laura Mercier Foundation Powder Shade % Asbestos PLM Heavenly Honey NAD Number 2 NAD % Asbestos by TEM NAD NAD Face Powder Brand LA Colors Pressed Powder Revlon Color Stay Pressed Powder Cover Girl TruBlend Mineral Loose Mineral Powder Physician's Formula Summer Eclipse Bronzing & Shimmery Face Powder Shade Nude BPP320 Fair 810 Translucent Fair 405 Moonlight Bronzer 3104 http://www.fda.gov/Cosmetics/ProductsIngredients/Ingredients/ucm293184.htm htp:/ww.fda.gov/Cosmetics/ProductsIngredients/Ingredients/ucm293184.htm % Asbestos by PLM NAD % Asbestos by TEM NAD NAD NAD NAD NAD NAD NAD Page 5 of 7 Ingredients > Talc Wet n Wild Bronzer Iman Luxury Pressed Powder Coty Air Spun Loose Face Powder Black Opal Color Fusion Powder Black Radiance Pressed Powder Posner Finishing Touch Pressed Powder N.Y.C. New York Color Loose Face Powder Almay Nearly Naked Loose Powder Clinique Stay Matte Sheer Pressed Powder BeneFit Hello Flawless Custom Powder Cover for Face SPF 15 Smashbox Fusion Soft Lights Intermix Pressed Powder Guerlain Meteorites Poudre de Perles Illuminating Perfecting Pressed Powder Urban Decay Baked Bronzer Medium 701 Clay Medium Dark Translucent 070-24 NAD NAD NAD Mosaic Raspberry Bronzer NAD Rich Mahogany Acajou riche 8607B NAD Honey Beige 53124 Translucent 741A NAD NAD Light 100 Invisible Matte 101 NAD NAD Me Vain Champagne 1B168 NAD Baked Stardust DL 106 NAD Mythic Parfait 01 Gilded NAD NAD 5/28/16 12:12 PM NAD NAD NAD NAD NAD NAD NAD NAD NAD NAD NAD NAD NAD Body Powder Brand Johnson's Baby Powder CVS Brand Baby Powder Rite Aid Baby Powder Anti Monkey Butt Powder Assured Shower & Bath Absorbent Body Powder Angel of Mine Baby Powder Family Dollar Mild Baby Powder Shade % Asbestos by PLM a NAD a NAD a NAD a NAD a NAD a NAD a NAD % Asbestos by TEM NAD NAD NAD NAD NAD NAD NAD http://www.fda.gov/Cosmetics/Products ucm293184.htm Page 6 of 7 Ingredients > Talc Shower to Shower Morning Fresh Absorbent Body Powder a NAD PLM average limit of quantitation and limit of detection = 0.19 -0.04 TEM average limit of detection = 0.0000044 -1.76229E TEM average limit of detection = 0.044 ppm -0.018 TEM average limit of quantitation = 0.39 -0.08 NAD 5/28/16 12:12 PM htp:/ww.fda.gov/Cosmetics/ProductsIngredients/Ingredients/ucm293184.htm http://www.fda.gov/Cosmetics/ProductsIngredients/Ingredients/ucm293184.htm htp:/ww.fda.gov/Cosmetics/ProductsIngredients/Ingredients/ucm293184.htm Page 7 of 7