As part of the Modernization of Cosmetics Regulation Act of 2022 (MoCRA), the U.S. Food and Drug Administration (FDA) was mandated to develop and propose a standardized test for detecting asbestos in talc-based cosmetics. On December 26, 2024, the FDA published the proposed rule, Testing Methods for Detecting and Identifying Asbestos in Talc-Containing Cosmetic Products.
The proposed rule would require manufacturers of talc-containing cosmetics to test their products for asbestos. Manufacturers shall conduct both Polarized Light Microscopy (PLM) and Transmission Electron Microscopy/Energy Dispersive Spectroscopy/Selected Area Electron Diffraction (TEM/EDS/SAED) testing to check for potential asbestos contamination. Each batch or lot of talc-containing cosmetics or the talc ingredient used shall be tested. A certificate of analysis from the talc supplier may be used if the supplier has been appropriately qualified. Records demonstrating compliance with these requirements shall be maintained for three years. If a manufacturer does not comply with the testing or recordkeeping requirements, or if any asbestos is detected the cosmetics would be considered adulterated and potentially subject to FDA enforcement.
Comments must be submitted by March 27, 2025. Per MoCRA, the FDA has 180 days after the closing of the public comment period to finalize this rule.
Link: https://www.fda.gov/cosmetics/cosmetics-news-events/fda-issues-proposed-rule-testing-methodsdetecting-and-identifying-asbestos-talc-containing-cosmetic
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