The US Food and Drug Administration (FDA) has proposed a rule to establish standardised testing methods to detect asbestos in talc-containing cosmetics.
Cancer-causing asbestos is found in the same rock types as talc deposits and may be inseparable from talc in the mining process.
Talc, meanwhile, is used in cosmetics to absorb moisture, prevent the appearance of caking and opacify facial make-up products.
It can also be used to improve the feel of products.
“For many years the FDA has been sampling and testing talc-containing cosmetics for asbestos, as well as working with our federal partners on efforts to reduce consumers’ risk of exposure to asbestos, a known human carcinogen, from contaminated talc-containing cosmetic products,” said Linda Katz, Director of the FDA’s Office of Cosmetics and Colors.
“We have carefully considered the scientific evidence and complex policy issues related to detecting and identifying asbestos in talc and talc-containing cosmetic products.
“We believe that the proposed testing techniques are appropriate methods to detect asbestos to help ensure the safety of talc-containing cosmetic products.”
The FDA’s proposed rule would require manufacturers of talc-containing cosmetic products to test for asbestos using an analytical approach.
This would include both Polarized Light Microscopy (PLM) (with dispersion staining) and either Transmission Electron Microscopy (TEM), Energy Dispersive Spectroscopy (EDS) or Selected Area Electron Diffraction (SAED) to detect and identify the presence of asbestos.
The FDA added that manufacturers may alternatively rely on a certificate of analysis from the talc supplier.
The proposed rule also contains provisions that would require manufacturers to keep records to demonstrate compliance with the rule.
This proposal forms part of the US agency’s work to fulfill the requirements of section 3505 of the Modernization of Cosmetics Regulation Act of 2022 (MoCRA).
If the proposed rule is finalised, talc-containing cosmetics from a manufacturer failing to operate in compliance with the testing or record keeping requirements would be considered adulterated.
The proposed rule further states that if asbestos is present in a cosmetic product, or in talc used in a cosmetic product, the product is adulterated.
And if asbestos is present in talc intended for use in a cosmetic, that talc is also adulterated.
Public comment is now open on the proposed rule for 90 days after the date of publication in the Federal Register on 27 December 2024.
The next step will see the FDA review and consider comments as it develops the final rule.
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