A major manufacturer of personal care products uses talc as a component in some of its products. The manufacturer needed to know whether another country’s proposed method for the analysis of talc was accurate for the identification and quantification of trace amounts of asbestos in the compound. Specifically, they needed to know if the proposed method could result in false positive findings for asbestos in the talc as well as in their products. The implications of false positives would not only impact our client’s reputation worldwide but both our client and other product manufacturers would need to recall their products and most likely would not be able to sell them in the future.
Once RJ Lee Group verified the translation of the proposed analytical method, we were able to evaluate it. Based on more than 25 years of expertise in identifying and differentiating amphibole and asbestos minerals, we identified deficiencies in the proposed method. We then conducted analytical tests on talc as well as product samples using both the proposed method and the USP method which is accepted by the U.S. FDA. Our tests demonstrated that unless the proposed method were to be modified, false positives were likely.
RJ Lee Group collaborated with the client’s decision makers, technical staff, public relations staff, and international representatives, as well as with representatives of the leading national trade association representing the global cosmetic and personal care products industry and representatives of other leading product manufacturers. We demonstrated, explained and clarified the factors that could influence analytical results using the proposed method both with and without modifications. We then met with the foreign country’s technical and regulatory representatives. We explained, through translators, the repercussions of their proposed analytical method and our suggested modifications.
Based on our scientific evidence, the analytical method proposed by the foreign country was modified to include additional steps in the analytical process to avoid false positive results. The method is awaiting final approval by the foreign government regulatory agency. RJ Lee Group continues to conduct analytical testing for the client manufacturer and other product manufacturers on an ongoing basis to ensure that the talc used in a variety of personal care products complies with quality standards.