Case Study
Personal care products manufacturer needs analytical method with sufficient level of detail
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.
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