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FDA soliciting "proven methodology" for impurities detection in color lakes -- proposed rule.

This article was originally published in The Rose Sheet

Executive Summary

FDA SOLICITING "PROVEN METHODOLOGY" TO ANALYZE COLOR LAKES FOR IMPURITIES in a proposed rule on the permanent listing of color additive lakes published in the March 4 Federal Register. In the absence of a "suitable methodology" for analyzing intermediates and other impurities in lakes, FDA has proposed that straight color batches used in the preparation of color additive lakes be certified by FDA. Under existing regulations, manufacturers can create lakes for use in cosmetic and drug products with uncertified batches of straight colors, followed by lake certification.
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