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Color additive lakes

This article was originally published in The Rose Sheet

Executive Summary

FDA requesting comments on a modified in situ manufacturing process for D&C Red No. 34 submitted by Fort Lee, N.J.-based Sun Chemical, the agency announced in the June 3 Federal Register. In a March 1996 proposed rule on color additive lakes, FDA tentatively concluded a lack of analytical methods to determine impurities levels in lakes prepared from uncertified straight color batches prevented the agency from determining lakes safe for use, including those lakes prepared in situ ("The Rose Sheet" March 18, 1996, p. 6). At the time, FDA solicited "proven methodologies" to analyze color lakes for impurities. Comments on Sun Chemical's method are due July 6...
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