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Sun Chem's in situ color lakes alternative manufacturing process complies with FDA.

This article was originally published in The Rose Sheet

Executive Summary

SUN CHEM's MODIFIED IN SITU COLOR ADDITIVE LAKES MANUFACTURING METHOD COMPLIANT with FDA specifications, the agency determined after reviewing the company's data on the alternative lakes development method. FDA asked Staten Island, N.Y.-based Sun Chemical Corp. to investigate whether it is "technically feasible" to replace the current in situ process with a substitute procedure to develop color additive lakes for D&C Red No. 34. Under the alternative process, the dried sodium salt form of D&C Red 34 is used to provide manufacturers with a water-soluble certifiable color additive from which to prepare a calcium lake, FDA said. The agency analyzed Sun Chemical's data and confirmed the results.
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