Sun Chem's alternative in situ color additive lakes process complies with FDA specs.
This article was originally published in The Tan Sheet
Executive Summary
SUN CHEM's MODIFIED IN SITU COLOR ADDITIVE LAKES MANUFACTURING PROCESS COMPLIES 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 comment on whether it is "technically feasible" to replace the current in situ process with a substitute procedure to develop color additive lakes of D&C Red No. 34. Under the new process, dried sodium salt of D&C Red 34 is used to prepare a calcium lake and provide a water- soluble certifiable color additive, FDA said. The agency analyzed Sun Chemical's data and confirmed the results.