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Executive Summary

FD&C YELLOW NO. 5: FDA FINAL RULE APPROVING DYE's PERMANENT LISTING as safe for use in cosmetics and externally applied drugs is effective retroactive to October, according to a notice due to be published in the July 7 Federal Register. The color additive already is approved for food and ingested drugs. A stay was placed on the rule permitting the dye's permanent listing because FDA received objections to it from industry and consumer groups and was required by law to review them before the final rule went into effect. Published Sept. 5, 1985, the final rule was to have been effective 30 days afterward. While the agency reviewed the objections, FDA extended the closing date of Yellow 5's provisional listing four times. With the stay on the rule now lifted, the original effective date of Oct. 7, 1985 is "confirmed for all portions of the final rule except the description of the manufacturing process modified in this notice," the Federal Register document states. Termination of the stay on the final rule approving Yellow 5 for cosmetic and external drug use actually goes into effect August 7. Of the three objections received and evaluated, FDA dismissed those of the Certified Chemical Manufacturers' Association (CCMA) and Public Citizen's Health Research Group (HRG) as "without merit." CCMA's objections centered on the final rule's specifications for six impurities found in the dye, the analytical methodology used by the agency to determine its safety and the exclusion of the additive's lakes from the permanent listing. HRG's complaints concerned lowered sulfonated forms of Yellow 5, its known potential to cause allergic reactions in humans and mutagenicity in lab animals. FDA concluded that the third objection, one from dye manufacturer Hilton-Davis regarding the general description of the dye's permitted manufacturing processes, "is correct" and the agency is modifying the section (21 CFR 74.2705) accordingly. In a separate same-day notice, FDA revised the identity and specifications for FD&C Yellow 5 for use in food and ingested drugs The agency stated that during its recent review of Yellow 5 in externally applied drugs and cosmetics, it determined "that continued safe use of the additive would require the adoption of a new identity and more extensive specifications for the color additive."

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