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Executive Summary

FD&C YELLOW No. 5 MANUFACTURING SPECIFICATIONS LIMITING SIX IMPURITIES are outlined by FDA in a proposed rule published in the Sept. 4 Federal Register. The proposal accompanies a same-day final rule permanently listing the color additive for external drug and cosmetics uses. The specifications would restrict the presence of six recently identified carcinogenic impurities in the dye. They are: 4-Aminoazobenzene; 4-Aminobiphenyl; Aniline; Azobenzene; Benzidine and 1,3-Diphenyltriazene. a Comments on the proposal are due within 60 days. However, in a third notice published the same day, FDA postponed the closing date of FD&C Yellow No. 5 to Nov. 5 to provide time for objections to its approval of the color. The agency earlier said it is permanently listing FD&C Yellow No. 5 based on its determination that the color does not produce a statistically significant carcinogenic response in animal testing. The specifications for FD&C Yellow No. 5 would limit the allowable amounts of 4-Aminoazobenzene to under 75 parts per billion (ppb); 4-Aminobiphenyl to under 5 ppb; Aniline to under 100 ppb; Azobenzene to under 40 ppb; Benzidine to under 1 ppb and 1,3-Diphenyltriazene to under 40 ppb. The specifications cover the impurities that are likely to result from the manufacturing processes for the additive that are currently in use. The agency said it is aware of two different processes and both are encompassed in the proposal. FDA also said it is willing to consider petitions for alternative processes. The notice added that any petitions should contain evidence that demonstrates that the processes will not produce hazardous impurities. FDA originally established the identity and specifications for FD&C Yellow No. 5 in 1966 when it permanently listed the color for use in foods. However, the new specifications are based on the results of analyses that are more specific and sensitive than those used before. As a result, the tentative revision contains specifications for specific manufacturing intermediates instead of a general specification for "uncombined: intermediates" in addition to limitations on six contaminants.

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