FDA issues letter to additive manufacturers regarding certification of irradiated colors
USA
Apr 29, 2024
The Food and Drug Administration is informing industry that have determined that certain color additives may be irradiated at a maximum dose of 25 kilograys (kGy) to reduce microorganisms in these color additives. Specifically, we have determined that the straight colors FD&C Yellow No. 5, FD&C Yellow No. 6, and FD&C Blue No. 11 may be irradiated at a maximum dose of 25 kGy. because, based on the available data, there does not appear to be a difference between the irradiated colors listed above and their non-irradiated color counterparts. Therefore, the color additive listings for FD&C Yellow No. 5, FD&C Yellow No. 6, and FD&C Blue No. 1 include these irradiated color additives. However, the use of irradiation in a substance used in food must be approved through a food additive regulation. See 21 U.S.C. 342(a)(2)(7) and 21 CFR Part 179.
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