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  1. Color Certification

Letter to Additive Manufacturers on Certification of Irradiated Colors

Color Certification

April 26, 2024

Dear Color Additive Manufacturers:

The Food and Drug Administration (FDA or we) is informing industry that we 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.

FD&C Yellow No. 5, FD&C Yellow No. 6, and FD&C Blue No. 1 require certification by FDA under 21 U.S. 379e(c). When seeking certification of these color additives, if they have been irradiated, under “Straight Color Additive Submission” in the color certification app, select the appropriate color from the drop-down menu annotated as “irradiated.” All other entries will remain the same. FDA’s testing will follow the same protocol as non-irradiated colors and the specifications from the relevant color additive listings will apply (see 21 CFR 74.101, 74.705, and 74.706). Please note that if a package of a certified color additive is closed for shipment and then is opened in order to irradiate the color additive, the material is required to be recertified (21 CFR 80.32(d)).

Package labeling for these color additives should provide the color name (e.g., FD&C Yellow No. 6) and a statement, reflected on the certificates, indicating the limitations for its use as required by 21 CFR 70.25(a)(2). Package labeling of the color additive should include the fact that these color additives have been irradiated because there may be other regulatory restrictions on the use of irradiated color additives, such as the requirement for separate approval for the use of irradiated color additives in food. 

We remind all color additive manufacturers of the applicable requirements under the Federal Food, Drug, and Cosmetic Act and FDA’s regulations. Color additives must be approved by FDA and listed in the color additive regulations before they may be used in food, drugs, cosmetics, and certain medical devices. Each color additive is permitted only for the intended use stated in its listing regulation. Some color additives are also subject to the FDA certification process. Please see Color Additive Laws, Regulations, and Guidance for more information.

1The term straight color means a color additive listed in parts 73, 74, and 81 of this chapter, and includes lakes and such substances as are permitted by the specifications for such color.

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