US FDA Releases Report on Color Additives


The U.S. Food and Drug Administration (FDA) announced the release of its first-quarter report on certified color additives for 2019. Ranging from D&C Black No. 2 and Green No. 5, through D&C Yellow No. 11 Lake and FD&C Yellow No. 6 Aluminum Lake, color certification is congressionally mandated for the FDA to enforce specifications by batch certification of the certifiable color additives to foods, drugs, cosmetics and medical devices in the U.S.

According to the FDA, under this program, color additive manufacturers provide FDA's Color Certification Branch (CCB) with a representative sample of each color additive batch. The CCB then analyzes the color additive sample to ensure it meets the specifications listed in the Code of Federal Regulations (21 CFR Part 74), which identifies the certifiable color additives.

For more information and to see the first quarter report, visit the FDA website.

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