On 7 April 2026 U.S. Food and Drug Administration (FDA), Colour Certification Branch (CCB) published information on the Colour Certification Reports program, outlining the regulatory system for certifiable colour additives used in foods, drugs, cosmetics, and certain medical devices in the United States. The Colour Certification program is a Congressionally mandated safety and quality assurance system that ensures colour additives meet strict regulatory specifications before being used in consumer and healthcare products. Under this system, manufacturers of colour additives submit representative samples from each production batch to the FDA's Colour Certification Branch for evaluation. The FDA laboratory analyses each submitted sample to verify compliance with specifications outlined in the Code of Federal Regulations (21 CFR Part 74), which governs approved certifiable colour additives. This testing ensures that the additives meet required purity, identity, and safety standards before market use. If a batch sample meets all regulatory specifications, the Colour Certification Branch issues a formal certificate confirming approval of that specific batch. This certification is required for the additive to be legally used in regulated products within the United States.
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