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U.S. FDA Color Additive Requirements

U.S. FDA CITATION: 21 C.F.R. § 70 (2015), 21 C.F.R. § 80 (2015)

Color Additives used in food, drugs, cosmetics, and medical devices require approval from U.S. FDA. The requirements associated with the approval vary depending on the particular Color Additive.  For many Color Additives, approval for use is contingent upon “batch certification,” whereby batch samples are submitted to FDA for testing to ensure that they conform to the specifications described in the applicable regulations.

For Color Batch Certification, manufacturers provide U.S. FDA with a representative sample of each Color Additive batch along with the required documentation. U.S. FDA analyzes the Color Additive sample to ensure that it meets the specifications required for certifiable Color Additives. For some Color Additives, Color Batch Certification may not be appropriate.

Registrar Corp helps companies comply with U.S. FDA’s extensive Color Additive requirements by cross referencing your color against thousands of pages within the Code of Federal Regulations as well as the Federal Register, EAFUS Database, Labeling Guides, and Warning Letters issued by U.S. FDA. Registrar Corp’s Color Additive service provides:

  • A detailed report (typically 15-20 pages) prepared by our team of Regulatory Specialists who scrutinize every element of your Color Additive’s chemical identity, intended use, restrictions, labeling requirements, and permitted diluents;
  • Guidance on batch treatment protocol, record-keeping requirements, and recommended best practices; and
  • Assistance filing for Color Batch Certification with the U.S. FDA, as well as record and registration retention to enable quicker certifications for future batches of the same color.

For assistance with FDA Color Additive requirements, simply complete the form below: