U.S. FDA Color Additive Requirements
Color Additives and dyes 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 and dyes, 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 and dyes, 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.
For assistance with FDA Color Additive and dye requirements, simply complete the form below:
