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Home › U.S. FDA Color Additive Requirements

U.S. FDA Color Additive Requirements

Color Additives in food, drugs, cosmetics, and medical devices require approval by U.S. FDA. The form and frequency of approval depends on the particular Color Additive. For most Color Additives, the appropriate approval process is U.S. FDA's Color Batch Certification program, which requires approval of each batch.

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 coloring against thousands of pages within the Code of Federal Regulations as well as the Federal Register, EAFUS Database, GRAS Notices, 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.

Registrar Corp helps companies comply with U.S. FDA Color Additive requirements
Select one of the following options:

Option 1: Obtain Guidance for particular Color Additives
If you do not know the requirements pertaining to your specific Color Additive, click the link below to obtain guidance.

Learn how U.S. FDA Color Additive regulations apply to your product >>

Option 2: File a Color Batch Certification with U.S. FDA
If you know that your Color Additive requires U.S. FDA Color Batch Certification, click the link below for assistance.

File for a Color Batch Certification with U.S. FDA >>





 
U.S. FDA Regulations:

U.S. FDA Color Additives: 21 C.F.R. Parts 73, 74, and 80


Fees:

Color Additive Initial Report
US$ 295/color

Color Batch Certification Filing
US$ 395/batch







Registrar Corp assists businesses with U.S. FDA compliance. Certificates of Registration issued by Registrar Corp provide confirmation to industry that you are fulfilling U.S. FDA registration requirements. U.S. FDA does not issue or recognize Certificates of Registration. Registrar Corp is not affiliated with the U.S. Food and Drug Administration.

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