People in industry, as well as consumers, sometimes have questions about FDA’s certification of color additives used in food, drugs, and cosmetics, such as how certification is different from approval. Here are answers to some common questions.
- How FDA Color Certification is Different from Approval
- How FDA Determines Whether a Color Additive Needs Batch Certification
- How to Check Whether a Listed Color Additive is Subject to FDA Batch Certification
- Where to Find the Regulations for Color Additive Batch Certification
- What a Color Additive Manufacturer Needs to Do to Obtain Batch Certification
- FDA’s Batch Certification Process
- Fees for Batch Certification
- What Happens If a Product Contains a Certifiable Color Additive From an Uncertified Batch
- How to Make Sure Certifiable Color Additives Are From a Certified Batch
- Where to Go for More Information on Color Additive Certification
- More Resources
By law, all color additives must have FDA approval for their intended use and be listed in the color additive regulations before they are permitted for use in food, drugs, cosmetics, and many medical devices.
Some color additives have an additional requirement: They are permitted only if they are from batches that FDA has certified. This means that FDA chemists have analyzed a sample from the batch and have found that it meets the requirements for composition and purity stated in the regulation—called a “listing regulation”—for that color additive.
Using an uncertified form of a color additive that requires FDA certification makes an FDA-regulated product adulterated under the law, and FDA can take action against the product.
Color additives that require FDA batch certification are often referred to as “certifiable.”
FDA determines the need for batch certification based on whether the color additive needs this level of control to protect the public health. Some color additives, in their uncertified forms, might contain impurities at levels that pose a health concern.
Color additives subject to certification are typically synthetic, made from raw materials obtained from petroleum.
Color additives that are subject to batch certification are listed in FDA’s regulations, in 21 CFR Parts 74 and 82. Color additives that are exempt from certification are listed in the regulations in 21 CFR Part 73.
You also can check the Summary of Color Additives Listed for Use in the United States in Food, Drugs, Cosmetics, and Medical Devices, which lists color additives according to whether they are certifiable or exempt from certification, and according to the product category in which they may be used.
Certified color additives generally have three-part names consisting of a group of letters (“FD&C,” “D&C,” or “Ext. D&C”), a color, and a number. An example is “FD&C Yellow No. 5.”
You can find the requirements for color additive certification in 21 CFR Part 80. In addition, the regulations in 21 CFR 70.25 provide the labeling requirements for color additive batches after certification.
If you would like to open a color certification account, please send us a letter requesting to open an account signed by the responsible company representative as an email attachment to email@example.com with the following requirements:
- Written on company letterhead
- Name of your company
- All addresses (manufacturing, business and warehouses)
- Contact information (email, phone numbers) for responsible company representative
- For foreign companies, name and contact information for your U.S. agent. All foreign companies are required to have an agent who is residing in the United States representing their interests.
After we open your account, we will provide further instructions.
When we receive a batch sample, FDA personnel evaluate its physical appearance and chemically analyze it for purity (total color content), moisture, residual salts, unreacted intermediates, colored impurities other than the main color (called subsidiary colors), any other specified impurities, and the heavy metals lead, arsenic, and mercury.
We review the results for compliance with the identity and specifications described in the listing regulation for the color additive.
If we find that the sample meets these requirements, FDA issues a certificate for the batch. The certificate identifies the color additive, the batch weight, the uses for which the color additive is certified, the name and address of the owner, and other information as required.
FDA also assigns a unique lot number for the batch (21 CFR 80.31). The batch can then be used in FDA-regulated products marketed in the United States, in compliance with the uses and restrictions in that color additive’s listing regulation. (FD&C Act, Sec. 721; 21 U.S. Code 379e; 21 CFR Parts 70 and 80.)
If the sample doesn’t meet the requirements, we reject the batch.
The evaluation and analyses typically take less than five business days.
Note: FDA certifies color additives before they are used in products. We cannot certify color additives that are already in a product.
Fees for analyzing batches of color additives for certification are based on the batch weight. See 21 CFR 80.10. These fees support FDA’s color certification program.
It’s against the law to market FDA-regulated products in the United States that contain a certifiable color additive from an uncertified batch.
Here’s why: Failure to meet U.S. color additive requirements is one of the ways an FDA-regulated product can become adulterated or misbranded (FD&C Act, 402, 403, 501, 502, 601, and 602; 21 U.S.C. 341, 342, 351, 352, 361, and 362). The FD&C Act prohibits the marketing of adulterated or misbranded foods, drugs, medical devices, and cosmetics in interstate commerce, whether they are manufactured in the U.S. or imported (FD&C Act, 301(a); U.S.C. 331 (a)).
FDA can take action against adulterated or misbranded products. For example, color additive violations are a common reason for import refusals of food and cosmetic products offered for entry into the United States.
First, check the label. A certified color additive must be labeled with the name of the color additive as it appears in the CFR, general limitations for use, any other limitations or tolerances, and the FDA certification lot number.
Mixtures of previously certified color additives must be labeled with the name of each ingredient in the mixture, general limitations for use, and any other limitations or tolerances. Instead of certification lot numbers, these mixtures must be labeled with manufacturers’ control numbers that can be used to verify the certification history of the straight color(s) (21 CFR 70.25).
It may also help to refer to Companies Requesting Color Certification Within the Last Two Years when selecting a supplier. If your supplier does not appear on this list, you can contact FDA at firstname.lastname@example.org to learn whether the supplier has in fact requested certification.
Color additive manufacturers can send questions on color additive certification to email@example.com.
- Improvements to Color Additive Certificates of Analysis
- Color Certification Reports: Amounts of Color Additives Certified by FDA, Updated Quarterly
- Companies Requesting Color Certification Within the Last Two Years: Updated Semi-annually
- Color Certification User Fees: From the Code of Federal Regulations