FDA Seeks Input on Color Additive Safety Certifications
Published Date: 4/10/2026
Notice
Summary
The FDA wants your thoughts on how they collect info about color additive certifications, which help keep our food and products safe and colorful. This is a chance for companies and the public to comment on the current process before it continues. You’ve got until June 9, 2026, to share your ideas—no cost changes are mentioned, just a smooth info check-in!
Analyzed Economic Effects
6 provisions identified: 1 benefits, 5 costs, 0 mixed.
Must Request Batch Certification
If you manufacture color additives for foods, drugs, cosmetics, or many medical devices, you must submit a request for batch certification and send a representative sample to FDA under 21 CFR part 80 before that batch may be used. FDA analyzes the sample and issues a certificate with a lot number if it meets the regulation; if it fails, the batch is rejected.
Time and Recordkeeping Burden
FDA estimates 67 respondents will make 112 responses each for a total of 7,504 certification requests annually. FDA estimates 0.22 hour (13 minutes) per certification request (total 1,651 hours) and 0.25 hour (15 minutes) per record of distribution (total 1,876 hours) for an annual combined burden of 3,527 hours.
Which Additives Need Certification
Color additives listed in 21 CFR part 74 and those provisionally listed in 21 CFR part 82 require batch certification by FDA. Color additives listed in 21 CFR part 73 are exempt from certification.
Fees Charged by Batch Weight
FDA charges a certification fee that is calculated based on the batch weight for each certified batch; fees support FDA's color certification program. The document does not state dollar amounts but confirms fees apply per batch.
Rejected Batches and Recordkeeping Requirements
If a submitted sample does not meet certification requirements, the batch is rejected and manufacturers are required to keep complete records showing disposal of all of the color additive covered by the certification. FDA also requires records of distribution per 21 CFR 80.39.
Electronic Submission and Account Setup
FDA offers a web-based color certification system for online certification requests, tracking, and account status. To use it, a manufacturer must open an account by sending a signed letter (as an email attachment) to FDA; certification results are returned electronically, and submitters may sell certified color before receiving a hard copy certificate.
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