FDA Seeks Input on Color Additive Safety Certification Forms
Published Date: 4/10/2026
Notice
Summary
The FDA wants your thoughts on how it collects info about color additive certifications, which are needed to make sure colors in food and products are safe. This affects companies that use or make color additives and could impact paperwork and costs. You’ve got until June 9, 2026, to share your comments and help shape the process!
Analyzed Economic Effects
5 provisions identified: 1 benefits, 4 costs, 0 mixed.
Annual Reporting Burden Totals
Manufacturers must submit requests for color additive certification a total of 7,504 times per year across 67 respondents. FDA estimates each certification request takes 0.22 hours (13 minutes) and the total annual reporting burden is 1,651 hours.
Recordkeeping and Disposal Record Burden
Manufacturers must keep records of batches pending and after certification, including records showing disposal of certified color additive. FDA estimates 7,504 annual recordkeeping actions at 0.25 hours (15 minutes) each, totaling 1,876 hours per year.
Fees Charged by Batch Weight
FDA charges a certification fee that is based on the weight of each batch, and those user fees support the color certification program. Businesses manufacturing color additives will need to pay these batch-weight fees when seeking certification.
Which Additives Require Certification
Color additives listed in 21 CFR part 74 and provisionally listed in 21 CFR part 82 must come from FDA-certified batches; additives listed in 21 CFR part 73 are exempt from certification. Manufacturers must follow these part-based rules when determining whether to seek batch certification.
Electronic Submission and Faster Market Use
FDA offers a web-based color certification system for online requests, tracking, and account status, and certified color may be sold before a hard copy certificate is received. Manufacturers must open an account by sending a signed letter as an email attachment to FDA before submitting requests online.
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