FDA Asks Comments on Food Additive Petition Paperwork
Published Date: 4/10/2026
Notice
Summary
The FDA wants your thoughts on how they collect info about food and color additive petitions, including labels and electronic forms. This affects companies and people who submit these petitions, aiming to keep the process smooth and clear. You’ve got until June 9, 2026, to share your comments—no fees, just your voice!
Analyzed Economic Effects
5 provisions identified: 3 benefits, 2 costs, 0 mixed.
Large Time Burden for Food Additive Petitions
The FDA estimates that food additive petitions (FAPs) average 7,093 hours per response and that three FAPs are submitted annually (21,279 total hours). Color additive petitions average 1,337 hours each with four CAPs per year (5,348 total hours), making FDA’s estimated annual review burden 26,632 hours in total.
Color Additive Petition Fees
If you submit a color additive petition (CAP), you must pay a listing fee that ranges from $1,600 to $3,000 depending on use and scope. The FDA expects an average of four CAPs per year and estimates the petitioners’ total annual fee burden could be up to $11,200 ((2 x $2,600) + (2 x $3,000)).
Electronic Submission Option Lowers Paperwork
You can submit FAPs, CAPs, and master file information electronically using Form FDA 3503 and the Human Foods Program Centralized Online Submission Module (COSM). COSM is a web-based tool available 24 hours a day, 7 days a week, and eliminates the need to print and mail paper submissions.
Master Files Reduce Repeat Paperwork
You may use master files as repositories for information that can be referenced in multiple petitions, which can minimize paperwork when the same data supports several submissions. The FDA says master files can help reduce the overall information collection burden for petitioners.
Labeling Data Included in Petition Burden
Labeling information required under 21 CFR 70.25 and parts 172, 173, 179, and 180 is treated as part of the CAP and FAP safety review and does not require extra recordkeeping beyond what is already needed for safety and regulatory conformance. FDA includes labeling burden hours within the petition burden estimates.
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