On August 19, 2026, the U.S. Federal Register Vol. 91, No. 159 published notices announcing the acceptance of three food color additive petitions. At the same time, the WTO issued SPS notifications G/SPS/N/USA/3592, G/SPS/N/USA/3594, and G/SPS/N/USA/3595.
The three petitions concern safflower extract, gardenia (genipin) blue, and acetone as a processing solvent for carrot oil, respectively. All three applications are currently under technical review.
It should be noted that acceptance of a petition does not constitute approval for use. The substances may only be legally used in food in the United States after the complete review process has been completed and the relevant provisions of 21 CFR Part 73 have been amended.
Summary of the Key Contents of the Three Petitions
|
Petition Item |
Docket No. |
Submission Date |
Key Request |
Remarks |
|---|---|---|---|---|
|
Safflower (Carthamus tinctorius L.) Extract |
FDA-2026-C-8086 |
2026-07-20 |
Request for authorization as a color additive produced in accordance with GMP for use in 17 food categories, including baked goods, alcoholic beverages, prepared tea, confectionery, sweeteners, sauces, frozen dairy products, soups, and flavored syrups. |
The petitioner has requested an exemption from the environmental assessment, and no public comment period is currently open. |
|
Gardenia (Genipin) Blue |
FDA-2026-C-8831 |
2026-08-04 |
1. Expand the permitted uses to 20 food categories, including sponge cakes, carbonated beverages, frozen tea, baked goods, fruit sauces, snack foods, chewing gum, etc.; 2. Tighten the arsenic impurity limit in the color additive from ≤2 mg/kg to ≤1 mg/kg. |
The impurity specifications will be subject to stricter requirements, and stricter arsenic control of raw materials will be required going forward. |
|
Acetone (Solvent for Carrot Oil Processing) |
FDA-2026-C-8883 |
2026-08-03 |
Permit acetone to be used as a processing solvent for carrot oil; establish additional heavy metal control specifications for carrot oil and supplement the substance identification information. |
An Environmental Assessment Report is included. The deadline for public comments is September 18, 2026. |
Compliance Considerations
- The three petitions have only been accepted for review, and the current provisions of 21 CFR Part 73 have not yet been updated. Food companies exporting to the United States should not adopt any newly proposed uses or processing applications before final approval. Companies should continue to monitor the Federal Register for final approval notices issued by the FDA.
- Exporters currently using gardenia (genipin) blue should strengthen control over raw material impurities in advance. If the arsenic specification is formally tightened in the future, companies will need to update their raw material acceptance criteria accordingly.
- Regarding the petition concerning the use of acetone as a solvent in the processing of carrot oil, interested parties may submit electronic or written comments on the environmental assessment through Regulations.gov by September 18, 2026.
All petition documents and related materials can be searched and reviewed through the U.S. federal electronic docket system, Regulations.gov. Companies can use the platform to monitor the progress of the FDA’s review in real time.
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