/>i- FDA announced a proposed order which would revoke the color additive authorization for the use of Orange B (21 CFR 74.250). The existing regulation permits its use in the coloring of casings or the surfaces of frankfurters and sausages at up to 150 ppm in the finished food.
- The cited rationale for the order is abandonment. Orange B is a batch-certified color additive, requiring FDA to test and certify every batch prior to marketing. FDA indicates that it has not certified nor has received a request for certification for a batch of Orange B since 1978, and therefore concludes that the color additive is no longer used. The abandonment of the color additive also allows FDA to avoid much more cumbersome notice and comment rulemaking that would otherwise be required to revoke the authorization. FDA indicates that the proposed order is consistent with President Trump’s executive orders directing agencies to eliminate regulations determined to be unnecessary and/or burdensome.
- Orange B is among the synthetic color additives the department of Health and Human Services (HHS) and FDA previously announced were to be phased out of the food supply. In those cases where FDA does not remove color additive authorizations from its regulations, the phase outs will be voluntary.
- Comments on the proposed order are due within 30 days (by October 17th). FDA proposes that any final order based on today’s proposal be effective 45 days following its publication.
Proposed FDA Order Would Revoke Authorization for Orange B in Food
Saturday, September 20, 2025
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