Type of Posting: General Announcement
Posting Date: 19-Dec-2025
Targeted Effective Date: To Be Determined
Expert Committee: Food Ingredients
In accordance with the Rules and Procedures of the Council of Experts, this is to provide notice that the Food Ingredients Expert Committee (FI EC) intends to omit FD&C Red No. 3 monograph and revise the Erythrosine monograph in the Food Chemicals Codex (FCC).
Due to an order issued by the U.S. Food and Drug Administration (FDA) revoking the authorization for the use of FD&C Red No. 3 as a color additive in foods (as well as dietary supplements and ingested drugs), it is proposed to omit the monograph for this ingredient. The effective date of the omission is aligned with the Agency’s implementation date for food. For more information on the Agency’s order and implementation timelines, please refer to the Federal Register docket number FDA-2023-N-0437 (document citation 90 FR 4628) at https://www.federalregister.gov/.
The FI EC has decided to update the Erythrosine monograph at the same time as the omission of FD&C Red No 3. The revision will align the FCC monograph with the JECFA monograph for Erythrosine prepared at the 86th meeting of the Joint FAO/WHO Expert Committee on Food Additives (JECFA Monograph 22;2018). This revision modernizes the monograph for global (non-US) stakeholders using this standard in jurisdictions where Erythrosine is approved as a color additive.
It is anticipated that the proposed omission of FD&C Red No 3, and the proposed revisions to Erythrosine monographs will be published in the December 2025 FCC Forum. The comment period for these revisions would end on March 31, 2026, and the changes would be scheduled to become effective on December 1, 2026.
Additionally, the FI EC is interested in developing new monographs for Gardenia (Genipin) Blue, Butterfly Pea Flower Extract, and Galdieria Extract Blue, all recently approved by US FDA as color additives, and are actively seeking sponsors to support this work. The FI EC also intends to revise the monographs for Allura Red, Fast Green, Tartrazine, Sunset Yellow, Brilliant Blue, and Indigotine, to align with the most recent JECFA monographs for each color additive, respectively. Target dates for publication of these proposals have not yet been determined.
If you wish to stay connected to USP’s ongoing work related to color additives, please sign up for updates at https://www.usp.org/color-additives.
Should you have any questions, please contact Gina M. Clapper, Principal Scientist (gina.clapper@usp.org).