Erythrosine (Red 3; FD&C Red No. 3)

What this is

Red 3 has a long, mixed regulatory history. Toxicology concern centers on high-dose lifetime feeding studies in male rats that produced thyroid tumors, apparently through increased TSH and a rat-sensitive hormonal pathway rather than direct DNA damage. FDA, JECFA, EFSA, and FSANZ have described the rat thyroid-tumor mechanism as having limited relevance to humans at typical exposures, and FDA said human and other animal data did not show the same effect. Even so, U.S. law treats an ingested color additive that induces cancer in animals as unsafe under the Delaney Clause, so FDA issued a final order in January 2025 revoking food authorization effective January 15, 2027. Canada and Codex still allow some uses under limits, while the EU permits only very narrow use, mainly specific cherry products. The practical takeaway separates toxicology from policy: the animal mechanism has limited human relevance, but FDA's broad revocation makes Red 3 a high-priority concern for ingredient transparency.

Safety Review

The critical endpoints experts review in safety assessments. This is not a prediction of harm.

Red 3 produced thyroid tumors in high-dose male-rat studies through a hormonal pathway considered rat-sensitive, and FDA concluded it is likely not directly DNA-reactive. Nevertheless, FDA revoked food authorization under the Delaney Clause, with food compliance effective January 15, 2027.