Answer: Yes — Red Dye 3 is banned in 3 countries/regions including European Union (restricted to cocktail cherries only at max 200 mg/kg), Norway, Iceland. The FDA still allows it in US food. Commonly found in: Maraschino cherries, Fruit cocktail, Certain popsicles.
TL;DR: Red Dye 3 is restricted in the EU but allowed in the US (food additives).
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Also called Erythrosine. (E127)
Other names: Erythrosine, E127, FD&C Red No. 3, CI 45430
| EU status | Restricted |
|---|---|
| US status | Allowed |
| Risk level | — |
| Where it shows up | Maraschino cherries, Fruit cocktail, Certain popsicles, Pink-tinted medications and supplements, Cake decorating gels, Candied cherries |
Red Dye 3 (erythrosine) is a synthetic cherry-pink fluorescent dye belonging to the xanthene class. It contains approximately 58% iodine by weight, distinguishing it from azo dyes. Its chemical formula is C20H6I4Na2O5. Approved since 1907, it is one of the oldest certified US food colorants and was notably the first synthetic food dye formally revoked by the FDA in decades.
Red Dye 3 produces a unique bright cherry-pink hue difficult to replicate with natural dyes. Its distinctive fluorescent appearance under certain lighting is prized in maraschino cherries, certain medications and capsules, and some confections. It is stable in sugar-based matrices and highly cost-effective at low concentrations.
The FDA revoked Red Dye 3 authorization in January 2025, marking the first synthetic food dye ban by the FDA since Red Dye 2 in 1976. The revocation was triggered by the Delaney Clause, which mandates revocation of any food additive found to cause cancer in animals regardless of dose. The carcinogenicity data stems from studies showing that high doses of erythrosine caused thyroid follicular cell tumors in male rats. The mechanism is indirect: erythrosine suppresses thyroid-stimulating hormone (TSH) feedback by elevating thyroxine (T4) levels, causing chronic TSH suppression that promotes thyroid cell proliferation and ultimately tumor formation. This is a rat-specific mechanism related to their thyroxine-binding protein system, which differs from human biology. EFSA's 2011 comprehensive safety assessment concluded erythrosine was unlikely to be genotoxic at typical food use levels and set an ADI of 0.1 mg/kg body weight — one of the lowest for any food color. EFSA restricted EU use to cocktail cherries only (max 200 mg/kg). The high iodine content (58% by weight) raises concerns for thyroid-sensitive individuals. Excessive erythrosine intake could theoretically contribute to iodine overload and thyroid disruption, particularly in individuals with hyperthyroidism or Hashimoto's disease. The FDA had been aware of the rat thyroid tumor data since 1990 but delayed action for 35 years. Advocacy groups including CSPI petitioned for a ban since 1983. The January 2025 revocation finally addressed this long-standing regulatory gap.
For educational use only. This page summarizes the regulatory status of Red Dye 3with citations to the primary sources below. It is not medical advice. Regulatory status is not the same as a proven health effect — read the cited sources for their exact wording, and consult a doctor for decisions about your or your family's health.
Beet juice extract provides natural pink-red tones used in health-oriented brands. Carmine (cochineal, E120) produces stable cherry-red for confections. Anthocyanins from black carrot, elderberry, or raspberry can provide pink-purple hues. Cherry juice concentrate is ideal for cherry-flavored products. Natural Maraschino brand uses natural cherry juice to color cherries. These alternatives have varying stability under heat and acidic conditions.
Yes. The FDA revoked Red Dye 3 (erythrosine, FD&C Red No. 3) in January 2025 — the first outright food dye ban by the FDA since Red Dye 2 in 1976. Food manufacturers must comply by January 15, 2027; pharmaceutical manufacturers by January 18, 2028. The EU had long restricted it to cocktail cherries only (max 200 mg/kg). After the FDA action, the US now has stricter red dye regulation than the EU for this specific compound.
The FDA invoked the Delaney Clause, which requires revocation when any food additive causes cancer in animals regardless of human exposure. Studies showed erythrosine caused thyroid follicular cell tumors in male rats at high doses. The FDA had known since 1990 but delayed action. Advocates petitioned since 1983. The January 2025 action closed a 35-year regulatory gap.
The final rule was issued January 2025. Food manufacturers must remove Red Dye 3 by January 15, 2027. Drug manufacturers have until January 18, 2028. Until those deadlines, existing products may still be manufactured and sold legally.
Maraschino cherries, fruit cocktail, certain popsicles, pink-colored medications and supplements, cake decorating gels, some Pop-Tarts flavors, candied cherries, and certain pink-frosted baked goods. Check labels for 'Red 3,' 'FD&C Red No. 3,' or 'erythrosine.'
In male rats, Red Dye 3 caused thyroid tumors at high doses, triggering the Delaney Clause. The mechanism is rat-specific (thyroid hormone regulation differs in rats vs. humans). EFSA found erythrosine unlikely to be genotoxic at food use levels. Human carcinogenicity is unproven, but the legal threshold for FDA action — any animal carcinogenicity — was clearly met.
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Erythrosine is the chemical name for Red Dye 3 (FD&C Red No. 3, E127). It is a synthetic cherry-pink xanthene dye containing four iodine atoms (58% iodine by weight). First approved as a food color in 1907, it was one of the oldest certified US food colorants before its 2025 revocation.
Beet juice extract, carmine from cochineal insects, and anthocyanins from berries, red cabbage, or black carrot replace Red Dye 3. For cherry applications, natural cherry juice concentrate or raspberry extract provides similar hues. The transition is complex because natural dyes vary in stability with pH, heat, and light.
Red Dye 3 is a xanthene dye containing iodine that produces a fluorescent cherry-pink; revoked by FDA January 2025. Red Dye 40 is an azo dye with no iodine producing an orange-red color; announced for phase-out April 2025 but not yet formally revoked as of mid-2025. Red Dye 40 is far more widely used than Red Dye 3 was in US food products.
Audited products that don't contain Red Dye 3.
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