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Is Red 3 banned? What the FDA revoked, and where it is still allowed

Synthetic food dye · Also known as: Erythrosine, Erythrosine B, FD&C Red No. 3, FD&C Red 3, Red Dye 3, Red No. 3, E127, CI 45430, Food Red 14 · Reviewed Oct 20, 2026 · 16 sources

Quick answerFor US food, yes, with a delay: FDA issued an order in January 2025 revoking the authorization for Red 3 (FD&C Red No. 3) in food and ingested drugs, and food makers have until January 15, 2027 (ingested drugs until January 18, 2028) to stop using it. It is not banned in Canada, which lists it as erythrosine with maximum levels, and the EU authorises it as E127 only for certain cherries. FDA acted because of tumors in male rats and said there is no evidence it causes cancer in humans.

Where Red 3 is allowed

United States

Restricted

FDA's order, published January 16, 2025, revokes the color additive listings for Red 3 in food (including dietary supplements) and in ingested drugs, effective January 15, 2027 for food and January 18, 2028 for ingested drugs. An objection from one company had stayed (paused) those dates from February 2025, but FDA rejected the objection, lifted the stay on August 5, 2026 and confirmed the dates, so the food listing stays in the regulations until January 15, 2027. FDA has urged food makers to stop sooner; products made before the effective date may still be on shelves afterward. Red 3 has not been an FDA-listed color for cosmetics or externally applied drugs since 1990. [1, 2, 3, 4, 5, 7]

As of 2026-10

Canada

Permitted with conditions

Erythrosine, the Canadian name for Red 3, is on Health Canada's List of Permitted Food Colours (the current version is dated October 20, 2025). Limits are set food by food, for example up to 300 ppm when used alone in unstandardized foods, bread, butter, jams and ice cream mix, and a good-manufacturing-practice amount not exceeding 125 ppm in salted anchovy, scad and shrimp. [8, 9]

As of 2026-10

European Union

Restricted

Authorised as E127 only for cocktail and candied cherries (up to 200 mg/kg) and bigarreaux cherries in syrup and in cocktails (up to 150 mg/kg). Regulation (EC) No 1333/2008 allows only listed additives in listed foods, and this colour may not be sold directly to consumers. [10]

As of 2026-10

What is Red 3?

Red 3 is a synthetic red dye. Chemically it is erythrosine, certified in the US as FD&C Red No. 3 and numbered E127 in Europe. FDA describes it as giving certain foods and drinks a bright, cherry-red color. Its chemical name includes four iodine atoms ("tetraiodo"), and it is a different dye from Red 40.

FDA says it was first listed in 1907 and permanently listed for food and ingested drugs in 1969. In 1990 FDA did not extend its provisional listing for cosmetics and externally applied drugs, citing thyroid tumors in rat studies.

Why it's used, and where you'll find it

Red 3's job is appearance: it adds a cherry-red shade. FDA says it was mainly used in candy, cakes and cupcakes, cookies, frozen desserts, and frostings and icings, plus certain ingested drugs.

  • candy
  • cakes and cupcakes
  • cookies
  • frozen desserts
  • frostings and icings
  • some ingested drugs
  • cocktail and candied cherries (EU)

What the research and regulators say

Why FDA acted: tumors in male rats

FDA concluded that Red 3 can induce thyroid tumors in male rats at high exposure. In FDA's account, a rise in thyroid-stimulating hormone (TSH) appears to be a key step, through a hormonal pathway FDA described as specific to rats. The Delaney Clause of US law deems an ingested color additive unsafe if it is found to cause cancer in people or animals, so FDA said it had to revoke the listings as a matter of law. [2, 3, 6]

What FDA said about people

FDA said the rat tumors are of limited relevance to humans, were not seen in female rats, mice, gerbils or dogs, and that human studies have not shown convincing evidence of consistent changes in thyroid hormone levels. FDA's cancer assessment committee judged thyroid tumors in people at low exposure from the uses at the time unlikely, and FDA stated there is no evidence Red 3 causes cancer in humans. The order also said Red 3 met the safety standard of reasonable certainty of no harm, but that the Delaney Clause left FDA no discretion. [1, 2, 6]

Other expert reviews

The international expert committee on food additives (JECFA) re-evaluated Red 3 in 2018 and confirmed an acceptable daily intake of 0 to 0.1 mg per kg of body weight. That figure comes from a human study in which 200 mg a day for 14 days had minimal effects on thyroid function and 60 mg a day had none, with a safety factor of 10 applied. JECFA concluded that dietary exposure for all age groups did not present a safety concern, while noting a high-end estimate for children (0.09 mg/kg a day) was close to the top of that limit. EFSA's 2011 re-evaluation did not change the limit, judged the rat thyroid tumors secondary to effects on thyroid function rather than DNA damage, and considered them of limited relevance to humans. Red 3 does not appear on IARC's current list of classified agents. [11, 12, 13, 14, 16]

Who might choose to avoid it

None of the regulators we read single out a group that needs to avoid Red 3. Some shoppers skip it because FDA revoked it, or to avoid synthetic dyes generally.

How to spot it on a label

On US labels it appears as FD&C Red No. 3, FD&C Red 3 or Red 3; FDA says the "FD&C" prefix and "No." can be dropped. In Canada the name is erythrosine; in the EU it is erythrosine or E127. FDA also lists CI 45430 and Food Red 14.

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Frequently asked questions

Is Red 3 banned in the US?

FDA has ordered its authorization revoked for food and ingested drugs, with dates of January 15, 2027 for food and January 18, 2028 for ingested drugs. FDA has asked food makers to switch sooner.

Is Red 3 banned in Canada?

No. Health Canada's List of Permitted Food Colours still includes erythrosine, with maximum levels that depend on the food.

Is Red 3 banned in Europe?

Not entirely. The EU authorises E127 only for cocktail and candied cherries and for bigarreaux cherries in syrup and cocktails.

Is Red 3 banned in California?

California's governor said when signing AB 418 in October 2023 that, after January 1, 2027, food made or sold in California cannot contain red dye 3, brominated vegetable oil, potassium bromate or propylparaben.

What is the difference between Red 3 and Red 40?

They are separate dyes with separate listings. The 2025 FDA order covers Red 3 only.

Does Red 3 cause cancer?

It caused thyroid tumors in male rats at high exposure, which triggered the US revocation. FDA said the mechanism is rat-specific and there is no evidence it causes cancer in humans.

Related ingredients

Sources

  1. U.S. FDA — FD&C Red No. 3 (content current as of 10/05/2026) (accessed 2026-10-20)
  2. Federal Register (FDA) — Color Additive Petition From Center for Science in the Public Interest, et al.; Request To Revoke Color Additive Listing for Use of FD&C Red No. 3 in Food and Ingested Drugs (90 FR 4628, January 16, 2025) (accessed 2026-10-20)
  3. Federal Register (FDA) — Micro-Tracers, Inc.; Response to Objections and Requests for a Public Hearing (91 FR 50475, August 5, 2026) (accessed 2026-10-20)
  4. U.S. FDA — Regulatory Status of Color Additives (entry: FD&C Red No. 3) (accessed 2026-10-20)
  5. eCFR (U.S. Code of Federal Regulations) — 21 CFR 74.303 - FD&C Red No. 3 (accessed 2026-10-20)
  6. U.S. FDA — FDA to Revoke Authorization for the Use of Red No. 3 in Food and Ingested Drugs (accessed 2026-10-20)
  7. U.S. FDA — FDA Encourages Food Manufacturers to Accelerate Phasing Out the Use of FD&C Red No. 3 in Foods Before 2027 Deadline (accessed 2026-10-20)
  8. Health Canada — 3. List of Permitted Food Colours (Lists of Permitted Food Additives) (accessed 2026-10-20)
  9. Canadian Food Inspection Agency — Food colours (accessed 2026-10-20)
  10. EUR-Lex (European Union) — Consolidated text: Regulation (EC) No 1333/2008 on food additives (version of 18.08.2026) (accessed 2026-10-20)
  11. WHO / FAO JECFA — Erythrosine (JECFA food additives database) (accessed 2026-10-20)
  12. EFSA (record held by University of Bologna repository) — Scientific Opinion on the re-evaluation of Erythrosine (E 127) as a food additive (EFSA Journal 2011;9(1):1854) (accessed 2026-10-20)
  13. EFSA — Food colours (EFSA topic page) (accessed 2026-10-20)
  14. IARC — IARC Monographs: List of Classifications (data dated 23 July 2026) (accessed 2026-10-20)
  15. Office of the Governor of California — Assembly Bill 418 signing message (October 7, 2023) (accessed 2026-10-20)
  16. WHO / FAO JECFA — Evaluation of certain food additives: eighty-sixth report of the Joint FAO/WHO Expert Committee on Food Additives (WHO Technical Report Series 1014, 2019), erythrosine section (accessed 2026-10-20)

This page summarizes what regulators and published research say, as of the review date above. Rules and evidence change; check the linked sources for the latest. It is general information, not medical advice — talk to a doctor or pharmacist about your own health.