Red dye 3: why the FDA revoked it, and what changes in 2027

Red dye 3 — FD&C Red No. 3, called erythrosine or E127 outside the United States — is a synthetic pink-red food colour whose US authorisation the FDA has revoked: for food from 15 January 2027, for ingested drugs from 18 January 2028. The order rests on the Delaney Clause, triggered by cancer in male rats.

Until those dates it remains a listed colour, which is why it can still appear on a US label today. This page sets out what the order says, the dates that are easy to confuse, and the names the colour goes by on a package.

15 Jan 2027

Date the FDA revocation of red dye 3 takes effect for food; ingested drugs follow on 18 January 2028Federal Register, 90 FR 4628, 2025

Why was red dye 3 banned?

The FDA revoked red dye 3 as a matter of law. The Delaney Clause of the Federal Food, Drug, and Cosmetic Act deems a colour additive unsafe under certain circumstances, and a 2022 petition cited two studies showing cancer in laboratory male rats exposed to high levels of the dye. The order follows from that finding, not from a new estimate of risk to people.

The FDA’s notice is explicit about the distinction. It states that the way red dye 3 causes cancer in male rats does not occur in humans, that relevant human exposure is typically much lower than in those studies, and that studies in other animals and in humans did not show the effects.

The revocation is a legal consequence of the rat finding. The agency’s own position is that the mechanism behind it does not occur in humans — both statements sit in the same notice.

When the red dye 3 ban takes effect

Four documents and six dates are involved, and news coverage tends to merge them into one. The table puts them in order.

DateWhat happensDocument
1 February 1990FDA does not extend the provisional listing for cosmetics and externally applied drugs55 FR 3516
2023California passes the California Food Safety ActAB 418
16 January 2025FDA order repealing the food and ingested-drug listings is published90 FR 4628
1 January 2027California bars food containing red dye 3AB 418
15 January 2027US food authorisation ends90 FR 4628
18 January 2028US authorisation for ingested drugs ends90 FR 4628

Until mid-January 2027 the federal regulation still reads as a listing: 21 CFR 74.303 permits the colour for coloring foods generally, except in foods with standards of identity unless those standards allow added colour. California’s law starts two weeks earlier and carries civil penalties of up to $5,000 for a first violation and $10,000 for each one after.

Is red dye 3 the same as Red 40?

Red dye 3 and Red 40 are different colour additives. Red 3 is erythrosine, E127 in Europe; Red 40 is Allura Red AC, E129. The January 2025 order covers red dye 3 alone, so a label that lists Red 40 is untouched by it — what the Red 40 rules say covers that colour. Yellow 5 is in the same position as Red 40: still listed, and named in the FDA’s April 2025 request to industry rather than in a revocation order.

Where red dye 3 is still allowed

US food: until 15 January 2027

The federal listing for food stays in force until the order takes effect. Imported foods sold in the US must meet the same requirements, even where the country of origin allows the colour.

US cosmetics: not since 1990

The provisional listing for cosmetics and externally applied drugs was not extended in 1990, so the colour has had no US cosmetic use for more than three decades.

EU: cherries only

E127 is authorised in two food categories — cocktail and candied cherries at up to 200 mg/kg, bigarreaux cherries in syrup and in cocktails at up to 150 mg/kg — and may not be sold to consumers on its own.

The FDA notes that other countries still allow certain uses of the colour. That is the practical reason to know its European names: an imported product may print erythrosine or E127 rather than the US name.

How to find red dye 3 on an ingredient label

The ultra-processed food checker matches all four names to a single entry and shows the regulatory note beside the match, so a pasted label returns the dates above rather than a bare flag.

  1. Step 1

    Look for every name

    The colour appears as Red 3, FD&C Red No. 3 or erythrosine, and as E127 on European packaging. All four point to the same colour additive.

  2. Step 2

    Read the end of the list

    Colours are usually declared among the last ingredients, often after a phrase such as contains 2% or less of. Scanning the first few ingredients will miss them.

  3. Step 3

    Treat imports separately

    Sweets and preserved cherries from abroad may carry the European names. Check for erythrosine and E127 as well as the US name.

What this page does not tell you

This page reports what regulators have decided and when. It does not assess what red dye 3 does in any one person, and a clinician is the right person for a diagnosed reaction or a child’s restricted diet. The rules this site follows for food claims are set out in our food methodology, and the other colours and additives are collected in the food additive guides.

Common questions

Is red dye 3 banned in the US right now
Red dye 3 is still a listed food colour in the United States until 15 January 2027, when the FDA revocation takes effect for food; ingested drugs follow on 18 January 2028. It has not been permitted in cosmetics or externally applied drugs since 1990, and California bars it from food sold in the state from 1 January 2027.
Is red dye 3 allowed in Europe
Red dye 3 is authorised in the European Union as E127 erythrosine, but only in cocktail cherries and candied cherries, at up to 200 mg/kg, and in bigarreaux cherries in syrup and in cocktails, at up to 150 mg/kg. EU rules also bar selling the colour on its own directly to consumers.
Does the FDA say red dye 3 causes cancer in people
The FDA says the way red dye 3 caused cancer in male rats does not occur in humans, and that typical human exposure is much lower than the levels in those studies. It revoked the authorisation anyway, as a matter of law, because the Delaney Clause applies once a colour additive is shown to induce cancer in animals.
Do imported foods have to follow the US red dye 3 rule
Imported foods sold in the United States must meet US requirements, so the red dye 3 revocation applies to them from the same dates. The FDA notes that other countries still allow some uses of the colour, which is why it may appear on an imported label under its European names, erythrosine or E127.
When is checking for red dye 3 the wrong question
Checking for red dye 3 is the wrong question when the concern is a diagnosed reaction or a child's restricted diet, which needs a clinician rather than an ingredient lookup. It also says nothing about a product's other colours — Red 40 is a different colour additive with its own listing and has to be checked by its own name.

Sources

Every factual claim on this page that can be checked against a document is listed here with the document it comes from.

  1. 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 DrugsFederal Register, vol. 90, p. 4628 (16 January 2025), via govinfo · govinfo.govThat FDA repealed the FD&C Red No. 3 listings for food and ingested drugs under the Delaney Clause on petitioners' data showing cancer in male rats, effective 15 January 2027 (ingested drugs 18 January 2028), and that in 1990 FDA did not extend the provisional listing for cosmetics and externally applied drugs (55 FR 3516).
  2. FDA to Revoke Authorization for the Use of Red No. 3 in Food and Ingested DrugsU.S. Food and Drug Administration, Human Foods Program constituent update (15 January 2025) · fda.govFDA's statements that the revocation is made as a matter of law under the Delaney Clause, that the way the dye causes cancer in male rats does not occur in humans, that human exposure is typically much lower, and that imported foods must comply with US requirements.
  3. 21 CFR 74.303 — FD&C Red No. 3Electronic Code of Federal Regulations (eCFR) · ecfr.govThat until the revocation takes effect the current regulation still lists FD&C Red No. 3 for coloring foods generally, except foods with standards of identity unless added color is authorised by those standards.
  4. AB-418 The California Food Safety Act (2023–2024)California Legislative Information · leginfo.legislature.ca.govThat from 1 January 2027 California bars manufacturing, selling or distributing food containing red dye 3 (CAS no. 16423-68-0), with civil penalties up to $5,000 for a first violation and $10,000 for each subsequent one.
  5. Regulation (EC) No 1333/2008 on food additives, consolidated text of 18 August 2026 — Annex IIEUR-Lex · eur-lex.europa.euThat E 127 erythrosine is authorised only in cocktail and candied cherries (200 mg/kg) and bigarreaux cherries in syrup and in cocktails (150 mg/kg), and that it may not be sold directly to the consumer.