Red Dye No. 3
erythrosine, FD&C Red 3, E127, erythrosine B
Sold freely in Canada and banned in United States. Same substance, same evidence, different decisions.
A synthetic cherry-red food, drug, and pill coloring.
Red Dye 3 inverts the usual pattern: on food the United States moved late, not first. The EU never issued a blanket ban; it restricted erythrosine (E127) decades ago to a narrow set of cherry uses under Regulation (EC) 1333/2008. The US left it in food and ingested drugs until January 2025, when the FDA revoked the listing under the Delaney Clause, with reformulation deadlines running to 2027 and 2028. It shows how two systems reading the same rat studies reach different outcomes years apart, driven by different legal triggers rather than different data.
Where it stands, jurisdiction by jurisdiction
Canada
Open, sold freelyDecided on: Evidence, Contested
Still permitted. Erythrosine appears on Health Canada's List of Permitted Food Colours. Health Canada concluded that dietary exposure does not pose a health risk to the general Canadian population at the levels set in that list, and said it would act, up to removing the colour, only if new evidence shows a human health risk.
European Union
Restricted, restrictedDecided on: Precaution, Evidence
Not a full ban. Erythrosine (E127) stays authorised under Regulation (EC) 1333/2008, but only for a narrow set of uses, cocktail cherries, candied cherries, and Bigarreaux cherries in syrup and in cocktails, at capped levels. General food use ended in the mid-1990s, well ahead of the US. EFSA's re-evaluation kept an Acceptable Daily Intake of 0.1 mg/kg body weight and judged the rat thyroid tumours of limited relevance to humans.
United States
Banned, bannedDecided on: Evidence, Contested
The FDA had already ended the use of FD&C Red No. 3 in cosmetics and externally applied drugs in 1990 over rat thyroid cancer findings. It revoked the listing for food, including dietary supplements, and for ingested drugs on January 15, 2025. The agency acted as a matter of law under the Delaney Clause, which bars any color additive shown to cause cancer in animals, while stating the rat-specific hormonal mechanism does not occur in humans. Manufacturers have until January 15, 2027 for food and January 18, 2028 for ingested drugs to reformulate, so it remains on shelves during the phase-out.
Regulatory positions change, sometimes quickly. Check the date on a source before relying on it.