Both Red Dye 40 and Red Dye 3 are synthetic food colorants, but they differ in chemical structure, regulatory history, and associated health concerns. Red Dye 40 (Allura Red AC) is still widely used, while Red Dye 3 (Erythrosine) has been banned by the FDA from food and ingested drugs, effective January 2027 and January 2028 respectively. This ban follows decades of debate over its potential risks.
Chemical and Physical Distinctions
The key chemical difference lies in their composition. Both are synthetic, petroleum-derived.
Red Dye 3 (Erythrosine)
Red Dye 3 is an iodine-based compound, contributing to concerns about thyroid function. It has the formula $C{20}H{6}I{4}Na{2}O_{5}$ and contains four iodine atoms.
Red Dye 40 (Allura Red AC)
Red Dye 40 is a monoazo dye without iodine. Its formula is $C{18}H{14}N{2}Na{2}O{8}S{2}$, and it is a sodium salt of an azo dye with a more polar structure than Red Dye 3.
Regulatory History and Status
The regulatory paths for these dyes have diverged significantly in the U.S.
The story of Red Dye 3
Approved for food in 1969, Red Dye 3 was partially banned from cosmetics and topical drugs in 1990 due to animal studies linking it to thyroid cancer, based on the Delaney Clause. After a 2022 petition, the FDA completely banned its use in food and ingested drugs in January 2025, with a phase-out period until January 2027 for food and January 2028 for drugs.
The status of Red Dye 40
Red Dye 40 remains FDA-approved since the 1970s, with the agency stating it's safe within limits. However, some states like California have banned it from school foods, and the EU requires a warning label about potential effects on children's activity and attention.
Associated Health Concerns
Health concerns are a major factor in the dyes' differing regulations.
Red Dye 3 Health Concerns
Due to its iodine, Red Dye 3 has been linked to thyroid issues and, in animal studies, thyroid tumors. Some studies also suggested a link to hyperactivity in children.
Red Dye 40 Health Concerns
While the FDA is not conclusive, studies link Red Dye 40 to increased hyperactivity in sensitive children. Allergic reactions have also been reported. Concerns also exist regarding contaminants like benzidine, a known carcinogen, although the FDA considers levels safe.
Comparison Table
| Feature | Red Dye 40 (Allura Red AC) | Red Dye 3 (Erythrosine) |
|---|---|---|
| Chemical Type | Azo dye | Iodine-based xanthene dye |
| Petroleum Derivative | Yes | Yes |
| FDA Status (as of 2025) | Approved for use in food, drugs, and cosmetics | Banned for food and ingested drugs (effective 2027) |
| EU Status | Approved, but requires a warning label for behavioral effects | Restricted since 1994, banned for most food uses |
| Key Health Concerns | Hyperactivity/ADHD in sensitive children, allergic reactions, carcinogenic contaminants | Thyroid issues and cancer (animal studies), behavioral problems |
| Common Food Sources | Cereals, soft drinks, condiments, candy, baked goods, snacks | Was used in maraschino cherries, candy corn, fruit snacks, beverages, some medications |
Finding Dyes on Labels
Labels list certified color additives by name, such as "FD&C Red No. 40" or "Red 40 Lake" and "FD&C Red No. 3" or "Erythrosine". Red Dye 3 should disappear from food labels in the next few years due to the ban.
Alternatives to Synthetic Red Dyes
Natural alternatives are increasingly used, including beet juice, beet powder, pomegranate juice, anthocyanins, paprika extract, and carmine.
Conclusion
The primary difference between red dye 40 and red dye 3 in food lies in their regulatory status and associated health risks. Red Dye 40 remains FDA-approved despite links to behavioral issues, while Red Dye 3's connection to animal thyroid cancer led to a federal ban. This ban will require manufacturers to change product formulations and will eventually remove the dye from food and drug labels. The ongoing scrutiny of synthetic dyes is promoting greater label transparency and the adoption of natural colorants. For more details, see the official FDA Color Additives page.