red no 3
red no 3

Red No 3

Common names: Erythrosine, Tetraiodofluorescein, C.I. 45430, Acid Red 51, E127 (European food additive code).
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KIDSADVISORY SAFETY RATING
See methodology
Risky
Published by Jordana Tobelem, RD, LDN — Last Updated on Apr 16, 2025
Medically reviewed by Dr. William Lin, MD
Red No. 3, also known as erythrosine, is a synthetic xanthene dye widely used in the food industry to impart a bright red color to products such as candies, baked goods, and certain beverages. Its high water solubility and stability under heat make it a popular choice for various food applications.[1]
However, studies have raised concerns about erythrosine's potential health risks, including its association with thyroid tumor formation in rodents.[2] These findings have led to strict regulations on its use in many countries.[2] As research continues to evaluate its safety, consumers and manufacturers are encouraged to consider these findings when choosing food colorants.[3]

Safety Overview

Regulatory Bodies

FDA (US)
In January 2025, the FDA banned the use of Red No. 3 in foods and ingested drugs due to studies indicating cancer development in male rats exposed to high levels of the dye. Manufacturers are required to remove the dye from food products by January 2027 and from ingested drugs by January 2028.[4]
Health Canada
Following the FDA’s 2025 ban, Health Canada reviewed the 2018 JECFA evaluation and stated that Red No. 3 does not pose a health risk to the general population in Canada. The agency indicated it would reconsider its position if new scientific data emerges.[5]
EFSA (Europe)
As of 2011, EFSA has not identified safety concerns with the continued use of Red No. 3 (erythrosine) in food. The dye is permitted for use in specific food items within the European Union.[6]
WHO (World Health Organization)
In 2018, the Joint FAO/WHO Expert Committee on Food Additives (JECFA) re-evaluated erythrosine and concluded that its use as a food additive does not pose a safety concern. This assessment considered studies involving both humans and animals.[7]

FDA GRAS

U.S. Food and Drug Administration – Generally Recognized as Safe (GRAS)
Current Status
Not Classified
Red No. 3, also known as erythrosine, is a synthetic dye previously approved by the U.S. Food and Drug Administration (FDA) for use in various food products. However, in January 2025, the FDA issued an order to revoke the use of FD&C Red No. 3 in food and ingested drugs, citing studies indicating cancer development in male rats exposed to high levels of the dye.[4]

EWG Rating

Environmental Working Group
  • EWG Rating: Red No. 3 is classified by the Environmental Working Group (EWG) as an ingredient of higher concern in food products.[8]
  • Level of Caution: The EWG advises caution when consuming products containing Red No. 3 due to its potential health risks.[8]
  • Possible Health Risks: Red No. 3 has been associated with cancer in animal studies and adverse neurobehavioral outcomes in children.[8]
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More about Red No 3

  • Candy and Sweets: Gummy bears, jelly beans, cotton candy
  • Baked Goods and Desserts: Frosted donuts, cake decorations, maraschino cherries
  • Beverages and Processed Snacks: Fruit punch, flavored gelatin, pre-packaged pudding

Historical Use
Red No. 3, also known as erythrosine, is a synthetic dye that has been used since 1907 to impart a bright red hue to various food products, including candies, baked goods, and beverages. In 1990, the U.S. Food and Drug Administration (FDA) banned its use in cosmetics and topical drugs due to studies linking it to cancer in laboratory animals, but it remained approved for use in food and ingested drugs until the recent ban in January 2025.[9][10]
Current Exposure
Prior to the 2025 FDA ban, Red No. 3 was present in thousands of food products, including candies, cereals, and sodas, leading to widespread consumer exposure, particularly among children. Manufacturers have been given until January 2027 to reformulate food products and until January 2028 for ingested drugs to comply with the new regulations.[11]

Carcinogenicity
Animal studies have demonstrated that erythrosine (Red No. 3) acts as a secondary carcinogen, exerting its carcinogenicity via an indirect pathway.[3]
Genotoxicity
Several studies have demonstrated the genotoxic potential of erythrosine using mammalian cells or in vivo methods, such as the comet assay.[3]
Thyroid Dysfunction
Erythrosine has been linked to thyroid tumor formation in rodents, indicating potential thyroid dysfunction upon exposure.[12]
Neurobehavioral Effects
While some studies have evaluated the developmental toxicity and psychotoxicity of erythrosine in rats, results have not consistently shown dose-dependent effects on behavior.[13]

Toxicological Studies
Research has demonstrated that high doses of erythrosine (Red No. 3) can lead to thyroid tumor formation in rats, potentially due to chronic stimulation of the thyroid by thyroid-stimulating hormone (TSH). However, these doses are significantly higher than typical human exposure levels, and similar effects have not been observed in humans.​[12][14]
Long-Term Safety
Despite the lack of direct evidence linking Red No. 3 to cancer in humans, the U.S. Food and Drug Administration (FDA) banned its use in food and ingested drugs in January 2025 as a precautionary measure. Manufacturers have been given until January 2027 to reformulate products accordingly.[4]

High-Risk Groups
Children are particularly vulnerable to the effects of Red No. 3 due to their higher consumption of artificially colored foods and their developing neurological systems. Additionally, individuals with sensitivities or allergies to synthetic dyes may experience adverse reactions upon exposure.​[15]
Health Impacts
In children, consumption of Red No. 3 has been associated with hyperactivity and attention deficits, although research findings are mixed. While animal studies have linked high doses of Red No. 3 to thyroid tumors, the relevance to human health remains uncertain.[4][15]

Recommended Intake
The World Health Organization, through the evaluation of JEFCA, has put the Accepted Daily Intake (ADI) for Red No. 3 at 0-0.1 mg/kg bw.[7] However, due to health concerns, the FDA has since prohibited its use in foods and ingested drugs.[4]

General Safety Level
Red No. 3 (erythrosine) has been widely used as a synthetic food dye, and while concerns have been raised about its potential health effects, including carcinogenicity and behavioral impacts, there is limited evidence directly linking it to allergic reactions in the general population.​[16]
Sensitive Individuals
Although rare, some individuals may experience sensitivities to synthetic food dyes like Red No. 3, manifesting as skin irritation, headaches, or respiratory symptoms. These reactions are uncommon and often occur in individuals with existing sensitivities to food additives.[17]

FAQ

What is Red Number 3 in food?

Red Number 3, also known as Erythrosine, is a synthetic food dye used in candies, baked goods, and processed foods.

Is Red 3 safe for humans?

Red 3 is FDA-approved for food use, but it has been banned in cosmetics and drugs due to potential links to thyroid tumors in animal studies.

References

  1. Zaouak A., Noomen A. & Jelassi H., 2019. Gamma Radiolysis of Erythrosine Dye in Aqueous Solutions. Journal of Radioanalytical and Nuclear Chemistry, 321, 965-971. Available at: https://link.springer.com/article/10.1007/s10967-019-06671-x ↩︎
  2. Zhang, B., Du, D., Yin, Y., Zheng, L., Zhao, J., Eremin, S. A., Rybakov, V. B., Meng, M., & Xi, R., 2014. A Direct Enzyme Immunoassay to Detect Erythrosine in Foods. Food Analytical Methods, 7, 1798-1803. Available at: https://link.springer.com/article/10.1007/s12161-014-9824-8 ↩︎
  3. Mishra D., 2022. Food Colors and Associated Oxidative Stress in Chemical Carcinogenesis. In Handbook of Oxidative Stress in Cancer: Mechanistic Aspects, 773-786. Available at: https://link.springer.com/referenceworkentry/10.1007/978-981-15-9411-3_182 ↩︎
  4. U.S. Food and Drug Administration, 2025. 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. Federal Register, 90(11), 4628-4632. Available at: https://www.federalregister.gov/documents/2025/01/16/2025-00830/color-additive-petition-from-center-for-science-in-the-public-interest-et-al-request-to-revoke-color ↩︎
  5. Health Canada, 2024. List of Permitted Food Colours (Lists of Permitted Food Additives). Available at: https://www.canada.ca/en/health-canada/services/food-nutrition/food-safety/food-additives/lists-permitted/3-colouring-agents.html ↩︎
  6. European Food Safety Authority, 2011. Scientific Opinion on the re-evaluation of Erythrosine (E 127) as a food additive. EFSA Journal, 9(1):1854. Available at: https://www.efsa.europa.eu/en/efsajournal/pub/1854 ↩︎
  7. World Health Organization, 2018. FD&C Red No. 3. Available at: https://apps.who.int/food-additives-contaminants-jecfa-database/Home/Chemical/503 ↩︎
  8. Environmental Working Group, n.d. Ingredient: RED 3. Available at: https://www.ewg.org/foodscores/ingredients/19151-RED3/ ↩︎
  9. U.S. Food and Drug Administration, 2025. FDA to Revoke Authorization for the Use of Red No. 3 in Food and Ingested Drugs. Available at: https://www.fda.gov/food/hfp-constituent-updates/fda-revoke-authorization-use-red-no-3-food-and-ingested-drugs ↩︎
  10. New York Post, 2025. US bans popular red dye from foods-35 years after it was banned in cosmetics. Available at: https://nypost.com/2025/01/15/health/us-bans-red-dye-no-3-from-foods-amid-evidence-it-causes-cancer/ ↩︎
  11. Inverse, 2025. The Just FDA Banned Red No. 3 Dye. What Took It So Long? Available at: https://www.inverse.com/health/fda-bans-red-3-dye-history ↩︎
  12. Jennings A.S., Schwartz S.L., Balter N.J., Gardner D., Witorsch R.J., 1990. Effects of oral erythrosine (2',4',5',7'-tetraiodofluorescein) on the pituitary-thyroid axis in rats. Toxicology and Applied Pharmacology, 103 (3): 549-56. Available at: https://www.sciencedirect.com/science/article/pii/0041008X9090327Q ↩︎
  13. Vorhees, C. V., Butcher, R. E., Brunner, R. L., Wootten, V., & Sobotka, T. J., 1983. A developmental toxicity and psychotoxicity evaluation of FD and C Red Dye #3 (erythrosine) in rats. Archives of Toxicology, 53(4), 253-264. Available at: https://link.springer.com/article/10.1007/BF00294991 ↩︎
  14. Borzelleca J.F., Capen C.C., Hallagan J.B., 1987. Lifetime toxicity/carcinogenicity study of FD & C Red No. 3 (erythrosine) in rats. Food and Chemical Toxicology, 25 (10): 723-33. Available at: https://www.sciencedirect.com/science/article/abs/pii/0278691587902262 ↩︎
  15. California Office of Environmental Health Hazard Assessment, 2021. New report shows artificial food coloring causes hyperactivity in some kids. Available at: https://publichealth.berkeley.edu/news-media/research-highlights/new-report-shows-artificial-food-coloring-causes-hyperactivity-in-some-kids ↩︎
  16. Yale New Haven Hospital, 2025, January. Are Food Dyes Bad for You? Available at: https://www.ynhh.org/articles/are-food-dyes-bad-for-you ↩︎
  17. Rupa Health, 2025, January 15. FDA's Red Dye No. 3 Ban: A Step Toward Cleaner and Safer Food Standards. Available at: https://www.rupahealth.com/post/fdas-red-dye-no-3-ban-a-step-toward-cleaner-and-safer-food-standards ↩︎

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