Carmoisine

Common names: Azorubine, C.I. 14720, Acid Red 14, E122 (European food additive code).
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Caution
Published by Jordana Tobelem, RD, LDN — Last Updated on Apr 16, 2025
Medically reviewed by Dr. William Lin, MD
Carmoisine, also known as Azorubine (E122), is a synthetic red azo dye widely used in the food industry to impart red to maroon hues to various products. Its high water solubility and stability under heat and light make it suitable for items that undergo thermal processing, such as jams, jellies, yogurts, and baked goods.[1] Additionally, Carmoisine is employed in beverages, confectionery, and certain dairy products to provide consistent and appealing red shades.[1]
While Carmoisine is approved for use in many countries, concerns have been raised regarding its potential health effects. Some studies suggest that excessive consumption may lead to adverse health effects, including carcinogenicity, genotoxicity, and negative impacts on vital organs such as the liver and kidneys.[2] Furthermore, research has indicated possible associations between certain synthetic food colorants and hyperactivity in children, although conclusive evidence is lacking.[3][4]

Safety Overview

Regulatory Bodies

FDA (US)
Carmoisine is not approved for use in food products in the United States. It was previously listed for use in externally applied drugs and cosmetics but was delisted in 1963 due to a lack of safety data.[5]
Health Canada
Carmoisine is not permitted for use as a food additive in Canada. Health Canada has expressed concerns about potential behavioral effects in children associated with certain azo dyes, including Carmoisine.[6]
EFSA (Europe)
EFSA has established an Acceptable Daily Intake (ADI) for Carmoisine (E122) at 0–4 mg/kg body weight. However, refined exposure assessments indicate that high consumers, particularly children, may exceed this ADI, raising potential safety concerns.[7]
WHO (World Health Organization)
The Joint FAO/WHO Expert Committee on Food Additives (JECFA) evaluated Carmoisine and established an ADI of 0–4 mg/kg body weight. They noted that, in rare instances, it may cause allergic reactions, including skin rashes and respiratory issues.[8]

FDA GRAS

U.S. Food and Drug Administration – Generally Recognized as Safe (GRAS)
Current Status
Not Classified
​Carmoisine, also known as Azorubine (E122), is not classified as “Generally Recognized As Safe” (GRAS) by the U.S. Food and Drug Administration (FDA). In fact, Carmoisine is not approved for use in food products in the United States. It was previously listed for use in externally applied drugs and cosmetics but was delisted in 1963 due to a lack of safety data.[5]

EWG Rating

Environmental Working Group
  • EWG Rating: Carmoisine (CI 14720) has been evaluated by the EWG and is permitted in EWG VERIFIED™ products, provided it meets specific use restrictions and warnings based on EWG's review of company data.[9]
  • Level of Caution: The Environmental Working Group (EWG) assigns a higher hazard score to Carmoisine when used in products that do not adhere to industry safety guidelines or governmental regulations, indicating a need for caution in such instances.[9]
  • Possible Health Risks: Concerns associated with Carmoisine include enhanced skin absorption, high use restrictions, non-reproductive organ system toxicity (low), and biochemical or cellular level changes (low to moderate).[9]
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More about Carmoisine

  • Beverages: Soft drinks, flavored syrups, alcoholic beverages
  • Confectionery: Candies, jellies, gummies
  • Baked Goods: Cakes, pastries, decorative icings

Historical Use
Carmoisine, also known as Azorubine (E122), is a synthetic red azo dye that has been widely used since the early 20th century in various food products, including candies, jams, jellies, and beverages. Its popularity grew due to its vibrant color and stability, leading to its incorporation into numerous processed foods and confections.[2]
Current Exposure
Today, consumers are exposed to Carmoisine through a variety of food items, such as sweets, jams, aromatic and fermented beverages, desserts, chewing gum, ice cream, spices, soups, and jellies. Despite its widespread use, concerns about potential health risks have led to regulatory scrutiny and usage restrictions in certain countries.[10]

Hepatotoxicity and Nephrotoxicity
High-dose exposure to Carmoisine has been linked to liver and kidney damage, as evidenced by increased serum markers and histopathological changes in animal studies.[2]
Genotoxicity
Research indicates that Carmoisine can induce chromosomal aberrations and reduce mitotic index in plant cells, suggesting potential genotoxic effects.[11]
Oxidative Stress
Exposure to Carmoisine has been associated with increased oxidative stress, leading to biochemical alterations in brain tissues.[1]
Carcinogenic Potential
The International Agency for Research on Cancer (IARC) has classified certain azo dyes, including Carmoisine, as Group 3 carcinogens, indicating that they are not classifiable as to their carcinogenicity to humans.[12]

Toxicological Studies
Research indicates that high-dose exposure to Carmoisine (400 mg/kg body weight) can lead to liver and kidney damage, as evidenced by increased serum markers and histopathological changes in animal models.[2]
Long-Term Safety
Chronic exposure to Carmoisine, even at acceptable daily intake (ADI) levels (4 mg/kg body weight), has been associated with alterations in hepatic and renal parameters, suggesting potential long-term health risks.[13]

High-Risk Groups
Children are particularly susceptible to the adverse effects of synthetic food dyes like Carmoisine due to their lower body weight and higher consumption of colored foods, often exceeding the acceptable daily intake (ADI) limits.[2]
Health Impacts
Excessive intake of Carmoisine in vulnerable populations, such as children, has been linked to potential health risks, including hepatotoxicity and nephrotoxicity, as indicated by elevated serum markers and histopathological changes in animal studies.[2]

Recommended Intake
The Acceptable Daily Intake (ADI) for Carmoisine (E122) has been established at 0–4 mg/kg body weight by both the Joint FAO/WHO Expert Committee on Food Additives (JECFA) and the European Food Safety Authority (EFSA).[8]

General Safety Level
Carmoisine (also known as Azorubine, E122) is a synthetic azo dye commonly used as a food additive. While regulatory bodies have established acceptable daily intake levels, some studies have raised concerns about potential adverse effects, including hypersensitivity reactions.[7] ​
Sensitive Individuals
Certain individuals may experience allergic reactions to Carmoisine, such as fixed drug eruptions, even at approved dosages. A case report documented a child developing hyperpigmented patches after consuming a carmoisine-containing syrup, highlighting the potential for rare but significant hypersensitivity responses.[14]

FAQ

What is Carmoisine?

Carmoisine is a synthetic azo dye (E122) used as a food coloring to give a red or maroon shade.

How is Carmoisine made?

Carmoisine is made through a chemical synthesis process involving the diazotization of aromatic amines and coupling with other compounds to form the final azo dye structure.

What is Carmoisine made from?

Carmoisine is derived from petroleum-based chemicals, primarily aromatic hydrocarbons, through a series of chemical reactions to produce its azo dye properties.

References

  1. Kiziltan T., et al., 2022. Effects of the food colorant carmoisine on zebrafish embryos at a molecular level. Archives of Toxicology, 96(4), pp. 1089-1099. Available at: https://pmc.ncbi.nlm.nih.gov/articles/PMC8831007/ ↩︎
  2. Reza M.S.A., et al., 2019. Study of a common azo food dye in mice model: Toxicity reports and its relation to carcinogenicity. Food Science & Nutrition, 7(2), pp. 667-677. Available at: https://pmc.ncbi.nlm.nih.gov/articles/PMC6392843/ ↩︎
  3. de Oliveira Z. B., 2013. Synthetic colors in food: A warning for children's health. International Journal of Environmental Research and Public Health, 21(6), p. 682. Available at: https://pmc.ncbi.nlm.nih.gov/articles/PMC11203549/ ↩︎
  4. Arnold L.E., Lofthouse N., & Hurt E., 2012. Artificial food colors and attention-deficit/hyperactivity symptoms: Conclusions to dye for. Neurotherapeutics, 9(3), pp. 599-609. Available at: https://pmc.ncbi.nlm.nih.gov/articles/PMC3441937/ ↩︎
  5. U.S. Food and Drug Administration, 2022. Summary of Color Additives for Use in the United States in Foods, Drugs, Cosmetics, and Medical Devices. Available at: https://www.fda.gov/industry/color-additives/summary-color-additives-use-united-states-foods-drugs-cosmetics-and-medical-devices ↩︎
  6. Health Canada, 2010. Health Canada Proposal to Improve Food Colour Labelling Requirements. Government of Canada. Available at: https://www.canada.ca/en/health-canada/services/food-nutrition/public-involvement-partnerships/proposal-improve-food-colour-labelling-requirements-2010/document.html ↩︎
  7. European Food Safety Authority, 2015. Refined exposure assessment for Azorubine/Carmoisine (E 122). EFSA Journal, 13(3), p. 4072. Available at: https://www.efsa.europa.eu/en/efsajournal/pub/4072 ↩︎
  8. World Health Organization, 1983. CARMOISINE. Available at: https://apps.who.int/food-additives-contaminants-jecfa-database/Home/Chemical/1081 ↩︎
  9. Environmental Working Group, n.d. 'CI 14720', EWG's Skin Deep. Available at: https://www.ewg.org/skindeep/ingredients/716339-CI_14720/ ↩︎
  10. Qasim D.A. & Lafta I.J., 2024. Characterization of food color additives and evaluation of their acute toxicity in Wistar albino rats. Veterinary World, 17(10), pp. 2329-2337. Available at: https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11606285/ ↩︎
  11. Khan I.S., et al., 2020. Genotoxic effect of two commonly used food dyes metanil yellow and carmoisine using Allium cepa L. as indicator. Toxicology Reports, 7, pp. 370-375. Available at: https://www.ncbi.nlm.nih.gov/pmc/articles/PMC7038579/ ↩︎
  12. Subramaniyan N.K., et al., 2022. Protective role of Vernonia Cinerea against the Carmoisine induced brain injury and anxiogenic effect in mice. Egyptian Journal of Basic and Applied Sciences, 10(1), pp. 12-24. Available at: https://www.tandfonline.com/doi/pdf/10.1080/2314808X.2022.2122289 ↩︎
  13. Elekima, I., Obisike, U.A., Ben-Chioma, A.E., Brown, H., Waribo, H.A., George-Opuda, I., Onwuli, D. and Brisibe, N., 2023. Assessment of Nephro-, Hepato-, and Sex-Dependent Toxicity of Carmoisine in Albino Rats. Journal of Biosciences and Medicines, 11(9). Available at: https://www.scirp.org/journal/paperinformation?paperid=127449 ↩︎

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