caramel color iv
caramel color iv

Caramel Color IV

Common names: Caramel color (Class IV), Plain caramel, Coca-Cola caramel (brand name), E150d (European food additive code).
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KIDSADVISORY SAFETY RATING
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Caution
Published by Jordana Tobelem, RD, LDN — Last Updated on Apr 1, 2025
Medically reviewed by Dr. William Lin, MD
Caramel Color IV, also known as Class IV Caramel Color or E150d, is a widely used food coloring agent that imparts a rich brown hue to various products. It is produced by heating carbohydrates in the presence of both ammonium and sulfite compounds, resulting in a color ranging from light brown to deep black-brown. This additive is particularly valued in the food and beverage industry for its stability across a wide pH range and its compatibility with other ingredients, making it a common choice for coloring acidic beverages like soft drinks.[1]
Despite its widespread use, concerns have been raised regarding the presence of 4-Methylimidazole (4-MeI), a byproduct formed during the production of Caramel Color IV. Studies have indicated that high doses of 4-MeI may be linked to cancer in animals, leading to regulatory scrutiny and consumer apprehension. However, regulatory agencies such as the U.S. Food and Drug Administration (FDA) have stated that the levels of 4-MeI found in foods and beverages do not pose a significant risk to human health. As with many food additives, it is advisable for consumers to be informed and moderate their intake of products containing Caramel Color IV.[2]

Safety Overview

Regulatory Bodies

FDA (US)
The U.S. Food and Drug Administration (FDA) permits the use of Caramel Color IV (Sulfite Ammonia Caramel) as a color additive exempt from certification, provided it conforms to specific purity criteria and is used in accordance with good manufacturing practices.[3]
Health Canada
Health Canada includes Caramel Color IV in its List of Permitted Colouring Agents, allowing its use in various food products, provided it meets established specifications and is used within acceptable limits.[4]
EFSA (Europe)
In 2011, EFSA re-evaluated Caramel Color IV (E 150d) and established an Acceptable Daily Intake (ADI) of 300 mg/kg body weight per day for the group of caramel colors (E 150a, E 150b, E 150c, E 150d), with a more restrictive ADI of 100 mg/kg bw/day specifically for E 150c due to potential effects on the immune system.[5]
WHO (World Health Organization)
The Joint FAO/WHO Expert Committee on Food Additives (JECFA) has evaluated Caramel Color IV and assigned an ADI of 0–200 mg/kg body weight, based on available toxicological data.[6]

FDA GRAS

U.S. Food and Drug Administration – Generally Recognized as Safe (GRAS)
Current Status
Classified

EWG Rating

Environmental Working Group
  • EWG Rating: Caramel Color IV is rated by EWG with a lower concern in food products.[1]
  • Level of Caution: Despite the lower concern rating, EWG advises caution due to potential contaminants formed during its production.[1]
  • Possible Health Risks: Caramel Color IV may contain impurities such as 4-Methylimidazole (4-MeI), which is listed by California's Proposition 65 as a chemical known to cause cancer.[2]
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More about Caramel Color IV

  • Beverages: Carbonated soft drinks, such as cola
  • Snacks: Potato chips, pretzels
  • Condiments: Soy sauce, salad dressings

Historical Use
Caramel Color IV, also known as sulfite ammonia caramel, has been in use since the early 20th century to provide a rich brown hue to various food and beverage products. It was primarily employed in cola beverages and brewed products to standardize their appearance and enhance visual appeal.[5][7]
Current Exposure
Consumers are frequently exposed to Caramel Color IV through a variety of processed foods and drinks, including cola beverages, sauces, baked goods, and syrups. Its widespread use in the food industry makes it one of the most commonly encountered color additives in modern diets.[5][7]

Potential Carcinogenicity
4-Methylimidazole (4-MEI), a byproduct formed during the production of Caramel Color IV, has been identified as a potential carcinogen. Studies have raised concerns about its presence in caramel-colored beverages and the associated cancer risks.[8]
Toxicity Concerns
Research has indicated that certain caramel colors, including Caramel Color IV, may exhibit toxicological properties. The European Food Safety Authority (EFSA) has evaluated these concerns, particularly focusing on the presence of contaminants like 4-MEI.[5]
Nutraceutical Potential
Some studies have explored the potential health benefits of Caramel Color IV, suggesting it may possess nutraceutical properties. However, further research is needed to fully understand these effects and their implications for human health.[9]

Toxicological Studies
Research indicates that high doses of 4-methylimidazole (4-MEI), a byproduct in Caramel Color IV, can cause convulsions in animals at doses around 360 mg/kg body weight. However, typical human exposure through food consumption is significantly lower.[10]
Long-Term Safety
Long-term studies have shown that 4-MEI can lead to increased cancer rates in rodents at high exposure levels. Nonetheless, regulatory bodies like the FDA consider the much lower levels present in foods to be safe for human consumption.[2][10]

High-Risk Groups
Individuals with sensitivities or allergies to specific food components may experience adverse reactions to caramel coloring. For example, those allergic to wheat, barley, or milk should be cautious, as caramel color can be derived from these sources.[5][2]
Health Impacts
While regulatory bodies like the FDA and EFSA have deemed caramel color safe for general consumption, concerns persist regarding its potential health effects. Some studies have linked caramel color to increased cancer risks in animals, leading to ongoing debates about its safety.[5][2]

Recommended Intake
The Acceptable Daily Intake (ADI) for Caramel Color IV, as established by regulatory bodies like the European Food Safety Authority (EFSA), is 0-200 mg per kg of body weight per day, which is considered safe for consumption over a lifetime without significant health risks.[6]

General Safety Level
Caramel Color IV is generally recognized as safe (GRAS) by food safety authorities, including the FDA and EFSA, for use in food and beverages based on current evidence. Toxicological studies suggest it is well-tolerated at typical dietary levels.[6]
Sensitive Individuals
Certain individuals with hypersensitivities, such as those with sulfite sensitivity, may experience mild allergic reactions since Caramel Color IV can contain trace amounts of sulfites. However, these cases are rare and typically involve pre-existing sulfite intolerance.[2]

References

  1. Givaudan Sense Colour What is Caramel Color? Available at: https://learn.ddwcolor.com/what-is-caramel-color/ ↩︎
  2. Internationally Peer Reviewed Chemical Safety Information n.d. Caramel colours classes I II III and IV Available at: https://www.inchem.org/documents/jecfa/jecmono/v20je11.htm ↩︎
  3. US Food and Drug Administration FDA 2021 Questions & Answers on Caramel Coloring and 4-MEI Available at: https://www.fda.gov/food/food-additives-ingredients/questions-answers-caramel-coloring-and-4-mei ↩︎
  4. Health Canada 2020 Lists of Permitted Colouring Agents Available at: https://www.canada.ca/en/health-canada/services/food-nutrition/food-safety/food-additives/lists-permitted/colouring-agents.html ↩︎
  5. European Food Safety Authority EFSA 2011 Scientific Opinion on the re-evaluation of caramel colours E 150a b c d as food additives EFSA Journal 9(3) 2004 Available at: https://www.efsa.europa.eu/en/efsajournal/pub/2004 ↩︎
  6. Joint FAO WHO Expert Committee on Food Additives JECFA 1985 Caramel Colours FAO Nutrition Meetings Report Series No. 31 Available at: https://www.fao.org/fileadmin/user_upload/jecfa_additives/docs/Monograph1/Additive-102.pdf ↩︎
  7. FAO WHO Expert Committee on Food Additives Evaluation of certain food additives and contaminants seventy-third report of the Joint FAO WHO Expert Committee on Food Additives WHO Technical Report Series No. 960 Available at: https://www.who.int/publications/i/item/9789241209601 ↩︎
  8. Smith TJS Wolfson JA Jiao D Crupain MJ Rangan U Sapkota A Nachman KE 2015 Caramel Color in Soft Drinks and Exposure to 4-Methylimidazole A Quantitative Risk Assessment PLOS ONE Available at: https://journals.plos.org/plosone/article?id=10.1371/journal.pone.0118138 ↩︎
  9. Mateo-Fernu00e1ndez M Alves-Martu00ednez P Del Ru00edo-Celestino M Font R Merinas-Amo T Alonso-Moraga u00c1 2019 Food Safety and Nutraceutical Potential of Caramel Colour Class IV Using In Vivo and In Vitro Assays Foods 8(9) 392 Available at: https://www.mdpi.com/2304-8158/8/9/392 ↩︎
  10. Smith TJ Wolfson JA Jiao D Crupain MJ Rangan U Sapkota A Bleich SN Nachman KE 2015 Caramel color in soft drinks and exposure to 4-methylimidazole a quantitative risk assessment PLoS One 10(2) Available at: https://pubmed.ncbi.nlm.nih.gov/25693062/ ↩︎

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