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Answer: Caramel Color IV is restricted (not fully banned) in California (Prop 65 requires cancer warning if 4-MEI exceeds threshold), European Union (EFSA-evaluated; ADI for 4-MEI under review). The FDA still allows it in US food. Commonly found in: Coca-Cola, Pepsi, Diet Coke.
TL;DR: Caramel Color IV is restricted in the EU but allowed in the US (food additives).
Reviewed for clarity & usefulness by the BannedPantry Parent Panel
Also called E150d. (E150d)
Other names: Sulfite-ammonia caramel, E150d, Class IV Caramel, Ammonia-sulfite caramel
| EU status | Restricted |
|---|---|
| US status | Allowed |
| Risk level | — |
| Where it shows up | Coca-Cola, Pepsi, Diet Coke, Diet Pepsi, Various cola beverages, Some other dark beverages |
Caramel Color IV (Class IV caramel, E150d) is a food coloring made by heating sugar with both ammonium and sulfite compounds. This production method creates a unique set of reactive byproducts, notably 4-methylimidazole (4-MEI), which has been linked to cancer in animal studies. It is the most widely used caramel coloring in beverages like Coca-Cola and Pepsi.
Caramel Color IV provides the dark brown color characteristic of cola beverages and other dark-colored food products. It is extremely stable, provides consistent color intensity, and is cost-effective at scale. Class IV caramel's specific color and flavor characteristics make it preferred for colas.
The primary concern with Caramel Color IV is 4-methylimidazole (4-MEI), a byproduct of the ammonia-sulfite caramel production process. The National Toxicology Program (NTP) found that 4-MEI caused lung cancer in male and female mice at high doses in 2-year bioassay studies, leading to California listing 4-MEI as a known carcinogen under Proposition 65 in 2011. The Prop 65 safe harbor level is 29 micrograms 4-MEI per day (the level that would cause 1 additional cancer per 100,000 people over a 70-year lifetime). CSPI testing in 2011-2012 found Coca-Cola and Pepsi sold in California contained 4-MEI levels that, at typical consumption rates, would exceed this threshold — triggering voluntary reformulation by both companies to reduce 4-MEI in their US products. The FDA reviewed 4-MEI and concluded that typical exposure levels 'are not a safety concern.' EFSA's evaluation found the NTP findings concerning but noted the margin of safety at typical European exposure levels. The cancer mechanism in mice involves high doses that may not extrapolate to typical human cola consumption.
For educational use only. This page summarizes the regulatory status of Caramel Color IVwith citations to the primary sources below. It is not medical advice. Regulatory status is not the same as a proven health effect — read the cited sources for their exact wording, and consult a doctor for decisions about your or your family's health.
Other caramel color classes (Class I, II, III) don't produce 4-MEI. For beverages, botanical-derived dark colors or Class I (plain caramel) can substitute in some applications. Some natural soda brands use fruit-derived colorings.
The 4-MEI in Class IV caramel color caused lung cancer in mice at high doses in NTP bioassays. California's Prop 65 lists 4-MEI as a known carcinogen based on these findings. CSPI found Coke and Pepsi potentially exceeded California's 4-MEI safe threshold at typical consumption, leading both companies to voluntarily reduce 4-MEI. The FDA considers current exposure levels not a safety concern.
4-MEI is a byproduct formed during the production of Class IV caramel color (E150d) using ammonium and sulfite compounds. It was found to cause lung cancer in mice at high doses in NTP studies and is listed as a California Prop 65 carcinogen.
Coca-Cola and Pepsi use Class IV caramel color (E150d, sulfite-ammonia caramel), which is the type associated with 4-MEI formation. Following CSPI's 2012 study and California Prop 65 pressure, both companies voluntarily reduced 4-MEI content in their US products.
Some commercial soy sauces contain caramel color to darken them to consumer-preferred darkness. Check ingredient labels for 'caramel color' or 'caramel.'
No major market has banned Class IV caramel color outright. California's Prop 65 requires cancer warning labels if 4-MEI exposure would exceed safe harbor levels, creating commercial incentive to reduce 4-MEI content.
No. Natural caramel (made by cooking sugar without ammonium or sulfite compounds) is Class I caramel (E150a) and does not produce 4-MEI. Only Classes III and IV, which use ammonium and/or sulfite compounds in production, generate 4-MEI during manufacturing.
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Coca-Cola and PepsiCo voluntarily modified their caramel color manufacturing process in California-sold products to reduce 4-MEI levels below California's Prop 65 warning threshold. These same formulations were later extended nationally in the US.
Choose beverages without caramel color (clear sodas, natural beverages, herbal drinks). Read labels for 'caramel color' — Class IV is the most common type in dark beverages. Some natural soda brands use fruit or plant-derived colorings instead.
Audited products that don't contain Caramel Color IV.
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