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Caramel Color IV vs Acesulfame Potassium: which is worse?

Quick answer: Acesulfame Potassium carries the heavier risk profile. Caramel Color IV is in the EU and in the US; Acesulfame Potassium is in the EU and in the US.

PropertyCaramel Color IVAcesulfame Potassium
EU status
US status
Risk level
Banned in
Restricted inCalifornia (Prop 65 requires cancer warning if 4-MEI exceeds threshold), European Union (EFSA-evaluated; ADI for 4-MEI under review)European Union (ADI 9 mg/kg body weight; must be labeled E950 or 'sweetener'), Australia, Canada
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Where it hides

What is Caramel Color IV?

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.

What is Acesulfame Potassium?

Acesulfame potassium (Ace-K) is a calorie-free synthetic sweetener approximately 200 times sweeter than sucrose. It contains a potassium atom bonded to an oxathiazinone dioxide ring structure. It is heat-stable and non-metabolized, passing through the body unchanged. Often blended with sucralose or aspartame to mask bitter aftertaste.

Documented risks

Caramel Color IV: 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.

Acesulfame Potassium: The safety database for Ace-K is considered less comprehensive than that for other sweeteners. Critics have argued that the original FDA approval studies from the 1970s-1980s were insufficient in quality and length to definitively establish long-term safety. The Center for Science in the Public Interest (CSPI) has petitioned for additional testing. Two rat studies found statistically significant increases in lung tumors (in male rats) and mammary tumors at high doses. Regulatory agencies have argued these doses far exceeded typical human exposure and attributed the tumor findings to other factors. However, the question of whether Ace-K's approval studies meet modern standards has been raised by independent researchers. A 2021 study in Cell found that Ace-K and other non-nutritive sweeteners altered gut microbiome composition and affected glucose tolerance in some human participants. Ace-K specifically was associated with changes in gut bacteria that correlated with glycemic effects. Neurological concerns: some animal studies suggest Ace-K may affect brain neurotransmitter systems. A 2013 study in PLoS ONE found that Ace-K consumption in pregnant mice altered offspring postnatal taste preference and increased weight gain, suggesting potential transgenerational effects. These findings were at doses exceeding typical human intake. Endocrine disruption potential has been raised in some in vitro studies, but comprehensive human data are lacking.

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