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Caramel Color IV vs Aspartame: which is worse?

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

PropertyCaramel Color IVAspartame
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 40 mg/kg body weight; must be labeled 'contains a source of phenylalanine' for PKU patients), United Kingdom, Australia, Canada
Categoryadditiveadditive
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 Aspartame?

Aspartame is a low-calorie synthetic dipeptide sweetener composed of two amino acids — phenylalanine and aspartic acid — bonded with methanol. When metabolized, it breaks down into these three components. It is approximately 200 times sweeter than sucrose, so tiny amounts provide significant sweetness with almost no calories.

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.

Aspartame: Aspartame has been one of the most studied food additives in history, with over 200 regulatory studies reviewed by multiple agencies. The FDA and EFSA have repeatedly reaffirmed its safety at permitted levels for the general population. IARC classification controversy (2023): In July 2023, IARC classified aspartame as Group 2B (possibly carcinogenic to humans), based primarily on limited evidence from human epidemiological studies associating aspartame intake with hepatocellular carcinoma (liver cancer) in some observational studies. Notably, the WHO Joint Expert Committee on Food Additives (JECFA) simultaneously re-evaluated aspartame and maintained the ADI at 40 mg/kg/day, concluding that the evidence does not establish that aspartame causes cancer at typical intake levels. This rare split between IARC (hazard identification) and JECFA (risk assessment) created significant public confusion. Phenylketonuria (PKU): Aspartame is definitively harmful for individuals with phenylketonuria — a genetic disorder affecting phenylalanine metabolism. People with PKU cannot process phenylalanine normally, and aspartame consumption can cause severe neurological damage. This is why all aspartame-containing products must carry a PKU warning on US and EU labels. Methanol release: aspartame metabolism releases methanol (~10% by weight). Critics including independent researcher Woodrow Monte have argued that methanol from aspartame is harmful, citing methanol's conversion to formaldehyde and formic acid in the body. However, methanol released from aspartame is a fraction of the methanol obtained from fresh fruit juices, and regulatory agencies consider the amounts released too small to be clinically significant. Gut microbiome concerns: a 2021 Cell study found that aspartame and other sweeteners altered gut microbiome composition and glucose tolerance in humans. These microbiome effects are an emerging area of research.

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