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Caramel Color IV vs Polysorbate 80: which is worse?

Quick answer: Both score equally on our risk model. Caramel Color IV is in the EU and in the US; Polysorbate 80 is in the EU and in the US.

PropertyCaramel Color IVPolysorbate 80
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 25 mg/kg body weight per day), Australia
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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 Polysorbate 80?

Polysorbate 80 (Tween 80) is a synthetic nonionic surfactant and emulsifier derived from sorbitol and oleic acid (from vegetable oils) through ethoxylation. It is widely used in food to keep water-based and oil-based ingredients uniformly mixed. Chemical formula: polyoxyethylene (20) sorbitan monooleate.

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.

Polysorbate 80: Emerging research has raised concerns about polysorbate 80's effects on the gut. A landmark 2015 study in Nature (Chassaing et al.) found that dietary polysorbate 80 and polysorbate 60 at concentrations approaching food use levels promoted colitis and metabolic syndrome in genetically susceptible mice by disrupting the intestinal mucus layer and altering gut microbiome composition. The emulsifiers thinned the protective mucus layer, allowing bacteria to come into closer contact with gut epithelial cells and triggering inflammation. This study was a seminal contribution to gut health research, though it was conducted in mice and requires confirmation in humans. A 2020 follow-up study found that dietary emulsifiers including polysorbate 80 promoted gut inflammation and altered gut microbiome in human participants with Crohn's disease. People with inflammatory bowel disease may be most vulnerable to polysorbate 80's potential gut effects.

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