Caramel Color IV vs Propylene Glycol: which is worse?

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 Propylene Glycol?

Propylene glycol is a synthetic organic compound used as a humectant, solvent, and emulsifier in food, pharmaceuticals, cosmetics, and industrial applications. It is produced from propylene oxide (derived from petroleum). Its chemical formula is C3H8O2.

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.

Propylene Glycol: Propylene glycol is generally considered safe by the FDA and is metabolized by the liver to lactic acid and pyruvate (normal metabolites). However, at high doses — particularly from intravenous pharmaceutical formulations — propylene glycol can accumulate and cause lactic acidosis, kidney toxicity, and CNS effects. These effects are seen in critically ill patients receiving high-dose PG-containing intravenous medications, not from food consumption. In children and people with impaired liver or kidney function, PG accumulation may occur at lower doses than in healthy adults. Animal studies have found reproductive and developmental effects at high doses. EFSA's 2018 re-evaluation found no concerns at typical food use levels but noted the EU limits PG use as a direct food additive, using it only as a carrier solvent for permitted additives.