Caramel Color IV vs Propyl Gallate: 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 Propyl Gallate?

Propyl gallate is a synthetic antioxidant preservative derived from gallic acid and propanol. It prevents oxidation of fats and oils, extending shelf life of fat-containing foods. It is often used in combination with BHA and BHT for synergistic antioxidant effect. Chemical formula: C10H12O5.

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.

Propyl Gallate: Animal studies have shown propyl gallate may cause liver damage at high doses. Concerns about estrogenic activity have been raised — some studies suggest propyl gallate may weakly mimic estrogen. Contact dermatitis and allergic reactions are documented in both food and cosmetic applications. Japan banned propyl gallate for food use as part of its precautionary approach to synthetic food preservatives. NTP bioassays found dose-dependent liver effects. EFSA's re-evaluation set an ADI of 0.1 mg/kg body weight — one of the lowest ADIs for food additives, reflecting toxicological concern.