Caramel colour

Caramel color is a common brown food coloring made by heating sugars. Fast-food chains use it to give colas, sauces, and baked goods a rich dark hue. There are four classes of caramel color, and those made with ammonia or sulfites (Class III & IV) can generate 4‑MEI, a chemical byproduct linked to cancer in rodent tests. Regulators have set impurity limits and report that the tiny 4‑MEI amounts in foods do not pose an acute health risk. Overall, caramel color is permitted in foods and is generally recognized as safe at the levels used in fast-food products.

Aliases / Common Names: Caramel coloring; burnt sugar; INS 150a–d (Class I–IV); E150a, E150b, E150c, E150d. Regulatory Status & Exposure: In the U.S., caramel color is a permitted color additive (exempt from certification) allowed in foods under good manufacturing practices. No specific maximum level is set in federal regulations aside from using the minimum needed for effect. FDA specifications ensure purity (e.g. limiting heavy metals) and the agency is currently reviewing 4‑MEI levels in Class III/IV caramels to confirm they remain below any risk concern. In the EU, EFSA reevaluated caramel colors in 2011 and established a group ADI of 300 mg/kg body weight per day (with a stricter 100 mg/kg for Class III due to an immunotoxic byproduct). California’s Proposition 65 added 4‑MEI as a carcinogen in 2011, requiring a warning label if someone would ingest over 29 µg per day (an amount equivalent to hundreds of cans of cola daily). Typical consumer intakes of caramel color are much lower than any doses of concern. Technical Evidence: The primary safety question with caramel color is its trace constituent 4‑MEI. NTP’s long-term studies (2007) showed that high doses of 4‑MEI led to increased lung tumors in mice. As a result, IARC classed 4‑MEI as possibly carcinogenic to humans (Group 2B) based on animal data. Notably, caramel color mixtures themselves are not genotoxic – studies found no DNA mutations or chromosomal damage from caramel classes III and IV. The exact mechanism by which 4‑MEI causes tumors in mice remains unclear, and no direct link to human cancer has been established. Both FDA and EFSA have reviewed all toxicology and human exposure data and concluded that caramel color in food does not show evidence of causing cancer or other harm at realistic intake levels. (For instance, EFSA found “no concern” even at the highest estimated 4‑MEI exposure from foods.) One minor component of certain caramel colors, 2-acetyl-4(5)-tetrahydroxyimidazole (THI), did show immune-related effects in animal studies, which led EFSA to assign a lower ADI for Class III caramel. Public health advocates have urged additional caution: for example, the Center for Science in the Public Interest filed a citizen petition in 2011 asking the FDA to ban ammonia-process caramel coloring due to 4‑MEI’s cancer risk, although regulators have not taken that step. Fast-Food Context: Caramel color is widely used across U.S. fast-food menus. It provides the characteristic brown color of cola soft drinks and is added to certain baked goods (like burger buns), fried foods, gravies, and sweet sauces to enhance their appearance. In fact, caramel color is one of the most prevalent additives in fast-food beverages and foods. After California implemented warning label requirements for 4‑MEI, major soda suppliers adjusted their formulas to significantly reduce 4‑MEI in caramel coloring nationwide. Today, the levels of 4‑MEI in a typical fast-food fountain drink or menu item are much lower than those found a decade ago and well within regulatory limits. Fast-food companies continue to use caramel color in moderation to achieve a visually appealing product, while complying with all safety guidelines. Sensitive Populations / Notes: Caramel color is not a common allergen, and adverse reactions are extremely rare. That said, people with a sulfite sensitivity (often associated with asthma) could potentially react to sulfite residues in Class II or IV caramel color. Sulfites are considered a priority allergen in Canada and can trigger asthma-like symptoms in sensitive individuals, though they do not cause true immunological allergies. The sulfiting agents used in caramel production are largely bound in the final product and present at low levels, making sulfite reactions to caramel color unlikely in practice. Even highly avid consumers of caramel-colored sodas are very unlikely to reach dangerous exposure levels. For example, an adult would have to drink on the order of 300+ cans of cola per day to approach the doses of 4‑MEI that produced tumors in rodent studies (after applying a 100× safety factor). In general, occasional fast-food eaters and even regular soda drinkers are not believed to be at risk from the amount of caramel color in foods under normal dietary patterns.

We assign the limited tier using published research, regulatory guidance, and PRūF’s additive taxonomy. Restaurant usage is derived from public ingredient disclosures and mapped to menu items where this additive appears.