Caramel III - Ammonia Caramel E150c
natural-derived — Primarily heat-treated carbohydrate.
Ammonia caramel
CAS: 8028-89-5
Factual Regulatory Reference
This database provides factual regulatory information compiled from official government sources. It does not constitute medical, nutritional, or safety advice. Regulatory status varies by country and is subject to change. Always refer to your local regulatory authority for the most current information.
What Is Caramel III - Ammonia Caramel?
Caramel III (E150c), also known as Ammonia Caramel, is produced by controlled heating of food-grade carbohydrates in the presence of ammonia or ammonium salts without sulfite compounds. It is commonly used in beer, soy sauce, certain vinegars, and other food products where a consistent brown color is needed. Like E150d, ammonia caramel can produce 4-methylimidazole (4-MEI) as a byproduct of the ammonia-catalyzed reaction, though typically at lower levels than sulfite-ammonia caramel (E150d). JECFA has established an ADI of 0-200 mg/kg body weight per day for Class III caramel (E150c). Regulatory authorities in various countries have set maximum levels for 4-MEI in caramel colors as a precautionary measure while maintaining that typical dietary exposure does not present a safety concern.
? Did You Know?
In the EU, Caramel III - Ammonia Caramel has a "quantum satis" authorization — Latin for "as much as needed." This means there's no specific maximum limit; manufacturers use only what's technologically necessary.
Regulatory Analysis
The regulatory controversy around Caramel III (E150c) centers on 4-methylimidazole (4-MEI), a process contaminant generated during ammonia-catalyzed caramelization. In 2011, IARC classified 4-MEI as Group 2B (possibly carcinogenic to humans) based on animal studies, which prompted California's Prop 65 program to list it as a known carcinogen requiring product warnings above 29 µg/day. EFSA's 2011 re-evaluation, which established an ADI of 100 mg/kg body weight for E150c, concluded that dietary exposure to 4-MEI from caramel colors was not a safety concern at typical levels. JECFA set maximum 4-MEI limits (250 mg/kg in E150c) rather than restricting the additive itself. Japan requires 4-MEI to be kept below 0.30 mg/g. This divergence — California precautionary labeling versus EFSA and JECFA's view that exposure levels are acceptable — reflects different risk communication standards rather than fundamentally different scientific conclusions.
Detailed Regulatory Assessment
European Union (EFSA)
Widely permitted; 4-MEI levels are monitored
Official EFSA LinkUnited States (FDA)
FDA monitors 4-MEI levels; California Prop 65 concerns about 4-MEI content
Japan (MHLW)
4-MEI limited to 0.30 mg/g or less (on solid basis) per Japanese Food Additives Compendium
Acceptable Daily Intake (ADI)
International Standard (JECFA)
mg/kg body weight per day
European Standard (EFSA)
Natural Occurrence
This additive is not known to occur naturally in significant quantities.
Manufacturing
Made by controlled heating of food-grade carbohydrates (sugars) at temperatures of 120-150°C in the presence of ammonium compounds such as ammonium hydroxide, ammonium carbonate, or ammonium bicarbonate. No sulfite compounds are used in this class. The ammonia incorporation gives the caramel a positive charge. This process can produce trace amounts of 4-methylimidazole (4-MEI) as a byproduct through Maillard-type reactions.