Caramel IV - Sulfite Ammonia Caramel E150d
natural-derived — Primarily heat-treated carbohydrate.
Sulfite ammonia caramel
CAS: 68909-72-8
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 IV - Sulfite Ammonia Caramel?
Caramel IV (E150d), also known as Sulfite Ammonia Caramel, is the darkest and most widely used caramel color worldwide, produced by heat treatment of food-grade carbohydrates in the presence of both sulfite and ammonia compounds. This manufacturing process can produce 4-methylimidazole (4-MEI) as a byproduct, a compound classified by IARC as Group 2B (possibly carcinogenic) based on animal studies. Caramel IV is primarily used in cola-type soft drinks such as Coca-Cola and Pepsi, as well as in beer, sauces, and other foods requiring dark brown coloring. Regulatory agencies including EFSA have evaluated 4-MEI exposure from caramel colors and set maximum limits on 4-MEI content to control exposure, while the FDA maintains that 4-MEI levels in caramel color used in food are not a safety concern at typical consumption levels.
? Did You Know?
In the EU, Caramel IV - Sulfite 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
Caramel color IV is the world's most widely consumed food colorant by volume, yet its regulatory controversy stems not from the caramel itself but from 4-methylimidazole (4-MEI), a process contaminant formed during ammonia-sulfite manufacturing. California's Proposition 65 listing of 4-MEI as a carcinogen triggered the reformulation of major cola products for a single US state, while federal regulators and international bodies maintained that exposure levels posed no concern -- a case where sub-national regulation drove global manufacturing changes that national and international agencies considered unnecessary. The episode illustrates how consumer-right-to-know legislation can achieve de facto reformulation outcomes that risk assessment-based regulation does not pursue.
Detailed Regulatory Assessment
European Union (EFSA)
Widely permitted; 4-MEI levels are monitored
United States (FDA)
FDA monitors 4-MEI levels; California Prop 65 requires warning if 4-MEI exceeds 29 mcg/day
Japan (MHLW)
Compliant with Japanese food sanitation law.
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 with both sulfite compounds and ammonia or ammonium compounds. This process can produce 4-methylimidazole (4-MEI) as a byproduct.