Ammonia Caramel | whatsinit

About

What it is and where it shows up.

Ammonia Caramel (E150c) is a dark reddish-brown to black food colouring produced by the controlled heat treatment of carbohydrates in the presence of ammonia compounds. It is widely used to impart or intensify brown colour in non-alcoholic beverages, beer, soups, seasonings, bakery products, confectionery, and sauces.

Safety summary

The regulatory and scientific consensus.

EFSA concluded E150c is neither genotoxic nor carcinogenic and shows no adverse effects on human reproduction; however, a more restrictive individual ADI of 100 mg/kg bw/day was set — lower than the 300 mg/kg bw/day group ADI for all caramel colours — due to unresolved uncertainties around THI (2-acetyl-4-tetrahydroxybutylimidazole), a constituent with immunosuppressive effects observed in animal studies. The manufacturing by-product 4-methylimidazole (4-MEI), present in E150c, is classified as IARC Group 2B (possibly carcinogenic in humans) and subject to maximum specification limits in the EU. At high doses in animal studies, E150c has been associated with decreased white blood cell counts, cramps, reduced appetite, and gastrointestinal disorders.

Regulatory landscape

What food-safety regulators have decided.

Jurisdiction	Status	Note
FDA (Food and Drug Administration) (United States)	Restricted	California Proposition 65 lists 4-methylimidazole (4-MEI), a by-product formed during the ammonia-process production of E150c, as a chemical known to cause cancer. Products containing E150c that expose consumers to 4-MEI above the safe harbor level require a Prop 65 warning label.source
EFSA (European Food Safety Authority) (European Union)	Approved	Approved under Regulation (EC) No 1333/2008. EFSA ANS Panel (2011) set an individual ADI of 100 mg/kg bw/day for E150c within the group ADI of 300 mg/kg bw/day for all caramel colours, due to THI immunotoxicity uncertainty. Regulation (EU) No 505/2014 subsequently introduced maximum use levels for ammonia caramel (E150c) specifically in beer. EU specifications also impose maximum levels for 4-MEI content.source
FSSAI (Food Safety and Standards Authority of India) (India)	Approved	Caramel colours are permitted food additives under the Food Safety and Standards (Food Products Standards and Food Additives) Regulations, 2011. Specific use levels for individual caramel classes follow Codex Alimentarius/JECFA guidelines. Specific maximum limits for E150c sub-class could not be independently confirmed from available FSSAI source text.source

Who should approach with care

Whose guidance would steer them away.

Children — EFSA noted that dietary exposure in child populations may approach or exceed the individual ADI of 100 mg/kg bw/day for E150c, as children have proportionally higher food-intake-to-body-weight ratios and are frequent consumers of coloured beverages and confectionery.

Other — Immunocompromised individuals should exercise caution, as THI — a constituent unique to E150c — has demonstrated immunosuppressive effects (lymphocyte sequestration and lymphocytopenia) in animal studies, with EFSA calling for additional human data to clarify risk.

Ibs — Animal studies have linked high-dose consumption of E150c with gastrointestinal disorders, suggesting potential exacerbation of pre-existing gastrointestinal conditions such as IBS.

Epilepsy — 4-MEI, a by-product present in E150c, has been shown to cause convulsions when fed at high doses to rats, mice, and chicks, raising a theoretical concern for individuals with seizure disorders, though human evidence is lacking.

Research citations

The sources behind this verdict.

1WHO. JECFA Monograph: Caramel Colour, Class III (INS 150c) — WHO Food Additives Database. apps.who.int
2PubMed. Food Colour Additives: A Synoptical Overview on Their Chemical Properties, Applications in Food Products, and Health Side Effects, 2022. pmc.ncbi.nlm.nih.gov
3PubMed. Caramel color safety — An update, 2017. pubmed.ncbi.nlm.nih.gov
4EFSA. Refined exposure assessment for caramel colours (E 150a, c, d), 2012. efsa.europa.eu
5EFSA. Scientific Opinion on the re-evaluation of caramel colours (E 150 a,b,c,d) as food additives, 2011. efsa.europa.eu

Independently researched5 citations