Caramel color safety – An update

Abstract

Caramel color has been used in foods and beverages for over 150 years and is globally regulated as a color additive. The four distinct classes of caramel color (Plain Caramel, Sulfite Caramel, Ammonia Caramel, and Sulfite Ammonia Caramel) are well characterized and each have specifications that take into account processing variables including reactants that can give rise to low molecular weight constituents (e.g., 4-MeI and THI) that may have toxicological significance for evaluating safety. Extensive safety testing has been conducted with the different classes of caramel color and its constituents, including toxicokinetics, genotoxicity, subchronic toxicity, carcinogenicity, and reproductive/developmental toxicity studies. In addition, data is available on uses and use levels that have been used to estimate intakes of caramel colors and their constituents. No Observable Adverse Effect Levels (NOAEL) have been identified for all classes and Acceptable Daily Intakes have been established to ensure safety of use. Available studies support a conclusion that caramel colors are not genotoxic or carcinogenic, and exposure estimates indicate that intake of caramel colors and constituents do not pose undue safety risks. This update summarizes available relevant safety studies and authoritative reviews on caramel colors and its toxicologically important constituents, 4-MeI and THI.

Caramel Dye IV Induces Oxidative Stress Damage In Liver And Kidney From Mice

“…C-IV dye production process is characterized by the presence of nitrogen and sulfur in their manufacture chemical reactions, and its production leads to the high molecular weight constituents (HMW) formation (responsible for color differentiation) and low molecular weight constituents (LMW) formation (responsible for unintentional substances such as 4-methylimidazole (4-MeI)) 5 . The effects of oxidative damage after C-IV administration here may be associated with 4-MEI, also classified as a human carcinogen and the most potent neurotoxic substance by the International Agency for Research on Cancer 22 .…”

“…This additive is produced through sulphite-ammonia process; some acids and alkalis may also be added during its production 4 , as sulfuric or citric acid, phosphoric, acetic and / or carbonic acid; alkalines such as hydroxides or mixtures of sodium, potassium and / or calcium; and salts such as carbonate, hydrogen carbonate, sulfate and ammonium, phosphate sodium, potassium or calcium. Some ammonium compounds, such as carbonate and ammonium hydrogen carbonate may also be added 5 . In this process, an ammonia interaction leads to sugar reduction, and byproducts such as 4-methyl imidazole (4-MEI) generation, which might presents highly toxic effects, such as neurological and cancerous pathologies 6 which lead, for example, the State of California to classify ut as a “cancer-causing chemical” 5 .…”

“…Some ammonium compounds, such as carbonate and ammonium hydrogen carbonate may also be added 5 . In this process, an ammonia interaction leads to sugar reduction, and byproducts such as 4-methyl imidazole (4-MEI) generation, which might presents highly toxic effects, such as neurological and cancerous pathologies 6 which lead, for example, the State of California to classify ut as a “cancer-causing chemical” 5 . According to the Expert Committee on Food Additives (JECFA) determined an Acceptable Daily Intake (IDA) of 300mg / kg p.c.…”

“…According to the Expert Committee on Food Additives (JECFA) determined an Acceptable Daily Intake (IDA) of 300mg / kg p.c. of Caramel IV dye 5 .…”

Dispersive liquid–liquid microextraction with in situ derivatization coupled with gas chromatography and mass spectrometry for the determination of 4‐methylimidazole in red ginseng products containing caramel colors

“…Caramel colors are food color additives that are classified as Class I, II, III, or IV based on the reactants used during their manufacture and their suitability for use in certain foods. Among them, Class III and IV caramel colors are commonly used for coloring various foods and soft drinks, and are produced by heating rich carbohydrates in the presence of ammonium compounds or both ammonium and sulfite‐containing compounds, respectively . It has been reported that these manufacturing processes generate 4‐methylimidazole (4‐MEI), a nitrogen‐containing heterocyclic organic compound derived from imidazole .…”