Is caramel color safe? 

Is caramel color safe? The answer is yes – caramel colors have been deemed safe by all major global food regulatory bodies, including the US Food and Drug Administration (FDA), the Joint FAO/WHO Expert Committee for Food Additives (JECFA)Codex Alimentariusthe European Food Safety Authority (EFSA) and Health Canada. Here’s why: 


The question around the safety of caramel color arose when California added a chemical found in class III and IV caramel colors called 4-Methylimidizole, or 4-MEI, to their Prop-65 list. Adding it was based on a controversial study by the National Toxicology Program (NTP) from 2007. The 2-year study on mice showed an increased incidence of certain lung tumors when they consumed 4-MEI. However, the levels of 4-MEI given to the mice far exceeded the normal amount humans would be exposed to when consuming food or beverages – an amount equivalent to a human drinking thousands of cans of cola every single day throughout their life. 

 What is 4-MEI? 

4-MEI is a chemical compound that naturally forms during the cooking of food and beverage items we consume on a regular basis: coffee, cooked meat, baked goods, etc. Since caramel colors are created by cooking sugars, 4-MEI is naturally formed during the manufacture of certain products – specifically class III and IV caramels. 4-MEI is not present in Class I and II caramels and 4-MEI itself is never added to foods or beverages. 

4-MEI occurs in very low levels in caramel colors. And since caramel is often used at dosage rates of around 0.1%-2.0% in final products, the occurrence of 4-MEI from caramel color in finished goods is miniscule. 

But since it was added to the Prop-65 list, in order to comply with California law, many caramel manufacturers (including us!) began to innovate new methods of cooking class III and IV caramel colors that resulted in even lower levels than already occur, called low 4-MEI caramels, some of which have levels so low they can be difficult to detect in the caramel color, let alone the finished product. 

 Safety Studies 

In order to ensure continued consumer safety, many studies on the safety of caramel color and the recommended daily intake levels on 4-MEI have been carried out since the controversial 2007 NTP study was published. 

In a review of the scientific literature on 4-MEI, EFSA found that the highest exposure level to 4-MeI that could result from the consumption of foods containing class III and IV caramels was not concerning. 

Interested in reading more about the safety of caramel color? Check out these resources: 

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