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Questions and Answers about Caramel Coloring and 4-methylimidazole (4-MEI or 4-MI)

January 22, 2014

What is 4-MEI and where is it found?
The compound 4-methylimidazole (4-MEI or 4-MI) is a byproduct formed in certain foods and beverages during the normal heating and browning process and possibly as a byproduct of fermentation.  It is a naturally occurring compound in caramel coloring and roasted and cooked foods. 4-MEI is not added to food.

What is an imidazole anyway?
An imidazole is a chemical structure commonly found in many critically important molecules in the human body.  The amino acid histidine is an imidazole, and even our DNA contains imidazole.

 

 

Is there concern about the 4-MEI that exists in our food supply?
At this time, no. In one mouse study, results indicate that 4-MEI is carcinogenic, although it was not carcinogenic in rats tested at the same doses.  The rat study also showed that 4-MEI reduced the risk of tumors in several organs.  These animal studies involved feeding enormous doses to identify any adverse health effects, which is the normal approach to how toxicological studies are designed and conducted, but it makes interpretation of human exposure very uncertain.  Also, there is no basis for concluding that the data from mice are more applicable to humans than that from rats.

Is there risk from eating foods that contain 4-MEI?  

 According to the FDA, "based on the available information, FDA has no reason to believe that there is any immediate  or shortterm danger presented by 4-MEI at the levels expected in food from the use of caramel coloring."

Has 4-MEI been shown to be a human carcinogen?
There is no available scientific evidence that 4-MEI causes cancer in humans.  In February 2011, the International Agency for Research on Cancer (IARC) classified the 4-MEI compound in Group 2B, possibly carcinogenic to humans; however, the IARC classification does not mean that consuming foods containing 4-MEI will cause cancer in humans. The European Food Safety Authority in its safety opinion on Caramel Colors reviewed the available information about 4-MEI and concluded that 4-MEI in caramel coloring is not of concern.

What’s being done to reduce 4-MEI in the marketplace?
The levels of 4-MEI in caramel colorings are already regulated. The 4-MEI in prepared foods, such as those cooked at home, are not. The U.S. Food and Drug Administration and other global authorities are currently working to better understand 4-MEI and its impact on public health.  At this time, there are no recommendations for consumers to change their diets because of concerns about 4-MEI.  The European Food Safety Authority in its safety opinion on Caramel Colors reviewed the available information about 4-MEI and concluded that 4-MEI in caramel coloring is not of concern.

Putting Risk in Perspective:  Here’s what you need to know . . .

The mere presence of trace-level naturally occurring compounds in food does not make a food unsafe.  Choosing a diet that is rich in variety, whole grains, fruits and vegetables would not only reduce exposure to 4-MEI, but it will also maximize your overall healthfulness.

Additional Resources:

Food Ingredients and Colors Brochure

EFSA Reviews Safety of Caramel Colours

EFSA: Scientific Opinion on the re-evaluation of caramel colours (E 150 a,b,c,d) as food additives

FDA Questions & Answers on Caramel Coloring and 4-MEI

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