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What is caramel color? The four classes, 4-MEI and what the FDA says.

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What caramel color is, how the FDA defines it, which classes contain 4-MEI, what the NTP and IARC found at very high doses, why labels do not say which class is used, and catalog products that list caramel color.

Quick answer

Caramel color is a brown food color made by heat-treating carbohydrates, sometimes with acids, alkalis or salts. Classes III and IV contain 4-methylimidazole (4-MEI), a by-product that also forms when coffee beans and meats are cooked; Classes I and II do not. IARC classes 4-MEI in Group 2B, and an NTP mouse study showed more lung tumors at doses far above human exposure. The FDA says it has no reason to believe 4-MEI poses immediate or short-term risk at expected food levels. Labels do not have to name the class.

FDA rule
21 CFR 73.85
Contain 4-MEI
Classes III and IV
IARC 4-MEI
Group 2B (2013)
Label names class?
Not required

01 · A closer look

How caramel color is defined.

Under 21 CFR 73.85, caramel is a dark-brown liquid or solid made by heat-treating food-grade carbohydrates, such as dextrose, invert sugar, molasses, starch hydrolysates or sucrose, under controlled conditions. Specified acids, alkalis and salts, including ammonium compounds and sulfites, may be used to assist caramelization. It may color foods generally and is exempt from batch certification.

21 CFR 73.85: caramel

02 · A closer look

What 4-MEI is.

The FDA says 4-MEI forms at low levels when some foods are cooked, such as coffee beans and roasted or grilled meats, and during manufacture of Class III and Class IV caramel color. Class I and Class II do not contain it. The agency adds that removing 4-MEI from food is not feasible because it forms during normal cooking, and that some manufacturers have reduced its levels in their products.

FDA: questions and answers about 4-MEI (content current as of Mar 27, 2020)

03 · A closer look

What the animal studies and IARC found.

In 2007 National Toxicology Program studies a two-year rat study was inconclusive and a two-year mouse study showed an increased incidence of certain lung tumors; a 2020 multigeneration rat study showed reproductive and developmental effects. The FDA says both used doses far above current estimates of human exposure from food. IARC’s official list classifies 4-methylimidazole in Group 2B, possibly carcinogenic to humans (Volume 101, 2013), which describes the strength of evidence, not the size of risk.

IARC Monographs: agents classified by the IARC Monographs, Volumes 1 to 123 (official list)

04 · A closer look

The FDA’s position and what is not settled.

The FDA says that based on current science it has no reason to believe 4-MEI presents immediate or short-term health risks at levels expected in food, is not recommending dietary changes, and is reviewing safety data, including possible limits for Class III and IV. Its Q&A is current as of March 27, 2020; check for newer action.

FDA: questions and answers about 4-MEI (content current as of Mar 27, 2020)

05 · A closer look

Reading the label.

The FDA does not require makers to name the caramel color class, and “caramel color” alone does not confirm that 4-MEI is present. This site therefore does not flag caramel color as one of its nine groups; the products below simply name it on their recorded label, picked across shelves. Open any for the full statement and verification date.

The short answer

Our picks for what is caramel color?

WinnersPyure Organic Organic Caramel Flavored Syrup and Wolfgang Puck Organic Soup, Signature Tortilla each score 100/100. They tie, so choose on the exact flavor or format you want.

Runners-upGood & Gather London Fog Tea Latte Concentrate (71), Quaker Caramel Rice Cakes (71), and Wholesome Provisions Pumpernickel Sliced Bread (71).

Clear noPost Honey Bunches of Oats with Almonds (lists seed oils, artificial preservatives and corn syrups), Dr Pepper Soda, 2 Liters (lists artificial preservatives and corn syrups), Kroger Rising Crust Pizza (lists seed oils and artificial preservatives), plus 13 more with a listed group.

Ranked from 24 of 24 products with current labels. Every product is in the table below; a score reflects labels and claims, not nutrition, allergies or safety.

Compare the recorded labels

Find the ingredients that matter to you.

24 of 24 products

“No …” columns: None found on the label · Listed on the label · Unknown. Diet fit: Fits · Doesn’t fit · Unknown (rules; not medical advice). Claims: verified · not established. Default: most check marks first; not a health score.

Compare product claims and recorded ingredients. Click a column heading to sort.
Buy
100 / 1009 of 9 groups clear · organicFind where to buy ↗Product details →5
100 / 1009 of 9 groups clear · organicProduct details →5
89 / 1008 of 9 groups clear · organic not applicableProduct details →3
71 / 1009 of 9 groups clear · no organic claimProduct details →4
71 / 1009 of 9 groups clear · no organic claimProduct details →4
71 / 1009 of 9 groups clear · no organic claimFind where to buy ↗Product details →4
71 / 1009 of 9 groups clear · no organic claimFind where to buy ↗Product details →4
71 / 1009 of 9 groups clear · no organic claimFind where to buy ↗Product details →4
63 / 1008 of 9 groups clear · no organic claimBuy on Amazon ↗Product details →3
63 / 1008 of 9 groups clear · no organic claimProduct details →4
63 / 1008 of 9 groups clear · no organic claimProduct details →3
63 / 1008 of 9 groups clear · no organic claimFind where to buy ↗Product details →3
63 / 1008 of 9 groups clear · no organic claimProduct details →3
63 / 1008 of 9 groups clear · no organic claimProduct details →3
63 / 1008 of 9 groups clear · no organic claimProduct details →3
60 / 1009 of 9 groups clear · no organic claimProduct details →4
55 / 1007 of 9 groups clear · no organic claimProduct details →4
55 / 1007 of 9 groups clear · no organic claimProduct details →4
55 / 1007 of 9 groups clear · no organic claimProduct details →3
55 / 1007 of 9 groups clear · no organic claimProduct details →3
55 / 1007 of 9 groups clear · no organic claimProduct details →4
53 / 1008 of 9 groups clear · no organic claimFind where to buy ↗Product details →4
53 / 1008 of 9 groups clear · no organic claimProduct details →4
47 / 1006 of 9 groups clear · no organic claimProduct details →3
How the clean score works

No setup needed, and strict: a full 100 needs every additive group clear and a verified organic claim (animal foods also need a verified grass-fed or pasture-raised claim; wild seafood and salt, which have no USDA organic standard, are scored without the organic points, and plant-based milks, cheeses and proteins without the feeding claim). Points: the nine additive groups (seed oils, artificial dyes, MSG, artificial sweeteners, carrageenan, artificial preservatives, hydrogenated oils, corn syrups, banned-abroad additives) share 60 points equally — not found earns a group’s full share, “may contain” earns half, listed earns 0; a verified organic claim is worth 25; a verified grass-fed or pasture-raised claim is worth 15 and counts only for animal foods. No claim, or an expired or unverified claim, earns nothing, so products without those claims cannot reach 100. Unverified or expired ingredient labels receive no score. Equal scores are equal. Ties are ordered by brand. Unknown and stale evidence never passes “Only show matches.” Producer claims and prices do not affect this score. This is not a nutrition, allergy, or safety rating.

As an Amazon Associate I earn from qualifying purchases. Buying links do not influence ingredient results. “Buy on Amazon” opens a reviewed product listing; “Find where to buy” opens the maker’s page. Confirm the package, seller, stock, and current price before checkout. Price observations expire after 30 days.

Primary sources

Sources

  1. 21 CFR 73.85: caramel law.cornell.edu
  2. FDA: questions and answers about 4-MEI (content current as of Mar 27, 2020) fda.gov
  3. IARC Monographs: agents classified by the IARC Monographs, Volumes 1 to 123 (official list) monographs.iarc.who.int