Caramel color: is it safe, and what is 4-MEI?
Where caramel color is allowed
United States
PermittedFDA lists caramel as a color additive exempt from certification, usable in foods generally at good manufacturing practice levels, except where a food's standard of identity does not allow added color (21 CFR 73.85). It sets no 4-MEI limit. FDA's 4-MEI Q&A page (content dated March 27, 2020) says it is reviewing the data and that a limit on 4-MEI in classes III and IV is one possible action; we found no later FDA action. [1, 2, 3]
Canada
Permitted with conditionsHealth Canada's List of Permitted Food Colours (published October 20, 2025) has one 'Caramel' entry (item C.3) with no classes. It allows caramel in named foods such as bread, jams, pickles, beer and whisky, and in unstandardized foods, at good manufacturing practice, with caps in a few (15% in sausage casings, for example). The list does not mention 4-MEI, and we found no Health Canada page setting a 4-MEI limit. [4]
European Union
Permitted with conditionsCaramels (E150a to E150d) are food colours authorised under Regulation (EC) No 1333/2008, mostly at 'quantum satis' (as much as needed, no numeric cap): Annex II Part E covers many categories such as flavoured drinks, soups and sauces, and only specific products in others (malt bread, sausages). E150c is capped in beer at 6,000 mg/l. Regulation (EU) No 231/2012 caps 4-MEI at 200 mg/kg in E150c and 250 mg/kg in E150d, on an equivalent-colour basis (consolidated texts of August 18, 2026). [5, 6]
What is caramel color?
Caramel color is a dark-brown liquid or solid made by carefully heating food-grade sugars such as dextrose, sucrose or starch hydrolysates, sometimes with acids, alkalis or salts (FDA's definition, 21 CFR 73.85). It is not the sugary caramel used as candy flavoring.
The classes differ in what is added during heating, per the EU specifications: class I, plain caramel (E150a), no ammonium or sulfite; class II, caustic sulfite caramel (E150b), sulfite only; class III, ammonia caramel (E150c), ammonium only; class IV, sulfite ammonia caramel (E150d), both. FDA says classes III and IV form 4-methylimidazole (4-MEI) during manufacture and classes I and II do not contain it. FDA's regulation does not use class numbers.
Why it's used, and where you'll find it
Caramel color gives food and drinks a dark brown shade. California's health agency (OEHHA) names cola, beer, wine coolers, and soy and other sauces among products where caramel colorings containing 4-MEI are added. FDA also allows caramel in drugs and cosmetics, including eye-area products.
What the research and regulators say
Four recipes, four different evaluations
JECFA, the FAO and WHO additive committee, gave class I an ADI of 'not specified', class II 0 to 160 mg per kg of body weight a day, and classes III and IV 0 to 200 (0 to 150 on a solids basis), in 1985 and 2000 evaluations. EFSA took another approach in 2011: one group ADI of 300 mg per kg a day for all four, but a stricter 100 within it for ammonia caramel (E150c) because of uncertainty about animal findings on immune effects of a by-product called THI. EFSA concluded the caramel colours are not genotoxic or carcinogenic, but noted that high consumers could exceed the ADIs for E150a, E150c and E150d at the maximum levels industry reported. A 2012 update using new industry data found the group ADI was not exceeded; only toddlers and adults with very high intake could still exceed the E150c figure. [7, 8, 9, 10, 11, 12]
4-MEI: animal studies, IARC and California
In a 2007 US National Toxicology Program (NTP) study, 4-MEI fed to mice for two years produced clear evidence of lung tumors in males and females; rats showed no evidence in males and equivocal evidence in females. The mouse doses (roughly 40 to 170 mg per kg a day) far exceed, FDA says, current estimates of human exposure from food. IARC (Monographs Volume 101, working group of February 2011) found sufficient evidence of carcinogenicity in experimental animals, had no human data, and placed 4-MEI in Group 2B, 'possibly carcinogenic to humans'. California listed 4-MEI under Proposition 65 on January 7, 2011, and its health agency (OEHHA) calculated a no-significant-risk level of 29 micrograms a day, the intake associated with a 1-in-100,000 lifetime cancer risk. [3, 13, 14, 15, 16]
Hazard versus typical intake
FDA says it has no reason to believe 4-MEI presents immediate or short-term health risks at levels expected in food and is not recommending diet changes. EFSA concluded in 2011 that even the highest possible 4-MEI exposure did not raise concern and the EU maximum was protective enough. There is no shared limit: the EU caps 4-MEI in the color, California sets a daily intake benchmark, and FDA has none. [3, 6, 7, 15]
Who might choose to avoid it
Some people who want to keep 4-MEI intake low skip products listing caramel color or ask the maker which class is used. That is a personal choice, not medical advice.
How to spot it on a label
In the US, look for 'caramel color' or 'caramel coloring'; exempt colors may also be declared as 'color added', and the class appears only if the maker volunteers it. In the EU the E number gives the class: E150a to E150d.
Check what's in your own productsScan a barcode or a label photo and Label X-Ray flags caramel color and everything else in plain English, with your allergies checked automatically.
Frequently asked questions
Is caramel color banned in Europe?
No. Caramels E150a to E150d are authorised EU food colours, and EU purity rules cap 4-MEI at 200 mg/kg in E150c and 250 mg/kg in E150d.
Is caramel color banned in California?
We found no ban in the sources we read. California lists 4-MEI under Proposition 65 and calculated a no-significant-risk level of 29 micrograms a day, a benchmark rather than a ban.
Does caramel color cause cancer?
In a 2007 US National Toxicology Program study, 4-MEI (the by-product formed in classes III and IV) caused lung tumors in mice at doses that FDA says far exceed estimated human exposure from food. IARC rates 4-MEI possibly carcinogenic to humans (Group 2B), based on animal evidence. EFSA concluded the caramel colours themselves are not genotoxic or carcinogenic.
How can I tell if a food has class III or IV caramel color?
In the US usually you cannot, because FDA does not require the class on the label. In the EU the E number (E150c or E150d) tells you.
Related ingredients
Sources
- eCFR (U.S. Government Publishing Office / National Archives) — 21 CFR 73.85 -- Caramel (eCFR, current text, up to date as of 2026-10-19) (accessed 2026-10-20)
- U.S. FDA — Regulatory Status of Color Additives: Caramel (accessed 2026-10-20)
- U.S. FDA — Questions & Answers About 4-MEI (accessed 2026-10-20)
- Health Canada — 3. List of Permitted Food Colours (Lists of Permitted Food Additives) (accessed 2026-10-20)
- European Union (EUR-Lex) — Regulation (EC) No 1333/2008 on food additives, consolidated text of 18 August 2026 (accessed 2026-10-20)
- European Union (EUR-Lex) — Commission Regulation (EU) No 231/2012 laying down specifications for food additives, consolidated text of 18 August 2026 (accessed 2026-10-20)
- EFSA — EFSA reviews safety of caramel colours (news story, March 8, 2011) (accessed 2026-10-20)
- EFSA — Caramel colours: consumer exposure lower than previously estimated (news story, December 19, 2012) (accessed 2026-10-20)
- WHO / FAO JECFA — JECFA database: Caramel colour, Class I (accessed 2026-10-20)
- WHO / FAO JECFA — JECFA database: Caustic sulfite caramel (Class II) (accessed 2026-10-20)
- WHO / FAO JECFA — JECFA database: Caramel colour, Class III (accessed 2026-10-20)
- WHO / FAO JECFA — JECFA database: Caramel colour, Class IV (accessed 2026-10-20)
- U.S. National Toxicology Program (NIEHS) — TR-535: Toxicology and Carcinogenesis Studies of 4-Methylimidazole in F344/N Rats and B6C3F1 Mice (Feed Studies) (accessed 2026-10-20)
- IARC — IARC Monographs List of Classifications (current data, last updated 2026-07-23): 4-Methylimidazole, Group 2B, Volume 101 (accessed 2026-10-20)
- California OEHHA — No Significant Risk Level (NSRL) for the Proposition 65 Carcinogen 4-Methylimidazole (October 2011) (accessed 2026-10-20)
- IARC — IARC Monographs Volume 101: 4-Methylimidazole (evaluation; working group met 15-22 February 2011) (accessed 2026-10-20)
This page summarizes what regulators and published research say, as of the review date above. Rules and evidence change; check the linked sources for the latest. It is general information, not medical advice — talk to a doctor or pharmacist about your own health.