Caramel colour
Colour
Carcinogen
Description
Caramel color is a common brown food coloring made by heating sugars. Fast-food chains use it to give colas, sauces, and baked goods a rich dark hue. There are four classes of caramel color, and those made with ammonia or sulfites (Class III & IV) can generate 4‑MEI, a chemical byproduct linked to cancer in rodent tests. Regulators have set impurity limits and report that the tiny 4‑MEI amounts in foods do not pose an acute health risk. Overall, caramel color is permitted in foods and is generally recognized as safe at the levels used in fast-food products.
Learn More Dossier
Aliases / Common Names: Caramel coloring; burnt sugar; INS 150a–d (Class I–IV); E150a, E150b, E150c, E150d.
Regulatory Status & Exposure: In the U.S., caramel color is a permitted color additive (exempt from certification) allowed in foods under good manufacturing practices. No specific maximum level is set in federal regulations aside from using the minimum needed for effect. FDA specifications ensure purity (e.g. limiting heavy metals) and the agency is currently reviewing 4‑MEI levels in Class III/IV caramels to confirm they remain below any risk concern. In the EU, EFSA reevaluated caramel colors in 2011 and established a group ADI of 300 mg/kg body weight per day (with a stricter 100 mg/kg for Class III due to an immunotoxic byproduct). California’s Proposition 65 added 4‑MEI as a carcinogen in 2011, requiring a warning label if someone would ingest over 29 µg per day (an amount equivalent to hundreds of cans of cola daily). Typical consumer intakes of caramel color are much lower than any doses of concern.
Technical Evidence: The primary safety question with caramel color is its trace constituent 4‑MEI. NTP’s long-term studies (2007) showed that high doses of 4‑MEI led to increased lung tumors in mice. As a result, IARC classed 4‑MEI as possibly carcinogenic to humans (Group 2B) based on animal data. Notably, caramel color mixtures themselves are not genotoxic – studies found no DNA mutations or chromosomal damage from caramel classes III and IV. The exact mechanism by which 4‑MEI causes tumors in mice remains unclear, and no direct link to human cancer has been established. Both FDA and EFSA have reviewed all toxicology and human exposure data and concluded that caramel color in food does not show evidence of causing cancer or other harm at realistic intake levels. (For instance, EFSA found “no concern” even at the highest estimated 4‑MEI exposure from foods.) One minor component of certain caramel colors, 2-acetyl-4(5)-tetrahydroxyimidazole (THI), did show immune-related effects in animal studies, which led EFSA to assign a lower ADI for Class III caramel. Public health advocates have urged additional caution: for example, the Center for Science in the Public Interest filed a citizen petition in 2011 asking the FDA to ban ammonia-process caramel coloring due to 4‑MEI’s cancer risk, although regulators have not taken that step.
Fast-Food Context: Caramel color is widely used across U.S. fast-food menus. It provides the characteristic brown color of cola soft drinks and is added to certain baked goods (like burger buns), fried foods, gravies, and sweet sauces to enhance their appearance. In fact, caramel color is one of the most prevalent additives in fast-food beverages and foods. After California implemented warning label requirements for 4‑MEI, major soda suppliers adjusted their formulas to significantly reduce 4‑MEI in caramel coloring nationwide. Today, the levels of 4‑MEI in a typical fast-food fountain drink or menu item are much lower than those found a decade ago and well within regulatory limits. Fast-food companies continue to use caramel color in moderation to achieve a visually appealing product, while complying with all safety guidelines.
Sensitive Populations / Notes: Caramel color is not a common allergen, and adverse reactions are extremely rare. That said, people with a sulfite sensitivity (often associated with asthma) could potentially react to sulfite residues in Class II or IV caramel color. Sulfites are considered a priority allergen in Canada and can trigger asthma-like symptoms in sensitive individuals, though they do not cause true immunological allergies. The sulfiting agents used in caramel production are largely bound in the final product and present at low levels, making sulfite reactions to caramel color unlikely in practice. Even highly avid consumers of caramel-colored sodas are very unlikely to reach dangerous exposure levels. For example, an adult would have to drink on the order of 300+ cans of cola per day to approach the doses of 4‑MEI that produced tumors in rodent studies (after applying a 100× safety factor). In general, occasional fast-food eaters and even regular soda drinkers are not believed to be at risk from the amount of caramel color in foods under normal dietary patterns.
Regulatory status
Australia
Allowed
Caramel colours can be declared by class name and number (e.g., Colour (150a)); uses governed by Schedule 15 and Standard 1.3.1 framework.
Basis: Other
Source
Canada
Allowed
Caramel is authorized as a food colour under Canada's permissions framework.
Basis: Other
Source
International
Allowed
Multiple category permissions and maximum levels exist by caramel class; some uses are GMP and others have numeric maxima depending on food category.
Basis: Other
Source
European Union
Allowed
Caramel colors are authorized as food additives; specifications include impurity limits for 4-MEI (E150c/E150d) and THI (E150c).
Basis: Commission Regulation (EU) No 231/2012 (specifications)
Source
Japan
Allowed
Caramel I–IV are listed as existing food additives of natural origin (per the unofficial English translation list linked from MHLW informational page).
Basis: Other
Source
New Zealand
Not Applicable
Basis: Other
United States
Allowed
Foods generally under GMP; not permitted in standardized foods unless the standard authorizes added color.
Basis: 21 CFR 73.85
Source
Registry review date: 2026-02-26
State policy updates
California (US)
Restricted
Warnings may be required for exposures to listed chemicals (e.g., 4-MEI) above safe harbor levels; this is not a ban on caramel color itself.
Source
Policy timeline
-
2023-07-12 — FDA tracking: 4-MEI (CAS 822-36-6) risk management review noted as impurity/process contaminant; concerns for levels in caramel color III/IV
(United States)
-
2023-10-07 — California AB 418 enacted (Food Safety Act) – caramel color not included in enacted ban list
(California (US))
Research Evidence Snapshot
Overall hazard concerns are largely tied to process byproducts (4-MEI in Class III/IV; THI in Class III). International risk assessments and ADIs support safety under permitted uses, but exposure certainty—especially for US restaurant foods—is limited due to undisclosed class and levels.
Critical endpoints: Cancer (4-MEI, high-dose rodent evidence); immune-related uncertainty factor (THI in E150c); exposure-driven uncertainty dominates the risk picture.
ACUTE SENSITIVITY HAZARD
Confidence: Medium
Low
Regulatory focus is on chronic/byproduct considerations (4-MEI/THI) rather than acute reactions; caramel is broadly permitted under GMP.
CHRONIC HEALTH EVIDENCE DIRECTION
Confidence: Medium
Neutral/unclear
Animal hazard evidence exists for 4-MEI at high doses; EFSA and FDA consumer-facing summaries emphasize exposure context and do not recommend diet change; human outcome evidence specific to caramel-color exposure is limited in cited materials.
EVIDENCE STRENGTH
Confidence: Medium
Limited
Strong toxicology datasets support ADIs for caramel classes, but consumer-relevant outcome certainty is constrained by limited direct human evidence and exposure uncertainty in restaurant foods.
REGULATORY POSTURE (U.S.)
Confidence: High
Authorized/Permitted
Caramel is listed in 21 CFR 73.85 for food use under GMP and appears as permanently listed, exempt from certification in FDA's inventory.
REGULATORY DIVERGENCE
Confidence: Medium
Moderate
Broad global permission but differing ADIs/specifications (EU and JECFA impurity limits; EFSA group/individual ADIs; California NSRL warning framework for 4-MEI).
HEALTH-BASED GUIDANCE AVAILABILITY
Confidence: High
Established
JECFA and EFSA have established ADIs relevant to caramel colours/classes; California has an NSRL for the related contaminant 4-MEI.
EXPOSURE CERTAINTY
Confidence: High
Low
Restaurant foods often do not disclose caramel class or concentrations; FDA notes labels typically cannot indicate whether Class III/IV is present unless voluntarily disclosed.
DATA RECENCY & STABILITY
Confidence: Medium
Evolving
Core authorization is stable, but FDA tracking indicates ongoing review activity for 4-MEI levels in caramel color III/IV and state-level additive policy activity is active.
Health guidance & exposure
- ADI — JECFA (1985): Not specified
- ADI — JECFA (2000): 160 mg/kg bw/day (Class II (INS 150b): 0–160)
- ADI — JECFA (1985): 200 mg/kg bw/day (Class III (INS 150c): 0–200)
- ADI — JECFA (1985): 200 mg/kg bw/day (Class IV (INS 150d): 0–200)
- ADI — EFSA (ANS Panel; referenced in 2012 statement) (2011): 300 mg/kg bw/day (Group ADI for E150a/b/c/d)
- ADI — EFSA (ANS Panel; referenced in 2012 statement) (2011): 100 mg/kg bw/day (Individual ADI for E150c due to THI immunotoxicity concern)
- RfD — OEHHA (2011): 29 µg/day (NSRL for 4-MEI (Prop 65 safe harbor style; contaminant-focused))
Agency exposure estimates
- EFSA — European toddlers/children/adolescents/adults/elderly (modeled exposures; ranges reported in EFSA statement): Not specified
Measured food levels
- EU; JECFA — Not an exposure value; impurity specification limits for 4-MEI/THI in certain caramel classes: Not specified
For US fast-food/restaurant items, caramel class and use levels are often proprietary; labels may not specify whether Class III/IV caramel is present unless voluntarily disclosed.
Data gaps
- US fast-food/restaurant item-level concentrations of caramel color and 4-MEI are often not public.
- Caramel class (I–IV) is usually not disclosed on US labels unless voluntarily provided; restaurant disclosures vary.
- Comparable, up-to-date national monitoring of 4-MEI in restaurant foods is limited in public sources.
Found in these Restaurants
We found this ingredient in menu items at the following chains:
Methodology
We assign the Low / Limited Concern tier using published research, regulatory guidance, and PRūF’s additive taxonomy. Restaurant usage is derived from public ingredient disclosures and mapped to menu items where this additive appears.
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Related questions and pages
Regulatory context
Learn how this additive is treated across different regulatory frameworks and why mixture effects can matter.
Scientific Sources & References
About this Audit
Data sourced from publicly available nutrition guides and ingredient lists as of 2026-03-04. Percentages represent the frequency of an ingredient's appearance across standard menu items, not the quantity within a specific item. Regional availability and supplier formulations may vary.
PRūF is an independent educational tool and is not affiliated with, endorsed by, or connected to any restaurant chain mentioned. All trademarks belong to their respective owners.
