Is Caramel Color IV Safe During Pregnancy?
The facts: Caramel Color IV is restricted in California (Prop 65 requires cancer warning if 4-MEI exceeds threshold), European Union (EFSA-evaluated; ADI for 4-MEI under review), though the FDA still allows it in the US. We can't tell you whether it's safe for your pregnancy — that's a conversation for your OB-GYN or midwife. What we can do is show you the regulatory facts and flag Caramel Color IV on any product's label so you can decide with your provider. Commonly found in: Coca-Cola, Pepsi, Diet Coke.
TL;DR: Caramel Color IV is restricted in the EU and allowed in the US. Here's what to know if you're pregnant.
Caramel Color IV: regulatory status at a glance
| EU status | Restricted |
|---|---|
| US status | Allowed |
| Risk level (regulatory) | — |
| Where it shows up | Coca-Cola, Pepsi, Diet Coke, Diet Pepsi, Various cola beverages, Some other dark beverages |
What is Caramel Color IV?
Caramel Color IV (Class IV caramel, E150d) is a food coloring made by heating sugar with both ammonium and sulfite compounds. This production method creates a unique set of reactive byproducts, notably 4-methylimidazole (4-MEI), which has been linked to cancer in animal studies. It is the most widely used caramel coloring in beverages like Coca-Cola and Pepsi.
Why is Caramel Color IV used in food?
Caramel Color IV provides the dark brown color characteristic of cola beverages and other dark-colored food products. It is extremely stable, provides consistent color intensity, and is cost-effective at scale. Class IV caramel's specific color and flavor characteristics make it preferred for colas.
What regulators have flagged about Caramel Color IV
The primary concern with Caramel Color IV is 4-methylimidazole (4-MEI), a byproduct of the ammonia-sulfite caramel production process. The National Toxicology Program (NTP) found that 4-MEI caused lung cancer in male and female mice at high doses in 2-year bioassay studies, leading to California listing 4-MEI as a known carcinogen under Proposition 65 in 2011. The Prop 65 safe harbor level is 29 micrograms 4-MEI per day (the level that would cause 1 additional cancer per 100,000 people over a 70-year lifetime). CSPI testing in 2011-2012 found Coca-Cola and Pepsi sold in California contained 4-MEI levels that, at typical consumption rates, would exceed this threshold — triggering voluntary reformulation by both companies to reduce 4-MEI in their US products. The FDA reviewed 4-MEI and concluded that typical exposure levels 'are not a safety concern.' EFSA's evaluation found the NTP findings concerning but noted the margin of safety at typical European exposure levels. The cancer mechanism in mice involves high doses that may not extrapolate to typical human cola consumption.
For educational use only. This page summarizes the regulatory status of Caramel Color IV with citations to the primary sources below. It is not medical advice and is not pregnancy-specific medical guidance. Consult your OB-GYN or midwife for decisions about your pregnancy.
Pregnancy-conscious swaps free from Caramel Color IV →
Audited products that don't contain Caramel Color IV.
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Caramel Color IV and pregnancy: common questions
Is Caramel Color IV banned anywhere?
Yes. Caramel Color IV is restricted in California (Prop 65 requires cancer warning if 4-MEI exceeds threshold), European Union (EFSA-evaluated; ADI for 4-MEI under review). The FDA still allows it in the US.
Should I avoid Caramel Color IV during pregnancy?
That's a decision for you and your OB-GYN or midwife — we don't give medical advice. What we can tell you is the regulatory status above. Many people choose to limit additives during pregnancy out of caution; bring this page and its sources to your next appointment.
What foods contain Caramel Color IV?
Commonly found in Coca-Cola, Pepsi, Diet Coke, Diet Pepsi, Various cola beverages, Some other dark beverages. Scan any product's barcode to check its label for Caramel Color IV.
What can I use instead of Caramel Color IV?
Other caramel color classes (Class I, II, III) don't produce 4-MEI. For beverages, botanical-derived dark colors or Class I (plain caramel) can substitute in some applications. Some natural soda brands use fruit-derived colorings. See the pregnancy-conscious swaps below.
Scan any product's barcode and instantly see if it contains Caramel Color IV or other ingredients restricted overseas.
Scan a product free →Other ingredients to check during pregnancy
Sources
- NTP Bioassay on 4-MEI — NTP/NIH
- California Prop 65: 4-Methylimidazole — California OEHHA
- CSPI Report on 4-MEI in Caramel Coloring 2012 — CSPI
- EFSA Scientific Opinion on Caramel Colours (E 150a–d) 2011 — EFSA
- FDA on Caramel Color Safety — FDA
Our scores are never influenced by brands. Last updated 6/10/2026.