Is Caramel Color Class III Safe During Pregnancy?
The facts: Caramel Color Class III is restricted in California (Prop 65 requires warning for 4-MEI above 29 mcg/day), 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 Class III on any product's label so you can decide with your provider. Commonly found in: Various beer brands, Kikkoman Soy Sauce, Heinz Brown Gravy.
TL;DR: Caramel Color Class III is allowed in the EU and allowed in the US. Here's what to know if you're pregnant.
Caramel Color Class III: regulatory status at a glance
| EU status | Allowed |
|---|---|
| US status | Allowed |
| Risk level (regulatory) | medium |
| Where it shows up | Various beer brands, Kikkoman Soy Sauce, Heinz Brown Gravy, Some malt beverages |
What is Caramel Color Class III?
Caramel color Class III (E150c) is produced by heating carbohydrates with ammonium compounds but without sulfite compounds. The ammonia processing creates byproducts including 2-acetyl-4-tetrahydroxybutylimidazole (THI) and 4-methylimidazole (4-MEI). It is commonly used in beer and malt beverages.
Why is Caramel Color Class III used in food?
Provides dark brown coloring in beer, gravy, and sauces; produces a characteristic malty flavor.
What regulators have flagged about Caramel Color Class III
The 4-MEI byproduct from ammonia-processed caramel colors was classified by IARC as a possible carcinogen (Group 2B) in 2012, based on mouse studies showing increased lung tumor incidence. California's Office of Environmental Health Hazard Assessment (OEHHA) classified 4-MEI as a carcinogen under Proposition 65 in 2011, requiring warning labels on products exceeding 29 mcg per serving. EFSA reviewed 4-MEI and in 2011 concluded there was no safety concern at expected dietary exposures, though the class B carcinogen designation remains.
For educational use only. This page summarizes the regulatory status of Caramel Color Class III 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 Class III →
Audited products that don't contain Caramel Color Class III.
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Caramel Color Class III and pregnancy: common questions
Is Caramel Color Class III banned anywhere?
Yes. Caramel Color Class III is restricted in California (Prop 65 requires warning for 4-MEI above 29 mcg/day). The FDA still allows it in the US.
Should I avoid Caramel Color Class III 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 Class III?
Commonly found in Various beer brands, Kikkoman Soy Sauce, Heinz Brown Gravy, Some malt beverages. Scan any product's barcode to check its label for Caramel Color Class III.
What can I use instead of Caramel Color Class III?
Class I caramel (E150a), malt extract, or carob powder provide dark coloring without ammonia processing. See the pregnancy-conscious swaps below.
Scan any product's barcode and instantly see if it contains Caramel Color Class III or other ingredients restricted overseas.
Scan a product free →Other ingredients to check during pregnancy
Sources
- EFSA Scientific Opinion on caramel colours — 4-methylimidazole assessment — EFSA
- IARC Monographs — 4-Methylimidazole (Group 2B) — IARC
Our scores are never influenced by brands. Last updated 6/11/2026.