Is Caramel Color Class III banned?
Caramel Color Class III is permitted by the US FDA. Several countries restrict, warning-label, or have reviewed it for safety concerns. The US has more lenient additive rules than the EU, UK, Canada, and Japan, which is why this ingredient remains widely used here.
Why Caramel Color Class III is flagged
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.
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