When did California warn about caramel color chemical, and how did makers respond?
Research question: When did California list 4-methylimidazole under Proposition 65, what evidence did OEHHA use, and how did caramel color manufacturers respond?
The records show California listed 4-methylimidazole as a chemical known to cause cancer under Proposition 65 on January 7, 2011 6. The listing rested on the U.S. National Toxicology Program's 2007 studies, which showed treatment-related increases in benign and malignant lung tumors in mice 139. OEHHA estimated the chemical's cancer potency from lung tumor dose-response data in male mice 11 and set a No Significant Risk Level of 29 micrograms per day 14, and it rejected industry claims that a safe exposure threshold exists 18. Coca-Cola and PepsiCo responded by having caramel color suppliers change manufacturing processes so beverages sold in California met the standard 2, and in 2012 they lowered 4-MEI levels to avoid Proposition 65 warnings 4. The newest fact is from 2026, and it reports that industry reformulations have cut 4-MEI so much that added caramel exposure is now similar to exposure from baking or roasting 5.
Sources
"A 2007 study by the United States National Toxicology Program (NTP) examined carcinogenic activity following long-term exposure to 4-Mel, and found clear evidence for lung tumors in mice, limited evidence for increased leukemia in female rats, and no evidence in male rats."4-Methylimidazole
"In March 2012, both The Coca-Cola Company and PepsiCo announced they had their caramel color suppliers modify their manufacturing processes to meet the new California standard; as of the announcement, the changes had already been made for beverages sold in California."4-Methylimidazole
"Similarly, Pepsi and some Coke lots sold in the states other than California in the United States contain 4-MeI levels considered safe by the FDA and EFSA, but exceeding California standards."4-Methylimidazole
"In 2012, Coca-Cola Co. and PepsiCo Inc. lowered the level of 4-MEI in the caramel color in their soft drinks to avoid having to place warnings on their beverages."The Soda Industry Faces Changes To Prop 65
"The cumulative reduction in 4-MEI levels in beverages and foods from industry reformulations results in exposures to added sources (caramel colour) and intrinsic sources (baking or roasting process) being similar."An updated U.S. population dietary exposure assessment for 4-methylimidazole (4-MEI) from foods containing colour and from formation of 4-MEI through thermal treatment of foods (2026)
"4-MEI was listed on January 7, 2011, as a chemical known"NO SIGNIFICANT RISK LEVEL (NSRL) FOR THE PROPOSITION 65 CARCINOGEN
"Both of these chemicals are identified on the Proposition 65 list as carcinogens."The Soda Industry Faces Changes To Prop 65
"assumes 4-MEI levels in foods being reduced by half to align with the 50% lowering of the Food Chemicals Codex specification limits for 4-MEI in caramel III or IV (Tier 3)"An updated U.S. population dietary exposure assessment for 4-methylimidazole (4-MEI) from foods containing colour and from formation of 4-MEI through thermal treatment of foods (2026)
"The listing was based on NTP’s findings of clear evidence of carcinogenicity in its"NO SIGNIFICANT RISK LEVEL (NSRL) FOR THE PROPOSITION 65 CARCINOGEN
"The chemical 4-MEI is found in caramel coloring used for soft drinks."The Soda Industry Faces Changes To Prop 65
"male mice exposed to 4-MEI via their feed (National Toxicology Program [NTP], 2007)."NO SIGNIFICANT RISK LEVEL (NSRL) FOR THE PROPOSITION 65 CARCINOGEN
"Compared to previous FDA estimates of 0.043 and 0.046 mg day−1 of 4-MEI from added caramel sources for the general population and adults, respectively, this updated assessment shows 4-MEI estimated exposures to be 0.016 and 0.017 mg day−1, when all reductions in foods and beverages are accounted for."An updated U.S. population dietary exposure assessment for 4-methylimidazole (4-MEI) from foods containing colour and from formation of 4-MEI through thermal treatment of foods (2026)
"Thus, the treatment-related increases in benign and malignant lung tumors in male and female B6C3F mice formed the basis of the listing"NO SIGNIFICANT RISK LEVEL (NSRL) FOR THE PROPOSITION 65 CARCINOGEN
"is calculated to be 29 micrograms per day (µg/day)."NO SIGNIFICANT RISK LEVEL (NSRL) FOR THE PROPOSITION 65 CARCINOGEN
"In 2011, California listed 4-MEI as a carcinogen under the Safe Drinking Water and Toxic Enforcement Act of 1986, which is better known as Proposition 65"Caramel Color in Soft Drinks and Exposure to 4-Methylimidazole: A Quantitative Risk Assessment
"The U.S. National Toxicology Program (NTP) assessed the carcinogenicity of 4-MEI in male and female mice and rats using two-year feeding studies in 2007, concluding that there was “clear evidence of carcinogenic activity in male and female mice”"Caramel Color in Soft Drinks and Exposure to 4-Methylimidazole: A Quantitative Risk Assessment
"Based on the NTP studies, the International Agency for Research on Cancer classified 4-MEI as Group 2B, or “possibly carcinogenic to humans”, indicating sufficient evidence of carcinogenicity in experimental animals while no human data were available"Caramel Color in Soft Drinks and Exposure to 4-Methylimidazole: A Quantitative Risk Assessment
"The OEHHA denied these claims on the basis of available evidence regarding the mode of carcinogenic action of 4-MEI"Caramel Color in Soft Drinks and Exposure to 4-Methylimidazole: A Quantitative Risk Assessment
"Similar statements are made regularly by the beverage industry, which submitted these claims to the OEHHA when the agency set the NSRL for 4-MEI under Proposition 65"Caramel Color in Soft Drinks and Exposure to 4-Methylimidazole: A Quantitative Risk Assessment
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