The Center for Environmental Health has filed a notice of violation under California’s Safe Drinking Water and Toxic Enforcement Act (Prop. 65) to inform the manufacturer and retailers of several carbonated soft drinks containing caramel coloring that it will file a citizen enforcement lawsuit against them for violating Prop. 65’s warning provision since January 7, 2012, with respect to 4-methylimidazole (4 MEI). According to the notice, “No clear and reasonable warning is provided with these products regarding the carcinogenic hazards associated with 4-MEI exposure.” The notice also states that the lawsuit will be filed unless each “alleged violator enters into a binding written agreement to remedy the violations alleged herein by: (1) recalling products already sold; (2) reformulating such products to eliminate the 4-MEI exposure or taking appropriate measures to otherwise comply with Proposition 65; and (3) paying an appropriate civil penalty based on the factors enumerated” in California’s Health…
Tag Archives caramel color/4-MEI
California’s Office of Administrative Law has approved a no significant risk level for the chemical 4-Methylimidazole (4-MEI) proposed by California EPA’s Office of Environmental Health Hazard Assessment (OEHHA). Beginning February 8, 2012, no Proposition 65 warning will be required for exposures to 4-MEI at or below 29 micrograms per day. The action follows a December 2011 court determination that OEHHA complied with the law when it found that 4-MEI, a chemical present in many common foods and beverages, is a carcinogen known to the state to cause cancer. Used in the manufacture of various products such as pharmaceuticals, the chemical is a by-product of fermentation often found in soy sauce, roasted coffee and the caramel coloring added to colas and beer. Additional information about the court challenge and ruling appears in Issue 420 of this Update.
A California court has determined that California EPA’s Office of Environmental Health Hazard Assessment (OEHHA) complied with the law in determining that 4-methylimidazole (4-MEI), a chemical present in many common foods and beverages, is a carcinogen known to the state to cause cancer. Cal. League of Food Processors v. OEHHA, No. 34-2011-80000784 (Cal. Super. Ct., decided November 21, 2011). As noted by the court, “The chemical is used in the manufacture of various products like pharmaceuticals, and it is a by-product of fermentation found in food products like soy sauce, roasted coffee, and caramel coloring added to colas and beer.” A number of trade associations representing an array of food and beverage interests challenged the listing, which will require product warnings under the state’s Safe Drinking Water and Toxic Enforcement Act of 1986 (Prop. 65). They claimed that OEHHA’s reliance on a National Technology Program technical report on 4-MEI did…
California EPA’s Office of Environmental Health Hazard Assessment (OEHHA) has extended the deadline for public comment on a proposal to increase the no significant risk level (NSRL) for 4-methylimidazole (4-MEI) to November 7, 2011. The action was taken in response to a request from the American Beverage Association and International Technical Caramel Association. The chemical has been identified as a by-product of fermentation, heating or roasting in certain foods and beverages, such as coffee, some carbonated beverages, beer and wine, soy sauce, molasses, and crackers. The new proposed NSRL is 29 micrograms per day, an increase from the 16 micrograms per day level that OEHHA proposed in January.
California EPA’s Office of Environmental Health Hazard Assessment (OEHHA) has issued a notice indicating that it has changed the proposed regulation establishing a No Significant Risk Level (NSRL) for 4-MEI and augmented the record with additional references. The new proposed NSRL is 29 micrograms per day, increased from the proposed 16 micrograms per day level. The chemical, 4 Methylimidazole, has been identified as a by-product of fermentation, heating or roasting in certain foods and beverages, such as coffee, some carbonated beverages, beer and wine, soy sauce, molasses and crackers. Comments are requested by October 24, 2011.
The European Food Safety Authority’s (EFSA’s) Scientific Panel on Food Additives and Nutrient Sources Added to Food (ANS) “has assessed the safety of a group of caramel colors authorized for use in food in the European Union,” concluding that all four classes “are neither genotoxic, nor carcinogenic and that there is no evidence to show that they have any adverse effects on human reproduction or for the developing child.” The ANS Panel evidently reevaluated the safety of Class I Plain Caramel or Caustic Caramel (E 150a), Class II Caustic Sulfite Caramel (E 150b), Class III Ammonia Caramel (E 150c) and Class IV Sulfite Ammonia Caramel (E 150d), setting a group acceptable daily intake (ADI) of 300 mg per kg body weight per day (mg/kg bw/day). It also set a more restrictive ADI of 100 mg/kg bw/day for caramel E150c. As ANS Panel Chair John Christian Larsen explained, “This means that…
The Center for Science in the Public Interest (CSPI) has filed a regulatory petition with the Food and Drug Administration (FDA), asking the agency to prohibit two types of caramel coloring used in cola, beer, soy sauce, and other foods. According to CSPI, “the artificial brown coloring in colas and some other products is made by reacting sugars with ammonia and sulfites under high pressure and temperatures,” resulting in “the formation of 2-methylimidazole [2-MI] and 4-methylimidazole [4-MI], which in government-conducted studies caused lung, liver, or thyroid cancer or leukemia in laboratory mice or rats.” The consumer watchdog is thus urging FDA to prohibit Caramel III and Caramel IV food colorings because both are made with ammonia. Experts with ties to the National Toxicology Program (NTP) have also penned a letter in support of this request, citing several NTP animal studies finding “’clear evidence’ for carcinogenicity” of both 2-MI and 4-MI. “[T]he…
California EPA’s Office of Environmental Health Hazard Assessment (OEHHA) has proposed a no significant risk level (NSRL) of 16 micrograms per day for 4-methylimidazole (4-MEI), a chemical commonly present in foods such as wine, soy sauce and Worcestershire sauce after they have been cooked. The food industry was apparently unable to prevent OEHHA from listing the ubiquitous chemical as a carcinogen under Proposition 65 (Prop. 65) and may now be considering challenging the NSRL. The proposed threshold will reportedly require Prop. 65 warnings on thousands of products. The chemical is also apparently used in the production of some pharmaceuticals. OEHHA requests comments by February 21, 2011. See Inside Cal/EPA, January 13, 2011.
California’s Office of Environmental Health Hazard Assessment (OEHHA) has extended the deadline for public comment on its notice of intent to list 4- methylimidazole (4-MEI) as a chemical known to the state to cause cancer under Proposition 65 (Prop. 65). The new deadline is May 29, 2009. According to a news source, the proposed intent to list has generated significant opposition from grocers and other food industry representatives who argue that the chemical, which is found in foods such as wine, soy sauce and Worcestershire sauce after cooking, “is just the latest in a series of near-ubiquitous chemicals created as an unavoidable consequence of heating the natural constituents of foods.” Once a chemical is listed under Prop. 65, products containing the chemical cannot be sold without warnings. The industry groups reportedly contend, “listing 4-MEI can be expected to impact a wide swath of foods by producing warnings, changes in cooking methods,…
