INTERNATIONAL TECHNICAL CARAMEL ASSOCIATION

1900 K Street, NW Washington, DC 20006

Caramel Colors Safety Status

Caramel Colors have been used safely in food products since the 19th century. Caramel Colors are authorized to be used in food products globally. Four different Classes (I, II, III and IV) of Caramel Colors exist based on their means of manufacture and their individual physical properties which are suitable for different applications. Caramel Color is used in a wide range of food products, including but not limited to soft drinks, beer, spirits, bakery products, cereals, sauces, soups, meats and spice blends, etc.

Recently, questions were raised about a trace component, 4-methylimidazole (4-MEI) generated during manufacture of certain Caramels Colors (Classes III and IV) as a result of a US National Toxicology Program (NTP) 2007 study finding lung tumors in mice fed very high levels of 4-MEI. In the same study, rats fed high levels of 4-MEI exhibited reductions in 5 tumor types. California’s Office of Environmental Health Hazard Assessment has chosen to list 4-MEI as a Proposition 65 chemical requiring a warning label on all foods/beverages, if the dietary intake of 4-MEI from the food/beverage product exceeds 29 micrograms/kg. No regulatory agency has taken any action concerning the use of Caramel Colors by any national or international regulatory body. .

The safety of Caramel Colors has been established and reaffirmed numerous times over the last four decades. Regulatory specifications, including specifications for 4-MEI have been established by The Joint Expert Committee for Food Additives (JECFA), The European Food Safety Authority (EFSA), the US Food and Drug Administration (US FDA)/Food Chemical Codex (FCC) and numerous other countries. Most recently, the European Union in its reassessment of all food additives had Caramel Colors reviewed by EFSA. In a March 2011 opinion, EFSA reaffirmed the safety of all Caramel Colors. EFSA “concluded that the carcinogenic effect of 4-MEI seen in mice in the NTP study was threshold, and that the intermediate dose of 625 mg 4-MEI diet, equivalent to 80 mg/kg bw/day could be considered to be a no observable adverse effect level (NOAEL) for these effects”. This NOAEL is equivalent to a dietary intake of 4.8 grams/day. The US FDA‘s August 2012 overall estimate of exposure to 4-MEI from the use of Class III and IV caramel color ranged from 0.5 to 0.9 mg/p/d at the mean and 1.2 to 2.0 mg/p/d at the 90th percentile for the U.S. population aged 2 years or more. In December 2012, EFSA concluded that the combined intake of caramel Colors for all consumer groups did not exceed the Acceptable Daily Intake (ADI). The U.S FDA has approved caramel as a color additive and has listed it as “a generally recognized as safe” food ingredient for decades. FDA reaffirmed Caramel Color safety in August 2013. In November 2011 Health Canada said that 4-MEI, including that found in certain Caramel colors, does “not represent a risk” to consumers.

Caramel Colors continue to have global authorization for regulatory authorities for use in food and beverage products.

Forrest L. Bayer Ph.D.

President ITCA