Internationally, JECFA has set the
Acceptable Daily Intake (ADI) of Class I caramel color as "not specified"; that of Class II as 0–160 mg/kg body weight; and that of Class III and IV as 0–200 mg/kg body weight. The
United States Food and Drug Administration (FDA) classifies and regulates caramel color in Title 21 CFR § 73.85 as an approved
color additive exempt from certification. Unless a food has a standard of identity, caramel color may be safely used in foods generally at levels consistent with "
good manufacturing practice" (GMP). Caramel color has excellent microbiological stability. Since it is manufactured under very high temperature, high acidity, high pressure, and high
specific gravity, it is essentially sterile, as it will not support
microbial growth unless in a dilute solution. When reacted with sulfites, caramel color may retain traces of sulfite after processing. However, in finished food products, labeling is usually required only for sulfite levels above 10
ppm.
Toxicology In 2010, the
International Programme on Chemical Safety (IPCS) concluded that commercially produced caramel color has the same toxicological properties as caramel produced by cooking or heating
sucrose, except for those prepared using ammonium (Class III and IV). The IPCS has concluded that caramel color does not exhibit
carcinogenicity or
mutagenicity, based on its studies. Additional long-term studies support a conclusion that caramel colors are not carcinogenic. While the US FDA, Canadian
Health Products and Food Branch and
European Food Safety Authority (EFSA) have found caramel color safe for use in food and beverages, California has listed
4-Methylimidazole (4-MeI), a compound formed in the manufacture of Class III and IV caramel colors, in the state's
Proposition 65, thus legally including it in the category of chemicals "known to the state to cause cancer or reproductive toxicity". According to the
Food Chemicals Codex, 4-MeI in caramel color is allowed up to 250 ppm on a color-adjusted basis, which means 250 ppm maximum for every 0.100 color absorbance of a 0.10% solution at 610 nm. The exposure to 4-MeI at levels present in Class III and IV caramel colors are not expected to be of concern for two reasons. Firstly, 4-MeI does not appear to be genotoxic or metabolized to a reactive metabolite. Secondly, carcinogenic doses of 4-MeI exceed estimates of exposure from the consumption of caramel coloring by several thousand-fold. North American and European manufacturers mostly use glucose derived from corn or wheat to produce caramel color, which is highly processed and is generally considered
gluten-free. ==References==