Scientific Opinion on the re-evaluation of curcumin (E 100) as a food additive.

The Panel on Food Additives and Nutrient Sources added to Food provides a scientific opinion re-evaluating the safety of curcumin (E 100). Curcumin has been previously evaluated by the Joint FAO/WHO Expert Committee on Food Additives (JECFA) and the EU Scientific Committee on Food (SCF). In 2004 JECFA allocated an ADI of 0-3 mg/kg bw/day. The Panel was not provided with a newly submitted dossier and based its evaluation on previous evaluations, additional literature that became available since then and the data available following a public call for data. The Panel considered that the indications provided by the positive results for curcumin in several in vitro and in vivo tests for genotoxicity, especially those detecting chromosomal aberrations and DNA adducts should not be disregarded, and that the available in vivo genotoxicity studies were insufficient to eliminate the concerns regarding genotoxicity. The Panel noted that all statistically significant effects noted by NTP in a long-term carcinogenicity study in rats and mice refer to benign neoplastic lesions (adenomas) and that the incidences for malignant neoplastic lesions (carcinomas) did not reach statistical significance. The Panel also noted that the effects observed were not dose-dependent, were in line with historical control values and not consistent across sexes and/or species. The Panel agreed with JECFA that curcumin is not carcinogenic. The Panel also concluded that this eliminates the concerns over genotoxicity. The Panel concluded that the present database supports an ADI of 3 mg/kg bw/day based on the NOAEL of 250-320 mg/kg bw/day from the reproductive toxicity study for a decreased body weight gain in the F2 generation observed at the highest dose level, and an uncertainty factor of 100. The Panel concluded that at the maximum levels of use, intake estimates for 1- to 10-year old children at the mean and the high percentile (95th) are above the ADI in some European countries. The Panel noted that intake of curcumin from the normal diet amounts to less than 7% of the ADI of 3 mg/kg bw/day.