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

Abstract

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 (95 th ) 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. © European Food Safety Authority, 2010 KEY WORDSCurcumin, E 100, CAS Registry Number Turmeric Yellow, Kurkum, INS no. 100(i), CI Natural Yellow 3, Diferoylmethane, EINECS number 207-280-5, Colour index number 75300. Curcumin (E 100) is a dicinnamoylmethane dye authorised as a food additive in the EU and was previously evaluated by the Joint FAO/WHO Expert Committee on Food Additives (JECFA) in 1974, 1978, 1980, 1982, 1987, 1990, 1992, 1995, 2000, 2002 and 2004, and Curcumin consists of three principal colouring components. It consists essentially of curcumins i.e. the colouring principle (1E, 6E)-1, 7-bis-(4-hydroxy-3-methoxyphenyl)-hepta-1, 6-diene-3, 5-dione and its desmethoxy-and bis-desmethoxy-derivatives.Regarding the kinetics of curcumin, in animal studies it appeared that curcumin is rapidly metabolised and excreted (mainly via faeces). Studies in humans also reveal that it is unlikely that substantial concentrations of curcumin occur...

Curcumin: Could This Compound Be Useful in Pregnancy and Pregnancy-Related Complications?

“…Numerous clinical trials have shown good tolerability, safety, and efficacy of curcumin in the treatment of multiple chronic diseases-including cardiovascular diseases, diabetes, neurodegeneration, arthritis, and cancer-at doses up to 6-12 g/day [10,11,13]. In light of this, the United States Food and Drug Administration (FDA) has "Generally Recognized As Safe" (GRAS) curcumin as an ingredient in various food categories (0.5-100 mg/100 g) [29]; and the European Food Safety Authority (EFSA) Panel on Food Additives and Nutrient Sources added to Food (ANS), defined the Allowable Daily Intake (ADI) value of 0-3 mg/kg bw/day of curcumin as a food additive [30]. However, despite its potential therapeutic benefits, curcumin is poorly bioavailable due to its rapid metabolism, and the small portion of substance that is absorbed is extensively bio-transformed into its water-soluble metabolites, glucuronides, and sulfates [10].…”

Dietary exposure of the Belgian adult population to 70 food additives with numerical ADI

“…E100 (curcumin) is authorized with MPL but may be used quantum satis in a number of food categories. EFSA concluded that at the maximum levels of use, intake estimates for adults for E100 were below the ADI, but not for children (EFSA, 2010b). Rosemary extract (E392) was also not included in the exposure assessment since there is no numerical ADI, however E392 is not classified as "ADI not specified" either.…”

Safety and efficacy of turmeric extract, turmeric oil, turmeric oleoresin and turmeric tincture from Curcuma longa L. rhizome when used as sensory additives in feed for all animal species

“…The Joint FAO/WHO Expert Committee on Food Additives (JECFA) assessed the food additive curcumin (turmeric rhizome extract) in 2003 and established an acceptable daily intake (ADI) of 0-3 mg/kg body weight (bw) (WHO, 2004a,b). In 2010, the EFSA Panel on Food Additives and Nutrient Sources added to Food (ANS) adopted a scientific opinion on the re-evaluation of the food additive colour curcumin (E 100) (turmeric rhizome extract) and concluded that the available data set supports the ADI allocated by JECFA based on the NOAEL of 250-320 mg/kg bw per day from the reproductive toxicity study in rats for a decreased body weight gain in the F2 generation observed at the highest dose level, and an uncertainty factor of 100 (EFSA ANS Panel, 2010). In 2014, the European Food Safety Authority (EFSA) took into account additional information on the use of curcumin (E 100) in foods and carried out a refined exposure assessment (EFSA, 2014).…”

“…No toxic effects were observed in a phase I study in 25 patients with high-risk cancerous conditions, receiving up to 8 g of curcumin (99.3% of purity) per day for 3 months for anticancer treatment (Cheng et al, 2001, EFSA ANS Panel, 2010. No side effects were reported in 18 patients with rheumatoid arthritis treated with daily doses of 1.2 g curcumin for 2 weeks (Deodhar et al, 1980 as referenced by EFSA ANS Panel, 2010).…”