Refined exposure assessment for curcumin (E 100)

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Article
European Food Safety Authority
EFSA Journal
EFSA Journal 2014;12(10):3876 [43 pp.].
doi
10.2903/j.efsa.2014.3876
Acknowledgements

EFSA wishes to thank the members of the Working Group on Exposure Assessment: Polly Boon, Jürgen König, Jean-Charles Leblanc, Oliver Lindtner, Christophe Matthys and Christina Tlustos for the preparatory work on this scientific output and EFSA staff: Alexandra Tard, Davide Arcella, Stavroula Tasiopoulou for the support provided to this scientific output.

Contact
Type
Statement of EFSA
On request from
EFSA
Question Number
EFSA-Q-2012-00882
Approved
21 October 2014
Published
23 October 2014
Affiliation
European Food Safety Authority (EFSA), Parma, Italy
Note
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Abstract

Following a self-tasking request, the European Food Safety Authority (EFSA) carried out a refined exposure assessment for curcumin (E 100) taking into account additional information on its use in foods. In 2010, the EFSA Panel on Food Additives and Nutrient Sources added to Food (ANS) adopted a scientific opinion on the re-evaluation of curcumin (E 100) used as a food additive. In that opinion, 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 level can be above the Acceptable Daily Intake (ADI) of 3 mg/kg body weight per day in some European countries. Following this conclusion, EFSA performed a refined exposure assessment for this food colour, using new usage data from industry, as well as monitoring data from Member States submitted to EFSA and the EFSA Comprehensive European Food Consumption Database. Usage data from industry were provided to EFSA for 52 out of the 57 food categories in which curcumin is authorised as a food additive. Analytical results provided to EFSA from Member States were all below the limit of detection (LOD) except for four samples of the food category edible ices. Using the reported use levels, exposure estimates for adolescents, adults and the elderly were below the ADI both at the mean and at the high level (95th percentile) of exposure. This was also true for the mean exposure estimates for toddlers and children. High level estimates were at the level of the ADI in these two population groups, with exceedance of the ADI in one survey each. In comparison to the previous assessment of 2010, the current exposure estimates based on reported use levels and consumption data at individual level were lower.

Summary

Following the adoption by the EFSA Panel on Food Additives and Nutrient Sources added to Food (ANS) of a scientific opinion on the re-evaluation of curcumin (E 100) used as a food additive in 2010, in which the Panel concluded that at the maximum levels of use, intake estimates for 1- to 10-year old children at the mean and at the high level could be above the Acceptable Daily Intake (ADI), EFSA carried out a refined exposure assessment for this colour, taking into account additional information on its use and use levels in foods.

Curcumin (E 100) is a cinnamoylmethane dye authorised as a food additive in the EU. This food colour has been previously evaluated by the Scientific Committee for Food (SCF) in 1975 and the Joint FAO/WHO Expert Committee on Food Additives (JECFA) in 1974, 1978, 1980, 1982, 1987, 1990, 1992, 1995, 2000, 2002 and 2004.

In 2010, the ANS Panel re-evaluated curcumin (E 100) as a food additive (EFSA, 2010a). The safety in use of curcumin (E 100) was assessed on the basis of uses and use levels authorised in the legislation and of reported use levels, as provided by industry. The ANS Panel established for curcumin an acceptable daily intake (ADI) of 3 mg/kg body weight (bw)/day based on the No-Observed-Adverse-Effect Level (NOAEL) of a reproductive toxicity study.

The ANS Panel concluded that at the maximum levels of use of curcumin (E 100), intake estimates for 1- to 10-year old children, both at the mean and the high percentiles (95th or 97.5th) were above the ADI in some European countries.

The present review provides a refined exposure assessment for curcumin (E 100) based on individual food consumption data which became available within the EFSA Comprehensive European Food Consumption Database and newly submitted information on the actual use levels and concentration data of curcumin (E 100) in foods as consumed, provided to EFSA by the food industry and Member States, following an EFSA call for data launched in March 2013.

Use levels of curcumin (E 100) reported by industry cover the majority of the authorised uses of curcumin as a food additive.

EFSA concluded that following the regulatory maximum level exposure assessment scenario, exposure estimates for toddlers, children and adolescents population groups were similar to those reported in the previous opinion of the ANS Panel in 2010 (EFSA, 2010a): both at mean and high level (95th percentile) exposure the ADI was exceeded; while adults and the elderly exposure estimates are below the ADI.

In the refined exposure assessment scenarios, using information on use levels and the EFSA Comprehensive Database, exposure estimates for adults and the elderly were lower than those reported in the previous opinion (EFSA, 2010a). The current exposure estimates for these population groups, as well as for adolescents, were below the ADI, both at the mean and at the high level (95th percentile). For children and toddlers, current exposure estimates were also lower compared to the previous opinion, both at the mean and at the high level. However, high level estimates were at the level of the ADI in these two population groups, with exceedance of the ADI in one survey each.

Intake of curcumin from natural sources was minor compared to the total intake of curcumin and did not affect the overall result with regards to the exceedance of the ADI in any of the population groups.

Keywords
curcumin, E 100, dietary exposure, EFSA Comprehensive European Food Consumption Database, food colours
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Number of Pages
43