Re-evaluation of Amaranth (E 123) as a food additive


Amaranth, E 123, CAS Registry Number 915-67-3, trisodium 2-hydroxy-1-(4-sulphonato-1- naphthylazo)naphthalene-3,6-disulphonate, CI Food Red 9, food colouring substance
First published in the EFSA Journal
26 July 2010
22 June 2010
Opinion of the Scientific Committee/Scientific Panel

The Panel on Food Additives and Nutrient Sources added to Food provides a scientific opinion re-evaluating the safety of Amaranth (E 123). Amaranth has been previously evaluated by JECFA in 1972, 1975, 1978 and 1984, and the SCF in 1976, 1979 and 1983. In 1984 the SCF set an ADI for Amaranth of 0-0.8 mg/kg bw/day based on results from a 90-day rat study. In contrast, in 1984 JECFA allocated an ADI of 0-0.5 mg/kg bw/day Amaranth based on a long-term carcinogenicity study in rats. In evaluating the overall toxicological database on Amaranth, the Panel concludes that the point of departure for establishing an ADI for Amaranth can be defined as 15 mg/kg bw/day, taking both the results from the 2-year study and the reproductive and developmental toxicity studies into account. Therefore using an uncertainty factor of 100, the Panel establishes an ADI for Amaranth of 0.15 mg/kg bw/day. The Panel concludes that at the maximum permitted level of use and/or reported use levels of Amaranth (Tier 2), estimates of anticipated exposure for children (1-14 years old) are around 30 times lower than the ADI of 0.15 mg/kg bw/day at the high percentiles (95th/97.5th). However, for adults the anticipated exposure to Amaranth at the 97.5th percentile can be up to 6 times higher than the ADI. The Panel also notes that main contributors to total anticipated exposure to Amaranth for adults were from aperitif wine drinks and Americano. The Panel notes that anticipated exposure to these uses have been made with the maximum permitted levels of use for Americano although no usage value for this beverage was provided by industry, and with the maximum reported levels of use for aperitif wine drinks, which were reported by Industry to be at the same level as the maximum permitted level.

Panel members at the time of adoption
F. Aguilar, B. Dusemund, P. Galtier, J. Gilbert, D.M. Gott, S. Grilli, R. Gürtler, J. König, C. Lambré, J-C. Larsen, J-C. Leblanc, A. Mortensen, D. Parent-Massin, I. Pratt, I.M.C.M. Rietjens, I. Stankovic, P. Tobback, T. Verguieva, R.A. Woutersen
Panel on Food Additives and Nutrient Sources Added to Food
ans [at]
EFSA Journal 2010;8(7):1649 [41 pp.].
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