Scientific Opinion on the re-evaluation of Amaranth (E 123) 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 Amaranth (E 123). Amaranth has been previously evaluated by JECFA in 1972, and the SCF in 1976. 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 (95 th /97.5 th ). However, for adults the anticipated exposure to Amaranth at the 97.5 th 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. KEY WORDSAmaranth, E 123, CAS Registry Number 915-67-3, trisodium 2-hydroxy-1-(4-sulphonato-1naphthylazo)naphthalene-3,6-disulphonate, CI Food Red 9, food colouring substance.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 1-to 14-year old children are around 30 times lower than the ADI of 0.15 mg/kg bw/day at the high percentiles (95 th /97.5 th ). However, for adults the anticipated exposure to Amaranth at the high percentile (97.5 th ) can be up to 6 times higher than the ADI.The Panel also notes that the main contributors to total anticipated exposure 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 level of use for Americano, although no usage value was provided by industry for this beverage, 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.The Panel further notes that the specifications for Amaranth need to be updated with respect to the percentage of material not accounted for that may represent sodium chloride or sodium sulphate as the principal uncoloured components.The Pa...

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