Safety evaluation of jagua (genipin‐glycine) blue as a food additive

The EFSA Panel on Food Additives and Flavourings (FAF Panel) provides a scientific opinion on the safety of jagua (genipin-glycine) blue as a new food additive. Jagua (genipin-glycine) blue is obtained by water extraction of the ground pulp of the peeled, unripe fruits of <i>Genipa americana</i> L. and is the result of a reaction between genipin (iridoid present in the fruit) and externally added glycine. This reaction leads to the formation of a blue-coloured polymer and minor colouring components. In vitro Caco-2 cell permeability test demonstrated a low permeability of jagua (genipin-glycine) blue, but repeated dose toxicity studies showed organs discoloration and green-coloured urine, demonstrating some absorption. The toxicological data set comprised acute, sub-chronic toxicity, genotoxicity studies and also a 12-month toxicity study including in utero exposure. Jagua (genipin-glycine) blue was not genotoxic, and no adverse effects were observed in the repeated dose toxicity studies up to the highest doses tested. The Panel derived an acceptable daily intake (ADI) of 34 mg/kg bw per day or 12 mg/kg bw per day expressed as blue polymer, based on a no observed adverse effect level (NOAEL) of 3385 mg/kg bw per day, the highest dose tested, from the 12-month toxicity study and an uncertainty factor of 100. At the proposed maximum use level exposure assessment scenario, the 95th percentile of exposure approximately ranged from 1 mg/kg bw per day in the elderly to 27 mg/kg bw per day in toddlers. The Panel noted that both the mean and 95th percentile estimates of exposure did not exceed the proposed ADI in all population groups. The same was true for the exposure to the blue polymer assuming a 40% content in the proposed food additive. The Panel concluded there is no safety concern for jagua (genipin-glycine) blue as a food additive at the proposed use and use levels.