The present opinion deals with the re-e valuation of thaumatin (E 957) when used as a food additive. Thaumatin is a natural plant protein, co nsisting of thaumatin I and thaumatin II proteins together with minor amounts of plant constituents, obtained by acidic aqueous extraction of the arils of the fruit of Thaumatococcus daniellii plant. The Panel followed the co nceptual f ramework for the risk assessment of certain food additives and co nsidered that thaumatin is a digestible protein; adequate exposure estimates were available; there was no co ncern with respect to the genotoxicity; no co nclusion on oral allergenicity could be drawn from the available human data; no adverse effects were observed in sub-chro nic toxicity studies in rats and dogs at the highest dose tested of up 5,200 and 1,476 mg/kg bodyweight (bw) per day, respectively, and in a prenatal developmental toxicity study up to 2,000 mg/kg bw per day; moderate co nfidence in the body of evidence supported the absence of association between exposure to thaumatin and adverse health outcomes. Therefore, the Panel co ncluded that there is no need for a numerical acceptable daily intake (ADI) for thaumatin (E 957) and, ba sed on a margin of safety (MOS) of 5,417, co nsidered to be an underestimate and derived using the highest 95th percentile (P95) exposure of 0.48 mg/kg bw per day in co nsumers only, there is no safety co ncern for thaumatin (E 957) at the regulatory maximum level exposure assessment scenario, which was co nsidered the most appropriate. The Panel recommended that European Commission co nsiders introducing in the EU specifications for thaumatin (E 957) a new specification limit for the minimum combined co ntent of thaumatin I and II proteins in E 957, a specification limit for yeast, mould counts and Salmo nella spp and lowering the existing maximum limit for arsenic along with the inclusion of maximum limits for mercury and cadmium.

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