Re‐evaluation of thaumatin (E 957) as food additive

Abstract

The present opinion deals with the re-evaluation of thaumatin (E 957) when used as a food additive. Thaumatin is a natural plant protein, consisting 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 conceptual framework for the risk assessment of certain food additives and considered that thaumatin is a digestible protein; adequate exposure estimates were available; there was no concern with respect to the genotoxicity; no conclusion on oral allergenicity could be drawn from the available human data; no adverse effects were observed in sub-chronic 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 confidence in the body of evidence supported the absence of association between exposure to thaumatin and adverse health outcomes. Therefore, the Panel concluded that there is no need for a numerical acceptable daily intake (ADI) for thaumatin (E 957) and, based on a margin of safety (MOS) of 5,417, considered to be an underestimate and derived using the highest 95th percentile (P95) exposure of 0.48 mg/kg bw per day in consumers only, there is no safety concern for thaumatin (E 957) at the regulatory maximum level exposure assessment scenario, which was considered the most appropriate. The Panel recommended that European Commission considers introducing in the EU specifications for thaumatin (E 957) a new specification limit for the minimum combined content of thaumatin I and II proteins in E 957, a specification limit for yeast, mould counts and Salmonella spp and lowering the existing maximum limit for arsenic along with the inclusion of maximum limits for mercury and cadmium.

Assessment of the feed additive consisting of thaumatin for all animal species for the renewal of its authorisation (ADISSEO France S.A.S.)

“…The NOAEL identified from the above‐mentioned subchronic toxicity study in dogs was confirmed to be 1,305 mg/kg bw per day in male dogs and 1,476 mg/kg bw per day in female dogs. Among all NOAELs identified in different toxicological studies, all corresponding to the highest dose tested, the FAF Panel used the highest NOAEL of 5,200 mg/kg bw per day (the highest dose tested in males), identified in a subchronic toxicity study with rats (Ben‐Dyke et al., 1976 , as cited by EFSA FAF Panel, 2021 ), to calculate the Margin of Safety (MOS) for humans. In addition, the FAF Panel concluded that thaumatin does not raise concern for genotoxicity and developmental toxicity.…”

“…In their opinions, the EFSA ANS Panel (EFSA ANS Panel, 2015 ) and the EFSA FAF Panel (EFSA FAF Panel, 2021 ) recalculated the NOAEL, from the same subchronic toxicity study in dogs, which resulted in values of 1,305 mg/kg bw per day in male dogs and 1,476 mg/kg bw per day in female dogs. These NOAELs are the lowest among all NOAELs (all corresponding to the highest dose tested) identified by the EFSA FAF Panel from the available toxicological studies.…”

“…In its recent opinion, the FAF Panel, considering the available toxicological information and the estimated exposure of consumer to thaumatin used as a food additive, concluded that there is no need for establishing a numerical acceptable daily intake (ADI) for thaumatin (E 957) (EFSA FAF Panel, 2021 ).…”

“…The ELS search carried out by the applicant identified a publication on potential respiratory allergenic potential of thaumatin in workers (Tschannen et al., 2017 ). The same study has been recently assessed by the FAF Panel (EFSA FAF Panel, 2021 ). The results of the study suggested that occupational exposure to a powder mixture containing thaumatin and gum arabic may cause rhinitis, in particular among susceptible individuals, and nasal mucosa signs of allergy.…”

“…The EFSA Panel on Food Additives and Nutrient Sources added to Food (ANS Panel) issued a scientific opinion on a proposed extension of use of thaumatin (E 957) in 2015 (EFSA ANS Panel, 2015 ). Thaumatin has been recently re‐evaluated by EFSA Panel on Food Additives and Flavourings (EFSA FAF Panel, 2021 ).…”