Dataset Information

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.

SUBMITTER: EFSA Panel on Food Additives and Flavourings (FAF)

PROVIDER: S-EPMC8630604 | biostudies-literature | 2021 Nov

REPOSITORIES: biostudies-literature

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Re-evaluation of thaumatin (E 957) as food additive.

Younes Maged M Aquilina Gabriele G Castle Laurence L Engel Karl-Heinz KH Fowler Paul P Frutos Fernandez Maria Jose MJ Fürst Peter P Gürtler Rainer R Gundert-Remy Ursula U Husøy Trine T Manco Melania M Mennes Wim W Passamonti Sabina S Moldeus Peter P Shah Romina R Waalkens-Berendsen Ine I Wölfle Detlef D Wright Matthew M Batke Monika M Boon Polly P Bruzell Ellen E Chipman James J Crebelli Riccardo R Fitzgerald Rex R Fortes Cristina C Halldorsson Thorhallur T LeBlanc Jean-Charles JC Lindtner Oliver O Mortensen Alicja A Ntzani Evangelia E Wallace Heather H Civitella Consuelo C Horvath Zsuzsanna Z Lodi Federica F Tard Alexandra A Vianello Giorgia G

EFSA journal. European Food Safety Authority 20211130 11

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 <i>Thaumatococcus daniellii</i> plant. The Panel followed the conceptual framework for the risk assessment of certain food additives and considered that thaumatin is a digestible protein; adeq ...[more]

PMID: 34876926

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Project description:This opinion deals with the re-evaluation of polydextrose (E 1200) when used as a food additive. The Panel followed the conceptual framework for the risk assessment of certain additives and considered that: adequate exposure estimates were available; the margin of safety (MOS)/margin of exposure (MOE) for arsenic was between 0.5-14 and 8.5 for lead; the exhaustions of the tolerable weekly intake (TWI) for cadmium would be 165%, 10% for mercury, whereas the exhaustion of the tolerable daily intake (TDI) for nickel would be 9%; the absorption is limited and part of polydextrose is fermented in the large intestine into short-chain fatty acids (SCFA); adequate toxicity data were available; there is no concern with respect to genotoxicity; no adverse effects were reported in subchronic studies in rats, dogs or monkeys nor in chronic or carcinogenicity studies in mice and rats at the highest doses tested of up 12,500 mg/kg body weight (bw) per day and 15,000 mg/kg bw per day, respectively; the nephrocalcinosis in dogs given high doses of polydextrose was considered to be a treatment-related but a secondary effect related to diarrhoea, and hence not relevant for the risk assessment; no adverse effects were reported in reproductive or developmental toxicity studies in rats administered up to 10,000 mg polydextrose/kg bw per day, or in a developmental toxicity study in rabbits up to 1,818 mg/kg bw per day (the highest dose tested). Therefore, the Panel concluded that there is no need for numerical acceptable daily intake (ADI) for polydextrose (E 1200), and that there is no safety concern for the reported uses and use levels of polydextrose as a food additive. The Panel recommended that European Commission considers to lower the maximum limit for lead and to introduce limits for arsenic, cadmium and mercury in the EU specifications for polydextrose (E 1200), and to verify that polydextrose-N as a food additive (E 1200) is no longer marketed in the EU.

Dataset Information

Re-evaluation of thaumatin (E 957) as food additive.

Publications

Re-evaluation of thaumatin (E 957) as food additive.

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