Open AccessRe‐evaluation of thaumatin (E 957) as food additive
Author(s) -
Younes Maged,
Aquilina Gabriele,
Castle Laurence,
Engel KarlHeinz,
Fowler Paul,
Frutos Fernandez Maria Jose,
Fürst Peter,
Gürtler Rainer,
GundertRemy Ursula,
Husøy Trine,
Manco Melania,
Mennes Wim,
Passamonti Sabina,
Moldeus Peter,
Shah Romina,
WaalkensBerendsen Ine,
Wölfle Detlef,
Wright Matthew,
Batke Monika,
Boon Polly,
Bruzell Ellen,
Chipman James,
Crebelli Riccardo,
Fitzgerald Rex,
Fortes Cristina,
Halldorsson Thorhallur,
LeBlanc JeanCharles,
Lindtner Oliver,
Mortensen Alicja,
Ntzani Evangelia,
Wallace Heather,
Civitella Consuelo,
Horvath Zsuzsanna,
Lodi Federica,
Tard Alexandra,
Vianello Giorgia
Publication year - 2021
Publication title -
efsa journal
Language(s) - English
Resource type - Journals
SCImago Journal Rank - 1.076
H-Index - 97
ISSN - 1831-4732
DOI - 10.2903/j.efsa.2021.6884
Subject(s) - thaumatin , food science , toxicity , acceptable daily intake , toxicology , microbiology and biotechnology , biology , chemistry , medicine , biochemistry , pesticide , agronomy , gene
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.