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...
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2021
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oai:doaj.org-article:60f4cb5f019a46a69ee5c457faf7216b2021-12-02T17:55:57ZRe‐evaluation of thaumatin (E 957) as food additive1831-473210.2903/j.efsa.2021.6884https://doaj.org/article/60f4cb5f019a46a69ee5c457faf7216b2021-11-01T00:00:00Zhttps://doi.org/10.2903/j.efsa.2021.6884https://doaj.org/toc/1831-4732Abstract 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.EFSA Panel on Food Additives and Flavourings (FAF)Maged YounesGabriele AquilinaLaurence CastleKarl‐Heinz EngelPaul FowlerMaria Jose Frutos FernandezPeter FürstRainer GürtlerUrsula Gundert‐RemyTrine HusøyMelania MancoWim MennesSabina PassamontiPeter MoldeusRomina ShahIne Waalkens‐BerendsenDetlef WölfleMatthew WrightMonika BatkePolly BoonEllen BruzellJames ChipmanRiccardo CrebelliRex FitzgeraldCristina FortesThorhallur HalldorssonJean‐Charles LeBlancOliver LindtnerAlicja MortensenEvangelia NtzaniHeather WallaceConsuelo CivitellaZsuzsanna HorvathFederica LodiAlexandra TardGiorgia VianelloWileyarticlethaumatinE 957food additivesweetenerNutrition. Foods and food supplyTX341-641Chemical technologyTP1-1185ENEFSA Journal, Vol 19, Iss 11, Pp n/a-n/a (2021) |
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DOAJ |
| collection |
DOAJ |
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EN |
| topic |
thaumatin E 957 food additive sweetener Nutrition. Foods and food supply TX341-641 Chemical technology TP1-1185 |
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thaumatin E 957 food additive sweetener Nutrition. Foods and food supply TX341-641 Chemical technology TP1-1185 EFSA Panel on Food Additives and Flavourings (FAF) Maged Younes Gabriele Aquilina Laurence Castle Karl‐Heinz Engel Paul Fowler Maria Jose Frutos Fernandez Peter Fürst Rainer Gürtler Ursula Gundert‐Remy Trine Husøy Melania Manco Wim Mennes Sabina Passamonti Peter Moldeus Romina Shah Ine Waalkens‐Berendsen Detlef Wölfle Matthew Wright Monika Batke Polly Boon Ellen Bruzell James Chipman Riccardo Crebelli Rex Fitzgerald Cristina Fortes Thorhallur Halldorsson Jean‐Charles LeBlanc Oliver Lindtner Alicja Mortensen Evangelia Ntzani Heather Wallace Consuelo Civitella Zsuzsanna Horvath Federica Lodi Alexandra Tard Giorgia Vianello Re‐evaluation of thaumatin (E 957) as food additive |
| description |
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. |
| format |
article |
| author |
EFSA Panel on Food Additives and Flavourings (FAF) Maged Younes Gabriele Aquilina Laurence Castle Karl‐Heinz Engel Paul Fowler Maria Jose Frutos Fernandez Peter Fürst Rainer Gürtler Ursula Gundert‐Remy Trine Husøy Melania Manco Wim Mennes Sabina Passamonti Peter Moldeus Romina Shah Ine Waalkens‐Berendsen Detlef Wölfle Matthew Wright Monika Batke Polly Boon Ellen Bruzell James Chipman Riccardo Crebelli Rex Fitzgerald Cristina Fortes Thorhallur Halldorsson Jean‐Charles LeBlanc Oliver Lindtner Alicja Mortensen Evangelia Ntzani Heather Wallace Consuelo Civitella Zsuzsanna Horvath Federica Lodi Alexandra Tard Giorgia Vianello |
| author_facet |
EFSA Panel on Food Additives and Flavourings (FAF) Maged Younes Gabriele Aquilina Laurence Castle Karl‐Heinz Engel Paul Fowler Maria Jose Frutos Fernandez Peter Fürst Rainer Gürtler Ursula Gundert‐Remy Trine Husøy Melania Manco Wim Mennes Sabina Passamonti Peter Moldeus Romina Shah Ine Waalkens‐Berendsen Detlef Wölfle Matthew Wright Monika Batke Polly Boon Ellen Bruzell James Chipman Riccardo Crebelli Rex Fitzgerald Cristina Fortes Thorhallur Halldorsson Jean‐Charles LeBlanc Oliver Lindtner Alicja Mortensen Evangelia Ntzani Heather Wallace Consuelo Civitella Zsuzsanna Horvath Federica Lodi Alexandra Tard Giorgia Vianello |
| author_sort |
EFSA Panel on Food Additives and Flavourings (FAF) |
| title |
Re‐evaluation of thaumatin (E 957) as food additive |
| title_short |
Re‐evaluation of thaumatin (E 957) as food additive |
| title_full |
Re‐evaluation of thaumatin (E 957) as food additive |
| title_fullStr |
Re‐evaluation of thaumatin (E 957) as food additive |
| title_full_unstemmed |
Re‐evaluation of thaumatin (E 957) as food additive |
| title_sort |
re‐evaluation of thaumatin (e 957) as food additive |
| publisher |
Wiley |
| publishDate |
2021 |
| url |
https://doaj.org/article/60f4cb5f019a46a69ee5c457faf7216b |
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