Dataset Information

Safety of use of Monk fruit extract as a food additive in different food categories.

ABSTRACT: The EFSA Panel on Food Additives and Flavourings (FAF) provides a scientific opinion on the safety of Monk fruit extract proposed for use as a new food additive in different food categories. Monk fruit extracts are prepared by water extraction of the fruits of Siraitia grosvenorii. Cucurbitane glycosides, mogrosides, are the main components of the S. grosvenorii fruit and mogroside V is the main mogroside in the Monk fruit extract. Mogroside V is absorbed to some extent and is systemically bioavailable. Monk fruit extract containing 25% and 55% mogroside V were negative in the bacterial reverse mutation assay and did not induce structural and/or numerical chromosomal damage. However, the Panel noted that the in vitro toxicity studies including study with metabolic activation were not sufficiently informative to evaluate the genotoxic potential of the metabolites generated after microbial metabolism, including the aglycone. The effects on the testis observed in a 90-day study with monk fruit extract-52% mogroside V cannot be dismissed and the adversity of these effects cannot be ruled out. No effects on parental, reproductive or development toxicity were observed in a reproductive and developmental screening study in rats. For male animals, the time of exposure did not cover the full length of spermatogenesis and, therefore, a longer term study at higher doses would be needed to clarify the effects on testes observed in the 90-day study. No maternal and developmental toxicity was observed. Considering the systemic availability of mogroside V, the effects observed in the rat subchronic study and following the principles of EFSA Guidance on food additives evaluation, data from chronic/carcinogenicity toxicity testing would have been warranted. Exposure to mogroside V was calculated based on the proposed use levels. The Panel concluded that toxicity database on Monk fruit extract is insufficient to conclude on the safety of the use of Monk fruit extract as a food additive.

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

PROVIDER: S-EPMC7008860 | biostudies-literature | 2019 Dec

REPOSITORIES: biostudies-literature

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Safety of use of Monk fruit extract as a food additive in different food categories.

Younes Maged M Aquilina Gabriele G 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 Mennes Wim W Moldeus Peter P Oskarsson Agneta A Shah Romina R Waalkens-Berendsen Ine I Wölfle Detlef D Degen Gisela G Herman Lieve L Gott David D Leblanc Jean-Charles JC Giarola Alessandra A Rincon Ana Maria AM Tard Alexandra A Castle Laurence L

EFSA journal. European Food Safety Authority 20191211 12

The EFSA Panel on Food Additives and Flavourings (FAF) provides a scientific opinion on the safety of Monk fruit extract proposed for use as a new food additive in different food categories. Monk fruit extracts are prepared by water extraction of the fruits of <i>Siraitia grosvenorii</i>. Cucurbitane glycosides, mogrosides, are the main components of the <i>S. grosvenorii</i> fruit and mogroside V is the main mogroside in the Monk fruit extract. Mogroside V is absorbed to some extent and is syst ...[more]

PMID: 32626208

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Dataset Information

Safety of use of Monk fruit extract as a food additive in different food categories.

Publications

Safety of use of Monk fruit extract as a food additive in different food categories.

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