TY - GEN
T1 - Safety of use of Monk fruit extract as a food additive in different food categories
AU - Younes, Maged
AU - Aquilina, Gabriele
AU - Engel, Karl-Heinz
AU - Fowler, Paul
AU - Frutos Fernandez, Maria Jose
AU - Fürst, Peter
AU - Gürtler, Rainer
AU - Gundert-Remy, Ursula
AU - Husøy, Trine
AU - Mennes, Wim
AU - Moldeus, Peter
AU - Oskarsson, Agneta
AU - Shah, Romina
AU - Waalkens-Berendsen, Ine
AU - Wölfle, Detlef
AU - Degen, Gisela
AU - Herman, Lieve
AU - Gott, David
AU - Leblanc, Jean-Charles
AU - Giarola, Alessandra
AU - Rincon, Ana Maria
AU - Tard, Alexandra
AU - Castle, Laurence
AU - EFSA Panel on Food Additives and Flavourings (FAF)
N1 - Acknowledgements: The FAF Panel wishes to acknowledge all European competent institutions, Member State bodies and other organisations that provided data for this scientific output.
PY - 2019/12
Y1 - 2019/12
N2 - 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 255V 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-52V 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.
AB - 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 255V 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-52V 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.
KW - monk fruit extract
KW - Luo Han Guo extract
KW - mogroside V
U2 - 10.2903/j.efsa.2019.5921
DO - 10.2903/j.efsa.2019.5921
M3 - Article
C2 - 32626208
SN - 1831-4732
VL - 17
SP - e05921
JO - EFSA Journal
JF - EFSA Journal
ER -