The Panelon Food Additives and Nutrient Sources added to Food (ANS) was asked to deliver a scientific opinion on the safety of monacolins in red yeast rice (RYR) and to provide advice on a dietary intake of monacolins that does not give rise to concerns about harmful effects to health. The Panelreviewed the scientific evidences available as well as the information provided by interested parties in response of a public Call for data' launched by EFSA. The Panelconsidered that monacolin K in lactone form is identical to lovastatin, the active ingredient of several medicinal products authorised for the treatment of hypercholesterolaemia in the EU. On the basis of the information available, the Panelconcluded that intake of monacolins from RYR via food supplements, could lead to estimated exposure to monacolin K within the range of the therapeutic doses of lovastatin. The Panelconsidered that the available information on the adverse effects reported in humans were judged to be sufficient to conclude that monacolins from RYR when used as food supplements were of significant safety concern at the use level of 10mg/day. The Panelfurther considered that individual cases of severe adverse reactions have been reported for monacolins from RYR at intake levels as low as 3mg/day. The Panelconcluded that exposure to monacolin K from RYR could lead to severe adverse effects on musculoskeletal system, including rhabdomyolysis, and on the liver. In the reported cases, the product contained other ingredients in addition to RYR. However, these reported effects in particular musculoskeletal effects, have both occurred after ingestion of monacolin K and lovastatin independently. On the basis of the information available and several uncertainties highlighted in this opinion, the Panelwas unable to identify a dietary intake of monacolins from RYR that does not give rise to concerns about harmful effects to health, for the general population, and as appropriate, for vulnerable subgroups of the population.
Scientific opinion on the safety of monacolins in red yeast rice / M. Younes, P. Aggett, F. Aguilar, R. Crebelli, B. Dusemund, M. Filipič, M.J. Frutos, P. Galtier, D. Gott, U. Gundert‐remy, G.G. Kuhnle, C. Lambré, J. Leblanc, I.T. Lillegaard, P. Moldeus, A. Mortensen, A. Oskarsson, I. Stankovic, I. Waalkens‐berendsen, R.A. Woutersen, R.J. Andrade, C. Fortes, P. Mosesso, P. Restani, F. Pizzo, C. Smeraldi, M. Wright. - In: EFSA JOURNAL. - ISSN 1831-4732. - 16:8(2018 Aug). [10.2903/j.efsa.2018.5368]
Scientific opinion on the safety of monacolins in red yeast rice
P. RestaniMembro del Collaboration Group
;F. Pizzo;
2018
Abstract
The Panelon Food Additives and Nutrient Sources added to Food (ANS) was asked to deliver a scientific opinion on the safety of monacolins in red yeast rice (RYR) and to provide advice on a dietary intake of monacolins that does not give rise to concerns about harmful effects to health. The Panelreviewed the scientific evidences available as well as the information provided by interested parties in response of a public Call for data' launched by EFSA. The Panelconsidered that monacolin K in lactone form is identical to lovastatin, the active ingredient of several medicinal products authorised for the treatment of hypercholesterolaemia in the EU. On the basis of the information available, the Panelconcluded that intake of monacolins from RYR via food supplements, could lead to estimated exposure to monacolin K within the range of the therapeutic doses of lovastatin. The Panelconsidered that the available information on the adverse effects reported in humans were judged to be sufficient to conclude that monacolins from RYR when used as food supplements were of significant safety concern at the use level of 10mg/day. The Panelfurther considered that individual cases of severe adverse reactions have been reported for monacolins from RYR at intake levels as low as 3mg/day. The Panelconcluded that exposure to monacolin K from RYR could lead to severe adverse effects on musculoskeletal system, including rhabdomyolysis, and on the liver. In the reported cases, the product contained other ingredients in addition to RYR. However, these reported effects in particular musculoskeletal effects, have both occurred after ingestion of monacolin K and lovastatin independently. On the basis of the information available and several uncertainties highlighted in this opinion, the Panelwas unable to identify a dietary intake of monacolins from RYR that does not give rise to concerns about harmful effects to health, for the general population, and as appropriate, for vulnerable subgroups of the population.
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