The German Federal Institute for Risk Assessment has raised safety concerns over the use of food supplements containing red yeast rice. Red yeast rice, claimed to lower blood cholesterol levels, originates from China and is becoming increasingly prevalent in supplements throughout Europe.
The German Institute notes that the active substance Monakolin K may produce considerable side effects, including headache, nausea, diarrhea, weakness, rashes and muscle cramps but also kidney and liver function disorders and skeletal muscle damage (rhabdomyolysis). On top of that, Citrinin can be formed which may induce genetic changes and damage the kidney and unborn child in the womb. The European Commission recently reduced the limit of citrinin in rice derived food supplements 100 Âµg / kg. The Euroepean Food Safety Authority has not been able to establish a safe dose of Monakolin K. The German Federal Institute for Risk Assessment endorses the Opinion and considers that recent literature does not relieve the health concerns on red yeast rice.
Therefore the institute advises not to consume supplements containing red yeast rice. In any case, it recommends to consult with health practitioners prior to taking red yeast rice supplements or to consume only under medical supervision, while taking the dose of Monakolin K into account.
Das Bundesinstitut fÃ¼r Risikobewertung: Cholesterinsenkung mit Folgen: NahrungsergÃ¤nzungsmittel mit Rotschimmelreis nur nach Ã¤rztlicher RÃ¼cksprache einnehmen - link