[Suggestions for revision of quality standards of red yeast rice for medicinal and edible purposes in China]

Red yeast rice(RYR) is fermented rice with a long history of medicinal and edible purposes in China. RYR has gained global popularity, particularly in South and Southeast Asia, Europe, and America, due to its blood lipid-lowering effect and abundant edible natural pigments. However, concerns have been aroused regarding the safety of RYR due to increasing reports on the side effects and toxicity associated with statins and mycotoxins in RYR. This review summarizes the chemical composition, bioactivity, and toxicity of RYR while discussing its safety concerns. Additionally, this review systematically analyzes the quality control standards for RYR in China as well as internationally. Several key issues have been identified in the quality standards in China. Specifically, taking lovastatin as the active component needs to be reconsidered, and the limits of citrinin and aflatoxin in the national and local standards remain to be unified. In view of these issues, it is suggested that all the standards should specify the limits of monacolin K, citrinin and aflatoxin. The medicines containing RYR should have limits about the total content of monacolin K(acid and ester forms) and the content or proportion of the ester form. In addition, the limits about the content of monascin and ankaflavin should be established for the lipid-lowering medicines. For all the food, healthcare products, and food additives with RYR as the raw material, limits about the total content of monacolins should be developed. Specifically, the content in the RYR raw material should be no more than 0.20 μg·g~(-1). The highest limits of citrinin at 0.050 μg·g~(-1) and aflatoxin(G_1+G_2+B_1+B_2) at 0.005 0 μg·g~(-1) should be established in the quality standards of RYR for medicinal and edible purposes. In addition, addition, efforts should be made to improve the quality control system for solid-state fermentation of RYR. The suggestions above provide a basis for relevant departments to revise the quality standards of RYR, aiming to improve the quality of RYR and safeguarding the public health and safety concerning food and drug consumption.