A volume in Woodhead Publishing Series in Food Science, Technology and Nutrition
2015, Pages 139–151
Abstract
Red
yeast rice has become one of the leading cholesterol-lowering
ingredients used in food supplements throughout the world. However, one
active compound of red yeast rice, monacolin K (also known as
lovastatin), was the first statin commercialised by pharmaceutical
companies. Therefore, monacolin K may be considered a drug in several
European countries, leading to uncertainties regarding the legal status
of red yeast rice-containing food supplements. Despite the fact that red
yeast rice is a borderline ingredient between food supplements and
drugs, the European Food Safety Authority has recognised the
cholesterol-lowering properties of monacolin K in the evaluation of two
health claims, and the European Commission has validated a health claim
related to monacolin K and the maintenance of normal blood
LDL-cholesterol concentration in Regulation (EC) No. 432/2012. The
condition of use of this claim, notably that the daily intake of
monacolin K imposed by this regulation can be considered a medicinal
dosage, is open to criticism. However, the validation of a health claim
related to monacolin K by the European Commission has led to a unique
situation in which an authorised health claim cannot be used in most
European countries, due to a dosage of monacolin K that may lead to the
requalification of red yeast rice-containing food supplements as a drug
by function.
Keywords
- Red yeast rice;
- Monacolin K;
- Health claim;
- Cholesterol;
- Monascus purpureus.
Copyright © 2015 Elsevier Ltd. All rights reserved.
