[Vitamins and minerals in food supplements. Up-to-date risk assessment]

The Federal Institute of Risk Assessment (BfR) has applied principles of scientific risk assessment to derive proposals for maximum levels of vitamins and minerals including trace elements in food supplements and fortified food products. This review describes the special features pertaining to the risk assessment of these essential micronutrients and the procedure used for the derivation of maximum levels for individual food supplements. The applied procedure takes into account tolerable upper intake levels (UL), intakes of vitamins and minerals in normal daily diets and dietary reference values for the derivation of maximum levels in individual food products. In this context, consideration must be given to the possibility of multiple exposure via daily intakes of several food supplements or several fortified food products. A careful risk-benefit analysis was necessary because, with nutrients having a narrow margin of safety, the need to compensate for possibly inadequate intakes or increased demands had to be weighed against the risk of excessive intakes. With nutrients where no UL could be derived due to inadequate databases, the BfR recommends that maximum levels should be set on the basis of nutritional-physiological aspects. It should be noted that this recommendation is based on reasons of preventive health protection.