A critique of prevailing approaches to nutrient risk analysis pertaining to food supplements with specific reference to the European Union.

In the European Union (EU), interest in risk analysis as applied to micronutrients is being stimulated by the increasing availability and marketing of food (dietary) supplements, functional and fortified foods. There is also strong inter-governmental interest in harmonizing methods regionally and globally. Various models are being evaluated in the EU for the purposes of developing Community-wide, mandatory maximum (and minimum) permitted levels, as required by EC Directive 2002/46/EC and Regulation (EC) No 1925/2006 on food supplements and fortified foods, respectively. This paper provides a scientific critique of models currently proposed in the EU and demonstrates weaknesses in both the risk assessment methods used to determine upper tolerable levels (ULs) as well as the risk management approaches being considered for the determination of maximum levels, particularly as applied to food supplements. Methods for ameliorating existing models are proposed here, including a proposal for using decision science as the underlying methodology in nutrient risk analysis. Risk management approaches based on more plausible scientific methods would avoid unnecessarily restrictive policy-based levels that would adversely impact consumer choice, while contributing to a 'better regulation' approach. Scientifically robust and rational methods of nutrient risk analysis are consistent with disease risk reduction, health management and consumer protection strategies.