Quantifiable risk–benefit assessment of micronutrients: From theory to practice

The EU Food Supplements Directive (2002/46/EC) mandates the determination of both maximum and minimum permitted levels (MPLs) for micronutrients. In order to determine MPLs which are feasible for particular population groups, a scientific approach should be used in which risk of high intake, risk of inadequacy and benefits are assessed in an integrated way taking all available data and severity and incidence of effect into account. In 2004, Renwick etal. (ILSI Europe) published a scientifically valid, flexible and pragmatic basis for a risk-benefit approach, which has been further developed here to make it a practical and quantifiable approach to be used by risk managers. The applicability of the approach is demonstrated using demo cases on iron and folate. The proposed approach has the capacity to utilize all relevant data available, including data from human studies, bioavailability data showing variability between specific forms of micronutrients and, in the case of animal studies, data on species comparability. The approach is therefore both practical and flexible, making it well suited to risk managers tasked with determining safe intake levels for micronutrients in different forms and for particular population groups.