Abstract

The provisions of the European regulation 1925/2006, which harmonise the conditions for the voluntary addition of vitamins and minerals to foodstuffs (food fortification), and of the Directive 2002 46/EC, which relate to food supplements, both set out criteria that must be taken into account when establishing the maximum amounts of these essential nutrients that are present in products. The current paper reviews the application of the principles of risk management in order to underpin these regulatory developments. It takes into account international risk assessments of tolerable upper intake levels (ULs) of vitamins and minerals, and current market practices in Europe. A methodology is proposed that characterises risk using a ‘population safety index’ and thus provides a process by which quantitative and qualitative data can be used to allocate the nutrients into three categories of risk. The proposed risk management model is also used as an aid to the setting of maximum levels of vitamins and minerals in fortified foods and food supplements.

Keywords: EU regulation, maximum levels, vitamins, minerals, food supplements, food fortification

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