Integrated risk–benefit analyses: Method development with folic acid as example

With the introduction of novel and functional foods, there is increasing need for an integrated quantitative risk–benefit assessment of foods. Consensus about a quantitative risk–benefit assessment mirroring the risk assessment approach has been reached during a recent EFSA workshop. In line, we propose a risk–benefit model that consists of: (1) hazard and benefit identification, (2) hazard and benefit characterization through dose–response functions, (3) exposure assessment, and (4) risk–benefit integration. The DALY, which combines morbidity and mortality serves as common health measure.The overall health impact of bread fortified with folic acid in the Netherlands has been simulated. The case study showed how the risk–benefit approach may assist a policy maker in decisions on food fortification programs. It illustrates general problems regarding the data demands, the assumptions and uncertainties. A simple sensitivity analysis showed which assumptions were most crucial. Modest fortification (140 μg/100 g bread) seems reasonable to improve public health but the results hinge on the assumptions one makes for the association between colorectal cancer and high folate intake. A precautious policymaker may very well decide against folic acid fortification. The often debated increase in masked vitamin B12-deficiency appears negligible compared to the health gain resulting from prevented neural tube defects.