Risk analysis applied to food fortification.

OBJECTIVE To describe how a risk analysis can be applied to food fortification, with emphasis on voluntary fortification and intake levels that might exceed usual dietary levels. DESIGN Use of the risk analysis model as a frame to classify nutrients according to the risk of exceeding upper safe intake levels. Furthermore, to apply the model when discussing possible consequences of liberal fortification practices on eating behaviour and disease patterns. SETTING The discussion on food fortification presently going on internationally. RESULTS Micronutrients can be classified according to their safety margin, i.e. the size of the interval between the recommended intake and the upper safe level of intake. We suggest that nutrients with a small safety margin, i.e. for which the upper safe level is less than five times the recommended intake, be placed in a category A and should be handled with care (retinol, vitamin D, niacin, folate and all minerals). Category B comprises nutrients with an intermediate safety margin (vitamins E, B6, B12 and C), while nutrients that according to present knowledge are harmless even at 100 times the recommendation (vitamin K, thiamin, riboflavin, pantothenic acid and biotin) are categorised as C. DISCUSSION The risk analysis model is a useful tool when assessing the risk of both too low and excess intakes of single micronutrients, but can also be applied to analyse the consequences of fortification practices on eating behaviour and disease patterns. Liberal fortification regulations may, for example, distort the conception of what is healthy food, and drive consumption towards a more unhealthy diet, contributing to the plague of overweight and concomitant increased risk of degenerative diseases. CONCLUSION The impact of fortification practices on the total eating pattern of a population should become an integrated part of the discussions and regulations connected to the issue.