Foods for special medical purposes in the European Union: an incomplete legislative update

This article analyses, from 1989 until 2019, the development of the European Union legislation on food for special medical purposes, aimed at patients, and examines how from 1997 the competent scientific bodies of the European Union and the United States of America have established dietary reference values, as well as tolerable upper intake levels for vitamins and minerals based on their safety. The update, through the Regulation (EU) 2016/128, of the European Union legislation on this food category seems appropriate in the case of infants. However, for patients older than one year, the minimums and maximums of vitamins and minerals per 100 kcal from the Directive 1999/21/EC were not modified in this Regulation, thus ignoring the dietary reference values and the tolerable upper intake levels from the period 1997-2015, both established by the aforementioned scientific bodies.