Resolution No. 25 of the Food Safety Agency on sanitary rules on food for special medical purposes.

These Rules have been drafted in line with the Commission Delegated Regulation (EU) 2016/128 supplementing Regulation (EU) No. 609/2013 of the European Parliament and of the Council as regards the specific compositional and information requirements for food for special medical purposes and the Regulation (EU) No. 609/2013. These Rules establish the minimum quality and safety requirements for food used in special diets, taken on the advice of a doctor, and prepared for medical purposes in order to prevent disorders caused by chronic exposure to harmful factors in the human body. These Rules classify food for special medical purposes in the following three categories: (i) nutritionally complete food that, when consumed in accordance with the instructions for use, can serve as the sole source of nutrition for the persons for whom it is intended, and whose composition is not adapted to any disease or health condition; (ii) nutritionally complete food that, when consumed in accordance with the instructions for use, can serve as the sole source of nutrition for the persons for whom it is intended, and whose composition is specific for a disease, disorder or medical condition; (iii) nutritionally incomplete food with a standard formulation or a nutrient-adapted formulation specific for a disease, disorder or medical condition which is not suitable to be used as the sole source of nourishment.