Compositional requirements
Article 2
1
Food for special medical purposes is classified in the following three categories:
a
nutritionally complete food with a standard nutrient formulation which, used in accordance with the manufacturer's instructions, may constitute the sole source of nourishment for the persons for whom it is intended;
b
nutritionally complete food with a nutrient-adapted formulation specific for a disease, disorder or medical condition which, used in accordance with the manufacturer's instructions, may constitute the sole source of nourishment for the persons for whom it is intended;
c
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.
The food referred to in points (a) and (b) of the first subparagraph may also be used as a partial replacement or as a supplement to the patient's diet.
2
The formulation of food for special medical purposes shall be based on sound medical and nutritional principles. Its use, in accordance with the manufacturer's instructions, shall be safe, beneficial and effective in meeting the specific nutritional requirements of the persons for whom it is intended, as demonstrated by generally accepted scientific data.
3
Food for special medical purposes developed to satisfy the nutritional requirements of infants shall comply with the compositional requirements set out in Part A of Annex I.
Food for special medical purposes other than that developed to satisfy the nutritional requirements of infants shall comply with the compositional requirements set out in Part B of Annex I.
4
The compositional requirements set out in Annex I shall apply to the food for special medical purposes ready for use, marketed as such or after preparation in accordance with the manufacturer's instructions.