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Food for Special Medical Purposes

Food for Special Medical Purposes (FSMP) is a very particular category of products, for people with specific food/nutritional difficulties.

From a regulation point of view, the definition of FSMP is provided by art. 2 of Regulation EU 609/2013, defining FSMP as “food specially processed or formulated and intended for the dietary management of patients, including infants, to be used under medical supervision

As for the specific provisions regarding the composition and information for FSMP, the reference regulation is Regulation EU 128/2016. In particular, the 3 FSMP categories are described under article 2:

  • nutritionally complete food with a standard nutrient formulation
  • nutritionally complete food with a nutrient-adapted formulation specific for a disease
  • and finally nutritionally incomplete food with a standard or nutrient-adapted formulation

A FSMP should mandatorily report the statement «For the dietary management of …» where the blank shall be filled in with the disease, disorder or medical condition for which the product is intended. It is also required to report a description of the properties and/or characteristics of the product that make it useful in relation to the disease, disorder or medical condition for the dietary management of which the product is intended.

The nutrition declaration must report, along with the mandatory prescriptions for common food, also the following information:

  • the amount of each mineral substance and of each vitamin present in the product;
  • the amount of components of protein, carbohydrate, fat and/or of other nutrients and their components, the declaration of which would be necessary for the appropriate intended use of the product;
  • information on the source and the nature of the protein and/or protein hydrolysates contained in the product.

One of the most important requirements introduced by Regulation EU 128/2016 is the ban to use nutrition and health claims for FSMP.

Based on the novelties introduced by these 2 Regulations, the Ministry of Health has drafted some guidelines aimed at providing elements for the correct classification of a product as FSMP.

Along with facilitating the interpretation of the European regulations, the guidelines also provide useful information regarding the characteristics that a FSMP should have to be classified as such, with special attention to the comparison between food supplements and FSMP.

Finally, the guidelines provide a (non exhaustive) list of the main categories of FSMP present on the market.

Written by Luigi Lepore on 14/03/2023

Foto di Bob da Pixabay