Foods for special medical purposes refer to a category of foods for specific groups specially processed or formulated and intended for the dietary management of patients. The products are used under medical supervision.
They are intended for the exclusive or partial feeding of patients with a limited, impaired or disturbed capacity to take, digest, absorb, metabolise or excrete ordinary food or certain nutrients contained therein, or metabolites, or with other medically-determined nutrient requirements, whose dietary management cannot be achieved by modification of the normal diet alone. A product that does not contain nutrients is not a food for special medical purposes.
The European Commission has published guidelines on the classification of food for special medical purposes. EFSA has provided scientific and technical guidance on foods for special medical purposes to advise on different aspects the Commission may consider when taking decision pursuant to Article 3 of the Regulation (EU) No 609/2013. There are links to the guidelines on the right side of this page.
Foods for special medical purposes may only be sold in the form of prepacked food under the name "dietary food for special medical purposes". They are consumed as such in the form of e.g. a drink, added in food or administered with a feeding system such as a naso-gastric tube.
The specific legislative requirements for foods for special medical purposes are laid down in the Regulation on foodstuffs intended for particular groups (EU) No 609/2013 and the Commission Delegated Regulation on foods for special medical purposes (EU) 2016/128. Links to relevant legislation and guidance can be found on the Instructions and legislation webpage under Foods for specific groups.
Composition
The composition of foods for special medical purposes shall meet generally accepted medical and nutritional criteria. Their use, in accordance with the manufacturer's instructions, shall be safe and beneficial and effective in meeting (partially or exclusively) the particular nutritional requirements of the patient. If necessary, this shall be demonstrated by generally accepted scientific data.
Foods for special medical purposes have to fulfil the requirements on composition stated in the Commission delegated regulation (EU) No 2016/128. 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. Other foods for special medical purposes shall comply with the compositional requirements set out in Part B of Annex I. Vitamins, minerals and certain other substances may be added to foods for special medical purposes in accordance with the Annex to Regulation (EU) No 609/2013.
Food information
In addition to the mandatory particulars listed in Article 9(1) of the Food information regulation, the labelling of foods for special medical purposes shall bear the following particulars, preceded by the words "important notice" or their equivalent:
- A statement that the product must be used under medical supervision
- A statement whether the product is suitable for use as the sole source of nourishment
- Where appropriate, a statement that the product is intended for a specific age group
- Where appropriate, a statement that the product poses a health hazard when consumed by persons who do not have the diseases, disorders or medical conditions for which the product is intended.
The labelling shall in addition include the following particulars:
- Indication of the illness, disorder or medical condition for the treatment of which the product is intended, expressed in the form "For the dietary management of . . ."
- A description of the nutritional or other properties that make the product useful and the rationale of the use of the product,
- in particular, as the case may be, relating to the special processing and formulation,
- the nutrients which have been increased, reduced, eliminated or otherwise modified
- The rationale of the use of the product
- Where appropriate, a statement concerning adequate precautions and contra-indications
- Where appropriate, a warning that the product is not intended for parenteral use
- Where appropriate, instructions for appropriate preparation, use and storage of the product after the opening of the container.
The additional particulars, when appearing on the package or on the label attached thereto, must be printed on the package or on the label in such a way as to ensure clear legibility. The font size has to fulfil the requirements set out in Article 13 (2 and 3) in the Regulation on the provision of food information to consumers (EU) No 1169/2011.
Nutrition declaration
The packaging of food for special medical purposes always has to include a nutrition declaration irrespective of the size of the largest surface of the packaging or container. The information included in the nutrition declaration must not be repeated elsewhere on the labelling.
The following nutrition information has to be included:
- The quantity of energy, fat, saturated fats, carbohydrates, sugars, protein and sodium in the product.
- The amount of each mineral substance and of each vitamin listed in Annex I to Regulation (EU) 2016/128 and 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.
- Information on the osmolality or the osmolarity of the product where appropriate.
Articles 31–35 to the Food information regulation are to be applied to all nutrients included in nutrition declarations for food for special medical purposes.
The information is given per 100 g or per 100 ml. The energy value and the amounts of nutrients shall be those of the food as sold and, where appropriate, those of the food ready for use after preparation in accordance with the manufacturer's instructions. They may be expressed per portion or per consumption unit, easily recognisable by the consumer, provided that the portion or the unit used is defined on the label and that the number of portions or units contained in the package is stated.
The energy value and the amount of nutrients must not be expressed as a percentage of the reference intakes set out in Annex XIII to Regulation (EU) No 1169/2011on the provision of food information to consumers.
The indication of the amount of sodium has to appear together with the other minerals and may be repeated next to the indication of the salt content as follows: ‘Salt: X g (of which sodium: Y mg)’.
Claims
The use of nutrition and health claims is not allowed on packages or in advertising of food for special medical purposes. They must not attribute to any food the property of preventing, treating or curing a human disease, nor refer to such properties.
On the packaging of food for special medical purposes, the disease, disorder or medical condition for the dietary management of which the product is intended may be used using the following statement: ‘For the dietary management of …’ The blank shall be filled in with the disease, disorder or medical condition for which the product is intended.
The dissemination of any useful information or recommendations on the product is exclusively intended for persons having qualifications in medicine, nutrition, pharmaceutics, or for other healthcare professionals responsible for maternal care and childcare.
Notification procedure
In accordance with the Delegated Regulation (EU) No 2016/128 Article 9 the Finnish Food Authority has to be notified of all foods for special medical purposes that is placed on the market in Finland. The notification has to be accompanied by a model of the label used and a power of attorney if needed.
The notification can be made using the Finnish Food Authority's Electronic Services or the notification form (links on the right).
The Food Authority does not assess the compliance with the rules when receiving the notifications for the products, but the food business operator who places the product on the market is responsible for it.
The Finnish Food Authority charges for the reception of the notification a fee as prescribed in the Decree of the Ministry of Agriculture and Forestry on fees to be collected for services performed by the Finnish Food Authority. More information on the Finnish Food Authority's price list.