Dietary foods for special medical purposes

Dietary foods for special medical purposes refer to a category of foods for particular nutritional uses specially processed or formulated and intended for the dietary management of patients and to be used under medical supervision. They are intended for patients with a disturbed capacity to take, absorb or metabolise ordinary foodstuffs, or with other nutrient requirements, which cannot be satisfied any other way.

Dietary foods for special medical purposes are foods for particular nutritional uses, which must be sold 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.

Composition

The composition of dietary foods for special medical purposes shall be based on sound medical and nutritional principles. 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 proven to Finnish Food Safety Authority Evira by generally accepted scientific data.

Dietary foods for special medical purposes shall comply with the compositional criteria specified in the Annex to the Decree of the Ministry of Trade and Industry on Dietary Foods for Special Medical Purposes (406/2000).

Labelling

The labelling of dietary foods for special medical purposes shall comply with the general labelling regulations. More information about these is provided (in Finnish) in the Labelling Guide published by Finnish Food Safety Authority Evira.

Mandatory labelling

The labelling of dietary foods for special medical purposes shall always bear the following particulars:

  1. The available energy value expressed in kilojoules (kJ) and kilocalories (kcal), and the content of protein, carbohydrate and fat, expressed in numerical form, per 100 g or per 100 ml of the product as sold and where appropriate per 100 g or per 100 ml of the product ready for use in accordance with the manufacturer's instructions.
  2. The average quantity of each mineral substance and each vitamin mentioned in the Annex to the Decree (406/2000) present in the product, expressed in numerical form per 100 g or per 100 ml of the product as sold and where appropriate per 100 g or per 100 ml of the product ready for use in accordance with the manufacturer's instructions.
  3. Selectively the content of components of protein, carbohydrate and fat and/or of other nutrients and their components the declaration of which would be necessary for the appropriate intended use of the product, expressed in numerical form, per 100 g or per 100 ml of the product as sold and where appropriate per 100 g or per 100 ml of the product ready for use in accordance with the manufacturer's instructions.

In addition, this information may be provided per serving as quantified on the label or per portion, provided that the number of portions contained in the package is stated.

More information about nutrition labelling is provided (in Finnish) in the Nutrition Labelling Guide published by Evira.

Mandatory additional labelling

The labelling of dietary foods for special medical purposes shall in addition bear the following mandatory particulars, preceded by the words "important notice":

  1. A statement that the product must be used under medical supervision
  2. A statement whether the product is suitable for use as the sole source of nourishment; 
  3. A statement that the product is intended for a specific age group, as appropriate;
  4. 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:
  5. Information on the origin and the nature of the protein and/or protein hydrolysates contained in the product.
  6. The statement For the dietary management of... where the blank shall be filled in with the diseases, disorders or medical conditions for which the product is intended.

Additional labelling to be used where appropriate

Where appropriate, the labelling of dietary foods for special medical purposes shall also include the following information:

  1. A description of the nutritional or other properties that make the product useful and the rationale of the use of the product
  2. Where appropriate a statement concerning adequate precautions and contra-indications
  3. A warning that the product is not for parenteral use
  4. Instructions for the appropriate preparation, the use and the storage of the product after the opening of the container.

Notification procedure

When a dietary food product for special medical purposes is placed on the market in Finland for the first time, the manufacturer, if the product is manufactured in Finland, or the importer, if the product is manufactured outside the European Economic Area, shall notify Finnish Food Safety Authority Evira.

The notification can be free-form and shall be accompanied by a model of the label intended to be used for the product.

Evira 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 Safety Authority (638/2010).


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