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 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.

Dietary 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.

Legislation

Regulation (EU No 609/2013) of the European Parliament and of the Council on food intended for infants and young children, food for special medical purposes and total diet replacement for weight control became applicable on 20 July 2016. It repealed Decree 121/2010 of the Ministry of Agriculture and Forestry on foods for particular nutritional uses. 

European Commission Delegated Regulation (EU) 2016/128 as regards the specific compositional and information requirements for food for special medical purposes becomes applicable 22 February 2019. The Decision of the Ministry of Trade and Industry on foods for special medical purposes (KTM 406/2000) is applicable until then.

Composition

The composition of dietary 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 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).

European Commission Regulation 953/2009 defines the vitamins, minerals and certain other nutrients and their chemical compounds that may be added in dietary foods for special medial purposes. The chemical compounds used in the production of these foods shall meet the purity criteria laid down for them.

Labelling

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

In addition to general labelling information, the labelling of dietary foods for special medical purposes shall contain

  • a nutrient declaration which meets the requirements and is consistent with the composition of the product
  • the mandatory additional labelling defined for dietary foods for special medical purposes
  • the additional labelling defined to be provided as appropriate for dietary foods for special medical purposes
  • 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 . . ." 

 

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.

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

  1. Information on the origin and the nature of the protein and/or protein hydrolysates contained in the product
  2. 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 . . ."

Additional labelling to be used as 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. Information on the osmolality or osmolarity of the product
  5. 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 and it has not previously been on the market in any other EU state, the manufacturer, if the product is manufactured in Finland, or the Finnish importer, if the product is manufactured outside the European Economic Area, shall submit a notification to Finnish Food Safety Authority Evira.

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.

 

RELATED TOPICS


RELATED LINKS