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. 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. EFSA has published guidelines on the classification of food for special medical purposes. There is a link to the guideline on the right side of this page.
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.
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 It repealed Decree 121/2010 of the Ministry of Agriculture and Forestry on foods for particular nutritional uses.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. After this date, food for special medical purposes placed on the market has to fulfil the requirements of this regulation. Products that have been placed on the market or labelled in accordance with the old legislation before this date may continue to be marketed after that date until stocks of such food are exhausted.
The Commission delegated regulation shall apply from 22 February 2020 in respect of food for special medical purposes developed to satisfy the nutritional requirements of infants. Until then, the Decree by the Ministry of Trade and Industry on food for special medical purposes intended for infants will be applied (406/2000).
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 Authority by generally accepted scientific data.
Food for special medical purposes has to fulfil the requirements on composition stated in the Commission delegated regulation (EU) No 2016/128. The vitamin and mineral compounds permitted in food for special medical purposes are listed in the annex to regulation (EU) No 609/2013.
The labelling of food for special medical purposes shall comply with the requirements in Regulation (EU) No 1169/2011 on the provision of food information to consumers. More information about these is provided in the Food Information Guide published by Finnish Food Authority.
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
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 always has to be expressed:
- 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 this Regulation 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 osmolality or the osmolarity of the product where appropriate.
- Information on the source and the nature of the protein and/or protein hydrolysates contained in the product.
Articles 31–35 to the Regulation on the provision of food information to consumers, (EU) No 1169/2011, 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 and/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)’.
Mandatory additional labelling
The labelling of dietary 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
- A statement that the product is intended for a specific age group, as appropriate
- 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:
- Information on the origin and the nature of the protein and/or protein hydrolysates contained in the product
- 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:
- 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 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.
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.
The Delegated Regulation (EU) No 2016/128 will be applied from 22.2.2019, which means that the Finnish Food Authority has to be notified of all food for special medical purposes that is placed on the market in Finland from that date onwards. The notification has to be accompanied by a model of the label used and a power of attorney if needed.
The duty to notify food for special medical purposes intended for infants will apply from 22.2.2020.
The notification is to be made using the form of the Food Authority's customer services (a link to the form on the right). Later it will also be possible to make the notification electronically.
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 Food Authority forwards the notifications to the food control authorities of the municipalities and Customs.
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.
Previously, the notification had to be made for food for special medical purposes manufactured in Finland or imported to Finland from countries outside the European Economic Area, and which had not previously been for sale in any other EU member state. Now a notification is required for all food for special medical purposes that is to be placed on the market.