Dietary foods for special medical purposes

This Directive lays down compositional and labelling requirements for dietary foods for special medical purposes.

ACT

Commission Directive 1999/21/EC of 25 March 1999 on dietary foods for special medical purposes [See amending act(s)].

SUMMARY

This Directive is a specific directive as described in Article 4 of Directive 2009/39/EC. It lays down compositional and labelling requirements for dietary foods which are intended for special medical purposes * and are presented as such.

Classification

Dietary foods for special medical purposes are classified in three categories:

• nutritionally complete foods with a standard nutrient formulation which, used in accordance with the manufacturer’s instructions, may constitute the sole source of nourishment for the persons for whom they are intended;
• nutritionally complete foods with a nutrient-adapted formulation specific for a disease, disorder or medical condition which, used in accordance with the manufacturer’s instructions, may constitute the sole source of nourishment for the persons for whom they are intended. These foods may also be used as a partial replacement or as a supplement to the patient’s diet;
• nutritionally incomplete foods with a standard formulation or a nutrient-adapted formulation specific for a disease, disorder or medical condition which are not suitable to be used as the sole source of nourishment. These foods may also be used as a partial replacement or as a supplement to the patient’s diet.

General obligation

Member States shall ensure that dietary foods for special medical purposes may be marketed within the European Union (EU) only if they comply with the rules laid down in this Directive.

Composition

The formulation 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 the particular nutritional requirements of the persons for whom they are intended, as demonstrated by generally accepted scientific data. They must comply with the compositional criteria specified in the Annex.

Trade name

This Directive specifies the name under which dietary foods for special medical purposes are sold in the 22 official languages of the EU.

Compulsory indications

In addition to the particulars provided for in Article 3 of Directive 79/112/EC, the labelling of dietary foods for special medical purposes shall bear the following mandatory particulars:

• the available energy value expressed in kJ and 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. This information may in addition be provided per serving as quantified on the label or per portion, provided that the number of portions contained in the package is stated;
• the average quantity of each mineral substance and each vitamin mentioned in the Annex 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. This information may in addition be provided per serving as quantified on the label or per portion, provided that the number of portions contained in the package is stated;
• 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. This information may in addition be provided per serving as quantified on the label or per portion, provided that the number of portions contained in the package is stated;
• information on the osmolality or the osmolarity of the product, where appropriate;
• information on the origin and the nature of the protein and/or protein hydrolysates contained in the product.

The labelling must also include the following mandatory particulars, preceded by the words "important notice" or their equivalent:

• a statement that the product must be used under medical supervision;
• a statement as to 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 also include:

• 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;
• where appropriate, a statement concerning adequate precautions and contra-indications;
• a description of the properties and/or characteristics that make the product useful in particular, as the case may be, relating to the nutrients which have been increased, reduced, eliminated or otherwise modified and the rationale of the use of the product;
• where appropriate, a warning that the product is not for parenteral use.

The labelling shall bear instructions for the appropriate preparation, use and storage of the product after the opening of the container, as appropriate.

Foods for infants

This Directive also sets maximum and minimum values for vitamins, minerals and trace elements in nutritionally complete foods intended for use by infants *.

Directive 2006/141/EC adapts one of its values, the minimum level of manganese in foods intended for infants, to take account of the latest scientific advice. The new requirements for infant formulae manufactured from cows' milk proteins or based on protein hydrolysates shall apply mandatorily to infant dietary foods for special medical purposes as of 1 January 2012.

Official monitoring

To facilitate efficient official monitoring of dietary foods for special medical purposes, when a product is placed on the market, the manufacturer or, where a product is manufactured in a third country, the importer shall notify the competent authority of the Member States where the product is being marketed by forwarding to it a model of the label used for the product. Member States may, if they can demonstrate that notification is not necessary in order to monitor those products efficiently in their territory, not impose that obligation.

Last updated: 07.07.2011