Foods for Particular Nutritional Uses – Foods for Special Medical Purposes

January 2016

Background

Foods for Special Medical Purposes are 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 foodstuffs or certain nutrients contained therein or metabolites, or with other medically-determined nutrient requirements, whose dietary management cannot be achieved only by modification of the normal diet, by other foods for particular nutritional uses, or by a combination of the two.

Foods for Special Medical Purposes are classified in the following 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 patient
  • 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.

Legislation

The Food for Special Medical Purposes (Scotland) Regulations 2000 (Scottish Statutory Instrument 2000 No. 130) implements Directive 1999/21/EC on dietary foods for special medical purposes. Commission Directive 1999/21/EC, as amended, is referred to in these notes as “the Directive”.

Notification requirements

The notification requirement for foods for special medical purposes is set out in Article 5 of the Directive which states:

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.

The competent authority for Scotland is Food Standards Scotland.

The notification requirement can be summarised as follows:

  • A separate notification is required for each food product.
  • Separate notifications should be made for each flavour of a product line.
  • Notification should be made when products are placed on the market for the first time.
  • When a food that has been reformulated such that there is a consequential labelling change it should be notified as if it is a new product.

The regulations prohibit the sale of products if the manufacturer/importer has failed to comply with the requirement to notify the competent authority or produce additional information to the competent authority, if required.

A model of the label of any food for special medical purposes should be forwarded to the competent authority of the Member State where the product is to be marketed.

A form is available that manufacturers and importers may use to help them with their notification. Copies of the form are available here.

Evidence of compliance

Food Standards Scotland may require the notifying company to produce the evidence to establish the products compliance with the definitions for “food for special medical purposes” (Article 1(2) of the Directive) together with information on the particular elements of the qualitative and quantitive composition. If such work is contained in a readily available publication, reference to this publication will suffice.

Failure to produce such information may lead to your product being regarded as non-compliant with the Directive and subject to enforcement action by local authorities. 

Nutritionally incomplete products

Foods for Special Medical Purposes which are nutritionally incomplete are permitted to contain vitamin and mineral levels above the levels set in legislation if such modification is required to fulfil the particular nutritional use of the product. For any such products, please supply FSS with the following information as part of the initial notification:

  • A list of the vitamin and mineral content of the product per 100g or 100ml as sold
  • The rationale behind the product deviations (i.e. why the vitamin and mineral content deviates from that set within the Directive)
  • How the product is used 
  • The recommended daily intake of the product