European Union Adopts Legislation on Dietary Foods for Special Medical Purposes

Date: Jun 10, 1999

On the basis of framework Council Directive 89/398/EEC on the approximation of the laws of the Member States relating to foodstuffs for particular nutritional purposes, Commission Directive 1999/21/EC (OJ L 91.29, 7.4.1999) "on dietary foods for special medical purposes" was recently adopted. Directive 1999/21/EC defines dietary foods for special medical purposes which covers foods for particular nutritional uses which have been specially processed or formulated and intended for the dietary management of patients and which are used under medical supervision. These are further classified into three different categories covering nutritionally complete and nutritionally incomplete foods. Such foods may only be marketed within the Community if they comply with the rules laid down under the Directive.

Compositional rules are laid down regulating the vitamin and mineral substances content for products considered to be nutritionally complete and establishing maximum levels of vitamins and mineral substances for nutritionally incomplete foods. These distinguish levels set for foods intended for infants as well as all categories of persons other than infants. The Directive also lays down labelling particulars which apply in addition to the labelling requirements applicable to normal foodstuffs under Community legislation. This includes the mandatory labelling of the name under which such foods may be sold in all 11 official Community languages, the energy value, quantity of minerals and vitamins and where appropriate, the content of components of protein, carbohydrate, fat and nutrients, the osmolarity of the product, nature and origin of any protein or hydrolysates. Provisions regulating the labelling of specific statements carrying warning notices, product descriptions and use instructions are also laid down, for example indicating if a product must be used under medical supervision.

Finally, to facilitate official monitoring of dietary foods for special medical purposes, the Directive requires manufacturers, or importers in the case of imports from third countries to notify the competent authorities of the Member States of marketing and to forward a model of the label used for the product, although the Directive permits individual Member States to waive this notification requirement. Member States must implement the provisions of this Directive by 30 April 2000, at the latest and prohibit trade in products not complying with he provisions of the Directive from 1 November, 2001. In the meantime, the specific labelling requirements for such products remain regulated under the general provisions of framework Directive 89/398/EEC.

For further information, please contact John Dobinson at dobinson@khlaw.be or Rachida Semail at rsemail@khlaw.com