Commission Directive 1999/21/EC on dietary foods for special medical purposes.

Member States shall ensure that dietary foods for special medical purposes may be marketed within the Community only if they comply with the rules laid down in this Directive. 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. The labelling shall bear: (a) the available energy value and the content of protein, carbohydrate and fat; (b) the average quantity of each mineral substance and each vitamin mentioned in the Annex present in the product; (c) selectively the content of components of protein, carbohydrate and fat or of other nutrients and their components; (d) information on the osmolality; (e) information on the origin and the nature of the protein or protein hydrolysates contained in the product. The Annex regards the essential composition of foods for special medical purposes and such food must comply with the criteria of the Annex. (8 articles and 1 Annex)