7.4.1999 Official Journal of the European Communities L 91/29 COMMISSION DIRECTIVE 1999/21/EC of 25 March 1999 on dietary foods for special medical purposes (Text with EEA relevance) THE COMMISSION OF THE EUROPEAN COMMUNITIES, Having regard to the Treaty establishing the European Community, Having regard to Council Directive 89/398/EEC of 3 May 1989 on the approximation of the laws of the Member States relating to foodstuffs intended for particular nutri- tional uses ('), as amended by Directive 96/84/EC of the European Parliament and of the Council (%), and in par- ticular Article 4(1) thereof, After consulting the Scientific Committee for food, (1) Whereas dietary foods for special medical purposes are intended to meet the particular nutritional requirements of persons affected by or malnourished because of a specific disease, disorder or medical condition; whereas for this reason they must be used under medical supervision which may be applied with the assistance of other competent health profes- sionals; (2) Whereas such foods are numerous and their compo- sition may differ substantially depending on the specific disease, disorder or medical condition of the patients for whom they are intended, the age of the patients and the place in which they receive health care support, on whether the foods are intended to be used as the sole source of nourishment or not, and possibly on other factors; (3) Whereas, because of the wide diversity of such foods and the rapidly evolving scientific knowledge on which they are based, it is not appropriate to lay down detailed compositional rules; (4) Whereas, however, some basic rules concerning vitamin and mineral substances content can be laid down for products considered to be nutritionally complete for covering the particular nutritional requirements of the intended user; whereas such rules for nutritionally incomplete foods can be laid down only for the maximum levels of these substances as appropriate; (5) Whereas this Directive reflects current knowledge about those products; whereas any modification to allow for innovation based on scientific and tech- () OJ L 186, 30.6.1989, p. 27. () OJ L 48, 19.2.1997, p. 20. (10) (1) nical progress will be decided in accordance with the procedure laid down in Article 13 of Directive 89/ 398/EEC; Whereas pursuant to Article 4(2) of Directive 89/ 398/EEC, the provisions relating to the substances with specific nutritional purposes to be used in the manufacture of foods for special medical purposes should be laid down in a separate Commission directive; Whereas pursuant to Article 7 of Directive 89/ 398/EEC, the products covered by that Directive are subject to the general rules laid down by Council Directive 79/112/EEC of 18 December 1978 on the approximation of the laws of the Member States relating to the labelling, presentation and advertising of foodstuffs (}), as last amended by Commission Directive 1999/10/EC (*); whereas the present Directive adopts and expands upon the additions and exceptions to those general rules, where appropriate; Whereas, in particular, in view of the nature and destination of dietary foods for special medical purposes, it is necessary to provide information concerning the energy value and principal nutrients contained in such foods; Whereas, given the particular nature of dietary foods for special medical purposes, additional means to those usually available to monitoring bodies should be available in order to facilitate efficient monitoring of those products; Whereas, in accordance with the principle of propor- tionality, it is necessary and appropriate for the achievement of the basic objective of approximating the laws of the Member States relating to foodstuffs intended for particular nutritional uses to lay down rules on foods for special medical purposes; whereas this Directive confines itself to what is necessary in order to achieve the objectives pursued in accordance with the third paragraph of Article 3b of the Treaty; Whereas the measures provided for in this Directive are in accordance with the opinion of the Standing Committee on foodstuffs, () OJ L 33, 821979, p. 1. 0] L 69, 16.3.1999, p. 22.