Directive 2002/46/EC of the European Parliament and of the Council on the approximation of the laws of the Member States relating to food supplements.

This Directive concerns food supplements placed on the market as foodstuffs and presented as such. These products shall be delivered to the ultimate consumer only in a prepackaged form. Medicinal products, as defined in Directive 2001/83/EC, are not covered by these provisions. For the purposes of the present Directive, "food supplements" means foodstuffs the purpose of which is to supplement the normal diet and which are concentrated sources of nutrients or other substances with a nutritional or physiological effect, alone or in combination. Only the vitamins and minerals listed out in Annex I may be used in the manufacture of food supplements. On the other side, Annex II specifies the vitamin and mineral substances which may be used when manufacturing food supplements. The labelling, presentation and advertising must not attribute to food supplements the property of preventing, treating or curing a human disease, or refer to such properties. Moreover, and without prejudice to Directive 2000/13/EC, the labelling shall bear the particulars referred to in article 6, paragraph 3 of this Directive. To facilitate efficient monitoring of food supplements, Member States may require the manufacturer or the person placing the product on the market in their territory to notify the competent authority of that placing on the market by forwarding it a model of the label used for the product. Where a Member State has detailed grounds for establishing that a product referred to in article 1 endangers human health though it complies with this Directive, that Member State may temporarily suspend or restrict application of the provisions within its territory. It shall immediately inform the other Member States and the Commission (art. 12).