Originally published October 2004
The European Court of Justice (the Court) has declared that by automatically classifying as medicinal products vitamin preparations lawfully manufactured or marketed as food supplements in other Member States where they contain three times more vitamins (other than vitamins A and D) than the daily amount recommended by the Deutsche Gesellschaft fr Ernhrung (German Food Association) Germany has failed to fulfil its obligations under Article 28 EC, which provides for the free movement of goods. References to vitamins hereinafter should be taken to be vitamins other than vitamins A and D.
THE GERMAN PRACTICE
The infringement proceedings, brought before the Court by the European Commission, related to the German practice of automatically classifying as medicinal products, vitamin preparations containing three times the recommended daily amount of vitamins despite being lawfully produced and marketed as food supplements in the other Member States. The classification of these products as medicinal products would require them to have, amongst other things, a marketing authorisation before being placed on the market.
At the relevant date, there were no Community harmonisation provisions on the classification of such preparations as either medicinal products or food products. Moreover, the fact that a product is classified as a foodstuff in another Member State cannot in itself prevent it being characterised as a medicinal product in another Member State. Therefore the Court had to determine if the vitamin preparations which contain more than three times the recommended daily amount are "function" medicinal products.
VITAMINS AS MEDICINES
In minute quantities vitamins form an essential part of the daily diet and are indispensable for the proper functioning of the body. They are not generally regarded as medicinal products when consumed in small quantities. However, vitamin preparations are sometimes used in large doses for therapeutic purposes, for example in combating certain diseases. When used in such a way, vitamin preparations constitute medicinal products. The Court stated that, in order to determine whether a vitamin preparation should be classified as medicinal product, national authorities must work on a caseby- case basis. The German practice did not make any distinction between the different vitamins or their effect on health in general. Neither did it look at the potential degree...