European Union: The German System of Classification of Preparations Containing Vitamins as Medicinal Products on the Grounds of Public Health is Not Compatible With EC Law on the Free Movement of Goods*

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 für Ernährung (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 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.

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 of harm caused by excessive intake of a vitamin. Even though the concentration at which a vitamin can be classified as a medicinal product varies according to the vitamin in question and it cannot necessarily follow that all vitamin preparations at a level of three times the recommended daily amount of vitamin restore, correct or modify physiological functions in order to be classified as medicinal products.

The Court found that the German practice created a barrier to trade, as vitamin preparations lawfully marketed or produced in other Member States as food supplements could not be marketed in Germany until they had a medicinal product marketing authorisation. However, the lack of harmonisation at EC level and in so far as there exists scientific uncertainties, Member States can decide on a degree of protection to public health, although Member States must act in accordance with the principle of proportionality. The Court considered if the German practice could be justified on the grounds of public health. The Court ruled that the automatic nature of the German practice does not allow identification and assessment of real risk to public health which would require detailed assessments on a case-by-case basis. Pursuant to the German practice, a medicinal marketing authorisation could be required for a vitamin preparation which would pose no real risk to public health. The Court found that there were less restrictive measures that would have achieved the same objective, for example the fixing thresholds for groups of vitamins on the basis of pharmacological properties.

In conclusion, the European Court of Justice ruled that by automatically classifying as medicinal products vitamin preparations, lawfully manufactured and marketed as food supplements in the other Member States, where they contain three times more vitamins than the daily amount recommended by the German Food Association, Germany had not fulfilled its obligations on the free movement of goods under Article 28 EC.

N.B. Directive 2002/46/EC of 20 June 2002 approximates the law of Members States relating to food supplements containing vitamins, minerals and their preparations identified in the annex of that Directive¹. In light of this Directive, the above judgement may be of purely historical interest in respect of the vitamins and minerals identified in the annex to the Directive, however, it will continue to be relevant, in the near future, in the regulation of other nutrients sold as food supplements.

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