I. Introduction

In Commission v Spain, the ECJ found Spain in breach of Articles 28 and 30 EC for withdrawing from the market botanical food supplements legally marketed and/or manufactured in other Member States following an administrative practice consisting of classifying as medicinal products by function any product based on medicinal herbs not included in a positive list laid down in a Spanish Instruction of 1973.

The action of the European Commission had been prompted by a number of complaints, filed since 2004, from food business operators whose products had been withdrawn from the market by the Spanish Medicines and Sanitary Products Agency (Agencia Española de Medicamentos y Productos Sanitarios – AEMPS) on the grounds that they were medicinal products marketed without the authorization required under Spanish Act No 25/1990 on medicinal products.

The complaints referred to products formulated with “various herbs and herb extracts”, some of which could qualify as “medicinal herbs”6 according to the common denomination, whilst other substances did not enter this definition. During court proceedings, the Commission specified, and this was picked up by the ECJ, that the products at hand were “products based on medicinal herbs”, described as “products containing one or more herbs which, because of their properties and their physiological effects, can be used as ingredients in medicinal products or in other types of products, such as food supplements”.