PATRICK COPPENS
EAS Strategic Advice, Rue de l’Association 50 B-1000, Brussels, Belgium

Abstract

In the European Union botanicals can legally be used as components of various product categories, including food, food supplements, cosmetics and medicinal products. However, differences of appreciation exist between the Member States and the Court of Justice of the European Union (CJEU) has established an extensive case law laying down the principles to consider when deciding on the legal classification of specific products. Recent legislation on nutrition and health claims and traditional herbal medicinal products have brought new elements into the legal framework. It has led the CJEU to limit the application of what can be considered as medicinal by function. It has also resulted in further discussions on how to regulate health claims for botanicals. This article covers the principles the CJEU has established and explores the consequences of recent legislation on the legal classification of products.

INTRODUCTION

When looking at the market in the European Union the wide range of products containing nutrients, bioactive substances and botanicals may be surprising to an unsuspecting visitor, especially since apparently similar products can be presented as either food supplements or medicinal products. This is mainly the consequence of different appreciations by national authorities and/or companies seeking the opportunities offered by the various legal frameworks that can be used to market products.
Legislation usually aims at two objectives: safeguarding consumer protection and ensuring fair competition. The correct classification of products is therefore important for the appropriate rules to apply as intended to meet these objectives. Most of the ‘borderline’ issues exist between food supplements and medicinal products, although also borderlines with other product categories such as cosmetics, medical devices and biocides are observed.
The lack of clear demarcation between these legal frameworks sometimes gives rise to problems, when a product could fall into two product categories. Examples exist of products that could be cons ...