Botanicals and the Regulatory Framework on Food Supplements in the European Union: a Tricky Relationship

In the EU and many other countries (China, Japan, Usa, Canada, etc.), there is a growing interest in producing and consuming health food products. Botanicals (e.g. plants and preparations made from plants, algae, fungi or lichens) represent a large segment of the health food category and their regulation presents several critical issues due to their complex nature and multifaceted usage. This article therefore gives an overview of the most important issues related to the regulation of botanicals in the food supplements sector. After a brief description of the regulatory status of botanical based foodstuffs, it outlines the legal framework of botanical food supplements, taking into consideration the interferences between the medicinal domain and the food sector in the classification of borderline botanical products and the issue of the safety assessment of botanicals. In the final part, it deals with the thorny question of the health claims made on such products.