Efficacy and safety regulations and scientific criteria applicable to traditional botanical food supplements and herbal medicinal products marketed in the European Union

Highly heterogeneous preparations obtained from many different botanical species and parts and contain-ning many different biologically-active substances have been widely used for long time and are still curren-tly used in EU Member States with the objective of:

• correcting altered physiological processes in case of diseases or preventing their occurence (traditional herbal medicinal products-THMP);

• helping the human body in maintaining its homeostasis, i.e. normal functioning of physiological processes (traditional plant food supplements- TPFS).

Therefore, the use of these preparations has become traditional, in the current European Member countries long before the adoption of the relevant EU regulations mainly depending on the country's availability of botanicals, on prevalent medical and nutritional practices, as well as cultural, technological and social fac-tors peculiar of each country and, therefore, without any coherence among the approaches adopted in differ-rent countries.

The European Institutions started their action for harmonizing applicable regulations and scientific criteria to these traditional botanical food supplements and medicinal products only recently (see Directive 2002/46/EC and Directive 2004/24/EC, respectively) and, not surprisingly, with a very limited success. In fact, the distinction and separation of the botanical species and parts being used as traditional food supple-ments and medicinal products in different EU Member States has remained highly problematic, as shown by the fact that a number of botanical species and parts currently used under a specific regulatory domain (e.g. food supplements) in some Member States are used in the other domain (e.g. traditional medi-cinal products) in other Member States, with a very broad overlap.

This situation, that has been present almost unnoticed in the European market for long time, is currently challenged by the on going implementation of Regulation (EC) 1924/2006 on nutritional and health claims to botanical food supplements.

This presentation intends, first, to provide all the information necessary to characterize the issue and, subsequently, to discuss practicable scientific and regulatory options in the ways forward to deal with this issue that has of significant economic importance as well as some health and safety implications for consumers.