Traditional Knowledge for the Assessment oh Health Effects for Botanicals- A Framework for data Collection

In the European Union (EU), botanicals have a long tradition of use for their health effects. Their medicinal use has evolved more recently. Medicinal products containing botanicals can be registered as traditional herbal medicinal products in the EU if bibliographical or expert evidence is available that the product has been in medicinal use throughout a period of at least 30 years. For food use however, the effects observed must be proven under the new health claims rules. The substantiation required relies mainly on the availability of randomised controlled trials. Evidence from traditional use is not considered. This is bound to lead to the loss of an important heritage. The consideration of traditional evidence from various sources is a valid scientific discipline. This paper is aimed at providing a framework for data collection in support of traditional use for botanicals. It provides guidance on how traditional use can be incorporated into the totality of the evidence and can be used as a basis for the assessment leading to the acceptance of health effects for botanicals