Regulatory challenges facing Ayurvedic products in the European Union
Dr. med. Oliver Werner, Switzerland
According to the regulations of the EU, any product designed to be taken in by humans can be either a food or a medicine. Medicines need to be registered with the authorities. For this, documentations showing the effectiveness, safety and pharmaceutical quality of the products need to be presented. Preparation of these is very costly (minimum several 100 000 Euro, but often millions). Therefore, Ayurvedic products until now are generally marketed as food supplements. Unfortunately, here it is not possible to make any claims about effects against diseases.
A troublesome issue is the Novel Food regulation, which stipulates that products introduced after May 1997 are “Novel Food” and need to go through a tedious registration process. Fortunately, most Ayurvedic plants have been available in the EU since before this date.
All products must be tested for purity. Levels of heavy metals, pesticide residues, bacteriology and fungal toxins need to be within with EU limits. Complying with this regulation is important, as there has been negative publicity about poor-quality products with high levels of such impurities, which creates a very bad image of our science.