The use and availability of herbal preparations covered by food law is increasing in the Netherlands and in other European Member States. Correspondingly, safety concerns relating to herbal preparations are growing as well. The aim of the present PhD project was therefore to review the toxicity of selected herbal preparations, to investigate the presence and actual levels of selected naturally-occurring toxic substances and contaminants in herbal preparations on the Dutch market and to estimate the associated risks. First, an overview is provided of the Dutch and European legal provisions for food commodities with botanical ingredients, the nature and mechanism of action of various toxic botanical ingredients specifically covered by these provisions, and the health concerns defined by risk assessors related to several botanicals for which no specific legal provisions exist. Secondly, data are presented on the actual occurrence in traditional herbal preparations (THPs) of a group of phytotoxins, i.e. aristolochic acids, which were banned by the Dutch Commodities Act Decree ‘Herbal preparations’. Aristolochic acids and derivatives are nephrotoxic, genotoxic and carcinogenic and are present in several plants from the Aristolochiaceae family. Aristolochic acids were found in 25 of 190 THPs used in Traditional Chinese Medicine (TCM) sampled on the Dutch market. This shows that testing for aristolochic acids of Chinese THPs at risk of contamination is essential in the framework of food safety. Thirdly, the presence of selected toxic contaminants in herbal preparations on the Dutch market was investigated. Lead, mercury and arsenic levels were analyzed in THPs used in several Asian traditional medicine systems, such as Ayurveda, TCM, and Traditional Tibetan Medicine (TTM). These metals and metalloids were present in 186 (64%) of 292 THPs and use at recommended dose levels of 59 THPs (20%) would result in intakes of these contaminants significantly above established toxicological safety limits. It was concluded that the ...