Risk characterisation of constituents present in jamu to promote its safe use.

Safety in use of jamu consumption, as part of traditional medicine from Indonesia, is dependent on the complete and adequate assessment of potential hazards and risks of the botanicals and botanical constituents included. This includes especially hazards and risks related to the presence in jamu of active pharmaceutical ingredients (APIs) as well as of constituents that are genotoxic and carcinogenic. The present review presents an overview of the current state-of-the art on these hazards and risks based on case reports on adulteration, and the actual detection of genotoxic and carcinogenic ingredients of concern in jamu. Based on the overview thus obtained, it appears that drug-adulteration presents important hazards responsible for potential adverse effects, due to overdosing. The potential hazards of exposure to APIs mainly relate to the presence of constituents that may cause liver damage, renal impairment, kidney failure, steroid dependence or genotoxicity and carcinogenicity. For these APIs, a risk characterisation was performed based on comparison of health-based guidance values (HBGVs) and exposure, while for the genotoxic carcinogens the margin of exposure (MOE) approach was used. Results of this risk characterisation should be used by risk managers to impose specification for constituents of health concern to protect consumers. It is concluded that to manage the risks identified and further improve the safety in use of jamu, a collaboration between farmers, manufacturer/producers, academia, government, health professionals, and consumers is indicated.