EMA: Public statement on the use of herbal medicinal products containing thujone

The HMPC prepared a public statement on the use of herbal medicinal products containing thujone, which is a natural constituent of the essentials oils of a number of plants widely used. Thujone is a major component in two herbal preparations: Artemisia absinthium L. (monograph EMA/HMPC/234463/2008) and Salvia officinalis L. (monograph EMA/HMPC/331653/2008). The Risk assessment of thujone poses many difficulties therefore determined of maximum limit of daily intakes of thujone, which in the case of Absinthii herba was set at 3.5 mg/person and in the case of sage leaf preparations 5.0 mg/person, both for a maximum duration of 2 weeks.