EMA: Reflection Paper on Ethanol Content in Herbal Medicinal Products and Traditional Herbal Medicinal Products Used in Children

The scope of this paper is to reflect the need for safety limits for ethanol exposure by oral herbal medicinal products intended for the paediatric population. Establishing these limits is viewed as necessary to protect health and to allow safe free movement of goods within the EU. In addition, this will ensure a harmonised approach in assessment work among Member States as well as in the establishment by the HMPC of Community herbal monographs and of the list of herbal substances, preparations and combinations thereof for use in traditional herbal medicinal products (respectively Article 16h (2,) and Article 16f (3) of Directive 2001/83/EC as amended).