Abstract:

A general framework for safety assessment is proposed by the EFSAs Scientific Committee, in which botanicals or botanical preparations for which an adequate body of knowledge exists could benefit from a “presumption of safety” without any need for further testing, based on long history of use without reported adverse effects and without significant larger exposition. Botanicals and botanical preparations for which a presumption of safety is not possible based on available knowledge would be subject to a more extensive safety assessment, requiring additional data to be provided. For these preparations with a potential to contain toxic, addictive, psychotropic or other substances that may be of concern (given in the Compendium), presumption of safety can be applied only if there is convincing evidence that these undesirable substances in the specific plant parts or preparations are either absent in the source material, or significantly reduced if not excluded, or inactivated during processing (EFSA Journal, 2009).

Publisher's Version