Guidance on Safety assessment of botanicals* and botanical preparations** intended for use as ingredients in food supplements

Botanicals, botanical preparations, safety assessment, food supplements, toxicological properties, medicinal properties.
First published in the EFSA Journal
10 septembre 2009
22 juillet 2009
Last Updated
20 novembre 2009. This version replaces the previous one/s.


In this opinion, EFSA’s Scientific Committee provides guidance on the scientific data needed to carry out a safety assessments of a botanical or a botanical preparation. It also proposes a two-tiered scientific approach for the safety assessment depending on the available knowledge on a given botanical and the substance(s) it contains. The guidance also provides a set of criteria to help prioritise the safety assessment of botanical ingredients which are in use. EFSA has also compiled the available information on a large number of botanicals which have been reported to contain substances that may be of health concern when used in food or food supplements. The resulting compendium, which will be regularly updated, should be considered as part of this guidance document and is intended to assist manufacturers and food safety authorities by highlighting possible safety issues which may require further consideration.

Panel members at the time of adoption

Susan Barlow, Andrew Chesson, John D. Collins, Albert Flynn, Corrado L. Galli, Anthony Hardy, Klaus-Dieter Jany, Michael-John Jeger, Ada Knaap, Harry Kuiper, John-Christian Larsen, David Lovell, Josef Schlatter, Vittorio Silano, Frans Smulders and Philippe Vannier
scientific.committee [at]
EFSA Journal 2009; 7(9):1249
Question Number
On request from