Safety assessment of botanicals and botanicals preparations intended for use as food supplements

Published:
Deadline:
Expired

In line with EFSA’s policy on openness and transparency and in order for EFSA to receive comments from the scientific community and stakeholders on its work, EFSA engages in public consultations on key documents. In this respect the EFSA Scientific Committee organised a consultation from 20 December 2007 to 15 February 2008 on its draft approach for the safety assessment of botanicals and botanical preparations used as ingredients in food supplements. Opportunity was offered to provide EFSA with comments on the approach itself and the level of confidence it gives regarding the safety assessment of the botanical and botanical preparations, and to submit additional sources of information to complete the two compendia of botanicals

The EFSA Scientific Committee received around 400 comments related to the draft guidance document, and 250 additional comments more specifically relating to the contents of the compendia. The Scientific Committee considered the comments directly related to the draft guidance for the safety assessment of botanical ingredients and whether an update of the document was needed. Comments related to the contents of the compendia were not reviewed and have been forwarded to the new EFSA Scientific Cooperation (ESCO) Working Group on Botanicals who will be in charge, among other tasks, to work further on the compendia.

The public consultation has resulted in the following documents: 

  •  The compilation of the comments received during the public consultation, 
  •  A report from the working group of the Scientific Committee on how the submitted comments were taken into consideration. Please note that comments will not be answered individually 
  •  The guidance document for the safety assessment of botanicals and botanical preparations used in food supplement, updated taking into consideration the comments submitted by the stakeholders. This scientific framework for safety assessment proposed in the guidance document will now be tested by the ESCO Working Group on Botanicals with a selected number of real cases.