Title: Scientific Opinion on a Qualified Presumption of Safety (QPS) approach for the safety assessment of botanicals and botanical preparations
Abstract: EFSA JournalVolume 12, Issue 3 3593 OpinionOpen Access Scientific Opinion on a Qualified Presumption of Safety (QPS) approach for the safety assessment of botanicals and botanical preparations EFSA Scientific Committee, EFSA Scientific CommitteeSearch for more papers by this author EFSA Scientific Committee, EFSA Scientific CommitteeSearch for more papers by this author First published: 13 March 2014 https://doi.org/10.2903/j.efsa.2014.3593Citations: 16 Scientific Committee members: Jan Alexander, Diane Benford, Qasim Chaudhry, Anthony Hardy, Michael John Jeger, Robert Luttik, Ambroise Martin, Bernadette Ossendorp, Simon More, Alicja Mortensen, Birgit Nørrung, Joe Perry, Iona Pratt†, John Sofos, Josef Schlatter, Kristen Sejrsen Correspondence: [email protected] Acknowledgement: The Scientific Committee wishes to thank the members of the Working Group on QPS, Andrew Chesson (Chair), Qasim Chaudhry, Luc Delmulle (until 7 August 2013), Birgit Dusemund, Karl-Heinz Engel, Kirsten Pilegaard, Ivonne Rietjens and Vittorio Silano for the preparatory work on this scientific opinion and EFSA staff: Bernard Bottex and Renata Leuschner for the support provided to this scientific opinion. Adoption date: 18 February 2014 Published date: 13 March 2014 Question number: EFSA-Q-2012-00642 On request from: EFSA AboutPDF ToolsExport citationAdd to favoritesTrack citation ShareShare Give accessShare full text accessShare full-text accessPlease review our Terms and Conditions of Use and check box below to share full-text version of article.I have read and accept the Wiley Online Library Terms and Conditions of UseShareable LinkUse the link below to share a full-text version of this article with your friends and colleagues. Learn more.Copy URL Abstract The Qualified Presumption of Safety (QPS) approach, initially developed for the assessment of microorganisms referred to EFSA and added to the food chain is equally applicable to the assessment of botanicals or botanical preparations. Using the principles to establish the suitability of a botanical preparation for QPS status, it has been possible to develop a structured assessment scheme that provides a practical method for assessing botanicals and botanical preparations for which an adequate body of knowledge exists and therefore without the need for further testing. Reiterative applications of the assessment scheme to related botanicals or different botanical preparations obtained from the same plant variety can allow a QPS status to be derived for specific groupings. However, the particularity of botanicals that may be presented in a wide variety of forms or whose morphology and chemical composition may be markedly affected by geographical and environmental factors, makes the possibility to establish QPS status at high taxonomic levels quite limited. Still, the above-mentioned structured approach for the assessment of botanicals and botanical preparations represents a considerable advancement in the development of a comprehensive, systematic and transparent methodology. The Scientific Committee recommends its use as an extension of the 2009 EFSA guidance for the safety assessment of botanicals and botanical preparations intended to be used in food supplements. References Constable A, Jonas D, Cockburn A, Davi A, Edwards G, Hepburn P, Herouet-Guicheney C, Knowles M, Moseley B, Oberdörfer R and Samuels F, 2007. History of safe use as applied to the safety assessment of novel foods and foods derived from genetically modified organisms. Food and Chemical Toxicology 45 (2007) 2513– 2525. doi:10.1016/j.fct.2007.05.028 EFSA (European Food Safety Authority), 2009. Guidance of the Scientific Committee on safety assessment of botanicals and botanical preparations intended for use as ingredients in food supplements, on request of EFSA. 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