Scientific Opinion on a Qualified Presumption of Safety (QPS) approach for the safety assessment of botanicals and botanical preparations

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.