In June 2008, following a public consultation, the Scientific Committee published a guidance document for the safety assessment of botanicals and botanical preparations intended for use as ingredients in food supplements.
An EFSA Scientific Cooperation (ESCO) Working Group composed of experts identified by the members of the Advisory Forum, and by the Scientific Committee was created to advise on the adequacy of the proposed approach for the safety assessment of botanicals and botanical preparations.
The ESCO Working Group considered six botanical preparations to test the science-based framework described the guidance document: i) hydroalcoholic extract of dried peel of Citrus aurantium L. ssp. aurantium L., ii) dried green tea extract of Camellia sinensis (L.) Kuntze, iii) dried leaves extract of Ocimum tenuiflorum L., iv) dried fruits water extract of Foeniculum vulgare Mill. ssp. vulgare var. vulgare, v) dried ripe seeds of Linum usitatissimum L., and vi) wheat bran from Triticum aestivum L. These examples were selected in order to address various safety issues, such as misidentification or adulteration, liver toxicity, possible presence of genotoxic and carcinogenic compounds. Based on the experience acquired through the examples, the ESCO Working Group identified a number of possible amendments and additions for the guidance document of the Scientific Committee.
The Working Group also updated a compendium compiled by EFSA’s Scientific Committee and containing information on botanicals reported to contain substances that may be of possible health concern. The Compendium aims at highlighting possible safety issues which may require further consideration. It will be updated regularily.
Links for more information
Discussion paper adopted in June 2004 by the Scientific Committee
Public consultation held 17 December 2007 – 15 February 2008
Documents
Mandate of the ESCO working group on Botanicals and Botanical Preparations
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