EFSA Scientific Cooperation (ESCO) Report (2009) Advice on the EFSA guidance document for the safety assessment of botanicals and botanical preparations intended for use as food supplements, based on real case studies. ESCO Working Group on Botanicals and Botanical Preparations, European Food Safety Authority (EFSA)

In June 2008, after an initial public consultation, the Scientific Committee of EFSA published a guidance document for the safety assessment of botanicals and botanical preparations intended for use as ingredients in food supplements. Recommendation was made at the same time to test the proposed approach for safety assessment with a number of examples, and consider amending the Compendia i) of botanicals reported to contain toxic, addictive or psychotropic substances and ii) of botanicals reported to have also a medicinal use.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 fulfill this request, and advise on the adequacy of the proposed approach for the safety assessment of botanicals and botanical preparations for EFSA and the European Member States' needs. In addition the Working Group was asked to update the Compendia.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 / 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.Taking into account comments received during the public consultation, the ESCO Working Group merged the two compendia into a single one, after removing references made to possible medicinal use of botanicals. The resulting Compendium now focuses on toxicity aspects, listing botanicals reported to contain toxic, addictive, psychotropic, or other substances of concern. The Compendium aims at flagging plants or parts of plants or compounds of possible concern for human heath naturally present in the listed botanicals and that therefore require specific attention while assessing the safety of the product(s) containing such botanical(s). It is recommended that EFSA keeps updating the Compendium on a regular basis.After possible update of the EFSA guidance document for the safety assessment of botanicals and botanical preparations by the Scientific Committee, based on the recommendations made in this advice, the guidance document and the Compendium will be made publicly available on the EFSA website.