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EFSA Compendium Botanicals Downloaded from orbit.dtu.dk on: Oct 05, 2021 Compendium of botanicals reported to contain naturally occuring substances of possible concern for human health when used in food and food supplements EFSA authors Link to article, DOI: 10.2903/j.efsa.2012.2663 Publication date: 2012 Document Version Publisher's PDF, also known as Version of record Link back to DTU Orbit Citation (APA): EFSA authors (2012). Compendium of botanicals reported to contain naturally occuring substances of possible concern for human health when used in food and food supplements. Europen Food Safety Authority. the EFSA Journal Vol. 10(5) No. 2663 https://doi.org/10.2903/j.efsa.2012.2663 General rights Copyright and moral rights for the publications made accessible in the public portal are retained by the authors and/or other copyright owners and it is a condition of accessing publications that users recognise and abide by the legal requirements associated with these rights. Users may download and print one copy of any publication from the public portal for the purpose of private study or research. You may not further distribute the material or use it for any profit-making activity or commercial gain You may freely distribute the URL identifying the publication in the public portal If you believe that this document breaches copyright please contact us providing details, and we will remove access to the work immediately and investigate your claim. EFSA Journal 2012;10(5):2663 SCIENTIFIC REPORT OF EFSA Compendium of botanicals reported to contain naturally occuring substances of possible concern for human health when used in food and food supplements1 European Food Safety Authority2, 3 European Food Safety Authority (EFSA), Parma, Italy ABSTRACT In April 2009, EFSA published on its website a Compendium of botanicals reported to contain toxic, addictive, psychotropic or other substances of concern. The purpose of the Compendium is to assist risk assessors responsible for the evaluation of specific ingredients in food supplements, in more easily identifying the compound(s) of concern on which to focus the assessment. The Scientific Committee worked on a second version of that Compendium between January 2010 and February 2012, considering botanicals that appear on a negative list or subject to restricted use (e.g. max. level or certain parts allowed only) in at least one European Member State. Two annexes have been added compared to the first version; the first one lists botanicals for which not enough information on possible substances of concern could be found, or for which the information present could not be verified. The second one lists botanicals for which, although some data were available, the Scientific Committee could not identify substances of concern, or other reasons for the inclusion in the compendium. This new “Compendium of botanicals reported to contain naturally occuring substances of possible concern for human health” replaces the first version published in 2009; it lists in alphabetical order botanicals without any judgment on whether they are suitable or not suitable for food applications in Europe; it has no legal or regulatory force pertaining to the legal classification of products or substances. © European Food Safety Authority, 2012 KEY WORDS Compendium, botanicals, food supplements, hazard identification, compounds of concern, adverse effects 1 On request from EFSA, Question No EFSA-Q-2010-00154, approved on 17 April 2012. 2 Correspondence: [email protected] 3 Acknowledgement: EFSA wishes to thank the members of the Working Group Compendium: Robert Anton, Ulla Beckman Sundh, Luc Delmulle, Maria Teresa Nogueira, Kirsten Pilegaard, Mauro Serafini and Vittorio Silano (Chair) for the preparatory work on this scientific output, and EFSA staff Bernard Bottex for the support provided to this scientific output. Suggested citation: European Food Safety Authority; Compendium of botanicals reported to contain naturally occuring substances of possible concern for human health when used in food and food supplements. EFSA Journal 2012;10(5):2663. [60 pp.] doi:10.2903/j.efsa.2012.2663. Available online: www.efsa.europa.eu/efsajournal © European Food Safety Authority, 2012 Compendium of Botanicals – Version N° 2 SUMMARY Since August 2005, the Scientific Committee (SC) of EFSA has been developing a compendium (in table format) of compounds present in botanicals, that can be of concern for human health. This work has been undertaken in cooperation with the Advisory Forum Representatives of the European Member States. A first version of the Compendium entitled “Compendium of botanicals reported to contain toxic, addictive, psychotropic or other substances of possible health concern” was published on the EFSA website in April 2009. At that time, the SC underlined that the compendium of botanicals is a living document and should be updated on a regular basis by EFSA. As a follow up, the SC considered botanicals appearing on a negative list or subject to restricted use (e.g. max. level or certain parts allowed only) in at least one European Member State. A literature search was performed to get information on compound(s) and/or possible health effects that would have motivated the insertion of the botanicals in the above-mentioned lists. In cases where not enough information on possible substances of concern could be found, or for which the information present could not be verified, the botanical species have been transferred to an attached “insufficient information” list (Annex A). In cases where some data were available, but the Scientific Committee could not identify substances of concern, or other reasons for the inclusion in the compendium, the botanical species were then transferred to another attached list (Annex B). The resulting “Compendium of botanicals reported to contain naturally occuring substances of possible concern for human health” replaces the previous version published on the EFSA website in 2009. The Compendium is intended to help with the safety assessment of botanicals and botanical preparations intended for use as food supplements, by facilitating hazard identification. The Compendium aims at flagging plants or part of plants or compounds of possible concern for human health naturally present in the listed botanicals and that therefore require specific attention while assessing the safety of products containing such botanical(s). It is underlined that the presence of a substance of concern in a given botanical does not necessarily mean that this substance will also be present in the botanical preparation and, if present, that it is at a dosage causing a health concern. The absence of a given botanical species in this Compendium cannot be interpreted as this species is devoid of compounds hazardous for human health. In the same way, not mentioning a specific part of plant does not imply absence of substance(s) of concern in this part. The compendium has no legal or regulatory force pertaining to the legal classification of products or substances. EFSA Journal 2012;10(5):2663 2 Compendium of Botanicals – Version N° 2 TABLE OF CONTENTS Abstract .................................................................................................................................................... 1 Summary .................................................................................................................................................. 2 Table of contents ...................................................................................................................................... 3 Background as provided by EFSA ........................................................................................................... 4 Terms of reference as provided by EFSA ................................................................................................ 4 1. Preamble .......................................................................................................................................... 5 2. Legal disclaimer .............................................................................................................................. 6 3. Purpose of the Compendium ........................................................................................................... 6 4. Structure of the Compendium .......................................................................................................... 6 5. Recommendations ........................................................................................................................... 7 EFSA Journal 2012;10(5):2663 3 Compendium of Botanicals – Version N° 2 BACKGROUND AS PROVIDED BY EFSA In September 2009, 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. The opinion specifies what data are needed to carry out such safety assessments. It also suggests a two-tiered scientific approach depending on the existing level of knowledge on a given botanical and the substance(s) it contains. Moreover, working together with EU Member States, EFSA has also established a large database by compiling the available literature data and other information on a large number of botanicals and botanical preparations which have been reported to contain substances that may be of health concern when used in food or food supplements. The Compendium comprises around 900 botanical entries, identifying for
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