Artigo Acesso aberto Revisado por pares

Guidance on Safety assessment of botanicals and botanical preparations intended for use as ingredients in food supplements

2009; Wiley; Volume: 7; Issue: 9 Linguagem: Inglês

10.2903/j.efsa.2009.1249

ISSN

1831-4732

Tópico(s)

Pharmaceutical Quality and Counterfeiting

Resumo

EFSA JournalVolume 7, Issue 9 1249 GuidanceOpen Access Guidance on Safety assessment of botanicals and botanical preparations intended for use as ingredients in food supplements European Food Safety Authority, European Food Safety AuthoritySearch for more papers by this authorEFSA Scientific Committee, EFSA Scientific CommitteeSearch for more papers by this author European Food Safety Authority, European Food Safety AuthoritySearch for more papers by this authorEFSA Scientific Committee, EFSA Scientific CommitteeSearch for more papers by this author First published: 10 September 2009 https://doi.org/10.2903/j.efsa.2009.1249Citations: 61 Scientific committee members: Susan Barlow, Andrew Chesson, John D. Collins, Albert Flynn, Corrado L. Galli, Anthony Hardy, Klaus-Dieter Jany, Michael-John Jeger, Ada Knaap, Harry Kuiper, John-Christian Larsen, David Lovell, Josef Schlatter, Vittorio Silano, Frans Smulders and Philippe Vannier. Correspondence: [email protected] Adoption date: 22 July 2009 Published date: 10 September 2009 Question number: EFSA-Q-2009-00668 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 In this opinion, EFSA's Scientific Committee provides guidance on the scientific data needed to carry out a safety assessments of a botanical or a botanical preparation. It also proposes a two-tiered scientific approach for the safety assessment depending on the available knowledge on a given botanical and the substance(s) it contains. The guidance also provides a set of criteria to help prioritise the safety assessment of botanical ingredients which are in use. EFSA has also compiled the available information on a large number of botanicals which have been reported to contain substances that may be of health concern when used in food or food supplements. The resulting compendium, which will be regularly updated, should be considered as part of this guidance document and is intended to assist manufacturers and food safety authorities by highlighting possible safety issues which may require further consideration. References AFSSA, 2003. Framework for the evaluation of the safety, the effect and the claims of foodstuff made from plants for the human diet. Codex Alimentarius, 1997. Hazard Analysis and Critical Control Point (HACCP) system and guidelines for its application. Annex to CAC/RCP 1–1969, Rev-3 Council of Europe, 2005. Guidelines on the safety of plant-based food supplements and consumer interest in those supplements. Public health Committee, Committee of Experts on Nutrition, Food safety and consumer health, Ad-hoc Group on Food Supplements, 24 May 2005. EFSA, 2005. Opinion of the Scientific Committee on a request from EFSA related to a harmonised approach for risk assessment of substances which are both genotoxic and carcinogenic. The EFSA Journal (2005) 282, 1– 31. www.efsa.europa.eu/EFSA/efsa_locale-1178620753812_1178620763354.htm EFSA, 2006a. Guidance document of the Scientific Panel on Genetically Modified Organisms for the risk assessment of genetically modified microorganisms and their derived products intended for food and feed use. The EFSA Journal (2006) 374, 1– 115. www.efsa.europa.eu/EFSA/efsa_locale-1178620753812_1178620775770.htm EFSA, 2006b. Guidance of the Scientific Committee on a request from EFSA related to uncertainties in dietary exposure assessment. The EFSA Journal (2006) 438, 1– 54. www.efsa.europa.eu/EFSA/efsa_locale-1178620753812_1178620763403.htm EFSA, 2007a. Opinion of the Scientific Committee on a request from EFSA on the introduction of Qualified Presumption of Safety (QPS) approach for assessment of selected microorganisms referred to EFSA. The EFSA Journal (2007) 587, 1– 16 www.efsa.europa.eu/EFSA/efsa_locale-1178620753812_1178667590178.htm EFSA, 2007b. Opinion of the Panel on dietetic products, nutrition and allergies (NDA) on a request from the Commission related to scientific and technical guidance for the preparation and presentation of the application for authorisation of a health claim. The EFSA Journal (2007) 530, 1– 44. www.efsa.europa.eu/EFSA/efsa_locale-1178620753812_1178623592448.htm EFSA, 2009. Opinion of the Scientific Committee on a request from EFSA on existing approaches incorporating replacement, reduction and refinement of animal testing: applicability in food and feed risk assessment. The EFSA Journal (2009) 1052, 1– 77. www.efsa.europa.eu/EFSA/efsa_locale-1178620753812_1211902559349.htm Hanelt, P. (Ed.) 2001. Mansfeld's Encyclopedia of Agricultural and Horticultural Crops. Springer. ISBN 3540410171. Mansfeld's World Database of Agricultural and Horticultural Crops. IPK © Gatersleben. mansfeld.ipk-gatersleben.de/pls/htmldb_pgrc/f?p=185:3:1017216509346775 OECD, 1998. Ninth addendum to the OECD Guidelines for the testing of chemicals. OECD Paris February 1998. SCF, 2001a. Guidance on submissions for safety evaluation of sources of nutrients or of other ingredients proposed for use in the manufacture of foods. ec.europa.eu/food/fs/sc/scf/out100_en.pdf SCF, 2001b. Guidance on submissions for food additive evaluations by the Scientific Committee on Food. ec.europa.eu/food/fs/sc/scf/out98_en.pdf Schilter, B., Andersson, C., Anton, R., Constable, A., Kleiner, J., O'Brien, J., Renwick, A.G., Korver, O., Smit, F., and Walker, R., 2003. Guidance for the safety assessment of botanicals and botanical preparation for use in food and food supplements. Food Chem. Toxicol. 41, 1625– 1649. The International Plant Names Index. Published on the Internet www.ipni.org United States Department of Agriculture (USDA), ARS, National Genetic Resources Program. Germplasm Resources Information Network – (GRIN) [Online Database] National Germplasm Resources Laboratory, Beltsville, Maryland. www.ars-grin.gov/cgibin/npgs/html/splist.pl?598 World Checklist of Selected Plant Families. (DATE) The Board of Trustees of the Royal Botanic Gardens, Kew. Published on the Internet: apps.kew.org/wcsp/. Citing Literature Volume7, Issue9September 20091249 This article also appears in:Cross-cutting guidance ReferencesRelatedInformation

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