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Risk and Benefit Assessment: Methodologies and Scientific Acceptance

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References

  • Bent S, Padula A, Moore D, Patterson M, Mehling W. Valerian for sleep: a systematic review and meta-analysis. Am J Med. 2006;119:1005–12.

    Article  Google Scholar 

  • Bjelakovic G, Nikolova DD, Gluud LL, Simonetti RG, Gluud C. Antioxidant supplements for prevention of mortality in healthy participants and patients with various diseases. JAMA. 2007;297:842–57.

    Article  CAS  Google Scholar 

  • Chung M, Balk EM, Ip S, Raman G, Yu WW, Trikalinos TA, Lichtenstein AH, Yetley EA, Lau JJ. Reporting of systematic reviews of micronutrients and health: a critical appraisal. Am J Clin Nutr. 2009;89:1099–113.

    Article  CAS  Google Scholar 

  • Dietary Supplement Health and Education Act of 1994, Pub. L. No 103-417, Stat 4325.

    Google Scholar 

  • EFSA. Guidance of the scientific committee on a request from EFSA related to uncertainties in dietary exposure assessment. EFSA J. 2006;438:1–54.

    Google Scholar 

  • EFSA. Opinion of the scientific panel on contaminants in the food chain on a request from the European Commission to perform a scientific risk assessment on nitrate in vegetables. EFSA J. 2008;689:1–79.

    Google Scholar 

  • EFSA. Guidance on safety assessment of botanicals and botanical preparations intended for use as food supplements. EFSA J. 2009a;7:1249.

    Google Scholar 

  • EFSA. EFSA SCIENTIFIC COOPERATION (ESCO) REPORT. 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. EFSA J. 2009b;7:280.

    Google Scholar 

  • EFSA. Compendium of botanicals that have been reported to contain toxic, addictive, psychotropic or other substances of concern on request of EFSA. EFSA J. 2009c;7:281.

    Google Scholar 

  • EFSA. Guidance on human health risk-benefit assessment of foods. EFSA J. 2010a;8:1673–714.

    Article  Google Scholar 

  • EFSA. Panel on dietetic products, nutrition and allergies (NDA). Scientific opinion on the substantiation of health claims related to meal replacements for weight control (as defined in directive 96/8/EC on energy restricted diets for weight loss) and reduction in body weight (ID 1417), and maintenance of body weight after weight loss (ID 1418) pursuant to article 13(1) of regulation (EC) no 1924/2006. EFSA J. 2010b;8:1466.

    Article  Google Scholar 

  • EFSA. Panel on dietetic products, nutrition and allergies (NDA). EFSA journal, scientific opinion on the substantiation of health claims related to melatonin and alleviation of subjective feelings of jet lag (ID 1953), and reduction of sleep onset latency, and improvement of sleep quality (ID 1953) pursuant to article 13(1) of regulation (EC) no 1924/2006. EFSA J. 2010c;8:1467.

    Article  Google Scholar 

  • EFSA. Panel on dietetic products, nutrition and allergies (NDA). Scientific opinion on the substantiation of a health claim related to oat beta-glucan and lowering blood cholesterol and reduced risk of (coronary) heart disease pursuant to article 14 of regulation (EC) no 1924/2006. EFSA J. 2010d;8:1885.

    Article  Google Scholar 

  • EFSA. Panel on dietetic products, nutrition and allergies (NDA). Scientific opinion on the substantiation of health claims related to caffeine and increase in physical performance during short-term high-intensity exercise (ID 737, 1486, 1489), increase in endurance performance (ID 737, 1486), increase in endurance capacity (ID 1488) and reduction in the rated perceived exertion/effort during exercise (ID 1488, 1490) pursuant to article 13(1) of regulation (EC) no 1924/2006. EFSA J. 2011;9:2053.

    Article  Google Scholar 

  • EMA. Benefit-Risk methodology project. EMA/213482/2010, 2010a.

    Google Scholar 

  • EMA. Benefit-Risk methodology project. EMA/549682/2010, 2010b.

    Google Scholar 

  • EMA/HMPC. Assessment report on salvia officinalis l., folium and salvia officinalis l., aetheroleum. EMA/HMPC/330383/2008, 2008a.

    Google Scholar 

  • EMA/HMPC. Assessment report on hypericum perforatum l., herba. EMA/HMPC/101303/2008, 2008b.

    Google Scholar 

  • EMA/HMPC. Assessment report on Taraxacum officinale Weber ex Wigg., folium EMA/HMPC/579634/2008, 2008c.

    Google Scholar 

  • EMA/HMPC. Assessment report on Ilex paraguariensis St. Hilaire, folium EMA/HMPC/580545/2008, 2008d.

    Google Scholar 

  • EMA/HMPC. Draft community herbal monograph on Rosmarinus officinalis L., folium 13631/2009, 2009a.

    Google Scholar 

  • EMA/HMPC. Assessment report on Thymus vulgaris L., Thymus zygis Loefl. ex. L., aetheroleum EMA/HMPC/131903/2009, 2009b.

    Google Scholar 

  • EMA/HMPC. Assessment report on Ribes nigrum L., folium. EMA/HMPC/142989/2009, 2009c.

    Google Scholar 

  • EMA/HMPC. Community herbal monograph on Trigonella foenumgraecum L., semen EMA/HMPC/146221/2010, 2010a.

    Google Scholar 

  • EMA/HMPC. Assessment report on Potentilla erecta (L.) Raeusch., rhizoma. EMA/HMPC/5511/2010, 2010b.

    Google Scholar 

  • EMEA/CHMP. Report of the CHMP working group on benefit-risk assessment models and methods. EMEA/CHMP/15404/2007.

    Google Scholar 

  • EMEA/HMPC. Overview of comments received on ‘guideline on the clinical assessment of fixed combinations of herbal substances/herbal preparations’ EMEA/HMPC/419395/2005.

    Google Scholar 

  • EMEA/HMPC. Draft community herbal monograph on Peumus boldus molina, folium EMEA/HMPC/591648/2007, 2007a.

    Google Scholar 

  • EMEA/HMPC. Assessment report on Salicis cortex (willow bark) and herbal preparation(s) thereof with well-established use and traditional use. EMEA/HMPC/295337/2007, 2007b.

    Google Scholar 

  • EMEA/HMPC. Assessment report on Aesculus hippocastanum L., semen. EMEA/HMPC/225304/2008, 2008a.

    Google Scholar 

  • EMEA/HMPC. Assessment report on Echinacea pallida (Nutt.) Nutt., radix. EMEA/HMPC/332358/2008, 2008b.

    Google Scholar 

  • EMEA/HMPC. Assessment report on Althaea officinalis l., radix. EMEA/HMPC/98718/2008, 2008c.

    Google Scholar 

  • EMEA/HMPC. Assessment report on centaurium erythraea rafn s. L. Including c. Majus (h. Et l.) Zeltner and c. Suffruticosum (griseb.) Ronn., herba, for the development of a community herbal monograph. EMEA/HMPC/105535/2008, 2008d.

    Google Scholar 

  • European Parliament and of the Council Directive 2002/46/EC of 10 June 2002 on the Approximation of the Laws of the Member States relating to Food Supplements.

    Google Scholar 

  • Fernández-San-Martín MI, Masa-Font R, Palacios-Soler L, Sancho-Gómez P, Calbó-Caldentey C, Flores-Mateo G. Effectiveness of valerian on insomnia: a meta-analysis of randomized placebo-controlled trials. Sleep Med. 2010;11:505–11.

    Article  Google Scholar 

  • Geng J, Dong J, Ni H, Lee MS, Wu T, Jiang K, Wang G, Zhou AL, Malouf R. Ginseng for cognition. Cochrane Database Syst Rev. 2010;8:CD007769.

    Google Scholar 

  • Graham JD, Wiener JB. Risk versus risk: tradeoffs in protecting health and the environment. Cambridge, MA: Harvard University Press; 1997.

    Google Scholar 

  • Hoekstra J, Verkaik-Kloosterman J, Rompelberg C, van Kranen H, Zeilmaker M, Verhagen H, de Jong N. Integrated risk-benefit analyses: method development with folic acid as example. Food Chem Toxicol. 2008;46:893–909.

    Article  CAS  Google Scholar 

  • Hoekstra J, Hart A, Boobis A, Claupein E, Cockburn A, Hunt A, Knudsen I, Richardson D, Schilter B, Schütte TPR, Verhagen H, Watzl B, Chiodini A. BRAFO tiered methodology for benefit-risk assessment of foods. Food Chem Toxicol. 2012;4:S684–98.

    Article  Google Scholar 

  • Jepson RG, Craig JC. Cranberries for preventing urinary tract infections. Database Syst Rev. 2008;23:CD001321.

    Google Scholar 

  • Porter R. The Cambridge history of medicine. Cambridge., 408p.: Cambridge University Press; 2006.

    Google Scholar 

  • Reinhart KM, Talati R, White CM, Coleman CI. The impact of garlic on lipid parameters: a systematic review and meta-analysis. Nutr Res Rev. 2009;22:39–48.

    Article  CAS  Google Scholar 

  • Renwick AG, Flynn A, Fletcher RJ, Müller DJ, Tuijtelaars S, Verhagen H. Risk-benefit analysis of micronutrients. Food Chem Toxicol. 2004;42:1903–22.

    Article  CAS  Google Scholar 

  • Schoop R, Klein P, Suter A, Johnston SL. Echinacea in the prevention of induced rhinovirus colds: a meta-analysis. Clin Ther. 2006;28:174–83.

    Article  Google Scholar 

  • US Food and Drug Administration Guidance for Industry: Final Rule Declaring Dietary Supplements Containing Ephedrine Alkaloids Adulterated Because They Present an Unreasonable Risk; Small Entity Compliance Guide, 2007. http://www.fda.gov/Food/GuidanceComplianceRegulatoryInformation/GuidanceDocuments/DietarySupplements/ucm07299.htm

  • US Food and Drug Administration Center for Food Safety and Applied Nutrition. Draft Risk and Benefit Report. Report of Quantitative Risk and Benefit Assessment of Consumption of Commercial Fish, Focusing on Fetal Neurodevelopmental Effects (Measured by Verbal Development in Children) and on Coronary Heart Disease and Stroke in the General Population, 2009. http://www.fda.gov/Food/FoodSafety/Product-SpecificInformation/Seafood/FoodbornePathogensContaminants/Methylmercury/ucm088758.htm

  • Watzl B, Gelencsér E, Hoekstra J, Kulling S, Lydeking-Olsen E, Rowland I, Schilter BS, van Klaveren J, Chiodini A. Application of the BRAFO-tiered approach for benefit-risk assessment to case studies on natural foods. Food Chem Toxicol. 2012;50:S699–709.

    Article  CAS  Google Scholar 

  • Wei ZH, Wang H, Chen YX, Wang BS, Rong ZX, Wang BS, Su BH, Chen HZ. Time- and dose-dependent effect of psyllium on serum lipids in mild-to-moderate hypercholesterolemia: a meta-analysis of controlled clinical trials. Eur J Clin Nutr. 2009;63:821–7.

    Article  CAS  Google Scholar 

  • Weinberg BA, Bealer BK. The world of caffeine: the science and culture of the world’s most popular drug. New York: Routledge; 2001, 394p.

    Google Scholar 

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Authors and Affiliations

  1. Hylobates Consulting srl, Rome, Italy

    Antonella Guzzon & Luca Bucchini

Authors
  1. Antonella Guzzon
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  2. Luca Bucchini
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Correspondence to Antonella Guzzon .

Editor information

Editors and Affiliations

  1. Department of Pharmacological and Biomolecular Sciences, Università degli Studi di Milano, Milan, Italy

    Patrizia Restani

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Guzzon, A., Bucchini, L. (2018). Risk and Benefit Assessment: Methodologies and Scientific Acceptance. In: Restani, P. (eds) Food Supplements Containing Botanicals: Benefits, Side Effects and Regulatory Aspects. Springer, Cham. https://doi.org/10.1007/978-3-319-62229-3_14

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