Use of botanicals in food supplements: Regulatory scope, scientific risk assessment and claim substantiation

Annals of Nutrition and Metabolism

Volumn 50, Issue 6, 2007, Pages 538-554

  Coppens, P ^a,h   Delmulle, L ^b   Gulati, O ^c   Richardson, D ^d   Ruthsatz, M ^e   Sievers, H ^f   Sidani, S ^g  

^a European Responsible Nutrition Alliance   (Belgium)

^b Ortis ^*  (Belgium)

^c Horphag Research   (Switzerland)

^d DPR Nutrition Limited   (United Kingdom)

^e Innéov   (France)

^f PhytoLab GmbH   (Germany)

^g Seven Seas   (United Kingdom)

^h European Disability Forum   (Belgium)

Author keywords

Botanicals, safety assessment; Food supplements, health claims; Functional foods, herbal; Herbal medicinal products, legislation; Risk assessment, herbal medicine

Indexed keywords

BOTANY; CONFERENCE PAPER; DIET SUPPLEMENTATION; FOOD COMPOSITION; FOOD SAFETY; HERBAL MEDICINE; LAW; MARKETING; PRIORITY JOURNAL; RESEARCH; RISK ASSESSMENT;

ANIMALS; BIOMEDICAL ENHANCEMENT; CONSUMER PRODUCT SAFETY; DECISION TREES; DIET THERAPY; DIETARY SUPPLEMENTS; DOSE-RESPONSE RELATIONSHIP, DRUG; DRUG LABELING; EUROPEAN UNION; EVALUATION STUDIES; EVIDENCE-BASED MEDICINE; FOOD LABELING; HEALTH PROMOTION; HUMANS; LEGISLATION, FOOD; PHYTOTHERAPY; PLANT PREPARATIONS; PLANTS, TOXIC; RISK ASSESSMENT; SPECIES SPECIFICITY;

EID: 33846891101     PISSN: 02506807     EISSN: None     Source Type: Journal    
DOI: 10.1159/000098146     Document Type: Conference Paper

References (53)

1. European Advisory Services: Marketing Food Supplements, Fortified and Functional Foods in Europe. Report 2005. ISBN 90-806995-1-9. www.eas.be
2. Directive 2004/24/EC of the European Parliament and of the Council of 31 March 2004 amending, as regards traditional herbal medicinal products, Directive 2001/83/EC on the Community code relating to medicinal products for human use. Official Journal of the European Union: L183/51, 30 April 2004.
3. Regulation (EC) No. 178/2002 of the European Parliament and of the Council of 28 January 2002 laying down the general principles and requirements of food law, establishing the European Food Safety Authority and laying down procedures in matters of food safety. Official Journal of the European Union: L31/1, 1 February 2002.
4. Directive 2002/46/EC of the European Parliament and of the Council of 10 June 2002 on the approximation of the laws of the Member States relating to food supplements. Official Journal of the European Union: L136/85, 12 July 2002.
5. Common Position (EC) No. 3/2006 adopted by the Council on 8 December 2005 with a view to adopting Regulation (EC) No. .../2006 of the European Parliament and of the Council of ...on nutrition and health claims made on foods (2006/C 80 E/03). Official Journal of the European Union: C80E/43 April 2006.
6. Common Position (EC) No. 2/2006 adopted by the Council on 8 December 2005 with a view to adopting Regulation (EC) No .../2006 of the European Parliament and of the Council of ... on the addition of vitamins and minerals and of certain other substances to foods (2006/C 80 E/02). Official Journal of the European Union: C80E/27, 4 April 2006.
7. Directive 2001/83/EC of the European Parliament and of the Council of 6 November 2001 on the Community code relating to medicinal products for human use. Official Journal of the European Union: L311/67, 28 November 2001.
8. Directive 2004/27/EC of the European Parliament and of the Council of 31 March 2004 amending Directive 2001/83/EC on the Community code relating to medicinal products for human use. Official Journal of the European Union: L136/34, 30 April 2004.
9. Case 227/82. Judgment of the Court (Fifth Chamber) of 30 November 1983. Criminal proceedings against Leendert van Bennekom. European Court Reports 1983, p 3883.
10. Case C-369/88. Judgment of the Court (Fifth Chamber) of 21 March 1991. Criminal proceedings against Jean-Marie Delattre. European Court Reports 1991, p I-1487.
11. Case C-60/89. Judgment of the Court (Fifth Chamber) of 21 March 1991. Criminal proceedings against Jean Monteil and Daniel Samanni. European Court Reports 1991, p I-1547.
12. Case C-112/89. Judgment of the Court (Fifth Chamber) of 16 April 1991. Upjohn Company and Upjohn NV v Farzoo Inc. and J. Kortmann. European Court Reports 1991, p I-1703.
13. Case C-290/90. Judgment of the Court of 20 May 1992. Commission of the European Communities v Federal Republic of Germany. European Court Reports 1992, p I-3317.
14. Case C-219/91. Judgment of the Court (Fifth Chamber) of 28 October 1992. Criminal proceedings against Johannes Stephanus Wilhelmus Ter Voort. European Court Reports 1992, p I-5485.
15. Joined Cases C-211/03, C-299/03 and C-316/03 to C-318/03. Judgment of the Court (First Chamber) of 9 June 2005. References for a preliminary ruling from the Oberverwaltungsgericht für das Land Nordrhein-Westfalen: HLH Warenvertriebs GmbH, Orthica BC v Federal Republic of Germany, European Court Reports 2005, p I-5141.
16. Bogaert P: EC Pharmaceutical Law. Chancery Law Publications 1992. ISBN 0-471-93648-0.
17. Bast A, Chandler F, Choy PC, Delmulle LM, Gruenwals J, Halkes BA, Keller K, Koeman JH, Peters P, Przyrembel H, de Ree EM, Renwick AG, Vermeer ITM: Botanical health products: positioning and requirements for effective and safe use. Environ Toxicol Pharmacol 2002; 12: 195-211.
18. Council of Europe: Guidelines on the quality, safety and marketing of plan-based food supplements. 2005;http://www.coe.int/t/e/social_cohesion/ soc%2Dsp/public_health/nutrition_food_consumer_health/ Guidelines%20food%20supplements%20%2023.06.05.pdf ref
19. European Food Safety Authority: Discussion Paper on Botanicals and Botanical Preparations Widely Used as Food Supplements and Related Products: Coherent and Comprehensive Risk Assessment and Consumer Information Approaches. 2004:http://www.efsa.eu.int/science/sc_commitee/sc_documents/616/ scdoc_advice03_botanicals_en1.pdf
20. Regulation (EC) No 258/97 of the European Parliament and of the Council of 27 January 1997 Concerning Novel Foods and Novel Food Ingredients. Official Journal of the European Union: L043/1, 14 February 1997.
21. Scientific Committee for Food: Opinions of the Scientific Committee for Food on the Assessment of Novel Foods. Reports of the Scientific Committee for Food, 40th Series, 1997, http://europa.eu.int/comm/food/fs/sc/scf/reports/ scf_reports_40.pdf
22. Schilter B, Andersson C, Anton R, Constable A, Kleiner J, O'Brien J, Renwick AG, Korver O, Smit F, Walker R: Guidance for the safety assessment of botanicals and botanical preparations for use in food and food supplements. Food Chem Toxicol 2003;41:1625-1649.
23. AFSSA Démarche d'évaluation de la sécurité, de l'intérêt et de l'allégation des denrées alimentaires contenant des plantes destinées a la consommation humaine. 2003;http://www.afssa.fr/ftp/afssa/actu/RapportPlantes.pdf
24. US Food and Drug Administration. http://www.fda.gov/
25. World Health Organisation. http://www.who.int/medicines/publications/ pharmprep/en/
26. US Agency for Healthcare Research and Quality. http://www.ahrq.gov/
27. US Pharmacopoeia. http://www.uspnf.com/uspnf/login
28. US Pharmacopoeia Dietary Supplement Verification Program. http://www.usp.org/USPVerified/
29. American Herbal Pharmacopoeia. http://www.herbal-ahp.org/bot_ref.htm
30. American Herbal Products Association. http://www.ahpa.org/
31. American College of Clinical Pharmacy, Natural Medicines Comprehensive Database. http://www.accp.com/th_06nmcd.php
32. Bundesinstituts für Arzneimittel und Medizinprodukte, Kommission E. http://www.bfarm.de/cln_042/nn_424630/DE/Arzneimittel/besTherap/amPflanz/ ampflanz-node.html__nnn = true#doc424646bodyText2
33. Health Canada National Health Products Directorate. http://www.hc-sc.gc. ca/sr-sr/finance/nhprp-prpsn/index_e.html
34. European Cooperative on Phytotherapy. http://www.escop.com/
35. European Pharmacopeia Commission. http://www.pheur.org/site/page_607.php
36. British Herbal Medicine Association. http://www.bhma.info/
37. Physician's Desk Reference. http://www.pdr.net/Home/Home.aspx
38. EMEA Committee for Medicinal Products for Human use (CHMP) - Committee for Medicinal Products for Veterinary Use (CVMP): Guideline on Quality of Herbal Medicinal Products / Traditional Herbal Medicinal Products. CPMP/QWP/2819/00 Rev 1 - EMEA/CVMP/814/00 Rev 1. 30 March 2006. www.emea.eu.int/pdfs/human/qwp/ 281900en.pdf
39. EMEA Committee for Medicinal Products for Human use (CHMP) - Committee for Medicinal Products for Veterinary Use (CVMP): Guideline on Specifications: Test Procedures and Acceptance Criteria for Herbal Substances, Herbal Preparations and Herbal Medicinal Products / Traditional Herbal Medicinal Products. CPMP/QWP/2820/00 Rev 1 - EMEA/CVMP/815/00 Rev 1. 30 March 2006. www.emea.eu.int/pdfs/human/qwp/282000en.pdf
40. World Health Organization: WHO Expert Committee on Specifications for Pharmaceutical Preparations. http://www.who.int/medicines/publications/ pharmprep/en/;
41. Good manufacturing practices: supplementary guidelines for the manufacture of herbal medicinal products. World Health Organ Tech Rep Ser 1996; 863: 34th Report, pp 109-113, 1996 (Annex 8). http://whqlibdoc.who.int/trs/ WHO_TRS_863_(p99-p194).pdf;
42. WHO Guidelines on Good Agricultural and Collection Practices (GACP) for Medicinal Plants. Geneva, WHO, 2003. whqlibdoc. who.int/publications/2003/ 9241546271.pdf;
43. Quality Control Methods for Medicinal Plant Materials, 1998, ISBN 92 4 154510 0.whqlibdoc.who.int/publications/1998/9241545100.pdf
44. European Commission: Rapid Alert System for Food and Food (RASFF). http://ec.europa.eu/food/food/rapidalert/index_en.htm
45. International Life Sciences Institute: Passclaim Project. http://passclaim.ilsi.org/file/Passclaim%20Newsflash%20final%20results%208de05. pdf
46. Aggett PJ, Antoine JM, Asp NG, Bellisle F, Contor L, Cummings JH, Howlett J, Muller DJ, Persin C, Pijls LT, Rechkemmer G, Tuijtelaars S, Verhagen H: PASSCLAIM: consensus on criteria. Eur J Nutr 2005;44(suppl 1):i5-i30.
47. Richardson DP: The scientific substantiation of health claims with particular reference to the grading of evidence Eur J Nutr 2005;44(suppl 1):319-324.
48. EMEA Working Party on Herbal Medicinal Products: Updated draft points to consider on the evidence for safety and efficacy required for well-established herbal medicinal products in bibliographic applications. 25 October 1999. EMEA/HMPWP/23/99. www.emea.eu.int/pdfs/human/hmpc/002399en.pdf
49. EMEA Working Party on Herbal Medicinal Products: Final concept paper on the implementation of different levels of scientific evidence in core-data for herbal drugs. 3 March 2004. EMEA/CPMP/HMPWP/1156/03. www.emea.eu.int/pdfs/human/ hmpc/115603en.pdf
50. World Cancer Research Fund - American Institute for Cancer Research: Food, Nutrition and the Prevention of Cancer: A Global Perspective. Washington, World Cancer Research Fund, 1997. http://www.wcrf-uk.org/report/index.lasso
51. US Food and Drug Administration, Center for Food Safety and Applied Nutrition: Guidance for Industry: Significant Scientific Agreement in the Review of Health Claims for Conventional Foods and Dietary Supplements. 22 December 1999. www.cfsan.fda.gov/~dms/ssaguide.html
52. WHO Monographs on Selected Medicinal Plants, vol I, 1999, ISBN 92 4 154517; vol II, 2002, ISBN 92 4 154537. whqlibdoc.who.int/publications/1999/ 9241545178.pdf
53. Agence Française de Sécurité Sanitaire des Aliments; http://www.afssa.fr/