The European regulation of food supplements and food fortification: Intended normal use - The ultimate tool in organising level playing field markets and regulations, or how to break the fairy ring around 'other substances'

Environmental Law and Management

Volumn 19, Issue 1, 2007, Pages 19-29

  Schwitters, Bert ^a   Achanta, Geetha ^a   van der Vlies, Dennis ^a   Morisset, Hervé ^a   Bast, Aalt ^b   Hanekamp, Jaap C ^c  

^a INC Agency BV ^*

^b MAASTRICHT UNIVERSITY   (Netherlands)

^c HAN Research   (Turkey)

Author keywords

[No Author keywords available]

Indexed keywords

EUROPEAN UNION; FOOD MARKET; FOOD POLICY; FOOD SAFETY; LEGISLATION; MARKETING; REGULATORY FRAMEWORK;

EURASIA; EUROPE; NORTH AMERICA; UNITED STATES;

EID: 34249078791     PISSN: 10676058     EISSN: None     Source Type: Journal    
DOI: None     Document Type: Article

References (37)

1. Council Directive of 21 December 1988 (89/106/EEC) on the approximation of laws, regulations and administrative provisions of the Member States relating to construction products [1989] OJ L0106/1-19.
2. 'Discussion Paper on "Botanicals and Botanical Preparations widely uses as food supplements and related products: Coherent and Comprehensive Risk Assessment and Consumer Information Approaches"' (2004) European Food safety Authority, Brussels (emphasis added).
3. Tacit knowledge, as opposed to codified (usually scientific) knowledge, is part and parcel of our daily lives and is transmitted through interpersonal contact, not through schoolbooks or scientific publications. Skills and traditions that have formed in laboratories, for instance, are utilised extensively, yet are not part of the codified output, such as journal publications and books. Therefore, even scientific knowledge in the public domain needs to be found, interpreted by specialists, and reprocessed for actual use.
4. C Starr 'Social benefit versus technological risk' (1969) 165 Science 1232-38.
5. Regulation (EC) 258/97 of the Europen Parliament and the Council of 27 January 1997 concerning novel foods and novel ingredients [1997] OJ L43/ 1-7.
6. See eg D 5 Wheeler et al 'The Medicinal Chemistry of Tea' (2004) 61 Drug Dev Res 45-65.
7. J M Buchanan and G Tullock The Calculus of Consent (University of Michigan Press Ann Arbor 1962).
8. 'Guidance for Industry. Botanical Drug Products' (2004) US Department of Health and Human Services, Food and Drug Administration, Center for Drug Evaluation and Research (CDER).
9. See http://www.fda.gov/cdrh/k863.html (last accessed on 11 April 2007).
10. ibid.
11. Regulation (EC) 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 [2002] OJ L31/1-24.
12. 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 [2002] OJ L183/51-57.
13. Regulation (EC) 1925/2006 of the European Parliament and of the Council of 20 December 2006 on the addition of vitamins and minerals and of certain other substances to foods [2006] OJ L404/26-38.
14. See http://europa.eu.int/eur-lex/en/treaties/dat/C_2002325EN.003301.html (last acccessed on 11 April 2007).
15. ibid.
16. Commission v Germany (2004) Case C-387/99.
17. See http://eurlex.europa.eu/LexUriServ/ LexUriServ.do?uri=CELEX:61999J0387:EN:HTML (last accessed on the 11 April 2007).
18. J C Hanekamp 'The precautionary principle: a critique in the context of the EU Food Supplements Directive' (2006) 2 Env. Liability 43-51;
19. J C Hanekamp and A. Bast 'Food supplements and fortified foods: the EC's patriarchal precautionary perspective on public health' (2006) 5 Env. Liability 181-91.
20. See http://europa-eu/scadplus/leg/en/lvb/126073.htm (last accessed 11 April 2007, emphasis added).
21. Commission of the European Communities (2007) 'Communication from the Commission to the Council, the European Parliament, the European Economic and Social Committee and the Committee of the Regions: A Single Market for Citizens' Brussels.
22. See n 3.
23. See note 9, emphasis added.
24. See http://www.ars.usda.gov/Aboutus/docs.htm?docid=4142 (last accessed on 11 April 2007).
25. See n 3.
26. See n 18.
27. J C Hanekamp and A Bast 'Food Supplements and European Regulation within a Precautionary Context: A Critique and Implications for Nutritional, Toxicological and Regulatory Consistency' (2007) 47 Crit Rev Food Sci Nutr 267-85.
28. See n 18.
29. See n 15.
30. See n 17 (emphasis added). Similar wording can be found in the ECJ's judgment of 9 June 2005 in Joined Cases C-211/03, C-299/03 and C-316 to C-318/03.
31. See http://eur-lex.europa.eu/LexUriServ/ LexUriServ.do?uri=CELEX:62003J0211:EN:HTML (last accessed on 11 April 2007).
32. See https://portal.health.fgov.be/pls/portal/docs/PAGE/INTERNET_PG/ HOMEPAGE_MENU/VOEDSELVEILIGHEID1_MENU/VOEDINGSMIDDELEN1_MENU/ SUPPLEMENTEN1_MENU/SUPPLEMENTEN1_DOCS/KB_29_08_97_PLANTEN.PDF (last accessed 11 April 2007).
33. P Coppens et al 'Use of Botanicals in Food Supplements. Regulatory Scope, Scientific Risk Assessment and Claim Substantiation' (2006) 50 Annals of Nutr & Metab 538-54.
34. See Coppens et al (n 31) at 540. Coppens specifically refers to the ETAF (European Training and Assessment Foundation) publication of 2002 in which pharmacological dosage (not therapeutic dosage) is a key element in the decision tree. However, in view of the intended use approach suggested in the current paper, pharmacological dosage is consistently secondary to intended use.
35. A Bast et al 'Botanical health products, positioning and requirements for effective and safe use' (2002) 12(4) Env Tox Pharm 195-211.
36. Regulation (EC) 1924/2006 of the European Parliament and the Council of 20 December 2006 on nutrition and health claims made on foods [2006] OJ L404/9-25.
37. B Yandle 'Public Choice at the Intersection of Environmental Law and Economics' (1999) 8 Eur J Law Econ 5-27.