Regulating nanotechnology in the European Union

European Environmental Law Review

Volumn 15, Issue 8-9, 2006, Pages 238-247

  van Calster, Geert ^a  

^a UNIVERSITY OF LEUVEN   (Belgium)

Author keywords

[No Author keywords available]

Indexed keywords

ENVIRONMENTAL LEGISLATION; ENVIRONMENTAL POLICY; ENVIRONMENTAL PROTECTION; EUROPEAN UNION; NANOTECHNOLOGY; REGULATORY FRAMEWORK; TECHNOLOGY POLICY;

EURASIA; EUROPE;

EID: 33748741558     PISSN: 09661646     EISSN: None     Source Type: Journal    
DOI: 10.54648/eelr2006024     Document Type: Article

References (58)

1. Adapted from the Royal Society: http://www.royalsoc.ac.uk/ page.asp?id=1211.
2. The Economist, 1 January 2005.
3. Biotechnology has various "colours": white (industrial); red (pharmaceutical/medical), green (food and feed) and blue (environment/ marine; less frequently used). See Edgar Da Silva, "The Colours of Biotechnology: Science, Development and Humankind", Electronic Journal of Biotechnology, Vol.7, issue 3, editorial: http://www.ejbiotechnology.info/content/vol7/issue3/editorial.html. Interestingly, Dr Da Silva classiffies nanobiotechnology under the colour code "gold".
4. For the application to nanotechnology, see Thomas Kalil, in John C Miller (ed.), The Handbook of Nanotechnology (Wiley: Hoboken (NJ), 2005) xi.
5. For general purpose technology, see Boyan Jovanovic and Peter Rousseau, "General purpose technologies" in Aghion and Durlauf (eds), Handbook of Growth (Elsevier: 2005).
6. See also John C Miller (ed.), The Handbook of Nanotechnology (Wiley: Hoboken (NJ), 2005) 63: the lack of a formal regulatory review process provides political ammunition for those opposed to the technology, e.g. on precautionary grounds.
7. See however the warnings against over-simplifying the analogy: R. Sandler and W.D. Kay, "The GMO-Nanotech (dis)analogy?", Bulletin of Science, Technology and Society, Vol.26, No. 1, February 2006, 57-62.
8. J.C. Davies, 'Managing the effects of Nanotechnology', Woodrow Wilson International Center for Scholars, paper for the Project on emerging nanotechnologies, January 2006. Over and above the specific references in this section, this section is largely based on Dr Davies' analysis.
9. Ibid.
10. The Environmental Protection Agency - EPA, in applying TSCA, has also exempted chemicals produced in volumes of 10 MT or less per year - an exemption which obviously will need to be amended should one consider applying TSCA to nanotechnology products.
11. Davies, note 7 above, 8;
12. Linda Breggin, Securing the promise of nanotechnology: Is US environmental law up to the job?, Environmental Law Institute and Woodrow Wilson International Center for Scholars, October 2005, www.eli.org.
13. Ibid.
14. National Geographic defines these as "Tiny molecules strung in long repeating chains". The European Commission's proposal on a new European chemicals policy, defines them somewhat more legalistically as "Polymer means a substance consisting of molecules characterised by the sequence of one or more types of monomer units. Such molecules must be distributed over a range of molecular weights wherein differences in the molecular weight are primarily attributable to differences in the number of monomer units. A polymer comprises the following: (a) a simple weight majority of molecules containing at least three monomer units which are covalently bound to at least one other monomer unit or other reactant; (b) less than a simple weight majority of molecules of the same molecular weight. In the context of this definition a "monomer unit" means the reacted form of a monomer substance in a polymer.: Article 3(4) of Commission proposal COM(2003) 644: http://europa.eu.int/ eur-lex/en/com/pdf/2003/act0644en03/1.pdf.
15. Davies, note 7 above, 11-12.
16. John C. Miller (ed.), note 5 above, 53.
17. Breggin, note 10 above, 9 ff
18. Davies, note 7 above, 13.
19. A similar issue may apply to the FDA regulation (see below) in future: see Miller, note 5 above, 102.
20. Miller, note 5 above, 90 ff.
21. Ibid., 95.
22. Davies, note 7 above, 13.
23. See www.icta.org (last visited 24 May 2006).
24. Breggin, note 10 above, i.a. 12 ff.
25. See J.C. Monica, (jr) and P.T. Lewis, "Preparing for future health litigation: The application of products liability law to nanotechnology", Nanotechnology Law & Business, Vol.3 No. 1 (2006), 54-63.
26. Ibid.
27. See however the review of the 'usual suspects' by Stefan Tormans, "Nanotechnology in Europe - Regulating the infinitely small", in van Calster and Deketelaere (eds), Energy and Environmental Law - 2005, Leuven, Institute of Energy and Environmental Law, 2005, 479-505. Available via http://www.law.kuleuven.be/imer/ Yearbook%20-%20Energy%20&%20Environmental%20Law_2005.pdf.
28. See the various policy documents via http://cordis.eur-opa.eu/ nanotechnology/, last visited 24 May 2006.
29. OJ 2001 L106/1.
30. Tormans, note 24 above, 489.
31. OJ 1967 L196/1.
32. COM(2003) 64, Proposal for a Regulation of the European Parliament and of the Council concerning the Registration, Evaluation, Authorisation and Restriction of Chemicals (REACH), establishing a European Chemicals Agency and amending Directive 1999/45/EC and Regulation (EC) on Persistent Organic Pollutants.
33. European Commission Q&A document on REACH, last visited 24 May 2006: http://ec.europa.eu/enterprise/reach/docs/reach/ qa_reach_council_2006_03_23.pdf.
34. Veerle Heyvaert, "Guidance without constraint: Assessing the impact of the precautionary principle on the European Community's chemicals policy", in Thijs Etty and Han Somsen (eds), Yearbook of European Environmental Law, Vol.6 (OUP: Oxford, 2006) 27 ff.
35. Giorgia Guerra, "A model for regulation of medical nanobiotechnology: The European status quo", Nanotechnology Law and Business Vol.3, No. 1 (2006), 84 ff.
36. Nanoforum Report on Nanotechnology in Agriculture and Food, April 2006, available via http://www.nanoinfo.jp/whitepaper/WP81NA.pdf.
37. Regulation 258/97 on novel foods, OJ 1997 L43/1. See Raymond O'Rourke, European Food Law, 3rd edn (Sweet & Maxwell: London, 2005).
38. Directive 2004/35, OJ 2004 L143/56.
39. European Commission, Memo 04/78 of 1 April 2004, available via the European Commission press room: http://europa.eu.int/rapid/ searchAction.do.
40. Directive 85/374 on the approximation of the laws, regulations and administrative provisions of the Member States concerning liability for defective products, OJ 1985 L210.
41. See the case-law of the European Court of Justice: Case C-183/00, Gonzalez Sanchez v. Medicina Asturiana SA [2002] ECR I-3901.
42. D. Fairgrieve, Product liability in comparative perspective (Cup: Cambridge, 2005) 1.
43. COM(2000) 1.
44. The Aarhus Convention grants the public rights and imposes on Parties and public authorities obligations regarding access to information and public participation and access to justice: http://www.unece.org/env/pp/ treatytext.htm
45. Commission Communication of 12 May 2004 "Towards a European Strategy for Nanotechnology", COM(2004) 338, at p. 22.
46. Mihail Roco, "The emergence and policy implications of converging new technologies integrated from the nanoscale", 2005, Journal of Nanoparticle Research, 2005, number 7, 129-143.
47. David Winickoff, Sheila Jasanoff, Lawrence Busch, Robin Grove-White, and Brian Wynne, 2005, "Adjudicating the GM food wars: Science, risk and democracy in world trade law", The Yale Journal of International Law, 2005, Vol. 30, 81-123.
48. Geert van Calster, International and EU trade law - The environmental dimension (Cameron May, London, 2000).
49. Graeme Hodge and Diana Bowman, "Governing nanotechnology: Setting the regulatory agenda", 2004, The Journal of Contemporary Issues in Business and Government, 2004, Vol. 10, Number 2, pages not specified (internet-based: www.cbs.curtin.edu.au/business/research/journals), 16p.
50. Gary Marchant, 2002, "Genomics and Environmental Regulation - Scenarios and Implications", White Paper published with the EPA (Environmental Protection Agency) and the Woodrow Wilson International Centre for Scholars, 2002, available via www.epa.gov;
51. Glenn Harlan Reynolds, 2003, "Nanotechnology and Regulatory Policy: Three Futures", 2003, Harvard Journal of Law and Technology, 179-209;
52. Scott Segal, 2004, "Environmental regulation of nanotechnology: Avoiding big mistakes for small machines", Nanotechnology Law and Business, 2004, Vol.1, 290-303;
53. Jason Wejnert, 2004, "Regulatory mechanisms for molecular nanotechnology", Jurimetrics Journal 2004, Vol. 44, 1-29.
54. More details in the author's forthcoming contribution in Environmental Law Reporter, "Governance structures for nanotechnology regulation in the European Union".
55. April 2001 White Paper on European Governance, COM(2001) 428.
56. www.iso.org, last visited 24 May 2006.
57. Ibid.
58. The interim ruling is available via http://www.foeeurope.org/biteback/ WTO_decision.htm - last visited 24 May 2006.