Regulating nanotechnology in the European union

Nanotechnology Law and Business

Volumn 3, Issue 3, 2006, Pages 359-372

  Van Calster, Geert ^a,b,c  

^a UNIVERSITY OF LEUVEN   (Belgium)

^b UNIVERSITY OF OXFORD   (United Kingdom)

^c Brussels Bar ^*  (Belgium)

Author keywords

[No Author keywords available]

Indexed keywords

AUTHORIZATION; CHEMICAL POLICY; REGISTRATION; REGULATORY FRAMEWORKS;

CHEMICAL INDUSTRY; LAWS AND LEGISLATION; PRODUCT LIABILITY; REGULATORY COMPLIANCE; SAFETY FACTOR;

NANOTECHNOLOGY;

EID: 33750330226     PISSN: 15462080     EISSN: 15462080     Source Type: Trade Journal    
DOI: None     Document Type: Article

References (54)

1. See JOHN C. MILLER ET AL., THE HANDBOOK OF NANOTECHNOLOGY: BUSINESS, POLICY, AND INTELLECTUAL PROPERTY LAW 63 (2004) (noting that the lack of a formal regulatory review process provides political ammunition for those opposed to the technology, e.g., on precautionary grounds).
2. See R. Sandier & W. D. Kay, The GMO-Nanotech (Dis)Analogy?, 26 BULL. OF SCI. TECH. & SOC'Y 57 (2006) (warning against the oversimplification of some of those analogies).
3. J. CLARENCE DAVIES, MANAGING THE EFFECTS OF NANOTECHNOLOGY (Woodrow Wilson International Center for Scholars, Paper for the Project on Emerging Nanotechnologies, 2006) available at http://www.innovationsgesellschaft.ch/ images/publikationen/manangingeffects.pdf (last visited July 14, 2006). Over and above the specific references in this section, this section is largely based on Dr. Davies' analysis.
4. Id.
5. The EPA, in its applying the 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.
6. See DAVIES, supra note 3, at 8
7. ; see also LINDA K. BREGGIN, SECURING THE PROMISE OF NANOTECHNOLOGY: Is US ENVIRONMENTAL LAW UP TO THE JOB? (2005).
8. Id.
9. National Geographic defines these as "[t]iny molecules strung in long repeating chains." National Geographic Society, What Are Polymers? (1997), at http://www.nationalgeographic.com/education/plastics/describe.html. The European Commission's proposal on a new European chemicals policy, defines them somewhat more legalistically as follows: 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. Comm'n of the Eur. Communities, Proposal for a Regulation of the European Parliament and of the Counsel 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, Proposal for a Directive of the European Parliament and of the Council, amending Council Directive 67/548/EEC in Order to Adapt it to Regulation (EC) of the European Parliament and Council concerning the registration, evaluation, authorization, and restriction of chemicals, {SEC(2003 1171)}, Chap. 2, Art. 3(4), COM (2003) 644, available at http://europa.eu.int/eurlex/en/com/pdf/2003/ act0644en03/1.pdf (last visited July 14, 2006).
10. See DAVIES, supra note 3, at 11-12.
11. MILLER ET AL., supra note 1, at 53.
12. See BREGGIN, supra note 6, at 9.
13. See DAVIES, supra note 3, at 13. A similar issue may apply to the FDA regulation (see infra) in the future.
14. See MILLER ET AL., supra note 1, at 102.
15. MILLER ET AL., supra note 1, at 90.
16. See id. at 95.
17. DAVIES, supra note 3, at 13.
18. See International Ctr. for Tech. Assessment, Citizen Petition to the United States Food and Drug Administration, http://www.icta.org/doc/ Nano%20FDA%20petition%20final.pdf (last visited July 14, 2006).
19. BREGGIN, supra note 6, at 12 ff.
20. See John C. Monica, Jr., Patrick T. Lewis & John C. Monica, Preparing for Future Health Litigation: The Application of Products Liability Law to Nanotechnology, 3 NANOTECH. L. & Bus. 54 (2006).
21. Id.
22. Stefan M. L. Tormans, Nanotechnology in Europe-Regulating the Infinitely Small, ENERGY AND ENVIRONMENTAL LAW-2005: RECENT DEVELOPMENTS IN INTERNATIONAL, EUROPEAN, AND COMPARATIVE ENERGY AND ENVIRONMENTAL LAW (Geert van Calster & Kurt Deketelaere eds., 2005), available at http://www.law.kuleuven.be/imer/ Yearbook%20-%20Energy%20&%20Environmental%20Law_2005.pdf (last visited July 14, 2006) (reviewing the "usual suspects").
23. Comm'n for Eur. Communities, Welcome to the Nanotechnology Homepage of the European Commission, CORDIS.EUROPA.Eu, http://cordis.europa.eu/ nanotechnology/ (last visited July 14, 2006) (listing various policy documents with regard to nanotechnology regulation in Europe).
24. Council Directive 2001/18, art. 2(1), 2001 O.J. (L106) 1.
25. See Tormans, supra note 201, at 489.
26. Council Directive 67/548/EEC, of 27 June 1967 on the approximation of laws, regulations and administrative provisions relating to the classification, packaging and labelling of dangerous substances, 196 O.J. 16.8.1967, at 1.
27. See Comm'n of the Eur. Communities, supra note 9, and accompanying text.
28. Comm'n of the Eur. Communities, Questions and Answers on REACH, EC.EUROPA.EU (Mar. 23, 2006), http://register.consilium.eu.int/pdf/en/05/st15/ st15921.en05.pdf (last visited July 14, 2006).
29. Veerle Heyvaert, Guidance without Constraint: Assessing the Impact of the Precautionary Principle on the European Community's Chemicals Policy, in 6 Yearbook of European Environmental Law 27 (Thijs Etty & Han Somsen eds., 2006).
30. Giorgia Guerra, A Model for Regulation of Medical Nanobiotechnology: The European Status Quo, 3 NANOTECH. L. & Bus. 84 (2006).
31. TIJU JOSEPH & MARK MORRISON, NANOTECHNOLOGY IN AGRICULTURE AND FOOD, NANOFORUM.ORG (Apr. 2006), http://www.nanoinfo.jp/whitepaper/WP81NA.pdf (last visited July 14, 2006).
32. Regulation 258/97 on novel foods, 1997 O.J. (L43) 1.
33. See also, RAYMOND O'ROURKE, EUROPEAN FOOD LAW 300 (3d ed. 2005).
34. Council Directive 2004/35, 2004 O.J. L(143) 56.
35. Comm'n of the Eur. Communities, Questions and Answers Environmental Liability Directive, Memo 04/78 (Apr. 1, 2004), available at http://europa.eu/rapid/pressReleasesAction.do?reference=MEMO/04/78&format= HTML&aged=0&language=EN&guiLanguage=en (last visited July 14, 2006).
36. Council Directive 85/374, on the approximation of the laws, regulations and administrative provisions of the Member States concerning liability for defective products, [1985] O.J. L210.
37. See Gonzalez Sanchez v. Medicina Asturiana S.A., [2002] ECR I-3901, Eur. Ct. of Justice, Case No. C-183/00.
38. DUNCAN FAIRGRIEVE, PRODUCT LIABILITY IN COMPARATIVE PERSPECTIVE 1 (2005).
39. COM (2000) 1.
40. 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. See http://www.unece.org/env/pp/treatytext. htm (last visited July 14, 2006)
41. Comm'n for the Eur. Communities, Towards a European Strategy for Nanotechnology, at 22, COM(2004) 338 (2004), available at http://ec.europa.eu/ research/industrial_technologies/pdf/nanotechnology_communication_en.pdf (last visited July 14, 2006).
42. Mihail C. Roco, The Emergence and Policy Implications of Converging New Technologies Integrated from the Nanoscale, 7 J. OF NANOPARTICLE RES. 129, 129-43 (2005);
43. David Winickoff et al., Adjudicating the GM Food Wars: Science, Risk and Democracy in World Trade Law, 30 YALE J. OF INT'L L. 81, 81-123 (2005).
44. GEERT VAN CALSTER, INTERNATIONAL AND E.U. TRADE LAW - THE ENVIRONMENTAL DIMENSION (2000).
45. Graeme Hodge & Diana Bowman, Governing Nanotechnology: Setting the Regulatory Agenda, 10 J. OF CONTEMPORARY ISSUES IN BUS. & GOV'T 25 (2004).
46. Gary E. Marchant, Genomics and Environmental Regulation - Scenarios and Implications, Paper Published for the Foresight and Governance Project of the Woodrow Wilson International Center for Scholars, 2002, available at http://www.law.asu.edu/riles/Programs/Sci-Tech/Commentaries/marchantwhitepaper. pdf (last visited July 14, 2006);
47. Glenn Harlan Reynolds, Nanotechnology and Regulatory Policy: Three Futures, 17 HARV. J. OF L. & TECH. 179 (2003);
48. Scott Segal, Environmental Regulation of Nanotechnology: Avoiding Big Mistakes for Small Machines, 1 NANOTECH. L. & Bus. 290 (2004);
49. Jason Wejnert, Regulatory Mechanisms for Molecular Nanotechnology, 44 JURIMETRICS J. 1 (2004).
50. More details in the author's forthcoming contribution in Geert van Calster, Governance Structures for Nanotechnology Regulation in the European Union, ENVT'L. L. REP. (forthcoming, manuscript on file with author).
51. COMM'N OF THE EUR. COMMUNITIES, EUROPEAN GOVERNANCE: A WHITE PAPER, (Apr. 2001), COM (2001) 428, available at http://ec.europa.eu/governance/white_paper/ en.pdf (last visited July 14, 2006).
52. ISO, TC 229: Nanotechnologies, http://www.iso.org (last visited July 14, 2006).
53. Id.
54. The interim ruling is available at http://www.foeeurope.org/biteback/ WTO_decision.htm (last visited July 14, 2006).