REACHing down: Nanomaterials and chemical safety in the European union

Law, Innovation and Technology

Volumn 2, Issue 2, 2010, Pages 193-217

  Lee, R G ^b   Vaughan, S ^a  

^a CARDIFF UNIVERSITY   (United Kingdom)

^b NONE

Author keywords

[No Author keywords available]

Indexed keywords

EID: 80052901667     PISSN: 17579961     EISSN: 1757997X     Source Type: Journal    
DOI: 10.5235/175799610794046168     Document Type: Article

References (139)

1. HM Government, UK Nanotechnologies Strategy: Small Technologies, Great Opportunities (BIS, March 2010) (hereinafter Strategy).
2. HM Government, UK Nanotechnologies Strategy: Small Technologies, Great Opportunities (BIS, March 2010) (hereinafter Strategy), 6.
3. M Roco and WS Bainbridge (eds), Societal Implications of Nanoscience and Nanotechnology (National Science Foundation, March 2001).
4. Science and Trust Expert Group, Starting a National Conversation about Good Science (BIS, March 2010).
5. Strategy (n 1) 5.
6. Regulation No 1907/2006 of the European Parliament and of the Council of 18 December 2006 concerning the Registration, Evaluation, Authorisation and Restriction of Chemicals (REACH), establishing a European Chemicals Agency, amending Directive 1999/45/EC and repealing Council Regulation (EEC) No 793/93 and Commission Regulation (EC) No 1488/94 as well as Council Directive 76/769/EEC and Commission Directives 91/155/EEC, 93/67/EEC, 93/105/EC and 2000/21/EC.
7. This is not, however, to dismiss the current debate on the appropriate nomenclature to use for substances at the nano scale, on which see BSI (2005) PAS 71:2005 Vocabulary-Nanoparticles, ASTM E2456-06 Standard Terminology Relating to Nanotechnology;
8. S Desmoulin, ‘French and European Community Law on the Nanometric Forms of Chemical Substances: Questions about How the Law Handles Uncertain Risks’ (2008) 5(3) Nanotechnology Law & Business 341.
9. H Laursen, ‘EU and US Regulatory Responses’, TACD Nanotechnologies Conference, 11 June 2009, Brussels, http://tacd.org/index.php?option=com_docman&task=cat_view&gid=86&Itemid=40.
10. D Bowman and G van Calster, ‘Does REACH Go Too Far?' [2007] Nature Nanotechnology, 2525, 2526.
11. G van Calster, ‘Regulating Nanotechnology in the European Union’ (2006) 3(3) European Environmental Law Review 238.
12. For some sense of scale, a previously used example is that a strand of human hair is approximately 80,000 nanometres in diameter (see E Stokes, ‘Regulating Nanotechnologies: Sizing up the Options’ (2009) 29 Legal Studies 281).
13. L Frater, E Stokes, R Lee and T Oriola, An Overview of the Framework of Current Regulation Affecting the Development and Marketing of Nanomaterials: A Report for the Department for Trade and Industry, ESRC BRASS Research Centre, December 2006.
14. Instead, see eg DM Bowman and GA Hodge, ‘A Small Matter of Regulation: An International Review of Nanotechnology Regulations’ (2007) 8 Columbia Science and Technology Law Review 1;
15. GH Reynolds, ‘Nanotechnology and Regulatory Policy: Three Futures’ (2003) 17 Harvard Journal of Law and Technology 179;
16. S Segal, ‘Environmental Regulation of Nanotechnology: Avoiding Big Mistakes for Small Machines’ (2004) 1 Nanotechnology Law & Business 290;
17. RF Wilson, ‘Nanotechnology: The Challenge of Regulating Known Unknowns’ (2006) 34 Journal of Law, Medicine and Ethics 704.
18. Royal Society and Royal Academy of Engineering, Nanoscience and Nanotechnologies: Opportunities and Uncertainties (Royal Society, 2004).
19. H Laursen, ‘How Nanomaterials are Covered by REACH’, ETUI-REHS, HESA Dpt/ FNV 3rd Seminar on Workers’ Protection and Chemicals, Amsterdam, 21-22 January 2008; PowerPoint presentation downloadable at www.sustainlabour.org/dmdocuments/EN144-2008.ppt.
20. European Commission, ‘Introduction to Nanotechnologies’, http://ec.europa.eu/nanotechnology/index_en. html;
21. MC Roco and WS Bainbridge, ‘Societal Implications of Nanoscience and Nanotechnology:Maximising Human Benefit’ (2005) 7 Journal of Nanoparticle Research 1.
22. See eg www.tresemme.co.uk/electrical-product.aspx?id=HD-salon-straight-nano-silver.
23. European Commission, ‘Regulatory Aspects of Nanomaterials’, SEC(2008) 2036, p 3.
24. Stokes (n 12) 283.
25. R Lee and PD Jose, ‘Self-Interest, Self-Restraint and Corporate Responsibility for Nanotechnologies:Emerging Dilemmas for Modern Managers’ (2008) 20 Technology Analysis & Strategic Management 113.
26. European Commission, ‘Communication from the Commission: Towards a European Strategy for Nanotechnology’, COM (2004) 338.
27. European Commission (n 20).
28. European Commission (2008 III), Recommendation of 07/02/2008 on a Code of Conduct for Responsible Nanosciences and Nanotechnologies Research, COM (2008) 424.
29. Resolution of the European Parliament, ‘Regulatory Aspects of Nanomaterials’, 24 April 2009, A6-0255/2009.
30. Frater et al (n 13).
31. C Hey, J Klaus and V Axel, ‘Better Regulation by New Governance Hybrids? Governance Models and the Reform of European Chemicals Policy’ (2007) 15(18) Journal of Cleaner Production 1859, 1874;
32. JS Applegate, ‘Synthesizing TSCA and REACH: Practical Principles for Chemical Regulation Reform’ (2008) 35 Ecology Law Quarterly 721;
33. E Fisher, ‘The Perfect Storm of REACH’ (2008) 11 Journal of Risk Research 541.
34. K Fischer and T Fetzer, ‘The Establishment and Empowerment of a European Chemicals Agency’ (2004) 1(1) Journal for European Environmental and Planning Law 52.
35. V Heyvaert, ‘No Data, No Market: The Future of EU Chemicals Control under the REACH Regulation’ (2007) 9(3) Environmental Law Review 201.
36. See www.sinlist.org.
37. EU Commission, White Paper, Strategy for a Future Chemicals Policy, 2001, p 4.
38. See ‘Cefic Views on the Impact of the Economic Crisis and Suggestions for the Implementation of the European Economic Recovery Plan’, February 2009, www.cefic.be/Files/Publications/Papier_Economic_ crisis_final.pdf.
39. S Milmo, ‘Reach Chemicals Regulation Hit by Computer Problems’ (2008) Chemistry World (June), www.rsc.org/chemistryworld/News/2008/June/17060801.asp.
40. D Bowman and G van Calster, ‘Reflecting REACH Global Implications of the European Union’s Chemicals Regulation’ (2007) 4 Nanotechnology Law & Business 375.
41. European Parliament, Recommendation For Second Reading on the Council common position for adopting a regulation of the European Parliament and of the Council concerning the Regulation, Evaluation, Authorisation and Restriction of Chemicals, Final A6-0352/2006, 13 October 2006.
42. European NanOSH Conference, Nanotechnologies: A Critical Area in Occupational Safety and Health, 3-5 December 2007, Marina Congress Center, Helsinki, Finland.
43. Q & A on the New Chemicals Policy, REACH (December 2006), http://europa.eu/rapid/pressReleasesAction. do?reference=MEMO/06/488.
44. ECHA, Frequently Asked Questions about REACH, Version 3.2, October 2010, http://echa.europa.eu/doc/reach/reach_faq.pdf.
45. The sub-group is made up of the Commission, Member State representatives and other, undisclosed, ‘stakeholders’. See http://ec.europa.eu/transparency/regexpert/detail.cfm?ref=2385.
46. European Commission, ‘Nanomaterials in REACH’, 16 December 2008, CA/59/2008, 6th Meeting of the REACH Competent Authorities.
47. European Commission, DG Environment, News Archive, http://ec.europa.eu/environment/chemicals/reach/ news_en.htm.
48. REACH, Art 5.
49. REACH, Art 5, Art 3(1).
50. European Commission (n 43) para 1.1.
51. REACH, Art 2(7)(b).
52. REACH, Art, Art 2(7)(a).
53. Commission Regulation (EC) No 987/2008 of 8 October 2008 amending Regulation (EC) No 1907/2006 of the European Parliament and of the Council on the Registration, Evaluation, Authorisation and Restriction of Chemicals (REACH) as regards Annexes IV and V, OJ L268/14, 9 October 2008
54. M Blainey, ‘REACH-Still Being Developed!' (2009) 6(1) Journal for European Environmental and Planning Law 51.
55. For a review see C Lam, JT James, R McCluskey, S Arepalli and RL Hunter, ‘A Review of Carbon Nanotube Toxicity and Assessment of Potential Occupational and Environmental Health Risks’ (2006) 36(3) Critical Reviews in Toxicology 189;
56. C Poland et al, ‘Carbon Nanotubes Introduced into the Abdominal Cavity of Mice Show Asbestos-like Pathology in a Pilot Study’ (2008) 3(7) Nature Nanotechnology 423.
57. Health and Safety Executive (HSE), Nanoparticles: An Occupational Hygiene Review (HSE, 2004) 54;
58. Scientific Committee on Emerging and Newly Identified Health Risks (SCENIHR), ‘Modified Opinion (after Public Consultation) on the Appropriateness of Existing Methodologies to Assess the Potential Risks associated with Engineered and Adventitious Products of Nanotechnologies’, SCENIHR/002/05, 55, http:// ec.europa.eu/health/ph_risk/committees/04_scenihr/docs/scenihr_o_003b.pdf.
59. In the United States, the Project on Emerging Nanotechnologies has inventoried more than 800 manufacturer- identified nanotechnology-based consumer products currently on the US market (see www. nanotechproject.org/inventories), but this figure has been questioned by various trade associations.
60. Royal Commission on Environmental Pollution (n 27) para 4.37.
61. See eg the June 2008 Resolution of the European Trade Union Conference (www.etuc.org/IMG/pdf_ETUC_ resolution_on_nano_-_EN_-_25_June_08.pdf) and a briefing paper by Friends of the Earth (www.vivagora. org/IMG/pdf/REACH_nano_briefing_final.pdf).
62. Stokes (n 12) 286.
63. European Commission (n 43) para 2.6.
64. B Hansen and M Blainey, ‘Registration: The Cornerstone of REACH’ (2008) 17(1) Review of European Community & International Environmental Law 107.
65. European Commission (n 43) para 2.
66. Dancet (n 36).
67. ECHA, Guidance on Registration, November 2009, http://guidance.echa.europa.eu/docs/guidance_docu ment/registration_en.pdf?vers=26_11_08.
68. REACH, Art 22(1).
69. European Commission (n 43) 4.
70. REACH, Art 22.
71. REACH, Art 14.
72. ECHA, ‘Chemical Safety Assessment and Report’, http://guidance.echa.europa.eu/chemical_safety_ en.htm.
73. CO Robichaud, D Tanzil, U Weilenmann and MR Wiesner, ‘Relative Risk Analysis of Several Manufactured Nanomaterials: An Insurance Industry Context’ (2005) 39(22) Environmental. Science and Technology 8985.
74. S McEldowney, ‘EU Chemicals Policy-A Foundation for Environmental Protection or a Missed Opportunity?' (2004) 4 European Yearbook of Environmental Law 85.
75. For the legal background to EINECS, see F Geiss, G Delbino, G Blech, O Norager, E Orthmann, G Mosselmans, J Powell, R Roy, T Smyrniotis and WG Town, ‘The EINECS Inventory of Existing Chemical Substances on the EC Market’ (1992) 37(1-2) Toxicology and Environmental Chemistry 21.
76. And which are detailed in Art 32 of REACH, running up to 2018.
77. Chemical Watch, ‘Unease over Nano Substance Identification under REACH’, 20 March 2009, http:// chemicalwatch.com/1967.
78. Personal communication of 28 May 2009 from S Vaughan to ECHA Communications team. Response sent 16 June 2009.
79. Bowman and van Calster (n 10).
80. Royal Society (n 15) 71.
81. SCENIHR (n 53).
82. European Commission (n 43) para 2.1.
83. Chemical Watch (n 72);
84. ENDS Report, EU Mulls Nanomaterials’ Status under REACH (31 March 2009), www.endsreport.com/20537/eu-states-consider-nanomaterials-reach-status.
85. In a 2008 White Paper (TSCA Inventory Status of Nanoscale Substances-General Approach), the EPA commented that not all nanoscale substances will qualify as ʼnew’ substances subject to TSCA oversight, stating that the agency will determine such matters on a case-by-case basis.
86. Chemical Watch, ‘British Firm takes REACH Stand over Carbon Nanotubes’, 17 February 2009, http:// chemicalwatch.com/1810.
87. Pre-registration ran between 1 June 2008 and 1 December 2008 and was (in essence) an optional reporting window for manufacturers or importers of phase-in substances.
88. REACH, Art 29(1) (emphasis added).
89. H Scheidmann and A Rosenfeld, ‘Forming Consortia for REACH Registration: Contractual and Competition Law Issues’ (2005) 2(3) Journal for European Environmental and Planning Law 173;
90. DA Motaal, ‘Reaching REACH: The Challenge for Chemicals Entering International Trade’ (2009) 12(3) Journal of International Economic Law 643.
91. On which see ECHA, ‘Lead Registrants’, http://echa.europa.eu/sief/lead_registrants_en.asp.
92. ECHA, Guidance on Data Sharing (September 2007), http://guidance.echa.europa.eu/docs/guidance_docu ment/data_sharing_en.pdf, p 34.
93. European Commission (n 43) para 2.3.
94. ECHA, Guidance for Identification and Naming of Substances under REACH (June 2007), http://guidance. echa.europa.eu/docs/guidance_document/substance_id_en.pdf.
95. ECHA, Guidance for Identification and Naming of Substances under REACH (June 2007), http://guidance. echa.europa.eu/docs/guidance_document/substance_id_en.pdf, 28.
96. It is somewhat difficult to search the register of all pre-registered substances (http://apps.echa.europa.eu/ preregistered/pre-registered-sub.aspx#searchthelistheader) for specific nanosubstance entries, and ECHA was unable to provide such information following a request sent by one of the authors on 20 May 2007.
97. Royal Commission (n 55).
98. For a review see RG Lee and E Stokes, ‘Twenty First Century Novel: Regulating Nanotechnologies’ (2009) 21(3) Journal of Environmental Law 469.
99. www.rcep.org.uk/news/2007-08/081112.htm.
100. SCENIHR, Risk Assessment of Products of Nanotechnologies (2009), http://ec.europa.eu/health/ph_risk/ committees/04_scenihr/docs/scenihr_o_023.pdf.
101. SCENIHR (n 53).
102. SCENIHR, Opinion on the Appropriateness of the Risk Assessment Methodology in Accordance with the Technical Guidance Documents for New and Existing Substances for Assessing the Risks of Nanomaterials (June 2007), http://ec.europa.eu/health/ph_risk/committees/04_scenihr/docs/scenihr_o_010.pdf;
103. SCENIHR, Opinion on the Scientific Aspects of the Existing and Proposed Definitions Relating to Products of Nanoscience and Nanotechnology (November 2007), http://ec.europa.eu/health/ph_risk/committees/04_ scenihr/docs/scenihr_o_012.pdf.
104. SCENIHR (n 94) 9.
105. European NanOSH Conference (n 39). This is essentially the same conclusion as that drawn by the Dutch National Institute for Public Health and the Environment. In 2009, the Institute attempted a ‘mock’ registration of nanosilver to see how, in practice, REACH applied to nanosubstances.
106. (on which see ISO, TC 229 ‘Nanotechnologies’, www.iso.org/iso/iso_technical_committee?commid=381983).
107. European Commission (n 43) 4.
108. European Commission (n 43), para 2.4.
109. ECHA, ‘Guidance on Information Requirements and Chemical Safety Assessment’, http://guidance.echa. europa.eu/docs/guidance_document/information_requirements_en.htm.
110. REACH, Title VI.
111. REACH, Title VI, Art 44(1).
112. REACH, Title VI, Art 44(2).
113. REACH, Title VI, Art 45(1).
114. European Commission (n 43) para 4.
115. n 25.
116. REACH, Art 56.
117. REACH, Art 56, Art 57.
118. REACH, Art 56.
119. European Commission (n 43) 5.
120. European Commission (n 43) 5, para 5.
121. As to why this is so, see A Franco, SF Hansen, SI Olsen and L Butti, ‘Limits and Prospects of the “Incremental Approach” and the European Legislation on the Management of Risks Related to Nanomaterials’ (2007)
122. Regulatory Toxicology and Pharmacology 171.
123. Bowman and van Calster (n 10) 382;
124. SF Hansen, L Carlsen and JA Tickner, ‘Chemicals Regulation and Precaution: Does REACH Really Incorporate the Precautionary Principle?' (2007) 10(5) Environmental Science and Policy 395.
125. European Commission (n 43) 18.
126. REACH, Art 57(f).
127. European Parliament (n 26) Amendment 79.
128. See www.afsset.fr/upload/bibliotheque/138750949955923936400847724164/afsset-report-nanomaterials. pdf.
129. ECHA, ‘Candidate List of Substances of Very High Concern for Authorization’, http://echa.europa.eu/chem_ data/candidate_list_table_en.asp.
130. Member State Committee, Support Document for Identification of Anthracene as a Substance of Very High Concern, 8 October 2008, http://echa.europa.eu/doc/candidate_list/svhc_supdoc_anthracene_publication. pdf.
131. REACH, Art 60(4).
132. See http://guidance.echa.europa.eu/authorisation_en.htm.
133. Van Calster (n 11) 242.
134. D Bryden, ‘Regulating Nanotechnology: Can Old Dogs Really Learn New Tricks?' (2008) 10 Environmental Law Review 5.
135. Frater et al (n 13).
136. European Commission (n 43) 5. It is also worth noting here that the Commission is scheduled to update its Communication on the Regulatory Aspects of Nanomaterials in 2011.
137. (on which see European Commission Joint Research Centre, ‘Policy Support on Assessment of Nanomaterials under REACH’, February 2010, http://ec.europa.eu/dgs/jrc/index. cfm?id=1410&obj_id=9830&dt_code=NWS&lang=en).
138. Strategy (n 1) 5.
139. The Institute’s conclusion was that ‘REACH is not sufficiently implementable for nanomaterials’ (see above, n 98).