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Overcoming Nanomaterial Uncertainties: A Responsive Governance Framework

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Environmental Law and Economics

Part of the book series: Economic Analysis of Law in European Legal Scholarship ((EALELS,volume 4))

Abstract

The UN Sustainable Development Goals aim to minimize the adverse impacts of chemicals on human health and the environment by 2020. It is up to legislators to provide the appropriate framework conditions for such developments. In the case of nanomaterials , this task is however quite challenging, as risks of these substances to human health and the environment are to a great extent uncertain. In situations of such regulatory complexity, legislators can benefit from responsive governance approaches that take into account the actual incentive and impediment situation of the relevant actors to facilitate innovation behaviour that is directed at sustainable development. To this end, this article suggests an integrative governance perspective, based on institutional analysis , taking into account all relevant external framework conditions as well as behavioural settings of actors along the supply chain of nanomaterials .

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Notes

  1. 1.

    UN General Assembly, Transforming our world: the 2030 Agenda for Sustainable Development, Resolution adopted by the General Assembly, 25.9.2015, A/70/L.1.

  2. 2.

    Para. 13, 17 Agenda 2030.

  3. 3.

    See UN General Assembly, Addis Ababa Action Agenda of the 3rd International Conference on Financing for Development, Resolution adopted by the General Assembly, 27.7.2015, A/RES/69/313 as well as references hereupon in para. 40, 62, 70 and 36 Agenda 2030.

  4. 4.

    Para. 47 et seq., 72 et seq. Agenda 2030.

  5. 5.

    This target refers to para. 23 of Johannesburg Declaration on Sustainable Development and Plan of Implementation of the World Summit on Sustainable Development, 26 August - 4 September 2002, South Africa.

  6. 6.

    Para. 28 Agenda 2030.

  7. 7.

    Para. 67 Agenda 2030, c.f. ibid. para. 28, 39, 52.

  8. 8.

    Para. 28 and e.g. target 12.1 Agenda 2030.

  9. 9.

    High-Level Group on Key Enabling Technologies 2011.

  10. 10.

    E.g., the EU Horizon 2020 programme provides €13.557 billion for “Leadership in enabling and industrial technologies”, including nanotechnologies, see European Commission 2014, p. 9 et seq.

  11. 11.

    Annex to Decision No 1386/2013/EU, 2013 OJ L. 354, p. 171.

  12. 12.

    Calliess 2011, Art. 191 AEUV, para. 8.

  13. 13.

    van Leeuwen 2007, p. 16.

  14. 14.

    Savolainen, Backman, Brouwer et al. 2013.

  15. 15.

    Recital 16 Decision No 1386/2013/EU; ibid, Annex, para. 50; target 12.4 of the UN Agenda 2030.

  16. 16.

    Para. 50, 71(3) Annex to Decision No 1386/2013/EU.

  17. 17.

    Para. 50, 54 lit.f. Annex to Decision No 1386/2013/EU.

  18. 18.

    European Commission 2015, p. 20 et seq.

  19. 19.

    No 2 Commission Recommendation 2011/696/EU, 2011 OJ L. 275, p. 38.

  20. 20.

    For other characteristics refer to Commission Recommendation 2011/696/EU.

  21. 21.

    Auffan, Rose, Bottero et al. 2009, p. 634.

  22. 22.

    Steinfeldt, v. Gleich, Petschow et al. 2010.

  23. 23.

    SRU 2011, para. 77 et seq.; European Commission 2012, p. 10 et seq.; WHO 2013, 1.

  24. 24.

    Anses 2015, p. 28.

  25. 25.

    Führ 2014, para. 46.

  26. 26.

    van Leeuwen 2007, p. 22 with further references; NRC 1983, p. 11 et seq.; ECHA 2012.

  27. 27.

    European Commission 2000, p. 15.

  28. 28.

    Savolainen, Backman, Brouwer et al. 2013, p. 45.

  29. 29.

    Such as the Globally Harmonized System of Classification and Labelling of Chemicals (GHS). In Europe GHS was implemented by the CLP Regulation, c.f. below.

  30. 30.

    Grieger, Hansen and Baun 2009, p. 222.

  31. 31.

    Wehling 2011, p. 536 et seq.

  32. 32.

    A prominent example of this is the substance CFC whose unexpected ozone-depleting effect was recognized only decades later, see for this and further examples EEA 2001.

  33. 33.

    European Commission 2012, p. 13.

  34. 34.

    Krug, Wick, Nowack et al. 2013, p. 15.

  35. 35.

    Nell, Xia, Meng et al. 2013, p. 607.

  36. 36.

    Dupuy 2004, p. 16.

  37. 37.

    C.f. Hussein 2015.

  38. 38.

    WHO 2013, 1; Savolainen, Backman, Brouwer et al. 2013, p. 165, 134, 159.

  39. 39.

    Führ and Bizer 2007.

  40. 40.

    Ayres and Braithwaite 1992; Bizer, Führ and Hüttig 2002. For recent examples of responsive regulation see Ivec and Braithwaite 2015.

  41. 41.

    North 1991.

  42. 42.

    The following explanation is based on Bizer and Führ 2015 as well as Bizer and Führ 2016.

  43. 43.

    For structuring the identification and analysis of factors it is useful to refer to the three behaviourally relevant categories motivation, capabilities and opportunities developed by Ashford 2000.

  44. 44.

    The “principle that the polluter should pay” also forms one basis for EU policy on the environment, see Article 191(2) TFEU.

  45. 45.

    Regulation (EC) No 1907/2006 concerning the Registration, Evaluation, Authorisation and Restriction of Chemicals (REACH). 2006 OJ L. 396 p. 1.

  46. 46.

    Article 1(3) REACH.

  47. 47.

    Regulation (EC) No 1272/2008 on classification, labelling and packaging of substances and mixtures, 2008 OJ L. 353, p. 1.

  48. 48.

    European Commission 2008, p. 4 and 6; European Commission 2009.

  49. 49.

    Articles 10(a), 12 and Annexes VI to XI REACH.

  50. 50.

    As of 9.2.2016 the ECHA database of registered substances contains information from 53.231 dossiers on 13.876 unique substances (http://echa.europa.eu/de/information-on-chemicals/registered-substances).

  51. 51.

    Derived No-Effect Level for effects toxic to humans.

  52. 52.

    Predicted No-Effect Concentration for ecotoxic effects.

  53. 53.

    Annex I, Sect. 6.4 REACH. In addition, “the likelihood and severity of an event occurring due to the physicochemical properties of the substance” has to be negligible.

  54. 54.

    Articles 10(b), 14 and Annex I REACH.

  55. 55.

    Article 31 REACH.

  56. 56.

    Article 37 REACH.

  57. 57.

    For a definition see Führ and Bizer 2007.

  58. 58.

    Recital 86 REACH.

  59. 59.

    Articles 7(2), 33, 55 et seq. REACH.

  60. 60.

    Articles 67 et seq. REACH.

  61. 61.

    Directive 2010/75/EU on industrial emissions (integrated pollution prevention and control) (Recast), 2010 OJ L. 334, p. 17, cor. 2012 OJ L. 158f, p. 25.

  62. 62.

    Article 3(2) IPPC.

  63. 63.

    Article 6(1) Directive 98/24/EC on the protection of the health and safety of workers from the risks related to chemical agents at work (CAD), 1998 OJ L. 131, p. 11.

  64. 64.

    Article 2(c)(iii) CAD.

  65. 65.

    Directive 96/82/EC on the control of major-accident hazards involving dangerous substances (Seveso II Directive), 1997 OJ L. 10, p. 13.

  66. 66.

    Directive 2000/60/EC establishing a framework for Community action in the field of water policy (Water Framework Directive), 2000 OJ L. 327, p. 1.

  67. 67.

    Articles 3(1), 2(a), 2(b) Directive 2001/95/EG on general product safety (GPS), 2002 OJ L. 11, p. 4.

  68. 68.

    According to Article 3(3) REACH article “means an object which during production is given a special shape, surface or design which determines its function to a greater degree than does its chemical composition”.

  69. 69.

    Such substance related rules are, however, to some extend not applicable to imported articles, see Führ and Schenten et al. 2015.

  70. 70.

    See e.g. Art. 16 Regulation (EC) No 1223/2009 on cosmetic products, 2009 OJ L. 342, p. 59; Regulation (EU) No 528/212 concerning the making available on the market and use of biocidal products, 2012 OJ L. 167, p. 1; Regulation (EU) No 2015/2283 on novel foods, 2015 OJ L. 327/1, which stipulates specific rules for the authorisation of nanoscale “novel food” applies from 1 January 2018; until this date legal frameworks in the food sector generally lack appropriate rules for nanomaterials, see Schenten 2011.

  71. 71.

    See examples in fn. 1047.

  72. 72.

    Pronk, Wijnhoven, Bleeker et al. 2009, p. 13.

  73. 73.

    Führ, Hermann, Merenyi et al. 2007, p. 18 et seq.

  74. 74.

    Schenten and Führ 2012, p. 89; Gaia 2012, p. 20.

  75. 75.

    For a review of environmental legislation for the regulatory control of nanomaterials see Ganzleben, Pelsy, Hansen et al. 2011.

  76. 76.

    According to Article 4(1) CAD, to determine and assess risk of hazardous chemical agents, the employer shall consider available information provided by the supplier, e.g. in the REACH SDS; Article 5(3) GPS Directive obliges producers and distributors to inform authorities of product risks to consumers provided they “know or ought to know [such risks], on the basis of the information in their possession; see also Recital 14 REACH.

  77. 77.

    Articles 1, 2 Directive 85/374/EEC on the approximation of the laws, regulations and administrative provisions of the Member States concerning liability for defective products, 1985 OJ L. 210, p. 29 amended by Directive 1999/34/EC, 1999 L. 141, p. 20.

  78. 78.

    Ibid, Article 6.

  79. 79.

    Howells 2009.

  80. 80.

    See e.g. Schenten and Führ 2011 on interlinks between duty of care in REACH and due diligence in German corporate law.

  81. 81.

    COM(2011) 547 fin, 4.

  82. 82.

    Meili 2010, p. 1187.

  83. 83.

    SwissRe 2004; Mullins, Murphy, Baublyte et al. 2013, p. 222.

  84. 84.

    Hett and Herold 2005, p. 25.

  85. 85.

    For likely scenarios see Blaunstein, Trump and Linkov 2014, p. 259 et seq.

  86. 86.

    Lobanov 2012.

  87. 87.

    Andersson 2015.

  88. 88.

    Gubbels, Pelkmans and Schrefler 2013, p. 3.

  89. 89.

    Rossi 2014.

  90. 90.

    See corresponding findings of the annual Eurobarometer at TNS Political & Social 2014, p. 11 and 39.

  91. 91.

    See http://www.greenpeace.org/international/en/campaigns/detox/timeline/ (4.2.2016).

  92. 92.

    Schenten and Führ 2012, p. 89; Gaia 2012, p. 69, 154, 165, and 185.

  93. 93.

    Federal High Court of Justice as of 06–07-1990 - 2 StR 549/89; c.f. Schmidt-Salzer 1990, p. 2966 et seq.

  94. 94.

    Lach and Burckhardt 2013, p. 253.

  95. 95.

    See http://www.oecd.org/science/nanosafety/ (4.2.2016).

  96. 96.

    See http://www.saicm.org/index.php?option=com_content&view=article&id=456&Itemid=689 (18.4.2016).

  97. 97.

    See above fn. 5.

  98. 98.

    See Dubai Declaration on International Chemicals Management of 6 February 2006.

  99. 99.

    See e.g. the approach introduced at http://www.coso.org/-erm.htm (29.2.2016).

  100. 100.

    Pfister 2009, p. 127 et seq.

  101. 101.

    See http://www.faz.net/aktuell/wirtschaft/vw-abgasskandal/techniker-will-vw-manager-neusser-informiert-haben-13830897.html (19.2.2016).

  102. 102.

    See http://www.welt.de/wirtschaft/article146978672/Fuer-die-Trickser-im-VW-Konzern-wird-es-eng.html (19.2.2016).

  103. 103.

    Pfister 2009, p. 127 et seq.

  104. 104.

    See Führ, Merenyi et al. 2005, p. 5 et seq.

  105. 105.

    See e.g. the EU FP7 projects MARINA, MembraneNanoPart, MODERN, ModENPTox, NanoPUZZLES, NanoVALID, PreNanoTox.

  106. 106.

    See e.g. the EU FP7 projects SUN, SANOWORK, NANOMICEX, NANOVALID, GUIDEnano, NANoREG II and ProSAFE.

  107. 107.

    See e.g. the NanoRiskCat at http://nanodb.dk/en/nanoriskcat/ (29.2.2016) and the Swiss Precautionary Matrix at http://www.bag.admin.ch/nanotechnologie/12171/12174/index.html?lang=en (29.2.2016).

  108. 108.

    Schenten 2016 shows that preliminary considerations of the European Commission to change the REACH Regulation are not appropriate to make substance legislation work for nanomaterials; see also CIEL, ECOS, Öko-Institut 2015.

  109. 109.

    To some extent, FP 7 projects SUN, GUIDEnano and NANOSOLUTIONS are developing decision support systems, partly accompanied by practical tools.

  110. 110.

    For such an approach see already Stone, Führ, Bizer et al. 2016.

  111. 111.

    Führ and Bizer 2007.

  112. 112.

    European Commission 2015.

  113. 113.

    Purnhagen and Feindt 2015, p. 366 et seq.

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Authors and Affiliations

  1. Society for Institutional Analysis, University of Applied Sciences Darmstadt, Haardtring 100, Darmstadt, 64295, Germany

    Julian Schenten

  2. Department for Social and Cultural Studies, University of Applied Sciences Darmstadt, Haardtring 100, Darmstadt, 64295, Germany

    Julian Schenten & Martin Führ

  3. Department of Economics, Georg August Universität Göttingen, Platz der Göttinger Sieben 3, Göttingen, 37073, Germany

    Kilian Bizer

Authors
  1. Julian Schenten
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  2. Martin Führ
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  3. Kilian Bizer
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Correspondence to Julian Schenten .

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  1. Faculty of Law, University of Lucerne, Lucerne, Switzerland

    Klaus Mathis

  2. Notre Dame Law School, University of Notre Dame, Notre Dame, Indiana, USA

    Bruce R. Huber

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Schenten, J., Führ, M., Bizer, K. (2017). Overcoming Nanomaterial Uncertainties: A Responsive Governance Framework. In: Mathis, K., Huber, B. (eds) Environmental Law and Economics. Economic Analysis of Law in European Legal Scholarship, vol 4. Springer, Cham. https://doi.org/10.1007/978-3-319-50932-7_11

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  • DOI: https://doi.org/10.1007/978-3-319-50932-7_11

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