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Defining Nanomaterials for the Purpose of Regulation within the European Union

Published online by Cambridge University Press:  20 January 2017

Diana Bowman ,
Joel D'Silva  and
Geert van Calster
Diana Bowman
Affiliation:
Melbourne School of Population Health, The University of Melbourne, the Department of International and European Law, KU Leuven. Email: dbowman@unimelb.edu.au; Phone: +61 3 8344 0885; Fax: +61 3 9348 1174.
Joel D'Silva
Affiliation:
K.U. Leuven, Tiensestraat 41, 3000 Leuven, Belgium. Email: joel.dsilva@ law.kuleuven.be; Phone: +32 16 32 54 68; Fax: +32 16 32 54 82.
Geert van Calster
Affiliation:
Department of International and European Law at K.U. Leuven, Belgium and a of the Brussels Bar, Of Counsel (practicing) with DLA Piper. Email: gavc@law.kuleuven.be; geert.van.calster@dlapiper.com; Phone: +32 16 32 51 32; Fax: +32 16 32 54 82.
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Abstract

Consumer desire for superior and new products has provided industry with the opportunity and market demand to incorporate and experiment with new technologies, including nanotechnologies. While these products and processes have fallen under the scope of existing regulatory frameworks, potential health and safety concerns has prompted some stakeholders to call for new, nano-specific regulations. Until now, governments have been hesitant to respond to such demands given the evolving state of the scientific art and limited international agreement as to what nanotechnologies or nanomaterials “are”. Despite these challenges, in November 2009 the European Union formally embraced the idea of specifically regulating the use of nanomaterials in cosmetic formulations. To achieve this objective, the Parliament and Council had to define what they meant by nanomaterials within the context of the adopted text in order to regulate them. It appears likely that other instruments will be similarly amended so as to include nano-specific provisions, including definitions. This article explores this policy shift within the European Union and the implications of the Parliament and Council's stance at this stage due to the absence of a generally accepted definition within the international community.

Type
Articles
Information
European Journal of Risk Regulation , Volume 1 , Issue 2 , June 2010 , pp. 115 - 122
Copyright
Copyright © Cambridge University Press 2010

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References

1 Hodge, Graeme A., Bowman, Diana and Ludlow, Karinne, “Introduction: Big questions for small technologies”, in Hodge, Graeme A., Bowman, Diana and Ludlow, Karinne (eds), New Global Regulatory Frontiers in Regulation: The Age of Nanotechnology (Cheltenham: Edward Elgar 2007), pp. 10–14 CrossRefGoogle Scholar; see also, Hunt, Geoffrey, “Nanomaterials: Nomenclature, Novelty and Necessity”, 56 Journal of Materials (2004), p. 13 Google Scholar; Drexler, Eric, “Nanotechnology: From Feynman to Funding”, in Geoffrey Hunt, W. and Mehta, Michael (eds), Nanotechnology: Risk, Ethics and Law (London: Earthscan 2006), pp. 25–34 Google Scholar.

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3 Ibid., supra note 2.

4 Council Directive of 27 July 1976 on the approximation of the laws of the Member States relating to cosmetic products (76/768/EEC).

5 Regulation (EC) 258/97 concerning Novel Foods and Novel Food Ingredients.

6 This approach can be contrasted to that of the current regulatory framework for chemical substances provided for under Regulation 1907/2006 of the European Parliament and of the Council concerning the Registration, Evaluation, Authorisation and Restriction of Chemicals (REACH). For a detailed analysis of how nanomaterials are regulated under REACH see, for example, Montfort, Jean-Philippe, Indirli, Giovanni, Georgieva, Daniela and Carrega, Claire-Marie, “Nanomaterials under REACH: Legal Aspects”, 1(1) European Journal of Risk Regulation (2010), pp. 51–62 CrossRefGoogle Scholar; Gergely, Anna, “Regulation of Nanotechnology – within REACH?”, NanoNow (February 2007), pp. 44–46 Google Scholar; and Bowman, Diana M and van Calster, Geert, “Does REACH Go Too Far?”, 1 Nature Nanotechnology (2007), pp. 525–526 CrossRefGoogle Scholar.

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8 Ibid.

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13 See, for example, the statement by the Commission in their regulatory review report that stated “that current legislation covers to a large extent risks in relation to nanomaterials and that risks can be dealt with under the current legislative framework” (European Commission, Regulatory Aspects of Nanomaterials (Brussels: EC, 2008)), at p. 3, available on the Internet at <http://ec.europa.eu/nanotechnology/pdf/comm_2008_0366_en.pdf> (last accessed on 15 December 2009).

14 Adopted Cosmetics Regulation, available on the Internet at <http://register.consilium.europa.eu/pdf/en/09/st03/st03623.en09.pdf> (last accessed on 17 December 2009).

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17 Guy Montague-Jones, “New EU rules on nanomaterials cause controversy”, 26 March 2009, available on the Internet at <http://www.cosmeticsdesign-europe.com/Products-Markets/New-EU-rules-on-nanomaterials-cause-controversy> (last accessed on 18 December 2009).

18 Guy Montague-Jones, “Trade body fights back against criticisms of new EU rules”, 1 April 2009, available on the Internet at <http://www.cosmeticsdesign-europe.com/formulation-science/trade-body-fights-back-against-criticisms-of-new-eu-rules> (last accessed on 18 December 2009).

19 For a discussion on this in relation to engineered nanoparticles see Auffan, Melanie, Rose, Jerome, Bottero, Jean-Yves, Lowry, Gregory V., Jolivet, Jean-Pierre and Wiesner, Mark R., “Towards a definition of inorganic nanoparticles from an environmental, health and safety perspective”, 4 Nature Nanotechnology (2009), pp. 634–641 CrossRefGoogle Scholar.

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