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What's in a Name? – Defining a ‘Nanomaterial’ for Regulatory Purposes in Europe

Published online by Cambridge University Press:  20 January 2017

Joel D'Silva
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Extract

Attempts at suitable identification of a generally accepted definition of a ‘nanomaterial’ have been going on in Europe and worldwide for some time. Definitions are important from a regulatory perspective as “they assist in establishing the subject matter and scope of what is to be regulated”. However, considering the complexities associated with nanoscience and also the differing opinions on various definitions, this has not been an easy task. Reaching an agreement on fundamental terms and definitions such as ‘nanotechnology’, ‘nanoparticle’, ‘nanoscale’, and a ‘nanomaterial’ is both complex and contested. To date, there is no internationally recognised and accepted definition of a ‘nanomaterial’ even though several definitions have been discussed and proposed by national authorities, scientific committees, international organisations, and other bodies.

Type
Reports
Information
European Journal of Risk Regulation , Volume 2 , Issue 1 , March 2011 , pp. 85 - 91
Copyright
Copyright © Cambridge University Press 2011

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References

1 Bowman, Diana, D’Silva, Joel and Van Calster, Geert, “Defining Nanomaterials for the purpose of Regulation within the European Union”, 1(2) European Journal of Risk Regulation (2010), p. 115 CrossRefGoogle Scholar; see also Williams, David, “The Scientific Basis for regulating nanotechnologies”, in Hodge, Graeme A., Bowman, Diana M. and Maynard, Andrew D. (eds), International Handbook on Regulating Nanotechnologies (Cheltenham: Edward Elgar, 2010), pp. 109–111 Google Scholar.

2 Ibid.; 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.

3 Ibid.

4 John Miles, “Nanotechnology Captured”, in Graeme A. Hodge, Diana M. Bowman and Andrew D. Maynard (eds), International Handbook on Regulating Nanotechnologies, supra note 1, p. 85; see also Maynard, Andrew and Kuempel, E.D., “Airborne nanostructured particles and occupational health”, 7 Journal of Nanoparticle Research (2005), pp. 587–614 CrossRefGoogle Scholar; D’Silva, Joel and Van Calster, Geert, “Taking Temperature – A Review of European Union regulation in Nanomedicine”, 16(3) European Journal of Health Law (2009), pp. 249–269 CrossRefGoogle Scholar.

5 Diana Bowman et al., “Defining Nanomaterials”, supra note 1, pp. 115–122; see also John Miles, “Nanotechnology Captured”, in Graeme A. Hodge, Diana M. Bowman and Andrew D. Maynard (eds), International Handbook on Regulating Nanotechnologies, supra note 1, pp.85–89. The number of published national standards on nanotechnology is steadily increasing. For example, the Standardization Administration of the People's Republic of China has published seven national standards and implemented them in 2005. Russia's National Standards Body-Federal Agency for Technical Standards has also developed various standards.

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

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

8 Diana Bowman et al., “Defining Nanomaterials”, supra note 1, p. 116.

9 For more definitions, see Diana Bowman et al., “Defining Nanomaterials”, supra note 1, pp. 121–122. For comparison of definitions, see Report of the International Cooperation on Cosmetic Regulation (ICCR) Joint Ad Hoc Working Group On Nanotechnology in Cosmetic Products, Toronto Canada, (2010), pp. 15–17, available on the Internet at <http://www.hc-sc.gc.ca/cps-spc/alt_formats/hecs-sesc/pdf/person/cosmet/info-ind-prof/iccr-4_2010-eng.pdf> (last accessed on 6 January 2011).

10 European Commission, Regulatory Aspects of Nanomaterials (Brussels: Commission of the European Communities, 2008), p. 3 Google ScholarPubMed.

11 Scientific Committee on Emerging and Newly Identified Health Risks, Opinion on the Scientific aspects of the existing and proposed definitions relating to products of nanoscience and nanotechnologies (Brussels: SCENIHR, 2007), p. 18, available on the Internet at <http://ec.europa.eu/health/ph_risk/committees/04_scenihr/docs/scenihr_o_012.pdf> (last accessed on 1 January 2011).

12 Regulation (EC) No 1223/2009, L 342/59 – Article 2(1)(k).

13 Article 3(2)(cc) – Proposed text of the Novel Foods Regulation, available on the Internet at <http://register.consilium.europa.eu/pdf/en/09/st10/st10754.en09.pdf> (last accessed on 1 January 2011).

14 This definition is also being used by the European Food Safety Authority (EFSA) in its Draft Guidance on risk assessment concerning potential risks arising from applications of nanoscience and nanotechnologies to food and feed (endorsed for public consultation in 2011). The document gives practical guidance for carrying out risk assessment on the use of engineered nanomaterials (ENM) in food and feed. Available on the Internet at <http://www.efsa.europa.eu/en/consultations/call/scaf110114.pdf> (last accessed on 20 January 2011).

15 Special or unique properties that are characteristics of the nanoscale are similarly deemed to be important, even where the structures, agglomerates or aggregates are above the 100 nm threshold

16 JRC Reference Report, EUR 24403 EN (2010), available on the Internet at <http://ec.europa.eu/dgs/jrc/downloads/jrc_reference_report_201007_nanomaterials.pdf> (last accessed on 14 December 2010).

17 Ibid., p. 7.

18 JRC Report, p. 30.

19 Ibid.

20 Ibid., p. 31.

21 Ibid., p. 5.

22 Ibid., p. 30.

23 SCENIHR Opinion Paper (2010), available on the Internet at <http://ec.europa.eu/health/scientific_committees/emerging/docs/scenihr_o_030.pdf> (last accessed on 4 January 2011).

24 Ibid., p. 4.

25 Ibid., p. 30. The document also clarifies that the European Commission urgently needs to elaborate a working definition of the term ‘nanomaterials’ to “ensure the consistency of forthcoming regulatory developments to guide, as appropriate, the effective implementation of existing regulation, and to contribute to international work and dialogue on nanotechnology definitions.” Clarification is needed more specifically on “the size ranges and other relevant characteristics and corresponding metrics reported in the scientific literature, the types of physical and chemical properties particular to nanomaterials, the relevant thresholds, as well as the most appropriate metrics to express such thresholds” (Ibid., p. 9).

26 Ibid., p. 9.

27 Ibid., p. 24.

28 Ibid.

29 Ibid.

30 Ibid.

31 SCENIHR Opinion Paper (2010), p. 24.

32 Ibid., p. 31.

33 Ibid., p. 27.

34 Ibid., p. 26.

35 Ibid., p. 34.

36 Using 500 nm as high upper threshold and 100 nm as the low upper threshold. SCENIHR Consultation opinion, pp. 33–34.

37 Final SCENIHR Opinion, 8 December 2010, p. 36, available on the Internet at <http://ec.europa.eu/health/scientific_committees/emerging/docs/scenihr_o_032.pdf> (last accessed on 7 January 2011).

38 Ibid., p. 6.

39 JRC Report (2010), p. 7.

40 Final SCENIHR Opinion (2010), p. 35.

41 Ibid., p. 4.

42 See for example, European Association for Chemical and Molecular Sciences (EuCheMS), reply to the public consultation, available on the Internet at <http://www.euchems.org/binaries/Consultatio-Nanomaterial_tcm23-195664.pdf>.

43 For example, Position of AmCham EU, available on the Internet at <http://www.amchameu.eu/DesktopModules/Bring2mind/DMX/Download.aspx?TabId=165&Command=Core_Download&EntryId=5768&PortalId=0&TabId=165>.

44 NIA Comments on the SCENIHR opinion, p. 3, available on the Internet at <http://www.nanotechiaopustest.com/managed_assets/files/20101119_nia_replyform_eu_nanomaterialsdefinition_final.pdf>.

45 Ibid.

46 Ibid., p. 13.

47 Ibid.

48 The Commission justified the short consultation period by stating that this draft proposal builds on the SCENIHR opinion, and the SCENIHR pre-consultation opinion on the Scientific basis for the definition of the term ‘nanomaterial’ was closed after 8 weeks of consultation on 15 September 2010. It also states that the draft Recommendation is only intended for consultation purposes and does not represent or prejudge the Commission's final position.

49 Draft Commission Recommendation on the definition of the term ‘nanomaterial’, p. 5, available on the Internet at <http://ec.europa.eu/environment/consultations/pdf/recommendation_nano.pdf> (last accessed on 16 January 2011).

50 ISO 146446:2007.

51 Background note available on the Internet at <http://ec.europa.eu/environment/consultations/pdf/background_nano.pdf> (last accessed on 16 January 2011).

52 Liden, Goran, “The European Commission Tries to Define Nanomaterials”, Vol. 55, No. 1, Annals of Occupational Hygiene (2011), p. 3 Google ScholarPubMed.

53 Ibid.

54 Ibid., p. 3.

55 Draft Commission Recommendation (2010), p. 3.

56 Ibid.

57 For the definition to be useable, the EC foresees a strong need for standardisation of all aspects of measurement related to the definition. Due to the development of science and technology and potential problems with the application of the definition in the writing of legislation, the EC aims to carry out a new public consultation on the definition in 2012. See Liden, Goran, “The European Commission Tries to Define Nanomaterials”, Vol. 55, No. 1, Annals of Occupational Hygiene (2011), p. 2 Google ScholarPubMed.

58 Dana, David, “Can the Law track Scientific Risk and Technological Innovation? The Problem of Regulatory definitions and Nanotechnology”, in Dana, David (ed.), The Nanotechnology Challenge (Cambridge University Press, 2010), p. 1 Google Scholar; Northwestern Public Law Research Paper No. 10-83. Available on the Internet at SSRN <http://ssrn.com/abstract=1710928>.

59 Diana Bowman et al., “Defining Nanomaterials”, supra note 1, p. 120.

60 For example, in Australia, the National Industrial Chemicals Notification and Assessment Scheme (NICNAS) defines nanomaterials as “industrial materials intentionally produced, manufactured or engineered to have unique properties or specific composition at the nanoscale, that is a size range typically between 1 nm and 100 nm, and is either a nano-object (i.e. that is confined in one, two, or three dimensions at the nanoscale) or is nanostructured (i.e. having an internal or surface structure at the nanoscale).” Further, the Notes to the working definition add that “where size distribution shows 10% or more of a substance (based on number of particles) is at the nanoscale, NICNAS will consider this substance to be a nanomaterial for risk assessment purposes.” The difference between 1%, as per the European Commission definition, and 10% in the NICNAS, could mean that many more substances would fall within the definition under EU standards than under Australian standards. See, NICNAS, Chemical Gazette (2011), available on the Internet at <http://www.nicnas.gov.au/Publications/Chemical_Gazette/pdf/2011jan_whole.pdf>.

61 See Violet, Franck, “Analysis of Technical Standards in the field of nanotechnology”, 7 Nanotechnology Law & Business (2010), p. 301 Google Scholar.

62 Ibid.

63 Bergeson, Lynn and Auer, Charles, “Nano Disclosures: Too Small to Matter or Too Big to Ignore?”, 25(3) Natural Resources & Environment (2011)Google Scholar; see also Rizzuto, Pat and Pritchard, Bill, “Industry Developing Nanoengineered Goods Frustrated by Regulators’ Lack of Definitions”, 93 Daily Envt. Rpt. (BNA) B-1 (2010)Google Scholar.

64 Diana Bowman et al., “Defining Nanomaterials”, supra note 1, p. 121.

65 Ibid.

66 Morris Jeff et al., “Science Policy Considerations for responsible nanotechnology decisions”, Nature Nanotechnology (2010), Commentary:doi:10.1038/nnano.2010.191, p. 3.

67 Ibid., p. 4.

68 John Miles, “Nanotechnology Captured”, in Graeme A. Hodge, Diana M. Bowman and Andrew D. Maynard (eds), International Handbook on Regulating Nanotechnologies, supra note 1, p. 105.

69 Rathenau Instituut, Reply to the Consultation on the Proposal for a Commission definition of the term ‘nanomaterial’ (2010), available on the Internet at <http://www.rathenau.nl/fileadmin/user_upload/rathenau/NanoDialoog/Nieuws/reply_form_nanomaterials_-_Rathenau_Institute.pdf>.

70 Ibid.