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NanoEthics

, Volume 7, Issue 3, pp 189–199 | Cite as

The European and Member States’ Approaches to Regulating Nanomaterials: Two Levels of Governance

  • Aida Maria Ponce Del CastilloEmail author
Original Paper

Abstract

The nanotechnologies and nanomaterials sector is a huge and growing industry. The amount of legislation already in place and still to be produced in order to regulate it will be very substantial. What process is used to produce such regulation? The answer is that very diverse regulatory approaches are and will be used. The approach taken by the European Commission diverges from the one taken by the European Parliament. Moreover, at national level, Member States add their own contribution to the process. This article attempts to describe the landscape and various regulatory actions that have been undertaken by all these actors in the European Union. It first describes the role played by the European Commission and Parliament. It then looks at specific regulatory initiatives from a more sectoral perspective: Cosmetics, Food information, Restriction of the Use of Certain Hazardous Substances in Electrical and Electronic Equipment, Waste Electrical and Electronic Equipment and Biocides. The third part of the paper describes some major national initiatives, in particular those concerning the establishment of reporting systems for nanomaterials, mixtures, articles and consumer products containing them, as an example of how to improve the current governance in the EU and to prevent the risks to human health and the environment. The fourth part gives the perspective of the European Trade Union Confederation. Finally it presents some conclusions and policy recommendations, taking into consideration the diversity of regulatory approaches.

Keywords

Nanomaterials Nanotechnologies European nanomaterials governance Nano-regulation Harmonised databases Reporting systems 

References

  1. 1.
    Industry associations (2013) Europe needs safe and innovative nanotechnologies and nanomaterials. http://www.cefic.org/Documents/PolicyCentre/Nanomaterials/Industry-messages-on-nanotechnologies-and-nanomaterials-June2013.pdf [Accessed: 27 June 2013]
  2. 2.
    ETUC (2012) Stakeholders response to the communication on the Second Regulatory Review on nanomaterials http://www.etuc.org/IMG/pdf/Nanomaterials_joint_letter_23_10_2012_ETUC.pdf [Accessed: 27 June 2013]
  3. 3.
    European Commission (2004) Communication towards a European strategy for nanotechnology, COM(2004) 338 final, 12.5.2004Google Scholar
  4. 4.
    European Commission (2008) Communication towards a European strategy for nanotechnology, COM(2008) 366 final, 17.6.2008Google Scholar
  5. 5.
    European Commission (2012) 2nd Regulatory Review on Nanomaterials, COM(2012) 572 final, 3.10.2012.Google Scholar
  6. 6.
    European Parliament (2009) Resolution on regulatory aspects of nanomaterials (2008/2208(INI)), 24.04.2009Google Scholar
  7. 7.
    European Commission (2011) Recommendation on the definition of the term nanomaterial. (2011/696/EU) 18.10.2011Google Scholar
  8. 8.
    Official Journal of the European Union (2009) Regulation (EC) 1223/2009 of the European parliament and of the Council on cosmetic products (recast). 30 November 2009. BrusselsGoogle Scholar
  9. 9.
    European Parliament (2009) Proposal for a directive for the European Parliament and the Council on the restriction of the use of certain hazardous substances in electrical and electronic equipment (recast). [Accessed 07 June 2012]Google Scholar
  10. 10.
    European Parliament (2012) Legislative resolution on the Council position at first reading with a view to the adoption of a directive of the European Parliament and of the Council on waste electrical and electronic equipment (WEEE) (Recast) (07906/2/2011 – C7-0250/2011 – 2008/0241(COD)) 19.01.2012Google Scholar
  11. 11.
    Official Journal of the European Union (2012) Directive 2012/19/EU of the European Parliament and of the Council on waste electrical and electronic equipment (WEEE). (recast). 04.07.2012Google Scholar
  12. 12.
    European Parliament (2011) Second reading with a view to the adoption of Regulation (EU) of the European Parliament and of the Council the provision of food information to consumers, 06.07.2011Google Scholar
  13. 13.
    Official Journal of the European Union (2012) Regulation (EU) 528/22012 of the European Parliament and of the Council concerning the making available on the market and use of biocidal products. 22.05. 2012Google Scholar
  14. 14.
    LOI n° 2009–967 du 3 août 2009 de programmation relative à la mise en œuvre du Grenelle de l’environnement (1) Article 42Google Scholar
  15. 15.
    Commission Nationale de débat public (2010) Bilan du débat public sur le développement et la régulation des nanotechnologies 15 octobre 2009 – 24 février 2010Google Scholar
  16. 16.
    LOI no 2010–788 du 12 juillet 2010 portant engagement national pour l’environnement (1)Google Scholar
  17. 17.
    Décret n° 2012–232 du 17 février 2012 relatif à la déclaration annuelle des substances à l’état nanoparticulaire pris en application de l’article L. 523–4 du code de l’environnementGoogle Scholar
  18. 18.
    Belgian Presidency Delegation (2010) Main environmental events organised by the Belgian Presidency - Information from the Presidency. Council of the European Union, 14672/10. Brussels, 11 October 2010. http://register.consilium.europa.eu/pdf/en/10/st14/st14672.en10.pdf [Accessed: 06 June 2012]
  19. 19.
    Council of the European Union (2010) Improving environmental policy instruments – Council Conclusions. 3061st ENVIRONMENT Council meeting. Brussels, 20 December 2010Google Scholar
  20. 20.
    Piñeros Garcet J (2012) Nanomaterials registries: EU member states initiatives. Federal Public Service Health, Food safety and Environment, on behalf of the Member states nano-databases harmonisation group. Presentation at CEFIC, 02.03.2012, BrusselsGoogle Scholar
  21. 21.
    Bipro (2013) Study of the scope of a belgian national register for nanomaterials and products containing nanomaterials. Reference: dg5/mr/jp/12026. Final report. http://www.health.belgium.be/filestore/19086003/BE%20Nano%20Register%20Report_final.pdf [Accessed: 02 July 2013]
  22. 22.
    ACV-CSC (2013) Carte blanche. Etablir un register Belge des nanomatériaux. http://www.csc-en-ligne.be/Actualite/Nouvelles/details/registre_nanomateriaux.asp [Accesses: 23 July 2013]
  23. 23.
    Hagen Mikkelsen et al (2011) Survey on basic knowledge about exposure and potential environmental and health risks for selected nanomaterials. Environmental Project No. 1370 2011. Miljoproject. http://www2.mst.dk/udgiv/publications/2011/08/978-87-92779-09-0.pdf [Accessed: 02 July 2013]
  24. 24.
    Chemical Watch (2011) Denmark to target hazardous substances, nanomaterials in 2012Google Scholar
  25. 25.
    Danish Ministry of Environment (2012) Information requirements for nanomaterials - IRNANO. Miljoprojekt 1469Google Scholar
  26. 26.
    Netherlands delegation (2011) Risks associated with nanomaterials. Information from the Netherlands delegation. Council of the European Union. 11626/11. Brussels, 16 June 2011. http://register.consilium.europa.eu/pdf/en/11/st11/st11626.en11.pdf [Accessed: 06 June 2012]
  27. 27.
    Bennett D et al (2011) Country report The Netherlands. NanoCode. http://www.nanopodium.nl/CieMDN/content/NanoCode_Country_Report_NL_Final.pdf [Accessed: 02 June 2012]
  28. 28.
    Ministry of Infrastructure and the Environment (2012) Note on the safety of nanomaterials. To Mr. J.Potočnik, European Commissioner for EnvironmentGoogle Scholar
  29. 29.
    Ministry of Infraestructure (2013) Conference “building blocks for completing EU regulation of nanomaterials” The Hague, 11–12 April 2013 Majority AgreementsGoogle Scholar
  30. 30.
    Norway Ministry of Environment (2012) Effective regulation of nanomaterials- comment from Norway. Ministry of Environment. http://www.eu-norge.org/PageFiles/606326/Innspill_nanomaterialer_23april2012.pdf [Accessed: 17 June 2013]
  31. 31.
    KEMI (2013) Draft proposal of regulation for nanomaterials. http://www.kemi.se/Documents/Forfattningar/Reach/Draft-proposal-regulation-nanomaterials.pdf [Accessed: 2 July 2013]
  32. 32.
    Ponce Del Castillo AM (2013) Nanomaterials and workplace health & safety. What are the issues for workers? ETUI, Brussels, 44pGoogle Scholar
  33. 33.
    European Trade Union Confederation (2008) Resolution on nanotechnologies and nanomaterials. Brussels http://www.etuc.org/a/5163 [Accessed: 31 July 2013]
  34. 34.
    European Trade Union Confederation (2010) 2nd resolution on nanotechnologies and nanomaterials. Brussels http://www.etuc.org/a/8047 [Accessed: 31 July 2013]
  35. 35.
    European Trade Union Confederation (2010) ETUC concept of a regulatory definition of a substance in a nanoform http://www.etuc.org/a/7817 [Accessed: 31 July 2013]
  36. 36.
    European Chemicals Agency, Joint Research Centre (2012) Nano Support project, Scientific technical support on assessment of nanomaterials in REACH registration dossiers and adequacy of available information. Final Report on analysis and assessment (Task I, step 3&4&5) and options for adapting REACH (Task II, step 1)Google Scholar

Copyright information

© Springer Science+Business Media Dordrecht 2013

Authors and Affiliations

  1. 1.Unit Health and Safety, Working Conditions, European Trade Union InstituteBrusselsBelgium

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