Skip to main content Skip to page footer

Regulation of Nanomaterials under present and future Chemicals legislation Analysis and regulative options

Stefanie Merenyi, Martin Führ and Kathleen Ordnung

elni Review 2009, Issue 1,  pp. 31-38.

Nanotechnology has already entered our everyday life. It finds application in a large number of industrial areas, for instance in the automobile industry, in energy and environmental technology, mechanical engineering, the chemicals and pharmaceuticals industry, in medicine, cosmetics and the food industry. Nanoscale titanium dioxide in sunscreen products, for example, provides UV protection, car tyres contain – not only recently – nanoscale carbon black, and many scratchproof, antireflection, non-stick and de-misting surfaces are manufactured with the help of nanomaterials. What distinguishes nanomaterials from previously used substances and processes is, above all, their large and active surface in proportion to their volume. The small particle size can result in modified chemical properties and functionalities compared to conventional substance in a non-nanoscale form, which can range from varied melting and boiling points to greater hardness, magnetism and catalytic effects.
Nanotechnology is regarded as a key technology of the 21st century. Considerable economic expectations are attached to its further development. Due to its low consumption of resources and high energy efficiency, nanotechnology also offers potential ecological relief that should be exploited. At the same time, little is presently known about risks to human health and the environment associated with nanotechnology. The modified properties of nanoscale substances can lead to different risk assessment compared to conventional materials. Early knowledge in this respect has been available for some time. As far as titanium dioxide is concerned, the suspicion has been confirmed: This material, which has been manufactured and used as white pigment for many years, was regarded as unproblematic before its appearance in this small particle size, since tests carried out with non-nanoscale particles were negative. Results of tests on titanium dioxide in the nanoscale form showed, however, that these particles could have ecotoxic effects. In view of this conflict between expected benefits and potential risks, the question arises as to which legal requirements nanotechnology is subject to. In the spring of 2006 the Federal Environmental Agency commissioned a legal appraisal of the present framework of environmental legislation with regard to nanotechnologies and the drawing up of proposals for initial action should regulatory gaps be identified. The main focus of this analysis was chemicals law, and its findings are presented in this article.

Access full article


  1. Commission of the European Communities, 2008, Communication From The Commission To The European Parliament, The Council And The European Economic And Social Committee Regulatory Aspects Of Nanomaterials, COM (2008) 366 final.
  2. Report of the Royal Commission on Environmental Pollution: „Novel Materials in the Environment: The case of nanotechnology“, November 2008.
  3. Federal Environmental Agency (UBA), Nanotechnik: Chancen und Risiken für Mensch und Umwelt, Hintergrundpapier, Dessau August 2006.
  4. Scientific Committee on Emerging and Newly Identified Heath Risks (SCENIHR): Risk Assessment of Products of Nanotechnologies, adopted at its 28th plenary on 19 January 2009.
  5. Hund-Rinke, K.; Simon, M.; Ecotoxic Effect of Photocatalytic Active Nanoparticels (TiO2) on Algae and Daphnids. In: Environ. Sci. Pollut Res 13, pp. 225-232 (2006). DOI:
  6. Führ, M.; Hermann, A.; Merenyi, S. et al.: Rechtsgutachten Nanotechnologien (ReNaTe)/Legal appraisal of nano technologies.
  7. German Basic Constitutional Law (“Grundgesetz”).
  8. Führ, M.: Rationale Gesetzgebung - Systematisierung verfassungsrechtlicher Anforderungen, in: Gawel, E./Lübbe-Wolff, G., Rationale Umweltpolitik - Rationales Umweltrecht, Baden-Baden 1999, pp. 193-226.
  9. Regulation (EC) No. 1907/2006 of 18 December 2006 concerning the Registration, Evaluation, Authorisation and Restriction of Chemicals (REACh), OJ 2007 L 136/3.
  10. Führ, M./Merenyi, S.: Mind the Gap - Interface Problems between EC Chemicals Law and sectoral environmental legislation, (RECIEL) 15 (3) 2006, pp. 281-292. DOI:
  11. Führ M./ Lahl U.: Self-responsibility as a regulatory concept - as illustrated by the REACh decision-making process, in: Ormond, Th./ Führ, M./ Barth, R.: Environmental law and policy at the turn to the 21st century, Berlin (Lexxion) 2006, pp. 209-220.
  12. Führ, M./Bizer, K.: REACh as a paradigm shift in chemical policy - responsive regulation and behavioural models; in: Journal of Cleaner Production (JCLP), 15, 2007 (4), pp. 327-334. DOI:
  13. Council Directive 67/548/EEC on the approximation of laws, regulations and administrative provisions relating to the classification, packaging and labelling of dangerous substances OJ 1967 L196/1.
  14. Directive 1999/33/EC of the European Parliament and of the Council of 10 May 1999 amending Council Directive 67/548/EEC as regards the labelling of certain dangerous substances in Austria and Sweden, OJ 1999 L 199/57.
  15. Winter, G.: Risks, costs and alternatives in EC environmental legislation: The case of REACh, RECIEL 15(1) 2006.
  16. REACH CASG(Nano)/European Commission, Follow-up to the 6th Meeting of the REACH Competent Authorities for the implementation of Regulation (EC) 1907/2006 (REACH), 16 December 2008, Doc. CA/59/2008.
  17. Manual of Decisions (MoD) for implementation of the 6th and 7th amendments to Directive 67/548/EEC of 3 July 2006, EUR 22311.
  18. Regulation (EEC) 793/93 of 23 March 1993 on the evaluation and control of the risks of existing substances (known as the Existing Substances Regulation, ESR), OJ 1993 L/1.
  19. Council Directive 76/768/EEC of 27 July 1976 on the approximation of laws of the Member States on cosmetic products, OJ 1976 L 262/169.
  20. Scientific Committee on Emerging and Newly Identified Health Risks (SCENHIR): Opinion on the appropriateness of existing methodologies to assess the potential risks associated with engineered and adventitious products of nanotechnologies, SCENIHR/002/05 of 10 March 2006.
  21. Report of the Royal Commission on Environmental Pollution: „Novel Materials in the Environment: The case of nanotechnology“, November 2008.
  22. Van Calster, Geert, Regulating Nanotechnology in the European Union, Nanotechnology Law & Business, September 2006.
  23. Report of the Committee on Education, Research and the Implications of Technology, TA-Project - Nanotechnology, 15 March 2004, Bundestag Documents (BT-Drs.) 15/2713.
  24. Commission of the European Communities, 2004, Communication of the Commission.Towards a European strategy for nanotechnology, COM (2004) 338 final.
  25. Commission of the European Communities, 2005, Communication of the Commission to the Council, the European Parliament and the Economic and Social Committee. Nanosciences and Nanotechnologies: An Action Plan for Europe 2005-2009, COM (2005) 243 final.
  26. Federal Institute for Occupational Safety and Health, the Federal Institute for Risk Assessment and the Federal Environmental Agency, "Nanotechnologie: Gesundheits- und Umweltrisiken von Nanopartikeln“ (Nanotechnology: Risks of nano particles to human health and the environment").
  27. Chaudhry, Q. et. al., A scoping study to identify gaps in environmental regulations for the products and applications of nanotechnologies, 2006.
  28. First quarterly update on the Voluntary Reporting Scheme for engineered nanoscale materials, December 2006.
  29. Royal Commission on Environmental Pollution, Novel Materials in the Environment: The case of nanotechnology, 27th report, Cm 7468, November 2008.
  30. Final report of the Nano Commission: “Verantwortlicher Umgang mit Nanotechnologien - Bericht und Empfehlungen der NanoKommission der deutschen Bundesregierung 2008”, November 2008.
  31. „Current Developments/ Activities on the Safety of Manufactured Nanomaterials – Tour de Table at the 4th Meeting of the WPMN, Paris” of December 2008, Series on the Safety of Manufactured Nanomaterials, No. 7, ENV/JM/MONO(2008)29.
  32. “Manufactured Nanomaterials: Work Programme 2006-2008” of February 2008, Series on the Safety of Manufactured Nanomaterials, No. 4, ENV/JM/MONO(2008)2.
  33. REACh CASG(Nano)/Commission; Nanomaterials in Reach. (Doc. CA/59/2008).
  34. Minutes of the 12th ECHA-MB Meeting, 26/27 February 2009.