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European Nanotechnology Law?

Friday, December 1, 2006

A few days ago the European Parliament issued an action plan on Nanoscience and Nanotechnologies. This action plan is not legally binding and is deemed simply as a declaration of intention in regulating nanotechnology further. In general, there is nothing special under the action plan as it only stresses on the importance of research and impact assessments. There are, however, some paragraphs that reflects the position of the European Union with regards to nanoscience and nanotechnologies.

For example, the action plan:
  • Recommends that lists of ingredients in consumer products identify the addition of manufactured nanoparticulate material;
  • Regrets the fact that the patenting of nanoscience and nanotechnology inventions in Europe is developing slowly; calls on the EU to create a nanoscience and nanotechnology patent monitoring system governed by the European Patent Office;
  • Encourages general reforms in the field of the European patent system in order to cut the costs of patenting and to improve accessibility to patents for SMEs; stresses the need for greater transparency and clear limits to the scope of patent protection;
  • Emphasises the need to respect high ethical principles and welcomes the planned reviews on issues such as non-therapeutic human enhancement and links between nanosciences and nanotechnologies and individual privacy; expects the reviews to be public and to include a thorough analysis of nanomedicine;
The above points suggests the EU position toward labelling and patent reform. The last point on human enhancement is especially important and this shows EU's high awareness on the interconnectedness between human enhancement and nanotechnologies. You can compare it with UNESCO's view on human enhancement here.

Currently, the status of european nanotechnology regulation is more or less equal to the US': There are no specific law regulating it. It is questionable whether existing regulations in the field of environmental (such as the REACH proposal), health, workplace and food and drugs can directly apply to nanotechnology, due to differences of characters. There are suggestions to put nanotechnology under the REACH proposal but there are also worries that it may not be able to cover "finished product" such as a transistor.

Nevertheless, there are general environmental regulations under EU auspices which applies to every risky activities, including nanotechnologies. The factories, laboratories and storing facilities of nanoproducts could be subjected to environmental impact assessment directive 85/337/EEC, or IPPC Directive 96/61/EC. Nevertheless, this is NOT without difficulties. Nanotechnology projects are not listed in the mandatory impact assessment list under the EU impact assessment directive (see Annex II), so states may exempt them from impact assessment obligation, by relying solely on the directive . Lack of effects data will also prevent stakeholders from conducting assessments.

The case with the IPPC directive is similar. The IPPC deals with limiting the amount of "emission" of pollutants, which is irrelevant with regards to nanoparticles. It has been mentioned in several researches that it is the size, surface structure, solubility and shape of the nanomaterials that contributes to its toxicity, and not the amount/weight.

Last but not least, although nanotech is not specifically regulated, there are general principles of EU Law that will safeguard public health and the environment. The EU is known to be a strict adherent of precautionary principle, so recklessness with regards to the production or research of nanomaterials will arise liability. There could be special cases where nanotech is categorized under strict liability, for example in its connection with military uses. There is yet an established due dilligence rule with regard to nanotechnology, but to avoid law suit, it could be safer to refer to the emerging "best practices" and to the formal position of the EU as reflected on its action plans, communications or existing directives and regulations.

(Hat Tip to Nanologue and Prof Geert van Calster!)