EU Prefers an Incremental Approach to Regulating Nanotechnology

The 'incremental approach' to regulating nanotechnology, rather than a new regulatory framework, would be the EU's optimum approach to protecting both the health of its citizens and that of the environment, according to a new report drawn up by a team of scientists from Denmark and Italy. They add that amendments to current laws and legislation on products containing nanomaterials should be made immediately, before thousands of products become commercially available, and before the environment and workers become exposed on a regular basis.

'The major conclusion of our study is that almost every aspect of the various laws and legislations along the life-cycle of products containing nanomaterials needs to be adapted,' Dr Hansen from the Technical University of Denmark (DTU) told the Nanowerk portal.

'Legislation needs to be proactive in scope and focused on prevention of emission and exposure rather than assessment of risks and establishment of safe exposure levels' the scientist added.

The starting point for the report was a European Commission workshop on nanotechnology risk analysis in 2004, which concluded that the European Union could protect health and the environment by using an incremental approach to regulating nanotechnology and adapting existing legislation.

Nanotechnologies are already in use in a number of fields, including medicine, textiles and electronics. It is predicted that the value of nanotechnology-enabled products entering the market will rise from €22.6 billion in 2005 to €2 trillion in 2014. However, many are concerned by the threats that nanotechnologies could pose to both our health and that of the environment.

In their study, the researchers from the Technical University of Denmark (DTU) and the University of Padua in Italy (UNIPD) investigated the effectiveness of the incremental approach proposed by the European Commission by studying the life cycle of three commercially available nano-enabled products.

These were a badminton racquet, produced by Yonex in Japan and sold in the EU and US, where fullerenes were dispersed in a resin between carbon fibres to strengthen the composite material; an oil lubricant produced by Bardahl in the US and sold in Italy, where soot containing fullerenes is mixed together with other chemical additives in order to improve sliding between metallic surfaces; and a baseball bat, produced by Easton Sports, with carbon nanotubes added to the resin to strengthen the composite material.

Their analysis identified four areas of EU legislation, on safety at work, pollution prevention, chemicals registration and waste management where these products could cause problems. But the researchers also found that most of the specific problems could be solved individually, for example by changing the definition of substances in the newly launched EU chemicals legislation REACH.

In the long run, using this product-by-product approach could pose serious problems as undertaking risk assessments on millions of nanomaterials would prove unfeasible in the long term. Nevertheless, identifying the key risk characteristics of nanomaterials would be of vital importance in assessing their impact on health and environment, the researchers argue.

'Somehow we need to make sure that all studies of health, safety, and environment measure and report the properties of the nanomaterial they test in a comparable way,' said Mr Hansen, from the Technical University of Denmark. 'This will be vital in identifying these key risk characteristics. Once this has been done, we might be able to develop some kind of hazard screening that could support risk management decision in an informed manner,' he added.

Having ruled out a specific long term regulation on nanotechnology, the researchers conclude that the incremental approach is the only practical method to tackling the risks caused by engineered nanoparticles in Europe.

In addition, the Danish-Italian team also make six specific recommendations for amending current EU rules and regulations in the short term:

  • Define standards for labs and other workplaces handling nanoparticles;
  • Actively promote research and development of usable metrological tools;
  • Establish a technical working group within the EU Bureau of Integrated Pollution Prevention and Control to organise an exchange of information;
  • Adapt the Chemical Abstract Service (CAS) to properly classify nanoparticles;
  • Establish a specific regime for nanoparticles within REACH requiring industry to submit information on nanoparticles characteristics and health, safety and environmental information;
  • Add free nanoparticles to the list in Directive 689/1991 on hazardous wastes.

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