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June 11, 2007

Study Recommends Amendments to EU Legislation to Address Nanomaterials

Lynn L. Bergeson

The July 2007 issue of Regulatory Toxicology and Pharmacology includes an article entitled “Limits and Prospects of the ‘Incremental Approach’ and the European Legislation on the Management of Risks Related to Nanomaterials.” According to the authors, the European Commission (EC) has adopted an incremental approach, focusing on adopting existing laws to regulate nanotechnologies. The authors concluded that the current regulations fail to address the environmental, health, and safety risks posed by nanomaterials and recommended specific revisions to European regulatory policies and the information on which they are based.

The authors analyzed in a life cycle perspective three commercially available products containing fullerenes to map current applicable regulations, determine their applicability to nanomaterials, identify their gaps, and suggest proper solutions. After mapping the life cycle of the three products, the authors reviewed applicable regulations in the order in which they became relevant in their life cycle, i.e.:

  • The Safety at Workplace Directives;
  • Directive 61/1996 on the Integrated Pollution Prevention and Control;
  • The European Union’s Directive on the Registration, Evaluation, Authorization and Restriction of Chemicals (REACH); and
  • The Waste Management Directives.

The authors concluded that the applicability of environmental laws is limited due to difficulties in generating sufficient data on the nanomaterials residing in the products according to their life cycles.  Further, metrology tools, which measure nanoparticles in the environment or at the work site, are unavailable; thresholds are not tailored to the nanoscale and are based on ecotoxicological and toxicological data from larger chemicals; and occupational exposure limits cannot be established with existing methodologies.  According to the authors, the incremental approach can be applicable only with the implementation of due amendments.