Nanomaterials: stricter European regulation in the pipeline

The federal government of Germany has just published a position paper on the regulation of nanomaterials within the European Union. Nanomaterials are those substances that are now being used in industry and consumer products that are in the form of extremely fine particles. Use of such materials is growing and it is increasingly recognized that such particles may have chemical and biological properties that are different from those of the bulk material. Nanomaterials in current use range from metals like silver and gold to carbon-based nanoparticles such as ‘Buckyballs’ and nanotubes.

The German government recognizes that regulation of nanomaterials presents a challenge of a kind not previously addressed because nanoparticles may behave, and hence present risks, in a significantly different manner than the bulk material. The present regulatory requirements in Europe, as well as in Canada, do not often recognize this. However, many industry groups are opposing specific regulations for nanomaterials. The German government is quite clear that it considers that a new regulation under the European REACH framework (Registration, Evaluation, Authorisation and Restriction of Chemical substances) should be adopted for nanomaterials.

Prior to granting approvals under REACH, the German government proposes that a nanomaterial that is used in significant quantities should be technically evaluated under a range of criteria:

  • Physicochemical data
  • Toxicological data
  • Ecotoxicological data
  • Chemical Safety
  • Obligations of downstream users

These are similar to the requirements for introduction of new chemicals. In addition, Germany is proposing that surface-treated nanomaterials might need to be evaluated separately from the coating and particle materials of which they are comprised.

All in all the German proposal is a call for setting the environmental health and safety bar significantly higher than some proponents of nanomaterials in industry have previously considered.

The German government proposal can be found at http://www.bfr.bund.de/cm/349/nanomaterials-and-reach.pdf
A summary is at http://www.bfr.bund.de/en/press_information/2013/02/the_reach_regulation_as_an_effective_way_of_regulating_nanomaterials-132673.html

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