The regulation of nanomaterials and nano-enabled products is a dynamic and evolving activity, due largely to the wide range of nanomaterials, nano-enabled products, and applications that are being developed and the uncertainties that are associated with defining, characterising, and appropriately testing them for efficacy and safety. Significant work is on-going in Europe, and the rest of the world, to determine the extent to which nanotechnology products and applications fall within existing regulatory frameworks, and the adequacy of these frameworks for managing potential risks.
The European Commission (EC) has undertaken two regulatory reviews on nanomaterials, assessing the adequacy and implementation of EU legislation for nanomaterials (EC, 2008; EC, 2012). Although it has been concluded that nanomaterials are in principle covered by the various existing regulatory frameworks, the EC have acknowledged that there are difficulties at the implementation level due to the lack of available safety information needed for hazard and risk assessments. As such, additional measures and guidance may be needed to support the nanomaterials industry and work is in progress to address these needs.
Specific provisions on nanomaterials have been introduced into several consumer product legislations, including for biocides, cosmetics, food and food contact materials, and modification of the annexes of the European Chemicals Regulation ‘REACH’ is under consideration.
Further information about regulatory aspects for nanomaterials is available on our Knowledge pages highlighting, where applicable, any nano-specific considerations across the following subject areas: substances and products; environment; and worker protection.
SAFENANO can provide a range of bespoke services to help identify and address regulatory obligations for your nanomaterials and nano-enabled products. For further information, please contact us.