The European Commission adopted a recommendation for a definition of nanomaterials on October 18, 2011. The definition responds to a 2009 resolution by the European Parliament for a comprehensive, science-based definition to apply across a range of existing laws on chemicals, pesticides and other substances.
David Azoulay, CIEL Managing Attorney in Geneva and head of CIEL’s nanotechnology project, welcomes the adoption of this definition, but he cautioned that it is “not an end goal, but a tool for regulatory oversight of the manufacture and use of nanomaterials, with limitations.”
The adoption of this definition concludes a process started almost two years ago, during which CIEL, with partners from the EU and the developing world, offered recommendations.
CIEL appreciates the inclusion of some of these recommendations in the final draft (such as the inclusion of aggregate and agglomerate in the definition, the inclusion of a review clause, and the use of particle number rather than mass as a measuring unit for size distribution) as well as the inclusion of fullerenes, graphene flakes and single-walled carbon nanotubes outside the defined size range.
However, the cutoff limit for a material to be identified as a nanomaterial under this definition is very worrying. The adopted definition sets this threshold at 50% of the size distribution, rather than the 1% originally proposed. The net effect is that materials with nano properties and possible toxicity, will fall outside the definition. It also raises questions about the process when even the German industry proposed a cutoff limit of approximately 10%.
CIEL therefore reiterates its call for a sensitivity analysis to verify that the adopted size range captures materials about which there is already concern, while avoiding materials that do not give rise to nano scale-related concerns. This study should start immediately in order to be considered in the future revision process of the definition.
The EU led the world in requiring prior declaration and labeling of nanomaterials in cosmetics and labeling of nanomaterials in food packaging. This science-based legal definition of nanomaterials opens the door to further regulatory initiatives, bringing adequate scrutiny to these substances and facilitating progress around the world. ”The real challenge starts now,” said Azoulay,” by applying this definition to protect human health and the environment.”
For more information please contact David Azoulay.