It’s been a long time coming, but the European Commission published its definition of nanomaterials on October 18, 2011. Though not binding on EU member countries, this is a major step toward the use of a uniform definition throughout the EU and – who knows? – elsewhere in the world. The Commission adopted the following previously recommended definition of “nanomaterial”:
“a natural, incidental or manufactured material containing particles, in an unbound state or as an aggregate or as an agglomerate and where, for 50% or more of the particles in the number size distribution, one or more external dimensions is in the size range 1 nm – 100 nm”
The Recommendation containing the definition and further definitions of terms used within it are available at
ec.europa.eu/environment/chemicals/nanotech/pdf.commission_recommendation.pdf
Further review of the definition is to be conducted by December 2014 on the belief that nanotechnology will continue to develop and evolve, and the definition may require adjustment. “Technological development and scientific progress continue with great speed,” the Commission stated. (Recommendation, p. 4)
This is good news. It has important immediate ramifications for the EU’s REACH chemical regulation which currently does not regulate based on scale. The Commission stated in its recommendation that “[t]he definition . . . should be used as a reference for determining whether a material should be considered as a ‘nanomaterial’ for legislative and policy purposes in the Union.” (Recommendation, p. 2)
In September, a joint report of the European Academies Science Advisory Council (EASAC) and the EU’s Joint Research Centre (JRC) of the Institute for Health and Consumer Protection (IHCP) was published. The report was on the “Impact of Engineered Nanomaterials on Health: Considerations for Benefit-Risk Assessment.” Referring to “continuing scientific uncertainty” regarding the safety of nanomaterials, the Joint Report stressed the need for “timely policy development.” (Joint Report, p. 5) The Joint Report concluded that:
“A clear regulatory framework to address potential health and environmental impacts, within the wider context of evaluating and communicating the benefit-risk balance, must be a core part of Europe’s integrated efforts for nanotechnology innovation.
. . .
We conclude that it is essential to invest significantly in research for safety assessment while seeking to expedite regulatory review of the products emanating from that science.”
(Joint Report, p. 5)
The Joint Report is available at
ihcp.jrc.ec.europa.eu/our_activities/nanotechnology/nanoreport-10-11/JRC-EASAC-report.pdf
There is much to consider in the Joint Report, and I will address some of its observations and recommendations in future posts. Suffice it to say, however, that the European Commission’s adoption of the nanomaterial definition comes at a particularly appropriate time, in light of the Joint Report. We will continue to follow developments in the EU on this front.
