The publication of the EU definition of Nanomaterials (view it here) continues to make waves. We spoke with leading North American nanotoxicology commentator, Professor Andrew Maynard, the Charles and Rita Gelman Risk Science Professor at the University of Michigan School of Public Health and Director of the University of Michigan Risk Science Center.
His work focuses on the responsible development and use of emerging technologies, and on innovative approaches to addressing emergent risks. He has testified on a number of occasions before congressional committees on nanotechnology, served on National Academy panels and other advisory boards, and is a member of the World Economic Forum Global Agenda Council on Emerging Technologies.
Professor Maynard commented: “I have been a rather outspoken opponent of the EU definition since its release – worrying that it is informed less by science and more by a political desire to codify assumed changes in material behaviour below 100 nm. Despite SCENIHR trying extremely hard, they struggled to justify a definition of engineered nanomaterial on the basis of evidence alone.
The committee’s report left the impression that they established a basis for a definition because this is what they were told to do, not because they believed this is what the science dictated.
And while it is often assumed that black and white definitions are needed for regulatory purposes, this is not always the case – for example the US Food and Drug Administration has so far resisted the temptation to compromise its effectiveness through adoption of a definition of convenience rather than science.
Even if definite numbers were applicable here, I am far from convinced that the numbers in the EU definition help anyone - especially when applied to any source of nano material.
Is nanoscale sea spray to be regulated for instance?”
Continuing, Professor Maynard said, “Nevertheless, let’s look at this from a slightly different angle. Let’s say the writing is on the wall for the need to measure particle number at small sizes, and as the demand grows, so the need for viable techniques will grow. Irrespective of whether you buy into the EU definition or even agree with the science underpinning it, it is being adopted and is likely to be applied increasingly within Europe.And this will have knock-on effects for companies trading in Europe, as well as products marketed in the US.
How long will it be before US and Canadian regulators follow suit out of expedience if nothing else - maybe not along the precise lines of the EU definition, but nevertheless one that demands that manufacturers measure and report on the number of particles below a certain size in their products?And as they do, how will manufacturers measure nanosized particles in products to the required levels of accuracy and precision?”
A new NanoSight white paper addresses this issue. “The EU Definition of Nanomaterial – Potential Measurement Methodologies” is available at The NanoSight Website.