Nanotech Europe moves toward harmonized regulations by defining a nanomaterial
Keywords: nanotechnology, nanomaterials, European Union
The European Commission, the administrative arm of the European Union has defined the term “nanomaterial,” opening the door for future regulations on nanoscale particles in consumer products sold in the EU. The chemical industry and consumer groups both welcomed and criticized the action.
The definition is intended to help EU regulators and industry determine which products contain nanomaterials and therefore might need special safety provisions, such as risk assessments or ingredient labeling. Under the definition, a nanomaterial is made up of natural or manufactured particles that are unbound or aggregated. Of these particles, at least 50% must have one or more dimensions between 1 nm and 100 nm.
Consumer and environmental groups welcomed the definition as a first step toward more uniform nanotechnology legislation, but they characterized it as “too narrow,” arguing that numerous products will escape regulation. Many groups were disappointed that the threshold was raised from 1% of the particles in the draft definition released last year to 50%.
In contrast, CEFIC, the European Chemical Industry Council, called the definition too broad. The industry group pointed out that “some decades-old substances such as mineral pigments used in paints” would now be considered nanomaterials. CEFIC supports having a regulatory definition for nanomaterials, but the group worries that the current definition will add unnecessary burden to industry.
Andrew Maynard, director of the University of Michigan’s Risk Science Center, believes the definition will create public confusion and raise economic barriers without protecting health. “There is no clear science behind its use,” he says.
- Chemical & Engineering News
- ISSN 0009-2347
- Copyright © American Chemical Society
If I had said that there was no clear science behind concerns over materials engineered at the nanoscale, I truly would deserve to be ashamed. But before I go out and indulge in sack cloth and ashes, I should point out that I claim in the piece above that there is no clear science behind the EC's definition of a nanomaterial for regulatory purposes. This is a very different issue, and arises from size alone not being a good determinate on its own - from the published evidence - of whether a substance is likely to present a risk that is not captured by conventional methods. Instead, I have argued in the literature and elsewhere that we need a more sophisticated approach to determining where there are emergent risks if we are to avoid regulating benign substances to death, while letting potentially harmful ones through the net.
"...[n]o science behind it"? Surely there is; not unlike femtochemistry and attophysics which have made significant strides and contributions.
"...[a]void regulating benign substances to death": or consign the unknowing populace to ever-increasing mortality and morbidity rates due to environmental triggers - as in the cases of adult-onset of lupus wherein mis-diagnosed maladies are hidden behind masked mutations for years.
Any near-term "economic barriers" constructed by these conservative measures hold longer-term health/medical disability claims and payouts in check.
Scientists, technologists, economists, bureaucrats, investors, journalists - all serve different masters. It is beneficial to meaningfully re-evaluate on what side of the bench one sits...and to periodically re-visit that place.