Nanotech Europe moves toward harmonized regulations by defining a nanomaterial

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.