Today's article in GEN (Genetic Engineering & Biotechnology News) about the European Commision's recommended definition of nanomaterials highlights the challenge and promise in regulating nanotechnology. It also underscores the potential need for a next generation regulatory framework for the US that is based on the latest science.... 

By Alex Philippides

"Unlike in Europe, the FDA has been reluctant to give nanomaterials a single, overarching definition. Explaining FDA’s approach to regulating nanotech products last month in a guest column for Science, Commissioner Margaret A. Hamburg, M.D., Ph.D., reiterated, “although one definition for nanomaterial may offer meaningful guidance in one context, that definition may be too narrow or broad in another. For this reason, FDA is not at this time adopting a regulatory definition of nanotechnology.” FDA issued a draft guidance on the subject last year.

The EU doesn’t share Dr. Hamburg’s reluctance, however. In October the EC published a recommended definition of nanomaterials that alarmed many. The commission defines nanomaterials as materials that meet any of three criteria:

• At least 50% of the particles have one external dimension between 1 nm and 100 nm;
• The material has a surface area by volume greater than 60 m² / cm³.
• The substance appears on a list that captures materials that would otherwise fall outside the definition.

The dimension standard echoes FDA’s draft guidance for nanomaterials published last year, under which “at least one dimension” must be between 1 nm and 100 nm. The U.S. agency would also check whether nanomaterials exhibit physical or chemical properties or biological effects attributable to its dimensions, even if they fall outside the nanoscale range, going up to one micrometer..."

Read the full article here.