Nanomaterials Regulatory Framework: Implementing the new definition

Anna Gergely, Director EHS Regulatory, Steptoe & Johnson LLP (Belgium) said the EU has identified nanotechnology as a Key Enabling Technology with great opportunities is personal care products but the EU Commission has now “locked horns” with the EU Parliament over the details of the regulatory framework.  The EUC feel consumer protection needs to be enhanced by improving the implementation of the current legislation and their 2^nd review addressing the risks of nanomaterials is now due.  However in 2009 the EUP called for the review to be complete by end 2011, to include a comprehensive definition of nano and a publicly available database of the different types and uses of nano in the EU, along with labelling recommendations and testing protocols.

Current legislation on Product Safety, Product Liability, Environmental Protection, REACH and CLP is applicable to nano, but being drafted pre-nano is general rather than application specific (i.e. Horizontal).  The product liability legislation issue is important because it would not cover problems which arise from science discovered after product launch.  Vertical or application specific legislation is needed.

REACH covers all chemical substances including nano forms, but there is no specific mention of new nano materials.  A draft nano definition is evolving with
the latest recommendation being:

·         Consists of natural, incidental or manufactured particles, in an unbound state or as an aggregate or agglomerate with one or more external dimensions in the size range 1nm – 100nm for more than 50% of their number size distribution, in specific cases between 1-50%.

·         Has internal or surface structures in one or more dimensions in the size range 1nm-100nm. (Fullerenes, graphene flakes and SWCNT with one or more external dimensions below 1 nm are nanomaterials.)

·         Has a specific surface area by volume greater than 60m²/cm³, excluding materials consisting of particles with a size lower than 1nm, but number size distribution prevails.

·         Particle: means a minute piece of matter with defined physical boundaries.

A review of this definition is due by December 2014 and in the meantime, while producers are invited to use the definition, no legal certainty exists and there is no agreed method of analysis.  Personal care products will eventually have to use labels with the word “nano” against the relevant ingredient. 

The FDA is also working on a definition for materials with one dimension in the 1nm to 100nm range but this may be extended to 1000nm in some cases.  They argue nanomaterials should also exhibit properties that are attributable to their dimensions as well as their chemistry.

In summary, Ms Gergely said the regulatory framework is changing by the minute and its up to producers to use due-diligence to stay up to date.  Very fine fibres would be covered by the regulations, as would very thin films.  The definition could also cover non-nano aggregates or agglomerates of nano-sized particles.