In a recent memo, the European Commission (EC) advocated a case-by-case approach to assessing the risks nanomaterials pose to public health and the environment.  The EC also believes the general hazard and risk patterns of nanomaterials do not differ from those of other chemical substances–i.e., some are toxic and others are not–and so should be regulated no differently under the Registration, Evaluation, Authorisation and Restriction of Chemical Substances (REACH) directive.   But the EC memo also indicates that several changes to REACH may be necessary to account for risks uniquely associated with nanomaterials. 

Large and small volumes

The memo notes that 99.9 percent of traditional nanomaterials have been on the market for decades.  These include carbon black (a filler in tires, rubber, and polymer materials) and synthetic amorphous silica (used to provide antislip properties to paints and adhesives and as an anticoagulant in beverages).  Nanomaterials occupying the remaining 0.1 percent of the market and attracting the most attention include nanotitanium dioxide, carbon nanotubes, fullerenes, and nanosilver.  Some of these materials are used in sunscreens, disinfectants, and cosmetics and have a high human exposure potential.  The newest nanosubstances are used in catalysts, electronics, solar panels, and biomedical applications.  With this group, there is very little potential for public exposure.  According to the EC, the business value of products underpinned by nanotechnology is projected to grow from about $250 billion in 2009 to $2.5 trillion by 2015.

More toxic?

The EC still adheres to a conclusion delivered in 2009 by the European Scientific Committee on Emerging and Newly Identified Health Risks (SCENIHR).  “The hypothesis that smaller means more reactive and thus more toxic cannot be substantiated by the published data,” stated SCENIHR.  “In this respect nanomaterials are similar to normal substances in that some may be toxic and some may not.  As there is not yet a generally applicable paradigm for nanomaterial hazard identification, a case-by-case approach for the risk assessment of nanomaterials is recommended.”

Learning from REACH

The EC states its commitment to obtaining additional information on nanomaterials, and REACH is one vehicle for doing so.  The most prevalent of nanomaterials in terms of tonnage and sales have already been registered under REACH.  However, the EC has found that many dossiers that have registered nanomaterials do not clearly indicate how specific risks of nanomaterials are addressed (for substances which can occur both in nanomaterial and nonnanomaterial forms). Therefore, the EC envisages modifying one or several REACH annexes to require clarity on these aspects. 

Moreover, despite the general applicability of existing risk assessment methods, specific aspects of testing requirements may need to be adapted for nanomaterials, says the EC. 

The EC adds that the European Chemicals Agency (ECHA) has updated guidance for nanomaterials and has set up a group to assess previously registered nanomaterials to gather experiences from existing registration dossiers.  A second group will give advice on scientific and technical issues relevant to nanomaterials registered under REACH.

Read EC’s most recent memo on assessing the risks of nanomaterials.