REACH law applied to nanomaterials

It has been argued that the characteristics of nanoparticles (e.g. increased toxicity and or persistency) demand specific regulation between nano-scale substances and their bulk equivalent at the micro or macro scale. In REACH there is no mention of nanoparticles/nanoscale materials anywhere in its 800+ pages of text. However, in December 2006, shortly after the regulation’s adoption by the European Parliament, the European Commission posted on its website a question-and-answer document that includes the following:
 
How will nanoparticles be treated under REACH?

“Substances in the nano-scale fall under the scope of REACH, and their health and environment properties must therefore be assessed following the provisions of this Regulation.  However, methodologies for identifying hazards and evaluating risks of substances at the nano-scale need to be further refined over the next few years.”

“The European Commission is funding research projects to assess the health and environment impacts of nano particles under the 7th Research Framework Programme.”

The Commission treats nanoparticles no differently to regular micron sized ones – at the moment. However, with its earlier statement in December 2006, the Commission has kept the door open for tightening the regulation. It is therefore possible that the Commission will take a further step. Industry should be prepared for it.

As with regular substances and mixtures, manufacturers and importers must take responsibility for the information about any hazard or risk linked to the chemicals they produce, process and pass it on to their customers. As usual then, a manufacturer or importer of nano-scale substances or articles containing nano-scale substances must register when the quantity of nanomaterial reaches one tonne or more per year per substance. It is vital that the REACH registration dossier includes information about the nanoform when it is submitted.

Currently, tonnages of nano-scale substances are relatively low. Only a small number of manufacturers or importers are expected to attain the tonnage threshold for registration. So the majority of companies working in this field will not be burdened by the registration of nanomaterials under REACH.