Nanomaterials under REACH

In Europe, the implementation of the REACH regulations has shifted responsibility from authorities to industry to assess their safety of the chemicals (including nanoparticles) they produce and use. For most nanomaterials, current production volumes are typically relatively low and only a few manufacturers, importers or producers are expected to exceed the tonnage threshold for registration. Whilst there is the potential for nanoscale substances to be addressed distinctly under REACH, the regulation does not currently distinguish between nanoscale substances and their bulk equivalent at the micro or macro scale. This has led to a degree of uncertainty over the adequacy of the regulation and the accompanying guidance for nanomaterials, which is being addressed, but it is clear that the registration requirements are applicable to nanomaterials as they are for any other substance within scope of REACH.

Related to REACH are the Classification, Labelling and Packaging of Substances and Mixtures regulations (CLP). Recently, the European commission published a paper describing some relevant aspect known at this stage related to the classification, labelling and packaging of nanomaterials in accordance with REACH and how registrants should proceed with this issue in other to ensure a coherent approach. The main conclusions from the paper include:

• When evaluating the available information for the purpose of classification, the manufacturers, importers and downstream users shall consider the forms or physical states in which the substance or mixture is placed on the market and in which it can reasonably be expected to be used.
• Registrants would consider the following approaches in the classification and labelling of nanomaterials:
  • The data sharing should cover all relevant information including (but not limited to) sizes, forms, and morphologies of the nanomaterials.
  • It is vital to evaluate whether changes in e.g. size, form or physical state influence considerably on the hazardous properties of the nanomaterials
  • All available information of nanomaterials should be evaluated in the hazard assessment of nanomaterials
  • Special attention needs to be devoted to the appropriateness of the sample preparation and dosimetry used in the testing of nanomaterials
  • The classification should be done on a case by case basis giving due consideration to relevant available data e.g. the bulk form and read across to other nanomaterials
  • On the basis of the classification in accordance with CLP, the nanomaterial should also be labelled and package in accordance to CLP.

IOM currently leads two service contracts for the European Commission dealing with the adequacy of the REACH guidance in relation to the specific issues of nanoparticles.