The JRC of the European Commission has recently published a report providing recommendations for a harmonised and coherent implementation of the nanomaterial definition in any specific regulatory context at European Union and national level. It addresses its key concepts and terms and discusses them in a regulatory context. Corresponding to the broad scope of the definition the considerations in this report can be applied across all relevant legislative areas; they are not specific to any particular piece of legislation.
The European Commission’s Recommendation on a definition of the term ‘nanomaterial’a (EC NM definition) provides a general basis for regulatory instruments across all areas of European Union policy, and a common understanding of its concepts and terms is necessary for its implementation. The definition, or core parts of it, has been utilised in sector specific EU legislation, (e.g. Biocidal Products Regulation, Medical Devices Regulation, annexes of REACH) and is also used in several EU national schemes.
This report aims to provide clarifications of the key concepts and terms that are used in the EC NM definition, and discusses them in a regulatory context. Corresponding to the broad scope of the definition, the considerations in this report can be applied across all relevant legislative areas; they are not specific to any particular piece of legislation. The report therefore supports a harmonised and coherent mplementation of the EC NM definition in any specific regulatory context at Community and national level.
The EC NM definition does not cover nanostructured materials (materials with nanoscale internal or surface structures) unless the external particle size criteria are met. Single molecules are not considered as particles, with the exception of fullerenes, graphene and single-wall carbon nanotubes, which are explicitly included by derogation.