The European Commission recently published its recommendation on a common definition (1) of the term ‘nanomaterial’ for regulatory purposes. Proper implementation of this definition requires appropriate tools and methodologies for which measurement aspects are crucial. This report describes the requirements for particle size measurements of nanomaterials based on the definition. It discusses the related generic measurement issues and reviews the capabilities of the measurement methods currently available. Moreover, it illustrates with practical examples the measurement issues that remain to be solved.
This brochure is intended to provide advice to potential registrants of nanomaterials. The guide is considering the particular situation that nanomaterials are not specifically regulated under REACH at present and there are in consequence no specific dossier requirements. It shall be clarified what information should be included in the registration dossier especially regarding the characterisation of nanomaterials.
This report supports the implementation of the European Commission’s Recommendation on a definition of nanomaterial (2011/696/EU). 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 report provides recommendations for a harmonised and coherent implementation of the nanomaterial definition in any specific regulatory context at European Union and national level.
European Nanomedicine Characterisation Laboratory (EUNCL)