Despite this being only a “Recommendation”, this is a green flag for legislators in European countries. They being subject to political pressures, this is what they have been awaiting to begin work on nanomaterial regulations mandating declarations and labeling. Indeed, a Commission recommendation obliges them to get to work in writing the rules.
Importantly, the definition specifies a number distribution: if more than 50% of particles have one dimension between 1nm and 100nm, then it’s a “nanomaterial”. Additionally, it is a nanomaterial if it has a specific surface per unit volume of greater than 60 m2/cm3, plus there are specific inclusions such as graphene. The biggest surprise is that natural and incidental materials are included as well as manufactured particles. Aggregates and agglomerates of such particles are also included. This definition captures a whole range of industries who would not until now have considered themselves within nano.
Nanomaterial-specific measurement methods are still not standardized nor are they validated. The recommendation is that the ‘best available alternative methods should be applied’. Clearly NanoSight has a major opportunity here, in complement to electron microscopy reporting the very bottom of the specified range. The other characterization alternative would appear to be the large and expensive set of electron micrographs required to obtain a robust result which is hardly a practical or cost-effective protocol.
Of course there is much dissent about this definition, much of which is valid when one attempts to link size alone to any measure of potential toxicity. And why 100nm? Why not 300nm? The response of the Commission is that one has to start somewhere, and the publication of this definition indicates the change from discussion to active progression to legislation.
Amongst the cries of angst from the scientific community and some manufacturers, there are supportive voices from some companies. These supporters of nano-regulation remind us that a robust regulatory framework for addressing issues of potential toxicity in nano is a prerequisite to major exploitation. They see this definition as the start of that process.