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The EU Definition of Nanomaterial – Potential Measurement Methodologies
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NanoSight Limited

In October 2011 the European Commission published a definition of Nanomaterials. This move followed more than six years of scientific consideration of the potential toxicological and environmental challenges posed by engineered nanomaterials.  

The definition has these principal elements:  

• Counting particles defines nanomaterials: The material is a nanomaterial if more than 50% of particles have at least one dimension between 1nm and 100nm.  

• Alternatively, it is also a nanomaterial if it has a specific surface per unit volume of greater than 60 m2/cm3.  

• There are specific inclusions such as graphene.  

• Naturally occurring and incidental materials are included, as well as manufactured particles.  

• Aggregates and agglomerates of such particles are included.  

No measurement methods are specified; the recommendation is ‘best available alternative methods should be applied. This definition is   not regulation, however its EU provenance informs its authority. For many regulators within the EU, this definition is the missing jigsaw piece to slot into potential regulation of publically-driven and government-derived legislation, covering nanomaterial matters from manufacture, labelling and handling, through transport and environmental fate. The FP7 project ObservatoryNANO describes current legislative work in their 4th report, April 2012. 

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