The EU Definition of Nanomaterial - Potential Measurement Methodologies
In October 2011 the European Commission published a definition of Nanomaterials1. 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 that ‘best available alternative methods’ should be applied1. 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 20122.
The Particle Counting Characterisation Challenge
Given the definition that a nanomaterial contains more than 50% by particle number of material with at least one dimension in the range 1-100nm, there are a number of techniques that might be considered as contributing to the analysis of putative nanomaterials to help implement the proposed definition. While no one technique is likely to be able to address the whole range (especially with a requirement to count such material), a combination of such techniques would form the best available alternative and ensure a higher level of confidence in meeting this characterisation challenge.
The candidate techniques are summarised in the table below.
- The European Commission (2011) Commission Recommendation of 18 October 2011 on the definition of nanomaterial. Official Journal of the European Union (2011/696/EU). http://eur-lex.europa.eu/LexUriServ/LexUriServ.do?uri=OJ:L:2011:275:0038:0040:EN:PDF.
- Mantovani E, Porcari A, Morrison M D, Geertsma R E (2012) Developments in Nanotechnologies Regulation and Standards 2021 - Report of the Observatory Nano. April 2012. www.observatorynano.eu.