The European Commission said its newly unveiled common nanomaterial definition will provide a basis for clear regulation that will boost industry’s ability to develop products while safeguarding consumers.
After a protracted debate and exhaustive consultation process, Brussels announced yesterday that nanomaterials are those whose main constituents measure between 1 and 100 billionth of a metre.
The EC said its definition was ground-breaking by clearly defining for the first time which materials needed “special treatment in specific legislation”.
“We have come up with a solid definition based on scientific input and a broad consultation,” said European Environment Commissioner Janez Potočnik.
Size really matters
The EU definition has been based on an approach that considers only the size of the constituent particles of a material, rather than hazard or risk
"Size is the only universally applicable, clear and measurable criterion which can be used to identify materials which due to their particle size may exhibit specific properties or risks," it added.
It stressed there was no evidence that nanomaterials were inherently hazardous – and that case-by-case assessments were the best way to measure risk.
It describes a nanomaterial as "a natural, incidental or manufactured material containing particles, in an unbound state or as an aggregate or as an agglomerate and where, for 50% or more of the particles in the number size distribution, one or more external dimensions is in the size range 1 nm – 100 nm."
The body said it had ignored the recommendation from the Scientific Committee on Emerging and Newly Identified Health Risks (SCENIHR) that this value should be 0.15% for “practical considerations” because of their widespread low-level presence in most solid materials.
“The percentage may be significant, in particular in certain powders. Therefore, a threshold of 0.15% could include too broad a range of materials within the definition, and would have made it difficult to tailor regulatory provisions appropriately,” said the EC. “The choice of 50% is based on the attempt to distinguish nanomaterials which may exhibit specific novel properties from conventional chemical substances.”
The EC said this figure and the definition itself would be reviewed in 2014.
Live up to potential
Nanomaterials are already employed in many products – with food packaging and formulation seen as two of the areas with huge potential for sectors for future development.
However, experts have said that take–up of the technology has been stifled by uncertainty over an accepted definition and consumer acceptance use of nanomaterials.
Potočnik said he believed the broad definition would go some way to addressing these hurdles.
“Industry needs a clear coherent regulatory framework in this important economic sector, and consumers deserve accurate information about these substances,” he said. “It is an important step towards addressing any possible risks for the environment and human health, while ensuring that this new technology can live up to its potential."
It noted the development of the technology was “an important driver for European competitiveness”.
However it acknowledged that uncertainties persisted over the risks of nanomaterials and highlighted the need for a clear definition to ensure the proper chemical safety rules were applied.
It said the pan-European definition would “help all stakeholders including industry associations, as it brings coherence to the variety of definitions that are currently in use in different sectors”.