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European Commission - Press release
What is a "nanomaterial"? European Commission breaks new ground with a common definition
Brussels, 18 October 2011 – "Nanomaterials" are materials whose main constituents have a dimension of between 1 and 100 billionth of a metre, according to a recommendation adopted by the European Commission today. The announcement marks an important step towards greater protection for citizens, clearly defining which materials need special treatment in specific legislation.
European Environment Commissioner Janez Potočnik said: "I am happy to say that the EU is the first to come forward with a cross-cutting designation of nanomaterials to be used for all regulatory purposes. We have come up with a solid definition based on scientific input and a broad consultation. Industry needs a clear coherent regulatory framework in this important economic sector, and consumers deserve accurate information about these substances. 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."
Nanomaterials are already being used in hundreds of applications and consumer products ranging from toothpaste to batteries, paints and clothing. Developing these innovative substances is an important driver for European competitiveness, and they have significant potential for progress in areas like medicine, environmental protection and energy efficiency. But as uncertainties remain about the risks they pose, a clear definition is needed to ensure that the appropriate chemical safety rules apply. The definition will help all stakeholders including industry associations, as it brings coherence to the variety of definitions that are currently in use in different sectors. The definition will be reviewed in 2014 in the light of technical and scientific progress.
The recommendation also delivers on a commitment made in 2009 to the European Parliament to issue a single definition that is broadly applicable to all EU legislation concerned by nanomaterials.
The definition adopted today is based on an approach considering the size of the constituent particles of a material, rather than hazard or risk. The wording 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 definition is based on scientific advice from the Scientific Committee on Emerging and Newly Identified Health Risks (SCENIHR) and the Joint Research Centre (JRC). A draft version of the definition was subject to a public consultation.
Nanomaterials are currently governed by a variety of legislative instruments at EU and national level. However, definitions have been developed on a case-by-case basis and vary across sectors, creating unnecessary burdens for industry and hampering public debate about risks and benefits of these substances. This recommendation gives EU legislators a legal reference for nanomaterials, when adopting new or implementing existing legislation.
The experience of the first registration deadline (30 November 2010) under REACH, the EU's overarching chemicals policy, showed that companies needed more clarity about their obligations with regard to nanomaterials. REACH has a key role to play in generating information about the properties of nanomaterials as chemical substances. With the adopted definition it will be easier for companies to assess their registration dossiers and determine exactly when they should consider their products as nanomaterials.