October 05, 2012
The European Commission yesterday released a Communication opening a second regulatory review to ensure the safe use of nanomaterials. The regulatory review is a systematic analysis of all current applicable EU legislation to determine whether it is adequate to ensure the safe use of nanomaterials, and to fill regulatory gaps without jeopardizing their contribution to innovation and growth in the European economy.
The Commission Communication is an update of the 2008 Regulatory Review and responds to a 2009 European Parliament Resolution, which criticized the earlier review on a number of points and called for further information and analysis, as well as to a 2010 request by the Council to evaluate the need for specific measures relating to nanomaterial risk assessment, management and monitoring. The Communication is accompanied by a Staff Working Paper on nanomaterial types and uses, which gives a detailed overview of available information on nanomaterials on the market, including their benefits and risks.
What are nanomaterials?
The 2011 Commission Recommendation on the definition of nanomaterials defines '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. In specific cases and where warranted by concerns for the environment, health, safety or competitiveness the number size distribution threshold of 50% may be replaced by a threshold between 1 and 50%. […]" The current review round does not envisage a change to this definition, although a review is planned for 2014 in the light of experience and of scientific and technological developments. Regulation – which places the responsibility on industry to manage risks and provide safety information on substances – is the best possible framework for the risk management of nanomaterials when they occur as substances or mixtures, but that within this framework more specific requirements for nanomaterials are necessary. Annexes and encourages development of guidance for registrations after 2013.
The total annual quantity of nanomaterials on the global market is around 11 million tonnes, with a market value of roughly 20bn €.
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