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European Commission proposes legal Definition of the Term 'Nanomaterial'

The European Commission has started an online consultation on a Proposal for a definition of the term ‘nanomaterial' that the European Commission intends to use as an over arching, broadly applicable reference term for any European Union communication or legislation addressing nanomaterials.

The consultation Background Note explains that ‘[t]he text builds notably on the work done by the Commission's Joint Research Centre (JRC) and the input of the Scientific Committee for Emerging or Newly Identified Health Risks (SCENIHR) which itself conducted a public consultation on its work earlier this year. It takes the work of international organisations and third-world countries in this field into account.

The draft definition consists of three criteria. Whenever one of the criteria is fulfilled a material is considered to be a nanomaterial. The reasoning behind the three criteria is explained in the recitals’. The full text of the Draft Commission Recommendation on the definition of the term 'nanomaterial clarifies the scope of the definition:

‘The definition in this recommendation should cover nanomaterials consisting of particles in the size range 1 nm - 100 nm. The number size distribution should cover the typical case where a nanomaterial consists of particles present in different sizes in a particular distribution...This approach conforms with the opinion of SCENIHR and others that the size distribution of a material should be presented as size distribution based on the number concentration (i.e. the particle number) and not on the mass concentration of a nanomaterial product as a small mass concentration may contain the largest number fraction. The one percent figure in this Recommendation is chosen in the absence of full scientific and technical knowledge about the actual distributions and available measuring techniques’.

Recommended Definition Text (Article 2):

1. 'Nanomaterial: means a material that meets at least one of the following criteria:

  • consists of particles, with one or more external dimensions in the size range 1 nm - 100 nm for more than 1 % of their number size distribution
  • has internal or surface structures in one or more dimensions in the size range 1 nm - 100 nm
  • has a specific surface area by volume greater than 60 m2/cm3, excluding materials consisting of particles with a size lower than 1 nm

2. Particle: means a minute piece of matter with defined physical boundaries (ISO 146446:2007)'

Comments on this Draft Commission Recommendation can be submitted until the deadline of 19 November 2010 as a free text, using this response form.

 

Follow these links to access the consultation website, to download the consultation Background Note, or to download the Draft Commission Recommendation.

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