European Commission releases Recommendation for the definition of nanomaterials

 On October 18th, 2011, the European Commission has released a Recommendation regarding a common definition of nanomaterials, which is now under public consultation. According to the Recommendation “Nanomaterials means 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 1nm-100nm”.

Nanomaterials have already found hundreds of applications in a variety of sectors, while at the same time have enormous research potential (e.g. in medicine, environmental protection etc.). Due to this plethora of uses and applications, the nanomaterials have acquired a number of different definitions in the various legislative texts (both in European and National level) that apply to them. This incompatibility of definitions preserves uncertainty over the risks they pose and the appropriate measures. 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 Recommendation, however, specifies that the definition may not be readily usable in pharma and medical devices legislation.

When the new definition is officially adopted, it is expected to influence the application of the REACH Regulation (1907/2006). The experience of the first registration deadline (30 November 2010 for substances produced or imported at more than 1000t/year) under REACH, the EU’s overarching chemicals policy, showed that companies needed more clarity about their obligations with regard to nanomaterials. 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.

You can find more information regarding the proposed single definition in the relevant press release of the Commission and the Commission’s webpage for nanomaterials, or you can contact us.