In 2011, the European Commission adopted a 'Recommendation on the Definition of a Nanomaterial', which 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%.
By derogation from the above, fullerenes, graphene flakes and single wall carbon nanotubes with one or more external dimensions below 1 nm should be considered as nanomaterials.”
The definition will be used primarily to identify materials for which special provisions might apply e.g. risk assessment or ingredient labelling. It is noted that those special provisions are not part of the definition but of specific legislation in which the definition will be used.
The definition is currently used in the EU regulations on biocides and medical devices. It serves also as a reference in the amendment of the older nanomaterial definitions in the cosmetics and food information regulations. Moreover the European Commission is looking at ways to use the definition in the context of potential nanomaterial specific provisions related to the Regulation on Registration, Evaluation, Authorisation and Restriction of Chemicals (REACH). The definition was also recommended for use by EU agencies such as the European Chemicals Agency (ECHA) and the European Food Safety Authority (EFSA) that have already started to apply it in their work.
The provisions of the recommendation include a requirement for review "in the light of experience and of scientific and technological developments," particularly focusing on whether the number size distribution threshold of 50 % should be increased or decreased. The Commission is expected to conclude the review in 2016, following the consultation of its draft findings with the stakeholders towards the end of 2015.
Further information is available on the European Commission website.
Unambioguious material characterisation is an important pre-requisite to most regulatory processes, and allows a robust and fit-for-purpose hazard and risk assessment to be undertaken. To find out more about our capabilities in this area, visit our service pages.