Companies must provide more information on nanomaterials on the EU market under the REACH Regulation by 1st January 2020. It is important that potential registrants familiarise themselves with the new legal requirements and ensure that they are ready.
The definition of a nanomaterial (2011/696/EU Recommendation on the definition of a nanomaterial) is as follows:-
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.
IUCLID has been updated with new data fields for reporting the characteristics of nanoforms and sets of nanoforms. From 1st January 2020 onwards, registrants who intend to submit registrations covering substances in nanoforms must provide complete characterisation information on their nanoforms or sets of nanoforms.