The second version of the Guidance, released in May 2016, is now available to download here.
Defined as a natural, incidental or manufactured material containing particles (nanomaterials), 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, fullerenes, graphene flakes and single wall carbon nanotubes with one or more external dimensions below 1 nm should be considered as nanomaterials.
- Particle: a minute piece of matter with defined physical boundaries.
- Agglomerate: a collection of weakly bound particles or aggregates where the resulting external surface area is similar to the sum of the surface areas of the individual components.
- Aggregate: a particle comprising strongly bound or fused particles.
- Nanofibre: nano-object with two similar external dimensions in the nanoscale and the third dimension being significantly larger [ISO/TS 27687, def. 4.3].
- Nano-object: material with one, two or three external dimensions in the nanoscale [ISO/TS 27687, def.2.2].
- Nanoparticle: nano-object with all three dimensions in the nanoscale [ISO/TS 27687, def. 4.1].
- Nanoplate: nano-object with one external dimension in the nanoscale and the two other external dimensions significantly larger [ISO/TS 27687, def. 4.2].
- Nanoscale: size range from approximately 1 nm to 100 nm [ISO/TS 27687, def. 2.1].
- Nanotube: hollow nanofibre [ISO/TS 27687, def. 4.4].
- Particulate nanomaterial(s): nanomaterials that consist of nano-objects such as nanoparticles, nanofibres, nanotubes, nanowires, as well as aggregates and agglomerates of these materials either in their original form or incorporated in materials or preparations, from which they could be released.