What are the main challenges?
In our work on the Second Regulatory Review on Nanomaterials we discovered that nanomaterials are much more common and normal than we would have expected from previous debate. Many known nanomaterials that have been there for decades, such as carbon black and synthetic amorphous silica, are widespread in many applications. Also, if objective criteria are applied, such as particle distribution in a size range of 1–100 nanometres, many more common materials may actually be nanomaterials, even those that have traditionally not been identified as nanomaterials.
What definition of nanomaterials did the Comission agree upon?
We started to use the ISO definition, the international standardized definition, but found that that was too broad. It covers too many materials, even many more than the EU definition does, and would have been even more challenging to enforce.
For example, we needed to define a minimum threshold on how many nanoparticles need to be in a material to make it a nanomaterial, because nanoparticles are everywhere and without such a threshold we would have covered almost all solid materials. We took a figure of 50 % of particles to be as practical as possible but we are far from claiming that this is a perfect and scientifically unequivocal value. We will have a review of the nanomaterial definition in the next year.
We also excluded nanostructured materials, that means materials with surface structures or pores in the nano range because most real-life materials have in one way or the other such structures. Defining a minimum threshold on how many and which structures would be needed to characterize a nanostructured material would have been an almost impossible task.
Where do you gain your knowledge about nanoparticles from?
There are different aspects to how we do that. On the one hand, we follow the ongoing research on nanomaterials, in terms of market developments and innovation, as well as safety assessment. Quite a lot of research programs and publications are in that field.
