Scope Statement

There are believed to be roughly 30,000 nanoparticle types under investigation in laboratories and industries internationally, all potentially seeking a place in the market. Neither REACH in Europe or TOSCA in the US have been designed with the unique challenges of nanomaterials in mind, and thus there is an opportunity for a harmonised approach to address and co-design the additional tests required to assess the risks posed by different classes of nanomaterials. Focus must urgently progress to so-called 2nd –4th generation nanomaterials, including composite, hybrid and complex structure and architecture nanomaterials, and development of a framework within which to assess the potential for unique risks posed by such advanced materials. The framework must have a sound fundamental and mechanistic basis, connected to exposure, uptake, localisation, persistence and biodegradation of nanoparticles, which is a much more secure approach to dealing with entirely new particle types than extrapolation from bulk materials or molecular chemicals. Meanwhile, (provisional) threshold limit values of exposure to (classes of) nanomaterials should be developed for initial safety assessment, based on the best available knowledge and explicitly addressing uncertainties. Epidemiological studies need to be started to evaluate the relevance of toxicological finding to (human) health and the appropriateness of the assigned limit values.