European nanomaterial legislation in the past 20 years - Closing the final gaps

In 2004, the potential societal implications related to nanotechnology were highlighted in an influential report by the Royal Society and the Royal Academy of Engineering (RS & RAE). It was made clear that legislation is an important tool to tackle the challenges related to nanomaterials and a list of recommendations were put forward. Shortly after, the European Commission also proposed a list of recommendations on how to handle nanomaterial challenges and adopted the so-called "incremental approach", describing that current legislations should be adapted, where relevant, to handle nanomaterials. Now almost 20 years have passed and it seems relevant to take stock and investigate how legislations have been adapted to tackle nano-specific challenges. In this review, we analyze key pieces of European legislations relevant to nanomaterials and assess to what extent these legislations compare with the original recommendations from 2004 by the RS & RAE and the European Commission. We uncover the cross-cutting challenges that remain and provide recommendations on next steps that should be taken to address the risks of nanomaterials. For each recommendation, we assessed whether it was met to a high, medium or low degree by conducting targeted literature searches at Web of Science, screening legislations, guidance documents, databases etc., and applying expert judgement. We found that >90% of the recommendations put forward in 2004 by the RS & RAE and the European Commission have been either met to a high degree (13 out of 29) or met to a medium degree (14 out of 29). This suggests important advancements in the field of nanosafety. At the same time, it is important to address the concerns still left partly or fully unsolved. Such efforts entail e.g. further development of measuring instruments and standardised characterization and risk assessment methods for nanomaterials, application of a uniform nanomaterial definition, maximization of containment of free nanomaterials until hazards assessed/handled and elimination/minimisation of unintentional nanomaterial emission. Furthermore, we recommend prioritising future efforts to ensure enforcement and implementation of existing nano-specific provisions, as well as revision, where needed, of legislations that currently do not account for nanomaterials, such as the Waste Framework Directive.