The JD was prepared based on a review of approximately 1,000 published articles and research reports by nine internationally recognized nanomaterial experts. The two key criteria used for the evaluation of the documented research were reliability and relevance, as defined by the OECD. The nine areas of concern studied in this report are: (1) physicochemical characterisation, (2) exposures through the life cycle, (3) fate, persistence and bioaccumulation, (4) exposure modelling, (5) ecological effects and biokinetics, (6) human health effects and biokinetics in vivo, (7) human health effects and biokinetics in vitro, (8) (Q)SAR modelling of nanomaterials and (9) risk assessment. For each of the areas of concern specific recommendations on the most appropriate protocols of regulatory relevance were identified, while gap analyses revealed specific high priority areas for further regulatory relevant research. A detailed list of all procedures and data sets that are ready for regulatory consideration and possible use are identified in the JD itself.
The key findings of the JD, and associated research gaps have been discussed during the OECD-ProSafe Joint Scientific Conference in November 2016. Critical comments and suggestions from conference delegates and participants are included in the final version of the JD. A number of papers, related to the areas of concern as mentioned above, will be published in a special issue of the NanoImpact journal.
The ProSafe White Paper ‘Towards a more effective and efficient governance and regulation of nanomaterials’ rests on the efforts and results of the FP7 project NANoREG and the H2020 project ProSafe. Both projects were driven by the need to reduce the uncertainty regarding the regulatory assessment of the EHS aspects of nanomaterials.
The White Paper recommends adjustments to the REACH annexes, aimed at making the current regulation better suited to nanomaterials. It includes proposals for further harmonisation of test methods by the OECD and proposals for a more efficient use of the results of nanosafety projects, by improving the data management infrastructure.
For the longer term, the White Paper sketches possibilities of innovation of risk assessment, the potential of promising approaches like QSARS to predict the EHS effects of nanomaterials, and Safe by Design as a way to include safety aspects of nanomaterials in the process of developing nanomaterials and their future applications.
The implementation of the recommendations will make the current legislation better applicable to nanomaterials, will reduce the uncertainty for industry with respect to the regulatory requirements and will reduce industry compliance costs and efforts. This is especially important for SMEs.
It is up to the EU Member States, the European Commission and international ha
