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Promoting the Implementation of Safe by Design

Periodic Reporting for period 1 - PROSAFE (Promoting the Implementation of Safe by Design)

Periodo di rendicontazione: 2015-02-01 al 2017-04-30

Reducing and eliminating these uncertainties and developing ways to incorporate nanosafety into the design of nanomaterials is an objective of a great number of nanosafety projects funded by the EU or national authorities. The ProSafe project is aimed at coordinating and supporting part of these efforts by bringing together and, where possible, aligning the results of these projects. The main aims and resulting products of the ProSafe project are:

1. The Joint Document (JD): This document compiles the results of an extensive evaluation by a Task Force of independent senior experts of the results of NANoREG and other EU NanoSafety Cluster (NSC) projects and the results of the OECD sponsorship programme. The document served as a reference document for the OECD-ProSafe Joint Scientific Conference in November 2016.
2. The White Paper: This document will come forward with recommendations for policymakers and legislators for measures to come to a more efficient and effective governance and regulation of nanomaterials, including evaluated methods for testing and assessing risks of nanomaterials, and including Safe by Design (SbD).
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
√ Joint Document
The Joint Document gives an impressive overview of the state of the art regarding testing and assessing the effects of nanomaterials in a regulatory context. It gives guidance to all involved stakeholders in regulating and governing the risks of nanomaterials, on whether a given method makes sense or not. Furthermore, it gives direction to future harmonisation activities in OECD and other harmonising bodies.

√ White Paper
The White Paper integrates the main NANoREG outcome (Framework and Toolbox), the ProSafe Joint Document and the results of numerous other projects. It provides recommendations for regulators and policymakers aimed at a more efficient and effective governance and regulation for use of nanomaterials. The impact of the recommendations will strongly depend on the position Member States will take with respect to the proposed actions. This is further elaborated in section 3.3.

√ Data management
Together with the NANoREG project and the eNanoMapper project, ProSafe has given a boost to the awareness that for an efficient and effective nanosafety research, an advanced system of data management is key. This includes the necessity to i) open up all experimental nanoEHS data generated in – at least – government-funded nanosafety projects, ii) cater for standardised logging of these data and a sustainable infrastructure for developing and maintaining ontology, iii) provide long-term storage of and access to data, and iv) enable data curation.

It is to be expected that the example given by NANoREG, eNanoMapper and ProSafe with respect to opening up all generated information, to standards for data logging, nanoEHS ontology and transferring all data to a public accessible database will inspire other nanosafety projects to do the same. It also is to be expected that the recommendation in the White Paper to take more structural measures in this field will be followed up by Member States and the EC, thus creating even more impact.

√ Accessibility of information
is critical to the effectiveness and efficiency of nanosafety research. It is the only way to build on the results of previous projects. To carry out this decision, the ProSafe Results Repository has been created with a strong connection to the NANoREG Results Repository.

Just like for data management (see above), the example set by NANoREG and ProSafe will probably inspire other nanosafety projects to do the same. Implementation of the recommendations on this White Paper topic by EC and Member States will strongly contribute to the impact of ProSafe in this field.
ProSafe Task Force during OECD-ProSAF scientific conference