Recommendations for European policy makers and regulators: The ProSafe White Paper

Abstract for ProSafe White Paper

The uncertainty regarding the effects and risks of nanomaterials on human health and the environment, and how they should be tested and assessed in the context of current regulations, is clearly holding back the full exploitation of the innovative potential of nanomaterials. To reduce this uncertainty the FP7 NANoREG project and H2020 ProSafe project (jointly referred to as N1P) have made a critical evaluation of methods to test and assess these risks in the context of the current REACH regulation. Where essential methods were lacking, new ones have been developed. For several existing methods, adjustments have been proposed. Possible improvements to the REACH regulation have also been identified in these projects.

The results of both projects have been translated in this White Paper into recommendations for European policy makers and regulators. Part of them have a “no regret” character, meaning that the proposed actions can be considered as necessary, feasible, effective and cost efficient.

Examples of such recommendations are the implementation of the test methods developed or adjusted in NANoREG to use at the OECD level, by establishing Technical Guidelines or modifying existing ones.

Another recommendation is the introduction of a compulsory requirement that all public funded nanosafety projects must open up and share their all their data and results. The NANoREG project has proven for the first time that this is possible.

Concrete recommendations to make REACH better suited for assessing the risk potential of nanomaterials are also given.

The recommended measures proposed for data quality and data management will create a more solid information basis for risk assessment of nanomaterials.

When implemented, the recommendations regarding REACH will improve the application of REACH in both a legal and scientific sense. In practical terms however, the application of REACH will remain complex, time-consuming and costly. Besides that, adapting and specifying the information requirements and test methods in REACH for nanomaterials that are now on the market, will not solve the regulatory hurdles for next generation (nano)materials. For this reason, the White Paper also recommends exploring the possibilities of a more future proof approach for securing the safety of (nano)materials. Possible options that are mentioned and to some extent developed in NANoREG and ProSafe are the “Safe-by-Design approach” and a more “Concern-based testing approach” of risk assessment.

It is for the Member States to decide what follow up they will give to the recommendations presented in the White Paper.




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