Development and implementation of Grouping and Safe-by-Design approaches within regulatory frameworks (NANoREG 2)

09/2015-02/2019

This third-party funded project is conducted in the framework of the BfR research programme on nanotechnology.

EU grant agreement number: 646221

Project homepage: www.nanoreg2.eu

Project description:

One of the greatest challenges facing regulators in the ever changing landscape of novel nanomaterials is how to design and implement a regulatory process which is robust enough to deal with a rapidly diversifying system of manufactured nanomaterials (MNM) over time. Not only does the complexity of the MNM present a problem for regulators, but the challenge is to build a regulatory system which is flexible enough to be able to deal with new targets and requirements in the future. This can be facilitated by the development and introduction of Safe by Design (SbD) principles. NanoReg2 is establishing „Safe by Design“ principles and also conducts various “Industrial Demonstrator Case Studies“.

Another major aim of NanoReg2 is the establishment of nanomaterial grouping approaches, which should be applicable in the context of different regulatory frameworks such as  REACH. Parallel to this, NanoReg2 is also developing integrated testing strategies to support nanomaterial grouping. This includes a complete physico-chemical characterisation of the nanomaterials as well as (eco) toxicological characterisation with respect to different toxicological endpoints.

BfR parts of the project:

BfR is the leader for WP1 (Regulatory orientated activities establishing a framework of grouping approaches), which includes several tasks (Interaction with Regulatory Bodies, Monitoring future regulatory needs, Result integration between ongoing projects, Development of Grouping Approaches, Establishment of an Integrated Testing Strategy, NanoReg2 Database).

More detailed information about the project can be found on the project homepage.

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