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A common European approach to the regulatory testing of nanomaterials

Final Report Summary - NANOREG (A common European approach to the regulatory testing of nanomaterials)

Executive Summary:
The R&D results of the project are impressive in terms of quantity and quality. Partners produced a large set of well-defined experimental nanoEHS data. This dataset is of great value in- and outside the project since the data on exposure and effects are linked to accurate physical-chemical data. These are required for meaningful QSAR approaches and in silico correlational studies regarding the toxicological mode of action of nanomaterials.
Numerous Standard Operation Protocols (SOPs) have been developed and tested regarding their reliability, reproducibility and relevance. Their status varies from “proof of concept” to “validated” by inter laboratory comparison. New insights have been developed regarding the importance of a standardized way of preparing dispersions, the need to characterize test media before and during experiments, the applicability of in vitro tests, the use of high throughput screening (HTS) and the importance of harmonized data reporting formats (ISA-TAB based), just to name a few. The results and knowledge acquired has been condensed in overarching deliverables such as the NANoREG Framework and accompanying NANoREG Toolbox providing, among others, a risk assessment (RA) scheme that supports a more cost-efficient RA of nanomaterials.
The NANoREG Framework (D1.11) provides a detailed overview of how the safety of NMs should be addressed / assessed in the context of the European REACH Regulation (Part I of the document). It also presents forward-looking strategies aiming at making safety assessment more practical and economically efficient (Part II).
The NANoREG Toolbox (D1.12) supports the implementation of the NANoREG Framework by providing an overview of test methods, datasets, models etc., applicable in a regulatory context. Just like the Framework, it will be a building block for the ProSafe White Paper.
All results together have been translated into Answers on the Regulatory Questions that formed the demand side of the project (D1.09).
To be able to combine and compare experimental data, a set of core nanomaterials was selected that all partners had to use. A web ordering system provided partners with the core nanomaterials from known selected suppliers (D2.01).
For all NANoREG materials, a state-of-the-art physico-chemical characterization was done with the aim to cover as many of the key endpoints of the OECD WPMN sponsorship program as technically and practically possible (D2.02). Dispersion SOPs and minimum requirements for characterization for toxicological studies were established and laid down in a Guidance Document, thus supporting reliability and comparability of data. It was mandatory for the partners to perform their experiments in accordance with the Guidance Document. During the course of the project, those fundamental requirements were further refined.
A policy for NANoREG data management was established comprising a standardized way of data logging, mandatory uploading of data to the NANoREG data platform and opening up the data at the end of the project. This dataset is now available to- and exploitable by the nanosafety community.

The NANoREG consortium has proven that it is feasible to come to a concerted action regarding the materials to be tested, test methods and cell lines to be applied, quality checks, etc. Such concerted action is an absolute must for generating meaningful data. The project also has proven that the basic willingness of partners to collaborate can be used to come to an agreement (possibly for the first time) to make data and deliverables publically available. This makes it possible for other projects to build on the results of NANoREG. In this context, it can be noted that NanoReg2 and caLIBRAte will further elaborate on the data generated in the project. It would be a major step forward if other nanosafety projects would copy the example NANoREG has set, with respect to opening up the results. All NANoREG results are available in the NANoREG Results Repository.

For an extensive description of the NANoREG project and its results, see the NANoREG Final Report Part 1.

Project Context and Objectives:
For a description of the project context and the main objectives see section 2.1 'Project context and objectives' of the NANoREG Final Report Part 1.

Project Results:
For a description of the project main S & T results / foregrounds see Chapter 3 'Project achievements and management' of the NANoREG Final Report Part 1.
Potential Impact:
For a description of the impact of the roject on a general level see section 2.2.5 Expected results and their impact of the NANoREG Final Report Part 1.

On a work package level, a description of impact has been included in Chapter 3 of the NANoREG Final Report Part 1.

For an evaluation and update of the impact chapter of the DoW, see NANoREG Final Report Part 2 Annex 1. Final Report Part 2 is available via CIRCABC, Annex 1 is available in the attached document.

List of Websites: with a hyperlink to the NANoREG Results Repository
a list of collaboration partners has been included in the NANoREG Final Report Part 1.