Understanding Nanosafety

« Nanotechnology is a booming business. Industry and governments are investing heavily in the development of nanomaterials and applications. Equally, great efforts are being made into understanding their environmental, health and safety (EHS) aspects.


Over the last decade, the latter has resulted in thousands of publications on nano-bio interaction. Yet it has not led to a common understanding on how to test and assess the effects and risks of nanomaterials on human health and the environment. Yes, we know that nano-particles can affect biological systems and yes, we are gaining understanding of the mechanisms at play.

This is good news. The bad news is, the practical relevance of the tests applied is questionable. For example: what is the predictive value of testing pristine nanomaterials for application of this material in paint? What is the reliability and reproducibility of the generated data?

We also learned that a number of proven methods for testing and assessing ‘traditional chemicals’ are not fit for this specific group of materials. Due to these uncertainties, we are unable to answer the question – to what extent do nanomaterials pose a threat to human health and the environment and what methods should be applied to determine adverse effects?

To take full advantage of the innovative, economic and environmental potential of nanomaterials, it is vital to, at least, reduce the aforementioned uncertainty regarding the safety aspects. More specific: industry needs clarity on how nanosafety will be regulated; society needs the assurance that the potential risks of these materials will be properly dealt with. To this end, it is necessary to develop a common understanding of what the risks are and how to assess the EHS effects of nanomaterials during their lifecycle.

Answers are needed to the following questions:
what tests are suitable and reliable for identifying the EHS effects?; and how do we assess the risks in different transformation states?

Addressing these questions are two European Commission projects, coordinated by the Dutch Ministry of Environment: NANoREG and ProSafe.

In NANoREG, over 80 institutional partners from member states, South Korea and Brazil collaborate in developing reliable, reproducible and relevant methods for testing and assessing the effects of nanomaterials on human health and environment in a regulatory context.

This “demand driven” project is focused on generating data, guidelines and standard operating procedures with the objective to answer 16 regulatory questions.
Partners must comply with the so-called guidance document. This stipulates a core set of nanomaterials to be used by partners and protocols on, for example, dispersion and characterisation of these materials before, during and after the experiments. Furthermore, the document (in progress) will define standards for quality control, provides benchmark data and defines the format for data logging (including quality data).

These provisions aim to link results from the project’s different work areas, such as those of an in vivo test with an in vitro test for a specific nanomaterial, with the specific aim of solving the internal dose problem or relevant dose levels for in vitro experiments.

The ProSafe project valuates and integrates the results of NANoREG and other nano safety cluster (EU) projects and the results of the OECD sponsorship programme into a joint document. This will be used as a reference for a three-day scientific conference that will be organised by the OECD in collaboration with NANoREG in November 2016.

The outcome of this process is a broadly supported approach (framework) and a set of instruments (“toolbox”) for testing and assessing the EHS aspects of nanomaterials.

The joint document serves as the technical annex to the EU policy-oriented white paper that covers nanosafety issues described in the joint document as well as innovation policy in relation to nanosafety. The white paper highlights the problems we are facing on regulation of nanomaterials and analyses the cause of these problems from a policy perspective. Based on the joint document and the results of the scientific workshop, the white paper will give an overview of “what we know” and “what we don’t know”; based on the regulatory questions.
This will be elaborated to offer guidance to policymakers and regulators. A regulatory framework and toolbox will be part of this.

Longer term, the way towards the implementation of Safe by Design and safe innovation will be elaborated.
A support platform for the results of both projects is of paramount importance. Therefore, the involvement of regulators and policymakers is key.”

Article from Aart Dijkzeul, Dutch ministry of environment and project manager of NANoREG and ProSafe

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