What is the context of this report ?
The goals of this document are to describe the current level of knowledge of the safety of nanomaterials and nanotechnologies and to set out concrete goals for the research on safety of engineered nanomaterials (ENM) within the foreseeable future.
The rapid development of nanotechnology has indeed promoted a new generation of products and processes and created a tremendous growth potential for a large number of industry sectors. This rapid growth also created some concerns about their possible effects on human health and safety, and environmental burden.
Even though there is increasing amount of information of the hazard potential for several nanomaterials, there is a dramatic lack of relevant, relaible and systematic information on the potential hazards associated with these materials.
The current debate, including the lack of regulatory clarity, and the uncertainty surrounding the potential risks of nanomaterials have had a negative effect on the development, uptake and exploitation of nanomaterials in Europe.
The European Commission is considering a new Action Plan for Nanotechnology, addressing the technological and societal challenges and strengthening the research and innovation efforts, with increased emphasis on sustainable development, competitiveness, and environmental, health and safety (EHS) issues. In this context, the European NanoSafety Cluster is an initiative of the Research and Innovation Directorate General to bring together current research projects all across Europe that adress these issues in a coherent and harmonized way in Europe.
What is the definition of a nanomaterial for this report?
The definition used here is the one that the European Commission adopted in 2011 :a ‘nanomaterial’ is a « natural, incidental or manufactured material containing particles, in an unbound state or as an aggregate or as an agglomerate and where, for 50 % or more of the particles in the number size distribution, one or more external dimensions is in the size range 1 nm-100 nm. In specific cases and where warranted by concerns for the environment, health, safety or competitiveness the number size distribution threshold of 50 % may be replaced by a threshold between 1 and 50 %. »
A gap in terms of classifying nanomaterials is the fact that there are multiple different variants of each type of nanomaterial, all of which may differ in terms of their health and environmental impacts. Thus, there is a critical need for a more descriptive approach to naming, describing and classifying nanomaterials.
What are the potential hazards and risks related to nanomaterials?
The understanding of how nanomaterials interact with living system is incomplete and, thus, we are not yet in a position to know what to look for exactly when testing for the toxicity of nanomaterials. Hence, the crucial challenge in all cases is to identify the harmful agents and to differentiate them from their innocent counterparts so that the appropriate regulatory decisions can be made to protect human health and the environment. The majority of ENM might be harmless or only modestly harmful, but there is a plethora of evidence revealing many of the materials may be highly harmful. In this context, the real concern is the lack of systematic studies on hazards of, or exposure to, nanomaterials.
Are appropriate tools available today to assess the safety of nanomaterials?
There are currently regulations that cover nanoparticles, but they might need to be adapted for the specificity of nanomaterials.
However, the available laboratory tools for the assessment of the safety of ENM are often inappropriate or so laborious that adequate safety assessment remains highly problematic. We still lack a fundamental understanding of how nanomaterials can interact with living systems and, thus we are not even yet in a position to assess the relevant end-points for evaluating nanomaterial toxicity. This means that new safety assessment paradigms need to be developed during the coming years.
Is it necessary to develop new ways to assess the safety of the present and future generations of nanomaterials?
We are faced indeed with a large number of new materials for which testing or screening of toxicity is required, and the rapid development of new technologies and applications means that methods for assessment of the safety of next generation nano-enabled products also must evolve: nanotechnology is a moving target.
There is thus an urgent need for a “new” approach of toxicity screening and/or testing. Tests could shift to in vitro assays, along with computer models. The ultimate goal would be to develop a computational tool that can predict ENM safety based on the evaluation of minimal but sufficient amounts of information generated by toxicity studies, to provide a robust safety classification. It is a tool that is beyond the current the technological capabilities, but when it becomes available it will allow the utilization of safety-by-design principle, and also be capable of improving the speed of hazard identification and risk assessment.