Minimizing the gap between nano-innovation and risk

Many products on the market rely on the exceptional properties of nanomaterials and many more are in the pipeline. But the unique behavior of these materials on the nanoscale could spell potentially unforeseen risks to humans and the environment. A coherent risk governance system to manage their safety is currently lacking, warns Lya G. Soeteman-Hernández of the National Institute for Public Health and the Environment in The Netherlands. Together with colleagues from across Europe as part of the Horizon 2020 NanoReg2 project, scientists have come up with a new, more proactive system that can keep pace with development and should lead to safer nanomaterials, products, and processes [L. G. Soeteman- Hernández et al. Materials Today Communications (2019), https://doi.org/10.1016/j.mtcomm.2019.100548].

“The ‘Safe Innovation Approach’ (SIA) combines the ‘Safe-by-Design’ (SbD) concept, which recommends industry integrate safety considerations as early as possible into the innovation process and ‘Regulatory Preparedness’ (RP) that aims to improve anticipation of regulators so they can facilitate the development of adaptable regulations able to keep up with the pace of knowledge generation and innovation,” explains Soeteman- Hernández.

The SbD concept, which was developed and implemented under two European-funded projects (NANoReg and ProSafe), aims to assess and deal with potential risks throughout the R&D process, not just when products come to market. Materials and products developed in this way should be safe to use (not damaging to humans or the environment), produce (risks eliminated from the workplace and reduce waste), and recycle or dispose of (end-of-life options prevent exposure). But the approach requires innovators to interact with regulators much earlier – and throughout – the development process.

Implementing a system where innovators address safety from the early stages of the innovation process and where regulators are more aware and prepared for innovations is challenging because it requires a change of mindset from both innovators and regulators, say the scientists.

The final piece of the puzzle – the ‘Trusted Environment’ (TE) – aims to help this interaction. This virtual or physical space enables industry, innovators, and government institutions to share and exchange knowledge, information, and views on new nanomaterials or nanotechnologies.

“A TE can facilitate safe design by providing a podium for dialogue between regulatory risk assessors and other stakeholders to reduce the uncertainty in the safety assessment of nanomaterials,” points out Soeteman- Hernández.

The scientists bring these three concepts together in a single approach for the first time and plan to implement it in a number of current EC-funded projects (Gov4Nano, NANORIGO, and RiskGONE).

The strengths of this approach are that SbD reduces the uncertainties and risks of human and environmental safety of nanotechnologies early in the innovation process and addresses not only in the design of safe materials and products but also in the design of safer production, use, and end-of life, say the scientists. But for regulators, the biggest challenge will be to transition from a reactive to a proactive role. Regulators need to proactively keep up-to-date with new innovations and engage with industry on how to deal with new developments.

In practice, says Soeteman- Hernández, this could mean a change in company mentality, choosing alternative less toxic nanomaterials or changing production processes to reduce exposure to workers and the environment or minimize waste. For Europe, it could mean an agile risk governance system for nanotechnologies ready to deal with the unexpected.

Further information:

http://www.nanoreg2.eu/about

https://www.gov4nano.eu/

https://cordis.europa.eu/project/rcn/220129/factsheet/en

https://riskgone.wp.nilu.no/