Laying the groundwork for guidelines in nanosafety

The safe and responsible use of engineered nanomaterials is hard to define without concrete systems indicating the risks. But nanosafety isn’t about restricting the use of nanomaterials, it’s about ensuring the production of safe products, human and environmental health and innovation in industry.

As a key enabling technology (KET) central to the future of European manufacturing, engineered nanomaterials (ENMs) will increasingly be a part of everyday life. With such prevalence in the modern world, it is important that events like EuroNanoForum 2017 can discuss the societal aspects of nanotechnology to explore issues concerning environment, health and safety (EHS), policy frameworks and regulatory requirements.

Currently, nanosafety regulations are almost nonexistent. There are no occupational exposure limits set for any of the ENMs so far, meaning safe and responsible use can easily be challenged, but in recent years there has been a shift from toxicological studies of individual nanomaterials towards the development of integrated, systematic assessment tools. In NanoSafety Cluster alone there are several large scale Horizon 2020 projects developing hazard assessment tools and safe-by-design (SbD) approaches.

Coming to a close in March, the NanoSolutions project has for the last four years been working on its own NanoSafety Classifier to allow scientists to predict harmful effects of ENMs. Kai Savolainen, research professor and director of the NanoSafety Research Centre at the Finnish Institute of Occupational Health (FIOH), is NanoSolutions’ coordinator: “our main goal has been the development of a tool which is able to categorise different types of ENMs into hazard classes based on assessing associations between material characteristics and the biological data we’ve collected.” The results of the project will be presented in a dedicated workshop during ENF2017.

The actualisation of the NanoSafety Classifier is dependent on the huge amounts of systematic data that’s been collected, so it’s only in the final stages that testing has begun in earnest on existing ENMs on the market. Savolainen has stated that the project had a risky element all along but now that the end is drawing near, he is positive about it’s successes. Whether it will be implemented, however, is another issue. “That’s the goal, of course. My prediction is that the project will provide a classifier and evidence that these materials can be categorised regarding their hazard properties, but it needs a lot of work to get it into a shape that regulators, policy makers and industry would be willing to use”.

There’s a lingering perception that the notion of ‘nanosafety’ means red tape. Rules and regulations aren’t immediately associated with innovation, but requirements to safeguard human and environmental health needn’t be a barrier to industrial and commercial interests. In fact, it can mean just the opposite. In the chemicals industry, products are almost hitting the market before the required hazard identification steps are taken. If there’s an unacceptable risk to the workers or the general population then the product is pulled at great expense. However, if businesses can incorporate hazard assessment into the design phase of their products, then they stand to make huge gains in the long term. Rather than talk about the dangers of ENMs and trying to ban them, nanosafety is concerned with awareness and helping manufacturers to design safer materials. By helping a number of industries get their products through complex regulatory and approval processes, nanosafety guidelines could be the point where innovation begins.

It’s unlikely that a rash of nanosafety policies are going to be implemented across European industry overnight. There are proposals for occupational exposure limits to NMEs by U.S., German and Dutch organisations but none have have yet been put in place. Although the NanoSafety Classifier has been four years in the making, it is early days for this type of hazard assessment tool. The project is yet to conclude and will soon

be delivering its key results to the European Commission and after that new projects will be established to develop it further.

Currently in the NanoSafety Cluster stables are two Horizon2020 projects working on hazard assessment tools of ENMs: NanoFASE and SmartNanoTox. NanoFASE is looking to deliver an integrated Exposure Assessment Framework that allows the early assessment of potential environmental and human exposure and risks. It is also intended to facilitate safe product design and the inclusion these aspects in nano regulation. SmartNanoTox, meanwhile, aims at significant advances in nanotoxicity prediction through the development of smart tools that combining state-of-the-art approaches based on systems biology, statistical and other computational methods of analysis to gauge nano hazards.

Projects like ProSAFE and NanoReg2 develop and promote the concept of nanosafety as a route to commercial innovation, to incorporate the SbD approach at every level of nanomaterial-oriented production value chains. The aim is to make the implications of SbD concrete and clear in order to encourage regulators, and eventually legislators, to enshrine them in a legal framework throughout the EU and beyond.

Cooperation is key. Just as the success of Europe’s industrial future is reliant on the capacity of its member states to club together, guidelines for the safe and responsible use of ENMs needs academia, research organisations, industry and regulators to collaborate and better understand each other’s needs. As coordinator of the NanoSafety Cluster, Savolainen set the agenda for the European Commission’s nanosafety research agenda for the 2015 to 2025 period. Although the issue of nanosafety hasn’t always taken centre stage in the nanotech world, it has certainly become a more prominent feature, despite appearances. While there might be fewer projects dedicated to nanosafety there is a growing trend for nanosafety components within purely material science research projects where the safety of materials and the safety of the processes in which they’re being used in industrial and occupational environments is assessed.

A new industrial revolution is an exciting opportunity for European economies. Nanosafety and EHS regulations can protect workers, the population and the environment without undermining the commercial interests of Europe’s manufacturing industries.