Published 2021-03-11

This post is also available in Swedish

Mobilising stakeholders in the nano field

Regulations and requirements regarding nanomaterials are, to say the least, a thorny problem for companies. There is also a disconnect between researchers’ work on useful techniques and methods and the access to results for industry and regulators. Now researchers at Mistra Environmental Nanosafety are building a database that will promote access to knowledge.

Proactive risk assessment, regulation and stakeholder involvement are the main focus in one of the work packages of the Mistra Environmental Nanosafety research programme. Steffen Foss Hansen, Associate Professor at the Technical University of Denmark, is one of the leading researchers.

‘Basically, we have three focus areas in our work package that all revolve around the fact that a “bio-eco-corona”, like a shell, forms around nanoparticles when they’re released into the environment.’

Foss Hansen explains that the work is about providing a method of risk assessment that takes into account the new properties that an eco-corona, a coating composed of natural organic matter, adds to the nanomaterial, including toxicity. The work also involves addressing the limitations of existing legislation and regulation, regarding both nanomaterials in general and the new properties in particular. The work package also focuses on mobilising stakeholders in Sweden and the EU to engage in innovation that is responsible in terms of nanomaterials.

Mobilisation for understanding and collaboration

Involving stakeholders is an important element of the programme. This is partly to identify who influence, and are affected by, regulation in Sweden and the rest of Europe, and the relationship between them. But it also serves to gather and engage them in research to create knowledge and a common understanding of obstacles and potential in learning, collaboration, innovation and nanosafety.

‘We’re interacting with our stakeholders as much as possible to understand, first and foremost, what issues and challenges they have, and also their experience of implementing the new nano-specific requirements in the EU related to the registration and safety testing of nanomaterials. Second, we’re explaining how we interpret the legal requirements, and what we know from the scientific literature and our own experience that enables us to meet these requirements in practice.

‘Finally, we’re starting a further dialogue on, for instance, testing and reporting requirements that are particularly challenging, and we design parts of our research to develop best practice for how to tackle the challenges,’ Foss Hansen says.

Challenges involved in current reporting

Under EU chemicals legislation, manufacturers and importers need to register their substances if these are produced in quantities of one tonne or more a year. The registration must contain data on toxicity and ecotoxicity, but the amount of data to be provided varies, depending on the annual production volume per registrant.

‘Since January 2021, producers and importers of nanomaterials have had to register all their “nanoforms” and submit information on properties that may affect toxicity, ecotoxicity and environmental exposure. In the EU, nanoforms are defined as forms of “a natural or manufactured material containing particles, in an unbound state or as an aggregate or agglomerate where, for 50% or more of the particles in the number size distribution, one or more external dimensions are in the size range of one to a hundred nanometres,’ Foss Hansen says.

According to Foss Hansen, the current reporting entails many different challenges. First, registrants need to provide a wealth of information for all the nanoforms they register. They also need to provide sufficient justification for each information requirement, document the test conditions and state scientific reasons for registering the test material. They then need to meet specific (eco)toxicity-related test requirements for various nanoforms, and demonstrate the safety of manufacturing, use and exposure to various nanoforms separately for every stage of the material’s life cycle. This is, to say the least, a great deal of information.

‘Three aspects make this information and test requirements challenging. First, for some of them we don’t know how tests of that kind can be performed so that they give meaningful results that can be used for risk assessment. Second, there’s currently no clear guidance from the European Chemicals Agency (ECHA) on what’s expected of registrants.

‘And third, manufacturers and importers face a dilemma: they have to choose between two unsatisfactory methods. One shows that their material isn’t nanomaterial, so they avoid registration and aren’t subject to safety assessment requirements. The other, which identifies their material as nanomaterial, means that then they face a raft of scientifically and technically challenging registration and testing requirements.’

How can your research meet these challenges?

‘I think our most important contribution is to make sure all project partners know what the challenges are, and every so often ask themselves the question of how their research can respond to this or that challenge. And make sure, too, that there’s an effort to communicate knowledge to potential registrants and regulators.’

Database provides access to knowledge

In Mistra Environmental Nanosafety, a nano-database on regulation is being built and is now in operation. It contains details of each individual regulation that has been implemented regarding nanomaterials so that industrial and other stakeholders have access to knowledge about, for example, information requirements and definitions. They can also learn about advantages and disadvantages of the regulations for the research programme and a reflection on how the provisions contribute to innovation.

The programme also looks at how risk assessment, as a method, can be revised to include existing data on toxicity and ecotoxicity as well, and can thus give decision-makers significant results.

Mistra Environmental Nanosafety has also worked to identify methods that can be used to meet the new reporting requirements under EU chemicals legislation. This work provided many good ideas on how joint efforts can be undertaken.

‘As researchers we’re often familiar with, and apply in our work, methods and techniques that may be useful to registrants and regulators. But our knowledge and insights are focused on reporting our findings in scientific articles that industry and regulators may not have access to, or follow.’