RIVM on Advanced Materials, March 2024

Researchers from the EU European Union (European Union) Graphene Flagship have highlighted the complexity of assessing the safety of graphene and related materials. Such assessment requires detailed knowledge of safety-related physicochemical properties and the development of harmonised test methods. These lessons must receive ample attention in future innovation programmes on new materials.

Understanding the safety of graphene and related materials

The EU Graphene Flagship Programme was a 10-year European research and innovation partnership. It aimed to advance the development and application of graphene and related materials. The programme also explored specific safety issues related to these materials. Researchers working on Health and Environment have shared some lessons learned on the EUON website. 

One of the key takeaways is that not all graphene-related materials are the same in terms of their safety profile. Different materials can interact differently with living systems. This largely depends on their physicochemical properties. Therefore, it is crucial to understand the relation between the properties of these materials and their safety profile. And to consider how these properties change throughout their life cycle. 

The authors also highlight the need for harmonisation and validation of test methods in support of regulation. 

Results from the Graphene Flagship reinforce the importance of including safety aspects in innovation programmes. This will generate crucial data that helps bridge critical information gaps. Close collaboration between different experts is essential. This should include experts on toxicology, materials, environmental, and occupational exposure sciences. 

Reflections by RIVM 

The efforts from the Graphene Flagship have gained a lot of knowledge on graphene and related materials. But there are still many uncertainties on how their physicochemical properties relate to their safety profile. Together with changes of these properties through the life cycle, this leads to concerns about the safety of graphene and related materials. And also establishing the safety profile itself may be a challenge. For example, there may be challenges with making stable dispersions of graphene and related materials remain. This may question the validity of existing testing methods. Similar information gaps have been recognised in the past for nanomaterials. Efforts for nanomaterials have been made to address these gaps, including changes in legislation. However, these changes have not been made with more advanced materials, such as graphene, in mind. So, it remains unclear whether these changes are sufficient to accommodate potential issues of advanced materials.  

Thus, a key and recurring question is whether current legislation is equipped to assess increasingly complex materials. Can legislation assess their human and environmental safety? Does it take into account the various stages of their life cycle? If this is not the case, how can we address the issue? Some options are discussed below. 

Grouping and read-across approaches 

Some of the variability of chemicals can be assessed by using grouping and read-across approaches. This may also be a way to deal with the enormous diversity of materials, including nanomaterials and graphene-related materials. However, this presents challenges regarding the comparability of materials and their safety profiles. It is unclear how these approaches should be applied to graphene and related materials. The Graphene Flagship has not addressed this. 

Addressing remaining uncertainties and concerns 

Several EU regulations now include specific requirements for nanomaterials, including the European chemicals regulation REACH. This may also allow safety assessment of graphene and related materials. The Netherlands has submitted graphene oxide to ECHA’s Draft Community Rolling Action Plan (CoRAP) as a first step in a Substance Evaluation. This process may lead to a request for additional safety information to address concerns that have been identified. In addition, it could offer insights into whether the current legislation is sufficiently equipped to assess these types of materials. 

Collaborating on safety and sustainability research

The European Commission expressed commitment to promoting safe and sustainable innovation. The ambitions of the EU Chemicals Strategy for Sustainability can only be achieved if safety and sustainability aspects are sufficiently addressed in innovative research programmes. The Graphene Flagship is a prime example that has tried to put this in use. In the proposal for the new EU partnership programme ‘I’M for EU’, it is a requirement that new materials must be safe, sustainable, and circular. This is in line with the ambitions of the EU Chemicals Strategy for Sustainability. However, putting this ambition in practice presents a significant challenge. 

Regulatory acceptance of new materials is important and can reduce barriers to innovation. This requires effective interaction and co-creation between researchers, risk assessors, and innovators at an early stage of innovation and product development. The use of OECD’s Early4AdMa approach may support these goals. It can be used to identify potential issues early on. Further it may provide guidance on necessary research funding, policies and standardisation/harmonisation.

RIVM on Advanced Materials, March 2024