RIVM on Advanced Materials, April 2024

Danish researchers assessed recommendations for adjustments to legislation for nanomaterials published in 2004. While many of these recommendations were partly or fully met, some legislation still needs adjustments for nanomaterials. For example, the definition of nanomaterials differs between legislations. Additionally, instruments to measure nanomaterials and test methods require further development to meet regulatory requirements and enable enforcement. Advanced materials may pose additional challenges in risk assessment. The legislation amendments for nanomaterials may not necessarily identify potential hazards and risks for advanced materials.

European nanomaterial legislation in the past 20 years

In 2004, a report was published about the potential effects of nanotechnology on human health and the environment, as well as on ethical and societal discussions. The report’s authors highlighted the importance of legislation and recommended ways to adjust it for nanomaterials. Over the next twenty years, legislation has been adapted to address nanomaterials. This includes legislation on cosmetics, novel food, biocides, and chemicals (REACH). In 2011, the EU European Union (European Union) published a Recommendation for a definition of nanomaterials, which was updated in 2022.

Significant progress has been achieved

Danish researchers have assessed the extent to which the 2004 recommendations are currently being met. They analysed the changes to the European legislation relevant to nanomaterials and compared them to the recommendations. They found that most recommendations were met to a medium or high degree. For instance, the REACH legislation now includes specific requirements for nanomaterials. And cosmetics with nanomaterials need to be assessed by the Scientific Committee on Consumer Safety (SCCS) to ensure their safety under foreseeable exposure.

Many recommendations were met to a medium degree only. Some regulatory frameworks still need to be equipped to handle the unique properties of nanomaterials. The Waste Framework, for instance, lacks nanospecific requirements. Additionally, there are remaining issues with measuring nanomaterials. Due to their small size, nanomaterials smaller than 30 nm are difficult to measure. High background levels provide further challenges to distinguish (additional) nanomaterials.

Further action is still needed

The authors have identified specific recommendations that still need to be implemented. One such recommendation is for manufacturers. They should provide procedures on how their materials will be managed to minimise human and environmental exposure.

Additionally, the authors highlight some challenges that may hinder the adaptation of regulatory requirements. These include the lack of test methods and guidance documents that are (sufficiently) applicable to nanomaterials. Differences also exist in legal definitions for nanomaterials. This means a material can be considered a nanomaterial under one legislation but not another.

To overcome these challenges, future efforts should focus on developing test methods and guidance documents tailored to nanomaterials. Moreover, revisions to legislation for nanomaterials should continue, and enforcement of these regulations needs to be improved.

Reflections by RIVM

RIVM acknowledges that significant progress has been made in the last twenty years in regulating nanomaterials. The review authors have analysed the 2004 recommendations and compared them to the current European legislation regarding nanomaterials. However, they did not discuss the current relevance of the recommendations. Some may no longer be applicable due to new insights, and new recommendations may be missing.

RIVM also sees the need to develop and improve guidance and instruments for measuring and testing nanomaterials. The Malta Initiative is working on this and has recently published a Prioritisation List. This list aims to support the development and amendment of OECD TGs for nanomaterials and (other) advanced materials.

Changes are made to the legislation to address nanomaterials. Yet, it is unclear whether these can also effectively identify potential hazards and risks associated with other advanced materials. 2D materials like graphene oxide or MXenes, for instance, may need further adaptations. A German report identifies many groups of such advanced materials. The regulation of these materials needs further attention.

RIVM on Advanced Materials April 2024