14th International Nano-Dialogue on "Life Cycle and Regulation of Advanced (Nano-)Materials»
On November 12th and 13th 2020, the 14th International Nano-Dialogue took place not as planned in Vaduz, but virtually – because of an approximately 100 nanometer-sized virus. The main topic of discussion were novel materials, also known as "advanced materials". A total of sixteen presentations were given and lively discussions were held at the event to broaden the understanding of advanced materials and highlight implications for the various stakeholders. The "Nano Roadmap 2025", a framework document of the nano-dialogue was also discussed and updated.
Following the traditional opening of the event by the host, the Office for the Environment Liechtenstein, and the “Tour de Table” with updates from the countries represented, the "Advanced Materials" were discussed in four blocks in the light of a life cycle approach.
New (nano-)materials and novel manufacturing processes
In the keynote speech on new (nano-)materials and novel manufacturing processes, Abdelqader Sumrein from ECHA presented the EUON study on second and higher generation nanomaterials and presented its results. The concept of "higher generations" has been introduced to highlight the potential of nanotechnology. The study concludes that due to the increasing complexity of and combination of organic and inorganic components in novel materials, new guidance documents might be necessary. With the basic statement "Graphene is not always graphene", Peter Wick from EMPA explained that the term "graphene" is imprecise because there exists a variety of different forms that can be summed up into "graphene-related materials" (GRMs). This can lead to misunderstandings in the dialogue between science, industry and authorities. The "Graphene Flagship Project" developed a helpful classification grid for such GRMs.
Additive manufacturing (AM) is regarded by experts as a novel manufacturing process with great potential. In his presentation, Steffen Scholz from KIT presented the DIMAP project in which the state of the art of additive manufacturing is being investigated by NM-reinforced printing inks, among other things. Within the project, an interesting "safe-by-design" approach was carried out. Adriaan Spierings from Inspire AG and Christoph Bosshard from SUVA gave a tandem presentation on additive manufacturing from the perspective of industry and occupational health and safety. In this context, a considerable need for practical information and simple guidelines/action aids for users, especially SMEs, that can be implemented in industry, is already apparent.
Occupational safety and implementation of safety-by-design concepts
In the next part, Rolf Packroff from BAuA pointed out challenges for occupational safety with regard to rigid CNTs and brittle materials that release dusts with critical morphology. Asbestos-like examples are pitch-based graphite carbon fibers. Although appropriate protective measures are in place for such "hazardous chemical agents", there is no obligation to pass on information in the supply chain. In addition, there are no fiber-specific test methods, evaluation and information requirements. Andreas Falk of BioNanoNet highlighted in his presentation the increasing importance of the "safety-by-design" concept in the application of new materials and especially the SbD approaches in European research projects.
Regulatory aspects of advanced materials and higher order nanomaterials
Thomas Kuhlbusch from BAuA presented the NanoHarmony project for the development of eight new test methods, in cooperation with ECHA, the Malta Initiative, the OECD Working Party on Manufactured Nanomaterials and nanomaterial manufacturers. In addition, the project aims to establish a long-term cooperation through the established network, to allow for quick and purposeful development and adaptation of future test guidelines.
The REFINE project and the resulting white paper was presented by Matthias Rösslein from EMPA. The paper summarizes the most important regulatory requirements of nanomedicine and highlights the challenges in regulation.
Beat Flühmann of Vifor Pharma also gave a presentation on nanomedicine and gave the perspective of a manufacturer. The characterization of the company’s products, Non-Biological Complex Drugs (NBCD), is complex and difficult because the entire product is considered an active substance. Thus, there are hurdles on the way to approval. This also applies to nanosimilars and their proof of equivalence, since even small changes in the manufacturing process can change the characteristics of the nanomedical product.
End-of-Life-Management of Advanced (Nano-)Materials
Manuela Kienegger from the AIT presented the "NanoCycle" study, which examines whether and how NM in plastics can influence or even impair the recycling process using PET as an example. The quantities of NM in plastic waste streams are unknown, but operators of recycling plants estimate the quantities to be relatively small. In addition, no effects on the processes or recycling products have been identified so far. Little is known about exposure to NM in waste and recycling streams, but it can be assumed that releases from polymer matrices are very low.
Great progress has been made in the environmental risk assessment of NM over the past ten years, as Bernd Nowack from EMPA reported. With his research group, he has particularly advanced the modeling of substance flows and releases. Specifically, he presented the possibility of dynamic and prospective modeling and the consideration of different nanoforms in the assessments. These methods are also interesting for the modeling of flows of novel (nano-)materials.
Andrea Haase presented the InnoMat.Life project, which is dedicated to three novel, as of yet little studied classes of materials. The overall goal is the establishment of grouping approaches and related criteria, so that novel or more complex materials can be grouped and evaluated with respect to their hazard and risk potentials, which includes the adaptation or establishment of appropriate experimental test methods. First research results suggest that grouping approaches for innovative or more complex materials can be established with the help of selected materials.
Tobias Walser from Vereala GmbH in Zurich concluded the series of presentations. He explained the innovations in the Swiss precautionary matrix for synthetic nanomaterials and pointed out that the tool will be updated in 2021. Synthetic nanomaterials can fall into the category of advanced materials. The Swiss precautionary matrix could also be suitable for the risk assessment of advanced materials. However, it would have to be adapted accordingly. In conclusion, he noted that a general understanding of advanced materials is more important than an exact definition, since a large and heterogeneous spectrum of materials is covered by the term.
Outlook
Even with the conference being held online, the response of the participants overall was very positive. In addition to many interesting presentations, there were also stimulating discussions and the "Nano Roadmap 2025" was discussed and updated. Although in a somewhat limited form, the 14th International Nano-Dialogue was successfully concluded according to the motto "Better to stick to the dialogue than to shake hands". The next Nano-Dialogue is set to take place in Switzerland - hopefully in person.