Seit 2005

16.10.2020

Important publications on nanotechnology and emerging technologies

The US FDA and the German BAuA have published two important reports and the European Commission has launched an online platform on novel technologies.

FDA publishes report "Nanotechnology - Over a Decade of Progress and Innovation”

The US Food and Drug Administration (FDA) has published the report "Nanotechnology-Over a Decade of Progress and Innovation".

The report highlights the FDA's progress in nanotechnology since the publication of its last report in 2007 and its role in promoting public health by regulating products within its jurisdiction that involve the use of nanotechnology.

It also refers to industry guidelines for the use of nanomaterials in human and animal food and pharmaceuticals.

It describes the FDA's two core facilities for nanotechnology, whose mission is to provide centralized characterization tools, training of researchers and regulatory research.

International cooperation is addressed, including the US-EU CoR (Communities of Research), the EU Joint Research Centre (JRC) and the US-India Emerging Materials and Manufacturing Sciences Working Group.

Final report on the substance evaluation of MWCNT of BAuA

ECHA has published the conclusion of the substance evaluation for Multi-Walled Carbon Nanotubes (MWCNT), synthetic graphite in tubular form and tangled, which summarises how the information on the substance can be used for regulatory risk management purposes.

The purpose of substance evaluation is to clarify whether a substance poses a risk to human health or the environment and EU Member States will evaluate the assigned substances with the aim of clarifying the potential concern and, if necessary, request further information on the substance from the registrant(s).

If the evaluating Member State concludes that no further information needs to be requested, the substance evaluation is completed. If additional information needs to be requested, it will be obtained from the evaluating Member State. The evaluating Member State shall then draw conclusions on how the available and received information can be used for the safe use of the substance.

Germany addressed several concerns, including consumer use, discrepancy in self-classification between different joint submission registrants, differences in physicochemical properties affecting toxicity, e., number of different nanoforms registered and choice of representative test material(s), suspected specific target organ toxicity, suspected carcinogen, effects on environmental organisms, suspected environmental exposure, cumulative exposure and suspected persistence.

The final report concluded that it was not possible to fully address the concerns, in particular in view of the changing landscape for dossiers since the 1 January requirement for nanoform sets and the late submission of data.

European Commission launches the "Advanced Technologies for Industry" platform

The European Commission has launched the new online platform "Advanced Technologies for Industry", which covers technologies, sectors, policies, products and EU and global actions.

It also maps technology centers and is a hub for data related to advances in robotics, AI, large data and advanced materials, among others.

The platform also highlights funding and events related to advanced technologies.

Sources: NIA - FDA publishes report "Nanotechnology - Over a Decade of Progress and Innovation
NIA - MWCNT Substance Evaluation Conclusion published by BAuA
NIA - EC launched "Advanced Technologies for Industry" Platform
Image Source: Eric Wieser