Assessment of the health effects of industrially used nanomaterials to be made more efficient

On 14 and 15 January 2016, international experts representing academia, government authorities and industry convened at the German German Federal Institute for Risk Assessment (BfR) for the joint launch event to the international research project NanoToxClass. Sponsored for three years as part of the EU funding scheme ERA-NET SIINN, the project is co-sponsored by Germany, Belgium, Israel, Portugal and Romania with total funds amounting to just under EUR 1.6 million. At present, each nanomaterial is subjected to its own experimental testing which is both time-consuming and expensive. The aim of the NanoToxClass project is therefore to develop classification methods for nanomaterials based on their hazard potential for humans. In particular, nanomaterials of wide industrial use will be taken into account. "The results of the project are highly relevant for regulatory practice, since classification will make the assessment of their health effects much easier", says BfR President Professor Dr. Dr. Andreas Hensel.

One important focus of the NanoToxClass project is the systematic generation of new data on the mode of action of nanomaterials by means of modern technology used in systems biology. These data are then used in combination with established toxicological endpoints. The project will furthermore incorporate transcriptome, metabolome and proteome analysis based on data derived from in vitro and in vivo experiments. Thus, the approach chosen allows for considering the mode of action of nanomaterials in the development of hazard categories. In addition, by correlating in vitro and in vivo data, this approach facilitates the development of new testing strategies and  selective refinement of existing in vitro tests.

Both at the European and international level, the development of categorisation methods for nanomaterials on the basis of their hazard potential for humans is of high relevance and has been the focus of the Organisation for Economic Co-operation and Development (OECD) for considerable time. Insights gained from the NanoTox Class project will thus be communicated to various national and international committees from the outset to verify their regulatory applicability in practice.

A large number of products produced by means of nanotechnology are already available in the market. The currently used nanomaterials consist of a limited number of precursor materials. The combination of different precursors as well as variations in size, shape and surface nevertheless gives rise to an almost infinite diversity of materials. Despite intensive research over the last two decades, it is still neither possible to draw general conclusions nor to conduct any definitive hazard assessments of nanomaterials. For this reason, every version of a nanomaterial currently needs to be subjected to separate experimental testing and health effect assessment. In contrast, categorisation methods covering all aspects from testing to modelling are available for conventional chemicals, and are used for regulatory purposes. Barring a few exceptions, no such procedures have been developed for nanomaterials. This means that the NanoToxClass project conducted as part of the ERA-NET SIINN programme makes a pioneering contribution to the development of categorisation methods for nanomaterials.

ERA-NET SIINN stands for European Research Area Network - Safe Implementation of Innovative Nanoscience and Nanotechnology. This EU programme aims to ensure the safe and fast transfer of European research results in nanoscience and nanotechnology to practical applications.

About the BfR

The German Federal Institute for Risk Assessment (BfR) is a scientific institution within the portfolio of the Federal Ministry of Food and Agriculture (BMEL) in Germany. It advises the Federal Government and Federal Laender on questions of food, chemical and product safety. The BfR conducts its own research on topics that are closely linked to its assessment tasks.


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