Final NanoValid Newsletter

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Welcome to the final Newsletter of the EU FP7 NanoValid project.

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NanoValid has reached a successful conclusion!

After 48 months of intensive research and development work, a vast amount of novel results has been produced, including a wide range of new and well -defined, representative tests and reference materials and a large number of newly validated standard operation procedures (SOPs) for methods to reliably characterise different types of nanomaterials, and to accurately assess their hazards and exposure. The most relevant achievements of the project were discussed and evaluated during the final regular project meeting held on the 1st October 2015 in Paris, and presented to relevant stakeholders and the wider scientific community at a final main international conference organized with Marina at the OECD Conference Centre in Paris, on 29-20 September 2015.

Launching both NanoValid and Marina was the consequence of the fact that many current measurement and testing techniques developed for conventional chemicals for risk assessment often do not reflect the size specific properties of nanomaterials and associated effects. This lack of reliable risk assessment tools that can be applied to nanomaterials has caused an enormous data uncertainty and lack of knowledge of what is really going on when nanomaterials enter living systems. It consequently provoked the urgent need to develop more reliable, namely validated methods that can help to overcome these uncertainties.

NanoValid was one of the first EU funded “flagship” projects solely devoted to address this need. An ambitious work program was set up and intensive research implemented over 4 years (2011-2015) involving more than 30 partners from more than 13 European countries, as well as from India, Brazil, Canada and the US. Comprehensive inter-laboratory comparison studies have been used to develop new and validated methods for characterizing, measuring and testing commercially and environmentally relevant nanomaterials.

In the end, the project generated a wide range of well defined reference tools, including new and validated SOPs, reference test materials, such as certified reference materials (CRM) that can be used by risk assessors and researchers in industry, academia and regulatory bodies to early identify and manage possible risks that may arise from manufacturing and handling of nanomaterials. For the first time, reference methods specifically applicable to engineered nanomaterials have been developed to assess their impact on human and environmental health..

Two different types of reference materials have been produced, (1) CRMs that can be used as calibrants to validate measurement/imaging methods (Au for particle size and TiO2 for specific surface area), and (2) reference materials produced in big batches suitable for eco-tox studies (2 SiO2 prototypes for size distribution and other size-related parameters). The reliability of these reference methods was confirmed by uncertainty and traceability measurement.

In addition, also other specific reference methods have been established, for (i) dispersion control in various test media (submitted for standardization under ISO TC 201), (ii) quantification of labeled NPs (lanthanide-doped Y2O3 NPs) in various matrices, (iii) assessing uptake and distribution of nanoparticles (such as SPIONS, Ag, Au, SiO2, CuO, ZnO, TiO2, nano-whiskers, C60) in the human body, including assays (SOPs) for in vitro human toxicity testing, such as ATP, Propidium Iodide, Mitochondrial Dehydrogenase, or NRU OECD GD 129, and for (iv) ecotoxicological testing, such as the Sinorhizobium meliloti bacteria test, the OECD 208 plant or Porcellio scaber terrestrial test, or the Daphnia magna (freshwater) and Artemia salina (seawater) test, all with a great potential for further standardization. To prove the robustness and applicability of theses validated methods under real conditions, six case studies have been successfully realized focusing on problems that may occur in working environments and natural systems, including a model to simulate a transport accident and an explosive release of nanoparticles.

The extensive method and material testing and development campaign did not only generate an enormous amount of new scientific data, knowledge and expertise on method reproducibility and applicability related to varying material types and properties, but gave also new insights into critical dose-response relationships, adverse (toxic) pathways and relevant end-points and on processes and factors that steer the release, distribution, bioavailability and uptake of nanoparticles in man and the environment along their life cycle. But NanoValid also produced a variety of more practical and commercially relevant tools and models, e.g. for on-site or in-situ sampling and exposure and fate assessment of nanomaterials.

This included a new prototype of a hot gas nano-sampler, a novel online exposure device combining physical and biological assays for airborne nanoparticles, a fish cell barrier model that can predict uptake of nanoparticles in aquatic systems, a new aerosol generation chamber to simulate accidental and/or work place releases and exposure, a test battery to rapidly screen the toxicological profile of newly synthesized or unknown nanomaterials and guide safe design or early detect adverse properties during material and product development, or a panel of “decision trees” that provide practical guidance in selecting appropriate methods during regulatory testing as part of the risk assessment.

Another handy outcome of the project was a new technical guidance document and training manual called “Nano to go!”, which can be directly used by research laboratories, instrument or material manufacturers, or small and start-up companies, to ensure safe handling of nanomaterials, and to prevent, reduce and minimize occupational health risks.

However, one of the most significant achievements of NanoValid was the strong and still ongoing contribution to current European (CEN) and international (ISO) standardization efforts, such as CEN/TC 352 “Nanotechnologies”, ISO/TC 229 “Nanotechnologies”, or ISO/TC 24/SC 4 “Particle characterization”. This was particularly obtained by drafting and preparing a considerable number of new work items proposals (NWIP) for method standardization, including a “ENP Specification Form” that has already entered into a new ISO standard, to specify properties of test materials used for toxicological testing.

Summarizing, the methodology developed by NanoValid, in particular the validated SOPs on particle measurements, dispersion control, labeling and in vitro / in vivo testing, will serve and support future regulatory method development, adaption and modification (such as planned within NanoReg), but also the characterization of more advanced and challenging functionalized nanomaterials embedded in complex product and environmental matrices.

At the end, NanoValid could prove that a scientifically sound sample preparation of nanomaterials prior to biological testing, and a reliable characterization of their properties, including dispersion, dissolution, agglomeration or aggregation behavior, is one of the most critical steps to finally arrive at comparable and reproducible results, which we urgently need to improve current regulatory risk and life cycle assessment schemes, and to enforce relevant legislation, such as REACH, CLP or the Biocides Directive. Upgrading these tools by using methods developed and validated through NanoValid, will help to early identify critical processes along product value chains of their life cycle, to design safer properties and prevent any harm to man or the environment.

A great deal of the produced results was already (and still will be) published in more than 100 peer-reviewed journals and by a wealth of numerous oral and poster presentations.

A big endeavor has come to an end. But for sure, the work performed and the results achieved will have a long-lasting effect far beyond the project. It will continue to inspire new expert groups and trigger new research activities that will take up and carry on the new knowledge and understanding that NanoValid has produced for the safe and sustainable use of nanotechnology.

Hope you will again enjoy this final NanoValid newsletter and thank you for sharing the work we have done over the past years!

With warm wishes,
Rudolf Reuther

NanoValid Project Coordinator

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