All posts by : Nanorigo back office

It is the task of hazard research and of toxicology to uncover detrimental effects. Once a substantial knowledge has been gained, it is important to shift gears and try to look at the problem from the other side: What is safe? This change in perspective is necessary to allow focusing on genuinely problematic materials and not focus too much work on less worrisome entities, merely because there is large body of literature about them.

The group of Albert Duschl from The Paris-Lodron University of Salzburg (PLUS), one of NANORIGO project partner, has recently published a review that addresses this issue with respect to the immunosafety of nanomaterials: Himly M, Geppert M, Hofer S, Hofstätter N, Horejs-Höck J, Duschl A. 2020. When would immunologists consider a nanomaterial to be safe? Recommendations for planning studies on nanosafety. Small. DOI:10.1002/smll.201907483. The paper tries to answer which data are needed to consider a nanomaterial as – from an immunological point of view – rather harmless. Of course, this does not cover other issues like genotoxicity of developmental toxicity, but since the immune system is often the first and certainly the professional responder upon exposure to nanoparticles, it is an important part of safety assessment.

The authors recommend to fully cover three aspects in the design of a study:

1. A stringent testing for contamination with Endotoxin / LPS is required to exclude that these powerful proinflammatory agents elicit reactions that can be falsely attributed to the particles tested. Due to assay interference it is necessary to use two different tests relying on different principles. The sensitivity of the test needs to match the sensitivity of the relevant cell, organ or species. Note that the sensitivity of human Dendritic cells is 0.2 EU/ml.
2. The dose needs to be justified by applying the same dose in vitro that may also be acting in vivo. The dose considered here is the dose that reaches a cell – NP per cell would be good expression. This requires to calculate which dose of nanoparticles is “seen” by cells that e.g. adhere to the bottom of a well. Dose per m² would in this case be a good measure, but dose per m³ would be not. A second calculation is needed to estimate the dose to which e.g. a lung epithelial cell of a human is exposed, which again is not the same as particles/m³.
3. If markers of cell stress or of inflammation are observed in absence of proinflammatory contaminants and at a dose that occurs in real life, then it needs to be checked whether this represents an immune reaction or merely a homeostatic fluctuation. It is easy to produce artifacts; for example, cells go into cell stress when they are handled due to the temperature shock. This analysis may require some help for experts, while the first two points can be addressed by any experimenter.

Within NANORIGO, we specifically address the second point, for example by producing an equivalence dose library for tissue-delivered dose, that will support the RGF and its users. Work with the partners should allow us to further improve this library and make it user-friendly.

A new Horizon 2020 Project “NANORIGO: NANOtechnology RIsk Governance” officially launched during its kick-off meeting which was held on the 7^th – 8^th of February 2019 at Moesgaard Museum in  Aarhus, Denmark.

The 4-year long, €4.7 million project is coordinated by Aarhus University from Denmark and received funding from the European Union’s Horizon 2020 Research and Innovation programme under the Grant Agreement nº 814530. NANORIGO project aims to develop and implement a transparent, transdisciplinary and active Risk Governance Framework (RGF) and establish the basis a related Council (RGC) for manufactured nanomaterials and nano-enabled products.

The RGF will be developed through engagement with stakeholders across research, industry, regulation and civil society, and will be based on high-quality scientific data and tools for the physicochemical characterization of nanomaterials, and the assessment of exposure, hazard and risk for humans and the environment.

The two-days meeting discussed in details each of the Work Package within the project, dissemination exploitation, and collaboration with other projects (including other governance projects), and implemented breakout group sessions for interrelated Work Packages.    

The project will be started with an in-depth research on of risk management approach for nanotechnology; to integrate available knowledge on ethical, social, environmental and economic concerns into a user-friendly format that can be easily adapted and transferred into regulation for hazard, exposure and risk assessment and management of nanomaterials.

The expected results of NANORIGO project are the following:

• A transparent, self-sustained and science-based Risk Governance Council;
• Transparent Risk Governance Framework (RGF) tools for managing possible nanotechnologies risks;
• Availability of high quality data for decision making;
• Consistency of approaches in all EU Member States and internationally.

The partnership of NANORIGO is involving 28 partners from 14 different European countries and a global advisory board. The partnership consists of the following organisations: Aarhus University (DK – Coordinator), Environmental Assessments (DE), Ecole Polytechnique Fédérale de Lausanne (CH), Tyoterveyslaitos (FI), Eidgenössischer Materialprüfungs- und forschungsanstalt (CH), Bundesanstalt für Materialforschung und –prüfung (DE), Instituto tecnológico del tmbalaje, transporte y logística (ES), ‘Fraunhofer Society; Institute for Molecular Biology & Applied Ecology’ (DE), Helmholtz-Centre for Environmental Research (DE), National Technical University of Athens (EL), Paris-Lodron-Universität Salzburg (AT), University of Bremen (DE), Universität für Bodenkultur Wien (AT), University of Aveiro (PT), Univerza v Ljubljani (SI), Transgero Ltd. (IE), Onderzoek en Adviesgroep Questions (NL), ‘Answers and More BV: Bureau KLB’ (NL), De Proeffabriek – Schuurbiers Daniel (NL), Engineering, Technical & Scientific Services (CH), ‘Society for Chemical Engineering and Biotechnology e.V – DECHEMA’ (DE), Optimat Ltd (UK), Sociedade Portuguesa de Inovação (PT), Fundación Gaiker (ES), Grupo Antolin Ingeniería (ES), ‘Oeko-Institut e.V. Institute for Applied Ecology (DE), European Environmental Citizen Organisations for Standardisation – ECOS (BE), Quercus ANCN (PT), and Women Engage for a Common Future France – WECF (FR).

The NANORIGO consortium will work closely with the two other projects funded under the NMBP-13-2018 call: RiskGONE (https://riskgone.eu/) and Gov4Nano (https://www.gov4nano.eu/), to ensure a sustainable and equitable RGF and NRGC is developed for all.