This report is from the fourth meeting of the User Committee (UC) of the NMBP-13 nanotechnology risk governance projects held on 03 March 2021. The UC is an external group of twelve stakeholders, all with a particular link to the development and safe use of nanomaterials. The UC follows and critically reflects on the developments and choices being made within the NMBP13 projects. Risk management requires a thorough and balanced weighing of the available evidence as well as an initiative to take account of gaps in knowledge related to the perceived risk by those who are responsible for making decisions. This meeting was organized as a 3-hours virtual session with four invited guests from the NMBP13 projects adding up to 21 attendees. The meeting focused on broad stakeholder-oriented data management with a deeper discussion on how the Precautionary Principle may be used within this context.
The European Commission has launched a targeted stakeholder consultation through an online survey to gather insights from experts in nanotechnology and the general public on the common definition of ‘nanomaterials’. The current definition of ‘nanomaterials’ was adopted by the European Commission in 2011 and stipulated in the Recommendation 2011/696/EU on the definition of nanomaterial. This consultation aims to gather stakeholders’ views on the Commission’s interim findings that were attained through preparatory evaluations, i.e., a targeted stakeholder survey, a comprehensive assessment, a workshop, and three technical reports published by the EC JRC. The overall aim is to consider potential changes in the Recommendation.
The report on the third meeting held on 03 December 2020 for the User Committee of the NMBP-13 nanotechnology risk governance projects is now available. The meeting brought together 27 participants which included stakeholders from research, industry, regulators, CSOs, Nanorigo, Gov4Nano and RiskGone and others. The meeting of the NMBP-13 User Committee was an assembly organised in October 2020 to allow for a more extensive reflection and discussion about the developments of the NMBP-13 projects in relation to the Nano Risk Governance Framework (NRGF), the council (NRGC) and the available data and tools.
The latest Newsletter from the NMBP-13 Projects is out now. This issue provides an update on the development of the NRGC, and the process of fine-tuning four different scenarios for the Council during the Council Workshops.
This Friday 27th November NANORIGO will feature in different events and activities in Austria and the UK.
• In the UK on Friday at 17.30 (GMT), Scotland’s ERN Explorathon is featuring Making Nano Work for Us – a NANORIGO video and family quiz
• The NANORIGO video is also featuring on the Scottish Research Showcase at 13.00 (GMT) [@EU_NANORIGO]
• In Austria, PLUS are hosting a Citizen Science Café here https://researchersnight.eu/2020/10/01/nano-science-gesundheit/ Nano Science and Health: – what makes SARS-CoV-2 successful? – viruses are biologic nanoparticles – what is nano and where do we find it? – can nano fight Covid? – how safe is nano and who cares?
The NANORIGO videos in English and German are available on our YouTube Channel
This virtual conference aims to demonstrate to the entire NanoSafety community how various research project bring together fruitful outcomes through interactive sessions with hands-on activities. It will serve as an opportune platform that allows different perspectives to meet in pro/contra discussions. For participation in the NanoSafety Cluster Education Day, please register here.
On 7 October 2020, the NANORIGO, Gov4Nano and RiskGONE projects
chaired a session at the recent 4th EU-Asia Dialogue on Nanosafety meeting. The projects gave a presentation
outlining the progress with the Governance work. The session “Risk Governance – Where do we stand and
where do we go”, was chaired by Dr. Janeck J Scott-Fordsmand (NANORIGO,
Europe), Dr. Tae G. Lee (KRISS, Korea), Dr. Monique Groenewold (Gov4Nano,
Europe) and Dr. Maria Dusinska (RISKGONE, Europe). The session consisted of two
presentations (from Korea and from the European projects) which were followed
by a lively dialogue showing the various risk roadmaps and governance
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
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.
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.
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.
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