Report on the 3rd meeting of the User Committee - NanoRIGO
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Report
on the 3rd meeting of the User Committee
of the NMBP-13 nanotechnology risk governance projects
Reflections on governance needs from daily practice
3 December 2020
Virtual meeting
NMBP-13-2018, H2020-NMBP-TO-IND-2018-2020
This project has received funding from The European Union's
Horizon 2020 Research and Innovation Programme
under grant agreement 814530.
NANORIGO project
European Union’s Horizon 2020, Research and Innovation programme
NMBP13, Grant Agreement 814530
Deliverable from task 3.1
January 2021
nanorigo.eu
gov4nano.eu
riskgone.eu
Contacts for the User Committee
Ridderspoorweg 50
1032LL Amsterdam
The Netherlands
Bureau KLB
Pieter van Broekhuizen,
Kees Le Blansch,
Cover Picture: Etching Charles Donker
Bare beech tree, 1977
Museum Het Rembrandthuis, Amsterdam
2
Report on the 3rd meeting of the User Committee
Reflections on governance needs from daily practice
Table of contents
Table of contents. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3
Agenda of the meeting. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4
Participants . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5
Glossary . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 6
Preface . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 7
Executive Summary. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 8
Introduction. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 10
Part 1
Ulla Forsström, Reflections of a scientist . . . . . . . . . . . . . . . . . . . . . . .. . . . . . . . . . . . . . . . 10
Delphine Bard, Reflections of a scientist working for HSE (UK). . . . . . . . . . . . . . . . . . . . . 13
Part 2
Rolf Gehring, Reflections of a CSO. . . . . . . . . . . . . . . . . . . . . . . . . . . . . .. . . . . . . . . . . . . . . 15
Vladimir Vrečko, Reflections of a company. . . . . . . . . . . . . . . . . . . .. . . . . . . . . . . . . . . . . 17
Part 3
The final Mentimeter poll . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .. 19
Next User Committee Meetings. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 20
Follow up of the meeting. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 20
Reactions UC members to the Report
Andrej Kobe . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 21
Take home messages invited guests. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 22
Marie-Valentine Florin. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 22
Damjana Drobne . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 23
Isabel Rodriguez . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 24
Maria Dusinska. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 25
Arto Säämänen. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 26
Panagotis Isigonis . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 26
Annexes
Annex 1 Power Point Reflections of a scientist – Ulla Forsström, VTT – FI . . . . . . . . . . . . 27
Annex 2 Power Point Reflections of an authority – Delphine Bard, HSL/HSE - UK. . . . . . 29
Annex 3 Power Point Reflections of a CSO – Rolf Gehring, EFBWW - EU. . . . . . . . . . . . . . 33
Annex 4 Power Point Reflections of a company - Vladimir Vrečko, Cinkarna – SI . . . . . . . 34
3
Agenda for the User Committee - meeting
Thursday, 3 December 2020, 09:30 – 12:00
Reflections on governance needs from daily practice
Introduction
9:30 - 9:40 Introduction and welcome (Kees Le Blansch, chairman)
First part *
09:40 – 09:55 Ulla Forsström, Reflections of a scientist (see annex 1)
09:55 – 10:10 Delphine Bard, Reflections of a scientist
working for HSE (UK). (see annex 2)
10:10 – 10:40 Discussion
10:40-10:50 Break
Second Part **
10:50 – 11:05 Rolf Gehring, Reflections of a CSO (see annex 3)
11:05 – 11:20 Vladimir Vrečko, Reflections of a company (see annex 4)
11:20 – 11:50 Discussion
Third part
11:50 – 12:00 Programme UC 2021, meetings and topics
12:00 End of the meeting
* Minutes part 1 taken by Dalila Antunes
** Minutes part 2 taken by Susanne Resch
Overall report by Pieter van Broekhuizen
4
Participants to the 3rd meeting of the User Committee
NANORIGO, Gov4Nano and RiskGONE
3 December 2020
Virtual Webex meeting
Members UC
Researchers Industry
*Ulla Forsström (VTT, FI) Martin Köhne (Robert Bosch, DE)
Heidi Foth (Martin-Luther-Univ., DE) *Vladimir Vrečko (Cinkarna Celje, SI)
Witold Łojkowski (Univ. Warsaw, PO) Raquel Puelles (Avanzare, ES)
CSOs Regulators
David Azoulay (CIEL, CH) *Delphine Bard (HSE-SRC, UK)
*Rolf Gehring (EFBWW, BE/EU) Andrej Kobe (EC ENV B.2, EU)
Paula Silva (Quercus, PT) Ana Maria Rincon (EFSA, EU)
Chantal van den Bossche (replacing
Elisabeth Ruffinengo (WECF, FR)
Organizational team
NANORIGO Gov4Nano
Pieter van Broekhuizen (BKLB, NL) Susanne Resch (BNN, AT)
Kees Le Blansch (BKLB, NL)
Rudolf Reuther (ENAS, DE) RiskGONE
Daan Schuurbiers (DPF, NL) Dalila Antunes (FS, PT)
Invitees (‘listeners’)
Arto Säämänen Maria Dusinska
Marie-Valentine Florin Damjana Drobne
Piet Sellke Isabel Rodriguez
Panos Isigonis
* speakers
5
Glossary
BKLB Bureau KLB
BNN BioNanoNet
CEN ISO European Committee for Standardisation / International Organization for
Standardisation
CIEL Center for International Environmental Law
CRNM Center on Risks of Nanomaterials
CSO Civil Society Organisation
DPF De Proeffabriek
EC ENF European Commission Directorate-General for Environment
EFBWW European Federation of Building and Wood Workers
EFSA European Food Safety Authority
ENAS Environmental Assessments
EPFL École Polytechnique Fédérale de Lausanne (EPFL)
F2F Face-to-face
FIOH Finnish Institute of Occupational Health
FS Factor Social
HSE-SRC Health and Safety Executive - Science and Research Centre
NILU Norwegian Institute for Air Research
NM Nanomaterial
NMBP Nanotechnologies, Advanced Materials, Biotechnology and Advanced Manufacturing
and Processing, EU Work Programme Horizon 2018-2020
NGO Non-Governmental Organisation
NRGC Nanotechnology Risk Governance Council
NRGF Nanotechnology Risk Governance Framework
OECD Organisation for Economic Co-operation and Development
PGNP Process-Generated Nanoparticle
PP Precautionary Principle
RA Risk Assessment
REACH Registration, Evaluation, Authorization and restriction of Chemicals
RNM Roundtable of Nanomaterials
SbD Safe by Design
SEA Socio-Economic Aspects
SME Small and Medium-sized Enterprise
UC User Committee
UFP Ultrafine Particle
VTT Finnish, state-owned, research institute
WECF Women Engage for a Common Future
6
Reflections on governance needs from daily practice
Preface
The 3rd meeting of the NMBP13 User Committee is an extra meeting organised after the October
meeting to allow for a more extensive reflection and discussion within the UC on the
developments within the NMBP13 projects of the nano risk governance framework (NRGF), the
council (NRGC) and the available data and tools.
Based on the wish of the UC-members themselves, the focus of the meeting was on their own
experienced practical needs regarding a framework and a council for nanotechnologies and
nanomaterials, approached from the specific perspectives of the UC-members’ backgrounds.
The used format for the meeting was chosen to allow only the UC-members to debate, while
the invited guests had been asked to participate as a listener. These guests were invited from
the projects NANORIGO, Gov4Nano and RiskGONE as being responsible for the topics that were
expected to be debated (framework, council, data quality and tools). For the guests the
discussion was supposed to function as a learning exercise, as practical input for their tasks
within the projects.
These virtual settings allow for a dual way of debating, i.e. a ‘live’-debating and ‘written’-debate
using a chat-box. For this reporting the choice was made to somewhat mixing up these two
modes of debating and to merge the chat remarks in between the monitored debate, using
different colours for the different modes:
black - for the introductions and the discussions
pink - for the chat-box discussions of UC
Amsterdam, January 2021
7
Executive Summary
The 3rd User Committee meeting, under the heading ‘Reflections on governance needs
from daily practice’, was organized on 3 December 2020, in a virtual 2,5-hours session.
The full UC participated, as well as seven invited guests from the NMBP13 projects.
Including the UC Organising Team totally 26 persons participated.
Four members of the UC, one from each societal sector, were invited to present their
reflections on the ongoing developments of the nano risk governance framework and the
council (NRGF/NRGC). Each presentation was followed by a discussion amongst the UC-
members. The guests were invited to participate as ‘listeners’, so they did not take part
in the discussion.
The actual practice of the use of nanotechnologies, e.g., the use of nanomaterials, nano-
enabled products and exposure to process-generated nanoparticles was reflected from
the position of the different market actors.
The pre-marketing obligations as CLP (Classification and Labelling of Products) and the
REACH requirements, which hold as well for manufactured nanomaterials, are brought
forward by different speakers as a large burden, especially for SMEs regarding the
required resources, the time and costs of hazard, exposure and (health and
environmental) risk assessments, as well as the required knowledge to communicate this
with the stakeholders. For them, the finding, identification and selection of appropriate
data and information is experienced as a tough and sometimes insurmountable
challenge. It was suggested that this burden weighs less on the large industries, who can
more easily generate the required data themselves or commit consultancies for further
data and advice.
The suggestion was made that the council in the format of the CRNM (Center on Risks of
Nanomaterials), as an advising and facilitating institution, might be a solution, especially
for SMEs, to support data collection and risk assessment information based on existing
reliable data and exposure assessment. However, others argued that the council should
not deliver decisions on ‘safety’ of NM or products with regulatory consequences: it was
stated that the council cannot be responsible to perform risk assessment.
The large diversity of practical tools for assessing health and safety issues was contrasted
with the lack of standardization of existing tools and reproducibility of practical tests. The
consequence is that many measurement results are not comparable, and also, that long-
existing useful tests are insufficiently used for effective workplace control. It was stated
that a so-called tier 2 approach for exposure assessment is generally sufficient for a
proper monitoring strategy at workplaces when combined with an assessment of the
control measures (e.g., checking Local Exhaust Ventilation (LEV) airflow, using a smoke
test and providing LEV expert judgement), while the highly qualified tier 3 approach
should be predominantly reserved for research. As such, the standardization of the
pragmatic and practical methodologies used at this tier 2 level might need to be
encouraged. It was suggested that the RGC could play role in promoting standardization.
Another tricky point is the workplace practice in ‘mobile’ workplaces, characterized by
highly diverse exposure risks, for which available generic data and information in
seemingly identical workplaces can’t give an answer. The construction industry, with its
long ‘life-cycle’ from construction to demolition and recycling, is used as an example for
8
this. This often requires a situation-specific approach, for which the input of the workers
and their representatives is indispensable. This demands for optimizing the
communication between those involved, and in fact between all users of the products. A
plea is made to give the RGC an explicit role in optimizing the transparency and access to
information for workers, and to stimulate communication and collaboration between the
involved stakeholders.
The industries’ position as profit-focused ready to solve societal challenges safely and
sustainably was contrasted with the need to assure reliable communication with
stakeholders in the highly vulnerable area with shareholders, regulators, NGOs and
commissioned scientists. It was stated that outsourcing of regulatory obligations, such as
preparation of safety dossiers and generation of data is not only very expensive, but it
also creates the ‘risk’ that no-effect results generally are not published and moreover
that industry-commissioned scientists get stigmatized due to their dependence on
external funds.
Again, the finding and selection of appropriate data and reliable information, and
especially uncertainties regarding the way this information will be ‘handled’ by regulators
is presented as a burden for industry. The suggestion that poor use of the precautionary
principle might lead to excessive regulation was opposed by stating that the past 15 years
no new technologies were prevented by applying this principle, and as regulators state,
potential actions from regulators are scientifically substantiated.
The final poll regarding the format of the RGC shows an interesting distribution of votes
for all the four options, with a slight preference for the non-governmental options, the
Round Table on Nanomaterials and the Centre on Risks of Nanomaterials. Nevertheless,
preferred tasks for the council, such as independent advice and support, as well as a role
for entrance to governmental advice also points in the direction of the scenario for the
Scientific Committee on Nanomaterials.
The report ends with a short reflection of the invited guests on the presentations and
discussion, their ‘take home messages’.
9Introduction
Kees Le Blansch
For this UC-meeting today the floor is explicitly given to the UC-members to discuss the topics
as brought forward in the four presentations, from different societal areas as represented in
the UC. Four UC-members are invited to reflect on the ongoing developments of the nano risk
governance framework, the council and the tools, based on their own experiences and
perceived needs from daily practice in their societal backgrounds in their institute, company or
organisation. They will share their views in a PowerPoint presentation (see annexes 1-4),
followed by questions & answers and a Mentimeter poll to explore the opinions of the UC-
members.
The invited guests from the NMBP13 projects, as responsible for the development of the
specific topics under debate, participate to this meeting as ‘listeners’. They are asked to share
their take home messages after the meeting.
PART 1
• Reflections of a scientist (see Annex 1, page 25)
Ulla Forsström – VTT
(Finnish state-owned research institutions for advanced utilisation and
commercialisation of research and technology in commerce and society).
Ulla starts with highlighting VTT’s
experience regarding the SME-needs for
reliable data and its translation into fit-for-
use information. These needs may differ
strongly from the needs of the well-
informed large industries, that know their
way in this field.
VTT’s work focuses mainly on industrial
renewal, for which health and safety issues
get a lot of attention. This relates to support and advice regarding safe and sustainable
production by design, improving the material handling and application processes. The SbD
approach includes the safety of end-users, the environmental safety as well as the health and
safety issues in the end-of-life phase.
VTT has also pilot facilities for developing and testing materials. Examples are the development
of products with higher added values, such as substitutes plastics by biobased coatings.
Nanocellulose is another example. VTT has several national and European projects which
include time consuming hazard and risk assessment. We cooperate as well with other
partners.
Ulla emphasizes that the main problem for SMEs in NM development and innovation is to find
time and resources to perform these tasks, to find and access reliable data and to make them
fit-for-use. She points as well to the assessment of the end-life of products with its needs to
10assure the recyclability for environmental purposes. This concerns especially questions related
to circular economy for new products that are brought on the market. This brings biobased
materials in focus because we need to make sure these materials can be recycled.
So, there is the need to identify experts in these fields and developers of these materials.
There are universities and research centres that get support from ministries and regulations
and education of the culture, but at this stage VTT has only limited resources to support the
requested development. The idea is that large companies have these resources. Nowadays,
the Finnish ministry has become interested in this issue and started supporting these
developments. VTT may use some of this support.
So, as Ulla reflects, coming back to my positioning in our UC October meeting, I was supporting
Scenario 3 of the RGC, the Center on Risks of Nanomaterials (CRNM), even though there were
not many UC members with same positioning. Nevertheless, I think a CRNM could be
supportive for getting innovative products to the market. Especially for those who lack the
resources we need a centre for data and information to guide SMEs to make their own testing
with best information about the earlier experiments and therefore minimum new amount of
work.
In practice, nanomaterials are brought to the market in an early stage where researchers and
even companies are still developing the required knowledge on it. For those involved in these
developments it is hard to find out the actual state of the art, what knowledge is already
available and where to find relevant information. Information is scattered. Moreover,
sometimes developments are not correctly carried out. It would be a good opportunity for
CRNM to involve in future foresight, to focus on what happens in the future and identify novel
opportunities in industrial areas. This relates for example to assessing consequences of use of
nanomaterials such as non-intentional chemical and physical reactions, e.g., oxidation,
degradation, slow release, wear. What happens when these materials are used? What is left
over in a compost?
-- -- -- --
The Mentimeter poll, carried out amongst the UC-members showed that the presentation
gave enough rise to further discussion. Questions brought forward in the Mentimeter are:
- How could nano risk governance be effective, especially regarding foresight?
- As regarding to the steps 5 to 7 in the shown slides (annex 1, slide 3 and 4) (safety issues
for workers, end-users and environments) how can we deal with the dynamics in the
related areas?
- How Ulla sees the role of the CRNM (examples) and about the certainty of about almost
zero risk of nanocellulose (and ability to compost)
-- -- -- --
Discussion (and chat)
Heidi: I like to bring forward three points.
First a question for further information on nanocellulose, which is a wonderful
example regarding risk assessment. What are the specificities that make it
different;
Hazard is sometimes a matter of tipping points where definitions can be made. We
have cut-off criteria that can be used.
And thirdly, environmental stressors you may get a smart nanoform, but
environmental stress itself is very close to natural forms.
11Ulla: The outcome of the recent Cellulose Review with many references from the EU
NanoTextSurf project concluded that nanocelluloses are commonly tested as non-
toxic. These nanocelluloses were natural or only chemically pretreated to make
processing easier. If toxic chemicals are used to modify them is another story but
not economically feasible to do. So, according to most literature nanocellulose is
safe, but under airborne conditions and pre-heated it may be inhaled deeply into
the lungs. This might cause harm. Exposure should be avoided for which we need a
Safety by Design approach. It is biodegradable. As such, the material is not
interesting for safety people because it is supposed to be safe.
Ana: An objective of RGC it is to share information, also on nanocellulose. One of the
activities or tasks of the council should be to share information so people can share
what they are working on and what they are doing.
Ana: The safety of the consumers is very relevant. In EFSA we receive several new
dossiers per year for new materials to be evaluated before their authorisations.
Witold: It seemed to me that Ulla presented the risk governance process as very time
consuming and resource consuming. My impression is that this is a pessimistic
perspective. The process to assess risks is too slow comparing to market demands
and people needs. Niagara water will find a way to go through anyway ..… This is
like a way to stop Niagara; products will find their way to go to the market despite
what we do. Can you provide a good example where you succeeded, where it works
and it can be done?
Ulla: The toxicological tests are published. Results of exposure measurements are not yet
published but disseminated in a public webinar available for anyone. Information is
scattered so collection is very challenging. The nanocellulose is already in the
market especially in Japan, Canada and USA. We started with research in
2008/2009 and there is a large manufacturer in Norway producing it as well as a
coarser, micro fibrillated grade and one large company making already innovative
wound dressing materials. The problem now is that everyone is so scared of ENM,
even if they are not toxic. The use of the materials is causing so much work to get
these high added value solutions to the market that SMEs cannot afford it.
A council with the format of the CRNM would allow to reduce loss of resources and
time, and avoid to have a never-ending story. There are people payed to do risk
analysis so this information could be shared.
Heidi: what is the add on of new platforms? Well, it is the opportunity to meet and
discuss in a room that is open for stake holders of different sectors in regulation
and development and consumers interest groups
Ana: I agree that NRGC should be a platform to share information and I completely
disagree with the proposal that this council would be responsible to performed
any RA.
David: Agreeing with Ana, I do not see how such a council, as described/defined in the
scenario could deliver a decision on "safety" that would carry regulatory
consequences...
Ulla: It was not proposed that the NRGC should perform any risk assessment, nor that
the NRGC should have a regulatory function in delivering decisions.
David: To pick up the RGC capacity to bring information together and have a final word on
the question whether it is safe or not seems illusionary in the context of the debate
today. Coming to a final answer. There is a very regular and almost constant
questioning that is in the aim of science. Why a material is safe or hazardous is
12never ending on itself. When we are going into business we have to make choices
for investments. So, I would like to know more about Ulla thoughts on this.
Ulla: Yes, you can study forever, but if you are making business on these materials, what
are the points at which you can sell? You need to have clear answers. This is
different in Europe, USA and Canada, but a never-ending story in Europe.
David: I understand the objective. But what makes you think this particular structure for
the council (format of the CRNM) will allow you to reach that point better than
other?
Ulla: I think the CRNM will be more facilitating. Helping and sharing information will
speed up the development of novel materials. And if it turns out not to be safe, you
stop using the material. If this facilitation of information supply does not exist it
takes more time to draw the right conclusion.
David: as a way to exchange information.. sure.. as way to decide what innovations
should be developed AND get on the market... I would have to also strongly
disagree with that
Ulla: David, I am not proposing that NRGC will decide about what innovations go
forward, only helping to speed up progress. Other existing regulators will
decide if they go forward or not.
Heidi: The used safety criteria differ for different use areas. What is safe is defined by
legal requirements set by regulators. For consumer products and non-food articles
however, this is quite vague. Clearer it is formulated for example for pesticides and
pharmaceuticals.
Ulla: But on a food packaging you cannot apply something new.
Heidi: You can, as soon as it is approved
Ulla: Yes, but how much does it cost and how many years. It is an illusion that SME’s will
contribute to this using their own resources. For SMEs the issue of costs may
dominate.
Witold: How to be successful? Some years ago, we were in a roadmap industry. One can
look and when there is a sense of a need for a specific product, resources can be
put to reach that success.
Ulla: For nanocellulose this is not the case. Europeans are small players here. USA,
Canada and Japan are big players in nanocellulose, which was invented in Japan
years ago. But now it is the time we need to replace plastic so there is the
opportunity to study it more. Safety issues are very conservative. We need to join
forces to move forward.
-- -- -- -- -- -- -- -- --
13• Reflections of a scientist at the HSE (see Annex 2, pages 27)
Delphine Bard – HSE
Health and Safety Executive, Science Division, UK
Delphine starts with introducing herself as an
exposure assessment expert working for HSE in
the UK. The presentation focusses largely on
the needs for reliable and practical exposure
assessment. For this, practical tools and
methods for health and safety assessment are
needed. If methods are based on extensive
measurements, it may turn out to be a
problem for SME’s due to limited resources
and time. Standardisation and validation are key to realise reproducible and comparable
results for occupational and consumer exposure as well as for environmental assessment. In
this respect the availability for good data and understandable information is pivotal. This holds
as well as for hazard assessment for which is the need to have better validated in vivo
screening methods, also to reduce animals testing. It should be emphasized that although
there is an abundance of valid methods available, there is the need for more cost-effective and
practical methods. The question is manifest on how to select and what to use.
Regarding monitoring strategies, distinguished in tier 1, 2 and 3 approaches, the tier 2
approach, based on simple to use hand-held instruments and conventional sampling, may in
general be sufficient for common workplace monitoring. Methods and tools for exposure
measurement need to be pragmatic and practical. Performing cost-effective practical
measurements is very important. They can be combined with an assessment of the control
measures (e.g. checking Local Exhaust Ventilation (LEV) airflow, using smoke test and providing
LEV expert judgement). Tier 3, which requires extensive measurements and off-line
characterisation, is mainly needed for modelling and extended research, but this is a different
goal to monitoring exposure of workers in the workplace.
Another example is dustiness testing, which was developed long ago and nowadays used for
assessing risks of handling NM powders. Data not only based on mass can be obtained, but still
there is the need to have insight in the effectiveness of exposure control measures, and which
exposure levels are acceptable. If you ask for too much, it will cost too much and this could
compromise the ability of industries to perform measurements.
-- -- -- -- -- --
The Mentimeter poll:
The presentation was endorsed to a large extend, but it was indicated that there are several
issues that need further debate.
-- -- -- -- -- --
Discussion (and chat)
Raquel: I think that the NRGC should gather all the information related safety and
hazard of nanomaterial/NOAA, but also it is needed to advised and
orientated to center, Universities or SME related tools and risk assessments if
not as users it will be really easy lost in this jungle of data.
As Delphine comments there are many, many tools and models. How do we
have to use these? How to get the data needed? Who has to support the cost
14of the tests needed? SMEs, Research Centres and Universities do not always
have enough resources...
Rolf: Taking for example the exposure to wood dust, there is the recalcitrant practice of
measuring, methods and standards, resulting in large differences between
comparable workplaces. There are many parameters that influence the results.
Consequentially, the control measures differ and practical differences in
prevention of workers people are really high. Having standards and systems is
extremely important but we see all these problems.
Delphine: Yes, standardization is important. Using different dust samplers and different
sampling methods results in large differences. The same holds for NMs. For
example, we did a quick review of papers on graphene exposure in the workplace.
This shows the utmost importance of the comparability of results. Proficiency
testing schemes can help for this. Standardisation, intercomparison and simple
methods are important.
David: Delphine, how to do see the role of the NRGC in developing this consensus on
methods and methodologies.. and do you think one of the scenarios is better
than others in this regard... Do you see a role for the council in promoting
standardisation?
Delphine: Yes, definitely. There are standards and others in development. But there is the
need to have wider community and more academics involved in standardisation.
It is so important for industry to understand the role of standardisation. If things
are not standardised you don’t have a way to compare gathered data.
Raquel: I agree with Ulla, NRGC does not have to decide, only advice related to
possible risks
Delphine: It would be a matter of adding to existing institutions (ISO, OECD…)
-- -- -- -- -- -- -- -- --
Part 2
• Reflections of a Civil Society Organisation (see Annex 3, pages 31)
Rolf Gehring – EFBWW (EU)
European Federation of Building and Wood Workers, Brussels
In my presentation, I will focus on workplace
exposure. This fits very much to what Ulla already
presented, especially the steps 5 – 7 in the life
cycle of a product. The question is what does
workplace mean here? Workplace can be very
different; for example, the production of NMs is
very often in closed systems, but at a later stage in
the lifecycle products use, there are no closed
systems and a stable workplace anymore. One of
the most prominent examples of this is construction industry.
15Regarding recycling and the potential re-use of NMs: do we already know how to re-use and
recycle NMs in the future? In all these processes, science and risk prevention institutions are not
always present. Beside the holistic general approach, we have to see where does it work and
where not. For instance, respirable crystalline silica, it’s impossible to test and measure all
different exposure scenarios. Some risk prevention institutes do some exemplary
measurements and then companies can decide if they have similar processes with comparable
exposure.
At the workplace it’s the employer who is responsible to minimize occupational risks. In practice,
it’s a collaborative work between the worker and the employer. In all EU countries, H&S
responsible persons and employers need to have knowledge about potential risks of NMs. In
practice we have some basic knowledge, as well as some specific knowledge relating to dynamics
of exposure. However, the level of knowledge is limited. Relating to nanomaterials, we had
focussed projects in the construction and in the furniture sectors, but we know little about
effects of exposure. Also, if you take for example demolition and recycling processes, it is unclear
where exactly we have what sort of exposures. While, compared to other sectors, exposure to
asbestos in the recycling sector is the largest and very often unexpected exposure.
Beside the more structured concepts and processes with external expertise, we additionally
need a stronger involvement at worker level. We need to better engage H&S responsible people
in the companies and tell them where they find more information, and to give a stronger role to
workers and their representatives in exposure prevention processes.
-- -- -- -- -- --
The Mentimeter poll, shows that as well for Rolf points made in his presentation were
endorsed by the majority of the UC-members, but there were quite some issues to be further
discussed.
-- -- -- --
Discussion (and chat)
Wittold: Regarding the exposure and risk assessment in real life in building places, what is the
real position of nanosafety issues in workers safety? Is it a marginal issue for a safety
inspector? In relation to the previous presentation, maybe “nano-dust” is not very
different from any ‘ordinary’ dusts. Maybe we need further research to clarify that.
Rolf: In our project we didn’t run own measurements at workplace level. For sanding in
furniture industry, the NMs are agglomerated with other particles, so they are not
nano-sized anymore. Regarding risk prevention in companies at the workplace: there
is not the one person that has the full overview. We do not have the one ingenious
person that oversees the whole situation. Thus, the worker is partly independent,
he’s the one working at the site and the H&S person is not. We need better
communication/knowledge sharing etc. Do we know what sort of geometric
composition of dust emerges when we use new tools that allow higher speed and
temperature in the machines? These new machines affect the dust, so do we need
to consider this? How is the NM treated in the process later, how does it interact at
later stages with other materials? Going back to step 5 – 7, we may have effects that
we don’t know by now yet. This needs to be considered too.
David: On of the challenges is, it’s critical to involve all users in the communication. Exposure
changes and does not always stay comparable to other situations. ANSES just
published a paper saying that a lot of information was not accurate or not available
16to workers, even with a mandatory notification system. My question is, how can the
NRGC support the need for transparency and access to information to workers, to
allow proper engagement with workers and others?
Paula: I would endorse David's idea of one of the Council roles being promoting
transparency and access to information by workers
Rolf: Two levels are needed: Communication and collaboration between “us” and the risk
prevention institutions responsible to support companies, where trade unions act as
intermediators. Some training centres of trade unions do deal with occupational
health and workplace exposure, but more is needed. In practice, we are far away
from this obligation, so we have to work on this. It’s the same with RA, only the big
companies do it properly. Regarding standardisation and Delphine’s presentation,
even if we use the same methodologies, we have a bias in the results that is
remarkable. So, it remains a problem.
Raquel In Spain, companies have the obligation to provide all sort of information related to
potential risks to their employees, as defined by REACH. The employees need to sign
that they have read and understood all information. From my experience, companies
do add potential “highest risks” regarding PPEs etc., to ensure that employees are
really safe. The current problem is the lack of information about what happens with
the NMs at their end-of-life.
Ulla: There is a ‘Mirka’ sanding machine available that includes a vacuum cleaner.
Delphine: Yes, you should have an extraction system attached to your tool. There are a number
of tools that have that included, but some have not. Also, there is a current
standardisation proposal from ISO TC 229 regarding a new work item on “release
from wood being treated with NPs in coatings”. Thus, there may come more ISO work
on this item in the future.
Rolf: “Mirka” is a Finnish company that produces such a sanding machine. They reduce the
wood dust and extract up to 98%. So, the technology is there, but companies may
not be aware of it.
Ulla: Or they are too conservative to look for innovative solutions and so poor that they
do not invest in the safety of the workers.
-- -- -- -- -- -- -- -- --
• Reflections of a Company (see Annex 4, pages 32)
Vladimir Vrečko, Cinkarna Celje, Slovenia
Manufacturer of (nano) titanium dioxide
Vladimir: The usual issues are already known
and addressed, so I tried in my presentation
to put some perspective on specific issues,
with a more provocative view. These are
meant to steer discussion.
In general, industry wants to solve societal
challenges. We want to produce the
materials in a safe and sustainable way with
a profitable revenue. The final product
17should have as least impacts (to human health and environment) as possible, and enter the
market successfully.
From the point of view of NMs, when several different aspects of nanosafety apply, production
safety is normally covered as well as safe use of our customers, as far as we have reliable
information.
Regarding management and investment decisions: the management board wants to have
information about potential problems. This is key information for any shareholder in the
industry. An important issue is communication with the stakeholders. Every industry is under
close observation, not only from regulators but also from NGOs, thus, we need clear messages
not to be proclaimed to share misinformation. Of course, regulatory compliance that companies
need to meet, is very important. Normally, industry associations deal with this complex frame
of health and safety issues and a ‘living’ regulatory framework. Only big companies have the
resources to deal with these issues in-house too. Large companies have their own people dealing
with that. Normal companies outsource this to external consultancies. We expect consultancies
to prepare safety dossiers and to choose correct methods, data, tools etc. to create the dossier.
The problem is that it is extremely costly for companies to get specific dossiers.
What can the NRGC provide? Biases are normal but can pose real problems. If you look at a
number of research papers, you find that scientists don’t publish results that show no effect.
Success in this research area is usually perceived when you find some problematic points. But
for industry and society that’s not the case, “no” result is equally important.
Another bias is that scientists who get paid by industry for their studies are considered as
tainted. Scientists are encouraged to do science for industry, but then they are immediately
considered to be influenced.
Another bias is that as much restriction as possible is good. This is a real great burden for
industry. Basic presumption in industry is that we do business as long as we get a good return
of investment. Thus, if the situation becomes that unstable, industry would push back
immediately from NTs. Some companies immediately stopped the production of NMs because
of the unstable situation and did move to regulatory framework. Customers are reluctant to
invest in an uncertain technology. The typical management perception is: how can you ensure
me, now that nanoTiO2 is banned, that any other NM dust form will not also be banned by
regulators in the future?
The NRGC could be a “reality check point” for regulators. In the regulatory process you have to
have a “reality check”, whether the limits proposed are realistic. I have witnessed a case where
in order to implement the precautionary principle a proposed limit value resulted in a lower
concentration than you find in the natural environment. Here we come to the more important
functions that the NRGC could have: as many companies don’t have the resources to do all
needed tests, this is usually outsourced, thus, we are not controlling which data is used.
So how can we control the quality of the data? For industry, this help would be very welcomed.
E.g., there is a dossier from an external consultancy, can you check the quality and the used
methods, are they appropriate, etc.? Next issue: expert statements. The EC invested a lot of
money in nanosafety projects. Still, we lack clear recommendations. Experts should take a clear
position. For example, a clear position could be: we don’t know everything, but the current data
are sufficient to say ok, for this material, under this condition, it’s safe enough to put them on
the market. This would provide industry a clear situation for at least the next 5 years. In addition,
the NRGC could support in communication. E.g., this data is trustworthy and recommended to
use it to communicate with the media, press, consumers, etc. A trusted source of data that is
accepted by all stakeholders would be really good.
-- -- -- --
18The Mentimeter poll shows that Vladimirs promise to present a provocative view succeeded.
Only three UC-members fully endorsed what he said, whereas two of them did not
endorse what he said. Most of the UC-members indicated that they wanted to discuss
issues, while three of them indicated to have serious problems with his approach, which
should be discussed.
-- -- -- --
Discussion (and chat)
Heidi: I share Vladimir’s position. There is a bias that when science and industry are co-
working that this may pose a disadvantage for scientific trust – that’s exactly the
point where the NRGC can step in, to increase transparency. The discussion with
nano-risks is far away from a usual risk discussion. However, it may be a role model
for the future. Sometimes advised limits are lower than natural concentrations
because even natural risks are not acceptable for health. For the precautionary
principle: it’s an instrument to protect, but it has a unique chance for regulators and
could strengthen also the NRGC role.
David: To the discussion on a better perception of consumers, or ensuring that consumers
better understand what industry is doing and have more trust on what their
activities: it cannot be a one-way communication. We need more a co-creation
approach. How should you organize your consultation and co-creation process to all
stakeholders to maximize the trust? The just finished project GoNano was focussing
on that topics. Regarding the precautionary principle: Is the idea that precaution is
an obstacle to innovation? Can anyone point out that any technology didn’t reach
the market because of the precautionary principle? I haven’t seen in the past 15 years
that any technology was prevented by the precautionary principle.
Vladimir: I’m not saying that the precautionary principle is an obstacle per se. But unreflected
use of it can be a problem, as the scientific proposed value was made smaller in order
to be precautionary. The precautionary principle shouldn’t be misused to get
completely unrealistic low numbers as limits.
Andrej: Any potential action from regulatory side is made in a scientific way.
Wittold: New regulations that are coming paralyze our work. I need a lawyer now with me.
The NRGC will not answer all problems, but we need advice/guidance for dynamic
situations.
Vladimir: If we look into the near future, we have a bundle of new regulations coming. Green
Deal, circular economy, etc. Around 50 regulation frameworks that will be
interconnected. How will we be able to check if everything matches? This requires a
lot of time and resources. Real winners will be lawyers and consultancies.
Ana: RA of nanoTiO2 needs 25 people at EFSA and several months to do it. It is very time
and resources consuming.
Ulla: We can start forbidding coal mining, diesel cars, plastics, etc...
Raquel: there are many economic interests, behind that is the reason there are diesels
car on road
Ulla: But nanoparticles from diesel cars are causing safety problems.
Raquel: That true, but it is no easy implement that change due to the oil companies
Ulla: So, regulators are afraid of oil companies....
Raquel: World moves for economics and politics interest....
19Martin: And what about nanoparticles from candles?
Ana: The proposal from Vladimir for the NGRC is similar to what you expect from a
consultant. Depending on the source of funding for the NGRC, this would be a
task of the Council.
To give you an example of the work that implies a RA, for the new assessment
of titanium dioxide as food additive, we started in February 2020 and around 25
people we are working on this to finalise the assessment by March 2021
-- -- -- -- --
Part 3
The final Mentimeter poll asked for what scenario(s) for the NRGC the participant’s do favour.
The surprising outcome of the poll was a quite even distribution over the four options for
the council, with a slight preference for the round table scenario.
-- -- -- -- --
Next User Committee Meetings
The suggestion is done to have another virtual meeting in spring 2021. Already now, Heidi and
Witold indicated to be interesting in getting the floor to present their reflections. Also, the plan
is to have a F2F meeting in September 2021, provided corona allows us. We will follow-up on
this suggestion with a Doodle poll.
Follow up of the meeting
The invited guests were asked to share their ‘take home’ messages: to give their reflection on
the UC-discussion and the issues brought forward relating or interfering with their tasks within
their NMBP13 project. We asked the guests to shortly reflect on the discussions in the UC-
meeting:
- What you ‘take home’ from this?
- How this influences your ideas regarding your tasks?
- Would you like to add something to the discussion, with remarks or existing papers?
20- Would you like to propose (and practically support) topics for one of the next UC-meetings
(spring, autumn 2021)?
- Do you have specific questions to the UC-members?
- Any other remarques?
Reactions were collected in the following (separate) paragraph in this report.
-- -- -- -- --
Reactions UC members to the Report
- Andrej Kobe
European Commission
DG ENV B.2
I’ll have a look at (a very specific, even ad verbatim) account of the discussion. Almost
intimidating!
As the NRGC ideas and plan move forward, and as I see the links being made with the chemical
strategy actions, selected UC members invited to contribute further and some EU institutions
have already been contacted regarding potential implementation, I would just like to re-state
reflection I made early in the process, and repeated it few times:
Regardless of widely shared positive objectives, a case must be made for both the need and
added value of the individual ‘services’ but also of the need of establishing specific institution
catering for them. Either
- because there might be others already addressing some or all of these services (note:
there is no inherent need one actor/institution covers them all), or
- even if the need is established for some or all of its services, its scope in terms of
substances/materials/technologies as considered might for example not be optimal
(note: scope modification might require at least some change of evidence base).
I am not necessarily pushing for extra effort in this regard, making further extra case for the
Council. Acknowledging potential existing actors and wider constellations (e.g. chemicals) and
assessing fit of the council objectives within them (as one potential solution, clearly identifying
gaps even when applying optimistic/realistic scenarios) is also a possibility that might be very
useful and sustainable.
With high appreciation of all the effort made to date, and looking forward to the continuation
in the near future, I wish the research team and fellow UC members relaxing holidays and a
good start in 2021!
Andrej
21Take Home Messages
- Marie-Valentine Florin
NANORIGO NRGC + NRGF
International Risk Governance Center
1) What you ‘take home’ from this
- UC members suggest among other things that the Council could
a) focus on future opportunities and risks, for example novel properties and non-
intentional outcome of current developments in the field of nanomaterials
b) help SMEs, universities and research institutes have broader access to studies
carried out by large companies, especially when funded by the EU
c) have some role in the sharing of information, including to and from exposed
workers (who need to have a more transparent access to information for the
purpose of improving their own safety, helping implement EU occupational
health and safety regulation, and also for participating in informed
deliberation with other stakeholders)
d) bring value if it could serve as a platform where all stakeholders from various
sectors can come and discuss (including to engage in dialogues about how to
implement safety-by-design)
e) have a role to promote standardization, for the benefits that standardization
brings, for example for data sharing and interoperability (which implies that
the Council should have effective and productive relationships with
organizations like the OECD and ISO/ CEN), and
f) provide advice concerning regulatory compliance.
- One UC member reminded that whether a nanomaterial is safe or not safe
depends to some extent on societal preferences, which calls from more dialogue
among various stakeholder groups and across sectors and application domains.
Another representative from industry reminded that the goal of industry is to
produce advanced materials that help solve existing physical and social challenges,
in a way that is safe, sustainable and profitable. This requires good collaboration
between society, science, industry and users. In this context, the Council could
help develop a climate of trust, to establish scientific validity of trustworthy risk
assessment information, whether produced by scientists, by industry or by NGOs.
- At this meeting, UC members expressed their individual preferences for each the
four scenarios, which they ranked as follows: 1) Roundtable, 2) Committee and
Center, 3) Panel. However, the group gave an almost equal number of preferences
for each scenario, so the ranking should be taken with caution.
2) how this influences your ideas regarding your tasks
- It is premature to ask stakeholders to choose from among the four scenarios.
Thematic focus of the Council, problems to be solved, etc. matter first
3) whether you would like to add something to the discussion, with remarks or existing
papers
22- No
4) whether you would like to propose (and practically support) topics for one of the next UC-
meetings (spring, autumn 2021)
- I would like to be able to engage bilaterally with some UC members who could be
very helpful in the refinement of the Council description. One from industry, one
from regulation and one from NGO.
- Did you notice, page 3 (end of section 1) of the new EU chemicals strategy
published in October that:
“The Commission will establish a high-level roundtable with representatives from
industry including SMEs, science and the civil society to realize the strategy’s
objectives in dialogue with the stakeholders concerned. Discussions of the
roundtable are envisaged to focus in particular on how to make the chemicals
legislation work more efficiently and effectively and how to boost the development
and uptake of innovative safe and sustainable chemicals across sectors.”
- You might wish to propose to the UC to discuss this new strategy, and way to
participate for what concerns nanotechnology.
- Damjana Drobne
NANORIGO Data refinery
Univ Ljubljana, Slovenia
1) What you ‘take home’ from this
- the stakeholders need access to knowledge;
- further discussion is needed to reach joint understanding on the criteria which data
and information is scientifically based and which not
- we need to develop joint vocabulary on explicit meaning of terms like hazard, risk,
safety, toxicity, data, information, knowledge, framework, council.
- We need to describe a physical form of data/information they are interested in. Is this
a value, an index or opinion; if they would come to council what would they ask for.
2) How this influences your ideas regarding your tasks
- Understanding what users need and how they express/describe their needs.
3) Whether you would like to add something to the discussion, with remarks or existing
papers,
- The users need access to „knowledge supply extracted form data“. We need to
jointly discover (in a co-creative manner)
- what form of knowledge is actionable for them (document, hazard statement,
comparison, number…).
- where do they get this type of information now
234) Whether you would like to propose (and practically support) topics for one of the next UC-
meetings (spring, autumn 2021)
Yes:
- A short introduction of data transformation to knowledge in line with needs
identified at the 3rd Dec 2020 meeting
- A short introduction of terms like hazard, risk, safety and toxicity; these terms are not
used in their explicit meaning of worked, but in their implicit what generates a lot of
misunderstanding
5) If you have specific questions to the UC-members
1. Are you doing material or product safety assessment by yourself or is this done by a
third party or you do not know or not at all??
- Third party (consultancy company)
- in-house
- I do not know
- we are not interested in safety assessment
2. Do you agree that the hazard is tipping point of decision?
- YES
- NO
3. When the stakeholders consider an opinion or decision (regulatory decision) to be
scientifically based and when not? What is a justification / a proof that a
decision/statement/opinion is scientifically based?
4. What are “good data”? Could you provide an example?
5. What are “bad data”? Could you provide an example?
6) Or any other remarks.
- No
• Isabel Rodriguez
NANORIGO Tools organization and assessment
Gaiker IK4, Bilbao, Spain
1. What you ‘take home’ from this
- There is a need for standards and guidances although this can also lead to biases.
- Information from scientific projects should be made available and easy to find.
- Employers are responsible for the safety of workers but workers should also be
involved in the safety process so they need to have easily accessible and
understandable information
- SMEs now do not have resources to prepare dossiers so they outsource this at a great
cost
242. How this influences your ideas regarding your tasks
- It is very important to include the information in the RGF in a clear and accessible way
to different groups of stakeholders.
3. if you have specific questions to the UC-members
- Would a clear guidance through the different tools/data be useful for SMEs and will
this avoid the need of outsourcing the preparation of dossiers?
- If you have to take safety decisions which are the main priority aspects that you
consider?
- How are decisions about safety taken now?
• Maria Dusinska
Coordinator RiskGONE
Norwegian Inst for Air Research
Director Health Effects Laboratory
Thanks a lot for organizing this workshop and the effort dedicated to the report. It was first
time I was attending the User committee action. I found it very interesting, especially to
see different sectors perspectives. For me the take home message would be the
complexity of the topic and how to bring together different perspectives of different
stakeholders’ group. An obvious common ground is safety and prosperity (or proper
addressing of risks and benefits). I unfortunately could not stay till the end of the
workshop so can’t give better feedback.
• Arto Säämänen
NANORIGO WP leader
FIOH
1. What you ‘take home’ from this
• stakeholder groups have varying needs/expectation for risk governance process
• How I recap the common needs based on the presentations and discussion on Dec 3
meeting:
o need for guidance:
§ Where to find information needed in risk governance? Access to that
information.
§ Do not know what is relevant
§ Where to find trustworthy tools for risk assessment? Which tools
should be used? Acceptance of the tools?
25o need for cooperation
§ inclusion of different stakeholder groups
§ need for dialogue between stakeholders
§ communication support
§ increased understanding
2. How this influences your ideas regarding your tasks
• I have utilised the information from all UC meetings in gathering stakeholder needs for
the Risk Governance Framework
• Based on commonly accepted stakeholder needs we will design and refine the
guidance for the risk governance process (=framework).
3. Whether you would like to propose (and practically support) topics for one of the next
UC-meetings (spring, autumn 2021)
• NANORIGO WP3 has created user narratives (use cases) for different stakeholder
groups. We will revere if relevant UC members could help NANORIGO project to
improve these narratives.
• First prototype of the NANORIGO’s web-based Nano Risk Governance platform will be
ready on March 2021. NANORIGO project will appreciate if UC members could give
feedback on that prototype. This could be e.g. individual demonstrations/interviews
• Panagotis Isigonis
RiskGONE NRGC
Ca Foscari University Venice
I do not have specific takehome messages, but nevertheless it was interesting to see how
different people perceive the same concepts in various ways, looking from different
viewpoints, expertise and needs. Which creates the necessity to reach some kind of
consensus when discussing, to make sure that all stakeholders/participants are on the
same level. But this is valid pretty much for all the stakeholder involvement activities we
are performing, and in some cases also internal NMBP-13 workshops.
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