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MonitoringNanos - "Safe by design" approach: a new eldorado?

“Safe by design” approach: a new Eldorado?

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By AVICENN Team – Last Added October 2022

Safe by design approach: a new Eldorado?

The “safe by design” approach, kézako?

The “safe by design” approach aims to minimize the risks of nanomaterials from their design, by modifying:

  • their size or structure (via the formation ofaggregates or dagglomerates which bind the nanoparticles together), for example to prevent the passage of titanium dioxide nanoparticles into the skin for sunscreens
  • and/or their surface – for example by coating or encapsulating the nanoparticles – in order to minimize their potential reactivity (and therefore their toxicity) and to stabilize it throughout the life cycle of the nanoproduct.

Originally promoted by American scientists1Beyond Implications and Applications: the Story of 'Safety by Design', Nanoethics, 2009, 3(2): 79-96., it has won the favor of European authorities (in particular the Joint Research Center2Impact of Engineed nanomaterials on health-Considerations for benefit-Risk Assessment, EASAC & JRC, Sept. 2011, the European Commission3Work Program 2013, Theme 4, Nanosciences, nanotechnologies, materials and new production technologies – NMP, European Commission, July 2012), and French organizations such as the Center for Strategic Analysis4See the 5th recommendation of the Analytical note 248 – For a responsible development of nanotechnologies from the Center for Strategic Analysis, November 2011 or the Academy of Technologies5See Risks of engineered nanoparticles, Academy of Technologies, April 2012 who in turn encouraged the development of this approach.

Before the marketing success of this Anglo-Saxon designation, there was already an older incentive from the European Union in favor of clean processes, or from the INRS in France, for example, which has long been promoting "risk prevention from design".6Medium Term Plan, 2003-2007, Inrs.

The “safe by design” approach, the solution to all problems?

An alternative to nano risk assessment? 

The "safe by design" approach is presented as a alternative to nano risk assessment as it has been practiced so far : insufficiently organized, confronted with methodological difficulties, it led to results that are difficult to use, many of which relate to insufficiently characterized nanomaterials7About 80% of nanotoxicology studies before 2007 did not sufficiently describe the different characteristics of the nanoparticles studied: Cf. "We must define what a nanoparticle is", Interview with Eric Gaffet, research director at the CNRS, Health & Work, No. 071 – July 2010 and without it necessarily being known whether they were present in products actually marketed.

A case-by-case approach involving high cost 

The "safe by design" approach is also presented as a more powerful solution than the so-called "case by case" approach widely advocated by the scientific community to health and environmental agencies in recent years8Justified by concern for take into account the particularities of each nanomaterial, this “case by case” approach proposes to better take into account:
– the different physico-chemical characteristics of nanoparticles (size, shape, structure, state of charge, degree of agglomeration, composition, solubility, etc.) which play a determining role in their toxicity and eco-toxicity
– the conditions under which the nanoparticles are synthesized, stored, possibly coated, then integrated into a product and which influence the characteristics and therefore also their toxicity and eco-toxicity
but lately decried by some scientists who consider it too expensive, too long and irrelevant because assimilated to an endless quest.

Proponents of the "safe-by-design" approach argue that by playing on the way nanoparticles are synthesized, coated and then integrated into a product, it will be possible to develop nanomaterials whose physico-chemical characteristics will make them safe materials from a health and environmental point of view.

An approach largely supported by public funding 

A reassuring argument… which explains why the application of the “safe by design” approach to nanotechnologies and nanomaterials is supported by public money.  

Some examples of projects

Several European projects:

  • Sbd4nano (2020-2024): “Safe by design for nano” – nearly 6 million euros received from the European Union (source : Cordys), with participation, on the French side, of the CEA
  • SUSnanofab (2020-2023): “Towards a competitive and sustainable nanofabrication industry” – nearly 2 million euros received from the European Union (Source Cordys), with participation, on the French side, of the CEA and the Center Technique Industriel de la Plasturgie et des Composites (ICP)
  • SABYDOMA (2020-2023): “SAfety BY Design of nanoMaterials” – more than 7 million euros received from the European Union (source : Cordys), with participation, on the French side, of the research company Rescoll.
  • SAbyNA (2020-2024), “Simple, robust and cost-effective approaches to guide industry in the development of safer nanomaterials and nano-enabled products” – 6 million euros from the EU (source : Cordys), with participation, on the French side, of the CEA, the CNRS, the ALLIOS company, the Symlog institute
  • NanoFabNet (2020-2022), aims to set up an international network bringing together all the expertise, infrastructures and key players to support the implementation of sustainable nanomanufacturing, this structure to be co-built with all the parties stakeholders, funded to the tune of 2,2 million as part of the H2020 program (source: Cordys)
  • SUN, Sustainable Nanotechnology Project (2013-2017)
  • NanoSustain ou SENSE (in which France participates, via the CEA-LITEN andANR), financed respectively to the tune of 2,5 and 1,5 million euros within the framework of the 7th PCRD
  • MODENA (Modelling Nanomaterial Toxicity), currently being deployed at European level with the support of COST (Cooperation in Science and Technology)
  • Le SERENADE 2012 in France, "Towards the design of innovative, sustainable and safe nanomaterials", with funding of 11 million euros9Labex SERENADE 2012, “Towards a design of innovative, sustainable and safe nanomaterials”, presentation of the Ministry of Research from the Ministry of Research, spread over eight years.

“Safe-by-design” approach vs classic toxicology: What consequences of this approach for risk assessment?

The “safe by design” approach is presented as an alternative to classic toxicology: quarrel between the ancients and the moderns? On paper, the two approaches are not mutually exclusive, but in the race for public funding, the "safe by design" approach, directly linked to funding and industrial products, seems to oust the classic approach of toxicology and eco-toxicology, independent of industrial interests, but whose means have already been greatly reduced over the past twenty years.

If it seems desirable to work on products actually marketed or in the process of being marketed, rather than in an abstract way and disconnected from reality, we should not throw the baby out with the bathwater; especially since the “nano safe-by-design” also has limits that should not be underestimated.

What degree of industrial participation? 

According to French researchers involved in the nano safe by design approach, “a structuring of research requiring a close network between the academic world and the industrial world«  is necessary and " the participation of industrialists is essential to develop faster research facilitating the manufacture of nano-products taking into account the risks”10"Towards a shared concept of risk assessment for humans and the environment for an eco-design of nanoproducts", JY Bottero, J. Rose, M. Auffan, A. Masion, J. Labille, J. Boszckowski, presentation at the day “Views on nanotechnology: challenges, debates, perspectives”, Institute for Risk Management, October 18, 2011. It is true that the studies on the toxicity of nanomaterials carried out until now have been carried out on nanoparticles synthesized in the laboratory, therefore different from those which are actually incorporated into the products currently on the market. Direct testing of nanomaterials in the research and development phase should therefore make it possible to improve the relevance of the results obtained and to work towards more efficient risk minimization.

With what influence on the research carried out and on its results?

But how to ensure nevertheless that theincreased industrial involvement lead to too marked an orientation of projects and their results?

Take the case of a study published in 2012 by researchers in the United States showing that chlorine from swimming pools can degrade the aluminum hydroxide coating that surrounds titanium dioxide nanoparticles (TiO2) integrated into certain sunscreens (the Neutrogena SPF 30): could it have been published if the Neutrogena brand had been involved in the setting up (financial in particular) of the study 11The study, funded by the US Environmental Protection Agency, revealed that in contact with water and under the effect of light, the core of the nanomaterial, nanoTiO2 can then release free radicals, responsible for skin aging and the appearance of cancers, see: Depletion of the protective aluminum hydroxide coating in TiO2-based sunscreens by swimming pool water ingredients, Virkutyte J et al., Chemical Engineering Journal, Volume 191, May 2012, Pages 95-103; note, this more recent publication on the same phenomenon: UV filters interaction in the chlorinated swimming pool, a new challenge for urbanization, a need for community scale investigations, Sharifan H et al., About Res., 148:273-276, July 2016 ?

Maintaining a nano-toxicology and ecotoxicology independent of industrial interests is important and necessary to guarantee reliable results and taking into account the needs of environmental protection and public health. Because in return for their investment in research on the health and environmental safety of nanos, manufacturers have expectations that are not all converging with the general interest. They have thus been publicly summarized by two American nanomedicine researchers interviewed by the American National Science Foundation (NSF): in addition to safer materials and new applications, the expected counterparties include easier access to the market and new intellectual property rights.12Nanotechnology long-term impacts and research directions: 2000-2020André Nel et David Grainger, WTEC, 2010. With what redistribution of economic income between private and public partners? And what sharing of knowledge13“Research institutions have been encouraged to set up “public-private” partnerships (PPP) with industry and to contribute more directly to the economy. Private research gained a lot of advantages from these new regulations. These new forms of property have led to a new parcelling of knowledge, and to new monopolies. The production of science itself has gone through a significant evolution. Scientific and technological developments have been more and more oriented by market forces, and short term profitable value of potential innovations polarize research more than long term public values”. Handbook for CSOs on European research, Citizen Science Foundation, 2010 ? Will the innovative nanomaterials produced within the framework of these projects be marked with the seal of confidentiality because they are protected by industrial and/or commercial secrecy?

There are still many scientific challenges

Especially since we should not err on the side of optimism: the "safe by design" approach will not be free from scientific and technical difficulties.14François Tardif of the CEA considered in November 2011 that “it will still take years to identify benign nanoparticles, See: Safety of Nanomaterials, Exposure Reduction State of the art and developments, François Tardif, presentation at the day “Views on nanotechnology: challenges, debates, perspectives”, Institute for Risk Management, October 18, 2011. A few months earlier, American scientists insisted on the fact that the nanomaterials being developed and to come will be much more complex than current nanoparticles and present challenges that will have plenty to keep toxicologists busy for the next fifty years, See: The new toxicology of sophisticated materials: nanotoxicology and beyond, Maynard Ad, Warheit DB, Philbert Ma., Toxicol sci., 2011.

The "safe(r) by design" approach will not be able to control everything, in particular because a large number of factors are beyond the control of researchers and engineers:

  • First, the conditions under which the nanomaterials are used and then released, transformations they can undergo in the environment or in the body, etc.15In order to be able to design "safe" nanomaterials, the Serenade labex shows that it wants to “understanding the mechanisms of interactions between inert matter (nanoparticles) and living matter (cells down to the level of chromosomes and DNA)”Labex SERENADE 2012, “Towards a design of innovative, sustainable and safe nanomaterials”, presentation of the Ministry of Research. This is in fact one of the aspects which have so far been little studied and of which much is unknown today (especially on the release, as well as on top the fate and behavior of nanomaterials in the environment and in the body), although essential to know if one wants to be able to claim to minimize the risks. It requires the development of experimental approaches reproducing more realistic exposure conditions than those that have been commonly used.
  • Moreover, by “isolating” or modifying nanomaterials, it is indeed difficult not to lose the advantages of their specificities at the same time.

However, paradoxically, the objectives pursued are both extremely ambitious but presented with an assurance and a fervor (candor?) that minimize the complexity of the task. The following questions then arise: can the challenge be met – both technically and financially – within a reasonable timeframe? When will the projects currently being deployed bear fruit? And with what guarantees as to the real harmlessness of the nanomaterials developed? Isn't the idea that we can totally control the risks by an irreproachable design illusory?

So many important questions. Waiting, nanoproducts continue to be marketed, without further information on their risks or safety.

The case of so-called "depolluting" paints

In concrete terms, research teams have been trying for years to develop “depolluting” applications based on titanium dioxide (TiO2) nanoparticles, for example. The CEA LITEN, reporting on the research carried out as part of the Safetipaint 1 and 2 projects funded by the SERENADE labex, published a press release in November 2020 showing that the benefit / risk ratio of TiO2 nanoparticles does not yet seem conclusive for what concerns "depolluting" paints Paints to purify the ambient air, CEA Liten, November 2020. Research will be continued as part of a new European project SAbyNA of 6 million euros, which is part of the development of the so-called "safer by design" approach. Can the challenge be met in a reasonable time and cost?

Behind the technique, questions and political choices

These non-technical but political questions, which have given rise to strong controversies in the case of GMOs, are still little discussed with regard to nanotechnologies. However, they constitute important issues: the question arises in particular of the choice of distribution of public funding between the various fields of research and the aims pursued (toxicology, eco-toxicology, environmental health and health at work on the one hand, innovation and competitiveness of the other), and that of funding methods for research projects to secure nanomaterials.

Finally, as William Dab wrote at the end of 2013, “it is very difficult, if not impossible, to demonstrate the non-existence of a danger. It's much more difficult, in fact, than proving its existence. It is a very disturbing situation and leaves room for speculation and confrontations often underpinned by struggles between contradictory interests. (…) harmlessness cannot, strictly speaking, be demonstrated. (…) science does not have all the answers. Therefore, we must not hide the uncertainties, but on the contrary, put them at the center of "scientific democracy", you might say. Which means debate what is or is not a risk, what is a risk worth taking« 16Can we demonstrate the non-existence of a danger?, William Dab, Of Risks and Men, December 9, 2013 .

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The next nano appointments

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Sheet initially created in November 2012

Notes & references

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