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VeilleNanos - "Safe by design" approach: a new Eldorado?

“Safe by design” approach: a new Eldorado?

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By the AVICENN team – Last added October 2022

Safe by design” approach: a new Eldorado?

What is the “safe by design” approach?

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

  • their size or structure (via the formation of aggregates or agglomerates that bind the nanoparticles together), for example, to prevent the passage of titanium dioxide nanoparticles into the skin for sun creams.
  • and/or their surface – for example, by coating or encapsulating the nanoparticles – in order to minimize and stabilize their potential reactivity (and therefore their toxicity) during the entire life cycle of the nanoproduct.

Initially promoted by American scientists1Beyond implications and Applications: the Story of ‘Safety by Design’, Nanoethics, 2009, 3(2): 79-96., it has gained the favor of European authorities (notably the Joint Research Centre2Impact of Engineered Nanomaterials on Health – Considerations for Benefit-Risk Assessment, EASAC & JRC, Sept. 2011, and the European Commission3Work program 2013, Theme 4, Nanosciences, nanotechnologies, materials and new production technologies – NMP, July 2012), and of French organizations such as the Centre d’analyse stratégique4See the 5th recommendation of the Note d’analyse 248 – Pour un dévelopement responsable des nanotechnologies of the Centre d’analyse stratégique, November 2011 or the Académie des Technologies5See Risques des nanoparticules manufacturées, Académie des Technologies, April 2012 who all played a role in 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 INRS in France, for example, which has long promoted “risk prevention from the design stage”6Medium term plan, 2003-2007, INRS..

Is the “safe by design” approach the solution to all ills?

An alternative to nano risk assessment?

The “safe by design” approach is presented as an alternative to nano risk assessment as it has been done until now: insufficiently organized, confronted with methodological difficulties, it has led to results that are difficult to use, concerning insufficiently characterized nanomaterials7Approximately 80% of nanotoxicology studies prior to 2007 did not sufficiently describe the different characteristics of the nanoparticles studied: Cf. “Il faut définir ce qu’est une nanoparticule” (We must define what a nanoparticle is), Interview with Eric Gaffet, Director of Research at the CNRS, Santé & Travail, n° 071 – July 2010 and without necessarily knowing whether they were present in products actually marketed.

A costly case-by-case approach

The “safe by design” approach is also presented as a more powerful solution than the “case by case” approach widely advocated by the scientific community to health and environmental agencies in recent years8Justified by the concern to 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, charge state, degree of agglomeration, composition, solubility, etc.) which play a determining role in their toxicity and eco-toxicity
– the conditions under which nanoparticles are synthesized, stored, possibly coated, and then integrated into a product and which influence their characteristics and therefore also their toxicity and eco-toxicity
. However, some scientists now critizise it as being too costly, too time-consuming and potentially never-ending.

The promoters of the “safe-by-design” approach argue that by modifying the way nanoparticles are synthesized, coated and then integrated into a product, it will be possible to develop nanomaterials whose physicochemical characteristics will make them safe 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 funding.

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: Cordis), with a 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: Cordis), with participation, on the French side, by the CEA and the Centre 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: Cordis), with a 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: Cordis), with participation, on the French side, from the CEA, the CNRS, the company ALLIOS, the Symlog Institute
  • NanoFabNet (2020-2022), aims to set up an international network bringing together all the expertise, infrastructure and key players to support the implementation of sustainable nanomanufacturing, this structure to be co-constructed with all stakeholders, funded by 2.2 million under the H2020 program (source: Cordis)
  • SUN, Sustainable Nanotechnology Project (2013-2017)
  • NanoSustain or SINN (in which France participates, via CEA-LITEN and ANR), financed respectively to the tune of 2.5 and 1.5 million euros within the framework of FP7
  • MODENA (Modelling Nanomaterial Toxicity), being deployed at the European level with the support of COST (Cooperation in Science and Technology)
  • The SERENADE 2012 labex in France, “Towards a design of innovative, sustainable and safe nanomaterials”, with a funding of 11 million euros9Labex SERENADE 2012, “Towards a design of innovative, sustainable and safe nanomaterials”, presentation of the Ministry of Research, spread over eight years.

Safe-by-design approach vs. classical toxicology: what are the consequences of this approach on risk assessment?

The “safe by design” approach is presented as an alternative to classical toxicology: a quarrel between old and new? 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 be winning over the classical toxicology and eco-toxicology approach, which is independent of industrial interests, but where funding has already been greatly reduced over the past twenty years or so.

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

How involved are industrialists?

According to French researchers involved in the nano safe by design approach, “a structuring of research requiring a close relationship between the academic and industrial worlds is necessary and “the industry participation is essential to develop faster research facilitating the manufacture of risk-sensitive nano-products”10“Towards a shared concept of risk assessment for humans and the environment for an eco-design of nanoproducts”, J.Y Bottéro, J. Rose, M. Auffan, A. Masion, J. Labille, J. Boszckowski, presentation at the day “Regards sur les nanotechnologies: enjeux, débats, perspectives”, Institut de Maîtrise des Risques, 18 October 2011. It is true that the studies on the toxicity of nanomaterials conducted to date have been carried out on nanoparticles synthesized in the laboratory, and therefore different from those that are actually incorporated into products currently on the market. Directly testing nanomaterials in the research and development phase should therefore improve the relevance of the results obtained and work towards more efficient risk minimization.

Does this influence the research conducted and its results?

How can we ensure that the increased involvement of industrialists does not lead to an overly strong orientation of projects and their results?

Consider a 2012 study published by researchers in the United States showing that chlorine in swimming pools can degrade the aluminum hydroxide coating that surrounds nanoparticles of titanium dioxide (TiO2) integrated into certain sun creams (Neutrogena SPF 30): could it have been published if the Neutrogena brand had been involved in the study (especially financially) 11The study, financed 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 the aging of the skin 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, Environ Res, 148:273-276, July 2016 ?

Keeping nano-toxicology and ecotoxicology independent of industrial interests is important and necessary to guarantee reliable results and to take into account the needs of environmental and public health protection. In return for their investment in research on the health and environmental safety of nanotechnology, industrialists have expectations that are not all in line with the general interest. They were 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 rewards include easier access to the market and new intellectual property rights12Nanotechnology long-term impacts and research directions: 2000-2020, André Nel and David Grainger, WTEC, 2010. With what redistribution of economic revenues between private and public partners? And with what degree of knowledge sharing13“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 polarise research more than long term public values”. Handbook for CSOs on European research, Fondation Sciences Citoyennes, 2010? Will the innovative nanomaterials produced in these projects be marked as confidential because protected by industrial and/or commercial secrecy?

Many remaining scientific challenges

We should not be overly optimistic: the “safe by design” approach will not be free of scientific and technical difficulties14François 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 developmentsFrançois Tardif, presentation at the day “Regards sur les nanotechnologies: enjeux, débats, perspectives”, Institut de Maîtrise des Risques, 18 October 2011. A few months earlier, U.S. scientists insisted that the nanomaterials being developed and coming will be far more complex than today’s nanoparticles and present challenges that will 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, especially because many factors are beyond the control of researchers and engineers:

Yet, paradoxically, the extremely ambitious objectives pursued are presented with an assurance and fervor (candor?) that minimize the complexity of the task. The following questions arise: Can the challenges be met – both technically and financially – within a reasonable time frame? When will the projects currently being deployed bear fruit? And with what guarantees as to the real safety of the nanomaterials developed? Isn’t the idea that we can totally control risks through flawless design an illusion?

These are all important questions. In the meantime, nanoproducts continue to be marketed, with no further information on their risks or safety.

The case of the so-called "depolluting" paints

As an example, research teams have been trying for years to develop “depolluting” applications based on titanium dioxide (TiO2) nanoparticles. The CEA LITEN, reporting on research conducted under the Safetipaint 1 and 2 projects funded by the SERENADE labex, published in November 2020 a statement showing that the benefit / risk ratio of TiO2 nanoparticles does not yet seem conclusive for “depolluting” paints. The research will be continued within the framework of a new €6 million European SAbyNA project, which is part of the development of the “safer by design” approach. Can the challenge be met within a reasonable timeframe and at a reasonable cost?

Besides technological questions, political issues and choices

These political questions, which have given rise to strong controversies in the case of GMOs, are still rarely discussed in the case of nanotechnologies. However, they are important issues: in particular, there is the question of the distribution of public funding between the different fields of research and the objectives pursued (toxicology, eco-toxicology, environmental health and occupational health on the one hand, and innovation and competitiveness on the other), and the one of the financing methods for research projects on the safety of nanomaterials.

Finally, as William Dab wrote in late 2013, “it is very difficult, if not impossible, to demonstrate the non-existence of a hazard. It is much more difficult, in fact, than proving its existence. This is a very disturbing situation that leaves room for speculation and confrontation, often underpinned by struggles between conflicting interests. (…) safety cannot, in all rigor, be demonstrated. (…) science does not have the answer to everything. Therefore, uncertainties should not be hidden, but on the contrary, put at the center of the “scientific democracy”, one might say. This means debating what is and is not a risk, what is a risk worth taking 16Can we demonstrate the nonexistence of a hazard?, William Dab, Of Risks and Men, December 9, 2013 . .

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File initially created in November 2012

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