Safe- and sustainable-by-design: The case of Smart Nanomaterials. A perspective based on a European workshop.

The European Commission's Green Deal is a major policy initiative aiming to achieve a climate-neutral, zero-pollution, sustainable, circular and inclusive economy, driving both the New Industrial Strategy for Europe and the Chemicals Strategy for Sustainability. Innovative materials can help to reach these policy goals, but they need to be safe and sustainable themselves. Thus, one aim is to shift the development of chemicals to Safe- and Sustainable-by-Design, and define a new systems approach and criteria for sustainability to achieve this. An online workshop was organised in September 2020 by the Joint Research Centre and the Directorate-General Research and Innovation of the European Commission, with participants from academia, non-governmental organisations, industry and regulatory bodies. The aims were to introduce the concept of Safe- and Sustainable-by-Design, to identify industrial and regulatory challenges in achieving safer and more sustainable Smart Nanomaterials as an example of innovative materials, and to deliver recommendations for directions and actions necessary to meet these challenges. The following needs were identified: (i) an agreed terminology, (ii) a common understanding of the principles of Safe- and Sustainable-by-Design, iii) criteria, assessment tools and incentives to achieve a transition from Safe-by-Design to Safe- and Sustainable-by-Design, and (iv) preparedness of regulators and legislation for innovative chemicals/nanomaterials. This paper presents the authors' view on the state of the art as well as the needs for future activities, based on discussions at the workshop and further considerations. The case of Smart Nanomaterials is used to illustrate the Safe- and Sustainable-by-Design concept and challenges for its implementation. Most of the considerations can be extended to other advanced materials and to chemicals and products in general.

Towards safe and sustainable innovation in nanotechnology: State-of-play for smart nanomaterials.

The European Green Deal, the European Commission's new Action Plan for a Circular Economy, the new European Industrial Strategy and the Chemicals Strategy for Sustainability launched in October 2020 are ambitious plans to achieve a sustainable, fair and inclusive European Union's economy. In line with the United Nations Sustainable Development Goals 2030, these policies require that any new material or product should be not only functional and cost-effective but also safe and sustainable to ensure compliance with regulation and acceptance by consumers. Nanotechnology is one of the technologies that could enable such a green growth. This paper focuses on advanced nanomaterials that actively respond to external stimuli, also known as 'smart nanomaterials', and which are already on the market or in the research and development phase for non-medical applications such as in agriculture, food, food packaging and cosmetics. A review shows that smart nanomaterials and enabled products may present new challenges for safety and sustainability assessment due to their complexity and dynamic behaviour. Moreover, existing regulatory frameworks, in particular in the European Union, are probably not fully prepared to address them. What is missing today is a systematic and comprehensive approach that allows for considering sustainability aspects hand in hand with safety considerations very early on at the material design stage. We call on innovators, scientists and authorities to further develop and promote the 'Safe- and Sustainable-by-Design' concept in nanotechnology and propose some initiatives to go into this direction.

Biotechnology for Tomorrow's World: Scenarios to Guide Directions for Future Innovation.

Depending on how the future will unfold, today's progress in biotechnology research has greater or lesser potential to be the basis of subsequent innovation. Tracking progress against indicators for different future scenarios will help to focus, emphasize, or de-emphasize discovery research in a timely manner and to maximize the chance for successful innovation. In this paper, we show how learning scenarios with a 2050 time horizon help to recognize the implications of political and societal developments on the innovation potential of ongoing biotechnological research. We also propose a model to further increase open innovation between academia and the biotechnology value chain to help fundamental research explore discovery fields that have a greater chance to be valuable for applied research.

The Microbiome: A Life Science Opportunity for Our Society and Our Planet.

Microbiome research and innovation (R&I) promises solutions to a broad range of business and societal challenges. To bridge the gap between today's potential and the moment at which concrete applications start generating societal impact, critical-scale efforts offering visible progress on topics of public interest will be essential.

Communicating Biotech Advances: Fiction versus Reality.

Bioscience novels use selected technologies of genetic engineering and synthetic biology to create entertaining stories. These novels are usually based on scientific knowledge, but they may arouse public concerns about technology and drive public reluctance to accept innovative technologies. The scientific community must adopt more efficient communication and transparency.

Plant breeding as the cornerstone of a sustainable bioeconomy.

A prime driver for a bioeconomy is the need to ensure the availability of sufficient biomass feedstock for food, feed, energy and industrial uses. This demand must be properly managed in the face of several challenges, including environmental changes and abrupt climate shifts. Plant breeding and breeding innovation is the cornerstone for sustainable supply of biomass. Not only does research and development in this sector aim at providing high yielding crops in order to maximize production, but R&D in this field will also allow to obtain highly specialized plant varieties with new or improved traits that fit to specific applications. At the same time, there is little awareness among the general public of the fact that state-of-the-art R&D is a prerequisite for the production of sufficient biomass of the right quality in a sustainable manner. Plant breeders in the EU have to grapple with a rather challenging policy and regulatory framework. An important way forward to overcome the existing impasse would be to ensure transparent and trustworthy communication with the general public.

The Role of Public Opinion in Shaping Trajectories of Agricultural Biotechnology.

Science and technology are not autonomous entities and research trajectories are largely influenced by public opinion. The role of political decisions becomes especially evident in light of rapidly developing new breeding techniques (NBTs) and other genome editing methods for crop improvement. Decisions on how those new techniques should be regulated may not be based entirely on scientific rationale, and even if it is decided that crops produced by NBTs do not fall under the umbrella of genetically modified organisms (GMOs), their commercialization is by no means certain at this time. If and when adopted regulations do not comply with the public's perception of risks, policy makers will find themselves under pressure to ban or restrict the use of the respective products.

Uninformed and disinformed society and the GMO market.

The EU has a complicated regulatory framework, and this is slowing down the approval process of new genetically modified (GM) crops. Currently, labeling of GM organisms (GMOs) is mandatory in all Member States. However, the USA, in which GMO labeling is not mandatory, continues to lead the production of biotech crops, biopharmaceuticals, biomaterials, and bioenergy.

Perception of GMOs by scientists and practitioners--the critical role of information flow about transgenic organisms.

The issue of GMOs arouses constantly strong emotions in public discourse. At the same time opinions of people particularly interested in this issues such as researchers, or potential users of this technology (e.g. farmers) are rarely subjected to analysis. Moreover, lack of knowledge about the flow of information "from the laboratory to the consumer" hinders implementation of any changes in this field. By using triangulation (combining quantitative and qualitative research and the use of various research tools) we explored the attitudes of Polish scientists, agricultural advisers and farmers (large scale agricultural producers) to the use of GMOs in the economy. On the basis of the performed research we diagnosed the effectiveness of information flow among these groups about transgenic organisms.

Social and legal determinants for the marketing of GM products in Poland.

The development of biotechnology is influenced by many factors unique for a specific region. In Poland the lack of legislative solutions (to facilitate the promotion of the inventions) and the public resistance against certain sectors of biotechnology are significant factors limiting any further development. Although, science and technology are the front runners in any innovation, the significance of social and legal aspects is difficult to overestimate. In our opinion those factors are interconnected and crucial for marketing of innovative products, therefore, we indicate and explain the most important issues restraining the implementation of innovative biotechnology in the context of national specificity in Poland.