Testing the Applicability of the Safe-by-Design Concept: A Theoretical Case Study Using Polymer Nanoclay Composites for Coffee Capsules

The production and use of engineered nanomaterials and nano-enabled products is increasing, enabling innovations in many application areas, e.g., in the sector of food contact materials. However, nanosafety-relevant information for chemical risk assessment is still scarce, leading to a high level of uncertainty and making the early integration of safety to the innovation process indispensable. This study analyzed the strengths, weaknesses, and applicability of the nano-specific Safe-by-Design (SbD) concept using nanoclay-containing polymer coffee capsules as a theoretical case study. In addition, a material flow analysis was conducted to identify exposure pathways and potential risks, and a multi-stakeholder approach was applied to discursively discuss challenges when attempting to combine safety and innovation at an early stage. The results indicate that the SbD concept is generally welcomed by all stakeholders, but there is a lack of clear rules on the transfer of information between the actors involved. Furthermore, a voluntary, practical application usually requires in-depth knowledge of nanotechnology and often additional financial efforts. Therefore, incentives need to be created, as there is currently no obvious added value from a company’s point of view. The SbD concept should be further developed, standardized, and integrated into existing legal frameworks to be implemented effectively.

Data Shepherding in Nanotechnology: An Antimicrobial Functionality Data Capture Template

In this paper, we exhibit how to construct a template for capturing antimicrobial capacity data of nanomaterials or nanoenabled products. The template promotes the principles of making data scientifically findable, accessible, interoperable and reusable (FAIR), encouraging scientists to reuse it. The template construction roadmap entails the following steps: (1) recognize appropriate stakeholders, (2) allocate surveys to collect a general explanation of the data that will be created, (3) comprehend each stakeholder’s requirements, (4) cooperating and using straightforward communication with the participants for the selection of the minimum data requirement reporting and (5) template layout and ontological annotation. We provide an annotated template for capturing antimicrobial data, increasing their interoperability while populating it with real measurements as an example. By applying the roadmap or by utilizing the template portrayed herein, in the case of a safe-by-design nanoproject (Anticipating Safety Issues at the Design of Nano Product Development (ASINA)), data creators of antimicrobial assessments can store the data using the FAIR approach. Furthermore, data shepherds and scientists can skip the lengthy template generation process and speed up the community’s progress on the FAIR route.

Structural Alterations of Antigens at the Material Interface: An Early Decision Toolbox Facilitating Safe-by-Design Nanovaccine Development

Nanomaterials have found extensive interest in the development of novel vaccines, as adjuvants and/or carriers in vaccination platforms. Conjugation of protein antigens at the particle surface by non-covalent adsorption is the most widely used approach in licensed particulate vaccines. Hence, it is essential to understand proteins’ structural integrity at the material interface in order to develop safe-by-design nanovaccines. In this study, we utilized two model proteins, the wild-type allergen Bet v 1 and its hypoallergenic fold variant (BM4), to compare SiO2 nanoparticles with Alhydrogel® as particulate systems. A set of biophysical and functional assays including circular dichroism spectroscopy and proteolytic degradation was used to examine the antigens’ structural integrity at the material interface. Conjugation of both biomolecules to the particulate systems decreased their proteolytic stability. However, we observed qualitative and quantitative differences in antigen processing concomitant with differences in their fold stability. These changes further led to an alteration in IgE epitope recognition. Here, we propose a toolbox of biophysical and functional in vitro assays for the suitability assessment of nanomaterials in the early stages of vaccine development. These tools will aid in safe-by-design innovations and allow fine-tuning the properties of nanoparticle candidates to shape a specific immune response.

Safe by design (SbD) and nanotechnology: a much-discussed topic with a prudence?

Safe-by-Design (SbD) has been put forward as a concept to assure that only safe nanomaterials will reach the market and that safety aspects have already been considered in a very early stage of the innovation process. In practice, several laboratory test have been proposed to screen newly developed nanomaterials and nano-enabled products to assess their hazardous nature. These tests need to have sufficient predictive power for possible adverse effects on human health, not only due to acute (peak) exposures, but also for long-term (low dose) exposures as these materials may accumulate over time in organs and tissues.

Safe by Design for Nanomaterials—Late Lessons from Early Warnings for Sustainable Innovation

The Safe by Design conceptual initiative being developed for nanomaterials offers a template for a new sustainable innovation approach for advanced materials with four important sustainability characteristics. Firstly, it requires potential toxicity risks to be evaluated earlier in the innovation cycle simultaneously with its chemical functionality and possible commercial applications. Secondly, it offers future options for reducing animal laboratory testing by early assessment using in silico predictive toxicological approaches, minimizing the number that reaches in vitro and in vivo trials. Thirdly, it promotes a culture of shared responsibility for ethical and sustainable outcomes in the innovation process by promoting early dialogue between groups with vested interests. Finally, it offers the prospect of a more democratized innovation process by including civil society actors in decisions on product safety, commercial applications, and social utility. Collectively, these four characteristics offer the prospect for a new social contract between science, technology, and society for the societal alignment and sustainable innovation of advanced materials.