Implementation of Safe-by-Design for Nanomaterial Development and Safe Innovation: Why We Need a Comprehensive Approach

Abstract

Manufactured nanomaterials (MNMs) are regarded as key components of innovations in various fields with high potential impact (e.g., energy generation and storage, electronics, photonics, diagnostics, theranostics, or drug delivery agents). Widespread use of MNMs raises concerns about their safety for humans and the environment, possibly limiting the impact of the nanotechnology-based innovation. The development of safe MNMs and nanoproducts has to result in a safe as well as functional material or product. Its safe use, and disposal at the end of its life cycle must be taken into account too. However, not all MNMs are similarly useful for all applications, some might bear a higher hazard potential than others, and use scenarios could lead to different exposure probabilities. To improve both safety and efficacy of nanotechnology, we think that a new proactive approach is necessary, based on pre-regulatory safety assessment and dialogue between stakeholders. On the basis of the work carried out in different European Union (EU) initiatives, developing and integrating MNMs Safe-by-Design and Trusted Environments (NANoREG, ProSafe, and NanoReg2), we present our point of view here. This concept, when fully developed, will allow for cost effective industrial innovation, and an exchange of key information between regulators and innovators. Regulators are thus informed about incoming innovations in good time, supporting a proactive regulatory action. The final goal is to contribute to the nanotechnology governance, having faster, cheaper, effective, and safer nano-products on the market.

Investigating a transcriptomic approach on marine mussel hemocytes exposed to carbon nanofibers: An in vitro/in vivo comparison

“…The application of SbD to MNMs was developed in the European FP7 projects NANoREG and Prosafe and is being expanded on in the European Horizon 2020 project NanoReg2. The objectives of an SbD approach is to apply the precautionary principle early in the production/innovation process and in this way, hazards and risks can be identified early and strategies to mitigate their effects without placing significant burdens for industry (Kraegeloh et al, 2018). It is important to note however that the aim of SbD is not to completely remove the risk but to find ways to lower the risk without hindering the performance of the product.…”

A Methodological Safe-by-Design Approach for the Development of Nanomedicines

“…Even though various concepts of SbD coexist, they share the purpose of assessing safety as early as possible in the innovation process of a nanomaterial or nanoproducts. They aim at reducing adverse effects on human health and the environment by altering nanoproduct design (Soeteman-Hernandez et al, 2019) and by ensuring safety along its lifecycle (Bottero et al, 2017;Kraegeloh et al, 2018). The SbD concept is therefore different from conventional risk assessment approaches, which only consider safety when the product is already fully developed (Schwarz-Plaschg et al, 2017).…”

“…Despite being a rather novel concept in the context of nanotechnology, the principle behind SbD is not new and already applied by other industries (Kraegeloh et al, 2018). The medicine field has also long expertise in ensuring safety throughout the drug discovery and development process (Hjorth et al, 2017).…”

How the Lack of Chitosan Characterization Precludes Implementation of the Safe-by-Design Concept

“…EU-NCL focuses on the pre-clinical characterization of nanomaterials in order to accelerate their development toward the approval by the regulatory agencies (European Nanomedicine Characterization Laboratory, 2019a). Moreover, in the European Union, other projects such as NANoREG, NANoREG II, ProSafe, and NanoDefine have also explored the standardization of nanomaterial characterization, and the development of better prediction models, such as the application of the Safe-by-Design (SbD) approach to nanosystems (Kraegeloh et al, 2018).…”

“…In general, the application of this concept requires the examination of which physicochemical properties render a nanomaterial safe, means to implement this knowledge into industrial innovation processes, and information exchange between stakeholders. The SbD concept can be implemented to design nanomaterials with an optimal balance between functionality and risk, based on relevant physicochemical parameters (Kraegeloh et al, 2018).…”