Safe-by-Design part I: Proposal for nanospecific human health safety aspects needed along the innovation process

Safe-by-Design aims to reduce uncertainties and/or increase the human health and environmental safety from already early in the innovation process onwards and will thereby contribute to increased innovation efficiency, economic viability, interdisciplinary collaboration, consumers trust and improve sustainability. Since most innovators or designers are neither toxicologists nor risk assessors, considering human health safety aspects within their innovation process may be challenging. This paper provides sets of questions that can help innovators to assess nanospecific human health safety aspects of their product or material along the various stages of the innovation process. Addressing these questions will facilitate innovators to identify which type of information may support decisions on how to address potential human health risks in the innovation process. The identified information on the human health safety aspects can help innovators to decide if further investments in the product or material are beneficial. It may allow them to rank, prioritize and choose safer alternatives early in the innovation process. This may enable innovators to better anticipate on potential safety issues in an early stage, preventing these safety issues to become an innovation killer in a later stage of the innovation process. This approach to identify potential nanospecific human health risks should be considered as complementary to current regulations. The applicability of this approach was evaluated using a few industrial case studies. To determine if the approach is applicable to the innovation of a broader group of nanomaterials and nano-enabled products, more experience within various industrial sectors is needed.