The Safe by Design (SbD) concept aims to ensure the production, use and disposal of materials and products safely. While there is a growing interest in the potential of SbD to support policy... Show moreThe Safe by Design (SbD) concept aims to ensure the production, use and disposal of materials and products safely. While there is a growing interest in the potential of SbD to support policy commitments, such as the EU Green Deal and the Circular Economy Action Plan in Europe, methodological approaches and practical guidelines on SbD are, however, largely missing. The combined use of Life Cycle Assessment (LCA) and Risk Assessment (RA) is considered suitable to operationalize SbD over the whole life-cycle of a product. Here, we explore the potential of the combined use of LCA and RA at Technological Readiness Level (TRL) 1–6. We perform a review of the literature presenting and/or developing approaches that combine LCA and RA at early stages of product design. We identify that basic early-on-evaluations of safety (e.g., apply lifecycle thinking to assess risk hotspots, avoid use of hazardous chemicals, minimize other environmental impacts from chemicals) are more common, while more complex assessments (e.g., ex-ante LCA, control banding, predictive (eco)toxicology) require specialized expertise. The application of these simplified approaches and guidelines aims to avoid some obvious sources of risks and impacts at early stages. Critical gaps need to be addressed for wider application of SbD, including more studies in the product design context, developing tools and databases containing collated information on risk, greater collaboration between RA/LCA researchers and companies, and policy discussion on the expansion from SbD to Safe and Sustainable by Design (SSbD). Show less
Similarity assessment is one of the means of optimally using scarcely available experimental data on the fate and hazards of nanoforms (NFs) for regulatory purposes. For a set of NFs that are shown... Show moreSimilarity assessment is one of the means of optimally using scarcely available experimental data on the fate and hazards of nanoforms (NFs) for regulatory purposes. For a set of NFs that are shown to be similar it is allowed in a regulatory context to apply the information available on any of the NFs within the group to the whole set of NFs. Obviously, a proper justification for such a similarity assessment is to be provided. Within the context of exemplifying such a justification, a case study was performed aimed at assessing the similarity of a set of spherical metallic NFs that different with regard to chemical composition (three metals) and particle size (three different sizes). The endpoints of assessment were root elongation and biomass increase of lettuce (Lactuca sativa L.) seedlings and exposure assessment was performed in order to express the actual exposure concentration in terms of time-weighted average particle concentrations. The results of the study show that for the specific endpoints assessed, chemical composition is driving NF toxicity and this is mostly due to impacts on the fate of the NFs. On the other hand, particle size of Cu NFs had a negligible impact on the dose-response relationships for the specific endpoints assessed. It is thus concluded that hazard data available on spherical Cu NF tested in our case can be used to inform on the hazards of any spherical Cu NF within the size range of 25–100 nm, but only applies for the certain endpoints. Also, toxicity data for the Cu2+-ion are suited for such a similarity assessment. Show less
