Paolo Bigini

Advanced nanomaterials (Ad-NMs), including micro- and nanoplastics (MNPs), are driving a new industrial revolution, with a global market projected to reach over 33 billion € by 2030. Despite this ongoing development, the actual sight of potential hazards could pose a barrier to innovation in key sectors. To move from perception to quantifying the impact of both Ad-NMs and MNPs, the Center of Preclinical Toxicology and Biochemistry has developed and validated a suite of reliable methods mainly focused on the bio-nano interaction across biological matrices at increasing levels of complexity. The philosophy is to apply and, if needed, integrate well-consolidated approaches developed over the last 60 years in the field of pharmaco-toxicology to the assessment of a broad range of industrial materials and environmentally dispersed end products, including MNPs. The main tools and skills, and a hypothetical workflow for the approach, are shown in Figure 1 (. A platform for assessing bio-nano interactions developed by the Center of Preclinical Toxicology and Biochemistry at the Istituto Mario Negri). In particular, within the POTENTIAL European project, we are developing a safety assessment platform to standardize an innovative, harmonized framework of experimental New Approach Methodologies that will be validated in in vivo studies. In addition, grouping and read-across approaches that meet regulatory risk-assessment requirements will be used to quantify risk thresholds. These methods will be integrated into a Methodological Framework for quantitative ranking of health and environmental hazards to support Safe-and-Sustainable-by-Design of Ad-NMs in line with the goals of the European Green Deal and the Chemical Strategy for Sustainability. The different in vitro and in vivo approaches used to assess the risk of selected MNPs and to serve as a reference for optimizing the platform will be described. We will also introduce paradigmatic examples of how the physicochemical properties of MNPs, such as the nature of the plastic material, size, and surface charge, can significantly impact interactions with the biological target and data interpretation. This extremely important concept further reinforces the need to carry out such risk assessments using quantitative criteria and complementary procedures and models. This work was supported by the European Union's Horizon Europe RESEARCH AND INNOVATION ACTIONS PROGRAMME, Project “Platform Optimisation to Enable Nanomaterial Safety Assessment for Rapid commercialization (POTENTIAL)”, Grant number 101092901. This study was conducted under the Italian Institute for Planetary Health (IIPH) framework. Reference Moscatiello, G.Y., Natale, C., Inserra, M., Morelli, A., Russo, L., Battajini, N., Sironi, L., Panzeri, D., Corbelli, A., De Luigi, A., Fiordaliso, F., Candiani, G., Bigini, P., Diomede, L. (2025) Environ Sci Nano 2025, DOI: 10.1039/d4en00962b.

Development and standardization of a platform to evaluate the biological interaction and safety of micro-nanoplastics

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