The Road to Achieving the European Commission's Chemicals Strategy for Nanomaterial Sustainability—A PATROLS Perspective on New Approach Methodologies

Abstract

The European Green Deal outlines ambitions to build a more sustainable, climate neutral, and circular economy by 2050. To achieve this, the European Commission has published the Chemicals Strategy for Sustainability: Towards a Toxic‐Free Environment, which provides targets for innovation to better protect human and environmental health, including challenges posed by hazardous chemicals and animal testing. The European project PATROLS (Physiologically Anchored Tools for Realistic nanOmateriaL hazard aSsessment) has addressed multiple aspects of the Chemicals Strategy for Sustainability by establishing a battery of new approach methodologies, including physiologically anchored human and environmental hazard assessment tools to evaluate the safety of engineered nanomaterials. PATROLS has delivered and improved innovative tools to support regulatory decision‐making processes. These tools also support the need for reducing regulated vertebrate animal testing; when used at an early stage of the innovation pipeline, the PATROLS tools facilitate the safe and sustainable development of new nano‐enabled products before they reach the market.

A systematic quality evaluation and review of nanomaterial genotoxicity studies: a regulatory perspective

“…At the moment it is not possible to evaluate all aspects of the study design as there is no clear consensus on the approaches that should be considered the most relevant. It can be considered important to be able to show the genotoxic potential of a NM regardless of how representative the test system or study design is, but on the other hand, more complex, representative, and realistic models are needed to increase the predictiveness and reduce the uncertainty, particularly related to non-animal models [ 98 ]. However, for regulatory purposes, the methods need to be reproducible and validated.…”

The State of the Art and Challenges of In Vitro Methods for Human Hazard Assessment of Nanomaterials in the Context of Safe-by-Design

“…SbD hazard assessment should first and foremost be based on material knowledge and material–activity relationships. Before even starting in vitro experiments, an elaborate evaluation of available physicochemical data should be performed [ 220 ]. Here, certain hazard warnings could already be noticed.…”

“…Establishing meaningful thresholds for these assays is important. Moreover, since pulmonary inflammation is mostly a chronic adverse effect, more work should be focusing on predicting chronic effects with in vitro assays, with which a promising start has been made in the PATROLS project [ 220 ].…”

Nanosafety: An Evolving Concept to Bring the Safest Possible Nanomaterials to Society and Environment

“…An amazing effort was completed in a European Union (EU) project that was fully dedicated to the development of reliable and robust physiologically anchored tools for nanomaterial hazard assessment (PATROLS). The developed advanced models included the lung (coculture comprising immune cells, interstitial cells, or barrier cell types using permeable transwell membrane inserts), intestine (cell triple coculture differentiated epithelial and immunocompetent macrophage-like cell line), and liver (hepatocyte-based microtissue and a HepG2 human hepatocyte spheroid) that were specially fabricated to allow cytotoxicity, genotoxicity, and inflammatory responses to nanomaterials in more realistic exposure scenarios [ 161 ].…”