Advanced materials earliest assessment (AMEA)†

Advanced materials are rapidly being developed in different material categories. They share little commonalities apart from their novelty, which raises concerns that these materials may fall into a regulatory gap with potentially inappropriate risk management. But how to assess materials that are still under development? Here we present the Advanced Materials Earliest Assessment (AMEA) approach to fill this gap by proposing simple assessment steps and guidance for design rules meant to be applied by innovators in early material development phases (ideation, business case and lab phases). AMEA provides a structured approach to exploit the available knowledge at each phase, starting from the intended product, application and global region, starting also from the conventional material in the same application, of which the sustainability benefits and sustainability challenges often constitute the motivation for advanced material development. During the lab phase, AMEA recommends focusing on acquisition of data with discriminating power, and triggers more requirements and/or specific testing methods depending on the positioning of the material with respect to the three dimensions “nano-enabled?”, “advanced?”, and “containing particles?” The methodological part can be amended for other material classes without relevance of nanostructures. Similarity and ranking approaches compare material versions synthesized in lab phases against each other and the conventional material in terms of performance, lifecycle emissions/exposures and hazards. AMEA prioritizes the discriminating power of specific data to refine the design targets instead of using generic assumptions with high uncertainties. It is the entry point of the HARMLESS decision support system covering the ensuing pilot and launch phases of innovation management to fulfill safe-and-sustainable-by-design material development.