EFSA has just released a “Review of New Approach Methodologies for Application in Risk Assessment of Nanoparticles in the Food and Feed Sector: Status and Challenges”
https://efsa.onlinelibrary.wiley.com/doi/epdf/10.2903/sp.efsa.2024.EN-8826
New Approach Methodologies (NAMs) include silico, in chemico, invitro and ex vivo methods and show great potential in advancing risk assessment. Based on this review, wide and varying applications can be found for NAMs, including the evaluation and definition of the physicochemical characteristics, the toxicokinetic and toxicodynamic properties, the general toxicity profile or the exposure assessment.
This review highlights various nano-relevant NAMs helpful to support risk assessment of NMs. EFSA proposes three general recommendations to further advance the regulatory application of NAMs. “First it is considered important to discuss selected NAMs that are deemed to be mature with regulatory and validation experts. Secondly, such NAMs need to be practically tested in nano-specific risk assessment case studies to better explore their potential along with remaining challenges and uncertainties. Thirdly, it is recommended to pay special attention to the development and the standardization of nano-relevant NAMs (e.g., at the level of the OECD WPMN) and provide unified consistent support from the regulatory agencies in the EU (i.e., EFSA, ECHA, EMA)”.
Based on this review, the development, updating and implementation of NAMs for the evaluation of NMs will be crucial as an evaluation tool applicable throughout the regulatory framework.