Implementation Plan for the proposed Qualification System for New Approach Methodologies (NAMs) in the food and feed sector with focus on nanomaterial risk assessment

Abstract Many promising New Approach Methodologies (NAMs) emerged in the last decades but only some are taken up as OECD Test Guidelines (TGs). For regulatory decision‐making data from non‐guideline studies is primarily considered as mechanistic support rather than direct evidence. The nanotechnology sector is particularly promising for the implementation of NAMs in risk assessment. The EFSA Guidance on risk assessment of nanomaterials (NMs) in the food and feed sector recommends using NAMs in the first steps to generate new information (EFSA Scientific Committee, 2021a). Qualification is a novel approach to accelerate the regulatory implementation of suitable NAMs for a specific context of use. Our consortium was mandated by EFSA to propose a generic framework for a NAMs Qualification System to be applied in the food and feed sector and to provide a first example for its implementation in NM risk assessment. This report provides an implementation plan for the NAMs Qualification System proposed by the NAMs4NANO consortium (Haase et al., 2024). Our consortium broadly consolidated feedback obtained i) during a public consultation phase, ii) in dialogues with key stakeholders (e.g. OECD, ECHA, SCCS, EMA, ECVAM) and iii) during several workshops, meetings and conferences. In addition, the proposed readiness criteria for assessing the scientific validity of the methods were tested for selected NAMs internally (case studies within our consortium) and externally (case studies in other projects). Overall, the Qualification System and the readiness criteria were well received by key stakeholders. The collected feedback facilitated an analysis of potential critical issues which may hamper the implementation of a NAMs Qualification System in the food and feed sector. Practical testing allowed the first adaptations and amendments of the proposed readiness criteria.