Background

The integration of data from application of New Approach Methodologies (NAMs) in chemical risk assessment is considered a critical area for the successful application of Next Generation Risk Assessment (NGRA) and for facilitating the routine use of NAMs in risk assessments.

One specific area in which the European Food Safety Authority (EFSA) considers NAMs to be promising tools is the safety assessment of nanomaterials. This is a cross-cutting matter which covers several regulatory frameworks within EFSA’s remit (nutrients and nutrient sources, novel foods, food additives, feed additives, food contact materials, pesticides) and includes nanomaterials as well as conventional materials with a fraction of nanoparticles. In the first case (engineered nanomaterials and nanoforms), a material is engineered at the nanoscale for giving it specific properties. The EFSA Scientific Committee Guidance on risk assessment of nanomaterials (2021) suggests the development of NAM-based Integrated Approaches to Testing and Assessment (IATA) for covering the nano-specific considerations based on mechanistic understanding of processes at the nanoscale. IATAs have been proposed by the OECD (2020) as the best tool for integrating data from different sources in the risk assessment process. Based on the available information, existing knowledge on the mode of action, and expectations from the nanoscale design, it is possible to formulate hypotheses regarding the nano-specific toxicokinetic and toxicodynamic considerations and develop hypothesis-driven problem formulations. In the second case (conventional materials with a fraction at the nanoscale), the main problem is that the existing safety studies are in most cases not designed to address nano-specific considerations. The EFSA Scientific Committee Guidance on Technical Requirements to establish the presence of small particles (2021) suggests the use of NAMs for fulfilling the data gaps and complementing the available safety studies, avoiding the need for conducting new in vivo studies. In both cases, nanoscale specificities are integrated in the risk assessment process as nanoscale-based hypotheses. According to the EFSA roadmap for NAMs, the development of “Proof of Concept Case Studies” representing real examples of risk assessments, within EFSA remit, is the best way for addressing this and demonstrate how existing information can be combined with newly conducted NAM studies covering the nanoscale considerations. These Case Studies should implement the proposals for IATAs of the EFSA Nano Guidance documents published in 2021 providing examples and recommendations to applicants (food business operators) and interested parties on the use of NAMs for addressing nanoscale considerations in the risk assessment process, avoiding the need for additional animal studies.

This EFSA-funded effort is subdivided in three projects with a 4-year duration (4 April 2023 to 3 April 2027). LOT 1 and 2 are coordinated by the German federal Institute for risk assessment (BfR), LOT 3 is coordinated by the Italian national Institute of health (ISS). The NAMS4NANO consortium includes several EU partners, complemented by international (non-EU) research centres.