NAMs4NANO

Integration of New Approach Methodologies results in chemical risk assessments: Case studies addressing nanoscale considerations

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NAMs4NANO at a glance

Currently, assessing health risks of food and feed, chemicals, and consumer products, often still requires results from animal studies. However, scientists around the world continue to work in accordance with the 3R principle of replacing animal experiments (Replacement) and, where this is not yet possible, reducing the number of animals per test or number of tests required (Reduction) and reducing animal suffering in experiments (Refinement), as far as possible. New Approach Methodologies (NAMs) include a variety of novel approaches such as in silico, in chemico, in vitro and ex vivo methods, aiming to replace animal tests. In the past decades, many promising NAMs have been developed in various research projects though their regulatory implementation is lagging, as only some are included in OECD Test Guidelines (TGs).

Implementing NAMs is particularly relevant for the assessment of nanomaterials (NMs), which exist in numerous variants for a given substance, differing in certain physicochemical properties such as shape, size/size distribution, or surface chemistry. Assessing the safety of this virtually infinite number of variants efficiently and correctly urgently requires NAMs. Moreover, certain aspects of NM risk assessment can be much better realised with NAMs than with animal experiments, for example, studies on NM uptake in specific cell models. The EFSA Guidance on NM risk assessment (EFSA Scientific Committee, 2021) suggests that evaluation begins with NAM-derived data concerning degradation/dissolution (in relevant biofluids), intestinal uptake/crossing, genotoxicity, cytotoxicity, oxidative stress, (pro-)inflammatory potential and barrier integrity, many of which do not have OECD TGs. Consequently, NM risk assessments involve data from non-guideline studies, requiring more time-consuming and challenging case-by-case evaluations.

The overarching aim of the EFSA-funded NAMs4NANO project (GP/EFSA/MESE/2022/01), which is organised into three sub-projects (LOTs), is to gain a comprehensive understanding of the opportunities, challenges and remaining uncertainties when using NAMs in the risk assessment of NMs in the food and feed sector. Importantly, this also applies to conventional materials with a fraction of nanoparticles.

In LOT 1, a review of existing NAMs for application in human health risk assessment of nanomaterials (NMs) was conducted. In addition, an initial concept for a NAMs qualification system was proposed. The system aims to support faster regulatory implementation of NAMs and to guide NAM development for a specific context-of-use. The qualification system is based on an expert judgement following specific criteria on which information needs to be provided, and can improve regulatory readiness of NAMs for development of OECD TG and validation.

In LOT 2, selected/prioritised NAMs are applied to NMs that have proven application in the food and feed sector in order to gain insights on how far existing NAMs can already support nano-specific risk assessments, based on integrating NAM data with available information and knowledge (e.g., data from in vivo studies).

In LOT 3, individual NAM-based methodologies on cross-cutting case studies for NM risk assessment will be further developed. These do not cover a full risk assessment for a specific material, but rather aim to support methodological progress that can contribute to guidance documents on nano-specific risk assessment.

April 2023 – March 2027

Call topic: NAMs4NANO ‘Integration of New Approach Methodologies results in chemical risk assessments: Case studies addressing nanoscale considerations’ (GP/EFSA/MESE/2022/01)

Funding Agency: European Food Safety Authority (EFSA)

Relevant links:

Link to publications:

Review of NAMs for NM risk assessment in the food and feed sector (https://www.efsa.europa.eu/en/supporting/pub/en-8826)
Proposal for a NAMs Qualification System in the food and feed sector (https://www.efsa.europa.eu/en/supporting/pub/en-9008

Contact

Project Coordinators:
- LOT 1-2: PD Dr. Andrea Haase (andrea.haase@bfr.bund.de), BfR
- LOT 3: Dr. Francesco Cubadda (francesco.cubadda@iss.it), ISS
Project website: No website
Project contact e-mail: andrea.haase@bfr.bund.de, francesco.cubadda@iss.it; shirin.usmani@bfr.bund.de, MESE@efsa.europa.eu