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Implementing NAMs in food safety assessments: Strategic objectives and actions taken by EFSA

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Cattaneo, I., Astuto, M.C., Binaglia, M., Devos, Y., Dorne, J.-L.C.M., Ana, F.A., Fernandez, D.A., Garcia-Vello, P., Kass, G.E.N., Lanzoni, A., Liem, A.K.D., Panzarea, M., Paraskevopulos, K., Parra Morte, J.M., Tarazona, J.V., Terron, A., Implementing New Approach Methodologies (NAMs) in food safety assessments: Strategic objectives and actions taken by the European Food Safety Authority, Trends in Food Science & Technology (2023)
doi: https:// doi.org/10.1016/j.tifs.2023.02.006.
This review provides an overview of the current EU regulatory requirements for food and feed safety and explores how NAMs can be included to meet (at least in part) such requirements. 

In silico methods such as (Q)SAR and read-across are included in this review together with the main references. 

Successful uses of QSAR for EFSA’s purposes include the prediction of genotoxicity from direct-acting mutagens, as well as for certain minor metabolites of plant protection products.
https://doi.org/10.2903/sp.efsa.2019.EN-1598
https://doi.org/10.2903/j.efsa.2016.4549

The grouping of chemicals into chemically related groups and the application of read across have been central to the approaches used for flavourings and used on an ad-hoc basis for food contact  materials and some data-poor impurities.

Read-across has also been proposed in the risk assessment of plant protection products’ metabolites and for the assessment of the combined exposure to multiple chemicals, especially when dealing with (sufficiently) similar mixtures and to support the grouping of chemicals into assessment groups.
doi: 10.2903/j.efsa.2021.7033 
doi: 10.2903/j.efsa.2019.5634

More recently, EFSA has initiated the development of a guidance on the use of the read-across approach in food safety assessment. The aim of this work is to develop a pragmatic guidance providing a harmonised approach for the use of read-across in the different sectors pertinent to EFSA’s remit, but also to assess the impact of NAM data to decrease the uncertainty associated with chemical-only based read-across. Completion is expected by 2024. 

Abstract

Background: New Approach Methodologies (NAMs) comprise in silico and in vitro methods applied as alternative to animal testing. Even though NAMs are already fully implemented as research tools, their use in regulatory risk assessments (RA) is limited currently. To promote the regulatory uptake/acceptance of NAMs, a paradigm shift in risk assessment approaches, and a proper dialogue between risk assessors and risk managers is needed.

Scope and Approach: Several reviews addressed the use of NAMs for chemical RA in generic terms, but without providing specific considerations on their use for food/feed safety assessments. Therefore, in this review, we give insights on the potential use of NAMs for regulatory purposes in the EU. We summarise relevant projects and activities on NAMs coordinated by the European Food Safety Authority (EFSA), which is the agency of the European Union that contributes to the safety of the European food and feed chain. The review informs on future developments on the use of NAMs in human health chemical RA, and touches on their use for the assessment of protein toxicity and allergenicity, as well as environmental risks.

Main findings and conclusions: Reducing animal testing and filling some RA gaps via NAMs is almost a reality. Moreover, there is a growing body of evidence confirming that the inclusion of mechanistic information improves risk assessments. EFSA’s projects address the main challenge of using intermediate effects observed in non animal models for safety assessments, especially those linked to adverse effects that are insufficiently covered or uncovered by animal apical endpoints.
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