PERSPECTIVE article
Front. Toxicol.
Sec. In Vitro Toxicology
Volume 7 - 2025 | doi: 10.3389/ftox.2025.1679506
This article is part of the Research TopicInnovative Non-Animal Approaches: Changing the Paradigm in Biomedical Research and Regulatory TestingView all articles
Refining the Safety Assessment of Newly Expressed Proteins in GMOs
Provisionally accepted
Elena Sanchez Brunete1Arianna Ferrari1
F. Javier Moreno2Tilemachos Goumperis1Michele Ardizzone1
REINHILDE Alfred Rachel SCHOONJANS1Ian Dewhurst3Ivan Dimitrov4
Michelle M. Epstein5
Frits Koning6Kevin Hogeveen7
Antonio Fernandez Dumont1*- 1European Food Safety Authority (EFSA), Parma, Italy
- 2Instituto de Investigacion en Ciencias de la Alimentacion, Madrid, Spain
- 3Health and Safety Executive Chemicals Regulation Division, York, United Kingdom
- 4Medicinski universitet-Sofia, Sofia, Bulgaria
- 5Medizinische Universitat Wien, Vienna, Austria
- 6Universiteit Leiden, Leiden, Netherlands
- 7Agence Nationale de Securite Sanitaire de l'Alimentation de l'Environnement et du Travail Laboratoire de Securite des Aliments, Maisons-Alfort, France
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The European Food Safety Authority (EFSA) carries out safety assessments of newly expressed proteins (NEPs) in genetically modified organisms (GMOs). Here, toxicity and allergenicity assessments are the cornerstone of NEP evaluation, ensuring that any potential health hazards are rigorously identified and characterised. Recent examples of EFSA's NEP safety assessments illustrate how novel methodologies, alongside established ones reconsidered from new perspectives, guide case-by-case decisions. These advances provide an opportunity to improve the robustness, proportionality, and scientific credibility of risk assessments. Moreover, it may alleviate the need for in vivo animal testing. Building on this development, EFSA aims to integrate new approach methodologies (NAMs) into risk assessment to provide a scientific basis for waiving in vivo testing, aligning its approach with the 3Rs principles (Replacement, Reduction, Refinement) and the European Commission's roadmap for phasing out animal testing. Overall, this shift reflects a broader transformation in EFSA's safety assessment of NEPs, characterised by openness to innovation, optimisation of existing methods, and ensuring preparedness for future risk assessment needs. The ultimate goal is to ensure the highest level of protection for human and animal health, while embracing scientific progress.
Keywords: Protein safety, newly expressed proteins, GMO, Risk Assessment, New approach methodologies, 3Rs
Received: 04 Aug 2025; Accepted: 29 Sep 2025.
Copyright: © 2025 Sanchez Brunete, Ferrari, Moreno, Goumperis, Ardizzone, SCHOONJANS, Dewhurst, Dimitrov, Epstein, Koning, Hogeveen and Fernandez Dumont. This is an open-access article distributed under the terms of the Creative Commons Attribution License (CC BY). The use, distribution or reproduction in other forums is permitted, provided the original author(s) or licensor are credited and that the original publication in this journal is cited, in accordance with accepted academic practice. No use, distribution or reproduction is permitted which does not comply with these terms.
* Correspondence: Antonio Fernandez Dumont, antonio.fernandezdumont@efsa.europa.eu
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