Implementing New Approach Methodologies (NAMs) in food safety assessments: Strategic objectives and actions taken by the European Food Safety Authority

Cattaneo, Irene; Astuto, Maria Chiara; Binaglia, Marco; Devos, Yann; Dorne, Jean-Lou C.M.; Ana, Fernandez Agudo; Fernandez, Dumont Antonio; García-Vello, Pilar; Kass, George E.N.; Lanzoni, Anna; Liem, A.K.D.; Panzarea, Martina; Paraskevopulos, Konstantinos; Morte, Juan Manuel Parra; Tarazona, José V.; Terron, Andrea

doi:10.1016/j.tifs.2023.02.006

Cited by 28 publications

(18 citation statements)

References 65 publications

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“…Importantly, opportunities for using NAMs have been highlighted in recent European Food Safety Authority (EFSA) risk assessment guidelines. Moreover, EFSA's 2027 Strategy encourages a more regular reliance on NAMs in support of food safety assessments, recognizing the need for paradigm evolution and guidance from apical effects measured in animal studies to use NAM‐based results in food risk assessment (Cattaneo et al., 2023).…”

Section: Discussionmentioning

confidence: 99%

Human‐based new approach methodologies to accelerate advances in nutrition research

Cassotta,

Cianciosi,

Elexpuru‐Zabaleta

et al. 2024

Food Frontiers

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Much of nutrition research has been conventionally based on the use of simplistic in vitro systems or animal models, which have been extensively employed in an effort to better understand the relationships between diet and complex diseases as well as to evaluate food safety. Although these models have undeniably contributed to increase our mechanistic understanding of basic biological processes, they do not adequately model complex human physiopathological phenomena, creating concerns about the translatability to humans. During the last decade, extraordinary advancement in stem cell culturing, three‐dimensional cell cultures, sequencing technologies, and computer science has occurred, which has originated a wealth of novel human‐based and more physiologically relevant tools. These tools, also known as “new approach methodologies,” which comprise patient‐derived organoids, organs‐on‐chip, multi‐omics approach, along with computational models and analysis, represent innovative and exciting tools to forward nutrition research from a human‐biology‐oriented perspective. After considering some shortcomings of conventional in vitro and vivo approaches, here we describe the main novel available and emerging tools that are appropriate for designing a more human‐relevant nutrition research. Our aim is to encourage discussion on the opportunity to explore innovative paths in nutrition research and to promote a paradigm‐change toward a more human biology‐focused approach to better understand human nutritional pathophysiology, to evaluate novel food products, and to develop more effective targeted preventive or therapeutic strategies while helping in reducing the number and replacing animals employed in nutrition research.

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Section: Discussionmentioning

confidence: 99%

Human‐based new approach methodologies to accelerate advances in nutrition research

Cassotta,

Cianciosi,

Elexpuru‐Zabaleta

et al. 2024

Food Frontiers

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“…hazard identification, hazard characterisation, exposure assessment and risk characterisation. Based on these insights, general recommendations are formulated, which can be considered as horizontal recommendations as these may be applicable to all workflow steps (Wittwehr et al, 2020;Isaacs, Kristin, 2022;Jeong & Choi, 2022;Cattaneo et al, 2023).…”

Section: General Recommendations -Risk Assessment Perspectivementioning

confidence: 99%

Exploring the use of Artificial Intelligence (AI) for extracting and integrating data obtained through New Approach Methodologies (NAMs) for chemical risk assessment

Blümmel,

Rehn,

Mereu

et al. 2024

EFS3

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The future of risk assessment cannot neglect to consider the vast literature produced through the application of new approach methodologies (NAMs). This, however, constitutes a challenge for the risk assessor, as the availability of data in this context is huge and heterogeneous both for the methods applied and the standardisation and quality of the results. The integration of results generated from NAMs is hence only feasible under some degree of automation of the risk assessment workflow, specifically for searching, extracting and integrating such results in "AOPlike" knowledge networks (AOP -Adverse Outcome Pathway). Artificial intelligence (AI) with its state-of-the-art methods and tools is one of the most promising sources to support automation of manual tasks among modern technologies. The present paper illustrates the results of the exploration of possible applications of AI to achieve this goal. After the introduction of an evaluation framework to quantitatively assess these tools and methods, the results of the implementation of six selected case studies with the support of a selection of such tools in a dedicated workflow are presented. A qualitative survey of the state-of-the-art tools and methods, which also incorporates the experience gathered during the case study implementation, is then presented. Finally, recommendations are formulated which address the main aspects identified through the case study implementation that should, in the opinion of the www.efsa.europa.eu/publications EFSA Supporting publication 2024:EN-8567 2 authors, be pursued by EFSA in the context of its SPIDO NAMs and AI roadmaps. In summary, potentials for AI tool support could be identified throughout the workflow. Although many of the tasks can be supported by (semi-)automation, experience showed that subject matter experts need to be involved in all workflow steps.

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“…Commission Regulation (EU) No 283/2013 [2] and 284/2013 [3] set out the data requirements for active substances and plant protection products, respectively, include a large number of experimental studies of different areas (identity, physical and chemical properties, methods of analysis, efficacy, toxicology, residues, environmental fate and behavior and ecotoxicology). New approaches methodologies, such as quantitative structure-activity relationship (QSAR) and computational analytical methods are being considered by the European Food Safety Authority (EFSA) as an alternative to substitute vertebrate studies and other type of studies that nowadays are required, without prejudice the safety and the robustness of the risk assessment [4]. Provisions in Regulation (EC)…”

Section: Introductionmentioning

confidence: 99%

Reactivity of Alloxydim herbicide: Force and Reaction Electronic flux profiles

Villaverde

Sandín‐España

Alonso‐Prados

et al. 2023

Preprint

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The reaction force profile and the electronic reaction flux concepts were explored for the herbicide alloxydim and some of its derivatives at B3LYP/6-311G(d,p) level of theory. The exploration was achieved by rotating the oxime bond which is the most reactive region of the molecule. The main objective is to understand how the rotation of this bond influences the properties of the molecule and induces an electronic reorganization. The results show that the rotation of the dihedral angle triggers alloxydim to go through three transition states. The first step of the transformation begins by the rupture of the hydrogen bond and is characterized by a pronounced structural reorganization. In the last step of the process the electronic reorganization is more important.

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Implementing New Approach Methodologies (NAMs) in food safety assessments: Strategic objectives and actions taken by the European Food Safety Authority

Cited by 28 publications

References 65 publications

Human‐based new approach methodologies to accelerate advances in nutrition research

Human‐based new approach methodologies to accelerate advances in nutrition research

Exploring the use of Artificial Intelligence (AI) for extracting and integrating data obtained through New Approach Methodologies (NAMs) for chemical risk assessment

Reactivity of Alloxydim herbicide: Force and Reaction Electronic flux profiles

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