Implementation Plan for the proposed Qualification System for New Approach Methodologies (NAMs) in the food and feed sector with focus on nanomaterial risk assessment
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Le résumé fourni par la source
Abstract Many promising New Approach Methodologies (NAMs) emerged in the last decades but only some are taken up as OECD Test Guidelines (TGs). For regulatory decision‐making data from non‐guideline studies is primarily considered as mechanistic support rather than direct evidence. The nanotechnology sector is particularly promising for the implementation of NAMs in risk assessment. The EFSA Guidance on risk assessment of nanomaterials (NMs) in the food and feed sector recommends using NAMs in the first steps to generate new information (EFSA Scientific Committee, 2021a). Qualification is a novel approach to accelerate the regulatory implementation of suitable NAMs for a specific context of use. Our consortium was mandated by EFSA to propose a generic framework for a NAMs Qualification System to be applied in the food and feed sector and to provide a first example for its implementation in NM risk assessment. This report provides an implementation plan for the NAMs Qualification System proposed by the NAMs4NANO consortium (Haase et al., 2024). Our consortium broadly consolidated feedback obtained i) during a public consultation phase, ii) in dialogues with key stakeholders (e.g. OECD, ECHA, SCCS, EMA, ECVAM) and iii) during several workshops, meetings and conferences. In addition, the proposed readiness criteria for assessing the scientific validity of the methods were tested for selected NAMs internally (case studies within our consortium) and externally (case studies in other projects). Overall, the Qualification System and the readiness criteria were well received by key stakeholders. The collected feedback facilitated an analysis of potential critical issues which may hamper the implementation of a NAMs Qualification System in the food and feed sector. Practical testing allowed the first adaptations and amendments of the proposed readiness criteria.
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Le contrôle bibliographique ouvert
DOI retrouvé dans Crossref DOI retrouvé ; titre concordant.
- Titre Crossref
- Implementation Plan for the proposed Qualification System for New Approach Methodologies (NAMs) in the food and feed sector with focus on nanomaterial risk assessment
- Date Crossref
- 01/07/2026
- Éditeur
- Wiley
- Type
- journal-article
Ce recoupement confirme des métadonnées liées au DOI. Il ne confirme ni la méthode ni les conclusions de l’étude, et il ne compte pas comme une seconde source scientifique indépendante.
Où se fait cette recherche
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Federal Institute for Risk Assessment pays non établi dans la noticeOrganisme public
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Freie Universität Berlin pays non établi dans la noticeUniversité ou école supérieure
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University of the Western Cape University of the Western Cape, Afrique du Sud (code pays fourni par la source)Université ou école supérieure
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Joint Research Centre pays non établi dans la noticeOrganisme public
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Istituto Superiore di Sanità pays non établi dans la noticeOrganisme public
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Fraunhofer Institute for Toxicology and Experimental Medicine pays non établi dans la noticeStructure de recherche
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Agence Nationale de Sécurité Sanitaire de l’Alimentation pays non établi dans la noticeOrganisme public
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Sciensano (Belgium) pays non établi dans la noticeEntreprise
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National Institute for Public Health and the Environment pays non établi dans la noticeStructure de recherche
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Luxembourg Institute of Science and Technology pays non établi dans la noticeOrganisation à but non lucratif
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Singapore Food Agency pays non établi dans la noticeOrganisme public
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University of Amsterdam pays non établi dans la noticeUniversité ou école supérieure
Federal Institute for Risk Assessment, Freie Universität Berlin et University of the Western Cape (University of the Western Cape, Afrique du Sud), avec 9 autres affiliations. Pays d’affiliation : Afrique du Sud.
Une affiliation ne permet pas de déduire la nationalité d’un auteur.