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A regulatory perspective on the applicability of NAMs in genotoxicity and carcinogenicity assessment in EU: current practices and future directions

2025-11-21Artigo científico Acesso aberto
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dc.contributor.authorBossa, Cecilia
dc.contributor.authorAlivernini, Silvia
dc.contributor.authorAndreoli, Cristina
dc.contributor.authorAquilina, Gabriele
dc.contributor.authorAttias, Leonello
dc.contributor.authorBenfenati, Emilio
dc.contributor.authorDusinska, Maria
dc.contributor.authorEl Yamani, Naouale
dc.contributor.authorLouro, Henriqueta
dc.contributor.authorMarcon, Francesca
dc.contributor.authorRaitano, Giuseppa
dc.contributor.authorRundén-Pran, Elise
dc.contributor.authorRusso, Maria Teresa
dc.contributor.authorSilva, Maria João
dc.contributor.authorBattistelli, Chiara Laura
dc.date.accessioned2026-01-28T15:46:18Z
dc.date.available2026-01-28T15:46:18Z
dc.date.issued2025-11-21
dc.description.abstractNew Approach Methodologies (NAMs) are gaining significant momentum globally to reduce animal testing and enhance the efficiency and human relevance of chemical safety assessment. Even with substantial EU commitment from regulatory agencies and the academic community, the full regulatory adoption of NAMs remains a distant prospect. This challenge is further complicated by the fact that the academic world, oriented toward NAMs development, and regulatory agencies, focused on practical application, frequently operate in separate spheres. Addressing this disconnect, the present paper, developed within the European Partnership for the Assessment of Risks from Chemicals (PARC), provides a clear overview of both the available non-animal tests and current evaluation practices for genotoxic and carcinogenic hazard assessment, while simultaneously highlighting existing regulatory needs, gaps, and challenges toward greater human health protection and the replacement of animal testing through NAMs adoption. The analysis reveals a complex landscape: while the EU is deeply committed to developing and adopting NAMs, as outlined in its Chemical Strategy for Sustainability and supported by initiatives like PARC, prescriptive regulations such as Classification, Labelling and Packaging (CLP) and Registration, Evaluation, Authorisation and Restriction of Chemicals (REACH) still heavily mandate in vivo animal data for hazard classification, particularly for germ cell mutagenicity and carcinogenicity. This reliance creates a "too-short-blanket-problem," where efforts to reduce animal testing may impact human health protection because of the current in vivo-based classification criteria. In contrast, sectors such as cosmetics and certain European Food Safety Authority (EFSA)-regulated products demonstrate greater flexibility toward progressive integration of NAMs. While the deep mechanistic understanding of genotoxicity and carcinogenicity has significantly advanced the integration of alternatives to animal tests into regulatory chemical hazard assessment, their broader and full implementation faces considerable challenges due to both scientific complexities (i.e., the development and validation of fit-for-purpose NAMs) and existing legislative provisions.eng
dc.description.abstractHighlights: The evolving landscape of New Approach Methodologies for genotoxicity and carcinogenicity assessment -Current regulatory reliance on animal data and challenges for NAMs implementation. -Diversified regulatory acceptance and future integration of NAMs in various EU sectors. -Regulatory needs and challenges for the implementation of NAMs in genotoxicity and carcinogenicity hazard assessment.eng
dc.description.sponsorshipAuthors developed the work in the course of their employment at their respective organizations and under the scope of the Partnership for the Assessment of Risks from Chemicals (PARC) that has received funding from the European Union’s Horizon Europe Research and Innovation Programme under Grant Agreement No. 101057014. HL and MJS acknowledge the support from the Comprehensive Health Research Centre (CHRC), NOVA Medical School, Universidade NOVA de Lisboa, Lisbon, Portugal.
dc.identifier.citationEnviron Int. 2026 Jan:207:109948. doi: 10.1016/j.envint.2025.109948. Epub 2025 Nov 21
dc.identifier.doi10.1016/j.envint.2025.109948
dc.identifier.issn0160-4120
dc.identifier.pmid41349322
dc.identifier.urihttp://hdl.handle.net/10400.18/10777
dc.language.isoeng
dc.peerreviewedyes
dc.publisherElsevier
dc.relationPartnership for the Assessment of Risks from Chemicals
dc.relation.hasversionhttps://www.sciencedirect.com/science/article/pii/S0160412025006993?via%3Dihub
dc.relation.ispartofEnvironment International
dc.rights.urihttp://creativecommons.org/licenses/by-nc-nd/4.0/
dc.subjectNon Animal Methods
dc.subjectNew Approach Methodologies
dc.subjectChemical Regulation
dc.subjectCarcinogenicity
dc.subjectHazard Assessment
dc.subjectGenotoxicity
dc.subjectNew Approach Methodologies
dc.subjectRegulatory Science
dc.subjectGenotoxicidade Ambiental
dc.titleA regulatory perspective on the applicability of NAMs in genotoxicity and carcinogenicity assessment in EU: current practices and future directionseng
dc.typejournal article
dcterms.referenceshttps://ars.els-cdn.com/content/image/1-s2.0-S0160412025006993-mmc1.docx
dspace.entity.typePublication
oaire.awardTitlePartnership for the Assessment of Risks from Chemicals
oaire.awardURIhttp://hdl.handle.net/10400.18/10776
oaire.citation.startPage109948
oaire.citation.titleEnvironmental International
oaire.citation.volume207
oaire.fundingStreamHORIZON Programme Cofund Actions
oaire.versionhttp://purl.org/coar/version/c_970fb48d4fbd8a85
person.familyNameLouro
person.givenNameHenriqueta
person.identifier157627
person.identifier.ciencia-id721D-2BB1-7DB1
person.identifier.orcid0000-0001-9744-7332
person.identifier.scopus-author-id6507971479
relation.isAuthorOfPublication2361a951-8b9a-4b90-92d6-f6384003a242
relation.isAuthorOfPublication.latestForDiscovery2361a951-8b9a-4b90-92d6-f6384003a242
relation.isProjectOfPublication87519d63-05e5-4a7a-9a69-893088bf7517
relation.isProjectOfPublication.latestForDiscovery87519d63-05e5-4a7a-9a69-893088bf7517

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