Use of New Approach Methodologies (NAMs) in regulatory decisions for chemical safety: Report from an EPAA Deep Dive Workshop

New Approach Methodologies (NAMs) are considered to include any in vitro, in silico or chemistry-based method, as well as the strategies to implement them, that may provide information that could inform chemical safety assessment. Current chemical legislation in the European Union is limited in its...

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Bibliographic Details
Published in:	Regulatory toxicology and pharmacology Vol. 135; p. 105261
Main Authors:	Westmoreland, Carl, Bender, Hans J., Doe, John E., Jacobs, Miriam N., Kass, George E.N., Madia, Federica, Mahony, Catherine, Manou, Irene, Maxwell, Gavin, Prieto, Pilar, Roggeband, Rob, Sobanski, Tomasz, Schütte, Katrin, Worth, Andrew P., Zvonar, Zvonimir, Cronin, Mark T.D.
Format:	Journal Article
Language:	English
Published:	Elsevier Inc 01-11-2022
Subjects:	Chemicals legislation Exposure Hazard In silico In vitro New approach methodology REACH Safety assessment REACH Safety assessment New approach methodology Chemicals legislation In silico Exposure In vitro Hazard
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Summary:	New Approach Methodologies (NAMs) are considered to include any in vitro, in silico or chemistry-based method, as well as the strategies to implement them, that may provide information that could inform chemical safety assessment. Current chemical legislation in the European Union is limited in its acceptance of the widespread use of NAMs. The European Partnership for Alternative Approaches to Animal Testing (EPAA) therefore convened a ‘Deep Dive Workshop’ to explore the use of NAMs in chemical safety assessment, the aim of which was to support regulatory decisions, whilst intending to protect human health. The workshop recognised that NAMs are currently used in many industrial sectors, with some considered as fit for regulatory purpose. Moreover, the workshop identified key discussion points that can be addressed to increase the use and regulatory acceptance of NAMs. These are based on the changes needed in frameworks for regulatory requirements and the essential needs in education, training and greater stakeholder engagement as well the gaps in the scientific basis of NAMs. •NAMs can provide human-relevant information for chemical safety assessment.•Numerous NAMs are fit for purpose and used by industry for chemical safety assessment.•NAMs have potential to inform regulatory decisions for chemical safety assessment.•Guidance is available for the use of NAMs for cosmetics, but less so elsewhere.•Opportunities to address scientific, regulatory and dissemination issues identified.
Bibliography:	ObjectType-Article-1 SourceType-Scholarly Journals-1 ObjectType-Feature-2 content type line 23
ISSN:	0273-2300 1096-0295
DOI:	10.1016/j.yrtph.2022.105261