New approach methodologies (NAMs) to support regulatory assessment of developmental immunotoxicity – a new PARC project
The current testing strategy for the assessment of developmental immunotoxicity (DIT) in European chemicals regulations has well recognised limitations. In response to these limitations, the Partnership for the Assessment of Risks from Chemicals (PARC) initiated a 4-year DIT project in May 2025. This project comprises 14 partner institutions and will tackle two primary objectives: a) to enhance the DIT knowledgebase and refine the understanding of critical phases of immune system development, and b) to facilitate the transition towards the use of New Approach Methodologies (NAMs) in DIT risk assessment. The first objective will be approached by reviews of existing literature and the continued advancement of a physiological map of human immune system development. The reviews and the physiological map will in turn serve as foundational tools to support NAMs and Adverse Outcome Pathway (AOP) development. Addressing the second objective, the project has a short-term aim to promote a testing strategy that leverages current immunotoxicity assays and their modifications to inform regulatory decision processes such as screening, prioritisation and read-across analyses. In the longer term, novel NAMs, encompassing developmental processes, will be developed and assessed for their regulatory applicability. While the primary focus of this PARC project is on the enhancement of human DIT risk assessment, it also aims to contribute to the advancement of ecotoxicological evaluation of immunotoxicity.
Authors
- Selma Hurem (ORCID: https://orcid.org/0000-0001-5379-3305)
- Karsten Beekmann (ORCID: https://orcid.org/0000-0002-6673-8644)
- Rita Hargitai (ORCID: https://orcid.org/0000-0002-5803-2393)
- Birgitte Lindeman (ORCID: https://orcid.org/0000-0002-0792-7541)
- Luı́sa Romão (ORCID: https://orcid.org/0000-0002-5061-5287)
- Julia Tigges (ORCID: https://orcid.org/0000-0002-0847-9939)
- Archibold Mposhi (ORCID: https://orcid.org/0000-0002-9481-5045)
- Jonathan D. Turner (ORCID: https://orcid.org/0000-0002-2760-1071)
- Véronique M P de Bruijn (ORCID: https://orcid.org/0000-0003-0248-2309)
- Birol Usta
- Johanna M. Gostner (ORCID: https://orcid.org/0000-0003-1532-5177)
- Saadia Kerdine‐Römer (ORCID: https://orcid.org/0000-0003-3313-952X)
- Christiane Spruck
- Katalin Lumniczky (ORCID: https://orcid.org/0000-0001-8661-1854)
- Rafaela Lacerda (ORCID: https://orcid.org/0000-0002-5582-9823)
- Rob J. Vandebriel (ORCID: https://orcid.org/0000-0001-9140-952X)
- Anne Bado‐Nilles
- Martina Iulini (ORCID: https://orcid.org/0000-0002-0275-6704)
- Pablo Monfort‐Lanzas (ORCID: https://orcid.org/0000-0003-2589-3960)
- Nicola M. Smith (ORCID: https://orcid.org/0000-0002-5137-1384)
- Ioanna Katsiadaki (ORCID: https://orcid.org/0000-0001-8649-2795)
- Marion Sebire (ORCID: https://orcid.org/0000-0003-1646-9623)
- Aafke W. F. Janssen (ORCID: https://orcid.org/0000-0002-7610-9796)
- Emanuela Corsini (ORCID: https://orcid.org/0000-0002-6927-5956)
- Violeta Stojanovska (ORCID: https://orcid.org/0000-0002-5772-2843)
- Giorgia Del Favero (ORCID: https://orcid.org/0000-0001-8633-5458)
- Humblenoble Stembridge Ayuk (ORCID: https://orcid.org/0000-0001-9245-6811)
- Ana C. Zenclussen
- Irene Cano
- Rémy Beaudouin
- Etienne B. Blanc
Institutions
- University of Vienna (AT)
- Centre for Environment, Fisheries and Aquaculture Science (GB)
- Norwegian Institute of Public Health (NO)
- Helmholtz Centre for Environmental Research (DE)
- University of Lisbon (PT)
- Innsbruck Medical University (AT)
- Inserm (FR)
- Universität Innsbruck (AT)
- Université Paris Cité (FR)
- Université Paris-Saclay (FR)
- German Center for Pediatric and Adolescent Rheumatology (DE)
- Leibniz Institute of Environmental Medicine (DE)
- Luxembourg Institute of Health (LU)
- National Institute for Public Health and the Environment (NL)
- Ospedale San Paolo (IT)
- National Public Radio (US)
- Institut national de l'environnement industriel et des risques (FR)
- National Institute of Health Dr. Ricardo Jorge (PT)
- Frédéric Joliot-Curie National Research Institute for Radiobiology and Radiohygiene (HU)
- Institute of Bioinformatics (IN)
- Saxon Institute for Applied Biotechnology (DE)
- Norwegian University of Life Sciences (NO)
- Wageningen University & Research (NL)
Publication Details
- Journal
- Frontiers in Toxicology
- Published
- 2026-04-16
- DOI
- https://doi.org/10.3389/ftox.2026.1740390
- Primary Topic
- Immunotoxicology and immune responses
- Type
- article
- Field-Weighted Citation Impact
- 0.00
Funders
- European Commission
- Horizon 2020 Framework Programme
- HORIZON EUROPE Framework Programme
- Rijksinstituut voor Volksgezondheid en Milieu