Mapping the Regulatory Application of NAMs in Pesticide Risk Assessment: Evidence from the PARC-PESTNAM Project
Teresa D’Amore1,2, Machera Kyriaki3, Anastasia Repouskou3, Katerina Kyriakopoulou3, Akrivi-Chara Mouzaki-Paxinou3, Sofia Pantaleoni4, Marina Marinovich4, Mattia Castagnaro3, Simone Mameli3, Angelo Moretto3, Emanuela Testai1, Emma Di Consiglio1
1Italian National Institute of Health−Istituto Superiore di Sanità, Rome, Italy
2Department of Pharmacy, University of Naples “Federico II”, Naples, Italy
3Scientific Directorate of Pesticides’ Control and Phytopharmacy (Laboratory of Pesticides Toxicology and Laboratory of Environmental Control of Pesticides), Benaki Phytopathological Institute, Athens, Greece
4Department of Pharmacological and Biomolecular Sciences, University of Milan, Milan, Italy
5Department of Cardiac, Thoracic and Vascular and Public Health Sciences, University of Padua, Padua, Italy
Background: The implementation of New Approach Methodologies (NAMs) in chemical risk assessment is a central goal of Next Generation Risk Assessment (NGRA). Within the European Partnership for the Assessment of Risks from Chemicals (PARC, Horizon Europe), the PESTNAM project (Task 6.3.2.a, WP6) investigates the application of NAMs and its regulatory impact on pesticide dossiers submitted under Regulation (EC) No. 1107/2009 [1]. Methods: A retrospective mapping analysis, following the PRISMA guideline, was performed on the EU pesticide databases and substance dossiers to identify NAM applications in human health and environmental risk assessment. NAMs were categorized by type (in vitro, in silico, in chemico, read across, literature data) and by final regulatory purpose (supporting data, data waiving, risk assessment refinement). Key regulatory and knowledge gaps, as well as strategies to improve regulatory implementation, were analyzed and discussed with stakeholders (EFSA and OECD) also to propose improvements in data requirements. Case studies were used to illustrate challenges and opportunities — focusing on in vitro comparative metabolism (IVCM) studies and endocrine disruption (ED) testing in non-target organisms (e.g., XETA). Results and Discussion: Data were extracted from official databases (EU COM pest database, Open EFSA) and the results were compared with the existing data requirements [2]. NAMs are increasingly cited in renewal dossiers but are inconsistently applied across endpoints. For human health, they mainly serve supportive or mechanistic purposes while for environmental assessments, ED-related assays such as XETA remain limited in impact. Disparities in IVCM study design and interpretation persist despite EFSA (2021) guidance [3], highlighting the need for harmonized protocols and dedicated OECD Test Guidelines. Conclusions: This work highlights the critical need for comprehensive regulatory implementation and active cross-stakeholder collaboration to ensure consistent evaluation practices and accelerate the development of harmonized guidelines. The outcomes of this project will directly support risk assessors, regulators, and applicants by promoting broader acceptance and practical implementation of NAMs within pesticide authorization processes.
Acknowledgements: This project is part of the European Partnership for the Assessment of Risks from Chemicals (PARC) [Project 101057014].
References:
1. EC. Regulation (EC) No 1107/2009 http://data.europa.eu/eli/reg/2009/1107/oj
2. EC. Commission Regulation (EU) No 283/2013 http://data.europa.eu/eli/reg/2013/283/oj
3. EFSA PPR Panel, 2021. Scientific Opinion of the PPR Panel on testing and interpretation of comparative in vitro metabolism studies. EFSA Journal 2021; 19(12):6970, 61 pp. https://doi.org/10.2903/j.efsa.2021.6970