Key messages

• The current regulatory uptake of New Approach Methodologies (NAMs ↗) and NAM-based approaches for hazard and risk assessment of chemical substances is limited.
• By conducting case studies addressing specific problem formulations for certain health effects and regulatory contexts we aim to highlight both opportunities and challenges related to the regulatory implementation of NAMs.
• The project will provide new insights into which regulatory areas and for which endpoints further implementation of NAMs is feasible and what refinements are needed.

Overview

The project test and evaluate how NAMs can be used in regulatory hazard and risk assessments of chemical substances. The work will explore the integration of NAMs across different regulatory frameworks, focusing on key aspects such as biological coverage, predictability, chemical applicability domain, data gaps, and uncertainty.

Case studies targeting specific health effects and regulatory contexts will highlight both opportunities and challenges in transitioning from animal-based testing to NAM-based decision-making.

Importantly, they aim to build confidence in using NAMs as standalone evidence, tailored to the needs and problem formulations of each regulatory scenario.

The project will work closely with other PARC initiatives and relevant external efforts to ensure scientific robustness and practical relevance. Outcomes will directly contribute to PARC’s identified needs, particularly the replacement of animal testing and the development of in vitro/in silico methods for chronic toxicity, and may also support work on developmental and reproductive toxicity (DART), carcinogenicity, and case studies for NAMs and read-across. The findings will support the regulatory acceptance of NAMs and promote their use for priority health endpoints, including neurotoxicity, endocrine disruption, and carcinogenicity.

Achievements & Results

• Demonstrating where and how NAM-based approaches can be used through real-life case studies, either supporting current approaches or as stand-alone.
• Defining key criteria for the implementation of NAMs for regulatory purposes.
• Building confidence in the integration of NAM-based approaches for regulatory decision-making.
• Providing concrete input on possible needs for changing data requirements and/or evaluation processes in regulations applicable to chemical safety assessment.

Policy relevance

Results from the project will directly contribute to the regulatory uptake of NAM-based approaches, in general as well as specifically for the legislations and health effects addressed in the case studies. This will be achieved, among others, through a continuous dialogue with relevant European bodies, like ECHA ↗, EFSA ↗ and JRC ↗, on the opportunities and challenges related to the implementation of NAMs. The outcomes of the case studies will lead to the identification of promising NAMs or NAM-based approaches to be considered within the OECD Test Guideline Program. In addition, it will reveal needs for change in legislations for chemical safety assessments.