Scientific publications

The ASPIS cluster, encompassing ONTOX, PrecisionTox, and RISK-HUNT3R, has published a pivotal paper named Animal-free Safety Assessment of Chemicals: Project Cluster for Implementation of Novel Strategies (ASPIS) definition of new approach methodologies in Environmental Toxicology and Chemistry outlining a comprehensive definition of New Approach Methodologies (NAMs). This effort is a major step toward standardizing animal-free testing strategies in regulatory toxicology, ultimately reducing reliance on animal models while ensuring robust chemical safety assessment.

One of the key contributions of this paper is the clarification of the definition of NAMs. The term has been interchangeably used to mean “new approach methodologies” and “nonanimal methods,” leading to confusion among scientists and regulators. ASPIS proposes an inclusive definition that recognizes NAMs as approaches providing mechanistic toxicological insights through alternative testing platforms such as in vitro, in silico, and computational models.

The paper also highlights the regulatory relevance of NAMs. For these methodologies to replace traditional animal testing, they must provide mechanistic insights into chemical toxicity, determine safe exposure thresholds, and support risk assessments. The authors emphasize how NAMs can contribute to next-generation risk assessment (NGRA) while aligning with international regulatory frameworks.

Another critical aspect explored in the paper is the distinction between predictive and protective applications of NAMs. Predictive NAMs are used to infer potential adverse effects by analyzing mechanistic data, while protective NAMs establish safe exposure limits through in vitro and in vivo extrapolation. By integrating these approaches, ASPIS demonstrates how NAMs can improve the accuracy of chemical risk assessment without relying on animal testing.

This publication is a major step forward in the global effort to transition toward animal-free safety assessment. It provides a clear roadmap for regulatory acceptance of NAMs, reinforcing ASPIS’s role in developing innovative, ethical, and scientifically robust alternatives for evaluating chemical toxicity. By addressing existing challenges and setting a standard for defining NAMs, this paper contributes significantly to shaping the future of nonanimal toxicology.