The European regulatory landscape for chemical safety is undergoing a significant transformation with the rapid development of New Approach Methodologies (NAMs) and their progressive integration into regulatory frameworks. Two recent publications offer valuable insights into this transition. Worth et al. (2024) introduces Chemicals 2.0, a framework based on five design criteria for safety assessment and management, positioning NAMs as central tools driven by biological questions. On the other hand, Hoogstraaten et al. (2024) explores an innovation systems approach for integrating NAMs into chemical safety evaluations, emphasising structural and procedural changes needed to support their adoption. Together, these publications outline complementary paths forward, highlighting the importance of coordinated efforts across five acceptance pathways and advocating for case-by-case adaptation to achieve successful NAM integration into the existing framework.

Part I: Transition to Chemicals 2.0: Phasing Out Animal Testing in Toxicology

Worth et al. (2024) discussed a five-design criteria-based safety assessment and management framework known as Chemicals 2.0. In this framework (as presented below), biological questions drive testing, thereby making NAMs the primary tool for safety assessment by enhancing human and environmental protection but also aligning with broader sustainability goals.

1. Augmenting: Introduction of non-animal methods under current legislation to address concerns that might be overlooked or in certain cases where there are no available animal methods (e.g., use of TTC for low level exposure).
2. Complementing: At the next level, non-animal methods can be utilised as weight of evidence to enhance confidence in the results of existing animal tests.
3. Repurposing: At the third level, non-animal methods can be repurposed to meet information requirements for different endpoints (e.g., using non-animal tests adopted under a regulation to meet information requirement for another regulation).
4. Replacing: Substitution of animal studies when they are believed capable of fulfilling the same information requirements.
5. Rebuilding: Given the limited prospects for replacing animal testing under current legislation, it is crucial to begin redesigning the regulatory framework to accommodate non-animal methods.

Central to this proposed approach is a three-tiered testing strategy, which aims to show chemicals based on basic (green chemicals), common (higher-risk red chemicals) and specific information (priority substances). This tiered strategy offers flexibility, allowing regulators to apply appropriate levels of testing while optimising resources and enhancing the overall sustainability of the process.

The article finally discusses the adaptation of the current legal framework to enhance the classification system by relying on non-animal methods. Changes that are suggested include bringing in classification criteria that predict intermediate effects, reducing the number of non-overlapping classes to simplify the classification process, addressing concerns overlooked by the current animal-based system etc.

Part II: Animal-Free Safety Assessment of Chemicals: An Innovation System Perspective

In the innovation systems approach, Hoogstraaten et al. (2024) emphasised that the transition to non-animal testing requires more than just technical innovation. The acceptance and effective use of NAMs depend on changes across education, policy-making, and public engagement. Innovation systems that involve collaboration between researchers, regulators, industry, and society could play a key role in accelerating the uptake of NAMs. By focusing on knowledge diffusion, resource mobilisation, and legitimacy creation, innovation systems would help address the socio-cultural barriers that often hinder the acceptance of new methodologies. Educational programs, funding for NAM validation studies, and public trust in non-animal methods are all crucial to moving this transition forward.

Our view

At ToxMinds, we are committed to advancing NAM-based regulatory solutions, bridging the gap between traditional toxicology and innovative safety assessment practices. Our experience in applying NAMs for chemical safety aligns with the principles outlined in the above-discussed articles. The Chemicals 2.0 framework’s focus on NAMs rooted in biological relevance mirrors our approach to integrating mechanistic insights into safety assessments. Hoogstraaten et al. (2024)’s emphasis on a systems approach for NAM integration resonates with our dedication to facilitating practical and adaptable solutions that fit within existing regulatory frameworks.

Through case studies and our consulting services, ToxMinds has consistently demonstrated expertise in implementing NAMs across various sectors, helping our clients navigate regulatory hurdles and enhance their sustainability profiles. We support companies in meeting regulatory requirements with innovative, scientifically robust solutions, aiding the transition toward an ecosystem where safety and sustainability go together. For more information about our expertise and how we can assist you, please contact us at info@toxminds.com. Stay informed by signing up for our newsletter.