- Guiding the creation of regulatory-relevant case studies across different product categories and regulatory frameworks.
- Addressing key regulatory challenges such as chemical data gaps, grouping decisions, diverse exposure scenarios, species selection, and hazard assessment models with the help of case studies.
- Fostering harmonisation efforts, advancing scientific collaboration, prioritising research needs, and supporting the integration of innovative methods into regulatory processes.
Key messages
The project applied an expert consultation in the form of a systematic literature review, qualitative interviews and a survey with risk assessors in Europe. The following are the key messages from the project.
- Improve familiarity and use of NAMs in regulatory risk assessment by showcasing success stories and offering the appropriate trainings that corresponds to the actors' needs.
- Utilise social science expertise for institutional change management to push forward systemic drivers of change, while empowering individuals to tackle smaller scale barriers.
- Improve dialogue among actors according to their individual strengths and core competencies (e.g., academia is seen as the major driver of the implementation of NAMs, whereas they might not be well equipped to mature NAMs from discovery to validation to actual use in regulatory decision making).
Overview
Innovative approaches to chemical risk assessment are vital for achieving the European Union's Chemicals Strategy for Sustainability ↗ and Green Deal ↗ goals. This project focuses on advancing New Approach Methodologies (NAMs ↗) – innovative tools for assessing chemical risks to human health and the environment – by addressing challenges such as complex chemical effects and knowledge gaps.
The project reviews how these methods are currently developed and used, consulting experts and analysing scientific literature to identify barriers like technical, legal, and cultural challenges. Despite scientific progress, integrating these tools into regulations has been slow due to limited alignment with regulatory needs. To address this, the project will establish criteria for accepting these methods, create guidelines for their use in daily workflows, and conduct case studies to demonstrate practical applications.
By collaborating with similar initiatives in Europe and the United States, the project will enhance knowledge sharing and ensure the methods are applicable across regions.
The outcome will promote the wider adoption of innovative risk assessment tools, supporting sustainability and regulatory harmonisation while protecting human health and ecosystems.
Achievements & Results
- Structured interviews with risk assessment experts were completed.
- Development and pilot testing of online questionnaires is ongoing.
This will enable to:
- Conduct a landscaping exercise to evaluate the integration and use of NAMs across sectorial frameworks, highlighting current implementation status and challenges.
- Identify gaps, needs, barriers, opportunities, and drivers for integrating NAMs into regulatory practices, outlining a roadmap for their application at desk level.
- Develop an action plan for prioritising regulatory-relevant scenario-based case studies, informed by international workshops, to demonstrate the practical utility of NAMs in diverse regulatory contexts.
Policy relevance
The project is sector- and legal framework agnostic and can inform overall policy efforts to reform the regulatory toxicology system towards a more effective integration of NAM innovations, such as the European Commission’s roadmap towards phasing out animal testing. Specifically, the project offers insights into European risk assessors' mindsets, beliefs and needs to inform training, educational and communication efforts to various actors in the regulatory toxicology system.
Related Publications
This article aims to investigate the perspectives of human health risk assessors on the status quo, barriers and drivers of the acceptance and use of New Approach Methodologies (NAMs) across different regulatory frameworks.
A mixed method design was applied: qualitative interviews (N = 19) and an online survey with human health risk assessors from industry, regulatory agencies/institutions and academia (N = 222).
The results show heterogeneity in familiarity and use of specific New Approach Methodologies (NAMs), the risk assessors’ background and the application contex.
The identified barriers and drivers offer pointers for the future integration and acceptance of New Approach Methodologies (NAMs) in regulatory risk assessment.
This article offers social science insights into the regulatory translation of New Approach Methodologies (NAMs) for increased acceptance and effective use of NAMs.
Three decades ago, several articles on the subjectivity in chemical risk judgments measured the divide between the public and toxicologists with different backgrounds regarding the validity of predicting health effects based on in vivo studies. Similar divides with impacts on societal discourse and chemical risk assessment practices might exist concerning alternative toxicity testing methods (i.e., in vitro and in silico).
To fill this knowledge gap, two online surveys were conducted, involving members of the German-speaking public in Switzerland and European human health risk assessors, respectively. This article presents the results of these two surveys regarding the divide in the public's and risk assessors’ perspectives on risk assessment based on in vivo, in vitro and in silico testing.
This study suggests that for risk assessors, in vivo testing—albeit not perfect—is generally still considered the gold standard, when compared to in vitro or in silico approaches.
The results further suggest that the public did not necessarily use the perceived complexity of the underlying model as a heuristic strategy to judge the validity of the test. Rather, the public expressed trust in in vitro testing, in some cases even more than in in vivo testing, for hazard identification and description of toxicity.
This study offers social science insights into the perspectives of risk assessors and the public on New Approach Methodologies (NAMs).
Three decades ago, several articles on the subjectivity in chemical risk judgments (i.e., labeled “intuitive toxicology”) measured the divide between the public and toxicologists with different backgrounds regarding the validity of predicting health effects based on in vivo studies. Similar divides with impacts on societal discourse and chemical risk assessment practices might exist concerning alternative toxicity testing methods (i.e., in vitro and in silico). However, studies to date have focused either on the public's views of in vivo or stem cell testing or on experts’ views of in vivo testing and potential alternatives (i.e., toxicologists and medical students), which do not allow for a direct investigation of potential divides. To fill this knowledge gap, we conducted two online surveys, involving members of the German-speaking public in Switzerland and European human health risk assessors, respectively. This article presents the results of these two surveys regarding the divide in the public's and risk assessors’ perspectives on risk assessment based on in vivo, in vitro, and in silico testing. Particularly, the survey with the risk assessors highlights that, beyond scientific and regulatory barriers, alternatives to in vivo testing may encounter individual hurdles, such as higher uncertainty associated with them. Understanding and addressing these hurdles will be crucial to facilitate the integration of new approach methodologies into chemical risk assessment practices as well as a successful transition toward next-generation risk assessment, bringing us closer to a fit-for-purpose and more efficient regulatory landscape.