In January 2025, the first major deliverable from the Modernizing Hazardous Chemicals Project, titled “Accelerated Testing of More Substances – Towards Better Chemicals Regulation” was released. The project is a collaboration of several Helmholtz Centers and aims to engage with stakeholders from industry, non-governmental organizations (NGOs), science, and legislation to discuss new indicators for assessing chemicals within the context of environmental pollution and health effects.
The discourse for the Modernizing Hazardous Chemicals Project involved 55 organizations, including the Food Packaging Forum, across five workshops from November 2023 to March 2024. During these conversations, participants agreed that, given the continuous innovation of new substances and mixtures, there is a need for the increased use of New Approach Methodologies (NAMs) in assessing chemicals.
They highlighted two key challenges with current EU chemical assessment strategies: 1) animal testing is the gold standard but requires intensive resources and does not account for interspecies variations, and 2) the regulatory bodies themselves lack the financial and human resources to keep up with the innovation of new substances and mixtures in terms of approved testing methods and to promote NAMs.
Proposing new indicators for hazardous substances
Based on the identified challenges, a team of researchers from the Helmholtz Associations’ Research Fields “Earth and Environment” and “Health” proposed two new indicators for hazardous substances that can be assessed using high-throughput bioassays: cumulative toxicity equivalents (CTE) and persistent toxicity equivalents (PTE). These indicators do not require animal testing, integrate persistence and toxicity assessment, and can be applied to single substances, groups of substances, and mixtures. The Helmholtz Center for Environmental Research is now working with stakeholders from industry and authorities to improve the indicators through case studies.
The new indicators would also help address previous gaps identified by researchers. In 2023, over 20 scientists led by Food Packaging Forum director Jane Muncke highlighted a need for a new chemical assessment framework that considers mixtures of chemicals migrating from food contact articles, including non-intentionally added substances (NIAS), and their effects on growing health concerns (FPF reported).
Avoiding regrettable substitutions
All stakeholders consulted in the Modernizing Hazardous Chemicals Project also stated that regrettable chemical substitutions should be avoided. Using a grouping method can help prevent replacing chemicals with those likely to have the same health and environmental impacts. According to the researchers involved, their high-throughput assay can help group chemicals by answering questions about their toxicity through CTE and how that toxicity changes with environmental degradation through PTE.
A grouping approach in which structurally similar chemicals are categorized together was advocated for and used in the 2024 PlastChem report, which synthesized the evidence on more than 16,000 chemicals in plastic (FPF reported). The report also classified and prioritized chemicals of concern based on their persistence, bioaccumulation, mobility, and toxicity.
Recommendations for the European Commission
Based on the five workshops, the resulting policy brief from the Modernizing Hazardous Chemicals Project outlines eight recommendations for the European Commission. These include:
- Shifting the regulatory focus from animal testing to NAMs
- Supporting the development and validation of NAMs for regulatory purposes
- Fostering cooperation among stakeholders to increase the acceptance of NAMs
- Exploring approaches to promote chemical simplification
- Adopting the Grouping of Chemical Substances approaches to promote chemical simplification
- Integrating a Mixture Assessment Factor to better identify and quantify chemical ubiquity
- Developing clear criteria for identifying endocrine-disrupting processes
- Restricting the use of substances with a high weight of evidence regarding adverse health and environmental effects
The recommendations come as the European Commission issues “A Competitiveness Compass for the EU” on January 29, 2025, to guide the EU’s work over the next five years in regaining economic competitiveness. The document commits to revising the Registration, Evaluation, Authorization, and Restriction of Chemical (REACH) regulation, bringing simplification and ensuring faster decision-making on important hazards, sustainability, competitiveness, security, and safety. The REACH revision has already been delayed for several years and is expected by the end of 2025.
References
Helmholtz Centers (January 2025) “Accelerated Testing of More Substances – Towards Better Chemicals Regulation.”
Muncke, J. et al. (2023) “A vision for safer food contact materials: Public health concerns as drivers for improved testing.” Environment International. DOI: 10.1016/j.envint.2023.108161
Wagner, Martin, et al. (2024). “State of the science on plastic chemicals – Identifying and addressing chemicals and polymers of concern.” NTNU Open. DOI: 10.5281/zenodo.10701706
European Commission (January 29, 2025) “A Competitiveness Compass for the EU.”
