In June 2025, the European Chemicals Agency (ECHA) updated its strategic report "Key Areas of Regulatory Challenge," introducing new key topics under the "Competitiveness Guidance" and "Clean Industry Pact" frameworks. It stresses the urgent need to establish a new chemical regulatory system through targeted scientific research to protect public health and the environment, and to promote sustainable development of EU industries.
Updates
In this update, ECHA has added several new key areas in line with the continuous expansion of its functions, including content related to future work under the Drinking Water Directive (DWD) and the Water Framework Directive. ECHA has also incorporated key issues related to the circular economy, such as the quantification of the environmental impact of chemicals and the accounting of emissions during the waste phase. In addition, ECHA has refined existing research priorities, particularly enhancing research in areas such as endocrine-disrupting effects, persistent pollutants, and polymer characterization methods. Compared to the 2024 edition, the status information of related topics has been systematically updated.The research needs of ECHA focus on the following five core areas:
(1) Preventing the risks of hazardous chemicals
- Neurotoxicity: Under REACH, data on adult neurotoxicity and developmental neurotoxicity are embedded in several standard information requirements. The current regulatory structure faces many challenges in using NAMs as independent information for REACH, BPR, and CLP. For example, the standards for STOT SE and STOT RE in the CLP regulation are based on the effects on humans and/or experimental animals. To better understand and develop suitable testing methods, further research is needed on new AOPs, further development of existing AOPs, and the establishment of their connection with NAMs. In addition, reliable positive and negative reference chemicals need to be identified to validate NAMs, and further validation and improvement of the DNT IVB testing method are required.
- Immunotoxicity: There is currently no scientific consensus on determining the critical time windows for immune system development, which are the most sensitive to immune dysfunction caused by chemical interference. Due to scientific uncertainties, regulation still relies on in vivo developmental immunotoxicity studies to ensure coverage of all critical windows. Basic research is needed to better understand the scientific possibilities and the potential of NAMs in the regulatory applicability of immunotoxicity.
- Endocrine disruption: The assessment of endocrine disruptors relies on vertebrate testing to collect information on adverse effects and endocrine activity in order to identify endocrine-disrupting substances. To reduce vertebrate testing, efforts should be made to use NAMs (including in vitro, computational, and omics methods) to achieve information levels comparable to current tests. Under the CLP regulation, if NAM data can demonstrate predictive capabilities comparable to human or animal data, it may be used for endocrine disruptor classification.
(2) Addressing environmental chemical pollution
- Persistence: Assessing the persistence of chemicals is crucial for the environment and human health, and there is a need to develop high-throughput methods and in vitro tools.
- Bioaccumulation: Bioaccumulation data is essential for understanding the environmental behavior of chemicals, and there is a need to develop non-vertebrate and/or non-in vivo methods to predict bioaccumulation potential.
- Biodiversity protection: New methods need to be developed to more effectively protect a wide range of species in ecosystems.
- Non-bee pollinators: The sensitivity of non-bee pollinators to biocidal active substances needs to be assessed.
- Monitoring: New tools need to be developed to improve environmental monitoring, such as effect-based approaches.
(3) Promoting non-animal testing alternatives
- Analogical reasoning and new methodologies: Analogical reasoning is one of the main methods used in REACH registration to fill data gaps. NAMs (such as in vitro and computational tools) can support analogical reasoning by generating toxicokinetic and toxicodynamic data for candidate analog substances and defining the boundaries of similar substance categories. This helps strengthen and validate analogical reasoning assumptions. Currently, analogical reasoning is insufficient in supporting (experimental) evidence of adverse effects, and more data, particularly related to toxicological mechanisms and ADME properties, is needed.
- In vitro/computational ADME and physiologically based pharmacokinetic models: Animal-free chemical hazard assessment systems will rely on in vitro and computational methods. Therefore, PBPK models need to be developed for hazard assessment. The current in vitro metabolic activation standards need to be reviewed and updated as they only cover phase I oxidation metabolism, leading to some hazardous substances being incorrectly identified as negative. In addition, in vitro to in vivo extrapolation (IVIVE), which links in vitro concentrations to external doses associated with potential hazards, requires data to describe the ADME properties of chemicals in the body.
- Short-term fish toxicity: NAMs and in vitro tests have the potential to reduce testing on live vertebrates such as fish. Certain in vitro studies can be used to predict whether a substance may be toxic to fish. However, it is currently unclear to what extent gill cell line studies can be applied to accurately predict acute fish toxicity for all types of substances, including large, very poorly soluble, strongly adsorbing, or volatile substances. To enable wider use of these in vitro methods in a regulatory context, a thorough understanding of their limitations is needed.
- Long-term fish toxicity: Similarly, more specific research is needed to cover long-term effects on fish. Overall, the fish chronic toxicity data generated represents chronic hazards to vertebrates, but this approach may not be sufficient to protect all vertebrate species. AOPs, in vitro systems, and embryonic assay methods need to be developed for fish, amphibians, and birds to predict chronic toxicity in fish/vertebrates.
- Carcinogenicity: Currently, the strategy for identifying carcinogens under REACH relies on two-year rodent bioassays. To accelerate this process, the use of alternative and new methods to speed up the detection of carcinogens, including those acting through non-genotoxic mechanisms, has been proposed. This may involve testing several available robust NAMs for known human carcinogens to identify which NAMs are associated with human carcinogens and have high sensitivity.
(4) Enhancing the availability of chemical data
- Polymers: Historically, regulatory frameworks have considered polymers to have lower hazards than their monomers. However, recent studies indicate that high-molecular-weight polymers may possess bioavailability and toxicity, and their harmlessness cannot be assumed by default. Further research is needed to understand their bioavailability and to support future hazard and risk assessments. For example, standardized methods need to be developed to determine the chemical composition of polymers, including molecular weight distribution, oligomer content, and reactive functional groups. Additionally, research is needed on the degradation stability of polymers in the environment and their potentially released substances.
- Micro/nano materials: Nano materials present specific challenges due to their unique physical and chemical properties. Further development and adaptation of testing methods are needed to assess their hazards. For example, new OECD testing guidelines for nano materials need to be developed, along with the use of non-targeted screening to identify unknown pollutants. Furthermore, research is needed on how nano-specific characteristics affect their behavior in environmental and biological systems.
- Analytical methods: Ensuring the safe management of chemicals requires reliable analytical methods to assess their presence in different matrices. For example, fast and reliable testing methods need to be developed to quantify the migration of specific substances in materials in contact with drinking water, and to identify relevant chemicals at low concentration levels. Additionally, screening technologies need to be developed to assess compliance with EU regulations in a high-throughput manner.
(5) Promoting the circular economy through safe materials
- Releases at the waste stage: A better understanding of chemical emissions from materials, products, and items at the waste stage, as well as exposure to humans and the environment, is needed.
- Composition of non-fossil hydrocarbon sources and fuels: In-depth knowledge of the complex chemical composition of these fuels and hydrocarbon sources, as well as emerging pollutants, is required.
- Valuation of chemical-related environmental impacts: Economic valuation studies need to be conducted to provide evidence for chemical regulation.
The over 20 research topics proposed this time have been submitted to the European Union's research and innovation body (Horizon Europe) for priority project evaluation.
Further Information
