Key messages

• The project focuses on improving food safety by detecting hazardous chemicals, including unknown and emerging contaminants, in food products.
• Traditional testing methods only target known compounds, but this project uses high-resolution mass spectrometry to identify a broader range of potential food contaminants.
• The project explores how advanced screening methods can be incorporated into food monitoring and control plans to detect complex contaminant mixtures.

Overview

Traditional food safety monitoring mainly relies on targeted analytical methods that focus on specific, known chemicals. However, the growing variety and quantity of both known and unknown chemicals in the market necessitate more comprehensive detection strategies.  

Currently, the presence of hazardous chemicals in food is monitored using targeted methods that focus on a limited number of compounds. Although laboratories are continuously expanding the list of chemicals they monitor, this strategy is inadequate for addressing hundreds of thousands of known and unknown chemicals that continuously enter the market or are produced as by-products. Advances in analytical technology, such as high-resolution mass spectrometry, allow for the identification of potentially hazardous contaminant in food samples using screening methods like suspect screening. Suspect screening is an approach that screens for chemicals suspected to be present in a sample, even if they are not confirmed.  

This project aims to develop innovative tools for analysing food samples, adapt them to fit regulatory needs, and promote consistency in food monitoring practices. 

It will compare various analytical strategies and workflows—from sample preparation to data processing—to identify their strengths and overlaps in detecting traces of known, emerging, and unknown chemicals in food. Additionally, the project will conduct a proof-of-concept study to assess the relevance of such developed screening methods as part of monitoring and control plans. This will help identify original contaminant mixtures from real-world data and contribute to the early warning system for emerging chemical concerns, ultimately benefiting food policy makers.  

Achievements & Results

The interlaboratory exercise was designed through a collaborative process involving all project partners. An online survey and detailed questionnaire collected information on partners’ analytical capabilities, preferred food matrices, and in-house protocols for sample preparation and analysis. This input was used to finalise the experimental design during an online meeting held in February 2024, with further refinements based on feedback from the partners and discussions with work package leaders.

The finalised experimental design included the analysis of two food matrices—baby food and honey—fortified with 30 substances, comprising 10 known and 20 unknown compounds. Samples were prepared at three concentration levels (blank, low, and high) and distributed to partners for analysis using their preferred methods involving liquid or gas chromatography coupled with High-Resolution Mass Spectrometry ↗. A total of 54 samples per partner were provided for triplicate extraction and analysis.

In November 2024, all samples were sent to all project partners, officially launching the interlaboratory comparison.

Policy relevance

This project will evaluate laboratories' capabilities to perform analyses with new instruments and methods, harmonize results and approaches, and assess their suitability for regulatory applications.

Key messages

• The project will provide valuable EU-specific data on chemical exposures and risks faced by workers in e-waste and plastics waste streams.
• It will generate evidence to support policies aimed at worker protection, public health, chemical safety, and environmental sustainability.
• By fostering training and knowledge exchange, the project will strengthen collaboration and enhance the capabilities of EU laboratories and research centres.

Overview

In 2020, the European Commission adopted a new Circular Economy Action Plan ↗, acting as one of the main building blocks of the implementation of the European Green Deal ↗, Europe's agenda for sustainable growth. Taking the entire life cycle of products into account, this action plan targets how products are designed, consumed and dealt with in the waste stream. With an adoption, the EU aims to make its economy fit for a green future, strengthen competitiveness while protecting the environment and provide new rights to consumers. The waste management sector is expected to play an important role in this development.  

This project focuses on two key waste streams, electronic waste ↗ and plastics ↗ coming from both private households and the industry. Through collaborative discussions among relevant stakeholders, mainly companies, associations, and workers representatives within the waste management sector, this project will identify significant waste streams that are becoming more relevant due to the expected increase in recycling and therefore also to the labour force needed in this sector.  

• This cross-sectional study, which involves 18 partners, aims to:
• Provide data on waste management workers’ exposure to various substances, through both environmental and biological monitoring.
• Assess the effectiveness of existing European regulations in minimising the presence of harmful substance within the circular economy ↗, thereby reducing exposure for workers and the general population.
• Translate the findings from occupational studies into a framework that outlines implications for general population exposure.

Results of this study will carry valuable information across various regulatory frameworks like the multi-annual strategies on Occupational Safety and Health (OSH ↗) and the EU regulation evolving around the production and use of chemical substances, such as the Registration, Evaluation, Authorization, and Restriction of Chemicals (REACH ↗). Additionally, regulations related to waste management, water and soil protection as well as standards for food and consumer products, will also benefit from this study’s findings.

Achievements & Results

In the first year of the project, foundational steps were completed, including finalising the list of chemicals and exposure biomarkers, defining study protocols and detailed standard operating procedures, and identifying participating companies. The protocols made in the scope of the human biomonitoring project HBM4EU ↗ were adapted to include new biomarkers.  

In the second year, study protocols were submitted to ethical committees, a data management plan was developed, and online training was conducted to support partners in implementing procedures. Biomonitoring and environmental monitoring campaigns began, with institutions from across Europe participating.  

By the third year, sampling campaigns began in many EU member countries after receiving ethical approvals. Key achievements include defining biomarkers for each waste stream, adapting protocols to include new biomarkers and matrices, and creating training materials for field teams. Many partners have started sampling activities, advancing the assessment of chemical exposures in waste management sectors.

Policy relevance

The project will provide exposure data to support regulatory processes under OSH ↗ standards as well as under the REACH ↗, addressing the production and use of chemical substances, and their potential impacts on both human health and the environment.

Key messages

• Closing critical data gaps on BPA alternatives for hazard assessment across five key toxicological endpoints.
• Providing regulatory agencies with data to support safer substitutions and regulatory decisions.
• Utilising advanced methods and multi-institution collaboration to ensure reliable results.

Overview

Bisphenol A (BPA) ↗ is a chemical which is mainly used in the production of various plastics for the manufacturing of consumer goods. It is a widely used and studied chemical that has been proven to be harmful to human health. Thus, over the course of the decade, there has been an increase of restrictions on the use of BPA, which in turn led to an introduction of several chemical substitutes ↗.  

Since their introduction, chemical substitutes to BPA have already been found in humans and the environment, raising concerns about their safety of use. For most BPA alternatives, information on potential effects on human and environmental health is either missing or too limited, restricting a sound hazard assessment or characterisation.  

With further restrictions on BPA in the coming years, the use of BPA alternatives is projected to significantly increase, giving the scientific assessment of these substances great significance.

The project will fill knowledge gaps on the effects of eight prioritised BPA substitutions on human health following five toxicological endpoints:

1. Endocrine disruptors, also referred to as hormonally active agents;
2. Developmental neurotoxicity, meaning toxic substances influencing the development of nervous systems;
3. Immunotoxicity, regarding toxic agents effecting the immune system;
4. Non-genotoxic carcinogenicity, as tumour inducing substances; and
5. Metabolism, meaning chemical reactions in the human body.

Another contribution of this project will be the identification of molecular biomarkers in order to develop a method to rapidly predict potential effects of BPA alternatives on human health. Identifying these biomarkers will help determine the mechanism(s) through which BPA alternatives act, revealing their adverse health effects. 

Achievements & Results

A collaborative workshop with key stakeholders, including the European Chemicals Agency (ECHA ↗) and the European Food Safety Authority (EFSA ↗), successfully prioritized eight alternatives to bisphenol A (BPA) for detailed toxicological assessment. A list of the prioritised alternatives and the methods used for prioritisation are documented in an additional deliverable on the hazard assessment activities. Early toxicological evaluations of these BPA alternatives suggest that some may have potential adverse effects, highlighting the importance of thorough assessments to prevent regrettable substitutions. The project has also fostered stronger partnerships among the 13 project participating institutions across Europe, promoting interdisciplinary collaboration and addressing critical data gaps in chemical safety research.

Policy relevance

Filling data gaps for the hazard assessment for BPA alternatives, that will be useful in avoiding adverse effects of substitutions.

Key messages

• Assessing chemical exposure at early stage of life is still a challenge.
• Today, new tools are available that enhance chemical exposure assessment.
• Efforts are ongoing to refine and clarify the applicability and effectiveness of these approaches.
• Their value in chemical prioritisation and contribution to early warning systems has been well established. 

Overview

To accurately reflect the complex reality of human exposure to chemicals, new conceptual frameworks and innovative methodological approaches are essential, encompassing every step from sample collection to the generation and analysis of exposure data. While promising new approaches are available, they require further development and rigorous performance evaluation before they can be widely implemented in large-scale human cohort studies.

Agencies such as the European Food Safety Authority (EFSA ↗) and the European Chemicals Agency (ECHA ↗) have highlighted the critical importance of early-life human exposure, particularly in the context of risk assessment and its implications for long-term health, as described by the Developmental Origins of Health and Disease (DOHaD ↗) concept. 

New sampling techniques, such as silicone wristbands and dried blood spots, offer non-invasive solutions for collecting samples from vulnerable populations like infants and children, where minimising invasiveness and sample size is paramount.

In parallel, suspect and non-targeted screening (SS/NTS ↗) approaches, leveraging high-resolution mass spectrometry and effect-directed analysis (EDA ↗), are gaining traction in analytical laboratories. These methods are designed to detect a broad spectrum of chemicals without prior knowledge of specific substances, enabling the identification of unexpected or previously unknown exposures.

This project aims to develop and validate a proof-of-concept to evaluate the performance and potential of these innovative methods as complementary tools to traditional, targeted approaches. The focus is on analysing human samples collected from mother-child pairs. These screening methods are designed to simultaneously detect diverse substances from multiple chemical classes, including both persistent and non-persistent organic pollutants of emerging concern. 

Achievements & Results

In Year 1, the project achieved key milestones, including finalising the global roadmap, developing a detailed work plan across three experimental pillars, identifying initial sample sets, arranging material transfer agreements and sample shipments, and sharing existing standard operating procedures for analytical methods.

By Year 2, partner roles were consolidated, and initial sample analyses (pillar 1) and interlaboratory assays for screening techniques (pillar 2) began, with both on track. Additionally, a working group on innovative sampling methods was established, conducting a literature review to identify existing knowledge and gaps. 

In Year 3, data analysis for the first round of sample characterisation and interlab assay results is underway, alongside progress in method harmonisation and experimental testing of clean-up procedures to refine standard operating procedures for sampling tools like silicone wristbands. 

Policy relevance

• Elaboration of templates for harmonised reporting of SS/NTS data and interlab assay.
• Contribution to the elaboration of a common QA/QC chemical mixture for harmonised method performance assessment to be possibly further handled by JRC as reference.
• Contribution to documenting real-life chemical exposure in perinatal period as a basis for further prioritisation of action. 

Key messages

• Human biomonitoring (HBM) data are being used to calculate the health impact of chemical exposure.
• Risk indicators as percentage of exceedance, extent of exceedance gives information if and how much human biomonitoring guidance values are breached or not.
• Indicators on burden of disease as attributable cases or disability adjusted life years (DALYs) provide information on the health impact.
• Indicators inform policymakers and can help to prioritise action with the primary goal to lower the impact of chemicals on our health.

Overview

Markers that reflect the health impact of chemical exposure are essential tools for national and European policy makers, helping to shape and support monitoring frameworks such as the Chemical Strategy for Sustainability ↗, the Zero Pollution Action Plan ↗, and the 8th Environment Action Programme ↗.

The choice of a health impact indicator depends on several factors, including the specific policy questions it aims to address, the availability and quality of data, the uncertainties associated with each indicator, and the resources and expertise required.

Indicators used to assess the harmful effects of chemicals include the number of attributable cases, the measurement of DALY or Quality-Adjusted Life Years, and the calculation of external costs. DALY represent the total years of healthy life lost due to illness, disability, or premature death. In situations where data are insufficient for a full health impact analysis, the exceedance of health-based guidance values already serves as a risk indicator. This approach estimates the portion of the population exposed to chemical levels above these guidance values, signalling a potential health risk.

This project is one of four interconnected initiatives focussed on assessing the health impacts of chemical exposure and works closely with related projects on data collection, methodological improvements, and case studies. Currently the focus in on the case studies from which indicators on health risk or impact can be developed to inform policymakers.

Achievements & Results

In this project,  an  inventory  of  existing  types  of  exposure, risk  and  health  impact indicators was compiled, including their application in regulatory and policy frameworks, based on expertise available among partners, literature search, communication materials of (inter)national organisations, and stakeholder input (JRC ↗ and EEA ↗ for indicators related to the Chemical Strategy for Sustainability ↗ and Farm to Fork Strategy ↗). Together with the case study prioritisation, this forms the basis for a proposal for indicator development. 

The first case study focused on the association between pyrethroid exposure and ADHD. The results are available here ↗.

Additional case studies scheduled for completion in 2025 include:

• Exposure to a mixture of lead and methylmercury and IQ loss.
• Exposure to lead and cardiovascular disease through hypertension.
• Exposure to arsenic and carcinogenic effects.
• Environmental burden of municipal solid waste incineration emissions on cancer-related mortality.
• Influence of waste co-incineration in a cement plant on cancer burden and risk assessment for selected chemicals based on HBM data.

Policy relevance

• Indicators on exposure to chemicals.
• Indicators on risk assessment (exposure vs hazard).
• Indicators on possible health impact (attributable number of cases, DALYs).
• These indicators inform policymakers and help with preparing, evaluating policy.

Key messages

• Nurses and other workers in hospitals may become exposed to various hazardous medicines unless proper precautions are taken.
• New measured data on exposure to hazardous medicines are collected together with detailed information on practises applied at hospitals to promote safe handling practises.
• The study supports the implementation of EU legislation on carcinogenic, mutagenic and reproductive toxic chemicals at work and its recent updates concerning the hazardous medicines. 

Overview

This cross-sectoral study focuses on hazardous medicinal products, such as cytotoxic drugs ↗, inhalation anaesthetics, and disinfectants. Cytotoxic drugs, which are medications commonly used in chemotherapy to treat cancer, work by destroying or preventing the growth of cancer cells. However, these drugs can also pose risks to human health because they often have harmful properties, including the ability to cause cancer (carcinogenic), create genetic mutations (mutagenic), or negatively affect reproduction (reproductive toxicity). Similarly, common inhalation anaesthetics have been suggested or are known to exert reproductive toxic properties. The aim of the study is to introduce human biomonitoring for assessing both exposure and early health effects in healthcare settings. It will take place in 20-24 hospitals across 10-12 EU member states, with the following objectives:

• Identify key exposures and relevant exposure scenarios in hospitals
• Explore how human biomonitoring can improve chemical risk assessments for priority chemicals in healthcare environments
• Examine the contributions of various exposure sources—such as drug spillages, patient excreta, and drug packaging—to assess aggregated exposure to these medicines in hospital settings
• Develop human biomonitoring-based approaches to better assess and manage chemical exposures in hospital settings

The project aligns with recent guidelines for hazardous drugs, including cytotoxic drugs, ensuring compliance with occupational health and safety protections outlined by the EU Occupational Safety and Health Directive ↗ and the Carcinogens, Mutagens and Reprotoxic substances Directive ↗. These were recently amended to include also hazardous medicinal products and reproductive toxic compounds. In this way, the study addresses key regulatory developments and contributes to the improvement of occupational health and safety standards in the healthcare sector.

Achievements & Results

A consortium of institutes from 11 countries has been established, with partners confirming their participation to recruit hospitals and study participants. Together, the consortium identified priority chemicals for the study and selected specific biomarkers to measure exposure and effects. A generic study design has been developed, alongside detailed protocols for hospital recruitment, participant involvement, information sharing, questionnaires, and the collection, storage, and shipment of biological samples.

The digitalisation of the workers' questionnaire has been completed, and candidate laboratories for biomarker analysis have been identified. Quality assurance and control measures for biomarker and occupational hygiene sample analyses have been developed, with sampling already underway in some countries.

The study’s focus on hazardous medicinal products was narrowed to cytotoxic drugs, as there was insufficient support to include antibiotics or other medicinal products.

Work is ongoing to prepare information materials for hospitals and workers. Informal discussions with the European Commission's Directorate-General for Employment (DgEMPL ↗) and the European Agency for Safety and Health at Work (EU OSHA ↗) have helped shape the project design. A protocol paper detailing the study methodology is currently being drafted.  

Policy relevance

• The project supports the implementation of the recent updates to EU CMRD, which now includes hazardous medicinal products. 

Key messages

• Developing three sets of health-based Human Biomonitoring Guidance Values helps to interpret biomonitoring results for the general population and workers.
• Human Biomonitoring Guidance Values are created for substances with a clear threshold where health effects occur. For carcinogenic substances that don’t have a safe threshold, special values called Exposure Equivalents for Cancer Risk are developed in certain cases.
• These guidance values will make it easier to assess chemical exposures and protect the health of different groups. 

Overview

This project aims to develop guidance values for human biomonitoring of priority chemical substances, using measurable biomarkers of exposure as a foundation for accurately interpreting potential health impacts. Biomarkers of exposure are substances in the body, such as chemicals or their breakdown products, that indicate whether and how much someone has been exposed to a chemical. The human biomonitoring guidance values, developed through collaborative consensus within the Partnership for the Assessment of Risks from Chemicals (PARC) project, will standardise the assessment of human biomonitoring results and support European chemicals policies.  

To enable a health-related interpretation of human biomonitoring results, human biomonitoring guidance values must be derived from epidemiological or toxicological data and correspond directly to measurable human exposure biomarkers. Epidemiological data refers to data or evidence relating to the occurrence, distribution, clinical characteristics, and control of disease within a group of people while toxicological data are used to evaluate the potential harm or hazard of a chemical. The main aim of this project is to create as many guidance values as possible for priority chemicals identified by PARC and measured in the Aligned Studies.  

Through the consensual approach, broad acceptance and promotion of the harmonised assessment of human biomonitoring results should be ensured. The guidance values for both the general population and worker groups are derived according to the agreed human biomonitoring guidance value methodology. However, ongoing refinement of this strategy will be incorporated as new data emerge. In certain cases, molecular modelling—a computer-based method for predicting how chemicals behave in the body—may be required, and corresponding results will be made available within PARC. Each human biomonitoring guidance value will include a confidence level, which indicates the degree of certainty about the value’s accuracy. 

Achievements & Results

The first values and associated substance dossiers are currently being finalised. The substances included in this initial release are:

• DHHB (diethylamino hydroxybenzoyl hexyl benzoate, Uvinul® A Plus
• (Gamma/Lambda) Cyhalothrin
• Benzophenone-3
• Diisononyl Phthalate (DiNP)
• Diethylhexyl Terephthalate (DEHTP)
• Aluminium
• Nickel
• Chromium VI
• Mercury
• Acetamiprid
• Imidacloprid 

Policy relevance

The evaluation of European human biomonitoring results with the help of harmonised guidance values makes it possible to check legal chemical regulation on their sufficiency or needs of improvement. 

Key messages

• Identifying toxicological effects of selected enniatins and Alternaria toxins.
• Providing urgently needed in vitro data for an appropriate risk assessment.
• Aim to set health-based guidance values for food (and feed).

Overview

Mycotoxins ↗ are secondary metabolites produced by fungi that can contaminate food (e.g. cereal products, fruits, and beverages) and animal feed. These toxins can have harmful effects, ranging from neurotoxicity (damage to the nervous system) to carcinogenesis (the development of cancer).

Due to the widespread human exposure to these toxins – an issue likely to worsen in Europe with climate change and the lack of mandatory reporting on their hazards – the Partnership on the Assessment of Risks from Chemicals (PARC) has identified the need for reliable toxicity data as a priority. This effort is supported by regulatory authorities, including the European Food Safety Authority (EFSA ↗)’s CONTAM Panel ↗, which assesses contaminants in the food chain.

This project focuses on two emerging groups of fungal toxins, enniatins and Alternaria toxins, which require urgent regulatory attention due to limited data on their potential health risks.

The main goal is to address gaps in knowledge about their harmful effects on human health by studying the following areas:

• Genotoxicity and mutagenicity: The potential of these toxins to damage genetic material which may lead to mutations.
• Endocrine effects: How these toxins may interfere with hormonal systems.
• Immunotoxicity: The effects of these toxins on the immune system’s ability to function properly.
• Metabolism: How the body processes these toxins, including pathways that may activate or deactivate their harmful properties and how they move through the body (toxicokinetics).

This research aims to provide critical data to support regulatory decisions and protect public health.

Key messages

• From 2022 – 2029, 67 institutions are collaborating under the EU Partnership for Assessment of Risks from Chemicals (PARC) initiative to enhance the utility of innovative analytical methods and tools for monitoring and surveys, supporting next-generation chemical risk assessment.  
• A network of harmonised laboratories operating standardised innovative methods for chemical exposure characterisation should be established for use as a tool within a European early warning system for chemical risks. 

Overview

This project evaluates how effectively European regulations minimise the risks posed by chemical use, protecting public health and the environment. By monitoring chemicals in people's bodies across different European regions using a harmonised approach and quality-assured analytical methods, this project will assess the impact of policies like the European Green Deal ↗ and the Chemicals Strategy for Sustainability ↗. It aims to understand how chemical exposure varies based on local environment, lifestyle, and diet. In addition, this project tracks emerging chemical risks and evaluates their health impacts, guiding safer chemical practices and preventing harmful substitutions. These efforts help ensure ongoing safety and build public trust in chemical management. The findings will be relevant to policy makers and regulatory frameworks that restrict chemical production, use, and environmental release, as well as those focused on environmental and human health protection.

Demonstrating the effectiveness of existing policies is essential for maintaining public trust and securing the ongoing collaboration of industry and stakeholders. Human biomonitoring is a tool of health-related environmental monitoring with which populations are examined for their exposure to pollutants from the environment. 

When carried out across Europe, this tool provides consistent data on the internal exposure of the European population to priority substances within the Partnership for the assessment of Risks from Chemicals (PARC), in different European regions. The results from European partnerships like the European Human Biomonitoring Initiative (HBM4EU ↗) and PARC, offer a baseline and when repeated show trends over time. These data help track the success of initiatives like the European Green Deal's Zero Pollution Action Plan ↗ and the Chemicals Strategy for Sustainability.  
This project will also identify exposure to new and potentially concerning chemicals, including substitutes for banned substances. Detecting these chemicals in the population can serve as an early warning system of hidden risk. By measuring biological markers that show how chemicals affect the body and linking them to health data, this study will provide insight into how these chemicals, including substitutes, impact health. This will also support efforts to group chemicals and avoid harmful substitutions.  

Achievements & Results

Although the primary project results are expected in 2027/2028, progress has been made in the preparatory phase. Participating countries contributing with human biomonitoring data have been identified, and supporting materials, including questionnaires, have been developed. The selected target groups include children (6-11 years), teenagers (12-17 years), and adults (18-39 years) and a finalized list of biomarkers includes substances like bisphenols, phthalates, PFAS, pesticides, metals, arsenic, and cotinine. Find out more about this here. 

A workshop held in Brussels on on 10 and 11 May 2023 brought together experts to align methodologies and protocols for PARC-aligned human biomonitoring studies. The workshop aimed to ensure a harmonised, consistent approach across participating countries, allowing for reliable and comparable data collection.

Initial studies have begun recruiting participants and collecting biological samples, marking the start of data generation for the project. This phase is crucial to generate high-quality data that will help assess chemical risks and policy effectiveness.

Policy relevance

Only a few countries have integrated exploratory analysis into regulatory frameworks for human, food, or environmental monitoring to support chemical risk assessment. This project identified key scientific barriers that must be addressed to incorporate advanced techniques like non-targeted analysis and effect-directed analysis into monitoring programs and early warning systems. These findings have been communicated to regulatory bodies and policymakers, providing valuable insights to guide priority-setting and assess the feasibility of adopting these innovative approaches in policy frameworks. 

Key messages

• The study identifies occupational exposure pathways and their health impacts, providing a foundation for evidence-based regulations to protect workers and reduce occupational health risks.
• Sentinel surveillance delivers early warnings on emerging health threats, enabling timely preventive actions and enhancing EU health resilience.
• The findings support targeted strategies to prevent work-related diseases, reducing the economic burden on healthcare systems and industries.
• Research fosters EU-wide collaboration and harmonisation, enhancing regulatory frameworks for occupational health and safety across Member States.
• Insights promote sustainable practices, aligning with EU Green Deal goals by enabling the substitution of hazardous substances with safer alternatives. 

Overview

A Sentinel Surveillance System in occupational settings is a strategic and cost-effective tool for monitoring health issues linked to environmental and occupational exposures, using the expertise of trained occupational health and safety professionals. This system involves selecting specific locations to gather comprehensive data on occupational and environmental health conditions alongside exposure data for substances of high concern. Sentinel surveillance generates vital data for advancing exposome research, improving innovative approaches in exposure studies, and offering cost-efficient methods for biomonitoring exposure data. 

Establishing national sentinel surveillance platforms enhances data collection in workplace settings, enabling continuous monitoring of exposure levels and related health outcomes. Additionally, the system serves as an early warning system for identifying and addressing emerging threats in workplaces.

This project aims to establish a European sentinel surveillance system to support human biomonitoring surveys in the general adult population, using occupational physicians and nurses. Sentinel networks, made up of motivated physicians, provide and efficient way to collect data and samples, a method that has proven successful in occupational health studies. The primary objective of this project is to assess the feasibility of using a sentinel system to enhance human biomonitoring surveys, covering a broad range of chemical exposures, including PFAS ↗ (also known as "forever chemicals"), pesticides ↗, bisphenols ↗, metals, and mercury ↗.

By involving occupational physicians and nurses, the project aims to improve recruitment for the Partnership for the Assessment of Risks from Chemicals (PARC) general population human biomonitoring survey, providing critical data on the environmental and occupational exposure for a representative sample of European working adults. This initiative supports regulatory frameworks related to the general population human biomonitoring survey and aligns with the EU’s Health & Safety at Work – Strategic Framework (2021-2027) ↗, which focuses on guidelines and standards for protecting workers’ health and safety.  

In addition, this project contributes to the EU's objectives of zero pollution ↗, one-substance-one-assessment ↗ approach, and exposome initiatives ↗ by generating aggregated exposure data from various sources. Ultimately, the project functions as a strategic tool to address current and emerging health risks, while promoting a safer working environment in line with EU regulations and standards.

From an international perspective, establishing and implementing a sentinel surveillance approach across EU countries, combined with training occupational health and safety professionals in assessing occupational and environmental exposures, is seen as a promising strategy. This approach has the potential to generate more reliable data and enable meaningful comparisons of large-scale exposure information across nations. 

Achievements & Results

In Belgium, a significant milestone has been achieved with the development and launch of the Human Sentinel Surveillance Platform (HSSP ↗), a web-based sentinel surveillance tool. The platform is currently undergoing testing to evaluate its feasibility for national-level surveillance of occupational chemical exposures. 

Policy relevance

• This project aims to explore, design, and test the feasibility of, and implement a European sentinel surveillance system to support human biomonitoring and assess the exposure of a representative sample of European working population exposed to substances of high concern. This will be achieved through the involvement of motivated and specifically trained occupational physicians and nurses, familiarised with the sentinel approach and human biomonitoring.
• The project hold significant potential to support regulatory processes under the Registration, Evaluation, Authorisation, and Restriction of Chemicals (REACH) and the Occupational Safety and Health (OSH) field. REACH regulations play a critical role in assessing chemical risks and proposing risk management measures, ensuring the protection of both the environment and the health of workers exposed to these substances in the workplace.  
• Meanwhile, the concept of a Sentinel Surveillance System has emerged as a dynamic tool for advancing occupational health within OSH regulations. By systematically monitoring workplace environments and the health of workers exposed to substances of high concerns, this system provides a robust framework for the early detection of hazards, proactive interventions, and data-driven decision-making. 

Key messages

• Burden of disease calculations are well-established for air pollution but remain underdeveloped for chemical exposure.
• Ongoing case studies on substances like lead, arsenic, pesticides, and PFAS are addressing this critical knowledge gap.
• These studies aim to develop policy indicators to assess health impacts and provide strategies to reduce them. 

Overview

Environmental burden of disease analyses how much disease is caused by environmental factors like chemical exposures, while health impact assessments estimate the health effects of policies or programs. Together, these analyses help identify priorities for preventive action for current chemical exposure in the EU ↗. Case studies on priority substances identified by the Partnership for the Assessment of Risks from Chemicals (PARC) will calculate health impacts, risks, and cost scenarios, depending on data availability and methodological improvements. Findings will support the creation of indicators for risk and health impact.  

Health impact assessments as well as social and external cost-benefit analyses help quantify the health impacts of chemical exposure across EU populations. These tools can prioritise actions to prevent or reduce exposure and estimate the environmental burden of disease and the avoided costs due to policies and regulations. 

Case studies will focus on key chemicals prioritised by PARC. Based on findings from related projects in PARC on data and methods, selected case studies will assess health impacts and risk or cost-benefit scenarios for certain chemical, chemical classes, mixtures ↗, adverse health effects, and affected populations, using both existing and newly generated data. The results will also contribute to a project dedicated to developing a set of risk and health impact indicators. 

This project is one of four interconnected initiatives focussed on assessing the health impacts of chemical exposure. 

Achievements & Results

In the first year, a framework was developed to prioritise chemical exposure case studies. This included creating criteria and scoring rules, which were applied to proposals from project partners to select the most relevant studies. Initial case studies were identified, and their design and implementation are now ongoing.

For the second year, the focus is on finalising the first set of studies and beginning their implementation. These studies aim to assess health impacts, including burden of disease and cost-benefit analyses. Plans are also underway to prioritise additional case studies for future years, targeting key health effects like endocrine disruption ↗, immunotoxicity ↗, and neurotoxicity ↗. Work will continue to improve methods and harmonise approaches across studies. 

Key messages

• It is relatively difficult to identify occupationally exposed groups from the general population data.
• In order to be able to identify potential occupational exposed groups from general population surveys, it is of utmost importance to have a high enough sample size with ISCO-coded information on occupations. This means that data from several national studies needs to be combined.
• ISCO-08 encoding of occupations with at least 4 digits is needed to get meaningful results. This requires that detailed data on occupations and job descriptions are collected as part of general population surveys.

Overview

This project uses human biomonitoring data from the European Human Biomonitoring Initiative (HBM4EU ↗) to examine occupational exposure to chemicals like cadmium ↗, chromium ↗, PAHs ↗, and bisphenols ↗. The goal is to determine whether data from general population studies can reveal elevated exposure levels among workers compared to non-occupationally exposed population groups. It is designed as a short-term feasibility (pilot) study but the results may help improving the design of future general studies in future, provide further information for improving exposure assessments and support regulatory frameworks in Europe, including the Registration, Evaluation, Authorization, and Restriction of Chemicals (REACH ↗) and Occupational Safety and Health (OSH ↗), to better identify and manage occupational health risks.  

By developing an approach to analyse HBM4EU general population data, this study aims to identify groups that are occupationally exposed to higher levels of harmful chemicals. It furthermore seeks to evaluate how general population studies, focused on adults can detect these elevated exposure levels. The results may also help to explain the variability observed in the general population biomonitoring data.  

The results of this feasibility study will be valuable for future human biomonitoring research on the general population. Thus, researchers conducting these studies will be among the key beneficiaries of the findings.  

The regulatory outcomes of this project can contribute to both REACH and OSH processes. When general population human biomonitoring data is used for exposure and risk assessments, it is crucial to identify the primary sources of exposure. If occupational exposure is a potential confounding factor, it needs to be detected and accounted for to avoid distorting the results. At the same time, the data may contribute to occupational exposure assessments under REACH and OSH processes.  

Since this is a feasibility study aimed at proving the concept, there is no need to align the project’s timeline with existing policy agendas.  

Achievements & Results

In the first year, relevant studies were identified, and initial work on selecting studies and coding occupations began. By the second year, agreements with data owners were finalised, but data analyses awaited access to datasets, and coding of occupations continued.

In the third year, data analyses for the International Standard Classification of Occupations 2008 (ISCO-08 ↗) coded datasets were completed, conclusions were drawn, and a report was finalised and a publication on the results is planned for the second half of 2025.

Policy relevance

Improves our understanding on the human exposure to chemicals, including occupational exposure. By doing so, it supports EU legislation on the Registration, Evaluation, Authorization, and Restriction of Chemicals (REACH) and Occupational Safety and Health (OSH) legislation in EU.

Overview

Monitoring chemicals in the environment is crucial to understanding their impact on human health and ecosystems. It helps identify where these substances come from, how widely they are spread, and whether stricter controls – such as limiting or banning their use – are needed. Monitoring also provides essential data to evaluate the effectiveness of measures taken to reduce pollution, aligning with the European Union’s Zero Pollution ambition ↗. However, monitoring is a complex, time-consuming, and costly process, requiring careful planning to focus on the most pressing issues while ensuring no harmful substances are overlooked.

This project aims to address these challenges by developing a flexible system to prioritise which chemicals need closer monitoring. It focuses on chemicals that are poorly monitored or entirely overlooked, including unintentional mixtures and new substances of emerging concern.

By creating a transparent, and reproducible framework, this project will help identify priority chemicals, environmental areas which are known as matrices, and specific health or ecological effects for targeted monitoring. Matrices are parts of the environment, like water, soil, or air, where pollutants can accumulate.

This framework will ensure that monitoring efforts are efficient, effective, and aligned with regulatory needs. It will also be adaptable to emerging risks and changing environmental challenges, helping to safeguard human and environmental health while supporting the EU’s goal of reducing pollution.

Overview

Over the years, various tools and database platforms have been created to store, analyse, and visualise data and trends on the presence of chemicals and trends in their exposure in the environment. However, each tool or platform was developed for different user groups, offering various services and addressing different topics. The available data is often organised by type of environmental sample (such as water, air, or soil), and these datasets vary in content, structure, and development, including differences in data standardisation, classification systems, and available tools.

The environmental monitoring and exposure component of the Partnership for the Assessment of Risks from Chemicals (PARC) focuses on studying how chemicals move and accumulate in multiple parts of the environment. It also examines how humans are exposed to these chemicals when they originate from different sources and travel through various pathways.

This research promotes a “one health” approach to chemical risk assessment, which considers the interconnected health of people, animals, and ecosystems. Researchers will evaluate combined exposures by analysing the presence of chemicals, their breakdown products, and their interactions across different environmental samples.

Members of the research and innovation teams in PARC are seeking better ways to access and connect existing data resources, such as monitoring programs, databases, and scientific libraries. These solutions will help map and access the diverse information already available. By gathering and combining information on chemicals in the environment, researchers aim to improve how risks to human health and ecosystems are assessed.

Overview

Establishing a process for environmental and multisource monitoring is a key focus of the PARC initiative. This process aims to support the European Union's chemical risk assessment efforts by addressing two main areas: (i) environmental ecosystems ↗ and (ii) human exposure ↗, closely linked to human biomonitoring.

Building on existing structures and knowledge is a prerequisite for achieving these goals, making environmental and multisource monitoring a complex but essential task that requires highly optimized processes to maximize its benefits.

As part of this effort, a pilot project will be launched to focus on per- and polyfluoroalkyl substances (PFAS) and endocrine disruptors. PFAS – also known as “forever chemicals” – are a group of synthetic chemicals found in various products that persist in the environment and the human body, while endocrine disruptors are substances that can interfere with hormonal systems, potentially causing adverse health effects. The pilot project aims to establish and validate environmental monitoring structures. In addition, the project will include a review of cutting-edge methods and the development of a study design for monitoring these substances.

Key messages

Reach a common understanding of what needs to be improved in the environmental risk assessment for plant protection products, such as the need to:

• Overcome the limitations of the current substance-by-substance approach,
• Adopt a more realistic consideration of the environmental context.

Address issues related to improving environmental risk assessment for plant protection products through the related research projects.

Overview

The project seeks to improve the prospective evaluation of the effects of plant protection products on biodiversity by simplifying environmental risk assessments ↗ and enhancing the level of protection. This will be achieved by overcoming the limitations of the current substance-by-substance approach and adopting a more realistic consideration of the environmental context and a more holistic approach. The project will compare current methods with new ones and cross-check both against independent environmental monitoring data.

The project also aims to explore more holistic approaches to risk assessment. This means evaluating environmental risks in a broader context rather than focusing on individual substances in isolation. By doing so, it considers how multiple factors interact under real-world conditions.

In addition, the project will review and refine existing models while developing new ones for risk assessment. It will also create new frameworks for risk characterization, supporting approaches that assess entire systems rather than isolated components.

The main objective of the project is to establish a more effective and efficient way to assess environmental risks by optimizing the use of data, knowledge, and expertise, as well as resources. This will also strengthen collaborations and improve overall risk assessment strategies.

Achievements & Results

Main activities aimed at better describing the challenges and needs for an improved environmental risk assessment of plant protection products:

• Establishing dialogue and connections between various research projects and stakeholders, while also considering publicly available documents.
• Collaboratively defining the term systems-based environmental risk assessment, which encompasses the entire system rather than isolated components.
• Conducting surveys and online workshops to better understand the needs of risk assessors in this field, supporting the transition towards more integrative approaches.

These activities have helped define what needs to change in the environmental risk assessment of plant protection products—“designing the right things”—before implementing the findings in the related research projects to “design things right.”

Policy relevance

The improved regulatory framework for plant protection products will be better aligned with new policy targets, e.g., European Green Deal ↗, the EU “Zero pollution ↗” ambition, and EU and national chemical risk assessment and risk management bodies. 

Overview

Wastewater and wastewater plants are important sources of information for advancing scientific understanding of human exposure to chemical substances. By measuring specific markers, such as human metabolites, in wastewater in wastewater treatment plants, we can significantly contribute to a better management of chemicals that threaten both public health and the environment,  

This project focuses on studying wastewater with an emphasis on both human and environmental exposure. It employs innovative methods including (i) wastewater fingerprinting for assessing community wide human exposure and (ii) screening of wastewater treatment plant effluents to assess the release of Chemicals of Emerging Concern into the water cycle ↗. While utilising wastewater-based epidemiology tools, further presence of pathogens ↗, chemicals ↗, and other indicators of health in a community can be monitored. These commonly arise from substances like viruses, bacteria and pharmaceuticals ↗being excreted by individuals through urine and feces, which then enter the sewage system.  

The methods used in this study can contribute to the establishment of a European scale monitoring system and facilitate the re-evaluation of existing data, greatly extending the knowledge base on Chemicals of Emerging Concern in the water cycle. 

This research will serve as a basis for revising and managing several water related legislations, such as the Urban Wastewater Treatment Directive ↗, with to the goal of reducing emissions of Chemicals of Emerging Concern. Additionally, it will provide information on river-basin-specific chemicals for the Water Framework Directive ↗. Furthermore, the study will provide information on chemical mixtures ↗, supporting the revision of the European regulation Registration, Evaluation, Authorization, and Restriction of Chemicals (REACH ↗). 

Achievements & Results

The results of this project will be disseminated toward the conclusion of the project timeline, in alignment with planned milestones. However, a significant achievement has already been realised with the successful implementation of the first pan-European sampling campaign as scheduled for 2024. 

Policy relevance

This research uncovers the need to revise European legislation on water management.

Overview

Although strict regulations govern the use of agricultural pesticides ↗ in Europe, field studies have revealed harmful effects on non-target organisms, which include species not intended to be affected by pesticides. This goes against European regulation ↗, which requires that pesticide use does not harm the abundance or diversity of these organisms. This project aims to improve the way environmental risks are assessed by considering the combined effects of multiple pesticides and other stressors on a broader landscape scale, rather than focusing on individual chemicals and crops.

A landscape-level approach takes into account how different types of agricultural land use, such as fields, forests, and water bodies, interact with pesticide exposure. It also considers the vulnerability of populations living in these environments. 

Given the complexity of such large-scale assessments, the project will focus on identifying the most important factors – referred to as “drivers” – that influence pesticide exposure and its effects on the environment.

To achieve this, the project will build on findings from three earlier studies to develop models tailored to different types of landscapes. These models will include recommendations from the European Food Safety Authority (EFSA ↗) to set protection goals based on safeguarding ecosystem services, such as pollination ↗, and preserving biodiversity ↗. The ultimate goal is to create tools that provide a clearer and more consistent way to assess environmental risks, addressing current gaps and inconsistencies in existing methods.  

Achievements & Results

The interlaboratory exercise was designed through a collaborative process involving all project partners. An online survey and a detailed questionnaire were used to gather input, ensuring that the design reflected a broad consensus and addressed the needs of all involved laboratories. 

• The project will leverage outcomes from other projects that compare predictions with monitoring data, enhancing the feedback loop from environmental monitoring to focus on factors impacting biodiversity in both terrestrial agro-biosystems and aquatic ecosystems.
• It will support regulatory decisions and the design and implementation of National Plans under the Sustainable Use Directive, aiming to provide management tools for informed decision-making in Integrated Pest Management and ecosystem restoration.
• Conceptualization of Landscape risk assessment: Four workshops held between November and December 2022 included partners, external experts, and EFSA. Minutes were compiled and distributed for comments, and key elements for Landscape-ERA were extracted.

Identification of the case studies: Several partners proposed case studies, with some confirmed and others pending. The design process for case studies is ongoing, with the next step being the adaptation of the conceptual model to each case study.

Key messages

• Assessment of reproduction and embryotoxicity in pond snails by mycotoxins commonly present in wastewater
• Assessment of cyanobacterial toxicity to marine and freshwater invertebrates on life history
• Assessment of cyanobacterial toxicity in combination with chemical pollution to green algae 

Overview

The EU uses regulations as a method to set threshold values for the concentration of natural toxins such as microcystins ↗, yessotoxin ↗ and saxitoxin ↗ to ensure they remain safe for human consumption. Microcystins are toxins produced by cyanobacteria ↗ in freshwater, while yessotoxin and saxitoxin are marine biotoxins associated with harmful algal blooms.

While there are regulations in place to protect human health, there is a gap in regulations regarding safe exposure levels for aquatic species from an environment health perspective.

In aquatic ecosystems, invertebrates have a crucial role in the food chain and the overall functioning of the ecosystem, as they are primary consumers and serve as food for higher trophic levels. Microalgae are in turn the primary food source for these invertebrates, which are positioned on an even lower level in the trophic chain forming the very base of aquatic ecosystems. Studying the effects and risks natural toxins have on aquatic organisms, such as invertebrates and microalgae, lays the cornerstone of assessing the need for regulations and toxin mitigation measures.

By investigating the toxicity of naturally occurring toxins alone or in combination on aquatic organisms, this project aims to make an impact on the regulatory landscape concerning the protection of marine and freshwater environments. Within EU legislation, this project draws on the Marine Strategy Framework Directive ↗ and the Water Framework Directive ↗. Additionally, the results of this project will also serve as a basis for further regulating nitrogen and phosphorus pollution ↗ within the EU, as these contribute to eutrophication ↗, a key driver of harmful algae bloom.  

Achievements & Results

The study investigated the effects of various natural toxins and environmental conditions on aquatic organisms. Here are the key findings:

• Toxicity of Mycotoxins: Several mycotoxins commonly found in wastewater, such as zearalenone and deoxynivalenol ↗, were tested for their effects on pond snail embryos. Toxicity levels were detected at concentrations well above environmental levels.  
• Impact on Tiny Crustaceans: Two marine toxins, yessotoxin and saxitoxin, were shown to reduce the number of offspring produced by the estuarine copepod N. spinipes. This impact became even stronger when water temperatures were elevated, highlighting the potential risks of climate change in amplifying toxin effects.
• Toxin Levels in Natural Waters: Measurements of four algal toxins in natural seawater (yessotoxin, saxitoxin, domoic acid, and microcystin-LR) found that, in the absence of algal blooms, their concentrations are below levels shown to cause harmful effects in this study.
• Effects on Green Algae: Testing the effects of microcystin-LR and cylindrospermopsin on green algae (C. vulgaris) revealed that growth was affected only at relatively high concentrations (4 to 40 mg/L) after 4 to 7 days of exposure. 

Policy relevance

• Drawing attention to the need of further regulations on threshold values of naturally occurring toxins in the aquatic environment
• Providing scientific support to prioritize specific toxins and sensitive species across marine and freshwater habitat based on effect assessments 

Key messages

• Consistent risk assessment requires that risks of compounds can be compared and ranked
• Evaluation of current approach and development of concepts and methodologies to improve comparability
• Risk assessment outcomes should also hold against relative risks of compounds identified in real world studies 

Overview

This project aims to demonstrate that environmental risk assessments ↗ of plant protection products, often referred to as pesticides ↗, can be used as benchmarks to evaluate the risks of other similar products. The process involves comparing and ranking the environmental risks of different plant protection products across various substances and groups of organisms, ensuring that all assessments follow the same level of refinement. By developing new concepts and methodologies, the project seeks to make individual risk assessments more comparable and consistent, which will improve their reliability when matched against real-world monitoring data and lead to more accurate environmental risk estimations.  

A key goal is to create a more comprehensive approach to environmental risk assessments that manages risks more effectively. The project will analyse existing data sets and case studies of products rejected during regulatory assessments. This will allow for both internal comparisons within a product’s risk profile and external benchmarking against other products. The findings will help identify weaknesses in the current environmental risk assessments system and propose immediate solutions. Over time, the project will develop a compatibility methodology aligned with the future environmental risk assessments framework envisioned by the Partnership for the Assessment of Risks from Chemicals (PARC) partners. Ultimately, these efforts aim to significantly improve the environmental risk assessments process under European regulation ↗, ensuring better protection for ecosystems and public health. 

Achievements & Results

• Investigated the heterogeneity of higher-tier data, leading to the preliminary conclusion that this would be a challenge to benchmarking plant protection products (a pre-print is available).
• Identified and highlighted the environmental risk assessment factors determining the rejection of a PPP under the EU regulatory framework EC No. 1109/2009.
• Conceptual Plant Protection Products Benchmarking Paper with the working title “A Benchmarking Framework to Improve the Quality and Expedience of Regulatory Environmental Risk Assessment for PPPs”
• Development of an internal risk benchmarking framework concept for plant protection products.
• Creation of database containing EU-authorized active substances for insecticides and acaricides, their toxicity endpoints, predicted environmental concentrations and other exposure data, environmental fate, mode of action and representative uses.
• The project will produce an environmental risk assessment concept and methodology to develop new guidance for environmental risk assessment within the authorization process. This environmental risk assessment will enhance the ability to capture the relative risk of different plant protection products across relevant spatial and temporal scales, using similar data and levels of refinement.  

Policy relevance

Environmental risk assessment is an important area contributing to a sustainable use of plant protection products as demanded by the Sustainable Use Directive and also contributes to meet biodiversity targets through a more efficient management of environmental risks.

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.

Overview

Traditional food safety monitoring mainly relies on targeted analytical methods that focus on specific, known chemicals. However, the growing variety and quantity of both known and unknown chemicals in the market necessitate more comprehensive detection strategies.  

In 2019, the Centre for Pesticides in the Environment at the Swedish University of Agricultural Sciences (SLU ↗) introduced a new method for predicting concentrations of plant protection products in surface water. This method uses fewer but more focused inputs based on well-understood environmental processes.  

The aims of this project are to refine these calculations and ensure that predictions match real-world measurements more closely. It also looks at simplifying the process further by testing and improving other models, such as the GERDA model ↗, which is used in Germany to assess pesticide exposure in surface waters. 

To ensure these simpler models are reliable, their predictions will be tested against data collected from various European Union member states and validated using existing models and additional monitoring data.  

Overview

This project aims to simplify and improve the process of assessing the environmental risks of plant protection products, such as pesticides. While these assessments have become more complex and resource-intensive, real-world studies still show harmful effects on ecosystems. These findings conflict with European regulations, such as the regulation on the uniform principles for evaluation and authorisation of chemical plant protection products ↗, which is designed to protect the diversity of species that are not targeted by pesticides but still may suffer damage because of exposure to it.

The project seeks on enhancing the environmental risk assessment ↗ by using data and methods that have been tested through ecosystem monitoring and effect modelling. Monitoring ecosystems means observing real-world impacts on plants, animals, and their environments, while effect modelling involves creating simulations to predict how products might harm ecosystems. This approach helps improve how well laboratory results can be applied to real-world conditions.

One of the tools being used is the stress addition model ↗, which predicts how different stress factors, like chemical exposure, combine to impact ecosystems. The model will be tested against actual monitored ecosystem data to ensure it is reliable.

The research also looks at how these products affect species differently, depending on their mode of action, which refers to how a chemical works to kill or control pests. By focusing on specific species groups, the project will create a more realistic and effective environmental risk assessment framework.

To make these improvements accessible, the project will develop a user-friendly software package. This tool will help create clear and reproducible risk assessments that can be used across different regulatory systems. 

Achievements & Results

• Collation of field monitoring data on plant protection product exposure and effects from multiple EU member states, initially focusing on Germany, Sweden, and Switzerland, with plans to incorporate data from diverse regions to reflect European variability.
• Formalisation of a feedback loop between current risk assessment thresholds and retrospective ecosystem monitoring results to enhance realism and validation of the environmental risk assessment process.
• Enablement of regulators to identify and integrate crucial ecological processes into the risk assessment framework based on comprehensive field monitoring data across European regions.

Key messages

• Investigation of the potential adverse effects (e.g. apical endpoints such as mortality, effects related to the anticipated mode of action or MIE, effects on reproduction, effects on endocrine system) of certain individual substances and “real-life” mixtures of BPA alternatives on non-mammalian organisms belonging to different taxa  
• The project is dedicated to developing innovative New Approach Methodologies (NAMs) to identify chemical hazards with respect to the environment.
• The methods under development cover a wide range of taxa across the phylogenetic tree and address diverse endpoints and approaches. 

Overview

Concerns about the harmful effects of bisphenol A (BPA) ↗, a chemical commonly used in plastics, and strict restrictions on its use in many countries have led to the development of alternative chemicals.  These substitutions, known as BPA alternatives, are now emerging as environmental contaminants found across the globe in water, sediment, sludge, soil, indoor dust, and air. The upcoming opinion from the European Food Safety Authority (EFSA ↗), which recommends significantly reducing daily BPA exposure, is expected to increase the use of these alternatives further.  

Many BPA alternatives share similar properties with BPA. They are often toxic to aquatic organisms, can disrupt endocrine ↗ (hormonal) systems, affect reproduction, metabolism, and immune systems, and may persist in the environment.  

BPA alternatives are regulated under the European Union’s REACH ↗ framework, which governs the safe use of chemicals. However, the data required for assessing the safety of those alternatives vary depending on the production volume, and existing information is often insufficient to fully evaluate their potential risks to humans and the environment. The risks posed by exposure to mixtures of these chemicals ↗—common in real-world scenarios—are particularly underexplored, especially for long-term effects at environmentally realistic concentrations. This research project seeks to address these gaps by studying the potential harmful effects of BPA alternatives on various organisms. It will also develop new methods and tools for assessing these chemicals, with a focus on improving regulatory approaches and environmental safety. 

Achievements & Results

Tests with individual compounds have been conducted, revealing that the toxicity of bisphenols varies, with some being more harmful than others. The observed effects are dependent on the specific test organism or system used. Discussions are ongoing regarding the mixtures to be tested in the next phase.

As part of the project, experts conducted an extensive review, sharing their insights on the toxicity of BPA alternatives and their presence in the environment. The article can be accessed here ↗.

The project is also advancing innovative methodologies aimed at replacing traditional vertebrate animal tests. This includes the development of high-content screening techniques using zebrafish embryos and the creation of 3D zebrafish spheroids. 

Policy relevance

• Filled data gaps: Investigation of the toxicity of bisphenols in organisms belonging in different taxa, in some cases different than the ones required by the European regulation.  
• Identification of safer than BPA bisphenols or other alternatives.  
• Investigation of the effects of bisphenol mixtures    
• Improved hazard identification: NAMs utilizing environmental models provide precise data on the ecological effects of chemicals across diverse taxa, enabling regulators to identify hazards efficiently without extensive animal testing.
• Ethical and sustainable practices: New NAMs reduce reliance on animal testing, aligning regulatory practices with ethical standards and global sustainability goals while ensuring robust environmental safety evaluations.
• New methods investigating toxicity for environmentally relevant models help better understand chemical risks that are necessary for the implementation of preventive measures and enforce regulations that minimize chemical risks.

Key messages

• Endocrine disrupting chemicals (EDCs) can cause long-lasting changes to how our bodies manage energy and fat storage – what scientist call metabolic disruption.
• Chemicals suspected to trigger these changes are known as metabolism-disrupting chemicals. They may contribute to obesity, type II diabetes, and non-alcoholic fatty liver disease.
• Our project develops and improves new approach methodologies (NAMs) to identify and assess metabolism-disrupting chemicals. These include: nuclear receptor models; in vitro test using fat (adipocyte) or pancreatic cells; whole organism test systems, i.e. a zebrafish embryo/larval assays.
• We found that some Bisphenol A alternatives – candidates for safer replacement – can still disrupt metabolic pathways.

Overview

Over the past decade, research into endocrine-disrupting chemicals ↗ – substances that interfere with the body's hormonal systems – has revealed that some of these chemicals can cause long-lasting disruptions to metabolism. These substances are now referred to as "metabolism-disrupting chemicals." They are strongly suspected to contribute to the development of metabolic disorders such as obesity, type II diabetes, and non-alcoholic fatty liver disease. These health issues arise in combination with genetic factors, diet, and lifestyle choices. Currently, over 50 million people in Europe suffer from metabolic disorders, and the role of environmental factors, including man-made and natural chemicals, is increasingly recognised.

To classify a substance as an endocrine or metabolism disruptor, specific scientific criteria must be met, as outlined by the World Health Organization (WHO ↗). Despite growing evidence that these chemicals may contribute to the rise of metabolic disorders like obesity and diabetes, there are no dedicated laboratory tests yet that identify the harmful effects of metabolism-disrupting chemicals. This lack of tools makes it challenging to assess the risks these substances pose. Developing reliable methods to identify and evaluate these risks is critically important for public health and regulatory decision-making.

This project focuses on creating new approach methodologies (NAMs ↗) to address regulatory gaps. These methods will allow scientists to better identify and assess the risks associated with metabolism-disrupting chemicals. The substances under investigation include chemicals identified on priority lists by the Partnership for the Assessment of Risks from Chemicals (PARC) and European agencies such as the European Chemicals Agency (ECHA ↗) and the European Food Safety Authority (EFSA ↗). By expanding the scope of research to include experimental systems not yet explored and focusing on priority chemical families, this work aims to provide regulators with essential tools to tackle the health challenges posed by these harmful substances.

Achievements & Results

• Improved in vitro test methods by: expanding test chemical datasets; comparing to in vivo data; generating more human-relevant test systems, e.g. 3D cell systems; reducing animal-derived components in the test methods like fetal bovine serum.
• Developed a zebrafish larval assay ↗ that combines exposure to Western diets and aquatic exposure to suspect metabolic disruptors like bisphenol A.
• Screened bisphenol A alternatives for their impact on metabolic disruption.
• Obtained metabolism-disrupting chemicals mechanisms accross multiple levels of the adverse outcome pathway - from receptor interaction to whole organism effects.
• Published a state-of-the-art summary ↗ on metabolism-disrupting chemicals for the scientific and regulatory community.

Policy relevance

• WHO/IPSC (2002) outlines clear criteria classifying endocrine disruptors, but no official criteria yet exits for metabolism-disrupting chemicals.
• Metabolism-disrupting chemicals could potentially be regulated under similar frameworks as EDCs.
• To bridge this gap, validated NAMs are urgently needed.
• Our project develops fit-for-purpose methods that will help regulators detect and manage the risks of metabolism-disrupting chemicals.

Overview

Every day, chemicals are released into the environment leading to human exposure (e.g. through the food we eat, the air we breathe, and the products we use) and exposure of natural animal and plant populations. Many of these substances can interfere with hormone systems, potentially affecting our health and the environment. Identifying these endocrine disrupting substances, which can mimic, block, or interfere with hormones, is therefore crucial to ensure their regulation and guarantee public and environmental safety.

The objective of this project is to provide a framework for the creation of Integrated Approaches to Testing and Assessment (IATAs), which combine multiple sources of information to conclude on the toxicity of chemicals. Specifically, this project aims to develop IATAs for evaluating endocrine disruption, a priority health effect outlined in the European Chemicals Strategy for Sustainability ↗ priority areas: disruption of the thyroid hormone system, and anti-androgenic action. Disruption of either of these mechanisms can lead to important defects during embryonic development, which may persist later in life (e.g. leading to impaired cognitive function, or affected male reproductive health).

This project brings together researchers, regulators, and industry experts to refine the IATA frameworks.

By creating flexible, science-driven tools that are capable of adapting to different regulatory needs, this work will not only fill critical knowledge gaps but also ensure that decision-makers have the best possible tools to protect human health and ecosystems.

For this, a modular approach is envisioned to allow IATA adjustments to specific regulatory needs. This effort will not only structure and pinpoint key gaps but also facilitate the direct regulatory application of project outcomes.  

Achievements & Results

Mechanistic IATA models identifying key mechanisms and effects involved in both thyroid and anti-androgenic endocrine activity and disruption, applicable for both human health and environmental protection and describing the links between them, were developed. The work utilised previously published OECD IATA approaches (OECD IATA guidance ↗; Jacobs et al. 2020 ↗; Louekari and Jacobs, 2024 ↗). Adverse Outcome Pathways (AOPs) available in the AOP wiki and a review of relevant literature were taken together and underpinned by expert knowledge. The OECD Conceptual framework (CF) for the identification of endocrine disruptors (OECD Guidance Document 150 ↗), which is also the basis of the EFSA-ECHA guidance on the assessment of endocrine disruptors, was applied and updated as appropriate. Method inventories for thyroid hormone system disruption and anti-androgenic activity were created, organised according to the differen OECD CF levels, annotated as a function of their readiness level, and aligned with the mechanistic models. Case studies were then developed describing how the IATA models may be implemented in selected, specific regulatory decision-making scenarios.

Policy relevance

Criteria for the identification of endocrine disruptors have been stipulated for the Biocidal or Plant Protection Products Regulations, and a guidance document, i.e. “Guidance for the identification of EDs in the context of Regulations (EU) No 825/2012 and (EC) No 1107/2009) ↗”, was written by ECHA and EFSA to guide identification of EDs to comply with these obligations. Endocrine disruptors for human and environmental health have recently been added as new hazard classes to the CLP (classification, labelling and packaging) regulation, and a Guidance on the Application of the CLP Criteria has been published by ECHA (ECHA, 2024 ↗). In that context there was a need to create an overview of available methods for the evaluation of endocrine disruptors for both human and environmental health, both validated methods and methods that are close to or under validation, and to structure the methods according to IATA development principles. A modular approach is envisioned to allow for tailoring an IATA to specific regulatory needs. An endocrine disruptor IATA framework could benefit all EU agencies and European regulators dealing with endocrine disruptor assessment (e.g. ECHA and EFSA, national regulatory authorities), as well as the different regulations addressing this hazard class thus contributing to the harmonization of data requirements among EU and member state agencies. This project will support better regulatory decision making and improve the hazard identification of endocrine disrupting chemicals with the long-term aim to limit exposure and improve human as well as environmental health. The use of predictive methods and NAMs will be explored, with the potential to significantly reduce the need for long-term, low-throughput and costly toxicity tests requiring large numbers of animals, thus contributing to the replacement of animal tests.

Overview

Risk assessment traditionally focuses on single chemicals to identify potential adverse effects on human health. However, humans are exposed daily to many multiple chemicals. Evaluating the health risks of these chemical mixtures has become a priority.

The exposome approach adds value by studying the total external exposures over a lifetime and their links to health outcomes, providing insights into exposure-effect relationships.

The project builds on international scientific advancements in assessing the risks of chemical mixtures developed by leading international organisations such as the European Food Safety Authority (EFSA ↗), the European Environment Agency (EEA ↗), the European Chemicals Agency (ECHA ↗), the European Commission’s Joint Research Centre (JRC ↗), and OECD ↗ assessment methods, which analyse the potential harm of chemicals, with epidemiological studies that investigate patterns and causes of health effects in populations. This combination addresses needs identified by various organisations, including EU Member States, the European Commission’s health and environment departments (DG SANTE ↗ and DG Environment ↗), and aligns with goals outlined in the EU Chemical Strategy for Sustainability ↗.

The main goals of the project are to:

• Develop a unified strategy for assessing human health risks from chemical mixtures.
• Combine exposome data (lifetime exposure) with traditional risk assessment methods.
• Identify and prioritise real-life chemical mixtures using data from human biomonitoring.
• Generate detailed hazard and kinetic information for prioritised chemical mixtures.
• Investigate how chemical traces in the body relate to health effects.
• Conduct risk assessments for the prioritised mixtures to better understand their impact on human health.

Overview

The European Chemicals Agency (ECHA ↗) is incorporating international guidelines like the revised OECD Guidance Document 150 ↗ into its regulatory processes for evaluating biocides ↗ and pesticides ↗ for potential endocrine-disrupting ↗ effects. However, current testing methods and regulations still fall short when it comes to identifying substances that interfere with the thyroid hormone system. These substances, known as thyroid hormone system disruptors, can impact the normal functioning of the thyroid, which is crucial for regulating metabolism, growth, and development.

Laboratory tests, called in vitro assays, can detect early molecular changes associated with thyroid hormone system disruptors, but they are still under validation for regulatory use.

Developing new approach methodologies (NAMs) would create the possibility to assess a wider range of effects caused by these disruptors, giving insights into the broader health impacts they may cause.

This project aims to understand how thyroid hormone system disruptors work at a molecular level. This way, more targeted testing methods that better detect these disruptors can be developed. The research will also improve methods for predicting how findings from lab models, such as rodent studies, actually apply to humans. To achieve this, the project will use computer modelling (in silico assays), human stem cell-based laboratory systems, and zebrafish. This approach will help refine how thyroid hormone disruptors are identified and assessed, ultimately contributing to better protect human health.

Overview

Developmental and adult neurotoxicity describe harmful effects on the developing or mature nervous system. They are currently assessed using specific studies and according to international guidelines ↗, such as those from the Organisation for Economic Co-operation and Development (OECD ↗). These guideline studies require significant resources, making them impractical for evaluating adverse effects of large numbers of chemicals. Because of this, there is an international agreement ↗ that testing for developmental neurotoxicity needs to be faster and more directly relevant to humans. To achieve this, experts are working to replace traditional methods with a group of new, more efficient tests designed for regulatory purposes.  

The current state-of-the-art involves a set of lab-based experiments called the Developmental Neurotoxicity in vitro test battery ↗ which use cells from humans and rats to study important processes in brain development. While this is a major step towards establishing an alternative testing regime, there are still gaps in the kinds of effects these tests can detect. The main goal of this project is to fill those gaps.  

To improve the current testing battery and create a system for testing effects on adult brains, this project will focus on three major tools: i) human cells, which avoid difference between species, (ii) zebrafish embryos, which are useful because they contain a complete nervous system capable of performing complex behaviours that could potentially be disrupted by chemical exposure, and (iii) computer-based methods that use models to predict neurotoxic effects.  

New Approach Methodologies (NAMs ↗) will look at areas that have not been fully explored before, such as:  

• How disruptions in hormone systems (endocrine disruption ↗), gene activity (transcriptomics), and long-term genetic regulation (epigenetics) affect brain development,  
• The formation and function of brain connections (synaptogenesis and neural networks),  
• The development of the blood-brain barrier (a protective layer in the brain),  
• Behavioural effects like reflex responses (startle), anxiety-like behaviour, and learning and memory.  

Achievements & Results

A joint paper ↗ identifies key research gaps that this project aims to address, providing a framework for advancing toxicological understanding. 

One study ↗ explored genes essential for brain development, including those involved in forming neural connections, maturing different types of brain cells, and responding to hormone-disrupting chemicals. 

In behavioral testing, researchers enhanced a zebrafish model by adding new ways to measure their reactions to light changes. This revealed how a chemical, PFOS, causes an exaggerated startle response, shedding light on how it affects behavior and brain function. Explore the findings here ↗.

Another publication distinguishes between testing methods for chemical safety from collecting data to developing comprehensive, reliable tests, emphasizing the importance of well-structured methodologies. Access the full publication here ↗.

Advances in testing strategies are reshaping developmental neurotoxicity research. A recent review highlights the growing use of innovative, animal-free testing methods to study the effects of chemicals on brain development. These approaches are driven by emerging technologies and international testing guidelines, such as those from the OECD. Learn more here ↗.

Finally, a new model using human-like brain cells, called LUHMES neurons, enables researchers to study nerve damage more effectively. This method allows detailed observation of nerve endings, measurement of specific markers, and analysis of biochemical changes after injury. See the full study here ↗.

Policy relevance

The EU's REACH ↗ regulations mandate comprehensive neurotoxicity testing for chemicals, but traditional methods are resource-intensive and impractical for evaluating large numbers of substances. This project seeks to create faster and more human-relevant testing methods for neurotoxicity, focusing on both developmental and adult effects. It emphasizes lab-based tests that address critical processes in brain development while working to close gaps in existing approaches. The ultimate aim is to recommend these improved methods for inclusion in regulatory testing frameworks.  

Overview

This project is focusing its research on developing new approach methodologies (NAMs ↗) to assess how chemicals effect the immune system. This addresses three key areas: organ-specific immune effects, particularly in the respiratory system and related allergic reactions; immune system suppression, measured through its response to vaccination; and improved models for studying how chemicals impact immune cells by identifying key biological processes involved.

The goal is to create innovative testing methods for these aspects of immune system effects.

To achieve this, well-understood reference chemicals will be used to develop and refine the methods. Once established, these methods will be tested on substances prioritised by the Partnership for the Assessment of Risks from Chemicals (PARC), where relevant. They will also contribute to the development of Adverse Outcome Pathways ↗, which link chemical exposure to harmful health effects, and integrated strategies for assessing chemical risk.

The results of this project will be relevant to improving chemical safety regulations across Europe.

Policy relevance

• REACH: several immune related outcomes are relevant for REACH such as skin sensitisation, respiratory sensitisation, immunosuppression. Currently under REACH, the immunotoxicity investigations are triggered based on repeated dose toxicity studies (28- or 90-day) in case there are some indications of immunotoxicity. If indications of immunosuppression are seen, one can include e.g. Cohort 3 into the study design of EOGRTS (developmental immunotoxicity) or request to have an immunotoxicity investigation included in a standard repeated dose toxicity study (adult immunotoxicity).
• CLP (Reg EC 1272/2008): While respiratory sensitisation is mentioned as a hazard in the CLP regulation, it is acknowledged that there is no respective method to detect respiratory sensitisers. Hence, a need to develop methods to detect respiratory sensitisers is recognized. On top of that, the CLP regulation foresees that non-animal testing is conducted wherever possible, implying support for the development of NAMS.
• Plant protection products (Reg EC 1107/2009) and biocides (Reg EC 528/2012): Sensitisation is analysed as part of the data requirements for plant protection products and biocides. The need to develop methods for respiratory sensitisation as well as alternative testing strategies is recognized.
• Cosmetic products: skin sensitisation.
• Food contact materials (Regulation (EC) No 1935/2004): allergenicity.
• Food contaminants (Regulation (EC) No 1881/2006) and enzymes (Regulation (EC) No 1332/2008): allergenicity.
• ECHA's KARC document ↗ (2023) stated the need for developmental immunotoxicity (DIT). NAMs developed and/or models characterized in this project could also feed the DIT needs.

Key messages

• Sixty-seven institutions are collaborating under the PARC initiative to enhance the utility of innovative analytical methods and tools for monitoring and surveys, supporting next-generation chemical risk assessment.  
• A network of harmonised laboratories operating standardised innovative methods for chemical exposure characterisation should be established for use as a tool within a European early warning system for chemical risks.
• Less conventional sampling, non-targeted mass spectrometry acquisition and effect-directed analysis show promise to advance chemical exposure characterisation but numerous scientific barriers limit their incorporation into regulatory frameworks.
• Uniform reporting practices need to be established and enforced to ensure transparency, reproducibility and comparability of generated results. Mandatory data sharing and metadata reporting, protocol sharing, and quality management procedures should be stipulated. Requirements include establishing fit-for-purpose identification scales, method performance criteria and software quality standards alongside mechanisms to assess compliance.  
• Continuous development of diverse and complementary analytical and computational methodologies is required to, and will improve the detection, annotation, quantification and prioritisation of chemicals and chemical features that pose current or emerging risks, safeguarding public health. 

Overview

The diversity of chemicals entering the environment is increasing, with some posing significant harm to ecosystems and human health. New analytical approaches, such as innovative sampling techniques, non-targeted profiling using high-resolution mass spectrometry, and effect-directed analysis, offer promising tools for detecting, identifying, and prioritising chemicals of concern ↗.

• Non-targeted profiling uses advanced instruments to scan samples broadly, detecting both known and previously unidentified chemicals.
• High-resolution mass spectrometry is a technique that accurately measures the mass of molecules, helping identify chemicals at very low concentrations.
• Effect-directed analysis combines chemical testing with biological responses to identify harmful substances.

Within PARC, 40 researchers from 30 institutes across 10 EU member states have outlined the scientific challenges in adopting these methods for regulatory use. These challenges include detecting and annotating chemicals (assigning identities to detected compounds), quantifying their levels, prioritising their risks, and ensuring results are scalable and easily reportable for widespread use.

The researchers recommend ways to incorporate these innovative tools into environmental and human monitoring programs. Doing so could significantly improve the characterisation of chemical exposure, provide better support for modern risk assessment methods, and contribute to early warning systems to protect health and the environment. 

Achievements & Results

The key needs and recommendations identified for leveraging innovative methodologies to support the development of next-generation chemical risk assessment were published here ↗.  

Recommendations from the publication were given further visibility being summarised in Chemical Watch News & Insight ↗. These included urging regulatory bodies like the European Chemicals Agency (ECHA ↗) to encourage companies to share mass spectral data. Such data can significantly enhance the ability to detect and identify chemicals, thereby improving monitoring programs and supporting chemical risk assessment.

Following discussion with ECHA, a working group is underway to develop a step-by-step strategy of how to implement some of the identified recommendations.  

Policy relevance

Only a few countries have integrated exploratory analysis into regulatory frameworks for human, food, or environmental monitoring to support chemical risk assessment. This project identified key scientific barriers that must be addressed to incorporate advanced techniques like non-targeted analysis and effect-directed analysis into monitoring programs and early warning systems. These findings have been communicated to regulatory bodies and policymakers, providing valuable insights to guide priority-setting and assess the feasibility of adopting these innovative approaches in policy frameworks. 

Overview

This project focuses on making human biomonitoring datasets more accessible and reusable for scientific and regulatory purposes. The goal is to ensure that these datasets are prepared and shared as FAIR datasets ↗, meaning they are Findable, Accessible, Interoperable, and Reusable. This approach helps researchers and regulators use the data effectively.  

Human biomonitoring datasets, which track chemicals and their effects in human bodies, pose challenges for reuse as they contain sensitive personal information requiring careful attention to ethical and legal issues. For example, maximising the scientific and regulatory value of the data required analyses on individual data points, maintaining the coherence of the dataset, and linking the data to other types of information, such as health, environmental, and lifestyle data. Additionally, human biomonitoring datasets often contain chemical measurements for which no standardised naming or identification systems exist, making them harder to use across different studies.

The project will make human biomonitoring datasets available to scientific users, who can reuse entire datasets, regulatory bodies, which might use the data to assess chemical risks and improve models and tools for environmental and public health policies, and the public, who might benefit from summaries or insights derived from the data.  

By doing this, the project indirectly supports multiple regulatory frameworks and aims to improve human risk assessment.

One of the broader impacts of the project is developing solutions to allow sensitive personal data to be reused while still safeguarding legal and ethical rights. This includes linking data across different domains—such as health, environment, and consumption—ensuring the systems used to analyse and share data can work together seamlessly.  

By tackling these challenges, this project aims to make human biomonitoring data more useful, while respecting the privacy and rights of individuals whose data is included. 

Achievements & Results

The final content, including outcomes, achievements, and actionable insights, will be published upon completion of the project.

Key messages

• Novel suspect and non-screening methods are crucial to detect a wide range of chemicals that may not be well understood or prioritised. Quality assurance and quality control for these methods is not yet well established. In this project, a harmonised quality assurance and quality control framework will be developed and implemented.

Overview

Chemicals are present everywhere in the environment. To understand the risks they pose to human health and the environment, it is essential to have reliable data about their presence in the environment, food and the human body. Well-established procedures and internationally agreed guidelines exist to validate methods for targeted analysis, which involves testing or specific substances, such as lead.

These guidelines include steps for quality control, often using control samples that contain the target substance. This helps to produce high-quality data that is FAIR (Findable, Accessible, Interoperable, Reusable), providing risk assessors with trustworthy data.

However, there are no universally accepted guidelines for suspect and non-targeted screening ↗, which involves scanning samples for a wide range of unknown chemicals without a specific one in mind. This approach is crucial in research projects like the Partnership for the Assessment of Risks from Chemicals (PARC) to identify chemicals that may not yet be well understood or prioritised. Suspect and non-targeted screening ↗ methods, which use chemical or biological techniques, are still relatively new, and necessary quality control and quality assurance processes are not yet well established and harmonised.

This project aims to establish the essential quality standards needed specifically for suspect and non-targeted screening ↗ methods. These methods rely on advanced techniques such as chromatography, which separates complex chemical mixtures, and high-resolution mass spectrometry, a process that identifies substances by measuring their molecular weight, as well as biological assays that reveal the effects of chemicals on living systems. The project will catalogue current quality control and quality assessment guidelines across food, environmental and human biomonitoring domains, identify any inconsistencies or gaps, and work to align these standards across the application fields to ensure robust, consistent procedures for identifying unknown chemicals.

Achievements & Results

An inventory document summarizing existing quality assurance and quality control used in environmental, human biomonitoring and food screening methods was drafted.

Policy relevance

Improving the quality and comparability of the results obtained by screening and non-target methods makes the results more reliable and usable for risk assessment.

Key messages

• This project will analyse data from the HBM4EU ↗ initiative to uncover new insights into chemical exposure, its regional variations, and its effects on health. It will specifically focus on chemicals like PFAS, PAHs, pesticides, arsenic, and cadmium, using data from the HBM4EU Aligned Studies.
• By incorporating biological markers such as BDNF, kisspeptin, epigenetic markers, and hormones, the project will expand our understanding of how chemical exposure impacts health and help identify potential causal pathways.
• The project will explore workplace exposure to harmful substances, including chromates, e-waste contaminants, and diisocyanates, providing valuable insights into occupational health risks using HBM4EU Occupational Studies data.
• It will study the relationship between fish consumption patterns and mercury exposure (from the MoM-study ↗) and examine common pesticide exposure routes and influencing factors (from the SPECIMEn study ↗). 

Overview

The HBM4EU ↗ project has generated extensive human biomonitoring data through the HBM4EU Aligned Studies ↗, covering various general population groups—adults, teenagers and children— as well as the HBM4EU occupational studies on occupational exposure to specific chemicals like chromium VI ↗, diisocyanates ↗ and e-waste. Chromium VI, for example, is a toxic form of chromium used in industrial processes, while diisocyanates are chemicals used in the production of foams, coatings, and adhesives. Electronic waste contains potentially harmful substances that are released during improper disposal. Additional studies include the MoM-study ↗, which looks at mercury exposure ↗ during pregnancy, and the SPECIMEn study ↗, examining pesticide ↗ hotspots. Data from these studies have already provided valuable insights, while more findings are expected to be published soon. However, further research questions are anticipated to arise from the data, and not all the generated data were analysed during HBM4EU.  

To maximise the use of HBM4EU data and apply them to new biomonitoring studies planned under the Partnership for the Assessment of Risks from Chemicals (PARC), additional statistical analyses will be conducted. These analyses are expected to shed more light on sources of exposure and health effects. This project is of relevance for all regulatory frameworks that aim to control the production, use, environmental release, and exposure to chemicals, as well as those focused on protecting environmental, human and worker health.  

Europe’s zero-pollution agenda ↗ should start with understanding the presence of synthetic chemicals in the bodies of its citizens and make reducing this chemical burden and its health impacts a key priority. 

By measuring exposure and effect biomarkers in human biomonitoring studies, researchers can gain insight into the health impacts of chemicals and their substitutes. This data will also support grouping similar chemicals together and help avoid replacing harmful substances with other chemicals that pose a similar risk.  

Achievements & Results

To date, two manuscripts are published as part of the exposure-effect analyses of the HBM4EU Aligned Studies, that is the manuscript on “Associations between urinary phthalate metabolites with BDNF and behavioral function among European children from five HBM4EU aligned studies ↗” and the manuscript on “Association of environmental pollutants with asthma and allergy, and the mediating role of oxidative stress and immune markers in adolescents ↗”.

For the remaining research questions, statistical analyses are ongoing and being finalised and manuscripts are being drafted. 

Key messages

• The existing databases containing information on chemicals in products and articles are heterogeneous in structure and coverage, which can hinder product safety and circularity.
• Enforcement agencies are challenged by lack of composition data in products and lack of analytical capacity to evaluate hazardous substances in products/articles.
• Lack of comprehensive data on chemicals in products/articles impacts outcomes of evaluation tools such as life cycle assessment.  

Overview

The European Commission has enacted several legislations like the European Green Deal ↗ and the Chemical Strategy for Sustainability ↗ to advance sustainable development in the EU. Strategic documents like these provide guidance for a toxic-free and sustainable future where the production and usage of chemicals is regulated to maximize benefit and minimize risks for the environment and human health. 

While several legislations set the foundation for higher levels of consumer and worker protection, enforcing them is vital to achieve all set goals.

This project will evaluate the current availability on chemicals and products and articles and assess how the availability and quality of data impacts a range of potential end uses of the data, in particular chemical enforcement, risk assessment and sustainability evaluation tools such as Life Cycle Assessments ↗ and Product Environmental Footprints ↗.

By improving our ability to identify and share data on chemicals in products and articles, the database structures will support to enforce regulation, develop risk-based identification tools for substances of concern ↗ due to health and environmental hazards, and the transition to a circular economy ↗.

Results of this study will support the decision-making of national enforcement authorities for chemical and product specific legislation as well as promote further restrictions of harmful chemicals in various consumer goods. 

Achievements & Results

The final content, including outcomes, achievements, and actionable insights, will be published upon completion of the project.

Overview

Physiologically Based Pharmacokinetic modelling is a method that uses mathematical representations of the body’s biological processes to predict how chemicals are absorbed, distributed, metabolised, and excreted in different tissues and organs. It plays a crucial role in evaluating how chemicals interact with the body, helping researchers to understand how different exposure levels lead to adverse health effects.

With increasing interest in using Physiologically Based Pharmacokinetic models for risk assessment, guidelines have been developed to guide the appropriate extrapolation of species, doses, and exposure scenarios.

These models’ mechanistic foundation makes them especially useful in toxicological risk assessment, particularly for complex extrapolations, such as predicting effects from in vitro to in vivo studies (lab-based cell studies to whole body studies), translating laboratory animal data to human scenarios, and addressing various exposure or dosing patterns.

The HBM4EU ↗ project reviewed existing Physiologically Based Pharmacokinetic models for multiple compounds and found significant gaps, including a lack of toxicokinetic data for many prioritised chemicals and limited models addressing sensitive populations, such as pregnant women and their foetuses, newborns, young children, and the elderly. Within PARC, Physiologically Based Pharmacokinetic models will be refined or newly developed to address the unique sensitivities of specific population subgroups. The project will integrate multiple exposure routes and sources (e.g. ingestion, inhalation, skin contact) and support the interpretation of human biomonitoring data. A variety of data sources will be used to refine or create models that incorporate internal dose metrics for accurate risk assessment.