HBM4EU: European Human Biomonitoring Initiative

Blutabnahme mit einer SpritzeClick to enlarge
Blood sample
Source: Guido Grochowski / Fotolia.com

To capture the availability of Human Biomonitoring data in the EU member states and to better understand the health impacts of exposure to harmful substances, the EU Commission funded the project "European Human Biomonitoring Initiative" (HBM4EU) with over 74 million euros within the framework of the "Horizon 2020" funding programme.

Table of Contents

The European Human Biomonitoring Initiative (HBM4EU) aimed at consolidating existing data and implementing joint studies to generate knowledge on the safe management of chemicals and thus protect human health in Europe. HBM4EU used Human Biomonitoring (HBM) to assess human exposure to chemicals in Europe, to better understand the associated health impacts and to improve chemical risk assessment. HBM4EU’s vision was to build up an innovative framework for Human Biomonitoring across Europe at the science policy interface, build on national capabilities and expertise, to answer policy questions on chemical safety based on evidence from HBM data, responding to the needs of EU and national authorities in the field of chemicals, environment and health, thereby improving chemical risk assessment in Europe.

The consortium of 120 partners from 30 countries was coordinated by UBA and brought together European Human Biomonitoring expertise from 24 EU Member States plus Norway, Iceland, Israel, United Kingdom, Northern Macedonia, and Switzerland. HBM4EU focused on the development of a pan-European network. Empirical data and results of the joint studies were (and will be) communicated and integrated into the European environment and health policy to improve targeted and effective policy measures to reduce human exposure to chemicals.

The long-term goal was a joint European programme to monitor and scientifically assess exposure of EU citizens to chemicals and potential health effects, and to improve the corresponding legal regulations.

At the end of the project, HBM4EU published 168 publications - and more are still in preparation.


The role of Human Biomonitoring in the assessment and management of chemical risks

Environmental chemicals are used in a wide range of products - including medical, veterinary, agricultural and pest control products - and offer numerous benefits to society. At the same time, hazardous environmental chemicals have harmful effects on human health and the environment, cause costs to health systems and lead to reduced environmental quality. Hence, the EU 7th Environment Action Programme aimed to “safeguard the Union's citizens from environment-related pressures and risks to health and well-being” and “to “improve of the knowledge and evidence base for the Union's environmental policy”.

At European level, there is a lack of harmonised information on the exposure of citizens to environmental chemicals and their interaction with other concurrent environment-related pressures and health effects. This makes reliable risk assessment and management of environmental chemicals difficult. We are exposed to a complex mix of chemicals in our daily lives - through the environment, consumer products, cosmetics, food and drinking water and at work. For many environmental chemicals, the effects on health associated with life-long exposure are unknown. In addition, knowledge of the health impacts of chemical mixtures is limited.

Human Biomonitoring (HBM) enables us to measure the extent to which the population is exposed to or affected by environmental chemicals. This involves measuring either the substances themselves, their metabolites or biomarkers of health effects in body fluids or tissues. Information on human exposure can then be combined with data on the sources of environmental chemicals and epidemiological studies.


Objectives of the Joint European Programme HBM4EU

Key objectives were:

  • Harmonised methods at EU level
  • Provision of existing national data, collection of new HBM data
  • Linking these data with data on external exposure, identification of exposure pathways
  • Development of new methods, also for HBM at work
  • Evidence on causal links between exposure and health
  • Answering questions from EU authorities and contribute to the improvement of policy making / risk assessment of chemicals
  • Providing information to policy makers and the public on health risks from exposure to pollutants
  • Establishing a sustainable HBM infrastructure throughout Europe

To achieve these objectives, the consortium harmonised Human Biomonitoring initiatives in 30 countries, drawing on existing expertise and building new capacities. In each country, so-called “National Hubs” were established to coordinate activities with the ultimate aim of creating a robust Human Biomonitoring platform at the European level.

The initiative contributed directly to improving the health and well-being of all citizens by studying how exposure to environmental chemicals affects the health of different groups - e.g. children, pregnant women, foetuses and workers. It also examined the extent to which factors such as behaviour, lifestyle and socio-economic status influence internal exposure to environmental chemicals in the EU population. This knowledge was directly fed into policy-making to reduce chemical exposure and protect human health.

HBM4EU ran for five and a half years - from 2017 to 2022 - and aimed to establish a sustainable programme. The HBM4EU consortium identified priority substance groups that were in the focus of the activities.

During the project existing HBM data for the prioritised substance groups were collected and aligned, suitable data was made available on the Information Platform for Chemical Monitoring (IPCHEM) and it was determined which policy issues could be addressed with the existing data. By this means, HBM4EU could assess the extent to which a robust database of comparable HBM data from the EU can provide answers to key policy questions.


Prioritisation and selected substance groups

While developing priorities, the consortium produced a list of substance groups. Both national and EU specific policy needs for knowledge on chemical exposure and health impacts were taken into account. Substances for which knowledge was needed to support EU policymaking were identified through a close dialogue with the EU Policy Board. Input from the national level was provided through a steering committee composed of national representatives.

The set of criteria included questions such as whether a substance is of concern to human health, whether there is evidence of exposure to humans and/or the environment at EU level and whether there are outstanding policy issues. The financial and technical feasibility of substance monitoring was also a criterion.

This priority setting resulted in groupings of substances which formed the main activities in HBM4EU.

The list of prioritised substance groups included

  • Phthalates and Hexamoll® DINCH,
  • Bisphenols,
  • per- and polyfluorinated compounds,
  • Flame retardant,
  • Cadmium and chromium (VI),
  • polycyclic aromatic hydrocarbons (PAHs),
  • the group of aniline,
  • chemical mixtures and
  • emerging substances
  • arsenic
  • acrylamide
  • aprotic solvents
  • diisocyanates
  • lead & lead compounds
  • mercury & organic mercury compounds
  • mycotoxins
  • pesticides , including pyrethroid
  • UV filter – benzophenone

HBM4EU results

HBM4EU developed strategies, guideline documents, HBM harmonisation methods across the EU, and a full analytical QA/QC programme to improve comparability of HBM data and their use for policy. A European network of HBM analytical laboratories now exists for chemical analysis qualified/expert laboratories, analytical method development and support/implementation of QA schemes for HBM4EU prioritised substances.

The HBM4EU Aligned Studies generated new comparable HBM data for Europe, informed on current internal exposure of the general population to selected priority substances and on effect biomarkers in over 10,000 citizens, e.g. exposure biomarkers of phthalates, DINCH, flame retardants, pesticides, acrylamide, PFAS, arsenic species, UV-filters, cadmium, bisphenols, PAHs and mycotoxins. Harmonised occupational studies were done on exposure to i.a. chromium (VI), other harmful chemicals, to diisocyanates and in E-waste handling. A targeted Intervention Study on Mercury was done to evaluate impacts of dietary advice for pregnant women in countries with a diet high in fresh water/marine products and high mercury levels, showing the successful collaboration between HBM experts and health providers for health promotion. Through feasibility studies HBM4EU also demonstrated the utility and drawbacks of combining HBM and health surveys.

HBM metadata and summary statistics are available through the HBM module of IPCHEM, contributing to the use of HBM data in policy processes.

A new interactive European HBM Dashboard allows visualisation of HBM data collections & summary statistics from HBM4EU, e.g. exposure levels, temporal/spatial trends in chemical exposure of citizens and exposure distributions (e.g. for sex, region, age group and educational level).

To interpret HBM data in a health risk context, HBM Guidance Values (HBM-GVs) for general and occupationally exposed population were derived. HBM based indicators were developed to enable the use of HBM data for assessing time/spatial trends in internal exposure of citizens and to get an overview of the population at risk.

Values of key toxicokinetic parameters and specific chemical-biological interactions to link external to internal exposure and improve exposure models for risk assessment were identified. A HBM4EU exposure database was built to provide necessary data for exposure models for reconstructing exposure from HBM data and to estimate internal doses for prioritised chemicals.

Biomarkers of exposure were complemented with biomarkers of effect as a proof of concept to increase the weight of evidence of exposure-health outcome associations in human studies. New methodologies based on artificial intelligence and systems toxicology were developed to link several priority substances to molecular initiating and key events in Adverse Outcome Pathways (AOPs). Existing data was analysed together with novel measurements, in line with health endpoints and prioritised effect biomarkers, to advance knowledge on exposure-health relationships, specifically concerning PFAS.

To identify chemicals of emerging concern, we developed the first proofs-of-concept illustrating 1) capabilities of suspect screening to capture simultaneously a range of exposure markers in human samples, 2) capabilities of non-targeted screening of halogenated markers of exposure to reveal new markers in human samples that are likely to be new emerging compounds, 3) elaboration of a never yet achieved aggregated and QA/QC consolidated EU database (CECScreen) inventorying >300.000 exposure markers related to chemicals of emerging concern, and 4) creation of an MS/MS spectral reference library to increase the confidence level in the identity of the detected exposure markers.

To identify health risks of chemical mixtures a diverse set of case studies and a decision tree for addressing mixture effects were developed. For combined exposure to multiple chemicals, we showed how network analysis of existing HBM data can be used to identify real-life mixtures, i.e. clusters of co-occurring chemicals. Network analysis of existing HBM datasets from 4 different countries across Europe, showed that combined exposures to multiple chemicals are common and occur in all population groups. In the SPECIMEn study on pesticides, harmonised suspect screening analyses was done on urine samples, resulting in the identification of 95 pesticide-related markers, related to 30 parent compounds, e.g. acetamiprid, chlorpropham, boscalid, and clothianidin.

A strategy and communication lines for feeding results into policy processes and main messages to targeted audiences were developed. Substance specific policy briefs and reports highlight the HBM4EU results and answers to policy questions and main messages for policy makers.

The 3rd list of prioritised substances was identified and a survey launched to identify policy needs/activities for chemical risk assessment – for continuation in the Partnership for the Assessments of Risk from Chemicals (PARC).

A vision for a sustainable HBM programme in Europe, based on input from National Hubs (NH), EU agencies, EC Directorate Generals and experience of HBM4EU and a concept anchored in the EU’s Chemicals Strategy for Sustainability, were created.


The legacy of HBM4EU

HBM4EU established a new type of “policy advising research project”, in which policy questions are taken into account right from the start, when planning the research activities. By linking science, national regulatory and assessment authorities and EU institutions, the research carried out answered current questions and thus effectively contributed to improving the protection of human health from chemical-related adverse effects.

A network of 30 so called National Hubs, providing national expertise to build the international pan-European HBM platform and strengthening national capacities using international networking, was created.

Analytical capacity and comparable HBM data at EU level were generated. Chemical safety research on e.g. chemical mixtures, chemicals of emerging concern, linkage between exposure and effects indicating health risks, was strengthened. Results obtained and the innovative methods and tools developed are highly relevant to policy makers.

The unique alignment of national HBM studies is a major achievement, which led to a broad availability of harmonised HBM data at EU level, feeding directly into policy development and evaluation.

New HBM exposure data increases the understanding of how EU citizens are exposed to chemicals. HBM-GV’s will promote HBM application to setting safe human exposure values for risk management decisions.

The European exposure distributions values and HBM data made available in IPCHEM will greatly contribute to exposure evaluation and risk assessment.

The HBM4EU Data Policy and strategy for data sharing, the European HBM dashboard and computational tools for the interpretation of HBM data, translated into external exposure estimates, to be used for chemical risk assessment, will be of great use in the future.

Key elements of HBM4EU’s legacy are the structured process for prioritisation of chemical substances and research activities, widely accepted by the scientific community, policy makers and stakeholders, and the network of laboratories engaged in the QA/QC Control Scheme.


HBM4EU publications

At the end of the project, HBM4EU published 168 peer-reviewed articles – and more are on the way.

HBM4EU published 14 „non-technical factsheets“ with infographics, 18 „policy briefs“, 18 „substance reports“ for the HBM4EU prioritised substance groups, 23 HBM4EU videos and a series of „research briefs“ on its website.

For the final conference the so called HBM4EU Newspaper was developed, which highlights the main results and milestones. Furthermore, a storytelling exhibition ‘We live in a chemical world’ took place in Brussels that aimed to 1) enable the visitors to understand data generated and presented by HBM4EU, 2) transfer the data into stories, and, 3) illustrate how science-based data from HBM4EU could be used in policy making.


Conclusions of the European Council on Chemicals of 26 June 2019

In its conclusions, the European Council recognised HBM4EU at the interface between science and European chemicals policy. It encourages a similar research programme on environmental monitoring and on improving the exchange and use of monitoring data collected locally, regionally, nationally and EU-wide - both between countries and between policy areas (e.g. water, chemicals, air quality, biomonitoring, health, etc.) and relevant institutions. The Council would like to see these activities continue under the new "Horizon Europe" programme. In particular, the Member States and the Commission should encourage the development of an appropriate infrastructure to make data findable, accessible, interoperable and usable.

Printer-friendly version
 HBM  Humanbiomonitoring