The European Human Biomonitoring Initiative
A major hurdle in reliable risk assessment and management of chemicals is the lack of harmonised information about the exposure of citizens, including workers, to chemicals and their interplay with other concurrent environmental exposures and impact on health. Each individual is today exposed to a large number of chemicals in their environment, including the workplace, through the air, food, water and consumer products. For many of the chemicals, the health impact, including long-term, is still unknown. Innovative approaches are needed to enable us to decipher the potential causal associations between exposures and health effects over a lifetime and, where such links are identified, to understand the underlying mechanisms.
A first step to better assess and understand this potential impact on heath is to gather harmonised and comparable information on population exposure to chemicals in Europe through human biomonitoring (HBM), to link this information to data on exposure sources and epidemiological surveys and to promote research on the exposure-response relationships in humans.
The objective is to create a European joint programme for monitoring and scientific assessment of human exposures to chemicals and potential health impacts in Europe, building on previous activities undertaken at EU and national levels. This European Human Biomonitoring Initiative (EHBMI) should:
- be achieved through coordination of HBM initiatives at national and EU level, with a special focus on linking research to evidence-based policy making.
- build on European excellence in the field and promote capacity building and the spread of best practice.
- provide a platform through which harmonised and validated information and data collected at national level can be accessed and compared.
- support research and innovation in various ways, e.g., by improving underlying methods and procedures (e.g., for sampling, sample analysis, data analysis, and data management), by improving the understanding of the impact of the exposure on human health (e.g., development of validated exposure and effect biomarkers and establishing correlation between biomarker levels and health risks) and by improving the use of HBM data in risk assessment of chemicals and their mixtures.
The acquired knowledge should support informed decision taking and policy making in a wide variety of sectors, one of the most important being the EU chemicals legislation under REACH[[http://echa.europa.eu/regulations/reach]].
The governance structure of the EHBMI should allow for review of the priority setting with regards to chemicals to be investigated by the initiative, taking into account the scientific advances at national and EU level.
The proposal should include a five-year roadmap describing the key priorities and governance processes as well as the first annual work plan.
The joint programme should be structured along three main components:
- a platform providing support for field sampling and analytical work by competent national laboratories and a data infrastructure;
- a research programme to assess the impact of chemical exposure on human health; and
- an activity focused on translation of programme results into policy.
The three components must operate in close coordination, in order to address the overall priorities of the initiative.
The platform on field sampling and analytical work should include joint activities aiming at advancing, harmonising and quality assurance in field work practices and analytical methods and contribute to the development of EU reference values. Potential research aspects to be addressed are, inter alia, related to developing innovative analytical methods, including in atypical biological matrices, non-invasive technologies, new biomarkers, and reference materials. A network of reference laboratories and field survey entities of high quality must be established, engaged in capacity building across Europe and facilitating access to special equipment. Best practices for management of data resulting from linking analytical results and field surveys must be established, facilitating the data inclusion into the Information Platform for Chemical Monitoring Data (IPChem platform[[IPChem aims to support a coordinated approach to collecting, storing and accessing monitoring data on chemicals and chemical mixtures in humans and in the environment: http://ipchem.jrc.ec.europa.eu/#home-page]]) currently under development by the EU Joint Research Centre.
The EHBMI should ensure the inclusion of new HBM data and whenever possible existing HBM data to IPChem and address outstanding issues related to HBM data policy and data quality assurance. Furthermore, the consortium should ensure that the new data, relevant for policy making, produced in this initiative, will be made available to regulators at the national and EU level. For this purpose the proposal should include a draft Data Management Plan, renewed annually, detailing what data the project will generate, how it will be used and/or made accessible for regulatory purposes.
The research programme to understand the impact of exposures on human health should include joint research on correlation, integration and analysis of data from different sources, e.g., HBM data, environmental, occupational, health examination and epidemiological surveys; research on exposure mechanisms and modes of actions and research for innovative approaches to risk assessment.
The work undertaken under the science-policy interface component should aim at informing existing policy making processes (from chemicals to health) at EU and national level about the outcome of the EHBMI, exploring the possibilities and requirements for an increased use of HBM data in evidence-based policy processes and mobilising existing committees and expert/advisory groups to contribute to setting priorities.
Research activities may be supported by open calls for proposals organised by the consortium, if deemed necessary, aiming at bringing in additional expertise and engaging with the wider research community.
Dissemination, communication and training activities should be included in the initiative, in particular efforts to increase public awareness and understanding of the obtained results and their implications for policy making and self-responsible lifestyle management. A public engagement component should be included whereby citizen science approaches to human biomonitoring are explored and sought.
The minimum number of participants is five independent legal entities from different Member States or associated countries owning or managing national research and innovation programmes. In addition to the minimum conditions, other legal entities may participate if justified by the nature of the action.
Horizon 2020 contribution will be limited to a maximum of 70% of the total eligible costs of the action with a maximum of EUR 50 million of EU contribution for the expected five years duration of the action.
The Commission will only fund one proposal under this topic.
- Coordinating HBM initiatives in Europe at national and EU level and spreading of best practice and capacity building.
- Advancing the understanding of the nature and level of chemical exposure of EU citizens at all ages, including workers, and the potential health risks leading to better protection of the health of EU citizens. Gender aspects should be taken into account where relevant.
- Establishing a strong EU-wide evidence base of comparable and validated exposure and health data for sound policy-making at EU and national level, based on evidence-based regulation, risk assessment and management, whilst striking an appropriate balance with industrial competitiveness.
- Preparation for a possible public-public partnership under Article 185 of the Treaty.