Report

Teaser, summary, work performed and final results

Periodic Reporting for period 2 - HBM4EU (European Human Biomonitoring Initiative)

Teaser

The European Joint Programme HBM4EU is a joint effort of 28 countries and the European Environment Agency, co-funded by the European Commission under Horizon 2020. HBM4EU started on 01 January 2017 and is running for five years. Detailed information on the programme as well as...

Summary

The European Joint Programme HBM4EU is a joint effort of 28 countries and the European Environment Agency, co-funded by the European Commission under Horizon 2020. HBM4EU started on 01 January 2017 and is running for five years. Detailed information on the programme as well as all deliverables referred to in this summary can be found on www.hbm4eu.eu.
The HBM4EU research programme is designed to answer policy questions related to chemical safety by providing scientific evidence. HBM4EU will harmonise HBM data at European level and use this data to understand human exposure to chemicals, their impact on health, and to thereby contribute to advance chemical risk assessment as well as the communication on chemicals risks in Europe.
The first exercise to prioritise substances for action within HBM4EU was performed in 2015 and resulted in nine substance groups:

(1) Phthalates and DINCH,
(2) Bisphenols,
(3) Per-/polyfluorinated compounds,
(4) Flame Retardants,
(5) Cadmium and Chromium VI,
(6) PAHs,
(7) Aniline family/MOCA,
(8) Chemical mixtures, and
(9) Emerging substances.

Building on the experience gained with the first prioritisation exercise a prioritisation strategy was developed and implemented leading to a second set of substances:

(1) Arsenic,
(2) Acrylamide,
(3) Aprotic solvents,
(4) Diisocyanates,
(5) Lead & its compounds,
(6) Mercury & its organic compounds,
(7) Mycotoxins,
(8) Pesticides, including Pyrethroids, and
(9) UV filters – Benzophenones.

For both set of substances HBM4EU is now engaged in various activities such as collecting new HBM data in aligned studies across Europe, assembling and harmonising existing data, defining data and research gaps, establishing a sound QA/QC system, developing European Reference Values, new methods or analysing the exposure pathways and health impacts. Additionally materials for communication and information of the general public as well as for policy makers are an integral part of the work. Requests according to the Rapid Response Mechanism will cover also the chemicals of both priority lists.

Work performed

Laying the foundations for a pan-European HBM platform that includes National Hubs and builds on existing expertise (Specific Objective 01)

During 2018, HBM4EU made significant progress in building the European HBM Platform. Twenty-one out of our 28 partner countries are engaged in the aligned studies. The surveys included six priority substances for three age groups, namely children, teenagers and adults, with around 3000 samples per age group.
HBM4EU started the implementation of a very ambitious Quality Assurance program for the first set of priority substances. A total of 78 exposure biomarkers were selected based on an in-depth analysis of the most adequate matrices and analytical methods for each of the priority substances. The program had a high participation rate with more than 100 laboratories from 26 out of the 28 partner countries.
In terms of existing datasets, the HBM module in IPCHEM was populated with metadata from 77 data collections.
The network of National Hubs has been frequently contacted by the National Hub Coordinator and provided feedback to specific questions. Their input and interest in the programme has been growing. They were active in the second prioritisation exercise (Deliverable D4.4), contributed to identifying relevant national data sets and studies (D7.5) as well as analytic laboratories, actively promoted the alignment of studies (D8.4), reviewed and improved the drafts for derivation of HBM Guidance Values for the phthalates DPHP, BBP and contributed to the sustainability discussion (D6.3).
In 2018, different approaches that could be used in the future to ensure the sustainability of HBM4EU were identified (AD 6.1) and are now being further discussed and elaborated.
Dr. Thomas Jakl, Austrian Federal Ministry for Sustainability and Tourism, responsible for Chemicals Policy and Biocides was nominated HBM4EU Ambassador, with the task to promote a European approach to human biomonitoring as developed by HBM4EU.

Developing a common methodology for the interpretation and use of HBM data in policy-making (Specific Objective 02)

All the work carried out in 2017 and 2018, including the harmonisation of protocols, questionnaires, alignment of studies, the quality assurance programme for the chemical analyses, the harmonisation of the data management and the statistical analyses provide the foundation for the subsequent interpretation of coherent European datasets to understand exposure (D7.2, D7.3, D8.4, D9.4, D10.1, D10.2, D10.5).
In order to better present results to policy makers, aid interpretation and foster the use of the HBM data, HBM4EU develops indicators (Buekers et al., Int. J. Environ. Res. Public Health 2018, 15, 2085), reference values and health based Human Biomonitoring Guidance Values (D5.2). In 2018, Human Biomonitoring Guidance Values (HBM-GV) were drafted for DPHP and DnBP, including an indication of the level of confidence (to be published in 2019). They will support the interpretation of internal exposure levels and the potential health impact in the general population and are currently under review by the National Hubs.

Harmonising and optimising the practices of national HBM programmes, including sample collection, quality assurance and data management (Specific Objective 03)

HBM4EU has paved the way for using existing samples in a harmonised manner, as well as for harmonised new studies. During 2018, a range of fieldwork materials, including questionnaires, recruiting, sampling, and exchange of biobanked samples, etc., were updated or developed (AD7.2, D7.3, D7.4, D8.2). On this basis the work on actually aligning studies started (D8.1, D8.4).
HBM4EU also paved the way for harmonised chemical analysis to ensure the quality and comparability of the analytical results. A complete program to guarantee the quality of the chemical analysis biomarkers and matrices was designed. Standard Operation Procedures (SOPs) for running the Quality Assurance program were developed an

Final results

In 2018, the structures, networks, collaboration and dissemination necessary for a successful work were further developed and optimised. HBM4EU is well on its way, with the majority of the tasks and objectives defined in the AWP 2018 having been reached.

In the second year, HBM4EU updated the overview on existing HBM programmes and data collections (D7.1, D7.5) and suitable laboratories in the partner countries (D9.6). Also guidance and harmonised protocols for fieldwork, sampling, data analysis, and QA/QC were further developed in 2018, as they are a necessary prerequisite to generate harmonised data, improving the comparability of HBM data. Based on the inventory of best-suited biomarkers and matrices for the set of prioritised substances, a selection of biomarkers has been made to be included in the QA/QC program set up in 2018. To harmonise chemical analysis of biomarkers in HBM surveys a database of candidate laboratories for analysis, development of new methods and supporting the QA was established. The laboratories responsible for organising interlaboratory exercises (ICI) as well as the participating laboratories were selected from these databases. The work on QA/QS revealed the urgent necessity of this activity to define criteria under which data from different studies can be combined and used together for risk assessnment purposes.

The scoping documents per substance group are the link between the policy questions and the research needs. They contain the most relevant background information and combine different perspectives (society, research and policy at national and EU level) as EU and national policy makers and stakeholders are involved in identifying priority substances (D4.2, D4.6).

To respond to the identified policy need for valid, harmonised and comparable data on internal chemical exposure of citizens, new and ongoing HBM studies were aligned to build a European HBM platform. First results are expected in 2019. This joint approach stimulates capacity building for less experienced countries, exchange and burden sharing between established programmes and, thus, laying the foundation of a European HBM platform.

In addition, a statistical analysis plan to calculate EU reference values or exposure distributions to describe human chemical exposures in the EU population and to evaluate the main determinants of exposures was developed (D10.5).

The first joint EU occupational exposure study targets occupational exposure to chromium VI in metal surface treatment activities and in welding. Sampling for the chromate study has been performed in 2018 in seven participating countries. The work on QS/QS brought new insights in the considerable challenges of the methodology and enhanced a stimulating discussion between European experts from different partner countries. In 2019 HBM4EU will continue to coordinate the efforts with regard to proposed occupational studies and their policy relevance.

Existing HBM data are becoming increasingly available through the HBM4EU repository and the Information Platform for Chemical Monitoring (IPCHEM). However, the new EU General Data Protection Regulation (GDPR) posed some additional challenges on this process, which are still cause of considerable additional efforts. IPCHEM makes Human Biomonitoring (HBM) data findable and accessible, stimulating the use of HBM data in European policy processes. The HBM4EU repository enables transfer and storage of non-anonymised individual HBM data.

Currently, 77 data collections, 24 aggregated data sets and 3 individual anonymous data sets are accessible via IPCHEM and more are expected in 2019. HBM4EU also makes an effort to harmonise European HBM data in IPCHEM. This harmonisation allows integrating standardised descriptive statistics in IPCHEM that are comparable across data collections and enhance pooling of single measurement data across data collections. Twenty aggregated datasets in IPCHEM are in harmonised format and originate from 4

Website & more info

More info: http://hbm4eu.eu.