CORDIS

We will revise the set of indicators following the first 2.5 years of the initiative and add, delete or modify the previous indicators taking into account societal, scientific, policy and stakeholder perspectives. DOMG is an LTP to VITO and is responsible for this deliverable.

List of known chemicals (parent compounds or metabolites) to be considered as exposure markers of emerging concern. IRAS is an LTP to RIVM and is responsible for this deliverable.

Database of the laboratories considered as candidate to perform the analysis of samples, to develop new methods and to support the QA/QC Program considering the substances included in the first round of prioritization. ULPGC is an LTP to ISCIII and is responsible for this deliverable.

This deliverable will report on the criteria that will have be used to select data and samples needed for determining exposure-response associations for all priority substances.

Update of the report under D11.1 adding new information about on-going/planned studies and updates to the SOPs based on the 2nd prioritization round.

Database of the laboratories considered as candidate to perform the analysis of samples, to develop new methods and to support the QA/QC Program considering the substances included in the first round of prioritization. ULPGC is an LTP to ISCIII and is responsible for this deliverable.

The report will be a comprehensive assessment of the long term needs and possible funding mechanisms.

A list with the selected biomarkers, matrices and analytical methods selected according to the criteria defined in task 9.1 and considering the substances included in the second round of prioritization.

Detailed working documents are provided for recruitment and sampling for the study conduct for the second prioritized substances to close identified data gaps.

The existing information about the substances prioritised in the second prioritisation round (M18) on ongoing or within the next five years initiated or planned studies in the field of HBM (general population and occupational exposure) and health will be reported and data gaps identified. Metadata that can be uploaded in IPCheM will be compiled. FMUL is an LTP to FCT and is responsible for this deliverable. FMUL is an LTP to FCT and is responsible for this deliverable.

Initial proposals and research plan for targeted occupational studies with EU added value on priority substances.

This deliverable will provide the comprehensive template that will have to be used to collect data on AOPs for the priority substances dealt with in HBM4EU. This will be fully compatible with the AOP KB of the OECD in order to ensure high level of coordination of the work done in WP13 with major international efforts in this domain.

Report on progress made to access biobanked samples from across Europe and how these samples will be used to address data gaps. KI is an LTP to SEPA and is responsible for this deliverable.

A generic canvas for policy interpretation of the HBM findings based on the input from EU policy board members; policy makers and stakeholders. UAntwerpen is LTP to VITO and is responsible for this deliverable.

Necessary material to communicate with the participants are compiled and examples for the second prioritised substances provided.

Report on the national studies which will align, the processes to integrate the requiremns from HBM4EU to these national structures and any obstacles.

Description of national HBM programmes, which may align, to form a network for HBM4EU EJP.

2nd substance-group specific risk assessment based on HBM data of first round priority substances collected in HBM4EU.

This initial report will provide specific proposals for the future of the initiative based on our initial interactions with a large number of bodies. It will include the mechanisms of cooperation with DG RTD, the financial plans for 2021-2030, a governance structure and an institutional anchor at EU level.

Derivation of health based guidance value for first round priority substances based on existing data.

The scoping document will outline targeted research activities proposed for 2019 and designed to address policy questions regarding a specific substance or group of substances. The descriptions will include goals, activities to be undertaken, methods, expected output and results, assumptions, constraints and budget estimates, as well as addressing ethical issues for each of the prioritized substances.

List of criteria to select biomarkers of effect according to the type of study, the biological matrices where they have been developed, and to the analytical methods used in coordination to task 9.1. UGR is an LTP to ISCIII and is responsible for this deliverable.

A list of biomarkers based on the human health effects, the quality of the assay and its usefulness for large population studies, which provide the most significant added value to HBM4EU by linking exposure data to measures of biological effects. This deliverable will also report on the outcome of the workshop organised in M18, as well as, the meta-analysis on existing data, if appropriate. UGR is an LTP to ISCIII and is responsible for this deliverable.

This report will provide estimates of the risk characterization ratios for the 1st set of priority substances based on the results of the quantitative estimates of exposure derived in task 12.2.a. In this context, any new regulatory thresholds discussed at the policy level for the 1st set of priority substances will be evaluated vis-à-vis the exposure estimates generated using the exposure reconstruction algorithms developed in HBM4EU.

This deliverable will provide a comprehensive inventory of all previously collected samples and data (including the inventory prepared in WP7 and WP8) that will be available and useful for the derivation of robust exposure-response relationships for the 1st list of priority substances.

The statistical analysis plan describes the statistical analyses that will be performed to test the hypotheses that are formulated as part of the study protocol for each of prioritized substances. ISGlobal is an LTP to ISCIII and is responsible for this deliverable.

Report on the new planned studies, the countries who will be involved and the material that has been prepared for these studies.

The scoping document will outline targeted research activities proposed for 2018 and designed to address policy questions regarding a specific substance or group of substances. The descriptions will include goals, activities to be undertaken, methods, expected output and results, assumptions, constraints and budget estimates, as well as addressing ethical issues for each of the prioritized substances.

This report describes the gaps in existing data as identified under 15.1, the outcome of the CGL and MS and EC institutions’ consultation, and outlines the workplan for a joint HBM survey on mixtures in 3-5 MS. IRAS is an LTP to RIVM and is responsible for this deliverable.

List of European reference values derived by analysis of consolidated data in IPCheM.

The templates will provide a consistent approach to the submission of requests for action by HBM4EU under the rapid response mechanism. Templates will be produced for two communities, the EU policy community and the national policy makers. ANSES is LTP to INSERM and is responsible for this deliverable.

This report will lay out the tiered methodology for exposure reconstruction from HBM data – the methodology will be structured in tiers on the basis of data availability and model estimation capacity for the compounds targeted in HBM4EU.

The first risk assessment will make use of already existing HBM data and will develop draft protocols for use in specific policy domains eg. food safety, chemical safety, occupational safety.

A legal, ethics, and intellectual property rights framework in parallel and in coordination with the Data Management Plan under task 10.1 to ensure that procedures for the collection, collation, transfer and use of HBM data fully respect data management and privacy legislation both at EU and at national level. UCPH is an LTP to NRCWE and is responsible for this deliverable.

The report describes available HBM mixture data and presents and discusses the results from the re-analysis of compiled database of existing HBM mixture data.

The Strategy for the communication and dissemination of HBM4EU results will frame our key messages and identifying target audiences and relevant communication tools. The Strategy will include a publication plan, establishing a policy for the publication of articles in scientific journals, including such issues as authorship, as well as proposing processes to ensure that policy makers have access to results without undue delays caused by journal publication timeframes.

An update of the Strategy for the communication and dissemination of HBM4EU results to reflect the activities and outputs foreseen in the 2018 AWP.

We will develop a first set of indicators capturing societal, scientific, policy and stakeholder perspectives, to measure the performance and impacts of the HBM4EU. LNE Department is an LTP to VITO and is responsible for this deliverable.

Report about what type of opportunities and obstacles were observed mainly in Germany, France and Israel when combining HBM and health studies, summary of the results to the questionnaires about on-going/planned health studies and administrative registers. SOPs for criteria for the use of existing biobanked samples for HBM analysis and guidelines for linking HBM and health studies

This report will provide the values of the biological half-lives of the 1st set of priority compounds targeted in HBM4EU on the basis of the PBTK modeling results. The PBTK models will have been parameterized and upgraded based on the experimental data obtained in task 12.3.b.

The report will detail the structure, functionalities and content of the online library. It will also report on usage over the first 21 project months, based on the number of online users and downloads from the library.

Standardised workflows for broad “suspect chemical screening” of known emerging chemicals and for screening unknown emerging chemicals. INRA is an LTP to INSERM and is responsible for this deliverable.

Experimental work: Report on results of the validation of specific biomarker of effect (i.e., ex vivo cell-based functional assays) in a set of available collected human samples from ongoing/current studies. UGR is an LTP to ISCIII and is responsible for this deliverable.

The existing information about the substances prioritised in the period of proposal preparation on ongoing or within the next five years initiated or planned studies in the field of HBM (general population and occupational exposure) and health will be reported and data gaps identified. Metadata that can be uploaded in IPCheM will be compiled. FMUL is an LTP to FCT and is responsible for this deliverable. FMUL is an LTP to FCT and is responsible for this deliverable.

This deliverable will report on the knowledge gaps identified in order to complete the establishment of AOPs for the 1st and 2nd list of priority substances in HBM4EU. It will also include a description of the studies (-omics, functional assays, etc.) necessary to complete the identified AOP knowledge gaps.

The statistical analysis plan describes the statistical analyses that will be performed to test the hypotheses that are formulated as part of the study protocol for each of prioritized substances. ISGlobal is LTP to ISCIII and is responsible for this deliverable.

Report of selected effect biomarkers selected for the 1st set of prioritised substances, including those that can provide integrated information on delineating the mode(s) of action (MOA) of the adverse response or toxicity. UGR is an LTP to ISCIII and is responsible for this deliverable.

A strategy for the pan-European exchange of biobanked human samples is developed and laid down and SOPs including technical, legal and ethical requirements for the safe and standardized exchange elaborated. IBMT is an LTP to UBA and is responsible for this deliverable.

The second list of prioritised substances will results from the prioritisation round from 2017 to 2018. It will identify substances that have been prioritised for inclusion in HBM surveys, analysis and/or research under HBM4EU in the three year period from 2019 to 2021. ANSES is LTP to INSERM and is responsible for this deliverable. ANSES is an LTP to INSERM and is responsible for this deliverable.

The prioritisation strategy will be transparent, credible and accountable and will set out the procedures by which substances will be prioritised for inclusion in HBM surveys, analysis and/or research under HBM4EU. Decisions regarding which substances to work on will be based on a set of criteria that capture both scientific evidence aspects, regulatory demands, societal concerns and take into account financial and technical feasibility. With regards to human exposure, the criteria will take into account environmental, consumer and occupational exposure pathways. ANSES is LTP to INSERM and is responsible for this deliverable. ANSES is LTP to INSERM and is responsible for this deliverable.

The 2018 programme of training activities, materials and capacity building mechanisms will provide a time schedule for the activities planned for 2018. For each activity it will identify objectives linked to the AWP, partner/s responsible for delivering training, available training materials and the likely location of training (expect for online training). Links to any existing training activities at international level will also be identified, together with contact names. RUMC is LTP to RIVM and is responsible for this deliverable.

An update of the Strategy for the communication and dissemination of HBM4EU results to reflect the activities and outputs foreseen in the 2019 AWP.

The report will summarise the outcomes of the 2017-2018 consultation on the prioritisation process, and will include a list of users of HBM4EU outputs and an inventory of gaps and needs, as well as the list of key terms and definitions. The report will be presented to the Governing Board and the Stakeholder Forum in support of the proposed list of priority substances and proposed CGLs.

The data management plan describes how existing and newly generated data are processed, managed, and quality controlled at the national level, harmonized, transferred and analysed at the European level and made available for different user communities.

Necessary material to communicate with the participants are compiled and examples for the first prioritised substances provided.

A list of the criteria that will be applied in the prioritization process of the biomarkers and matrices for the target substances. They will be general criteria and therefore common for the all prioritization rounds. ANSP is an LTP to INSERM and is responsible for this deliverable.

Overview of the different approaches to be implemented in the HBM4EU project to cover the necessities in the different prioritization rounds. IPASUM is an LTP to UBA and is responsible for this deliverable.

Detailed working documents are provided for recruitment and sampling for the study conduct for the first prioritised substances to close identified data gaps.

A list with the selected biomarkers, matrices and analytical methods selected according to the criteria defined in task 9.1 and considering the substances included in the first round of prioritization.

Selection criteria and members of Stakeholder Forum (SF) and Advisory Board (AB).

This is a review paper (to be published in the peer-reviewed literature) on current state of the art in PBTK/D modeling regarding the 1st set of priority compounds – analysis of capabilities and limitations and need for further refinement.

Governing Board (GB) members and terms of reference for its meetings.

Report about feasibility workshop with agenda, list of participants, presenations of the workshop and summary of the outcome.

The indicator will use HBM data for follow up of chemical exposure of the EU population.

A first review of the training materials that have been produced and used under the HBM4EU training programme. This may include both materials developed by the HBM4EU teams, as well as materials developed under other relevant initiatives. RUMC is LTP to RIVM and is responsible for this deliverable.

The HBM4EU website will promote the project and serve as an access point for results, including a link to IPCheM, as well as linking with other relevant projects. It will features an online library including technical materials on protocols and analytical methods, as well as training materials and guidance. It will also serve as an internal communication tool, featuring web pages for internal information sharing accessible via password. Continuous updates will ensure that the website is dynamic and effective as an information hub for the initiative.

Author(s): Stephanie K. Bopp, Robert Barouki, Werner Brack, Silvia Dalla Costa, Jean-Lou C.M. Dorne, Paula E. Drakvik, Michael Faust, Tuomo K. Karjalainen, Stylianos Kephalopoulos, Jacob van Klaveren, Marike Kolossa-Gehring, Andreas Kortenkamp, Erik Lebret, Teresa Lettieri, Sofie Nørager, Joëlle Rüegg, Jose V. Tarazona, Xenia Trier, Bob van de Water, Jos van Gils, Åke Bergman

Published in: Environment International, Issue 120, 2018, Page(s) 544-562, ISSN 0160-4120

DOI: 10.1016/j.envint.2018.07.037

Author(s): Lola Bajard, Lisa Melymuk, Ludek Blaha

Published in: Environmental Sciences Europe, Issue 31/1, 2019, ISSN 2190-4707

DOI: 10.1186/s12302-019-0195-z

Author(s): Jurgen Buekers, Madlen David, Gudrun Koppen, Jos Bessems, Martin Scheringer, Erik Lebret, Denis Sarigiannis, Marike Kolossa-Gehring, Marika Berglund, Greet Schoeters, Xenia Trier

Published in: International Journal of Environmental Research and Public Health, Issue 15/10, 2018, Page(s) 2085, ISSN 1660-4601

DOI: 10.3390/ijerph15102085

Author(s): Catherine Ganzleben, Jean-Philippe Antignac, Robert Barouki, Argelia Castaño, Ulrike Fiddicke, Jana Klánová, Erik Lebret, Nicolas Olea, Dimosthenis Sarigiannis, Greet R. Schoeters, Ovnair Sepai, Hanna Tolonen, Marike Kolossa-Gehring

Published in: International Journal of Hygiene and Environmental Health, Issue 220/2, 2017, Page(s) 94-97, ISSN 1438-4639

DOI: 10.1016/j.ijheh.2017.01.007

Author(s): Kirsten A. Baken, Nathalie Lambrechts, Sylvie Remy, Vicente Mustieles, Andrea Rodríguez-Carrillo, Christiana M. Neophytou, Nicolas Olea, Greet Schoeters

Published in: Environmental Research, Issue 175, 2019, Page(s) 235-256, ISSN 0013-9351

DOI: 10.1016/j.envres.2019.05.013

Author(s): Henriqueta Louro, Milla Heinälä, Jos Bessems, Jurgen Buekers, Theo Vermeire, Marjolijn Woutersen, Jacqueline van Engelen, Teresa Borges, Christophe Rousselle, Eva Ougier, Paula Alvito, Carla Martins, Ricardo Assunção, Maria João Silva, Anjoeka Pronk, Bernice Schaddelee-Scholten, Maria Del Carmen Gonzalez, Mercedes de Alba, Argelia Castaño, Susana Viegas, Tatjana Humar-Juric, Lijana Kononenko

Published in: International Journal of Hygiene and Environmental Health, Issue 222/5, 2019, Page(s) 727-737, ISSN 1438-4639

DOI: 10.1016/j.ijheh.2019.05.009

Author(s): Dimosthenis A. Sarigiannis, Spyros Karakitsios, Elena Dominguez-Romero, Krystalia Papadaki, Celine Brochot, Vikas Kumar, Marta Schumacher, Moustapha Sy, Hans Mielke, Mathias Greiner, Marcel Mengelers, Martin Scheringer

Published in: Environmental Research, Issue 172, 2019, Page(s) 216-230, ISSN 0013-9351

DOI: 10.1016/j.envres.2019.01.045