A13_Phthalates case study: Use of HBM-GV (as in HBM4EU) compared to DNELinternal approach from ECHA’s RAC to perform risk characterisation

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A13_Phthalates case study: Use of HBM-GV...

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Last Updated: 19-06-2019 8:08

The focus is on describing the use, strengths and limitations of HBM data in an existing risk assessment, here the 4 phthalates restriction dossier under the REACH regulation. Under this restriction dossier, Risk Characterisation Ratios (RCRs) were calculated using the DNELinternal approach.
Another approach to calculate RCRs, making use of the HBM-GV derived within HBM4EU, is presented. Various factors might induce uncertainty when calculating RCRs based on HBM data, making the overall uncertainty very important to assess.

Science to policy

HBM European platform

Exposure and health

Enrieco (Environmental Health Risks in European Birth Cohorts)
Enrieco (Environmental Health Risks in European Birth Cohorts) is a project conducted within the European Union's 7th Framework Programme [Theme 6, Environment (Including Climate Change)]. Its overall aim is to advance our knowledge on specific environment and health causal relationships in pregnancy and birth cohorts by providing support to exploitation of the wealth of data generated by past or ongoing studies funded by the EC and national programmes.
Environment and Health Information System (ENHIS)
ENHIS is an evidence-based information system aiming to support public health and environmental policies in the WHO European Region. The system is an interactive database, composed of country-level indicators and regional assessments (fact sheets).
EHES
European Health Examination Survey (EHES) is an initiative to set up a system of standardized, representative health examination surveys (HES) of the adult population of the European countries.
E-DOHaD
Environmentally-induced Developmental Origins of Health and Disease project aims to characterize the impact of environmental exposures on childhood health with focus on two families of pollutants with a highly prevalent and controllable exposure in humans: atmospheric pollutants and specific high-volume non-persistent chemicals (Bisphenol A, other phenols and phthalates).
EDC-MIXRISK
This EU project focuses on the effects of mixtures of endocrine disruptive chemicals on children. The aim is to promote safer use of chemicals for the next generation.
ECHEMNET
The European Chemical Emergency Network aims to set up an EU-level network of expert chemical health risk assessors who have experience in dealing with the acute phase of chemical incidents, ensure that experience of, and best practices adopted by, one Member State following an incident benefit other Member States and enable an efficient and coherent EU-level response to potentially devastating cross-border events through the consistent use of RASCHEM.
DENAMIC
Developmental neurotoxicity assessment of mixtures in children.
DEMOCOPHES
In DEMOCOPHES, 17 European countries tested a common approach for human biomonitoring surveys which was developed by COPHES. They produced data on the distribution of specific biomarkers and related lifestyle data among defined study populations which, for the first time, are comparable on a European scale. DEMOCOPHES aims at testing “the hypothesis that HBM can be performed in a coherent and harmonised manner throughout Europe, by means of commonly developed protocols, strategies and scientific tools, ensuring reliable and comparable data, whilst also leading to a more effective use of resources”.
DEER
Developmental Effects of Environment on Reproduction: EU funded project under framework 7 (FP7/2007-2013). It is a multidisciplinary research project aiming at improving our understanding of the role of environmental factors in the development and establishment of human reproductive health.
CYTOTHREAT
CytoThreat addresses the need to assess the risks of pharmaceuticals released in the environment, focusing on cytostatic drugs because they are highly hazardous compounds due to their genotoxic properties which may cause unexpected long term effects.
CROME
Introduction
The main environmental problem targeted by CROME-LIFE is the assessment of the impact on human health due to exposure to chemical agents originating either from environmental contamination (air, soil, water), or from consumer products (food contact materials, construction materials, cosmetics, clothes, etc.) through multiple routes, namely inhalation, ingestion and dermal contact in five distinct areas of southern Europe (Greece, Croatia, Slovenia, Italy and Spain).
COSMOS
This project addresses the safety assessment needs of the cosmetics industry, without the use of animals. The main aim of COSMOS is to develop freely available (open access and/or source) tools and workflows to predict the safety to humans following the use of cosmetic ingredients.
COPHES
COPHES is the Consortium to Perform Human Biomonitoring on a European Scale. Funded by the EU's Seventh Framework Programme, COPHES developed harmonised protocols allowing the collection of comparable HBM data throughout Europe. Its twin project, the feasibility study DEMOCOPHES, was launched one year later to test this hypothesis and to win information on levels and major determinants of exposure in Europe, as well as to establish protocols for the translation of HBM results into concrete policy recommendations.
CONTAMED
CONTAMED: Contaminant mixtures and human reproductive health – novel strategies for health impact and risk assessment of endocrine disrupters. CONTAMED aims to explore the hypothesis that combined exposure to endocrine disrupting chemicals in fetal life may lead to adverse delayed impacts on human reproductive health. To achieve this goal, CONTAMED will combine epidemiological approaches with laboratory science.
CITI-SENSE
CITI-SENSE works on development of sensor-based Citizens' Observatory Community for improving quality of life in cities. The project focuses on direct engagement of citizens within the fields of air quality, environmental quality of public spaces in cities and indoor air quality in schools. Funded by the EU's Seventh Framework Programme, 2010-2016, CITI-SENSE aims to empower citizens to contribute to and participate in environmental governance, to support and influence community and societal priorities and associated decision making.
CHICOS
Developing a Child Cohort Research Strategy for Europe - CHICOS is a project conducted within the European Union’s 7th Framework Programme. It's overall aim is to improve child health across Europe by developing an integrated strategy for mother-child cohort research in Europe.
ChemScreen
ChemScreen aims to provide practical solutions within the tight framework of REACH. The focus of the project is on the generation of a simple, rapid screening system for reproductive toxic chemicals, aiming at widespread implementation within the tight time schedule of the REACH program.
The CARBOTRAF
This project aims to realize a method, system and tools for adaptively influencing traffic in real-time. The project aims to reduce carbon dioxide CO2 and black carbon (BC) emissions caused by road transport in urban and inter-urban areas.
Bridge-Health
Bridging Information and Data Generation for Evidence-based Health policy and research. The BRIDGE Health project aims to prepare the transition towards a sustainable and integrated EU health information system for both public health and research purposes.
A-TEAM
Developing advanced tools for exposure assessment and biomonitoring.
ACROPOLIS
ACROPOLIS contributes to the development of a methodology to ensure that the missing aspects in the risk assessment of pesticides can be addressed in future risk management. This will increase trust of the consumer in safety regulation of pesticides.
ARCRISK
Focusses on impacts on health in the Arctic and in Europe resulting from climate-induced changes in contaminant cycling.
European, Middle Eastern, and African Society for Biopreservation and Biobanking
ESBB’s mission is to advance the field of biobanking in support of research relating to healthcare, agriculture and the environment. The focus is on Europe, the Middle East and Africa.
European Environment Agency
IPCHEM – The Information Platform for Chemical Monitoring

What is HBM4EU?

HBM4EU stands for “Human Biomonitoring for Europe”. The main aim of the initiative is to coordinate and advance human biomonitoring in Europe.

Who does HBM4EU consist of?

HBM4EU is a joint effort of 28 countries, the European Environment Agency and the European Commission, co-funded under Horizon 2020. The HBM4EU initiative represents a novel collaboration between scientists and chemical risk assessors and risk managers, including several Commission services, European agencies and national representatives. The project will build bridges between the research and policy worlds and deliver benefits to society in terms of enhanced chemical safety.

What is human biomonitoring?

People are exposed to a complex mixture of chemicals in their daily lives through the environment, consumer products, food and drinking water and at work. Human biomonitoring allows the measurement of exposure to chemicals by measuring either the substances themselves, their metabolites or markers of subsequent health effects in body fluids or tissues. Human biomonitoring provides a useful tool for assessing cumulative exposure to complex mixtures of chemicals. By collecting data from a representative sample of individuals under continuous surveillance programmes, health practitioners are able to evaluate the exposure of the general population to chemicals over time. Information on human exposure can be linked to data on sources and health effects, in order to inform research on exposure-response relationships in humans.

How will HBM4EU initiative work with human biomonitoring?

HBM4EU will use Human Biomonitoring to assess human exposure to chemicals in Europe, to better understand the associated health impacts and to improve chemical risk assessment. Despite the existence of human biomonitoring programmes at national level and the large number of research and development projects ongoing both at national and European Union level, there is a clear lack of data on aggregate exposure to single substances and to combinations of chemical substances, as well as insufficient evidence-based knowledge on the link between external exposure via different routes, internal levels and human health. This knowledge is essential to inform effective policy-making to protect the European population from the impacts of chemical exposure on health. HBM4EU will form a bridge between science and policy. Our research will explore current questions in chemical risk assessment and management and will deliver answers that help policy makers to protect human health. Policy makers, stakeholders and scientists will together shape the strategic direction of HBM4EU activities. This transparent and collaborative approach will ensure that our research generates knowledge that addresses genuine societal concerns.

What are the main objectives of HBM4EU?

- Harmonise procedures and tools for human biomonitoring at European Union level;
- Provide and, where missing, generate internal exposure data and link this data to external exposure and the relevant exposure pathways;
- Develop novel methods to identify human internal exposure to environmental and occupational chemicals and establish the causal links with human health effects;
- Provide policy-makers and the general public with science-based knowledge on the health risks associated with chemicals exposure; and
- Improve chemical risk assessment in the European Union through the effective use of human biomonitoring data.