Strategy for deriving EU EU- wide HBM reference values for the phthalates and bisphenols Greet Schoeters 28 th September 2018
Coll llecting existing data and new ali ligned studies EU-wide reference values ERV • the 95 th percentile of the exposure distribution and its 95% confidence interval (CI) Compare EU data with international data Compare country or regional data with ERV Homogeneous HBM data : same matrices, identical time periods, comparable study populations, have a degree of EU geographical coverage, similar study design, comparable analytical methodology and a certified quality assurance level of the laboratory analysis. Exposure distribution • Exposure estimates based on percentiles, median and other distribution statistics from HBM data 2
Coll llecting existing data and new ali ligned studies Time trends ? • BPA • ban in baby bottles Directive 2011/8/EU • ban in food contact materials : France (2015), • Ban in food contact materials used for children Denmark (2010), Belgium (2013) , Sweden (2013), Austria (2011) • Phthalates • Restriction of DEHP, DnBP, and BBzP for all toys and childcare articles (2007) • Subject to authorisation DEHP, BBzP, DnBP and DiBP) since February 2015 (Directive (EU) 2015/863) • Restriction(2018) : DEHP, BBzP, DnBP and DiBP, DiNP, DnOP, DiDP are restricted for use in children’s toys 3
Coll llecting existing data and new ali ligned studies Factors ( determinants) that influence exposures • Personal characteristics? Age, sex, BMI? • Life style factors eg. product use eg PVC? Plastic wrapped food ? Canned food? Indoor air quality… • Socio demographic factors: educational level? Income? 4
EU wid ide in internal exp xposure data + accessory data Domains for which representative data are needed (1) Geographical area Northern Europe Western Europe Eastern Europe Southern Europe (source: https://en.wikipedia.org/wiki/United_Nations_geoscheme_for_Europe) (2) Sex 0-2 yr, 3-5 yr, 6-11 yr, (3) Age groups 12-19 yr, 20-39 yr, 40-59 yr, 60- 79 yr (1) Socio economic status Information on: (2) Environmental/ life style information 5
HBM data of HBM4EU priority chemicals Compounds Nr. of North Ouest South East studies 21% 41% 28% 11% Phthalates 33 14 11 3 5 Bisphenols 28 12 10 4 2 6
Urin inary ry le levels ls of bis isphenol A (BPA) among European women and majo jor determinants • What is the current level of exposure to BPA among European women? • Which major determinants contribute to the difference in exposure levels to BPA in women? • General population surveys or targeted on mother/newborn or mother/child pair’s populations, or in pregnant women • Samples collections should have occurred between 2008 and 2015 • Urine samples and urinary concentration of BPA Protocol developed by Loic Rambaud ( ANSP) WP10.4, co-authors: Anna-Maria Andersson (RegionH), Tamar Berman (MOH-IL), Hanne Frederiksen (RegionH), Abdessattar Saoudi (ANSP), Romuald Tagne-Fotso (ANSP), Abdelkrim Zeghnoun (ANSP) 7
Origin of the data set (HBM4EU Metadata Characteristics of studies Number of countries involved ID) General Austria (77), Belgium (1021), Finland (1003; 5 population 1024), Germany (1041), Israel (115) Mothers (in Austria (142), Belgium (1057; 1061), child pairs 6 Denmark (1056; 1059), Norway (1025), Spain Addressed population) (1038), Slovenia (1004) population Belgium (1057), Denmark (1056), France Pregnant (1039; 1058), Greece (1058), Lithuania 8 women (1058), Norway (1058), Spain (1058), United Kingdom (1058) Other 1 Sweden (1042) Finland (1003; 1024), Lithuania (1058), Northern Norway (1025; 1058), Sweden (1042), 6 Europe Denmark (1026; 1059), United Kingdom (1058) Geographical Western Austria (77; 142), Belgium (1021; 1057; 4 area Europe 1061), France (1039; 1058), Germany (1041) Southern Greece (1058), Slovenia (1004), Spain (1038; 3 Europe 1058) Other 1 Israel (115) 8
Phthalates exposures in EU populations Time trends in Cat A & B Phthalates in Danish and German young adults between 2000 and 2017 Exposure to phthalates in the years 2005 to 2014 and across different geographical regions over Europe. Exposure determinants of Cat A & B Phthalates in Austrian, Israeli, Slovenian and Flemish populations • Protocol developed by Nina Vogel (UBA), co-authorsAnna-Maria Andersson (RegionH), Hanne Frederiksen (RegionH), Rosa Lange (UBA) • Protocol developed by Nina Vogel (UBA), co-authors: UBA (Rosa Lange), VITO (Eva Govarts, Sylvie Remy), ANSP (Loïc Rambaud), 1-2 persons per used data collection • Protocol under development by Zanna Martinsone (RSU Latvia) 9
Generate new harmonized data on recent exposure (2 (2014-2018) 27 European countries- 497 Million inhabitants 2 - 3 sampling units selected per region North - 21% West - 41% South – 28% East-11% 10-11 PSU selected 300 participants per PSU ~2950 Children 6-11 y NO HU FR IT Phthalates DK SK DE SL DINCH PL NL EL ~2900 Teenagers 12-18 y FR CZ NO ES Phthalates PL DE SE SL DINCH BE SK EL ~3165 Adults 19--39 y PT FR CZ DK Bisphenols HR CH PL FI 10 DE LU IS
Geographical l coverage: Children 6-11 years Targeted analysis Phthalates + DINCH Flame retardants Country coverage North 21% East 11% -Hungary -Norway -Slovakia -Denmark -Poland South 28% West 40% -Slovenia -France -Greece -Germany -Italy -The Netherlands Sample size 2950 25/09/2018 11
Geographical l coverage: teenagers 12-19 years Targeted analysis Phthalates + DINCH PFAS Country coverage North 21% East 11% -Czech Republic -Norway -Slovakia -Sweden -Poland South 28% West 40% -Slovenia -France -Greece -Germany -Spain -Belgium Sample size 2900 25/09/2018 12
Geographical l coverage: adults 20-39 years Targeted analysis Bisphenols Cadmium PAH’s Country coverage North 21% East 11% -Czech Republic -Iceland -Poland -Finland -Denmark South 28% West 40% -Portugal -France -Croatia -Germany -Luxembourg -Switzerland Sample size 3165 25/09/2018 13
New harmonized data on recent exposure in EU 2014-2018 Descriptive information: What is the average exposure level? What are the higher exposure levels? (95 th percentile) Stratify according to sex, age, EU region, population density, education level Main drivers of exposure: diet, occupation, environment, consumer behaviour? Substance specific information from the questionnaires (WP7) Linkage to environmental/ indoor monitoring data? (WP12/IPCHEM) Health risks? Link to health: Measurements of -Adverse Outcome Based- Effect biomarkers in the same Measure additional -adverse outcome based- effectbiomarkers in the samples (WP13 & WP14) samples (WP13 & WP14) % of population that exceeds “safe values” EU HBM Health Based Guidance % of the population above “safe values” (EU wide HBM - HBGVs) -WP5 Values (EU HBM HBGVs) Concern for Health Risk 14
Data to be fin findable le and centr tralized in in (IPC (IPCHEM) The Inf Informatio ion Pl Platform for or Ch Chemical Environment Mon onitorin ing • The European Commission’s reference access point for searching, accessing and retrieving indoor chemical occurrence data collected and managed in Europe • Different access levels possible • EU commission and Agencies • National bodies • HBM4EU consortium • Public Food HBM Identification of subject is no longer possible 15 https://ipchem.jrc.ec.europa.eu date
HBM data is Pers rsonal data Study persons should have given their consent to share their ethics data to reuse for the specific purpose of the study Ethical approvals should allow that data are shared at EU level Data sharing: “as open as possible, as closed as necessary” 16
Communication of personal results WP7 D7.4 : Prepared by A. Katsonouri (MOH-CY) Co-authors: Dora Partassides, Daphne Kleopa, Elena Anastasi, Catherine Ganzleben, Derya Ay, Ovnair Sepai, Lorraine Stewart, Tiina Santonen, Simo Porras “In reviewing and interpreting your results please remember that in general: • these results are only a snapshot of your exposure at the time the sample was taken • a high level can occur due to a temporary (short -term) exposure to a chemical • a high level can be reduced if you take actions to prevent your exposure to the chemical • high level(s) do not necessarily mean you will experience adverse health effect(s). Your personal results are enclosed in this correspondence. For each chemical, an explanation is provided to help you interpret your results. Fact sheets are also provided for these chemicals, which include recommendations for minimising exposure. “ 17
Time line: Alignment of studies Deadline delivering data to HBM4EU repository 12/31/2019 Today 2017 2018 2019 2020 2021 2021 2017 - 2018 2018-2019 Development of protocol sampling frame Fieldwork 2019 2020 2021 Communication and reporting Data analysis Chemical analysis WP 10: data management/analysis WP 7: Study design WP 8: Fieldwork • Biobanked samples or new Harmonization of data • Ethics • samples collected Joint analysis (calculating RV) • Questionnaires between: 2014-2019 • Communication material WP 9: Quality controlled analysis • Data management plan • Fieldwork manual • Matrix selection • Biomarker selection • QA/QC 25/09/2018 18
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