values for the phthalates and bisphenols Greet Schoeters 28 th - - PowerPoint PPT Presentation

Strategy for deriving EU EU- wide HBM reference values for the phthalates and bisphenols

Greet Schoeters

28th September 2018

Coll llecting existing data and new ali ligned studies

EU-wide reference values ERV

• the 95th 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

• f the laboratory analysis.

Exposure distribution

• Exposure estimates based on percentiles, median and
• ther distribution statistics from HBM data

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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

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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?

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EU wid ide in internal exp xposure data + accessory data

Domains for which representative data are needed

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(1) Geographical area (2) Sex (3) Age groups

0-2 yr, 3-5 yr, 6-11 yr, 12-19 yr, 20-39 yr, 40-59 yr, 60- 79 yr

(1) Socio economic status (2) Environmental/ life style information Information on:

HBM data of HBM4EU priority chemicals

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Compounds

• Nr. of

studies North 21% Ouest 41% South 28% East 11% Phthalates 33 14 11 3 5 Bisphenols 28 12 10 4 2

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)

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Characteristics of studies Number of countries involved Origin of the data set (HBM4EU Metadata ID) Addressed population General population 5 Austria (77), Belgium (1021), Finland (1003; 1024), Germany (1041), Israel (115) Mothers (in child pairs population) 6 Austria (142), Belgium (1057; 1061), Denmark (1056; 1059), Norway (1025), Spain (1038), Slovenia (1004) Pregnant women 8 Belgium (1057), Denmark (1056), France (1039; 1058), Greece (1058), Lithuania (1058), Norway (1058), Spain (1058), United Kingdom (1058) Other 1 Sweden (1042) Geographical area Northern Europe 6 Finland (1003; 1024), Lithuania (1058), Norway (1025; 1058), Sweden (1042), Denmark (1026; 1059), United Kingdom (1058) Western Europe 4 Austria (77; 142), Belgium (1021; 1057; 1061), France (1039; 1058), Germany (1041) Southern Europe 3 Greece (1058), Slovenia (1004), Spain (1038; 1058) Other 1 Israel (115)

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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)

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Generate new harmonized data on recent exposure (2 (2014-2018)

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27 European countries- 497 Million inhabitants North - 21% West - 41% South – 28% East-11% 10-11 PSU selected 300 participants per PSU ~2950 Children 6-11 y ~2900 Teenagers 12-18 y ~3165 Adults 19--39 y NO DK FR DE NL IT SL EL HU SK PL NO SE CZ PL SK FR DE BE ES SL EL DK FI IS FR CH DE LU CZ PL PT HR 2 - 3 sampling units selected per region Phthalates DINCH Phthalates DINCH Bisphenols

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Geographical l coverage: Children 6-11 years

Targeted analysis

North 21%

• Norway
• Denmark

East 11%

• Hungary
• Slovakia
• Poland

South 28%

• Slovenia
• Greece
• Italy

West 40%

• France
• Germany
• The Netherlands

 Phthalates + DINCH  Flame retardants

Country coverage Sample size

2950

25/09/2018

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Geographical l coverage: teenagers 12-19 years

Targeted analysis

North 21%

• Norway
• Sweden

East 11%

• Czech Republic
• Slovakia
• Poland

South 28%

• Slovenia
• Greece
• Spain

West 40%

• France
• Germany
• Belgium

 Phthalates + DINCH  PFAS

Country coverage Sample size

2900

25/09/2018

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Geographical l coverage: adults 20-39 years

Targeted analysis

North 21%

• Iceland
• Finland
• Denmark

East 11%

• Czech Republic
• Poland

South 28%

• Portugal
• Croatia

West 40%

• France
• Germany
• Luxembourg
• Switzerland

 Bisphenols  Cadmium  PAH’s

Country coverage Sample size

3165

25/09/2018

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New harmonized data on recent exposure in EU 2014-2018

Descriptive information:

• What is the average exposure level?
• What are the higher exposure levels? (95th 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?

• Measurements of -Adverse Outcome Based- Effect biomarkers in the same

samples (WP13 & WP14)

• % of population that exceeds “safe values” EU HBM Health Based Guidance

Values (EU HBM HBGVs)

Link to health:

• Measure additional -adverse outcome based- effectbiomarkers in the

samples (WP13 & WP14)

• % of the population above “safe values” (EU wide HBM - HBGVs) -WP5

 Concern for Health Risk

date

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Data to be fin findable le and centr tralized in in (IPC (IPCHEM)

The Inf Informatio ion Pl Platform for

• r Ch

Chemical Mon

• nitorin

ing

• The European Commission’s reference access

point for searching, accessing and retrieving chemical occurrence data collected and managed in Europe

• Different access levels possible
• EU commission and Agencies
• National bodies
• HBM4EU consortium
• Public

indoor Food HBM Environment

https://ipchem.jrc.ec.europa.eu

Identification of subject is no longer possible

• Ethical approvals should allow that data are shared at EU level
• Data sharing: “as open as possible, as closed as necessary”

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HBM data is Pers rsonal data

ethics Study persons should have given their consent to share their data to reuse for the specific purpose of the study

Communication of personal results

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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. “

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Time line: Alignment of studies

2021 Today 2017 2018 2019 2020 2021 Deadline delivering data to HBM4EU repository

12/31/2019 Development of protocol sampling frame 2017 - 2018 2018-2019 Fieldwork

2019

Chemical analysis

2020

Data analysis Communication and reporting

2021

WP 7: Study design

• Ethics
• Questionnaires
• Communication material
• Data management plan
• Fieldwork manual

WP 9: Quality controlled analysis

• Matrix selection
• Biomarker selection
• QA/QC

WP 8: Fieldwork Biobanked samples or new samples collected between: 2014-2019 WP 10: data management/analysis

• Harmonization of data
• Joint analysis (calculating RV)

25/09/2018

Field Studies Planned Y2 -3

• f HBM4EU
• Alignment of National Studies Task 8.1 Y2 - 3
• Time trend analysis Task 8.2 Y2 -3 (no new samples)
• Targeted Occupational Studies Task 8.5 Y2 -3

____ _____ _____ _____ ______

• Joint survey on HBM pesticide mixtures in 3 -5

countries WP15 Task15.2 Y3

• Targeted Field work in combining HES and HBM Task

8.4 and WP11 11.4 – Internal Call Y3

27th September 2018

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Thank you

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