The Practice of Consumer Exposure Assessment

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Preface

This textbook is the first one that compiles the current knowledge in exposure
science, with the focus on risk assessment. A number of experts working for many
years in this field brought their knowledge together for what is needed for exposure
estimations in their practical and daily work. In risk assessment, the results of the
exposure assessment are compared with the results of the hazard assessment.
Toxicologic evaluation covers the identification of toxic properties of substances
and the toxic doses; exposure assessment estimates the amount of the substance
(dose) that can be incorporated. While the evaluation of toxic effects is a very old
and well-established scientific task, scientifically based exposure evaluation is very
young. Due to the fact that many scientific disciplines are involved in exposure
assessment, it might be logical that many opinions exist about how exposure
assessment should be carried out due to the objective of the respective evaluations.
The different experimental instruments are used to identify the concentrations of
substances in numerous consumer products and in other items. Also, the habits of the
exposed persons and the characteristics of the populations and individuals involved
have influence on the results of exposure assessments. This might also be a reason
why the scientific instruments to estimate and measure exposure are so different, in
accordance with the current development of the particular scientific discipline, e.g.,
analytical laboratory work, statistics, public opinion evaluation, pharmacokinetics
and pharmacodynamics, chemistry, physics, and medicine. Because exposure sci-
ence brings together all these different disciplines, the understanding of the experts
representing them is sometimes difficult and controversial. For the uninformed
observer, exposure science might occur as a house which is still under construction.
However, it has a roof and rooms, and the tenants are already living in it.

vii
viii Preface

The intention of this book is to compile the current knowledge to show how the
lack of information needed for exposure assessment, differences, and controversies
might be overcome in the practical work.
The editors

Berlin, Germany Gerhard Heinemeyer

Kuopio, Finland Matti Jantunen
Bethesda, MD Pertti Hakkinen
Acknowledgements

The editors and contributors thank gratefully Dr. Stefan Fabiansson for critical
reading and revision.
The assistance of Katrin Pfeiffer (MRI) in preparing the manuscript of Sect. 4.6 is
gratefully acknowledged by the author.

ix
Contents

1 General Introduction . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1
Pertti Hakkinen, Gerhard Heinemeyer, and Matti Jantunen
1.1 Aims and Objectives of This Textbook . . . . . . . . . . . . . . . . . . . . 2
2 Major Principles and Concepts of Risk Assessment . . . . . . . . . . . . . . 5
Gianfranco Brambilla, Matthias Greiner, Ursula Gundert-Remy,
Gerhard Heinemeyer, Friederike Neisel, and Wouter ter Burg
2.1 Introduction . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5
2.2 Approaches for Risk Assessment . . . . . . . . . . . . . . . . . . . . . . . . 6
2.3 Risk Communication . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 20
2.4 Impact of Exposure on Risk Management . . . . . . . . . . . . . . . . . . 23
2.5 The Precautionary Principle . . . . . . . . . . . . . . . . . . . . . . . . . . . . 26
2.6 Risk Assessment for Intermittent or Continuous Exposures . . . . . 29
2.7 Epidemiology and Exposure . . . . . . . . . . . . . . . . . . . . . . . . . . . 37
References . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 48
3 General Aspects of Exposure Evaluation . . . . . . . . . . . . . . . . . . . . . . 55
Christiaan Delmaar, Gerhard Heinemeyer, Matti Jantunen,
Klaus Schneider, and Michael Schümann
3.1 Introduction . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 56
3.2 Exposure Scenario . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 59
3.3 Exposure Models and Measurements . . . . . . . . . . . . . . . . . . . . . 78
3.4 Exposure Parameters . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 91
3.5 The Impact of Internal Exposure in Consumer Exposure
Assessment . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 114
3.6 Results of Exposure Assessment . . . . . . . . . . . . . . . . . . . . . . . . 125
3.7 Ensuring Quality of Exposure Data . . . . . . . . . . . . . . . . . . . . . . 130
3.8 Uncertainty Analysis . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 135
3.9 Exposure Calculation Strategies in Exposure Analysis . . . . . . . . . 153
References . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 155

xi
xii Contents

4 Exposure to Substances via Food Consumption . . . . . . . . . . . . . . . . 167

Klaus Abraham, Davide Arcella, Katrin Blume, Polly E. Boon,
Gianfranco Brambilla, Francesco Cubadda, Birgit Dusemund,
Stefan Fabiansson, Rainer Gürtler, Gerhard Heinemeyer,
Sven Knüppel, Oliver Lindtner, Birgit Niemann, Christian Sieke,
and Andrea Straßburg
4.1 Scenario of Exposure via Food Consumption . . . . . . . . . . . . . . . 168
4.2 Modelling Exposure via Food Consumption . . . . . . . . . . . . . . . . 170
4.3 Parameters for Estimation of Exposure via Food Consumption . . . 171
4.4 Food Listing and Food Classification . . . . . . . . . . . . . . . . . . . . . 172
4.5 Population Aspects in Food Risk Assessment . . . . . . . . . . . . . . . 184
4.6 Activity Pattern Data: Assessing Food Consumption . . . . . . . . . . 190
4.7 Which Dietary Assessment Data Are Appropriate
for Exposure Assessments? . . . . . . . . . . . . . . . . . . . . . . . . . . . . 202
4.8 Chemical Occurrence Data: Substances (Agents) in Food . . . . . . 212
4.9 Censoring of Food Concentration Data . . . . . . . . . . . . . . . . . . . . 222
4.10 Modelling of Food Exposure and Computerized Tools
for Food Exposure Assessment . . . . . . . . . . . . . . . . . . . . . . . . . 229
4.11 Modelling Usual Dietary Intake Using Repeated
Short-Term Measurements . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 242
4.12 Impact of Downstream Use for the Food Chain
and Downstream Use for Consumer Exposure . . . . . . . . . . . . . . 251
4.13 Hazard Assessment and Derivation of Health-Based
Guidance Values . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 253
4.14 Risk Characterisation in Food Risk Assessment . . . . . . . . . . . . . 254
4.15 Food Regulations . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 254
4.16 Contaminants . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 265
4.17 Food Additives . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 267
4.18 Process Contaminants . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 280
4.19 Natural Substances in Food . . . . . . . . . . . . . . . . . . . . . . . . . . . . 289
4.20 Nutrients . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 300
4.21 Pesticide Residues . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 309
4.22 Nanoparticles in Food . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 323
References . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 331
5 Exposure to Substances by Use of Consumer Products . . . . . . . . . . . 361
Annette Bitsch, Annegret Blume, Christiaan Delmaar, Stefan Hahn,
Astrid Heiland, Gerhard Heinemeyer, Stefanie Klenow,
Wolfgang Koch, Friederike Neisel, Ralph Pirow, Thomas Rüdiger,
Yasmin Sommer, and Michal Wiecko
5.1 Introduction . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 361
5.2 Definition and Characteristics of Consumer Products . . . . . . . . . . 362
5.3 Exposure from Mixtures/Preparations . . . . . . . . . . . . . . . . . . . . . 371
5.4 Exposure from Articles . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 376
5.5 Cosmetics Regulation . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 387
Contents xiii

5.6 Chemicals Regulation (REACH) . . . . . . . . . . . . . . . . . . . . . . . . 396

5.7 Nanoparticles and Nanomaterials . . . . . . . . . . . . . . . . . . . . . . . . 416
5.8 Exposure via the House Dust Path . . . . . . . . . . . . . . . . . . . . . . . 427
5.9 Sprays, Aerosols . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 437
5.10 Dedicated Tools for Estimation of Exposure
from Consumer Products . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 449
References . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 466
6 Data Availability and Data Generation Concepts . . . . . . . . . . . . . . . 481
Gianfranco Brambilla, Astrid Heiland, Gerhard Heinemeyer,
and Christian Sieke
6.1 Introduction . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 481
6.2 How to Use Existing Data and Improve These
for Exposure Assessment . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 483
6.3 Food . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 487
6.4 Consumer Products . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 493
6.5 Uncertainty Analysis . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 496
6.6 Harmonisation of Exposure Assessment Methodology . . . . . . . . . 497
6.7 Exposure Scenarios and Models . . . . . . . . . . . . . . . . . . . . . . . . . 504
6.8 Communication and Co-operation Among
Exposure Assessors . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 505
6.9 The Exposome . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 507
References . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 508
7 Activities Encountered by European and Other
International Authorities . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 511
Andreas Ahrens, Jos Bessems, Yuri Bruinen de Bruin,
Alison Connolly, Peter Fantke, Mary Gilsenan, Gerhard Heinemeyer,
Matti Jantunen, Majlinda Lahaniatis, Demosthenes Papameletiou,
Artur Radomyski, Vittorio Reina, Urs Schlüter, Yasmin Sommer,
Anne Theobald, Natalie von Goetz, and Alexandre Zenié
7.1 EFSA . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 512
7.2 ECHA . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 527
7.3 Activities of the European Commission: Joint Research Centre . . . 537
7.4 Activities by the WHO . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 546
7.5 Activities by OECD . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 549
7.6 Anchoring Exposure Science in Europe . . . . . . . . . . . . . . . . . . . 553
References . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 561

Appendices . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 567
Appendix A: Web Resources . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 567
Appendix B: Example of the Documentation of Exposure Information as
Extracted from the EIS-ChemRisks Toolbox . . . . . . . . . . . . . . . . . . . . . 568
Index . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 577
Editors and Contributors

Editors

Gerhard Heinemeyer Department of Exposure, German Federal Institute for Risk

Assessment (Retired), Berlin, Germany
Matti Jantunen Department of Environmental Health, National Institute for Health
and Welfare (THL) (Retired), Kuopio, Finland
Pertti Hakkinen National Library of Medicine and the National Institutes of
Health, Bethesda, MD, USA

Contributors

Klaus Abraham Department of Food Safety, German Federal Institute for Risk
Assessment, Berlin, Germany
Andreas Ahrens European Chemicals Agency (ECHA), Helsinki, Finland
Davide Arcella European Food Safety Authority (EFSA), Parma, Italy
Jos Bessems VITO Health, Mol, Belgium
Annette Bitsch Department of Chemical Safety and Toxicology, Fraunhofer Insti-
tute for Toxicology and Experimental Medicine (ITEM), Hannover, Germany
Annegret Blume Department of Exposure, German Federal Institute for Risk
Assessment, Berlin, Germany
Katrin Blume Department of Exposure, German Federal Institute for Risk Assess-
ment, Berlin, Germany

xv
xvi Editors and Contributors

Polly E. Boon Department Food Safety, Institute for Public Health and the Envi-
ronment (RIVM), Bilthoven, The Netherlands
Gianfranco Brambilla Department Food Safety, Nutrition and Veterinary Public
Health, National Institute of Health (ISS), Rome, Italy
Alison Connolly ISES-Europe Board, Freiburg, Germany
Francesco Cubadda Department of Food Safety, Nutrition and Veterinary Public
Health, National Institute of Health (ISS), Rome, Italy
Yuri Bruinen de Bruin European Commission Knowledge Management Service,
European Commission Joint Research Centre, Ispra, Italy
ISES-Europe, Freiburg, Germany
Christiaan Delmaar Institute for Public Health and the Environment (RIVM),
Centre for Safety of Substances and Products (VSP), Bilthoven, The Netherlands
Birgit Dusemund Department Food Safety, German Federal Institute for Risk
Assessment, Berlin, Germany
Stefan Fabiansson European Food Safety Authority (EFSA), Dietary and Chem-
ical Monitoring (Retired), Parma, Italy
Peter Fantke ISES-Europe Board, Freiburg, Germany
Technical University of Denmark, Lyngby, Denmark
Mary Gilsenan Evidence Management Unit, European Food Safety Authority
(EFSA), Parma, Italy
Matthias Greiner Department of Exposure, German Federal Institute for Risk
Assessment, Berlin, Germany
Ursula Gundert-Remy Humboldt-University, Charité, Berlin, Germany
Rainer Gürtler Department of Food Safety, German Federal Institute for Risk
Assessment, Berlin, Germany
Stefan Hahn Department of Chemical Safety and Toxicology, Fraunhofer Institute
for Toxicology and Experimental Medicine (ITEM), Hannover, Germany
Pertti Hakkinen National Library of Medicine and the National Institutes of
Health, Bethesda, MD, USA
Astrid Heiland Department of Exposure, German Federal Institute for Risk
Assessment, Berlin, Germany
Gerhard Heinemeyer Department of Exposure, German Federal Institute for Risk
Assessment (Retired), Berlin, Germany
Matti Jantunen Department of Environmental Health, National Institute for Health
and Welfare (THL) (Retired), Kuopio, Finland
Editors and Contributors xvii

Stefanie Klenow Department of Exposure, German Federal Institute for Risk

Assessment, Berlin, Germany
Sven Knüppel Department of Epidemiology, German Institute of Human Nutrition
Potsdam-Rehbrücke (DIfE), Nuthetal, Germany
Wolfgang Koch Department of Chemical Safety and Toxicology, Fraunhofer
Institute for Toxicology and Experimental Medicine (ITEM), Hannover, Germany
Majlinda Lahaniatis International Affairs, German Federal Institute for Risk
Assessment, Berlin, Germany
Oliver Lindtner Department of Exposure, German Federal Institute for Risk
Assessment, Berlin, Germany
Friederike Neisel Department of Exposure, German Federal Institute for Risk
Assessment, Berlin, Germany
Birgit Niemann Department of Food Safety, German Federal Institute for Risk
Assessment, Berlin, Germany
Demosthenes Papameletiou European Commission, Joint Research Centre (JRC),
Ispra, Italy
Ralph Pirow Department of Chemicals and Products Safety, German Federal
Institute for Risk Assessment, Berlin, Germany
Artur Radomyski European Commission, Joint Research Centre (JRC), Ispra,
Italy
Vittorio Reina European Commission, Joint Research Centre (JRC), Ispra, Italy
Thomas Rüdiger Department of Exposure, German Federal Institute for Risk
Assessment, Berlin, Germany
Klaus Schneider Forschungs- und Beratungsinstitut Gefahrstoffe GmbH (FoBiG),
Berlin, Germany
Michael Schümann Hamburg, Germany
Urs Schlüter ISES-Europe Board, Freiburg, Germany
BAUA, Dortmund, Germany
Christian Sieke Department of Pesticide Safety, German Federal Institute for Risk
Assessment, Berlin, Germany
Yasmin Sommer Department of Exposure, German Federal Institute for Risk
Assessment, Berlin, Germany
Andrea Straßburg Max Rubner-Institut (MRI), Federal Research Institut of Nutri-
tion and Food, Karlsruhe, Germany
xviii Editors and Contributors

Wouter ter Burg Centre for Safety of Substances and Products (VSP), Institute for
Public Health and the Environment (RIVM), Bilthoven, The Netherlands
Anne Theobald European Food Safety Authority (EFSA), Parma, Italy
Natalie von Goetz ISES-Europe Board, Freiburg, Germany
ETH Zurich, Zurich, Switzerland
Michal Wiecko Department of Exposure, German Federal Institute for Risk
Assessment, Berlin, Germany
Alexandre Zenié European Commission, Joint Research Centre (JRC), Ispra, Italy
Abbreviations

24hDR 24-hour dietary recall

2NPPD 2-nitro-p-phenylenediamine
3-MCPD 3-Monochlorpropane-1,2-diol esters
A.I.S.E. Association Internationale de la Savonnerie, de la Détergence et
des Produits d’Entretien
Acropolis Cumulated and aggregated exposure to pesticides
ADI Acceptable Daily Intake
AEGL Acute Exposure Guideline Level
AFC Panel on Food Additives, Flavourings, Processing Aids and
Materials in Contact with Food (EFSA)
ALARA As Low As Reasonably Achievable
ANS Panel on Food Additives and Nutrient Sources (EFSA)
ANSES National Authority for Food Safety, Nutrition and Environment
(France)
AR Average Requirement
ARfD Acute Reference Dose
AUH Ausschuss für Umwelthygiene (Germany)
AVV DatA Allgemeine Verwaltungsvorschrift über den Austausch von
Daten im Bereich der Lebensmittelsicherheit und des
Verbraucherschutzes
BAuA Bundesanstalt für Arbeitsschutz und Arbeitsmedizin (Germany)
BBN BetaBinomial-Normal (model)
BfR Bundesinstitut für Risikobewertung (Federal Institute for Risk
Assessment, Germany)
BH Body Height
BLS Bundeslebensmittelschlüssel (German Nutrient Database)
BMD Benchmark Dose
BMDL Benchmark Dose Lower Confidence Limit
BMEL Bundesministerium für Ernährung und Landwirtschaft (Ministry
for Nutrition and Agriculture, Germany)

xix
xx Abbreviations

BMJ Bundesministerium für Justiz und Verbraucherschutz (Ministry

for Justice and Consumer Protection, Germany)
BMU Bundesministerium für Umwelt, Naturschutz und nukleare
Sicherheit Ministry for Environment, Nature Conservation and
nuclear Safety, Germany)
BNN Beta-binomial Normal (BBN))
BoA Board of Appeal (REACH)
BS Body Surface
BVL Federal Office for Consumer and Food Safety (Germany)
BW Body Weight
CAC Codex Alimentarius Commission
CARES Cumulative and Aggregate Risk Evaluation System
CCFA Codex Committee on Food Additives
CDC Centers for Disease Control and Prevention (USA)
CEF Panel on Food Contact Materials, Enzymes, Flavourings and
Processing Aids (EFSA)
CF Conversion factor
CFCD Comprehensive Food Consumption Database
CHAFEA Consumers, Health, Agriculture and Food Executive Agency
CHESAR Chemical Assessment and Reporting Tool (REACH)
CI Confidence Interval
CLP Classification, Labelling and Packaging
CMR Carcinogenic, Mutagenic, Reprotoxic (substances)
CONCAWE Conservation of Clean Air and Water in Europe
CONTAM Panel on Contaminants in the Food Chain (EFSA)
CoRAP Community Rolling Action Plan (REACH)
COT Committee on Toxicity of Chemicals in Food, Consumer
Products and the Environment
CSA Chemical Safety Assessment (REACH)
CSA Category System for Agents (see also TKS)
CSPA Consumer Specialty Products Association
CSR Chemical Safety Report (REACH)
DEEM-FCID Dietary Exposure Evaluation Model - Food Commodity Intake
Database
DEGS German Health Examination Survey (Deutscher Ernährungs
u. Gesundheits-Survey)
DEHP di-Ethyl-Hexyl-Phthalate
DG Directorate-General of the European Commission
DISHES Diet Interview Software for Health Examination Studies
DIY Do it yourself
DNEL Derived No-Effect Level
DRV Dietary Reference Values
EAR Estimated Average Requirement
ECDC European Centre for Disease Prevention and Control
Abbreviations xxi

ECHA European Chemicals Agency

ED Exposure Determinants
EDI Estimated Daily Intakes
EEA European Environmental Agency
EEC European Economic Community
EFCOSUM European Food Consumption Survey Method
EFSA European Food Safety Authority
EIS-ChemRisks European Information System on chemical risks
EMA European Medicines Agency
eo-FCS Exposure-oriented Food Consumption Survey
EPA Environmental Protection Agency (USA)
EPIC European Prospective Investigation into Cancer and Nutrition
ERNA European Responsible Nutrition Alliance
ESD Emission Scenario Document (OECD)
ESD Exposure Scenario Determinant (REACH)
EsKiMo Ernährungssurvey als KIGGS Modul (Nutrition Study as KiGGS
Module)
ETAD The Ecological and Toxicological Association of Dyes (and
Organic Pigments Manufacturers)
EU European Union
EuPCS European Product Categorisation System
EVA Ethyl Vinyl Acetate
FACET Food flavourings, food additives and food contact materials
exposure tool
FAIM Food Additives Intake Model
FAO Food and Agriculture Organization
FCS Food Consumption Study (Survey)
FDA Food and Drug Administration (USA)
FERA Food and Environmental Research Agency (UK)
FFQ Food Frequency Questionnaire
FIAP Food Improvement Agents Package
FNB/IOM Food and Nutrition Board of the Institute of Medicine (USA)
FOPH Federal Office of Public Health (Switzerland)
FSA Food Standards Agency (UK)
GEADE Global Estimate of Acute Dietary Exposure
GECDE Global Estimate of Chronic Dietary Exposure
GEMS Global Environment Monitoring System
GerES German Environmental Survey for Children
GMO Genetically Modified Organisms
GPSD General Product Safety Directive
GSFA General Standard for Food Additives
HBGV Health-Based Guidance Value
HBM Human Biomonitoring
HCPA Household & Commercial Products Association