WHO FOOD Safety evaluation of ADDITIVES FAO JECFA MONOGRAPHS 8

799 Pages·2011·4.04 MB·English

Safety evaluation of
WHO FOOD
ADDITIVES certain contaminants in
SERIES: 63
food
FAO JECFA
MONOGRAPHS 8
Prepared by the
Seventy-second meeting of the JointFAO/
WHO Expert Committee on FoodAdditives
(JECFA)
World Health Organization, Geneva, 2011
Food and Agriculture Organization of the United Nations,Rome, 2011
WHO Library Cataloguing-in-Publication Data
Safety evaluation of certain contaminants in food / prepared by the Seventy-second meeting
of the Joint FAO/WHO Expert Committee on Food Additives (JECFA).
(WHO food additives series ; 63)
(FAO JECFA monographs ; 8)
1.Food additives - toxicity. 2.Food contamination. 3.Flavoring agents - analysis.
4.Flavoring agents - toxicity. 5.Risk assessment. I.Joint FAO/WHO Expert Committee
on Food Additives. Meeting (72nd : 2010 : Rome, Italy). II.World Health Organization.
III.Food and Agriculture Organization of the United Nations. IV.Series.
ISBN 978 92 4 166063 1 (WHO) (NLM classification: WA 712)
ISBN 978-92-5-106736-9 (FAO)
ISSN 0300-0923
© FAO and WHO, 2011
All rights reserved. Reproduction and dissemination of material in this information product for educational
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The designations employed and the presentation of material in this information product do not imply the
expression of any opinion whatsoever on the part of the Food and Agriculture Organization of the United
Nations or of the World Health Organization concerning the legal or development status of any country,
territory, city or area or of its authorities, or concerning the delimitation of its frontiers or boundaries.
The mention of specific companies or products of manufacturers, whether or not these have been patented,
does not imply that these have been endorsed or recommended by FAO or WHO in preference to others
of a similar nature that are not mentioned.
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and the World Health Organization to verify the information contained in this publication. However, the
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responsibility for the interpretation and use of the material lies with the reader. In no event shall the Food
and Agriculture Organization of the United Nations or the World Health Organization be liable for damages
arising from its use.
This report contains the collective views of an international group of experts and does not necessarily
represent the decisions or the stated policy of FAO or of WHO.
Typeset in India
Printed in India
CONTENTS
Preface ................................................................................................................... v
Acrylamide (addendum) ................................................................................... 1
Arsenic (addendum) ........................................................................................ 153
Deoxynivalenol (addendum) ............................................................................ 317
Furan ............................................................................................................... 487
Mercury (addendum) ....................................................................................... 605
Perchlorate ...................................................................................................... 685
Annexes
Annex 1 Reports and other documents resulting from previous meetings of
the Joint FAO/WHO Expert Committee on Food Additives ............ 763
Annex 2 Abbreviations used in the monographs .......................................... 777
Annex 3 Participants in the seventy-second meeting of the Joint FAO/WHO
Expert Committee on Food Additives ............................................. 785
Annex 4 Summary of toxicological evaluations ............................................. 789
- iii -

PREFACE
The monographs contained in this volume were prepared at the seventy-second
meeting of the Joint Food and Agriculture Organization of the United Nations (FAO)/
World Health Organization (WHO) Expert Committee on Food Additives (JECFA),
which met at FAO headquarters in Rome, Italy, on 16–25 February 2010. These
monographs summarize the data on selected food contaminants reviewed by the
Committee.
The seventy-second report of JECFA has been published by the World Health
Organization as WHO Technical Report No. 959. Reports and other documents
resulting from previous meetings of JECFA are listed in Annex 1. The participants
in the meeting are listed in Annex 3 of the present publication.
JECFA serves as a scientific advisory body to FAO, WHO, their Member States
and the Codex Alimentarius Commission, primarily through the Codex Committee
on Food Additives, the Codex Committee on Contaminants in Food and the Codex
Committee on Residues of Veterinary Drugs in Foods, regarding the safety of food
additives, residues of veterinary drugs, naturally occurring toxicants and
contaminants in food. Committees accomplish this task by preparing reports of their
meetings and publishing specifications or residue monographs and toxicological
monographs, or joint monographs containing summaries of relevant analytical and
technical data and toxicological evaluations, such as those contained in this volume,
on substances that they have considered.
The monographs contained in this volume are based on working papers that
were prepared by temporary advisers. A special acknowledgement is given at the
beginning of each monograph to those who prepared these working papers. The
monographs were edited by M. Sheffer, Ottawa, Canada.
The designations employed and the presentation of the material in this
publication do not imply the expression of any opinion whatsoever on the part of the
organizations participating in WHO or FAO concerning the legal status of any
country, territory, city or area or its authorities, or concerning the delimitation of its
frontiers or boundaries. The mention of specific companies or of certain
manufacturers’ products does not imply that they are endorsed or recommended
by the organizations in preference to others of a similar nature that are not
mentioned.
Any comments or new information on the compounds evaluated in this
publication should be addressed to: Joint WHO Secretary of the Joint FAO/WHO
Expert Committee on Food Additives, Department of Food Safety and Zoonoses,
World Health Organization, 20 Avenue Appia, 1211 Geneva 27, Switzerland.
- v -

ACRYLAMIDE (addendum)
First draft prepared by
U. Mueller,1A. Agudo,2C. Carrington,3D. Doerge,4K.-E. Hellenäs,5
J.-C. Leblanc,6M. Rao,7A.Renwick,8W. Slob9 and Y. Wu10
1 Risk Assessment – Chemical Safety, Food Standards Australia New Zealand,
Canberra,Australia
2 Cancer Epidemiology Research Program, Catalan Institute of Oncology,
L’Hospitalet deLlobregat, Spain
3 Center for Food Safety and Applied Nutrition, Food and Drug Administration,
College Park,MD, United States of America (USA)
4 National Center for Toxicological Research, Food and Drug
Administration,Jefferson, AR, USA
5National Food Administration, Uppsala, Sweden
6Chemical Exposure and Quantitative Risk Assessment Unit, French Agency
for Food,Environment and Occupational Health Safety (ANSES),
Maisons-Alfort, France
7Quality Control Department, Department of the President’s Affairs, Al Ain,
United ArabEmirates
8School of Medicine, University of Southampton, Ulverston, England
9 National Institute of Public Health and the Environment (RIVM), Bilthoven,
the Netherlands
10 National Institute of Nutrition and Food Safety, Chinese Center for Disease
Control andPrevention, Beijing, China
1. Explanation ............................................................................ 3
2. Biological data ....................................................................... 4
2.1 Biochemical aspects ........................................................ 4
2.1.1 Absorption, distribution and excretion.................... 4
2.1.2 Biotransformation ................................................... 5
2.1.3 Physiologically based pharmacokinetic (PBPK)
modelling ................................................................ 9
2.2 Toxicological studies ....................................................... 16
2.2.1 Acute toxicity .......................................................... 16
2.2.2 Short-term studies of toxicity .................................. 16
2.2.3 Long-term studies of toxicity and
carcinogenicity ....................................................... 18
2.2.4 Genotoxicity ........................................................... 23
2.2.5 Reproductive and developmental toxicity ............... 27
2.2.6 Special studies ....................................................... 28
2.3 Observations in humans .................................................. 30
2.3.1 Enzyme polymorphism ........................................... 30
2.3.2 Biomarkers of exposure ......................................... 31
2.3.3 Epidemiological studies: cancer ............................. 38
3. Analytical methods ................................................................ 46
3.1 Chemistry ........................................................................ 46
- 1 -
2 ACRYLAMIDE (addendum)
3.2 Description of analytical methods .................................... 46
3.2.1 Common and established methods ........................ 46
3.2.2 Screening tests ...................................................... 46
3.2.3 Validated methods ................................................. 47
3.2.4 Analytical quality control ......................................... 47
3.2.5 Developments in pretreatment ............................... 47
3.2.6 Developments in instrumental analysis .................. 48
4. Effects of processing ............................................................. 50
4.1 Heat-induced formation of acrylamide in foods ............... 50
4.1.1 Formation from asparagine and sugar by Maillard
reaction .................................................................. 50
4.1.2 Formation from oil degradation products ............... 51
4.1.3 Formation from 3-aminopropionamide (3-APA) ..... 51
4.1.4 Formation from wheat gluten ................................. 51
4.1.5 Formation in olives ................................................. 52
4.2 Acrylamide intermediates and reaction products
in food .............................................................................. 52
5. Prevention and control .......................................................... 53
5.1 Mitigation methods .......................................................... 53
5.2 Mitigation achievements .................................................. 55
6. Levels and patterns of contamination in food
commodities .......................................................................... 57
6.1 Surveillance data ............................................................. 57
6.2 National occurrence ........................................................ 58
6.2.1 Australia ................................................................. 59
6.2.2 Brazil ...................................................................... 59
6.2.3 Canada ................................................................... 59
6.2.4 China ...................................................................... 60
6.2.5 Democratic People’s Republic of Korea ................. 60
6.2.6 European Union (including Norway and
Switzerland) ........................................................... 60
6.2.7 France .................................................................... 61
6.2.8 Japan ..................................................................... 61
6.2.9 Netherlands ............................................................ 61
6.2.10 New Zealand ........................................................ 62
6.2.11 Norway ................................................................. 62
6.2.12 Poland .................................................................. 62
6.2.13 Spain .................................................................... 62
6.2.14 Sweden ................................................................ 63
6.2.15 Turkey .................................................................. 63
6.2.16 United States of America ..................................... 63
6.2.17 Summary of national occurrence data ................. 63
6.3 International occurrence .................................................. 64
7. Food consumption and dietary exposure estimates .............. 69
7.1 National estimates of dietary exposure ........................... 69
7.1.1 Brazil ...................................................................... 69
7.1.2 China ...................................................................... 69
7.1.3 France .................................................................... 70
7.1.4 Ireland .................................................................... 70
7.1.5 New Zealand .......................................................... 71
7.1.6 Norway ................................................................... 71
7.1.7 Spain ...................................................................... 71
ACRYLAMIDE (addendum) 3
7.1.8 United Kingdom ...................................................... 72
7.1.9 Summary of national dietary exposure
estimates ................................................................ 72
7.2 Regional estimates of dietary exposure using
consumption cluster diets ................................................ 76
8. Dose–response analysis and estimation of
carcinogenic/toxic risk ........................................................... 117
8.1 Identification of key data for risk assessment .................. 117
8.1.1 Pivotal data from biochemical and toxicological
studies .................................................................... 117
8.1.2 Pivotal data from human clinical/epidemiological
studies .................................................................... 121
8.2 Estimates of BMDs and BMDLs ...................................... 127
9. Comments ............................................................................. 131
9.1 Absorption, distribution, metabolism and excretion ......... 131
9.2 Toxicological data ............................................................ 131
9.3 Genotoxicity ..................................................................... 132
9.4 Carcinogenicity ................................................................ 133
9.5 Observations in humans .................................................. 133
9.6 Analytical methods .......................................................... 134
9.7 Formation during cooking and heat processing .............. 135
9.8 Prevention and control .................................................... 135
9.9 Levels and patterns of contamination in food
commodities .................................................................... 136
9.10 Food consumption and dietary exposure
assessment ..................................................................... 136
9.11 Dose–response analysis ............................................... 138
10. Evaluation ............................................................................ 138
10.1 Recommendation .......................................................... 139
11. References .......................................................................... 139
1. EXPLANATION
Acrylamide (CH =CHCONH , Chemical Abstracts Service No. 79-06-01) is
2 2
a water-soluble vinyl monomer that is formed in many common foods during
cooking. Acrylamide is also a component of tobacco smoke. It is readily
polymerizable. Polyacrylamide has multiple applications in chemical and
manufacturing industries—for example, as a flocculant for clarifying drinking-water,
as a sealant for construction of dams and tunnels, as a binder in the paper and pulp
industry and in dye synthesis.
The sixty-fourth meeting of the Committee (Annex 1, reference 176)
evaluated dietary acrylamide and recommended that:
• acrylamide should be re-evaluated once the results of the planned study of
carcinogenicity and long-term studies of neurotoxicity become available;
• work should continue on physiologically based pharmacokinetic (PBPK)
modelling to better link biomarkers in humans with dietary exposure assessments
and toxicological effects in experimental animals;
• work to reduce exposure to acrylamide in food by minimizing its concentrations
should continue;