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Toxicological and Health Aspects of Bisphenol A Toxicological and Health Aspects of Bisphenol A Report of Joint FAO/WHO Expert Meeting 2–5 November 2010 and Report of Stakeholder Meeting on Bisphenol A 1 November 2010 Ottawa, Canada Food and Agriculture Organization of the United Nations WHO Library Cataloguing-in-Publication Data Joint FAO/WHO expert meeting to review toxicological and health aspects of bisphenol A: final report, including report of stakeholder meeting on bisphenol A, 1-5 November 2010, Ottawa, Canada. 1.Phenols - toxicity. 2.Food contamination. 3.Food packing. I.World Health Organization. II.Food and Agriculture Organization of the United Nations. ISBN 978 92 14 156427 4 (NLM classification: QV 223) © World Health Organization 2011 All rights reserved. Publications of the World Health Organization are available on the WHO web site (www.who.int) or can be purchased from WHO Press, World Health Organization, 20 Avenue Appia, 1211 Geneva 27, Switzerland (tel.: +41 22 791 3264; fax: +41 22 791 4857; e-mail: [email protected]). Requests for permission to reproduce or translate WHO publications – whether for sale or for noncommercial distribution – should be addressed to WHO Press through the WHO web site (http://www.who.int/about/licensing/copyright_form/en/index.html). 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 World Health Organization concerning the legal status of any country, territory, city or area or of its authorities, or concerning the delimitation of its frontiers or boundaries. Dotted lines on maps represent approximate border lines for which there may not yet be full agreement. The mention of specific companies or of certain manufacturers’ products does not imply that they are endorsed or recommended by the World Health Organization in preference to others of a similar nature that are not mentioned. Errors and omissions excepted, the names of proprietary products are distinguished by initial capital letters. All reasonable precautions have been taken by the World Health Organization to verify the information contained in this publication. However, the published material is being distributed without warranty of any kind, either expressed or implied. The responsibility for the interpretation and use of the material lies with the reader. In no event shall the World Health Organization be liable for damages arising from its use. Typeset in Switzerland Printed in Switzerland Toxicological and Health Aspects of Bisphenol A Report of Joint FAO/WHO Expert Meeting 2–5 November 2010 and Report of Stakeholder Meeting on Bisphenol A 1 November 2010 Ottawa, Canada Food and Agriculture Organization of the United Nations TAble of contents Acknowledgements _________________________________________________________________________ 5 List of acronyms and abbreviations _____________________________________________________________ 6 Executive summary _________________________________________________________________________ 7 Introduction ______________________________________________________________________________ 14 Declarations of interests ____________________________________________________________________ 16 Summary, conclusions and recommendations ___________________________________________________ 17 1. Analytical methods for the determination of BPA in food and biological samples ___________________________ 17 2. Sources and occurrence of BPA _____________________________________________________________ 18 3. Exposure assessment _____________________________________________________________________ 20 3.1 National estimates of exposure __________________________________________________________ 20 3.2 International estimates of exposure _______________________________________________________ 20 3.2.1 Potential dietary exposure for infants 0–6 months of age ___________________________________ 22 3.2.2 Potential dietary exposure for infants 6–36 months of age __________________________________ 23 3.2.3 Potential dietary exposure for children over 3 years of age _________________________________ 23 3.2.4 Potential dietary exposure for adults (including pregnant women) ____________________________ 24 3.3 Exposure from non-food sources _________________________________________________________ 24 3.4 Conclusions and data gaps _____________________________________________________________ 25 4. Metabolism and toxicokinetics _______________________________________________________________ 26 5. Biological activities of BPA __________________________________________________________________ 28 6. Human data ____________________________________________________________________________ 29 6.1 Biomonitoring data ___________________________________________________________________ 29 6.2 Epidemiological studies _______________________________________________________________ 31 6.2.1 Reproductive end-points __________________________________________________________ 32 6.2.1.1 Semen quality _____________________________________________________________ 32 6.2.1.2 Ovarian response ___________________________________________________________ 32 6.2.2 Puberty _______________________________________________________________________ 33 6.2.3 Growth and neurodevelopment _____________________________________________________ 33 6.2.4 Cardiovascular disease and diabetes _________________________________________________ 34 7. Toxicology ______________________________________________________________________________ 34 7.1 Acute and repeated-dose toxicity _________________________________________________________ 34 7.2 Genotoxicity ________________________________________________________________________ 35 7.3 Carcinogenicity _____________________________________________________________________ 35 7.4 Reproductive and developmental toxicity of BPA in mammalian species _____________________________ 36 7.5 Neurobehavioural, neurotoxic and neuroendocrine effects _______________________________________ 38 7.6 Other effects _______________________________________________________________________ 40 7.6.1 Immunotoxicity _________________________________________________________________ 40 7.6.2 Cardiovascular effects ___________________________________________________________ 40 7.6.3 Metabolic disorders _____________________________________________________________ 41 8. Risk characterization ______________________________________________________________________ 42 8.1 Exposure assessment _________________________________________________________________ 42 8.2 Hazard characterization _______________________________________________________________ 44 8.3 Conclusion _________________________________________________________________________ 45 9. Alternative materials ______________________________________________________________________ 46 References _______________________________________________________________________________ 47 Annex 1 List of participants _________________________________________________________________ 53 Annex 2 Agenda __________________________________________________________________________ 55 Annex 3 Report of Stakeholder Meeting on Bisphenol A ____________________________________________ 56 Acknowledgements The World Health Organization and the Food and Agriculture Organization of the United Nations gratefully acknowledge the contributions of the participants at the Expert Meeting (listed in Annex 1) as well as the authors of the background papers published electronically in addition to this report (http://www.who.int/ foodsafety/chem/chemicals/bisphenol/en/) to provide more detailed information. The financial support of the European Food Safety Authority, Health Canada, the United States National Institute of Environmental Health Sciences and the United States Food and Drug Administration is gratefully acknowledged. The World Health Organization and the Food and Agriculture Organization of the United Nations wish to thank Dr Ouahiba Laribi, working as a volunteer at the World Health Organization, for the significant work performed in the preparation of this meeting. The organizations also wish to thank Ms Marla Sheffer for her assistance in the preparation of this report. LIst of acronyms and abbreviations AC50 half-maximal activity concentration BASC-2 Behavioural Assessment System for Children-2 BMD benchmark dose BMDL 95% lower limit on the benchmark dose BMDL10 95% lower limit on the benchmark dose for a 10% response BMI body mass index BPA bisphenol A BRIEF-P Behavior Rating Inventory of Executive Function (Preschool Version) bw body weight CVD cardiovascular disease CYP cytochrome P450 DES diethylstilbestrol DMBA 7,12-dimethylbenz[a]anthracene DNA deoxyribonucleic acid ELISA enzyme-linked immunosorbent assay ESR1 estrogen receptor 1 F1 first filial generation FAO Food and Agriculture Organization of the United Nations GD gestation day HPG hypothalamic–pituitary–gonadal IUPAC International Union of Pure and Applied Chemistry JECFA Joint FAO/WHO Expert Committee on Food Additives LOAEL lowest-observed-adverse-effect level LOEC lowest-observed-effect concentration MS mass spectrometry MS/MS tandem mass spectrometry NHANES National Health and Nutrition Examination Survey (USA) NOAEL no-observed-adverse-effect level NTP National Toxicology Program (USA) P0 first parental generation PBPK physiologically based pharmacokinetic PC polycarbonate PND postnatal day PVC polyvinyl chloride USA United States of America USEPA United States Environmental Protection Agency
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