Survey of Bisphenol A and Bisphenol-A- diglycidylether polymer Part of the LOUS-review Environmental Project No. 1483, 2013 Title: Editing: Survey of Bisphenol A and Bisphenol-A- Lise Møller, Frank Leck Fotel og Poul Bo Larsen diglycidylether polymer DHI Published by: The Danish Environmental Protection Agency Strandgade 29 1401 Copenhagen K, Denmark www.mst.dk/english Year: ISBN no. 2012 978-87-93026-14-8 Disclaimer: When the occasion arises, the Danish Environmental Protection Agency will publish reports and papers concerning research and development projects within the environmental sector, financed by study grants provided by the Danish Environmental Protection Agency. It should be noted that such publications do not necessarily reflect the position or opinion of the Danish Environmental Protection Agency. However, publication does indicate that, in the opinion of the Danish Environmental Protection Agency, the content represents an important contribution to the debate surrounding Danish environmental policy. Sources must be acknowledged. 2 Survey of Bisphenol A and Bisphenol-A-diglycidylether polymer Table of Content Preface ...................................................................................................................... 5 Summary and Conclusion .......................................................................................... 7 Resume og konklusion ............................................................................................. 12 1. Introduction ...................................................................................................... 17 2. Identity of the substances ................................................................................. 19 2.1 Name, identity and composition of the substances ............................................................. 19 2.2 Physico-chemical properties ................................................................................................ 21 3. Regulatory framework...................................................................................... 25 3.1 Classification ........................................................................................................................ 25 3.1.1 Classification in Annex VI of the Classification and Labelling of Products (CLP) regulation .................................................................................................... 25 3.1.2 Selfclassification .................................................................................................... 26 3.2 Restrictions and initiatives in continents and regions (EU, US etc.) ................................ 27 3.3 Additional national initiatives ............................................................................................. 29 3.4 Other regulatory aspekts ...................................................................................................... 31 4. Manufacture, import, export and use................................................................ 32 4.1 Manufacturing ..................................................................................................................... 32 4.1.1 Manufacturing sites & volumes ............................................................................ 32 4.2 Import and export volumes ................................................................................................. 33 4.3 Information on uses ............................................................................................................. 34 4.3.1 Use volumes, BPA ................................................................................................. 34 4.3.2 Use volumes, Bisphenol-A-diglycidylether polymer ........................................... 38 4.3.3 Estimated trends in use ......................................................................................... 41 5. Exposure .......................................................................................................... 43 5.1 Environmental exposure, BPA ............................................................................................ 44 5.2 Exposure to humans, BPA ................................................................................................... 44 5.2.1 Consumer exposure .............................................................................................. 44 5.2.2 Human exposure via the environment ................................................................. 46 5.2.3 Occupational exposure.......................................................................................... 46 5.3 Combined exposure, BPA .................................................................................................... 46 5.4 BPA exposure, concentrations in humans measured by biomonitoring studies .............. 46 5.5 Bisphenol-A-diglycidylether polymer exposure ................................................................. 47 6. Environmental hazard assessment ................................................................... 49 6.1 Environmental persistence .................................................................................................. 49 6.2 Potential for bioaccumulation ............................................................................................. 50 6.3 Potential to Cause Ecological Harm .................................................................................... 50 6.4 Risk Characterization ........................................................................................................... 51 6.4.1 Aquatic compartment ............................................................................................ 51 6.4.2 Terrestrial compartment ....................................................................................... 51 6.5 Bisphenol-A-diglycidylether polymer ................................................................................. 52 Survey of Bisphenol A and Bisphenol-A-diglycidylether polymer 3 7. Human health hazard assessment .................................................................... 53 7.1 Bisphenol A .......................................................................................................................... 54 7.1.1 Toxicokinetics........................................................................................................ 54 7.1.2 Acute toxicity ......................................................................................................... 54 7.1.3 Irritation .................................................................................................................55 7.1.4 Skin sensitization ...................................................................................................55 7.1.5 Genotoxicity and carcinogenicity ..........................................................................55 7.1.6 Reproductive toxicity .............................................................................................55 7.1.7 Other effects .......................................................................................................... 58 7.2 BADGE polymers (CAS 25036-25-3 and CAS 25068-38-6) .............................................. 58 7.2.1 Human health assessment, BADGE polymer 25036-25-3 .................................. 58 7.2.2 Human health assessment, BADGE polymer 25068-38-6 ................................. 58 7.2.3 Human health assessment, BADGE (1675-54-3) ................................................. 59 7.3 Risk assessments.................................................................................................................. 60 7.3.1 BPA ........................................................................................................................ 60 7.3.2 BADGE ................................................................................................................... 61 8. Information on alternatives .............................................................................. 63 8.1 Alternatives identified for polycarbonates .......................................................................... 63 8.2 Alternatives identified for use in thermal papers ............................................................... 64 8.3 Alternatives identified for epoxy resin uses ........................................................................ 65 8.4 Exposure example, biomonitoring of alternative to BPA. .................................................. 65 8.5 Examples of economic, etc. consequences on substitution and use of alternatives.......... 65 9. Overall conclusions .......................................................................................... 67 References .............................................................................................................. 69 Abbreviations .......................................................................................................... 78 Appendix 1; Exposure .............................................................................................. 81 Appendix 2; Environmental hazard ......................................................................... 91 Appendix 3; Alternatives ......................................................................................... 95 Appendix 4; Overview of risk managements ........................................................... 107 Overview of status as present September, 2012 .......................................................................