European Union Risk Assessment Report: 4,4’-Isopropylenediphenol (Bisphenol-A)
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European Union Risk Assessment Report CAS: 80-05-7 EINECS No: 201-245-8 Environment Addendum of April 2008 (to be read in conjunction with published EU RAR of BPA, 2003) 4,4'-ISOPROPYLIDENEDIPHENOL (Bisphenol-A) Part 1 Environment EUR 24588 EN - 2010 The mission of the JRC-IHCP is to protect the interests and health of the consumer in the framework of EU legislation on chemicals, food, and consumer products by providing scientific and technical support including risk-benefit assessment and analysis of traceability. European Commission Joint Research Centre Institute for Health and Consumer Protection Contact information Address: Via E. Fermi 2749 - 21027 Ispra (VARESE) - Italy E-mail: [email protected] Tel.: +39 0332 785959 Fax: +39 0332 785730 http://ihcp.jrc.ec.europa.eu/ http://www.jrc.ec.europa.eu/ http://ecb.jrc.ec.europa.eu/ Legal Notice Neither the European Commission nor any person acting on behalf of the Commission is responsible for the use which might be made of this publication. Europe Direct is a service to help you find answers to your questions about the European Union Freephone number (*): 00 800 6 7 8 9 10 11 (*) Certain mobile telephone operators do not allow access to 00 800 numbers or these calls may be billed. A great deal of additional information on the European Union is available on the Internet. It can be accessed through the Europa server http://europa.eu/ JRC 59980 EUR 24588 EN ISBN 978-92-79-17541-1 ISSN 1831-9424 DOI 10.2788/40195 Luxembourg: Publications Office of the European Communities © European Communities, 2010 Reproduction is authorised provided the source is acknowledged Printed in ITALY Updated European Risk Assessment Report 4,4’-ISOPROPYLIDENEDIPHENOL (BISPHENOL-A) CAS Number: 80-05-7 EINECS Number: 201-245-8 Environment Addendum of February 2008 (to be read in conjunction with published EU RAR of BPA, 2003 for full details) Rapporteur for the risk assessment is the United Kingdom. Contact point: Environment Agency (environment) Chemicals Assessment Unit Red Kite House, Howbery Park, Wallingford, Oxfordshire, OX10 8BD Fax: +44 (0)1491 828 556 E-mail: [email protected] The scientific work on the environmental sections was carried out by the Building Research Establishment Ltd (BRE) (with input on the aquatic effects assessment by Watts & Crane Associates), under contract to the rapporteur. Date of Last Literature Search : 2007 Review of report by MS Technical Experts finalised: 2007 Final report: 2008 Introduction A risk assessment of bisphenol-A produced in accordance with Council Regulation (EEC) 793/93 has already been published (EC, 2003). The conclusion was that further information was needed about toxic effects in fish and aquatic snails (and potentially terrestrial organisms), and environmental risks were also identified for certain PVC applications and thermal paper recycling (for the aquatic, sediment and terrestrial compartments). The test requirements were published in two Commission Regulations (EC No. 642/20051 and 506/20072) with a delivery deadline of November 2006 and November 2007 respectively. The UK rapporteur began work on a risk reduction strategy for the environment shortly afterwards, and an interim report was prepared (Defra, 2003). Industry was able to provide more detailed information on use pattern and releases for a number of the applications being considered, including measured emissions data. Based on this evidence, the rapporteur considered that the emissions had been over-estimated in the published report, and revised PECs were agreed at EU Technical Meetings in 2003 and 2005. In addition, bisphenol-A may be formed via the degradation of tetrabromobisphenol-A (CAS no. 79-94-7), which is another ESR priority substance. The relevant information has been summarised in the risk assessment report for that substance (ECB, 2007). The test programme has now concluded, so this report brings together the revised exposure information and an updated review of ecotoxicity data, as an addendum to the original risk assessment report. The opportunity has been taken to include additional industry information and published data that have become available since the original risk assessment was completed3. The opinions of the European Commission’s former Scientific Committee for Toxicity, Ecotoxicity and the Environment (CSTEE) on the original report have also been considered (CSTEE, 2002). The assessment uses the latest version of the Technical Guidance Document, which was revised after the original report’s publication, so marine scenarios and a PBT assessment are included for the first time. 1 Official Journal L 107, 28/04/2005 p. 0014 – 0016. 2 Official Journal L 119, 09/05/2007 p. 0024 – 0026. 3 EC (2003) was based on a review of all data published up to 2001. For this report, studies were identified independently by Industry (who provided the rapporteur with an updated reference list) and the rapporteur up to March 2007. The abstracts and, where necessary, main text of these papers were reviewed to establish their relevance. Non-relevant papers are listed in Appendix 1, with a reason for their non-inclusion. Relevant papers have been reviewed in detail and are reported in the main text. IV The format of the report is broadly in line with that of the published assessment. A brief summary of the original information is given (the published report should be consulted for full details), followed by all significant new data and a comment to indicate how these differ from the original report. An exception is the section on aquatic effects, which has been entirely revised (although the original data have not been re-evaluated) and reformatted (the data had previously been divided into ‘toxicity test results’ and ‘endocrine disrupting effects’). To protect commercial confidentiality, site codes are presented in a separate confidential annex. This can be made available to regulatory authorities on request. V CONTENTS 1 GENERAL SUBSTANCE INFORMATION.......................................................................................... 5 1.1 IDENTIFICATION OF THE SUBSTANCE.................................................................................. 5 1.2 PURITY/IMPURITIES, ADDITIVES............................................................................................ 5 1.2.1 Purity ....................................................................................................................................... 5 1.3 PHYSICO-CHEMICAL PROPERTIES ........................................................................................ 5 2 GENERAL INFORMATION ON EXPOSURE..................................................................................... 6 2.1 NEW INFORMATION .................................................................................................................... 6 2.1.1 Tetrabromobisphenol-A...........................................................................................................6 2.1.2 PVC ......................................................................................................................................... 6 2.1.3 Thermal paper.......................................................................................................................... 7 2.1.4 Revised EU consumption figures ............................................................................................ 7 2.1.5 Other information .................................................................................................................... 8 3 ENVIRONMENT ...................................................................................................................................... 9 3.1 ENVIRONMENTAL EXPOSURE.................................................................................................. 9 3.1.1 Environmental releases – published information..................................................................... 9 3.1.2 Revised emission estimates ..................................................................................................... 10 3.1.2.1 Production of bisphenol-A......................................................................................... 10 3.1.2.2 Use as an inhibitor in PVC production ...................................................................... 10 3.1.2.3 PVC additive formulation.......................................................................................... 11 3.1.2.3.1 New information....................................................................................... 11 3.1.2.3.2 Calculation of emission factors................................................................. 11 3.1.2.4 Anti-oxidant in plasticizer production ....................................................................... 12 3.1.2.5 Thermal paper recycling............................................................................................ 12 3.1.2.5.1 Use pattern................................................................................................ 13 3.1.2.5.2 Amounts of bisphenol-A used in thermal paper ....................................... 13 3.1.2.5.3 Size of paper recycling sites ..................................................................... 14 3.1.2.5.4 Information from specific sites ................................................................. 14 3.1.2.6 Effect of updated tonnages on local emission estimates............................................ 18 3.1.2.7 Revised regional and continental