SOCIO-ECONOMIC ANALYSIS Public Version
Total Page：16
File Type：pdf, Size：1020Kb
SOCIO-ECONOMIC ANALYSIS Public Version Legal name of applicant: LANXESS Deutschland GmbH Submitted by: LANXESS Deutschland GmbH Substance: 1,2-Dichloroethane EC Number: 203-458-1 CAS Number: 107-06-2 Use title: Use 1: Industrial use as a swelling agent during the sulphonation reaction of polystyrene-divinylbenzene copolymer beads in the manufacturing of strong acid cation exchange resins Use 2: Industrial use as a swelling agent and reaction medium during the phthalimidomethylation reaction of polystyrene-divinylbenzene copolymer beads in the manufacturing of anion exchange and chelating resins Use numbers: 1 & 2 Copyright ©2016 LANXESS Deutschland GmbH. This document is the copyright of LANXESS Deutschland GmbH and is not to be reproduced or copied without its prior authority or permission. Disclaimer This report has been prepared by Risk & Policy Analysts Ltd, with reasonable skill, care and diligence under a contract to the client and in accordance with the terms and provisions of the contract. Risk & Policy Analysts Ltd will accept no responsibility towards the client and third parties in respect of any matters outside the scope of the contract. This report has been prepared for the client and we accept no liability for any loss or damage arising out of the provision of the report to third parties. Any such party relies on the report at their own risk. Table of contents 1 Summary of Socio-Economic Analysis .................................................................................... 1 1.1 Background ..................................................................................................................................... 1 1.2 Requested review period ................................................................................................................ 2 1.3 Key parameters of EDC use by LANXESS Deutschland GmbH......................................................... 2 1.4 Benefits from the continued use of EDC ......................................................................................... 3 1.5 Balance of benefits and costs ......................................................................................................... 3 2 Aims and Scope of SEA .......................................................................................................... 5 2.1 Aims and scope of SEA .................................................................................................................... 5 2.2 Definition of “Applied for Use” Scenario ...................................................................................... 20 2.3 Definition of “Non-use” Scenarios ................................................................................................ 25 2.4 Information for the length of the review period .......................................................................... 30 3 Analysis of Impacts ............................................................................................................. 35 3.1 Human health impacts .................................................................................................................. 35 3.2 Environmental impacts ................................................................................................................. 44 3.3 Economic impacts ......................................................................................................................... 46 3.4 Social impacts................................................................................................................................ 56 3.5 Wider economic impacts .............................................................................................................. 59 4 Combined Assessment of Impacts ....................................................................................... 61 4.1 Comparison of impacts ................................................................................................................. 61 4.2 Distributional impacts ................................................................................................................... 62 4.3 Uncertainty analysis ...................................................................................................................... 63 5 Conclusions ........................................................................................................................ 66 5.1 Socio-economic benefits of continued use ................................................................................... 66 5.2 Residual risks to human health and the environment of continued use ...................................... 66 5.3 Factors concerning operating conditions, risk management measures and monitoring arrangements ........................................................................................................................................ 67 5.4 Factors relating to the duration of the review period .................................................................. 67 6 References ......................................................................................................................... 69 7 Annex 1: Economic valuation of excess cancer cases ............................................................ 71 8 Annex 2: Justification for confidentiality claims ................................................................... 73 List of abbreviations AER: Anion Exchange Resin AfA: Application for Authorisation AoA: Analysis of Alternatives CR: Chelating Resin CSR Chemical Safety Report 1,3-DCP: 1,3-Dichloropropane EDC: 1,2-Dichloroethane FDA: Food and Drug Administration IER: Ion Exchange Resin NSF: National Sanitation Foundation (NSF International) OECD: Organisation for Economic Co-Operation and Development PNEC: Predicted No Effect Concentration R&D: Research and Development ResAP: Council of Europe, Committee of Ministers Resolution SAC ER: Strong Acid Cation Exchange Resin SEA: Socio-Economic Analysis SIDS: Screening Information Dataset TRIPS: World Trade Organisation agreement on Trade-Related Aspects of Intellectual Property Rights 1 Summary of Socio-Economic Analysis 1.1 Background This Application for Authorisation (AfA) has been submitted by LANXESS Deutschland GmbH. The substance of concern is 1,2-dichloroethane (hereafter referred to as EDC), EC No. 203-458-1, CAS No. 107-06-2. The applicant is applying for two uses of EDC (associated with the production of ion exchange resins (IERs) (see Figure 1-1)) which are associated with a combined consumption of '''#A' (Use 1 accounts for '''''#A ''''''' and Use 2 for ''''' '#A '''''' of the substance: Use 1: Industrial use as a swelling agent during the sulphonation reaction of polystyrene- divinylbenzene copolymer beads in the manufacturing of strong acid cation exchange resins (SAC ERs); and Use 2: Industrial use as a swelling agent and reaction medium during the phthalimidomethylation reaction of polystyrene-divinylbenzene copolymer beads in the manufacturing of anion exchange (AERs) and chelating resins (CRs). Both processes take place within the applicant’s Leverkusen production facility in Germany (Figure 1-2) and, to a certain extent, they are mutually supporting with EDC circulated in one closed loop. In addition, as can be deduced from the use wording, the function of EDC in the processes shares significant similarities. Given these similarities, to avoid extensive repetition and to ensure synergies between the uses are elucidated, both uses of EDC have been assessed within a single SEA document. Figure 1-1: LANXESS Lewatit® brand IERs Source: Applicant’s information Further justification for this approach is provided in Section 2.1.2. Despite both identified uses of EDC being confined to the applicant’s Leverkusen facility (as well as key associated ancillary operations), the wider scope of LANXESS’ activities are also of relevance to this SEA. Notably, as well as directly controlling the Leverkusen site, LANXESS operates IER production sites in Bitterfeld (Germany) and Jhagadia (India). Of particular relevance to the analysis in this SEA is Jhagadia, as this site would be affected by the global IER production restructuring Figure 1-2: Location of LANXESS Deutschland GmbH activities that would ensue following a Leverkusen site theoretically refused Authorisation. Source: Google, GeoBasis – DE/BKG Use numbers: 1 & 2 Legal name of the applicant: LANXESS Deutschland GmbH 1 1.2 Requested review period As discussed in detail in the corresponding Analysis of Alternatives (AoA) document, LANXESS Deutschland GmbH has selected separate preferred potential alternatives for each use of EDC. For Use 1, the applicant intends to implement the ‘solventless sulphonation technique’ and for Use 2 the applicant intends to implement the ‘'''''''''' ''#H'''''''''''''''' technique’ (a technique incorporating an alternative substance). It is critical to note that neither alternative is fully technically and economically feasible at present and both are currently the subject of extensive and targeted R&D campaigns, which began in ''''''''''#E '' '''''''''' (for Use 1) and '''''''''''''#E''''''''''' (for Use 2). Section 2.4 of the SEA sets out, in detail, the practical steps required for the implementation of each alternative and the considerable barriers that must be overcome for the applicant to preserve the high quality of the '''#C'' separate EDC- based IER product grades that are currently produced and sold1. For Use 1, to fully implement the solventless sulphonation