ANALYSIS OF ALTERNATIVES Public Version Legal name of applicant: LANXESS Deutschland GmbH Submitted by: LANXESS Deutschland GmbH Substance: 1,2-Dichloroethane (EDC) 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 and 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. 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Table of contents 1 Summary .............................................................................................................................. 1 1.1 Background to this analysis of alternatives .................................................................................... 1 1.2 Identification of potential alternatives for EDC and overall feasibility ........................................... 2 1.3 Technical feasibility of potential alternatives for EDC .................................................................... 3 1.4 Economic feasibility of potential alternatives for EDC ................................................................... 3 1.5 Risk reduction capabilities of the alternatives ................................................................................ 6 1.6 Availability of potential alternatives for EDC .................................................................................. 6 1.7 Actions needed to improve the suitability and availability of potential alternatives ..................... 7 2 Analysis of substance function .............................................................................................. 9 2.1 Introduction .................................................................................................................................... 9 2.2 Background information on IERs .................................................................................................. 10 2.3 Production and classification of IERs ............................................................................................ 13 2.4 Overview of the applicant’s IER production activities .................................................................. 17 2.5 Technical feasibility criteria for alternative substances................................................................ 29 2.6 Technical feasibility criteria for alternative techniques ................................................................ 34 2.7 Conclusion on technical criteria for alternatives .......................................................................... 35 3 Annual tonnage .................................................................................................................. 37 4 Identification of possible alternatives.................................................................................. 38 4.1 Introduction and list of possible alternatives ............................................................................... 38 4.2 Description of efforts made to identify possible alternative ........................................................ 38 4.3 Conclusion ..................................................................................................................................... 56 5 Suitability and availability of possible alternatives ............................................................... 58 5.1 Alternative 1: 1,3-DCP (Uses 1 and 2) ........................................................................................... 58 5.2 Alternative 2: 1,4-DCB (Use 2 only) .............................................................................................. 66 5.3 Alternative 3: Solventless sulphonation technique (Use 1 only) .................................................. 73 5.4 Alternative 4: '''''' '''''''#E'''''' ''''''''''''' '' technique (Use 2 only) ..................................................... 80 6 Overall conclusions on suitability and availability of possible alternatives ............................ 93 6.1 Alternative substances and technologies considered .................................................................. 93 6.2 Conclusions on comparison of alternatives to EDC ...................................................................... 93 6.3 Overall conclusion and future research and development .......................................................... 96 7 Annex 1: Risk evaluation of alternative substances .............................................................. 97 7.1 Methodological approach ............................................................................................................. 97 7.2 Hazard profiles for EDC and alternative substances ..................................................................... 98 7.3 Comparative assessment ............................................................................................................ 110 7.4 References for Annex 1 ............................................................................................................... 112 8 Annex 2: LANXESS screening - list of substances ................................................................ 117 9 Annex 3: LANXESS IER products ......................................................................................... 120 10 Annex 4: Qualification example - FDA food contact approval ............................................ 130 11 Annex 5: Justifications for confidentiality claims ............................................................... 131 References ............................................................................................................................... 132 List of abbreviations AER: Anion Exchange Resin AfA: Application for Authorisation AoA: Analysis of Alternatives CR: Chelating Resin CSR Chemical Safety Report 1,4-DCB: 1,4-Dichlorobutane 1,3-DCP: 1,3-Dichloropropane DMEL: Derived Minimal Effect Level DNEL: Derived No Effect Level DVB: Divinylbenzene EDC: 1,2-Dichloroethane FDA: Food and Drug Administration NOAEC: No Observed Adverse Effect Concentration IER: Ion Exchange Resin NSF: National Sanitation Foundation (NSF International) OECD: Organisation for Economic Co-Operation and Development OEL: Occupational Exposure limit OGTP: Off-Gas Treatment Plant PNEC: Predicted No Effect Concentration PS: Polystyrene 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 STOT: Specific Target Organ Toxicity STP: Sewage Treatment Plant SVHC: Substance of Very High Concern TRIPS: World Trade Organisation agreement on Trade-Related Aspects of Intellectual Property Rights 1 Summary 1.1 Background to this analysis of alternatives 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 which are associated with a combined consumption of '''''#B '''' (Use 1 accounts for ''''' '#B ''' and Use 2 for ''''''#B'''') 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 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. Both processes take place within the applicant’s Leverkusen production facility in Germany (discussed further in Section 2.4) 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 ensure process synergies are elucidated, both uses of EDC have been assessed within a single AoA document, although where important (e.g. in the identification of technical feasibility criteria and the detailed assessment of the shortlisted alternatives) discussion on the uses has been separated1. With regard to the relevant products manufactured by the applicant, strong acid cation exchange resins (SAC ERs), anion exchange resins (AERs) and chelating resins (CRs) are all sub-categories of ion exchange resin (IER) that find use across a very diverse range of downstream sectors, from water softening applications to waste decontamination in the