ANALYSIS OF ALTERNATIVES Public Version Legal name of applicants: Dow Italia Srl Rohm and Haas France S.A.S. Submitted by: Dow Italia Srl Substance: 1,2-Dichloroethane (EC No. 203-458-1, CAS No. 107-06- 2) Use title: Industrial use as a sulphonation swelling agent of polystyrene-divinylbenzene copolymer beads in the production of strong acid cation exchange resins Use number: 1 Copyright ©2016 Dow Italia Srl. This document is the copyright of Dow Italia Srl 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. 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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 .............................................................................................. 8 2.1 Introduction .................................................................................................................................... 8 2.2 Background information on Ion Exchange Resins........................................................................... 9 2.3 Production and classification of IERs ............................................................................................ 12 2.4 Overview of Dow’s IER activities ................................................................................................... 15 2.5 Conditions of EDC use ................................................................................................................... 20 2.6 Technical feasibility criteria for alternative substances................................................................ 25 2.7 Technical feasibility criteria for alternative technologies ............................................................. 30 3 Annual tonnage .................................................................................................................. 31 4 Identification of possible alternatives.................................................................................. 32 4.1 Introduction and list of possible alternatives ............................................................................... 32 4.2 Description of efforts made to identify possible alternatives ...................................................... 32 5 Suitability and availability of possible alternatives ............................................................... 55 5.1 Alternative 1: 1,2,4-Trifluorobenzene .......................................................................................... 55 5.2 Alternative 2: DCM ....................................................................................................................... 69 5.3 Alternative 3: Solventless sulphonation ....................................................................................... 79 6 Overall conclusions on suitability and availability of possible alternatives ............................ 89 6.1 Alternative substances and technologies considered .................................................................. 89 6.2 Conclusions on comparison of alternatives to EDC ...................................................................... 89 6.3 Overall conclusion and future research and development .......................................................... 92 7 Annex 1: Risk evaluation of alternative substances .............................................................. 94 7.1 Methodological approach ............................................................................................................. 94 7.2 Reference values (DNELs, PNECs) for EDC and alternative substances ........................................ 95 7.3 Exposure Assessment .................................................................................................................. 106 7.4 Results of the comparative exposure assessment and risk characterisation ............................. 107 8 Annex 2: Dow IER Products ............................................................................................... 111 9 Annex 3: Substances excluded from further analysis following screening step 2 ................. 119 10 Annex 4: Justifications for confidentiality claims ............................................................... 125 References ............................................................................................................................... 126 1 Summary 1.1 Background to this analysis of alternatives This Application for Authorisation (AfA) has been submitted jointly by two legal entities: Dow Italia Srl, and Rohm and Haas France S.A.S. The substance of concern is 1,2-dichloroethane (hereafter referred to as EDC), EC No. 203-458-1, CAS No. 107-06-2. Both applicants are applying for the same use of EDC (‘Industrial use as a sulphonation swelling agent of polystyrene-divinylbenzene copolymer beads in the production of strong acid cation exchange resins’), which is undertaken within similar closed (batch) processes at their respective production plants in Fombio, Italy and Chauny, France. The applicants’ activities are associated with a combined EDC use of '''''#B'''''. Strong acid cation exchange resins (SAC ERs) are a sub-category 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 nuclear industry. SAC ERs are characterised by their ability to exchange cations or split neutral salts and are useful across the entire pH range (Dow, 2000). EDC’s effectiveness and properties as a polystyrene-divinylbenzene (PS-DVB) sulphonation swelling agent allow the process to achieve high yields of acceptable quality SAC ERs (across 50 different product grades), with short cycle times for sulphonation. The solvent is also highly recoverable in the process. Such parameters are extremely important when considering the highly competitive global market the applicants compete in. The authorisation has been applied for so that EDC will continue to be used at the applicants’ plants until a suitable alternative becomes available. The argumentation in this AfA is based on two pillars: The lack of a technically and economically feasible (and sustainable) alternative for EDC, and The demonstration that the socio-economic benefits from the continued use of the substance significantly outweigh the risks to human health, as shown in the accompanying Socio-economic Analysis (SEA) document. Important note Although ‘Dow Italia Srl’ and ‘Rohm and Haas France S.A.S.’ can be considered as separate legal entities, their activities fall under the remit of ‘Dow Water & Process Solutions’, a business unit of The Dow Chemical Company. Both legal entities are ultimately owned 100% by The Dow Chemical Company. Consequently, in the context of this Analysis of Alternatives (AoA), the applicants’ activities must be considered ‘as one’ i.e. from the overall corporate strategy and business perspective of The Dow Chemical Company. However, where deemed particularly relevant, distinction is made between e.g. specific production processes. This overall business perspective is also very important to consider when the feasibility of alternatives is taken into account, as the applicants are duty-bound to justify any proposed capital projects to The Dow Chemical Company. These will be required to pass all financial, technical, business, and sustainability justification ‘gates’, and, as The Dow Chemical Company operates globally, be compared to other high-level options including the exit of operations and shutdown of the affected production within the EU. These issues are discussed further in the corresponding SEA document, but the requirement for the applicants to justify their actions in the context of a competitive global market remains a critical factor for consideration within this AoA Use number: 1 Legal name of the applicants: Dow Italia Srl and Rohm and Haas France S.A.S. 1 1.2 Identification of potential alternatives for EDC and overall feasibility Dow followed a detailed, stepwise