ANALYSIS OF ALTERNATIVES & SOCIO-ECONOMIC ANALYSIS Legal name of Applicant(s): SEBIA Submitted by: SEBIA Substance: 4-(1,1,3,3-Tetramethylbutyl)phenol, ethoxylated [covering well-defined substances and UVCB substances, polymers and homologues] Use title: Use-3 Industrial use of 4-tert-OPnEO for its detergent properties resulting in cellular lysis and protein interactions rupture and required for the production of reagents involved in the determination of proteins of interest in gel and capillary electrophoresis IVD tests Use number: 3 Analysis of Alternatives – Socio-Economic Analysis CONTENTS TABLES .......................................................................................................................................................... 4 FIGURES ........................................................................................................................................................ 5 LIST OF ABBREVIATION S ....................................................................................................................... 6 1. SUMMARY ........................................................................................................................................... 7 2. AIMS AND SCOPE OF TH E A N A L Y S I S ......................................................................................... 9 2.1. SEBIA ............................................................................................................................................................ 10 2.2. Scope of the AfA ........................................................................................................................................... 11 2.3. SEBIA’s site: Lisses ........................................................................................................................................ 12 2.4. Elements of context ..................................................................................................................................... 13 2.4.1. Electrophoresis: principle and uses .................................................................................................................. 13 2.4.2. Clinical use of gel and capillary electrophoresis tests ....................................................................................... 18 2.5. Products concerned...................................................................................................................................... 22 2.5.1. HYDRAGEL® product ranges ............................................................................................................................. 22 2.5.2. CAPILLARYS® product ranges ........................................................................................................................... 28 2.6. Supply chain ................................................................................................................................................. 31 2.7. Elements of contexts .................................................................................................................................... 32 2.7.1. General production process.............................................................................................................................. 32 2.7.2. Market .............................................................................................................................................................. 32 2.8. General methodology ................................................................................................................................... 35 2.8.1. Scope of the AfA ............................................................................................................................................... 36 2.8.2. Actualisation .................................................................................................................................................... 37 2.9. Substitution strategy .................................................................................................................................... 38 2.10. Presentation of the “applied for use” and “non-use” scenarios .................................................................. 38 2.10.1. “Applied for use” scenario ........................................................................................................................... 38 2.10.2. “Non-use” scenario ...................................................................................................................................... 38 3. “APPLIED FOR USE” SCENARIO ............................................................................................................... 40 3.1. Analysis of substance function ..................................................................................................................... 40 3.1.1. Functional properties ....................................................................................................................................... 40 3.1.2. Analytical and clinical performances ................................................................................................................ 43 3.2. Market and business trends ......................................................................................................................... 46 3.2.1. Use of 4-tert-OPnEO ......................................................................................................................................... 46 3.2.2. Business trends ................................................................................................................................................. 46 3.3. Human health impacts of the “applied for use” scenario ............................................................................ 47 3.4. Impacts on the environment and monetised damage of the “applied for use” scenario ............................ 47 3.4.1. Management of aqueous waste relative to Use-3: discharges evaluation, collection and treatment in the context of the “applied for use” scenario ....................................................................................................................... 47 3.4.2. Environmental context of the impacts ............................................................................................................. 48 4. SELECTION OF THE “NON-USE” SCENARIO ............................................................................................. 60 4.1. General presentation of SEBIA’s change management process ................................................................... 61 4.2. Substitution initiative ................................................................................................................................... 62 4.2.1. Elements of context .......................................................................................................................................... 62 4.2.2. Substitution initiative ....................................................................................................................................... 66 4.2.3. Substitution timeline and resources ................................................................................................................. 74 4.3. The most likely “non-use” scenario .............................................................................................................. 76 5. IMPACTS OF GRANTING AN AUTHORISATION ........................................................................................ 79 5.1. Cost-effectiveness analysis ........................................................................................................................... 79 5.2. Economic impacts......................................................................................................................................... 79 5.2.1. Direct loss of revenues...................................................................................................................................... 80 5.2.2. Loss of markets ................................................................................................................................................ 81 5.2.3. Penalties linked to the range discontinuation .................................................................................................. 81 5.2.4. Discussion: net impact for the global chain ...................................................................................................... 82 5.2.5. General conclusion on economic impacts ........................................................................................................ 83 5.3. Human health or Environmental impact ...................................................................................................... 84 5.4. Social impact ................................................................................................................................................ 84 Use-3 SEBIA 2 Analysis of Alternatives – Socio-Economic Analysis 5.4.1. Medical impacts ............................................................................................................................................... 84 5.4.2. Impact on employment .................................................................................................................................... 88 5.4.3. Impacts on the global health chain .................................................................................................................