ANALYSIS OF ALTERNATIVES & SOCIO-ECONOMIC ANALYSIS Legal name of Applicant(s): BioMérieux SA Submitted by: BioMérieux SA Substance: 4-(1,1,3,3-Tetramethylbutyl)phenol, ethoxylated [covering well-defined substances and UVCB substances, polymers and homologues] Use title: Use-1 Industrial use of 4-tert-OPnEO for its non-ionic detergent properties consisting in the filling of 4-tert-OPnEO- containing solution into specific single-use ampoules to be included in clinical and industrial in vitro testing applications a part of the BioFire and BioFire Next Gen FA products Use number: 1 Analysis of Alternatives – Socio-Economic Analysis CONTENTS LIST OF ABBREVIATIONS .......................................................................................................................... 6 1. SUMMARY ............................................................................................................................................. 8 2. AIMS AND SCOPE OF THE ANALYSIS .......................................................................................... 10 2.1. BioMérieux .................................................................................................................................................. 10 2.2. Scope of the Application for The Authorisation ..................................................................................... 12 2.3. Site concerned: Holopack Packaging Technology GmbH Sulzbach-Laufen .................................... 13 2.4. Products concerned .................................................................................................................................. 15 2.4.1. General elements regarding processes ................................................................................................ 17 2.4.2. The BioFire System: an efficient diagnostic tool to detect various diseases and pathogens ........ 21 2.4.3. Elements of context regarding BioFire products .................................................................................. 29 2.5. Supply chain ............................................................................................................................................... 43 2.6. Elements of contexts ................................................................................................................................. 44 2.6.1. General production process .................................................................................................................... 44 2.6.2. Market ........................................................................................................................................................ 44 2.7. General methodology ................................................................................................................................ 47 2.7.1. Scope of the AfA ....................................................................................................................................... 48 2.7.2. Actualisation .............................................................................................................................................. 49 2.7.3. Exchange rate ........................................................................................................................................... 50 2.8. Substitution strategy .................................................................................................................................. 50 2.9. Presentation of the “applied for use” and “non-use” scenarios ........................................................... 51 2.9.1. “Applied for use” scenario ....................................................................................................................... 51 2.9.2. “Non-use” scenario ................................................................................................................................... 51 3. “APPLIED FOR USE” SCENARIO ................................................................................................... 53 3.1. Analysis of substance function ................................................................................................................ 53 3.1.1. Functional properties ................................................................................................................................ 53 3.1.2. Technical and clinical performances ...................................................................................................... 57 3.2. Market and business trends ..................................................................................................................... 60 3.2.1. Use of 4-tert-OPnEO ................................................................................................................................ 60 3.3. Human health impacts of the “applied for use” scenario ..................................................................... 61 3.4. Impacts on the environment and monetised damage of the “applied for use” scenario.................. 61 3.4.1. Management of aqueous waste relative to Use-1: discharges evaluation, collection and treatment in the context of the “applied for use” scenario ........................................................................................................ 62 3.4.2. Environmental context of the impacts .................................................................................................... 63 4. SELECTION OF THE “NON-USE” SCENARIO .............................................................................. 82 4.1. General presentation of BioFire’s change management process....................................................... 82 4.2. Substitution initiative.................................................................................................................................. 84 4.2.1. Elements of context .................................................................................................................................. 84 4.2.2. Substitution works .................................................................................................................................... 89 4.2.3. Human resources and substitution costs ............................................................................................ 101 4.3. BioFire Next Gen FA and Ampoule Filling Line Relocation projects ................................................ 102 4.3.1. BioFire Next Gen FA development timeline ........................................................................................ 103 4.3.1. Relocation costs and human resources .............................................................................................. 106 4.4. The most likely “non-use” scenario ....................................................................................................... 108 4.4.1. Potential “non-use” scenarios ............................................................................................................... 108 4.4.2. Summary .................................................................................................................................................. 109 5. IMPACTS OF GRANTING AN AUTHORISATION......................................................................... 110 5.1. Economic impact ..................................................................................................................................... 110 5.1.1. Loss of revenues .................................................................................................................................... 110 5.1.2. Loss of markets ....................................................................................................................................... 112 5.1.3. Discussion: net societal impact ............................................................................................................ 113 5.1.4. General conclusion on economic impacts .......................................................................................... 114 5.2. Human health or Environmental impact ............................................................................................... 114 5.3. Social impact ............................................................................................................................................ 114 5.3.1. Loss of employment ............................................................................................................................... 115 5.3.2. Medical impacts ...................................................................................................................................... 115 Use-1 bioMérieux SA 2 Analysis of Alternatives – Socio-Economic Analysis 5.4. Wider impacts on the global value chain .............................................................................................. 119 5.4.1. Negative impacts ........................................................................................................................................... 119 5.4.2. Positive wider economic impacts ......................................................................................................... 120 5.4.3. Conclusion ............................................................................................................................................... 121 5.5. Conclusion of the socio-economic analysis ........................................................................................