ANALYSIS OF ALTERNATIVES non-confidential report Legal name of applicant(s): DEZA, A.S. Submitted by: DEZA, A.S. Substance: BIS (2-ETHYLHEXYL ) PHTHALATE (DEHP) Use title: Formulation of DEHP in compounds, dry-blends and plastisol formulations Industrial use in polymer processing by calendering, spread coating, extrusion, injection moulding to produce PVC articles [except erasers, sex toys, small household items (<10cm) that can be swallowed by children, clothing intended to be worn against the bare skin; also toys, cosmetics and food contact material (restricted under other EU regulation)] Use number: Uses 1 and 2 ANALYSIS OF ALTERNATIVES © DEZA, a.s. 2013 The information in this document is the property of DEZA, a.s. and may not be copied, communicated to a third party, or used for any purpose other than that for which it is supplied, without the express written consent of DEZA, a.s. While the information is given in good faith based upon the latest information available to DEZA, a.s., no warranty or representation is given concerning such information, which must not be taken as establishing any contractual or other commitment binding upon DEZA, a.s or any of its subsidiary or associated companies. ii ANALYSIS OF ALTERNATIVES CONTENTS 1 SUMMARY ............................................................................................................................................................ 1 1.1 Background to this Application for Authorisation .......................................................................................... 1 1.1.1 Identity of the Applicant ...................................................................................................................... 1 1.1.2 Background to the applied-for uses ..................................................................................................... 1 1.1.3 Hazards leading to listing of the substance under Annex XIV of the REACH Regulation ................. 3 1.1.4 Organisation of this AoA .................................................................................................................... 4 1.2 Identification and screening of potential alternatives ..................................................................................... 5 1.3 Assessment of suitability and availability of potential alternatives substances .............................................. 6 1.3.1 Overview of approach ......................................................................................................................... 6 1.3.2 Reduction of overall risks .................................................................................................................... 6 1.3.3 Technical and economic feasibility of potential alternative substances .............................................. 16 1.4 Summary of the findings on the suitability of potential alternative substances .............................................. 17 1.5 Conclusion ...................................................................................................................................................... 17 1.6 Actions required for making the alternatives suitable and available .............................................................. 17 2 ANALYSIS OF SUBSTANCE FUNCTION.......................................................................................................... 19 2.1 Introduction .................................................................................................................................................... 19 2.2 Introduction to plasticised polymers ............................................................................................................... 19 2.2.1 Roles and material flows in the polymers and plastics industries ....................................................... 19 2.2.2 Role of plasticisers .............................................................................................................................. 19 2.2.3 Role of DEHP in the applied-for uses ................................................................................................. 22 2.2.3.1 Scope of this Analysis of Alternatives .................................................................................. 22 2.2.3.2 Identification of applied-for uses for DEHP .......................................................................... 22 2.3 Technical feasibility considerations from the perspective of the applicant .................................................... 22 2.3.1 Technical characteristics of DEHP manufacture ................................................................................. 22 2.3.2 Parameters of technical feasibility from the applicant’s perspective ................................................... 23 2.3.2.1 Production integration ........................................................................................................... 23 2.3.2.2 Availability of precursors ...................................................................................................... 25 2.3.2.3 Production plant requirements and feasibility of process modification ................................. 26 2.4 Technical considerations in selecting a plasticiser ......................................................................................... 28 2.4.1 Overview of plasticiser types .............................................................................................................. 28 2.4.2 How to select a plasticiser ................................................................................................................... 28 2.4.3 General Purpose plasticisers and commercial success of DEHP ......................................................... 32 2.4.4 Technical feasibility and selection criteria for DEHP and alternatives ............................................... 33 2.4.4.1 Introduction ........................................................................................................................... 33 2.4.4.2 Approach to information collection ....................................................................................... 33 2.4.4.3 General technical comparison criteria ................................................................................... 34 2.4.4.4 Core Criterion 1: PVC compatibility .................................................................................... 35 2.4.4.5 Core Criterion 2: Processability ........................................................................................... 38 2.4.4.6 Core Criterion 3: Plasticiser efficiency ................................................................................ 38 2.4.4.7 Core Criterion 4: Permanence .............................................................................................. 40 2.4.4.8 Secondary Criterion 1: Low temperature performance ........................................................ 42 2.4.4.9 Secondary Criterion 2: Clarity / Colour ............................................................................... 42 2.4.4.10 Secondary Criterion 3: Elastic recovery ............................................................................... 43 2.4.4.11 Secondary Criterion 4: Odour .............................................................................................. 43 Use number: 1,2 Legal name of applicant: DEZA, a.s. iii ANALYSIS OF ALTERNATIVES 2.4.4.12 Secondary Criterion 5: Melting / Freezing point .................................................................. 44 2.4.4.13 Secondary Criterion 6: Sterilisability ................................................................................... 44 2.4.4.14 Secondary Criterion 7: Printability and adhesion properties ................................................ 45 2.4.5 Summary of technical requirements for DEHP as a plasticiser in PVC .............................................. 46 3 IDENTIFICATION OF POSSIBLE ALTERNATIVES ......................................................................................... 48 3.1 Introduction and scope of analysis.................................................................................................................. 48 3.2 Description of efforts made to identify possible alternatives .......................................................................... 49 3.2.1 Research and development activities ................................................................................................... 49 3.2.1.1 Activities of the applicant ...................................................................................................... 49 3.2.1.2 Activities of downstream users of DEHP .............................................................................. 49 3.2.2 Data searches for the purposes of this Analysis of Alternatives .......................................................... 50 3.2.3 Consultations ....................................................................................................................................... 51 3.2.3.1 Overview of key consultees .................................................................................................. 51 3.2.3.2 Consultation with the applicant ............................................................................................. 52 3.2.3.3 Consultation with downstream users ..................................................................................... 53 3.3 Identification of potential alternative substances