Final Report Part A: Polymers - European …

1 REVIEW OF reach WITH REGARD TO THE REGISTRATION REQUIREMENTS ON Polymers 070307/2011/602175/SER/D3 Final Report part A: Polymers Prepared for European Commission DG Environment December 2012 RPA Review of reach with regard to the Registration Requirements on Polymers 070307/2011/602175/SER/D3 Draft Final Report part A: Polymers December 2012 prepared for European Commission DG Environment by Risk & Policy Analysts Limited Farthing Green House, 1 Beccles Road, Loddon, Norfolk, NR14 6LT Tel: 01508 528465 Fax: 01508 520758 Email: RPA Report - ASSURED QUALITY RPA Project Ref: J762 Approach: In accordance with the agreed work plan Report Status: Draft Final Report : part A Report Prepared by.

2 Meg Postle (RPA) Philip Holmes (RPA) Marco Camboni (RPA) Anthony Footitt (RPA) Nigel Tuffnell (RPA) Mark Blainey (Milieu) Gary Stevens (GnoSys) Amy Pye (GnoSys) Report approved for issue by: Meg Postle, Director Date: 6 December 2012 RPA/GnoSys/Milieu - i - Contents Page 1. Introduction .. 1 Background to the Study .. 1 Introduction to 1 Reviews under Article 138 .. 2 Study Objectives .. 2 Organisation of Report .. 3 2. Polymers and reach .. 5 Definitions .. 5 reach Definitions .. 5 IUPAC Definitions .. 6 polymer Synthesis and Composition.

3 7 Manufacture of Polymers .. 7 polymer Types .. 8 Monomers .. 13 Additives to Polymers .. 18 Polymers and 20 Introduction .. 20 Registration of Monomers and Constituent Substances .. 20 Registration and Oligomers .. 21 Registration and Additives .. 21 Registration and Polymers .. 22 Assumptions for the Impact Assessment .. 26 3. polymer Synthesis and Industry .. 27 The European Chemicals Industry .. 27 The Sector at the EU Level .. 27 Germany .. 30 France .. 31 Italy .. 31 The UK .. 32 Spain.

4 32 The Production and Trade in Polymers .. 33 Sources of Production Data .. 33 Plastics Production in the EU .. 34 Numbers of Plastic Polymers .. 40 Rubber .. 43 Silicones .. 46 Assumptions for the Impact Assessment .. 46 4. The Risks Posed by Polymers and Other Substances .. 47 Information from Industry .. 47 Classification and Labelling Inventory .. 47 Hazards from Polymers .. 49 Introduction .. 49 Registration Requirements Under reach Polymers - ii - Polymers .. 50 Monomers .. 57 Oligomers .. 59 Emissions from Polymers .

5 60 Hazards from Polymers , Monomers and All Substances .. 61 Assumptions for the Impact Assessment .. 61 5. Approaches to the Risk Assessment of Polymers .. 63 Overview of Approaches to polymer Risk 63 Assumptions for the Impact Assessment .. 64 6. Previous reach Assessments on Polymers .. 71 Proposals for polymer Registration in 71 Previous Assessment of polymer Registration Proposals .. 73 Assumptions for Information Requirements and Sharing .. 73 Non-Registered Monomers and Other Substances .. 73 Estimates Used.

6 73 Previous Costings .. 74 Costs of Registrations Latest Data .. 75 7. Assumptions for Options Assessment .. 77 General Assumptions .. 77 Cost Assumptions for Impact Assessment .. 95 8. Registration Options for Polymers .. 99 Overview .. 99 Screening Options .. 100 Overview of Screening and Screening Criteria .. 100 Screening Option 1: One-dimensional Targeting/Screening .. 101 Screening Option 2: Multi-dimensional Targeting/Screening .. 101 Screening Option 3: Linear Targeting/Screening .. 102 Information Options.

7 104 Overview .. 104 Information Options for Separate Registration of Polymers (I) .. 105 Information Options for Extension of Monomer Registrations (II).. 106 Combined (Registration) Options .. 106 Overview .. 106 Registration Options for Separate Registration of Polymers (Scenario I)108 Registration Options for Extension of Monomer Registrations (Scenario II) .. 115 reach Registration Requirements - Relevance for Polymers .. 116 Introduction .. 116 Registration of Intermediates .. 116 Information Requirements.

8 119 CSA Overview .. 121 Risk Characterisation .. 124 9. Results of the Options Appraisal Predicted Costs .. 125 Introduction .. 125 RPA/GnoSys/Milieu - iii - Summary of Key Sector Statistics .. 125 The Options .. 127 Total Costs of the Options .. 129 Registration of Intermediates .. 129 Number of Polymers to be Registered Under Each Option .. 130 Total Costs of the Options .. 134 Total Costs by Company 136 Average Cost Per polymer Registered or Extended Monomer Registration140 Wider Implications .. 145 10.

9 Results of the Options Appraisal Predicted Health and Environmental Benefits147 Overview .. 147 Benefits Associated with New Classifications .. 151 Identification of Hazardous Polymers .. 151 Chemical Safety Assessment Requirements .. 154 Introduction .. 154 Linkages to Other Legislation .. 157 Overview .. 157 The Classification, Labelling and Packaging Regulation .. 157 Legislation on the Health and Safety of Workers .. 158 Legislation on the Environment .. 160 Legislation Regulating Products .. 161 11. Summary Comparison of Costs and Benefits.

10 163 Overview .. 163 Total Numbers to be Registered Under the Different Options .. 163 polymer Hazards .. 164 polymer Substance Identification .. 166 Extending Monomer Registrations .. 168 Costs and Benefits .. 169 Estimated Total Costs .. 169 Average Costs Per Substance .. 170 Cost-Effectiveness .. 171 Other Factors .. 173 12. References .. 175 Annex 1: Approaches to the Risk Assessment of Polymers Annex 2: Supplementary Tables Registration Requirements Under reach Polymers - iv - RPA/GnoSys/Milieu Page 1 1.