Technical Assistance Related to the Review of REACH with Regard to the Registration Requirements on Polymer Final Report
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Technical assistance related to the review of REACH with regard to the registration requirements on polymer Final report 17 February 2015 Document information BIO by Deloitte is a commercial brand of the legal entity BIO Intelligence Service. Since 26 June 2013 the legal entity BIO Intelligence Service is a 100% owned subsidiary of Société Fiduciaire Internationale d’Audit which is owned by Deloitte. CLIENT European Commission – DG ENV REPORT TITLE Final report PROJECT NAME Technical assistance related to the review of REACH with regard to the registration requirements on polymers DATE 17 February 2015 PROJECT TEAM BIO by Deloitte (BIO), Pólo de Inovação em Engenharia de Polímeros (PIEP) AUTHORS Ms Arianna De Toni (BIO) Ms Nada Saïdi (BIO) Ms Liliana Rosa Santos (PIEP) Mr Shailendra Mudgal (BIO) KEY CONTACTS Shailendra Mudgal +33(0)1 55 61 63 03 [email protected] Or Arianna De Toni +33(0)1 55 61 68 89 [email protected] DISCLAIMER The project team does not accept any liability for any direct or indirect damage resulting from the use of this report or its content. This report contains the results of research by the authors and is not to be perceived as the opinion of the European Commission. Please cite this publication as: BIO by Deloitte (2014). Technical assistance related to the review of REACH with regard to the registration requirements on polymers – Final report prepared for the European Commission (DG ENV), in collaboration with PIEP. Table of contents 1. INTRODUCTION ________________________________________________________ 7 1.1. Background ___________________________________________________________ 7 1.2. Objectives _____________________________________________________________ 8 1.3. Terminology ___________________________________________________________ 8 1.3.1. Registration and notification __________________________________________ 8 1.3.2. Existing substances and new substances ________________________________ 8 2. METHODOLOGY ______________________________________________________ 11 2.1. The country approach __________________________________________________ 11 2.2. Collecting information on the approaches: bibliographical review ______________ 11 2.3. Reporting information on the approaches: factsheets and reporting table _______ 11 2.3.1. Country factsheets ________________________________________________ 11 2.3.2. The reporting table ________________________________________________ 12 2.4. Mapping the approaches ________________________________________________ 16 2.5. Assessment of third countries approaches _________________________________ 16 2.5.1. Hazard assessment _______________________________________________ 16 2.5.2. Cost-effectiveness ________________________________________________ 17 2.6. Development and assessment of new PLC and grouping approaches ___________ 17 3. GENERAL REGISTRATION REQUIREMENTS FOR POLYMERS _______________________ 19 3.1. Reporting information on third countries __________________________________ 19 3.1.1. Selected countries ________________________________________________ 19 3.1.2. Data availability ___________________________________________________ 19 3.1.3. Country factsheet and reporting table __________________________________ 19 3.1.4. Competent Authorities feedback ______________________________________ 19 3.2. Overview of requirements _______________________________________________ 20 3.3. Mapping of the different approaches ______________________________________ 22 3.3.1. Definition of a polymer among the studied countries ______________________ 26 3.3.2. Exemption and reduced requirements for polymers _______________________ 26 4. REGISTRATION APPROACHES FOR POLYMERS OF LOW CONCERN _________________ 31 4.1. Approaches adopted in third countries ____________________________________ 31 4.1.1. Definition of a PLC ________________________________________________ 31 4.1.2. Rationale for establishing a PLC approach ______________________________ 35 4.1.3. Requirements for PLCs _____________________________________________ 35 4.1.4. Amount of PLCs registered or exempted _______________________________ 35 4.2. Hazard assessment of polymers__________________________________________ 36 4.2.1. Criteria for determining potential hazard: theoretical framework ______________ 36 4.2.2. Hazard assessment applied by Competent Authorities _____________________ 39 4.3. Proposal of a EU PLC approach __________________________________________ 42 4.3.1. Discrimination using hazard information available in REACH and CLP dossiers _ 44 4.3.2. Eligibility criteria __________________________________________________ 46 Technical assistance related to the review of REACH with regard to the registration requirements on 3 polymers 4.3.3. Criteria on average molecular weight and oligomer content _________________ 48 4.3.4. Criteria on Reactive Functional Groups (RFGs) __________________________ 49 4.3.5. Exception: polyesters ______________________________________________ 50 4.4. Cost effectiveness of PLC approaches (third countries and new approach) ______ 53 4.4.1. Equations _______________________________________________________ 54 4.4.2. Required data for numerical application ________________________________ 54 4.4.3. Calculation of reduction factors for third countries ________________________ 55 4.4.4. Conclusion on third countries approaches ______________________________ 57 4.4.5. Cost reduction for the EU with the proposed PLC approach _________________ 57 5. REGISTRATION APPROACHES FOR GROUPING POLYMERS ________________________ 59 5.1. Approaches adopted in the DSD and in third countries _______________________ 59 5.1.1. Definition of a group of polymer and process for determining similarity ________ 59 5.1.2. Amount of groups registered _________________________________________ 64 5.2. Assessment of grouping approaches with regards to environmental and health risks of polymers ______________________________________________________ 65 5.2.1. Criteria for assessing grouping approaches _____________________________ 65 5.2.2. Assessment of grouping approaches from the studied jurisdictions ___________ 68 5.3. Proposal of a EU grouping approach ______________________________________ 71 5.3.1. Grouping polymers with the same constituents ___________________________ 71 5.3.2. Grouping polymers with different constituents ___________________________ 74 5.4. Cost effectiveness of grouping approaches (third countries and new approach) __ 74 5.4.1. Equations _______________________________________________________ 74 5.4.2. Required data for numerical application ________________________________ 75 5.4.3. Calculation of reduction factors for third countries ________________________ 77 5.4.4. Cost reduction for the EU with the proposed grouping approach _____________ 77 6. CONCLUSION ________________________________________________________ 79 6.1. Third countries’ PLC and grouping approaches _____________________________ 79 6.2. Proposed approaches for the EU _________________________________________ 80 7. ANNEXES _________________________________________________________ 81 Annex 1. Country factsheets _______________________________________________ 82 Annex 2. Supporting data ________________________________________________ 196 Annex 3. Determination of FGEWs _________________________________________ 225 Annex 4. Proposed PLC approach – Reactivity of functional groups _____________ 227 Annex 5. Glossary_______________________________________________________ 233 Technical assistance related to the review of REACH with regard to the registration requirements on 4 polymers List of Tables Table 1: Structure of the reporting table .......................................................................................... 13 Table 2: List of Competent Authorities in the studied countries ....................................................... 20 Table 3: Overview of the characteristics of all studied countries ..................................................... 23 Table 4: Correspondence between number-average molecular weight and composition criteria in USA, Canada, Australia, China, South Korea (K-REACH) and Taiwan ....................................... 32 Table 5: Scoring of the criteria for determining potential hazard ..................................................... 38 Table 6: Inclusion of hazard assessment criteria in the different strategies .................................... 40 Table 7: Proposed list of approved polyesters reactants for an EU PLC approach ......................... 51 Table 8: Required data for estimating cost effectiveness of PLC approaches ................................ 55 Table 9: Estimated cost-effectiveness of PLC in Australia, Canada and the USA .......................... 57 Table 10: Grouped registrations in the studied jurisdictions ............................................................ 60 Table 11: The different processes for determining similarity ........................................................... 64 Table 12: Justification elements for read-across and their relevance for grouping polymers .......... 66 Table 13: Rationale for categorisation of read-across analogues and relevance for grouping polymers .......................................................................................................................................... 67 Table 14: Assessment of the Australian grouping approach with regards to environmental and health risks .....................................................................................................................................