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: 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.

2 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 .. 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 .. 32 The Production and Trade in Polymers .. 33 Sources of Production Data .. 33 Plastics Production in the EU .. 34 Numbers of Plastic Polymers .

3 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 .. 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 .. 73 Previous Costings.

4 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 .. 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 .

5 116 Introduction .. 116 Registration of Intermediates .. 116 Information Requirements .. 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. 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.

6 157 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 .. 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. INTRODUCTION Background to the Study Introduction to REACH Regulation (EC) No. 1907/2006 concerning the Registration, Evaluation, Authorisation and Restriction of Chemicals (REACH1) came into force on 1 June 2007.

7 REACH aims to provide a high level of protection of human health and the environment through the better and earlier identification of the intrinsic properties of chemicals and their uses, while at the same time enhancing the innovative capability and competitiveness of the EU chemicals industry. Furthermore, REACH aims to ensure the free movement of substances and the promotion the development of alternative methods for the assessment of hazards of substances (Recital 1). The regulation applies to substances manufactured, placed on the market and used in the EU either on their own, in mixtures or in articles (Article 1). Furthermore, REACH is based on the principle that it is for industry to ensure that they manufacture, place on the market or use such substances that do not adversely affect human health or the environment. Its provisions are underpinned by the precautionary principle (Article 1(3)).

8 The four key elements in REACH are: 1. Registration: of substances manufactured or imported in amounts starting at 1 tonne per year (per manufacturer or importer) (Title II). Notifications of substances by companies under Directive 67/548/EEC are considered to be registrations under REACH (Article 24); 2. Evaluation (Title VI): of which there are two types dossier evaluation and substance evaluation; 3. Authorisation: of substances of very high concern (SVHC), assuring that the risks of SVHC are properly controlled and that these substances are progressively replaced, while ensuring the good functioning of the internal market (Title VII); and 4. Restriction: aimed at addressing risks not adequately controlled on a Community wide basis (Title VIII). 1 Regulation (EC) No 1907/2006 of the European Parliament and of the Council of 18 December 2006 concerning the Registration, Evaluation, Authorisation and Restriction of Chemicals (REACH), establishing a European Chemicals Agency, amending Directive 1999/45/EC and repealing Council Regulation (EEC) No 793/93 and Commission Regulation (EC) No 1488/94 as well as Council Directive 76/769/EEC and Commission Directives 91/155/EEC, 93/67/EEC, 93/105/EC and 200/21/EC (REACH).

9 Registration Requirements Under REACH Polymers Page 2 Reviews under Article 138 Obligations were placed on the Commission to undertake a range of reviews of the operation of REACH, with these set out in Article 138, and summarised in Table Table : Summary of Reviews Required under Article 138 of REACH Section Summary of Review Deadline 1 Chemical Safety Assessment/ Report exemptions for substances manufactured/ imported in quantities less than 10 tonnes per company. CMRs Cat. 1 or 2 under Directive 67/538/EEC (Cat 1A or Cat 1B under Regulation (EC) No 1272/2008) 1 June 2019 1 June 2014 2 Consider registration of Polymers As soon as practicable 3 Registration requirements for substances manufactured/ imported in quantities less than 10 tonnes per company Every 5 years, starting 1 June 2012 (deadline for Article 117(4) Report ) 4 Annexes I, IV and V 1 June 2008 5 Annex XIII 1 December 2008 6 Scope of REACH regarding overlaps with other EU legislation 1 June 2012 7 Endocrine disrupting chemicals 1 June 2013 8 Communication on additional dangerous substances in articles 1 June 2019 9 Promotion of non-animal testing 1 June 2019 The reviews of specific concern for this element of the study are those required under Article 138 section 2, as described below.

10 The Commission may present legislative proposals as soon as a practicable and cost-efficient way of selecting Polymers for registration on the basis of sound technical and valid scientific criteria can be established, and after publishing a Report on the following: (a) The risks posed by Polymers in comparison with other substances; (b) The need, if any, to register certain types of polymer , taking account of competitiveness and innovation on the one hand and the protection of human health and the environment on the other. Study Objectives The Specifications state that: The objective of the contract is to provide technical, scientific and policy support to the Commission to undertake the reviews described in Articles 138(1), (2) and (3) of REACH. In particular, this element of the study (Task A) is to review the exemption from registration requirements for Polymers . RPA/GnoSys/Milieu Page 3 Organisation of Report The remainder of this Report has been organised as follows: Section 2 sets out the current requirements with regard to the registration of Polymers , monomers, and other polymer constituents under REACH; in Section 3, Polymers are described, along with the industry that manufactures and uses them; the hazards posed by Polymers are assessed in Section 4, and compared with the those posed by monomers and other substances; Section 5 sets out the current approaches to the control of risks posed by Polymers ; Section 6 summarises previous impact assessment conclusions on the registration of Polymers ; Section 7 lists the assumptions being taken forward for the Impact Assessment from the information set out in the previous sections; Section 8 details the policy options for the future registration of Polymers that have been examined here.