STUDY ON THE FEASIBILITY OF APPLYING EXTENDED PRODUCER RESPONSIBILITY TO MICROPOLLUTANTS AND MICROPLASTICS EMITTED IN THE AQUATIC ENVIRONMENT FROM PRODUCTS DURING THEIR LIFE CYCLE Module 2: Applicability of EU legislation for implementation of EPR FINAL REPORT January 2020 1 Module 2 – Applicability of EU legislation for implementation of EPR CONTENTS Part I. Objectives, scope & methodology 1. Objectives and scope 8 2. Methodology 12 Part II. Assessment of horizontal EU legislation 3. Water Framework Directive 2000/60 17 4. REACH Regulation 661/2009 21 5. Urban waste water treatment Directive 91/271 29 Part III. Assessment of product-specific EU legislation 6. Pharmaceuticals 32 7. Pesticides 43 8. Biocides 54 9. Textiles 59 10. Tyres 67 Part IV. Analysis of options for the way forward 11. Policy options & comparative analysis 77 12. Analysis of policy options 81 13. Key findings of legislative assessment 87 14. Recommendations for the way forward 92 Annex 95 2 Module 2 – Applicability of EU legislation for implementation of EPR List of figures: Figure 1: Study scope ............................................................................................ 9 Figure 2: Applicable EU legislation to address substance emissions .............................11 Figure 3: Pros and Cons of different financing tools used for EPR ................................12 Figure 4: Policy tools on diffuse water pollution ........................................................13 Figure 5: EPR implementation: overview of challenges and solutions...........................13 Figure 6: Full life-cycle approach to reduce emission of water pollutants......................15 Figure 7: Structure of ECHA guidance document on CSA ...........................................23 Figure 8: Applicable EU legislation across the life-cycle of pharmaceutical products.......33 Figure 9: Applicable EU legislation across the life-cycle of pesticide products ................44 Figure 10: Applicable EU legislation across the life-cycle of biocidal products ...............54 Figure 11: Applicable EU legislation across the life-cycle of textile products .................59 Figure 12: Applicable EU legislation across the life-cycle of tyres ................................67 Figure 13: Approach for analysis of options ..............................................................78 Figure 14: Scoring approach ..................................................................................78 List of boxes: Box 1: Blueprint to Safeguard Europe's Water Resources ...........................................18 Box 2: Key components of CSA under REACH Regulation 661/2009 ............................22 Box 3: Application of the REACH Regulation 661/2009 on PFASs ................................24 Box 4: Possible application of EPR principles on PFASs ..............................................28 Box 5: Recent updates to EU regulatory framework on pharmaceuticals ......................35 Box 6: Main components of the ERA for human pharmaceuticals (Directive 2001/83) ....36 Box 7: Components of the evaluation for pesticides products, Regulation 1107/2009 ....46 Box 8: REFIT evaluation of the EU pesticide legislation, .............................................47 Box 9: Market authorisation requirements for biocidal products (Regulation 528/2012) .55 Box 10: The BPR and the use of silver as a biocide in textiles (sportswear) ..................56 Box 11: Review of Tyre Labelling Regulation 1222/2009 ............................................69 Box 12: Tyre and Road Wear Particle Platform .........................................................69 Box 13: Ecodesign Directive 2009/125 – Relevant provisions & possible amendments ...96 Box 14: Industrial Emissions Directive 2010/75 – Relevant provisions & possible amendments ........................................................................................................97 Box 15: Waste Framework Directive 2008/98 – Relevant provisions and possible amendments ........................................................................................................98 Box 16: Strategic Approach to Pharmaceuticals in the Environment .......................... 102 List of tables: Table 1: Summary of most relevant EU legislation assessed.......................................10 Table 2: Criteria and framework for assessment of policy options ...............................14 Table 3: Key provisions of EQS Directive 2008/105 and Groundwater Directive 2006/118 ..........................................................................................................................17 Table 4: Summary of relevant provisions of REACH Regulation 661/2009 ....................21 Table 5: Summary of relevant product-specific provisions under REACH ......................24 Table 6: Possible amendments to the REACH Regulation 661/2009 .............................26 Table 7: Summary of most relevant provisions on pharmaceutical products .................33 Table 8: Potential legislative changes & EPR opportunities for pharmaceuticals .............39 Table 9: Potential obstacles and success factors .......................................................41 3 Module 2 – Applicability of EU legislation for implementation of EPR Table 10: Summary of most relevant provisions on pesticide products ........................44 Table 11: Potential legislative changes & EPR opportunities for pesticides ....................49 Table 12: Potential obstacles and success factors .....................................................52 Table 13: Summary of most relevant provisions on biocidal products ..........................55 Table 14: Potential legislative changes & EPR opportunities for biocides ......................57 Table 15: Summary of most relevant provisions on textile products ............................61 Table 16: Potential legislative changes & EPR opportunities for textiles .......................64 Table 17: Summary of most relevant provisions on tyres ...........................................68 Table 18: Potential legislative changes & EPR opportunities for tyres ...........................72 Table 19: Specific measures included in policy options ..............................................77 Table 20: Comparison of regulatory clarity of potential legal basis for EPR ...................81 Table 21: Comparative analysis of overall effectiveness of options ..............................83 Table 22: SWOT analysis of policy options assessed ..................................................85 Table 23: Priority substances (Environmental Quality Standards Directive 2008/105).. 100 Table 24: List of substances on the surface water Watch List ................................... 100 Table 25: PBT assessment criteria for pharmaceuticals ............................................ 101 Table 26: Assessment of regulatory clarity of legal basis of EPR ............................... 103 Table 27: Estimated timeframe for implementation of specific measures based on EU legislative review process .................................................................................... 104 4 Module 2 – Applicability of EU legislation for implementation of EPR Abbreviations API Active pharmaceutical ingredients BAT Best available techniques BPR Biocidal Products Regulation (Regulation 528/2012) CMR Carcinogens, mutagens and reprotoxic substances CSA Chemical safety assessment ECHA European Chemical Agency ELT End of life tyres EMA European Medicines Agency EPR Extended Producer Responsibility EQSD Environmental Quality Standards Directive (Directive 2008/105) EQS Environmental Quality Standards ERA Environmental Risk Assessment IED Industrial Emissions Directive (Directive 2010/75) IPM Integrated Pest Management JRC European Commission Joint Research Centre MBI Market-based instruments MPD Medicinal Products Directive (Directive 2004/27) NAPs National Action Plans NSAID Nonsteroidal anti-inflammatory drug OECD Organisation for Economic Cooperation and Development PBT Persistent, bioaccumulative and toxic substances PRO Producer responsibility organisation SDS Safety data sheet SVHC Substances of Very High Concern SWL Surface water Watch List REACH Registration, Evaluation, Authorisation and Restriction of Chemicals Regulation (Regulation 1907/2006) TLR Tyre Labelling Regulation (Regulation 1222/2009) TFEU Treaty on the Functioning of the European Union TRWP Tyre and road wear particles TWP Tyre wear particles UWWTD Urban Waste Water Treatment Directive (Directive 91/27) vPvB Very persistent and very bioaccumulative substances WFD Water Framework Directive (Directive 2000/60) 5 Module 2 – Applicability of EU legislation for implementation of EPR Terms and definitions Active pharmaceutical ingredients: Refers to the biologically active component or active ingredient of a pharmaceutical product. Medicinal products are usually composed of two core components: the active pharmaceutical ingredient, which is the primary ingredient or substance responsible for the activity of a medicine and all other ingredients, commonly referred to as excipients. Excipients are chemically inactive ingredients e.g. lactose or mineral oil. In the case of a pharmaceutical product such as a pill or capsule intended to treat headaches, acetaminophen is the active ingredient, while the liquid in the gel-capsule is the excipient. Communication: A policy document with no mandatory authority or no legal effect. The Commission takes the initiative of publishing a Communication