ANNEX to the ANNEX XV RESTRICTION REPORT PROPOSAL FOR A RESTRICTION SUBSTANCE NAME(S): intentionally added microplastics IUPAC NAME(S): N/A EC NUMBER(S): N/A CAS NUMBER(S): N/A CONTACT DETAILS OF THE DOSSIER SUBMITTER: European Chemicals Agency Annankatu 18, PO BOX 400, FI-00121, Helsinki, Finland VERSION NUMBER: 1.2 DATE: 22 August 2019 Annankatu 18, P.O. Box 400, FI-00121 Helsinki, Finland | Tel. +358 9 686180 | Fax +358 9 68618210 | echa.europa.eu ANNEX TO THE ANNEX XV RESTRICTION REPORT – MICROPLASTICS Contents Annex A : Background ............................................................................................ 1 A.1. Examples of definitions for ‘microplastics’ ....................................................................... 1 A.2. Other legislations on intentionally added microplastics .................................................... 10 A.2.1. EU Member State legislation on intentionally added microplastics .............................. 10 A.2.2. Legislation on intentionally added microplastics outside of the European Union ............ 12 A.2.3. Manufacture ...................................................................................................... 14 Annex B. Derivation of a regulatory definition of microplastic .............................. 15 B.1. Substance ................................................................................................................ 15 B.1.1. Presence of a particle or ‘polymer-containing particle’ .............................................. 15 B.1.2. (Bio)degradation of microplastics .......................................................................... 24 Annex C. Hazard, releases, exposure and risk ...................................................... 39 C.1. Summary of review articles ........................................................................................ 39 C.2. Most influential studies ............................................................................................... 74 Annex D. Impacts Assessment ........................................................................... 105 D.1. Analysis of risk management options (RMOs) ............................................................... 105 D.2. Other evaluated restriction options ............................................................................. 105 D.3. Other Union-wide risk management options than restriction ........................................... 108 D.4. Agricultural and Horticultural Products .........................................................................112 D.4.1. Current use ......................................................................................................113 D.4.2. Alternatives ......................................................................................................123 D.4.3. Restriction scenarios ..........................................................................................126 D.4.4. Environmental and health impacts ....................................................................... 129 D.4.5. Economic impacts .............................................................................................131 D.4.6. Other impacts ...................................................................................................135 D.4.7. Proportionality to risk ........................................................................................137 D.4.8. Uncertainties and sensitivities .............................................................................138 D.4.9. Summary .........................................................................................................139 D.5. Cosmetic Products ....................................................................................................139 D.5.1. Use and functions .............................................................................................140 D.5.2. Baseline ...........................................................................................................146 D.5.3. Rinse-off cosmetic products containing microbeads with exfoliating or cleansing functions ...................................................................................................................148 D.5.4. Other rinse-off cosmetic products ........................................................................152 i ANNEX TO THE ANNEX XV RESTRICTION REPORT – MICROPLASTICS D.5.5. Leave-on cosmetic products ...............................................................................166 D.6. Detergents and maintenance products ........................................................................182 D.6.1. Other Union-wide risk management measures than restriction ................................. 182 D.6.2. Use .................................................................................................................183 D.6.3. Uses, functions and alternatives ..........................................................................190 D.6.4. Overview of restriction response and restriction scenarios ....................................... 196 D.6.5. Restriction scenarios and key assumptions ............................................................197 D.6.6. Other impacts ...................................................................................................206 D.6.7. Cost-effectiveness, affordability and proportionality to risk ...................................... 207 D.6.8. Uncertainties and sensitivity analysis ...................................................................209 D.6.9. Impact of scope variations on proportionality to risk ............................................... 209 D.7. Medical devices (MD) and in vitro diagnostic medical devices (IVD MD) ............................ 209 D.7.1. Uses and functions ............................................................................................209 D.7.2. Baseline – tonnage used and releases ..................................................................212 D.7.3. Alternatives ......................................................................................................213 D.7.4. Other existing regulatory provisions .....................................................................214 D.7.5. Proposed action ................................................................................................215 D.7.6. Impact of scope variations on the proportionality to risk ......................................... 216 D.7.7. Uncertainties ....................................................................................................217 D.8. Medicinal products for human and veterinary use .......................................................... 217 D.8.1. Uses and functions: microplastics as pharmaceutical excipient or active substance ..... 217 D.8.2. Baseline – tonnage used and releases ..................................................................224 D.8.3. Alternatives ......................................................................................................228 D.8.4. Other existing regulatory provisions .....................................................................229 D.8.5. Proposed action ................................................................................................231 D.8.6. Impact of scope variations on the proportionality to risk ......................................... 233 D.8.7. Uncertainties ....................................................................................................233 D.9. Food supplements and medical food ............................................................................234 D.10. Oil & gas ............................................................................................................... 234 D.10.1. Uses ..............................................................................................................234 D.10.2. Alternatives ....................................................................................................239 D.10.3. Proposed action ..............................................................................................241 D.10.4. Existing provisions ...........................................................................................242 D.10.5. Analysis of a potential restriction on use under REACH .......................................... 248 D.10.6. Conclusion on proposed action for microplastic use in oil & gas .............................. 250 D.11. Paints and coatings .................................................................................................251 D.11.1. Use of microplastics in paints and coatings .......................................................... 252 D.11.2. Baseline – tonnages used & emitted ...................................................................259 ii ANNEX TO THE ANNEX XV RESTRICTION REPORT – MICROPLASTICS D.11.3. Alternatives ....................................................................................................263 D.11.4. Proposed action ..............................................................................................264 D.12. Option value theory ................................................................................................266 D.12.1. Introduction ...................................................................................................266 D.12.2. Model ............................................................................................................266