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Annex XV Reporting Format 040615 ANNEX XV RESTRICTION REPORT PROPOSAL FOR A RESTRICTION SUBSTANCE NAME(S): Perfluorohexane sulfonic acid (PFHxS), its salts and PFHxS-related substances IUPAC NAME(S): n.a. EC NUMBER(S): n.a. CAS NUMBER(S): n.a. CONTACT DETAILS OF THE DOSSIER SUBMITTER: Norwegian Environment Agency P.O. Box 5672 Torgarden, N-7485 Trondheim, Norway VERSION NUMBER: 1.1 DATE: 13 June 2019 Annankatu 18, P.O. Box 400, FI-00121 Helsinki, Finland | Tel. +358 9 686180 | Fax +358 9 68618210 | echa.europa.eu ANNEX XV REST RICT ION REPORT – PFHxS, its salts and PFHxS-related substances TABLE OF CONTENTS List of abbreviations ....................................................................................... viii S umma ry ....................................................................................................... 1 Report .......................................................................................................... 7 1. The problem identified ................................................................................... 7 1.1. Hazard, exposure/emissions and risk .............................................................. 7 1.1.1. Identity of the substance(s), and physical and chemical properties.................. 7 1.1.2. Justification for grouping .................................................................... 11 1.1.3. Classification and labelling .................................................................. 14 1.1.4. Hazard assessment........................................................................... 15 1.1.5. Emissions....................................................................................... 15 1.1.6. Environmental exposure and trends ...................................................... 20 1.1.7. Human exposure and trends ............................................................... 21 1.1.8. Risk characterisation ......................................................................... 23 1.2. Justification for an EU wide restriction measure................................................ 24 1.3. Baseline ................................................................................................ 25 2. Impact assessment ..................................................................................... 29 2.1. Int roduct ion............................................................................................ 29 2. 2. Ris k ma na ge me nt opt ions .......................................................................... 29 2.3. Restriction scenario(s)............................................................................... 31 2.4. Assessment of the rest rict ion opt ion.............................................................. 32 2.4.1. Economic impacts ............................................................................ 32 2.4.2. Human health and environmental impacts .............................................. 34 2.4.3. Other impacts, practicability and monitorability ........................................ 37 2.4.4. Proportionality................................................................................. 39 3. Assumptions, uncertainties and sensitivities ...................................................... 40 4. Conc lusion ................................................................................................ 41 Annexes ...................................................................................................... 43 Annex A: Manufacture and uses ......................................................................... 43 A.1. Manufacture, import and export................................................................... 43 i ANNEX XV REST RICT ION REPORT – PFHxS, its salts and PFHxS-related substances A.1.1 Manufacture of PFHxS ..................................................................... 43 A.1.2. REACH Registrations and CLP Notifications ........................................... 44 A.2. Uses ..................................................................................................... 46 A.2.1 Introduction ................................................................................. 46 A.2.2 Metal plating................................................................................. 49 A.2.3 Hydraulic fluids for the aviation industry .............................................. 51 A.2.4 Polishing agents and cleaning/washing agents ....................................... 51 A.2.5 Impregnation/proofing .................................................................... 51 A.2.6 Manufacture of semiconductors ......................................................... 51 A.2.7 Flame retardant............................................................................. 52 A.2.8 Textiles, carpets, leather and upholstery .............................................. 52 A.2.9 Fire-fighting foams ......................................................................... 56 A.2.10 PFHxS in continuing uses of PFOS ...................................................... 65 A.2.11 Conclusions .................................................................................. 68 A.3. Uses advised against by the registrants ......................................................... 74 Annex B: Information on hazard and risk ............................................................. 74 B.1. Identity of the substance(s) and physical and chemical properties ........................ 74 B.1.1. Name and other identifiers of the substance(s) ........................................ 74 B.1.2. Composition of the substance(s) .......................................................... 74 B.1.3. Physicochemical properties ................................................................. 74 B.1.4. Justification for grouping .................................................................... 74 B.2. Manufacture and uses (summary) ................................................................ 74 B.3. Classification and labelling.......................................................................... 75 B.3.1. Classification and labelling in Annex VI of Regulation (EC) No 1272/2008 (CLP Regulation) .................................................................................. 75 B.4. Environmental fate properties ..................................................................... 76 B.4.1. Degradation.................................................................................... 76 B.4.2. Environmental distribution.................................................................. 78 B.4.3 Monitoring and trends ........................................................................ 81 B.4.4. Bioaccumulation .............................................................................. 92 ii ANNEX XV REST RICT ION REPORT – PFHxS, its salts and PFHxS-related substances B.4.5. Sec ondary poisoning ......................................................................... 93 B.5. Human health hazard assessment ................................................................ 94 B.5.1. Toxicokinetics (absorption, metabolism, distribution and elimination) ............ 94 B.5.2. Acute toxicity .................................................................................. 96 B.5.3. Irritation ........................................................................................ 96 B.5.4. Corrosivity ..................................................................................... 96 B.5.5. Sensitisation ................................................................................... 96 B.5.6. Repeat ed dosed t oxic ity ..................................................................... 96 B. 5. 7. Muta ge nic ity ................................................................................... 96 B.5.8. Carcinogenicity ................................................................................ 96 B. 5. 9. T oxic it y for reproduction .................................................................... 96 B.5.10. Other effects ................................................................................. 96 B.5.11. Derivat ion of DNEL(s)/DMEL(s) .......................................................... 96 B.6. Human health hazard assessment of physicochemical properties .......................... 96 B.7. Environmental hazard assessment................................................................ 96 B.8. PBT and vPvB assessment .......................................................................... 97 B.8.1. Assessment of PBT/vPvB Properties – Comparison with the Criteria of Annex XIII ............................................................................................ 97 B.8.2. Emission Characterisation .................................................................. 97 B.9. Exposure assessment................................................................................ 98 B.9.1. General discussion on emissions and exposure ........................................ 98 B.9.2. Manufacturing ................................................................................. 99 B.9.3. Other sources (unintentional releases)................................................... 99 B.9.4. Human exposure.............................................................................104 B.9.5. Environmental exposure ...................................................................113 B.9.6. Overall exposure assessment .............................................................113
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