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Undecafluorohexanoic Acid (Pfhxa), Its Salts and Related Substances

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Undecafluorohexanoic Acid (Pfhxa), Its Salts and Related Substances Committee for Risk Assessment (RAC) Committee for Socio-economic Analysis (SEAC) Background Document to the Opinion on the Annex XV dossier proposing restrictions on Undecafluorohexanoic acid (PFHxA), its salts and related substances ECHA/RAC/RES-O-0000006976-57-01/F ECHA/SEAC/Opinion N°(opinion number will be added after adoption) EC Number CAS Number n/a n/a 9 June 2021 P.O. Box 400, FI-00121 Helsinki, Finland | Tel. +358 9 686180 | echa.europa.eu Background Document – Undecafluorohexanoic acid, its salts and related substances TABLE OF CONTENTS About this report ....................................................................................................... 7 Summary ................................................................................................................. 8 Report..................................................................................................................... 20 1 The problem identified......................................................................................... 20 1.1 Introduction ..................................................................................................... 20 1.2 Manufacture and Uses ....................................................................................... 20 1.3 Hazard, exposure/emissions and risk .................................................................. 23 1.3.1 Identity of the substances, and physical and chemical properties .................. 23 1.3.2 Justification for grouping.......................................................................... 28 1.3.3 Classification and labelling ....................................................................... 28 1.3.4 Approach to risk assessment .................................................................... 28 1.3.5 Hazard assessment ................................................................................. 28 1.3.6 Exposure/Emissions assessment ............................................................... 34 1.3.7 Risk characterisation ............................................................................... 39 1.4 Justification for an EU wide restriction measure .................................................... 43 1.5 Baseline .......................................................................................................... 44 2 Impact assessment ............................................................................................. 46 2.1 Introduction ..................................................................................................... 46 2.2 Risk management option ................................................................................... 46 2.3 Discussion on disregarded risk management options ............................................. 53 2.4 Restriction scenario(s)....................................................................................... 55 2.5 Assessment of the proposed restriction ............................................................... 56 2.5.1 Economic impacts ................................................................................... 56 2.5.1.1 Manufacture of fluoropolymers and side-chain-fluorinated polymers .......59 2.5.1.2 Textiles ..........................................................................................63 2.5.1.3 Fire-fighting foams ..........................................................................69 2.5.1.4 Mixtures for consumer use ................................................................74 2.5.1.5 Electronic devices ............................................................................75 i Background Document – Undecafluorohexanoic acid, its salts and related substances 2.5.1.5.1 Semiconductors ......................................................................75 2.5.1.5.2 Electronic grade coating...........................................................77 2.5.1.5.3 Others ...................................................................................78 2.5.1.6 Food contact materials and other paper ..............................................78 2.5.1.7 Printing inks....................................................................................81 2.5.1.8 Chrome plating ...............................................................................82 2.5.1.9 Building material .............................................................................85 2.5.1.10 Photographic applications ...............................................................87 2.5.1.11 Cosmetic products .........................................................................88 2.5.1.12 Watches .......................................................................................89 2.5.1.13 Medical Devices .............................................................................90 2.5.1.14 PTFE (Polytetrafluoroethylene) micro-powders ...................................93 2.5.1.15 Optical fibres .................................................................................94 2.5.1.16 Other special uses of PFHxA related substances .................................95 2.5.1.17 Administrative cost ........................................................................95 2.5.1.18 Enforcement cost ...........................................................................97 2.5.1.19 Summary of the costs ....................................................................97 2.5.2 Human health impacts ........................................................................... 103 2.5.3 Environmental impacts .......................................................................... 103 2.5.4 Other impacts, practicability and monitorability ........................................ 105 2.5.5 Proportionality ...................................................................................... 106 3 Assumptions, uncertainties and sensitivities ......................................................... 117 4 Conclusion ....................................................................................................... 118 References ............................................................................................................ 121 ii Background Document – Undecafluorohexanoic acid, its salts and related substances TABLE OF TABLES Table 1: Substance identity of PFHxA. .........................................................................24 Table 2: Substance identity of APFHx. .........................................................................25 Table 3: Substance identity of NaPFHx. .......................................................................26 Table 4: Overview of physicochemical properties of PFHxA. ...........................................27 Table 5: Proposed restriction on PFHxA, its salts and PFHxA-related substances. ..............47 Table 6: Summary of management options assessment. ...............................................53 Table 7: Summary of use volumes and substitution costs estimates of PFHxA, its salts and related substances.* .................................................................................................99 Table 8: Justifications for proportionality of restriction and derogations for certain uses. 109 TABLE OF FIGURES Figure 1: Current end use of low molecular PFHxA-related substances itemized to the sectors of use in the European Union. ....................................................................................23 Figure 2: Estimated cumulative releases of PFHxA over 20 years. ...................................45 Figure 3: Illustration of the increased need for technical performance (in terms of oil repellency and durability of oil- and water repellency) with more advanced user needs; advancing from fashion to comfort to hazard management (Holmquist et al., 2016). Examples of garments meeting user needs within the fashion segment are e.g. jackets primarily chosen based on looks (design, colour etc.) and never or seldom used in weather conditions requiring water repellency. Garments within the comfort segment could be e.g. jackets often used in weather conditions requiring water repellence to stay warm and dry but where the user can find shelter within a reasonable time and thus is unlikely to experience a life-threatening situation due to failing water repellency. Finally, garments in the hazard management segment must be water (and sometimes oil) repellent for protecting the life of the wearer. ..............................................................................................................................64 iii Background Document – Undecafluorohexanoic acid, its salts and related substances Abbreviations AF assessment factor AFFF aqueous film forming foams ALP Alkaline phosphatase ALT alanine aminotransferase APFHx ammonium salt of perfluorohexanoic acid ARC anti reflective coatings ASAT aspartate aminotransferase BAF bioaccumulation factor BCF bioconcentration factor BDD boron doped diamond BMF biomagnification factor CEA cost effectiveness analysis CEN European Committee for Standardization CMF ceramic membrane filtration decaBDE decabromodiphenyl ether diPAP polyfluoroalkyl phosphoric acid diesters DMEL derived minimum effect level DNEL derived no-effect level DOC dissolved organic carbon DWR durable water repellent ECF edible part concentration factor EEA European Economic Area ERC environmental release category EtOH ethanol FOD frequency of detection FT fluorotelomer FT(M)A fluorotelomer (meth)acrylate FTAL fluorotelomer
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