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RAC) Committee for Socio-Economic Analysis (SEAC 1 (385) Committee for Risk Assessment (RAC) Committee for Socio-economic Analysis (SEAC) Background document to the Opinion on the Annex XV dossier proposing restrictions on Perfluorooctanoic acid (PFOA), PFOA salts and PFOA-related substances ECHA/RAC/RES-O-0000006229-70-02/F ECHA/SEAC/[reference code to be added after the adoption of the SEAC opinion] EC Number CAS Number 206-397-9 335-67-1 11 September 2015 Annankatu 18, P.O. Box 400, FI-00121 Helsinki, Finland | Tel. +358 9 686180 | Fax +358 9 68618210 | echa.europa.eu ANNEX XV PROPOSAL FOR A RESTRICTION – Perfluorooctanoic acid (PFOA), PFOA salts and PFOA-related substances About this document This Background Document to the opinions of RAC and SEAC is an amended version of the Annex XV restriction report submitted by Germany and Norway. The amendments include further information obtained during the public consultation and other relevant information resulting from the opinion making process. The evaluation made by RAC and SEAC of the information presented in this document can be found in their opinions and justification. Where relevant some additional assessment by the RAC or SEAC rapporteurs can be found in boxes in the document. TABLE OF CONTENTS Abbreviations ................................................................................................................ 7 About this report ........................................................................................................... 8 A. Proposal ............................................................................................................... 10 A.1 Proposed restriction ........................................................................................ 10 A.1.1 The identity of the substances .............................................................. 10 A.1.2 Scope and conditions of restriction ........................................................ 12 A.2 Targeting ....................................................................................................... 13 A.3 Summary of the justification ............................................................................ 14 A.3.1 Identified hazard and risk .................................................................... 14 A.3.2 Justification that action is required on a community-wide basis ................. 16 A.3.3 Justification that the proposed restriction is the most appropriate community-wide measure .................................................................... 16 A.3.4 Uncertainties ...................................................................................... 18 B. Information on hazard and risk ............................................................................... 20 B.1 Identity of the substances and physical and chemical properties ........................... 20 B.1.1 Name and other identifiers of the substances ......................................... 20 B.1.2 Physicochemical properties .................................................................. 23 B.1.3 Justification for grouping ...................................................................... 27 B.2 Manufacture and uses ..................................................................................... 28 B.2.1 Production and import of PFOA and PFOA-related substances in(to) the EU 28 B.2.2 Uses of PFOA and PFOA-related substances ............................................ 30 B.2.3 Summary and conclusions on manufacturing, import and use of PFOA and related substances .............................................................................. 37 B.3 Classification and labelling ............................................................................... 38 B.3.1 Classification and labelling in Annex VI of Regulation (EC) No 1272/2008 (CLP Regulation) ................................................................................. 38 B.3.2 Classification and labelling in classification and labelling inventory/Industry’s self-classification(s) and labelling .......................................................... 38 B.4 Environment .................................................................................................. 40 B.4.1 Environmental fate properties............................................................... 40 B.4.2 Environmental hazard assessment ........................................................ 61 B.4.3 PBT and vPvB assessment .................................................................... 61 B.4.4 Characterisation of environmental releases and exposure ........................ 67 B.4.5 Environmental risk characterisation ....................................................... 89 B.5 Human Health ................................................................................................ 89 B.5.1 Human health hazard assessment ......................................................... 89 B.5.2 Human health hazard assessment of physico-chemical properties ........... 116 B.5.3 Human health exposure assessment ................................................... 116 B.5.4 Human health risk characterization ..................................................... 130 B.5.5 Summary and discussion on human hazard and risk .............................. 137 ANNEX XV PROPOSAL FOR A RESTRICTION – Perfluorooctanoic acid (PFOA), PFOA salts and PFOA-related substances C. Available information on alternatives ........................................................................ 143 C.1 Identification of potential alternative substances and techniques ........................ 143 C.2 Assessment of fluorotelomer-based short-chain chemistry ................................. 145 C.2.1 Availability of fluorotelomer-based short-chain chemistry ....................... 145 C.2.2 Human health risks related to fluorotelomer-based short-chain chemistry 145 C.2.3 Environment risks related to fluorotelomer-based short-chain chemistry .. 147 C.2.4 Technical and economic feasibility of fluorotelomer-based short-chain chemistry ........................................................................................ 150 C.3 Assessment of alternatives for fluoropolymer polymerisation processing aid ......... 150 C.3.1 CAS 62037-80-3 – Ammonium 2,3,3,3-tetrafluoro-2- (heptafluoropropoxy)propanoate (C3 Dimer salt) .................................. 151 C.3.2 EC 480-310-4 – Ammonium 2,2,3-trifluoro-3-(1,1,2,2,3,3-hexafluoro-3- trifluoromethoxypropoxy)propionate (ADONA) ..................................... 153 C.3.3 CAS 908020-52-0 - Ammonium difluoro[1,1,2,2-tetrafluoro-2- (pentafluoroethoxy)ethoxy]acetate (EEA-NH4) ..................................... 156 D. Justification for action on a Community-wide basis ................................................... 159 D.1 Considerations related to human health and environmental risks ........................ 159 D.2 Considerations related to internal market ........................................................ 159 D.3 Other considerations ..................................................................................... 160 D.4 Summary .................................................................................................... 160 E. Justification why the proposed restriction is the most appropriate Community-wide measure .............................................................................................................. 161 E.1 Identification and description of potential risk management options .................... 161 E.1.1 Risk to be addressed - the baseline ..................................................... 161 E.1.2 Options for restrictions ...................................................................... 163 E.1.3 Other Union-wide risk management options than restriction ................... 169 E.2 Assessment of risk management options ......................................................... 173 E.2.1 Restriction option 1a: Phase out of PFOA, its salts, and PFOA-related substances over 18 months ................................................................ 173 E.2.2 Restriction option 1b: Phase out of PFOA and PFOA-related substances within 18 months including possible exemptions ............................................ 181 E.3 Comparison of the risk management options ...................................................... 185 E.4 Main assumptions used and decisions made during analysis ................................. 185 E.5 The proposed restrictions and summary of the justifications ................................. 186 F. Socio-economic Assessment of Proposed Restriction ................................................. 187 F.1 Human health and environmental impacts ....................................................... 187 F.1.1 Risks of PFOA and PFOA-related substances as PBT substances .............. 187 F.1.2 Benefits of reducing emissions of PFOA and PFOA-related substances ...... 187 F.2 Economic impacts ........................................................................................ 193 F.2.1 Overview of supply chains affected ..................................................... 193 F.2.2 Cost assessment of the proposed restriction ......................................... 194 F. 2.3 Use of PFOA and its salts ................................................................... 194 F.2.4 Use of PFOA-related substances .......................................................... 197 F.2.5 Summary of economic impacts ........................................................... 200 F.2.6
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