ANNEX XV RESTRICTION REPORT PROPOSAL FOR A RESTRICTION SUBSTANCE NAME: Bis(pentabromophenyl) ether IUPAC NAME: 1,1'-oxybis(pentabromobenzene) EC NUMBER: 214-604-9 CAS NUMBER: 1163-19-5 CONTACT DETAILS OF THE DOSSIER SUBMITTER: European Chemicals Agency, Helsinki, Finland prepared in collaboration with the Norwegian Environment Agency VERSION NUMBER: 1.0 DATE: 1 August 2014 1 ANNEX XV PROPOSAL FOR A RESTRICTION – [Bis(pentabromophenyl) ether] Table of contents About this report ....................................................................................................... 9 A. Proposal .............................................................................................................. 10 A.1 Proposed restriction ...................................................................................... 10 A.1.1 The identity of the substance ............................................................... 10 A.1.2 Scope and conditions of restriction(s) ................................................... 10 A.2 Targeting ..................................................................................................... 11 A.3 Summary of the justification .......................................................................... 11 A.3.1 Identified hazard and risk .................................................................... 11 A.3.2 Justification that action is required on a Union-wide basis ........................ 12 A.3.3 Justification that the proposed restriction is the most appropriate Union- wide measure ................................................................................. 12 A.4 Uncertainties ................................................................................................ 13 B. Information on hazard and risk .............................................................................. 14 B.1 Identity of the substance(s) and physical and chemical properties ....................... 14 B.1.1 Name and other identifiers of the substance .......................................... 14 B.1.2 Composition of the substance(s) .......................................................... 15 B.1.3 Physicochemical properties .................................................................. 15 B.2 Manufacture and uses.................................................................................... 15 B.2.1 Manufacture, import and export of decaBDE .......................................... 15 B.2.2 Uses ................................................................................................. 17 B.2.3 Uses advised against by the registrants ................................................ 17 B.3 Classification and labelling ............................................................................. 17 B.3.1 Classification and labelling in Annex VI of Regulation (EC) No 1272/2008 (CLP Regulation) ............................................................................. 17 B.3.2 Classification and labelling in classification and labelling inventory/Industry’s self classification(s) and labelling ...................................................... 17 B.4 Environmental fate properties ......................................................................... 18 B.4.1 Degradation ....................................................................................... 18 B.4.1.1 Abiotic degradation .............................................................................. 18 B.4.1.2 Biotic degradation ............................................................................... 18 B.4.2 Environmental distribution ................................................................... 19 B.4.3 Long range transport .......................................................................... 19 B.4.4 Bioaccumulation and transformation ..................................................... 19 B.4.4.1 Aquatic species ................................................................................... 19 B.4.4.2 Terrestrial species ............................................................................... 19 B.4.5 Secondary poisoning ........................................................................... 20 B.5 Human health hazard assessment ................................................................... 20 B.5.1 Toxicokinetics (absorption, metabolism, distribution and elimination) ....... 20 B.5.2 Toxicity for reproduction ..................................................................... 21 B.5.2.1 Developmental toxicity ......................................................................... 21 B.5.2.2 Other reproductive toxicity ................................................................... 22 B.5.3 Human health hazard of other PBDE congeners ...................................... 22 B.6 Human health hazard assessment of physico-chemical properties ....................... 23 B.6.1 Explosivity ......................................................................................... 23 B.6.2 Flammability ...................................................................................... 23 B.6.3 Oxidising potential .............................................................................. 23 B.7 Environmental hazard assessment .................................................................. 23 B.7.1 Aquatic compartment (including sediments) .......................................... 24 B.7.2 Terrestrial compartment ...................................................................... 24 B.8 PBT and vPvB assessment .............................................................................. 24 B.8.1 Assessment of PBT/vPvB Properties – Comparison with the Criteria of Annex 2 ANNEX XV PROPOSAL FOR A RESTRICTION – [Bis(pentabromophenyl) ether] XIII ............................................................................................... 24 B.8.2 Emission Characterisation.................................................................... 25 B.8.2.1 Introduction ....................................................................................... 25 B.8.2.2 Results............................................................................................... 25 B.9 Exposure assessment .................................................................................... 26 B.9.1 General discussion on releases and exposure ......................................... 26 B.9.1.1 Summary of the existing legal requirements ........................................... 27 B.9.1.2 Summary of the effectiveness of the implemented operational conditions and risk management measures ............................................................................. 31 B.9.2 Human Exposure ................................................................................ 32 B.9.3 Environmental Exposure ...................................................................... 33 B.9.4 Overview of monitoring data from tetra- to heptaBDEs ........................... 34 B.10 Risk characterisation ................................................................................... 34 B.10.1 General introduction ......................................................................... 34 B.10.2 Summary of information on releases ................................................... 34 B.10.3 Humans .......................................................................................... 35 B.10.4 Environment .................................................................................... 35 B.10.4.1 Environmental exposure to decaBDE .................................................... 35 B.11 Summary of hazard and risk ......................................................................... 35 C. Available information on alternatives....................................................................... 37 C.1 Identification of potential alternative substances and techniques ......................... 37 C.2 Assessment of shortlisted alternatives ............................................................. 37 C.2.1 Availability of shortlisted alternatives .................................................... 37 C.2.2 Human Health and Environment Risks related to shortlisted alternatives ... 37 C.2.3 Technical and economic feasibility of shortlisted alternatives ................... 38 C.2.4 Conclusions on the shortlisted alternatives to decaBDE ........................... 38 C.2.4.1 Plastics .............................................................................................. 39 C.2.4.2 Textiles .............................................................................................. 39 D. Justification for action on a Union-wide basis ........................................................... 42 D.1 Considerations related to human health and environmental risks ........................ 42 D.2 Considerations related to internal market ........................................................ 42 D.3 Other considerations ..................................................................................... 42 D.4 Summary .................................................................................................... 42 E. Justification why the proposed restriction is the most appropriate Union-wide measure . 43 E.1 Identification and description of potential risk management options .................... 43 E.1.1 Risk to be addressed – the baseline ...................................................... 43 E.1.2 Options for restrictions .......................................................................