ANNEX XV RESTRICTION REPORT PROPOSAL FOR A RESTRICTION SUBSTANCE NAME: Lead IUPAC NAME(S): Not applicable EC NUMBER(S): 231-100-4 CAS NUMBER(S): 7439-92-1 CONTACT DETAILS OF THE DOSSIER SUBMITTER: European Chemicals Agency Annankatu 18, Helsinki, Finland DATE: 7 April 2017 Annankatu 18, P.O. Box 400, FI-00121 Helsinki, Finland | Tel. +358 9 686180 | Fax +358 9 68618210 | echa.europa.eu ANNEX XV RESTRICTION REPORT – LEAD IN GUNSHOT IN WETLANDS Contents Annex A: Manufacture and uses ......................................................................... 1 Lead shot production .................................................................................................. 1 A.1.1. Tower process .................................................................................................... 1 A.1.2. Bleimeister process ............................................................................................. 2 A.1.3. Wire process....................................................................................................... 2 Use of lead gunshot in or over wetlands......................................................................... 2 A.2.1. Hunting within or over a wetland ........................................................................... 2 A.2.2. Sports shooting in or over wetlands ....................................................................... 3 Annex B: Information on hazard, releases, exposure and risk ........................... 9 Identity of the substance and physical and chemical properties ......................................... 9 B.1.1. Name and other identifiers of the substances .......................................................... 9 B.1.2. Composition of the substances .............................................................................. 9 B.1.3. Physicochemical properties .................................................................................. 12 B.1.4. Justification for grouping ..................................................................................... 13 Manufacture and uses (summary) ................................................................................ 14 B.2.1. Lead shot production .......................................................................................... 14 B.2.2. Use of lead gunshot in or over wetlands ................................................................ 14 Classification and labelling .......................................................................................... 15 B.3.1. Regulation (EC) No 1272/2008 (CLP Regulation) ..................................................... 15 B.3.2. Industry self-classification and labelling ................................................................. 15 Environmental fate properties ..................................................................................... 16 B.4.1. Degradation ...................................................................................................... 16 B.4.2. Biodegradation .................................................................................................. 16 B.4.3. Environmental distribution ................................................................................... 17 B.4.4. Bioaccumulation ................................................................................................. 42 B.4.5. Secondary poisoning ........................................................................................... 45 Human health hazard assessment ................................................................................ 46 B.5.1. Toxicokinetics .................................................................................................... 46 B.5.2. Acute toxicity .................................................................................................... 48 B.5.3. Irritation ........................................................................................................... 49 B.5.4. Corrosivity ........................................................................................................ 49 B.5.5. Sensitisation ...................................................................................................... 49 B.5.6. Repeated dose toxicity ........................................................................................ 49 B.5.7. Mutagenicity ...................................................................................................... 58 B.5.8. Carcinogenicity .................................................................................................. 58 B.5.9. Toxicity for reproduction...................................................................................... 58 i ANNEX XV RESTRICTION REPORT – LEAD IN GUNSHOT IN WETLANDS B.5.10. Lead gunshot in food ......................................................................................... 59 B.5.11. Derivation of DNEL(s) and other hazard conclusions .............................................. 60 Human heath hazard assessment of physico-chemical properties...................................... 62 Environmental hazard assessment ............................................................................... 62 B.7.1. Compartment specific hazard assessment .............................................................. 62 B.7.2. Non compartment specific effects ......................................................................... 63 B.7.3. PNEC derivation and other hazard conclusions ........................................................ 87 PBT and vPvB assessment .......................................................................................... 91 Exposure assessment ................................................................................................. 91 B.9.1. Exposure Scenario: use of lead gunshot in or over wetlands ..................................... 91 Risk characterisation .............................................................................................. 112 B.10.1. Environment (risks to birds) ............................................................................. 112 B.10.2. Human health ................................................................................................ 129 Appendix B.1: Bioconcentration / bioaccumulation factors for lead in freshwater organisms and soil...................................................................................................................... 130 Appendix B.2: Benchmark dose estimated and IQ impacts of lead ......................................... 146 Appendix B.3: Summary of the existing legal requirements (and international agreements) ...... 148 Annex C: Justification for action on a union-wide basis ................................. 156 Annex D: Baseline .......................................................................................... 157 Problem definition – risk to be addressed .................................................................... 157 Outlook without any additional risk management ......................................................... 157 D.2.1. Current quantities of lead dispersed in wetlands ................................................... 157 D.2.2. Estimates of bird mortality due to lead poisoning .................................................. 157 Additional consequences of non-action ....................................................................... 158 Annex E: Impact Assessment ......................................................................... 160 Risk Management Options ......................................................................................... 160 E.1.1. Proposed restriction .......................................................................................... 160 E.1.2. Other evaluated but discarded restriction options .................................................. 165 E.1.3. Other union-wide risk management options than restriction .................................... 170 Alternatives ............................................................................................................ 175 E.2.1. Description of the use and function of the restricted substances .............................. 175 E.2.2. Identification of potential alternatives/ techniques (overview of existing alternatives) . 175 Risk reduction, technical and economic feasibility and availability of alternatives ............... 177 E.3.1. Most likely alternative: steel .............................................................................. 177 Restriction scenario(s) ............................................................................................. 217 E.4.1. Proposed restriction .......................................................................................... 217 Economic impacts .................................................................................................... 217 E.5.1. Substitution costs ............................................................................................. 217 ii ANNEX XV RESTRICTION REPORT – LEAD IN GUNSHOT IN WETLANDS E.5.2. Enforcement costs ............................................................................................ 222 Human health and environmental impacts ................................................................... 222 E.6.1. Human health impacts ...................................................................................... 222 E.6.2. Environmental impacts .....................................................................................