ANNEX XV RESTRICTION REPORT PROPOSAL FOR A RESTRICTION SUBSTANCE NAME: Calcium cyanamide IUPAC NAME(S): Calcium cyanamide EC NUMBER: 205-861-8 CAS NUMBER: 156-62-7 CONTACT DETAILS OF THE DOSSIER SUBMITTER: EUROPEAN CHEMICALS AGENCY VERSION NUMBER: 1.0 DATE: 19 July 2019 Annankatu 18, P.O. Box 400, FI-00121 Helsinki, Finland | Tel. +358 9 686180 | Fax +358 9 68618210 | echa.europa.eu RESTRICTION REPORT ON CALCIUM CYANAMIDE CONTENTS 1. Summary ................................................................................................................ 1 2. Report .................................................................................................................... 5 3. The problem identified .............................................................................................. 5 3.1. Introduction ........................................................................................................ 5 3.2. Hazard, exposure/emissions and risk .......................................................................... 7 3.2.1. Identity of the substance(s), and physical and chemical properties ............................... 7 3.2.2. Classification and labelling ................................................................................ 9 3.2.3. Reliability of the studies cited in this report .......................................................... 10 3.2.4. Fate, behaviour and transformation in the environment ........................................... 11 3.2.5. Summary of fate, behaviour and transformation of calcium cyanamide in the environment 11 3.2.6. The fate, behaviour and transformation of PERLKA® and calcium cyanamide in the environment ........................................................................................................ 12 3.2.7. The transformation of cyanamide and its transformation products in the environment ...... 13 3.2.8. Bioaccumulation ........................................................................................... 16 3.2.9. Hazard assessment ....................................................................................... 16 3.2.10. Exposure assessment ................................................................................... 29 3.2.11. Risk characterisation .................................................................................... 50 3.3. Justification for an EU wide restriction measure ........................................................... 61 3.4. Baseline ........................................................................................................... 62 3.4.1. Manufacture and uses .................................................................................... 62 3.4.2. Impact on the environment from the use of calcium cyanamide as a fertiliser ................ 64 4. Impact assessment ................................................................................................. 65 4.1. Introduction ...................................................................................................... 65 4.2. Risk management options ..................................................................................... 66 4.3. Proposed restriction ............................................................................................. 68 4.3.1. Justification for the selected scope of the proposed restriction ................................... 69 4.3.2. Enforcement conditions and entry into force ......................................................... 70 4.4. Response to the restriction scenario ......................................................................... 70 4.4.1. Alternatives ................................................................................................ 71 4.5. Economic Impacts ............................................................................................... 71 4.5.1. Economic impacts on end users ........................................................................ 72 4.6. Environmental and human health impacts .................................................................. 75 4.6.1. Benefits of the proposed restriction for the environment .......................................... 76 Annankatu 18, P.O. Box 400, FI-00121 Helsinki, Finland | Tel. +358 9 686180 | Fax +358 9 68618210 | echa.europa.eu i RESTRICTION REPORT ON CALCIUM CYANAMIDE 4.7. Wider impacts .................................................................................................... 78 4.7.1. Impacts on the Registrant ............................................................................... 78 4.8. Practicability and monitorability .............................................................................. 78 4.9. Proportionality to the risk ...................................................................................... 78 4.9.1. Affordability ................................................................................................ 79 4.9.2. Cost-effectiveness ........................................................................................ 80 4.10. A short description of potential restriction option two .................................................. 80 5. Assumptions, uncertainties and sensitivities ............................................................... 83 6. Conclusion ............................................................................................................. 85 7. References ............................................................................................................ 87 Annex B. Information on hazard and risk ....................................................................... 97 B.1. Identity of the substance(s) and physical and chemical properties .................................... 97 B.1.1. Name and other identifiers of the substance(s) ..................................................... 97 B.1.2. Composition of the substance(s) ....................................................................... 97 B.1.3. Physicochemical properties ............................................................................. 98 B.1.4. Justification for grouping .............................................................................. 106 B.2. Manufacture and uses (summary) ......................................................................... 106 B.3. Classification and labelling ................................................................................... 106 B.3.1. Classification and labelling in Annex VI of Regulation (EC) No 1272/2008 (CLP Regulation)106 B.3.2. Classification and labelling in classification and labelling inventory/ Industry’s self- classification(s) and labelling .................................................................................. 106 B.4. Environmental fate properties .............................................................................. 108 B.4.1. Degradation .............................................................................................. 108 B.4.2. Environmental distribution ............................................................................ 115 B.4.3. Bioaccumulation ......................................................................................... 116 B.4.4. Secondary poisoning ................................................................................... 117 B.5. Human health hazard assessment ......................................................................... 117 B.6. Human health hazard assessment of physicochemical properties .................................... 117 B.7. Environmental hazard assessment ......................................................................... 117 B.7.1. Aquatic compartment (including sediment) ........................................................ 117 B.7.2. Terrestrial compartment ............................................................................... 125 B.7.3. Atmospheric compartment ............................................................................ 135 B.7.4. Microbiological activity in sewage treatment systems ............................................ 135 B.7.5. Non compartment specific effects relevant for the food chain (secondary poisoning)...... 135 B.8. PBT and vPvB assessment ................................................................................... 135 Annankatu 18, P.O. Box 400, FI-00121 Helsinki, Finland | Tel. +358 9 686180 | Fax +358 9 68618210 | echa.europa.eu ii RESTRICTION REPORT ON CALCIUM CYANAMIDE B.9. Exposure assessment ......................................................................................... 135 B.9.1. General discussion on releases and exposure ..................................................... 135 B.9.2. Manufacturing ........................................................................................... 135 B.9.3. Use 1: Use of calcium cyanamide as a fertiliser ................................................... 135 B.9.4. Other sources ............................................................................................ 148 B.9.5. Overall environmental exposure assessment ...................................................... 148 B.9.6. Combined human exposure assessment1 ........................................................... 148 B.10. Risk characterisation ........................................................................................ 148 B.10.1. Manufacturing .........................................................................................