Annex: Impact Assessment - ECHA
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ANNEX XV RESTRICTION REPORT PROPOSAL FOR A RESTRICTION SUBSTANCE NAME(S): [INSERT SUBSTANCE NAME(S)] IUPAC NAME(S): [INSERT IUPAC NAME(S)] EC NUMBER(S): [INSERT EC NUMBER] CAS NUMBER(S): [INSERT CAS NUMBER] CONTACT DETAILS OF THE DOSSIER SUBMITTER: [INSERT CONTACT DETAILS] VERSION NUMBER: [INSERT VERSION NUMBER] DATE: [INSERT DATE] Annankatu 18, P.O. Box 400, FI-00121 Helsinki, Finland | Tel. +358 9 686180 | Fax +358 9 68618210 | echa.europa.eu TABLE OF CONTENTS PROPOSAL FOR A RESTRICTION .................................................................................. 1 Summary ................................................................................................................. 1 Report...................................................................................................................... 1 The problem identified ......................................................................................... 1 The hazard, exposure/emissions and risk .......................................................... 1 Justification for an EU wide restriction measure ................................................. 1 Baseline ....................................................................................................... 1 Impact assessment .............................................................................................. 1 Introduction .................................................................................................. 1 Risk management options ............................................................................... 1 Restriction scenario(s) .................................................................................... 1 Assessment of restriction option 1 ................................................................... 1 Economic impacts .................................................................................... 1 Human health and environmental impacts .................................................. 2 Other impacts, practicability and monitorability ........................................... 2 Proportionality ......................................................................................... 2 Assessment of restriction option 2 ................................................................... 2 Assessment of restriction option 3 ................................................................... 2 Comparison of restriction options ..................................................................... 2 Introduction ............................................................................................ 2 Risk Management Options ......................................................................... 2 Restriction scenario(s) .............................................................................. 2 Economic impacts .................................................................................... 2 Human health and environmental impacts .................................................. 2 Other impacts, practicability and monitorability ........................................... 2 Proportionality (including comparison of options) ......................................... 3 Assumptions, uncertainties and sensitivities ............................................................ 3 Conclusion .......................................................................................................... 3 Annexes ................................................................................................................... 4 Annex: Information on hazard and risk .................................................................. 4 Identity of the substance(s) and physical and chemical properties (B.1) ............... 4 Annankatu 18, P.O. Box 400, FI-00121 Helsinki, Finland | Tel. +358 9 686180 | Fax +358 9 68618210 | echa.europa.eu Name and other identifiers of the substance(s) (B.1.1) ................................. 4 Composition of the substance(s) (B.1.2) ..................................................... 4 Physicochemical properties (B.1.3) ............................................................ 4 Justification for grouping (B.1.4) ............................................................... 4 Manufacture and uses (B.2) ............................................................................ 4 Manufacture, import and export of a substance (B.2.1) ................................ 4 Uses (B.2.2) ............................................................................................ 4 Uses advised against by the registrants (B.2.3) ........................................... 4 Classification and labelling (B.3) ...................................................................... 4 Classification and labelling in Annex VI of Regulation (EC) No 1272/2008 (CLP Regulation) (B.3.1) .................................................................................. 4 Classification and labelling in classification and labelling inventory/ Industry’s self classification(s) and labelling (B.3.2( .................................................... 4 Environmental fate properties (B.4) ................................................................. 5 Degradation (B.4.1) ................................................................................. 5 Environmental distribution (B.4.2) ............................................................. 5 Bioaccumulation (B 4.3) ........................................................................... 5 Secondary poisoning (B.4.4) ..................................................................... 5 Human health hazard assessment (B.5) ........................................................... 5 Toxicokinetics (absorption, metabolism, distribution and elimination) (B.5.1) .. 5 Acute toxicity (B.5.2) ............................................................................... 5 Irritation (B 5.3) ...................................................................................... 5 Corrosivity (B 5.4) ................................................................................... 5 Sensitisation (B 5.5) ................................................................................ 5 Repeated dosed toxicity (B 5.6) ................................................................. 5 Mutagenicity (B 5.7) ................................................................................ 5 Carcinogenicity (B 5.8) ............................................................................. 5 Toxicity for reproduction (B 5.9) ................................................................ 5 Other effects (B 5.10) .............................................................................. 6 Derivation of DNEL(s)/DMEL(s) (B 5.11) ..................................................... 6 Human health hazard assessment of physico-chemical properties (B.6) ................ 6 Explosivity (B 6.1) ................................................................................... 6 Flammability B 6.2 ................................................................................... 6 Oxidising potential B 6.3 ........................................................................... 6 Environmental hazard assessment B.7 ............................................................. 6 Aquatic compartment (including sediments) B 7.1 ....................................... 6 Annankatu 18, P.O. Box 400, FI-00121 Helsinki, Finland | Tel. +358 9 686180 | Fax +358 9 68618210 | echa.europa.eu Terrestrial compartment B 7.2 ................................................................... 6 Atmospheric compartment B 7.3 ................................................................ 6 Microbiological activity in sewage treatment systems B 7.4 ........................... 6 Non compartment specific effects relevant for the food chain (secondary poisoning) B 7.5 ...................................................................................... 6 PBT and vPvB assessment (B.8) ...................................................................... 6 Assessment of PBT/vPvB Properties – Comparison with the Criteria of Annex XIII B 8.1 ............................................................................................... 6 Emission Characterisation B 8.2 ................................................................. 6 Exposure assessment B.9 ............................................................................... 7 General discussion on releases and exposure B.9.1 ...................................... 7 Manufacturing B.9.2 ................................................................................. 7 “Use 1” … B.9.3 ....................................................................................... 7 Add subheadings if more than one use is described and change the following subheadings accordingly (this should also be reflected in the risk characterisation section) B.9.x .................................................................. 8 Other sources (for example natural sources, unintentional releases) B.9.4 ...... 8 Overall environmental exposure assessment B.9.5 ....................................... 8 Combined human exposure assessment B.9.6 ............................................. 8 Risk characterisation B.10............................................................................... 8 Manufacturing/’Use 1’ etc. (Use the relevant headings from section B.9) B.10.1 ............................................................................................................. 8 Annex: Justification for action on a Union-wide basis............................................... 10 Annex: Baseline ................................................................................................. 11 Annex: Impact Assessment .................................................................................. 12 Risk Management Options............................................................................. 12 Alternatives ................................................................................................ 12 Identification of potential alternative substances and techniques ................. 12 Restriction scenario(s) ............................................................................ 12 Economic impacts .................................................................................. 12 Human health and environmental impacts ................................................ 13 Practicality and monitorability ................................................................. 13 Annex: Assumptions, uncertainties and sensitivities ................................................ 14 Annex: Stakeholder information ........................................................................... 15 Annankatu 18, P.O. Box 400, FI-00121 Helsinki, Finland | Tel. +358 9 686180 | Fax +358 9 68618210 | echa.europa.eu TABLE OF TABLES TABLE OF FIGURES 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 – [SUBSTANCE NAME] PROPOSAL FOR A RESTRICTION Summary Add summary Report The problem identified The hazard, exposure/emissions and risk Add text Justification for an EU wide restriction measure Add text Baseline Add text Impact assessment EITHER ASSESS EACH RESTRICTION OPINION SEPERATELY1 Introduction Add text Risk management options Add text Restriction scenario(s) Add text Assessment of restriction option 1 Economic impacts Add text 1 Delete headings in the unnecessary either/or section – only one set of headings here is required. The box is just to indicate there are 2 options here for presenting the information and should be deleted in the final opinion. Annankatu 18, P.O. Box 400, FI-00121 Helsinki, Finland | Tel. +358 9 686180 | Fax +358 9 68618210 | echa.europa.eu 1 (20) ANNEX XV RESTRICTION REPORT – [SUBSTANCE NAME] Human health and environmental impacts Add text Other impacts2, practicability and monitorability Add text Proportionality Add text Assessment of restriction option 2 Add text Assessment of restriction option 3 Add text Comparison of restriction options Add text OR ASSESS ALL RESTRICTION OPTIONS TOGETHER 1 Introduction Add text Risk Management Options Add text Restriction scenario(s) Add text Economic impacts Add text Human health and environmental impacts Add text Other impacts, practicability and monitorability Add text 2 Such as social, distributional and wider economic impacts. Annankatu 18, P.O. Box 400, FI-00121 Helsinki, Finland | Tel. +358 9 686180 | Fax +358 9 68618210 | echa.europa.eu 2 (20) ANNEX XV RESTRICTION REPORT – [SUBSTANCE NAME] Proportionality (including comparison of options) Add text Assumptions, uncertainties and sensitivities Add text Conclusion Add text Annankatu 18, P.O. Box 400, FI-00121 Helsinki, Finland | Tel. +358 9 686180 | Fax +358 9 68618210 | echa.europa.eu 3 (20) ANNEX XV RESTRICTION REPORT – [SUBSTANCE NAME] Annexes Annex: Information on hazard and risk Identity of the substance(s) and physical and chemical properties (B.1) Add text Name and other identifiers of the substance(s) (B.1.1) Add text Composition of the substance(s) (B.1.2) Add text Physicochemical properties (B.1.3) Add text Justification for grouping (B.1.4) Add text Manufacture and uses (B.2) Add text Manufacture, import and export of a substance (B.2.1) Add text Uses (B.2.2) Add text Uses advised against by the registrants (B.2.3) Add text Classification and labelling (B.3) Classification and labelling in Annex VI of Regulation (EC) No 1272/2008 (CLP Regulation) (B.3.1) Add text Classification and labelling in classification and labelling inventory/ Industry’s self classification(s) and labelling (B.3.2) Add text Annankatu 18, P.O. Box 400, FI-00121 Helsinki, Finland | Tel. +358 9 686180 | Fax +358 9 68618210 | echa.europa.eu 4 (20) ANNEX XV RESTRICTION REPORT – [SUBSTANCE NAME] Environmental fate properties (B.4) Degradation (B.4.1) Add text Environmental distribution (B.4.2) Add text Bioaccumulation (B 4.3) Add text Secondary poisoning (B.4.4) Add text Human health hazard assessment (B.5) Toxicokinetics (absorption, metabolism, distribution and elimination) (B.5.1) Add text Acute toxicity (B.5.2) Add text Irritation (B 5.3) Add text Corrosivity (B 5.4) Add text Sensitisation (B 5.5) Add text Repeated dosed toxicity (B 5.6) Add text Mutagenicity (B 5.7) Add text Carcinogenicity (B 5.8) Add text Toxicity for reproduction (B 5.9) Add text Annankatu 18, P.O. Box 400, FI-00121 Helsinki, Finland | Tel. +358 9 686180 | Fax +358 9 68618210 | echa.europa.eu 5 (20) ANNEX XV RESTRICTION REPORT – [SUBSTANCE NAME] Other effects (B 5.10) Add text Derivation of DNEL(s)/DMEL(s) (B 5.11) Add text Human health hazard assessment of physico-chemical properties (B.6) Explosivity (B 6.1) Add text Flammability B 6.2 Add text Oxidising potential B 6.3 Add text Environmental hazard assessment B.7 Aquatic compartment (including sediments) B 7.1 Add text Terrestrial compartment B 7.2 Add text Atmospheric compartment B 7.3 Add text Microbiological activity in sewage treatment systems B 7.4 Add text Non compartment specific effects relevant for the food chain (secondary poisoning) B 7.5 Add text PBT and vPvB assessment (B.8) Assessment of PBT/vPvB Properties – Comparison with the Criteria of Annex XIII B 8.1 Add text Emission Characterisation B 8.2 Add text Annankatu 18, P.O. Box 400, FI-00121 Helsinki, Finland | Tel. +358 9 686180 | Fax +358 9 68618210 | echa.europa.eu 6 (20) ANNEX XV RESTRICTION REPORT – [SUBSTANCE NAME] Exposure assessment B.9 General discussion on releases and exposure B.9.1 Add text Summary of the existing legal requirements B.9.1.1 Add text Summary of the effectiveness of the implemented operational conditions and risk management measures B.9.1.2 Add text Manufacturing B.9.2 Add text Occupational exposure B.9.2.1 Add text Environmental release B.9.2.2 Add text “Use 1” … B.9.3 General information B.9.3.1 Add text Exposure estimation B.9.3.2 Add text Workers exposure B.9.3.2.1 Add text Consumer exposure B.9.3.2.2 Add text Indirect exposure of humans via the environment B 9.3.2.3 Add text Environmental exposure B.9.3.2.4 Add text Annankatu 18, P.O. Box 400, FI-00121 Helsinki, Finland | Tel. +358 9 686180 | Fax +358 9 68618210 | echa.europa.eu 7 (20) ANNEX XV RESTRICTION REPORT – [SUBSTANCE NAME] Add subheadings if more than one use is described and change the following subheadings accordingly (this should also be reflected in the risk characterisation section) B.9.x Other sources (for example natural sources, unintentional releases) B.9.4 Add text Overall environmental exposure assessment B.9.5 Add text Combined human exposure assessment B.9.6 Add text Risk characterisation B.10 Manufacturing/’Use 1’ etc. (Use the relevant headings from section B.9) B.10.1 Human health B.10.1.1 Add text Workers B.10.1.1.1 Add text Consumers (B.10.1.1.2) Add text Indirect exposure of humans via the environment (B.10.1.1.3) Add text Combined exposure (B.10.1.1.4) Add text Environment (B.10.1.2) Add text Aquatic compartment (including sediment and secondary poisoning) (B.10.1.2.10) Add text Terrestrial compartment (including secondary poisoning) (B.10.1.2.2) Add text Atmospheric compartment (B.10.1.2.3) Add text Annankatu 18, P.O. Box 400, FI-00121 Helsinki, Finland | Tel. +358 9 686180 | Fax +358 9 68618210 | echa.europa.eu 8 (20) ANNEX XV RESTRICTION REPORT – [SUBSTANCE NAME] Microbiological activity in sewage treatment systems (B.10.1.2.4) Add text Add subheadings accordingly from section B.9 if needed e.g. 10.2. etc. (B.10.x) Annankatu 18, P.O. Box 400, FI-00121 Helsinki, Finland | Tel. +358 9 686180 | Fax +358 9 68618210 | echa.europa.eu 9 (20) ANNEX XV RESTRICTION REPORT – [SUBSTANCE NAME] Annex: Justification for action on a Union-wide basis Add text Annankatu 18, P.O. Box 400, FI-00121 Helsinki, Finland | Tel. +358 9 686180 | Fax +358 9 68618210 | echa.europa.eu 10 (20) ANNEX XV RESTRICTION REPORT – [SUBSTANCE NAME] Annex: Baseline Add text Annankatu 18, P.O. Box 400, FI-00121 Helsinki, Finland | Tel. +358 9 686180 | Fax +358 9 68618210 | echa.europa.eu 11 (20) ANNEX XV RESTRICTION REPORT – [SUBSTANCE NAME] Annex: Impact Assessment Risk Management Options Add text Alternatives Identification of potential alternative substances and techniques Add text Assessment of alternative 13 Add text Availability of alternative 1 Add text Human health risks related to alternative 1 Add text Environment risks related to alternative 1 Add text Technical and economic feasibility of alternative 1 Add text Other information on alternative 1 Assessment of alternative 2 …. Restriction scenario(s) Add text Economic impacts Add text If it is considered more feasible to describe all alternatives in parallel, use headings: Assessment of alternatives; Availability of alternatives; Human health risks related to alternatives; Environmental risks related to alternatives; Technical and economical feasibility of alternatives and Other information of alternatives 3 Annankatu 18, P.O. Box 400, FI-00121 Helsinki, Finland | Tel. +358 9 686180 | Fax +358 9 68618210 | echa.europa.eu 12 (20) ANNEX XV RESTRICTION REPORT – [SUBSTANCE NAME] Human health and environmental impacts Human health impacts Add text Environmental impacts Add text Risk reduction capacity Add text Other impacts, practicability and monitorability Social impacts Add text Wider economic impacts Add text Distributional impacts Add text Practicality and monitorability Add text Proportionality (comparison of options) Comparison of Risk Management Options Add text Comparison of costs and benefits Add text Annankatu 18, P.O. Box 400, FI-00121 Helsinki, Finland | Tel. +358 9 686180 | Fax +358 9 68618210 | echa.europa.eu 13 (20) ANNEX XV RESTRICTION REPORT – [SUBSTANCE NAME] Annex: Assumptions, uncertainties and sensitivities Add text Annankatu 18, P.O. Box 400, FI-00121 Helsinki, Finland | Tel. +358 9 686180 | Fax +358 9 68618210 | echa.europa.eu 14 (20) ANNEX XV RESTRICTION REPORT – [SUBSTANCE NAME] Annex: Stakeholder information Add text Annankatu 18, P.O. Box 400, FI-00121 Helsinki, Finland | Tel. +358 9 686180 | Fax +358 9 68618210 | echa.europa.eu 15 (20)
