Review of the List of restricted substances under RoHS II 2 nd Stakeholder Meeting 12 May 13 1 Review of the List of restricted substances under RoHS II- 2nd Stakeholder Meeting, Brussels, 13.5.2013
Proposal for a methodology for the identification and assessment of substances for potential restriction in EEE PART I Identificationof substances used in EEE, which may cause problems during WEEE management Hazardous properties (human health and environment) Production volumes Waste problems PART II Pre-assessment : Exclusion and prioritization PART III Assessment of priority substances 2
Recital 10: RoHS II: requirements The measures provided for in this Directive should take into account existing international guidelines and recommendations and should be based on an assessment of available scientific and technical information. The measures are necessary to achieve the chosen level of protection of human health and the environment, with due respect for the precautionary principle, and having regard to the risks which the absence of measures would be likely to create in the Union. 3
Background RoHS2 Article 6 detailed assessment of a candidate substance on: criteria according to RoHS2, Article 6 (1) negative impacts on the WEEE treatment processes Releases of the substance into the environment, or generation of hazardous residues or transformation or degradations products through the WEEE management under current operational conditions exposure of workers involved in WEEE collection and treatment substitutes or alternative technologies which have less negative impacts compilation of a RoHS2-Annex II dossier 4
STEP I: info comp. STEP II: waste info STEP III: exposure STEP IV: impact STEP V: alternatives STEP VI: socio-econ. PART III: Assessment of priority substances 1a identification, CL-status, legal status, 1b use in EEE (components/ materials) 1c hazard and risk human health 1d hazard and risk environment 2 Determination of the relevant waste streams and treatment processes and release estimation 3 exposure during waste management: - for workers - for the environment 4a impact on waste management 4b: risk for workers in WEEE management 5 availability and hazardous properties of alternatives 6 socioeconomic considerations 4c environmental risks related to WEEE management Recommendation 5 for restriction under RoHS II
STEP I: info comp. STEP II: waste info STEP III: exposure STEP IV: impact STEP V: alternatives STEP VI: socio-econ. PART III: Assessment of priority substances 1a identification, CL-status, legal status, 1b use in EEE (components/ materials) 1c hazard and risk human health 3 exposure during waste management: - for workers - for the environment 4a impact on waste management 4b: risk for workers in WEEE management 5 availability and hazardous properties of alternatives 6 socioeconomic considerations 1d hazard and risk environment 2 Determination of the relevant waste streams and treatment processes and release estimation 4c environmental risks related to WEEE management Recommendation 6 for restriction under RoHS II
Assessment of priority substances STEP I: Compilation of information on: 1a Basic information on the substance 1b use in Electric and Electronic Equipment: EEE 1c hazard for human health 1d environmental hazard 7
Step 1a: substance information aim: Provide basic information of substance Identification and physico-chemical properties Name, CAS-Nr., other identifiers and composition Physico-chemical properties Classification and Labelling Status harmonized Classification: Annex I Directive 67/548/EEC, Annex IV Regulation No 1272/2008 Self-classification(s) CLP inventory, ECHA website; companies classifications 8
Step 1a: legal status aim: provide basic information of substance legal status and use restrictions - regulation of the substance under REACH - POP candidate substance to be included in the UNEP Stockholm convention (time frame) - other legislative measures - non-governmental initiations 9
Step 1b: Use in EEE Aim: Compile details on the use of the substance in EEE waste streams & processes substitutes 10
Step 1b: Use in EEE? Main materials/components of EEE where the substance is used at which amounts and concentrations: ferrous metals 11
Step 1b: Use in EEE? Main materials/components of EEE where the substance is used at which amounts and concentrations: ferrous metals non ferrous metals 12
Step 1b: Use in EEE? Main materials/components of EEE where the substance is used at which amounts and concentrations: ferrous metals non ferrous metals plastics 13
Step 1b: Use in EEE? Main materials/components of EEE where the substance is used at which amounts and concentrations: ferrous metals non ferrous metals plastics electronic components 14
Step 1b: Use in EEE? Main materials/components of EEE where the substance is used at which amounts and concentrations: ferrous metals non ferrous metals plastics electronic components cables 15
Step 1b: Use in EEE? Main materials/components of EEE where the substance is used at which amounts and concentrations: ferrous metals non ferrous metals plastics electronic components cables glass 16
Step 1b: Use in EEE? Main materials/components of EEE where the substance is used at which amounts and concentrations: ferrous metals non ferrous metals plastics electronic components cables glass powders 17
Step 1b: Use in EEE? Main materials/components of EEE where the substance is used at which amounts and concentrations: ferrous metals non ferrous metals plastics electronic components cables glass powders liquids others 18
Step 1b: Use in EEE? Types of appliances, where the substance is used Fridges PCs Energy saving lamps 19
Step 1b: Use in EEE? Types of appliances, where the substance is used? Which function the substance fulfills (flame retardant, plastisizer, pigment etc.) 20
Step 1c: human health hazard aim: provide basic information on hazard to be used for risk characterization. identification of hazard potential for human health with focus on: Endpoints of concern No Observable Adverse Effect Levels (NOAELs) Toxicological guideline values: (DNELs (Derived No Effect Levels), OELs (Occupational Exposure Levels), other reference values (EU- RAR, ECHA, WHO, IPCS, EPA, ATSDR ) 21
Step 1d: environmental hazard aim: provide basic information on hazard to be used for risk characterization identification of hazard potential for the environment with focus on: degradability and persistency lipophilicity, BCF (bioconcentration) secondary poisoning and bioaccumulation potential ecotoxicity (aquatic and terrestrial compartment) Predicted No Effect Concentrations (PNECs) 22
STEP I: info comp. STEP II: waste info STEP III: exposure STEP IV: impact STEP V: alternatives STEP VI: socio-econ. PART III: Assessment of priority substances 1a identification, CL-status, legal status, 1b use in EEE (components/ materials) 1c hazard and risk human health 3 exposure during waste management: - for workers - for the environment 4a impact on waste management 4b: risk for workers in WEEE management 5 availability and hazardous properties of alternatives 6 socioeconomic considerations 1d hazard and risk environment 2 Determination of the relevant waste streams and treatment processes and release estimation 4c environmental risks related to WEEE management Recommendation 23 for restriction under RoHS II
Step 2: Determination of the relevant waste streams and treatment processes and release estimation Aims: 1) Determination which of the overall WEEE treatment steps are relevant in terms of potential releases of the substance 2) Give guidance on how to perform release estimations for WEEE treatment 24
Step 2: Determination of the relevant waste streams and treatment processes and release estimation 25
Step 2: Relevant wastes and treatments reporting obligation according to WEEE treated outside EU detailed studies Presence in main materials/component s (e.g. Plastics) Info collected in1b Use EU: e.g. EEA: Reports on transboundary shipments of waste national level: NL (Huisman et al. 2012), UK (WRAP, 2011), DE (UBA, 2010) Presence in WEEE category Eurostat (reporting obligations according to WEEE Directive; amounts put on the market ; amounts separately collected ) Collection rates Treatment processes applied Shipment to third countries Info on types of appliances (see step 1b Use ) Alignment to categories: Annex III (WEEE-D); national comprehensive lists (e.g. AT) 26
Step 2: Relevant wastes and treatments Initial treatment processes For separately collected WEEE The substance is present in appliances belonging to: Cat1 Temp. Exch. Equipm ent Mechanical treatment (of residual waste) x x x x 27 Incineration (of residual waste) x x x x Uncontrolled treatment in third countries x x x x x Cat2 Screens Cat3 Lamps Cat4 Large Equipm. Cat5 Small Equipm. Cat6 Small IT&T Collection and transport x x x x x x Dedicated treatment processes for cooling & freezing appliances Dedicated treatment processes for screens Dedicated treatment processes for lamps x Manual dismantling x x x x x Shredding (and automated sorting) x x x x For WEEE not separately collected and treated in the EU Landfilling (of residual waste) x x x x x x
Step 2: Relevant wastes and treatments Treatment processes for The substance is present in following main component/material wastes derived from WEEE treatment Ferrous metals Nonferrous metals Plastics Electron ic compon ents Cables Glass Powders Fluids Others Under current operational conditions in the EU Storage of secondary wastes x x x x x x x x x Shredding and automated sorting of secondary wastes x x x x x x Recycling of ferrous metals x Recycling of NE-metals x x Recycling of plastics x x Recycling of glass x Recycling as building material x x Landfilling of residues (x) x x x x x x Incineration of residues x x x x x x Co-incineration of residues x x x Dedicated processes for hazardous residues x x x 28 Under uncontrolled conditions Uncontrolled dumping of residues x x x x X Uncontrolled Review of the burning List of restricted residues substances under RoHS II- x 2nd Stakeholder x x Meeting, Brussels, x 12.05.2013 x
Step 2: Relevant wastes and treatments Which overall amount of the substance used in EEE enters the process? large quantities Process dedicated to WEEE or secondary wastes? Landfilling of residual waste yes Are other wastes a major contributor to the Manual dismantling substance input into the treatment process? minor quantities Mechanical treatment of residual waste Dedicated processes for cooling & freezing appliances, screens, lamps, Incineration of residual waste Shredding/sorting of metals Shredding & automated sorting of WEEE (batchwise) Recycling of ferrous no and non-ferrous metals Shredding/sorting of cables yes Recycling of glass RoHS relevant Shredding/sorting process of electronic components Recycling as construction material Shredding/sorting of plastics Landfilling of residues from WEEE treatment Recycling of plastics Incineration Exposure of residues / release from estimation WEEE treatment Uncontrolled treatment in 3 rd countries Uncontrolled burning/dumping of residues Qualitative description why low exposure Process not RoHS relevant no 29
Step 2: Release estimation of relevant WEEE treatment processes - Taking into account principles of REACH Guidance R18 - Quantity of the substance entering the process per day Annex: collection rates, material compositions, processes applied - Releases to air, water and soil per installation Annex: release factors if available, waste concentrations - Releases to air, water and soil on EU-level Annex: numbers of installations 30
STEP I: info comp. STEP II: waste info STEP III: exposure STEP IV: impact STEP V: alternatives STEP VI: socio-econ. PART III: Assessment of priority substances 1a identification, CL-status, legal status, 1b use in EEE (components/ materials) 1c hazard and risk human health 3 exposure during waste management: - for workers - for the environment 4a impact on waste management 4b: risk for workers in WEEE management 5 availability and hazardous properties of alternatives 6 socioeconomic considerations 1d hazard and risk environment 2 Determination of the relevant waste streams and treatment processes and release estimation 4c environmental risks related to WEEE management Recommendation 31 for restriction under RoHS II
Step 3: Exposure estimation Aim: Estimate human and environmental exposure during waste management processes Estimation of exposure of:? workers (EEE processing plants)? neighbouring residents? environment 32
Step 3: Exposure estimation Two options: 1) Collection of available data on exposure (monitoring data, exposure concentrations, exposure time, ) 2) Estimation of exposure based on release estimations (Step 2) (EUSES) and exposure scenarios (ECETOC TRA) Exposure scenarios: - Taking into account operational conditions - Taking into account existing risk reduction measures 33
STEP I: info comp. STEP II: waste info STEP III: exposure STEP IV: impact STEP V: alternatives STEP VI: socio-econ. PART III: Assessment of priority substances 1a identification, CL-status, legal status, 1b use in EEE (components/ materials) 1c hazard and risk human health 3 exposure during waste management: - for workers - for the environment 4a impact on waste management 4b: risk for workers in WEEE management 5 availability and hazardous properties of alternatives 6 socioeconomic considerations 1d hazard and risk environment 2 Determination of the relevant waste streams and treatment processes and release estimation 4c environmental risks related to WEEE management Recommendation 34 for restriction under RoHS II
Assessment of candidates STEP IV: Evaluation of impact : 4a impact on waste management 4b risk for human health 4c risk for the environment related to WEEE management STEP V: Evaluation of alternatives : 5 availability and hazardous properties of alternatives 35
Step 4a: Impact on WEEE treatment Aim: Evaluate whether relevant negative impacts on any step within the overall treatment process of WEEE exist The presence of the substance in wastes requires - higher sophisticated techniques for: collection, transporting, handling or storage disintegration and separation material recycling incineration processes - Substance is to large extent not transferred to safe sinks but stays in recycling loop 36
Step 4b: Risk for human health aim: evaluate data on risk due to direct or indirect contact with the substance during the EEE WMP Risk characterization: workers in waste management processing plants neighbouring residents of EEE - WMP human health due to environmental exposure Comparison of exposure estimations and/or epidemiologic data with reference values Estimation of margin of safety and uncertainty 37
Step 4c: Environmental risks aim: to assess if the substance could give rise to uncontrolled or diffuse release into the environment. Risk characterization: Environment Comparison of predicted and measured environmental concentrations with PNECs (P)EC: PNEC [ratio of (predicted) environmental conc. to Predicted No Effect Concentration] risk of secondary poisoning and bioaccumulation risk to the environment with focus on WEEE management 38
Step 5: Alternatives aim: evaluation of availability of substitutes and on their hazardous properties Compilation of information on alternatives: suitability and performance Classification and labelling status toxicity and eco-toxicity PBT properties impact on waste management 39
Step 6: Socio-economic analysis aim: to compare positive and negative impacts of a restriction In case of lacking of alternatives evaluation of impact on : production consumers waste management environment and health 40
Impact on production Substance level Are substance and alternative produced in Europe? If yes, comparison of potential turnover, costs, jobs when producing substance or alternative Product level Is substance used in products which are produced in Europe? If yes, comparison of costs, compatibility, jobs when using substance or alternative 41
Impact on consumers Private/Industrial consumers: estimation of additional/saved product costs effect on product lifetime, functionality and usability estimation of consequences on competitiveness and jobs Industrial consumers: estimation of consequences on competitiveness and jobs 42
Impact on waste management In case of no restriction: Are changes in the waste management organization or infrastructure necessary to control identified risks? Additional costs? Additional revenues from recycling? Potential effects on turnover? Potential effects on jobs? 43
Total impact Sum up positive and negative impacts considering life-cycle thinking costs competitiveness of the European economy jobs usability of products environment and health 44
Weight of Evidence approach within the REACH legislation, the so-called weight of evidence approach is a component of the decision-making procedure on substance properties and thus an important part of the chemical safety assessment. (Annex XI 1.2.for meeting the information requirements in Column 1 Annex VII - X of REACH Regulation (EC) No 1907/2006) involves an assessment of the relative values/weights of different pieces of the available information that have been retrieved and gathered in previous steps. clear and transparent documentation and argumentation 45
Result of assessment aim: rationale for recommendation Justification/Substantiation for selecting the substance for inclusion in Annex II RoHS why the substance should not (yet) be selected for inclusion in Annex II under RoHS using precise and clear wording* providing references and scientific evidence* * As required in annex VI RoHS II 46
Sources to be used for the assessment EC: RAR: Risk Assessment Reports; ECHA: CSR: Chemical Safety Reports? ECHA: CLP- inventory, registered substances, substances of concern,... SCOEL: Scientific Committee on Occupational Exposure Limits: Document database ECOTOX- database (EPA) Pubmed: (US National Library of Medicine National Institutes of Health) SYRAUSE Environmental Fate Data Base TOXNET (Toxicological Data Network) of the US National Library of Medicine The Carcinogenic Potency Database NITE DataBase GESTIS (Gefahrenstoffinformation) WHOLIS Library and information networks for knowledge database, WHO IPCS Inchem (International Programme of Chemical Safety) OECD echemportal IARC International Agency fort he Research on Cancer ECETOC: European Centre for Ecotoxicology and Toxicology of substances ATSDR: Agency of Toxic Substances and Disease Registry Subsport: Substitution support portal 47
Result of assessment: RoHS II dossier aim: documentation Chapters: 1. Basic information on the substance 2. Use in EEE 3. Waste management operations 4. Human health 5. Environment 6. Alternatives 7. Socioeconomic assessment 8. Summary 9. Rationale 48
Contact & Information * Maria Uhl Department Pollutants and Man maria.uhl@umweltbundesamt.at Maria Tesar Department Waste and Material Flow Management maria.tesar@umweltbundesamt.at Sabine Cladrowa, Christine Hölzl Department Chemicals sabine.cladrowa@umweltbundesamt.at christine.hoelzl@umweltbundesamt.at Brigitte Karigl Department Waste and Material Flow Management brigitte.karigl@umweltbundesamt.at Umweltbundesamt www.umweltbundesamt.at *symbols used: http://thenounproject.com/ 49 Review of the List of restricted substances under RoHS II- 2nd Stakeholder Meeting, Brussels, 13.5.2013