Review of the List of restricted substances under RoHS II

Similar documents
Review of the List of restricted substances under RoHS II

Study for the Review of the List of Restricted Substances under RoHS2

REACH REGULATION: the new management of chemicals in Europe and operational tools. R egistration. E valuation. A Ch. uthorisation.

Chemical Safety Assessment Under REACH

HBCD Factsheet. Brominated Flame retardant October Hexabromocyclododecane

Prepared in the framework of the Study for the Review of the List of Restricted Substances under RoHS2 Reference: ENV.C.

COMMISSION OF THE EUROPEAN COMMUNITIES COMMUNICATION FROM THE COMMISSION

Integrated Testing Strategies for REACH. Perspective from the European Chemicals Agency

Justification Document for the Selection of a CoRAP Substance

Justification Document for the Selection of a CoRAP Substance - Update -

General Approach for Prioritisation of Substances of Very High Concern (SVHCs) for Inclusion in the List of Substances Subject to Authorisation

SVHC Authorisation and Restrictions

Endocrine discuptors under REACH

Study on hazardous substances in electrical and electronic equipment, not regulated by the RoHS Directive

COMMISSION DIRECTIVE 2011/71/EU

Substitution of hazardous chemicals: training on decision support tools to assess hazard and sustainability of chemicals and alternatives

Freiburg,

Summary of the Impact Assessment

Guidance on information requirements and chemical safety assessment

June Copyright. Disclaimer

Guidance on information requirements and chemical safety assessment

Guidance on information requirements and chemical safety assessment

COMMISSION DELEGATED DIRECTIVE../ /EU. of

Workshop Assessment of Persistent, Bioaccumulative and Toxic (PBT) substances in different EU legislations

Recommendations for registrants to improve data quality in registration dossiers for chemicals 1000 tpa Based on the project REACH Compliance

Risk Management Option Analysis Conclusion Document

REACH: how to deal with 30,000 chemicals

Feedback from ECHA on dossier and substance evaluation

Chesar training Box 3. Outlines. Organisation of Chesar

TC NES SUBGROUP ON IDENTIFICATION OF PBT AND VPVB SUBSTANCES RESULTS OF THE EVALUATION OF THE PBT/VPVB PROPERTIES OF:

ROHS ANNEX II DOSSIER FOR BBP

Please find below the Commission Communication and the Commission Recommendation for the substance

Registration data and dossier handling

AmCham EU s response to the second stakeholder consultation on RoHS II

Exemption Request Form

Guidance on Information Requirements and Chemical Safety Assessment. Chapter R.11: PBT/vPvB assessment

Assess hazards and risks What does it mean?

Implementation of REACH and CLP: Overview, Status and post 2018 possible actions

Current challenges from Evaluation point of view - Introduction case studies

The European Union REACH regulation was adopted

COUNCIL OF THE EUROPEAN UNION. Brussels, 1 June /10 Interinstitutional File: 2008/0240 (COD) ENV 356 MI 182 CODEC 494

Chemical safety report (CSR) and exposure scenarios

Risk Assessment Report on hexabromocyclododecane Environmental Part

Extended safety data sheets under REACH and CLP regulations

ECHA 1(7) Helsinki, 19 May 2014

AGREEMENT OF THE MEMBER STATE COMMITTEE ON THE IDENTIFICATION OF PENTADECAFLUOROOCTANOIC ACID (PFOA) AS A SUBSTANCE OF VERY HIGH CONCERN

Chesar 3 User manual

HPD Open Standard Supplemental List Update Policy July 2, 2018

How to bring your registration dossier in compliance with REACH Tips and Hints - Part 5

Training Workshop on the Updating of National Implementation Plans (NIPs) for Persistent Organic Pollutants (POPs) 4-6 April 2016 Suva, Fiji

ABB Drives. Recycling instructions and environmental information ACx drives

Current and future EU policy on Substance Restrictions. Halogen-free Symposium Brussels October 27-28, 2009

Risk Assessment of PBT Chemicals. Technical Report No. 98

Draft agreed by Environmental Risk Assessment Working Party (ERAWP) 31 May Adopted by CVMP for release for consultation 12 July 2012

IT tool training. REACH 2018 Stakeholders Day January European Chemicals Agency

Exposure informed testing under REACH

Intertek Regulatory Services

Position Paper. Ensuring a truly complementary, coherent and consistent implementation of REACH and RoHS2 EXECUTIVE SUMMARY

Band-Aid Brand Adhesive Bandages Novelty Strips

EVALUATION AND FITNESS CHECK (FC) ROADMAP. A. Purpose

Chesar 2 User manual. Part 1 - Manage substances and CSAs

REACH and RoHS updates for EU and Asia Pacific countries Mike McNally Antea Group

REPORT FROM THE COMMISSION TO THE EUROPEAN PARLIAMENT, THE COUNCIL, THE EUROPEAN ECONOMIC AND SOCIAL COMMITTEE AND THE COMMITTEE OF THE REGIONS

Water Management, Ankara, Turkey

Methods for the Risk Assessment of Priority Assessment Chemical Substances

Evaluating POPs & PBT as part of the approval

Lyreco Mechanical Pencil 0.5mm Blk

Public consultation addressing the interface between chemical, product and waste legislation

EUROPEAN COMMISSION HEALTH AND CONSUMERS DIRECTORATE-GENERAL. Safety of the Food chain Chemicals, contaminants, pesticides

ROHS ANNEX II DOSSIER DEHP

Exponential growth of an invisible Pollutant

Johnsons Pure Cotton Balls - White & Coloured

REGULATORY ACTIONS UNDER REACH & CLP FEEDBACK FROM ECHA S RAC

WASTE STATISTICS IN GERMANY

SUMMARY. 1 Large household appliances. 2 Small household appliances. 3 Informatics and Telecommunication (IT) equipment. 4 Consuming products

Risk Management Option Analysis Conclusion Document

EUROPEAN COMMISSION SUMMARY REPORT OF THE STANDING COMMITTEE ON PLANTS, ANIMALS, FOOD AND FEED HELD IN BRUSSELS ON 22 JUNE 2016

An Illustrative Example of a CSR

David Owen Shell Chemicals Ltd ISRTP Workshop, Baltimore November 2005

3 The REACH regulation

Request to renew Exemption 21

Circular Economy. Jiannis Kougoulis European Commission DG Environment

SAFETY DATA SHEET in accordance with 1907/2006/EC (REACH, as amended by 2015/830/EU) and 29 CFR

How to bring your registration dossier in compliance with REACH Tips and Hints - Part 5

REACH Roadmap for Petroleum Substances update

Nanomaterials in REACH

1.1. When does the recycling process start and when does it end? Definition of system boundaries (input and output) of the recycling process

Guidance on information requirements and chemical safety assessment Part F: Chemical Safety Report

Waste & Chemicals in WEEE recycling Setting the right balance for a safe environment EERA meeting March 30 th 2017

EU legal context of glass recycling

Guidance on information requirements and chemical safety assessment

Waste Management Plan of the Pilsen region

Creation Date: July 6,2015 Revision Date: -

Implementing REACH - Safer chemicals in Europe

How ECHA identifies the design for the extended one-generation reproductive toxicity study (EOGRTS) under dossier evaluation.

Implementing Regulation 1107/2009 Stage of Progress An Industry Perspective CEUREG Forum, Brno, 7 October 2010

Public consultation addressing the interface between chemical, product and waste legislation

Guidance for Setting Occupational Exposure Limits: Emphasis on Data-Poor Substances

Exemption Request Form

Creation Date:April 20, 2015 Revision Date: -

Transcription:

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