Review of the List of restricted substances under RoHS II 2 nd Stakeholder Meeting 14 May 13 1 Review of the List of restricted substances under RoHS II- Kick-off Meeting, Brussels, 12.12.2012
Proposal for a Methodology for the Pre-Assessment of substances for potential restriction in EEE 2 Review of the List of restricted substances under RoHS II- Kick-off Meeting, Brussels, 12.12.2012
Option 1: Periodic review of Annex II initiated by COM Option 2: Review of Annex II following submission of a proposal by a MS Part I Identification of substances Hazardous properties (human health and environment) Waste problems PART II pre-assessment: Exclusion and prioritization - Legal restriction status -Hazardous properties (human health and environment) -Waste problems (degradation products, hazardous wastes) -Production volumes RESULT: NO RECOMMENDATION FOR RESTRICTION IN EEE PART III assessment of priority candidates -Risk for workers and environment during WEEE management -Other risks to human health and /or the environment -Adverse effects on waste management -Availability of substitutes with less negative impact RESULT: RECOMMENDATION FOR RESTRICTION IN EEE 3
Aim Identification of those substances on the RoHS working list, which are assumed to be of very high concern and of potential high risk 4
Workflow exclusion of already regulated substances identification of high priority substances with regard to further detailed assessment. 5
Identification Substances used in EEE, which may be harmful during WEEE management Step P 1 Evaluation of the legal restriction status Q: Is there a legally binding restriction (expected) overruling RoHS? yes Restriction under RoHS not necessary no Step P 2 Prioritization of substances using a scoring system considering the following attributes: - Hazard properties / Human health - Hazard properties / Environmental hazards - Problems during WEEE management - Production volumes Score: 35-50* Score: 20-35* Score: < 20* High priority For detailed assessment Medium priority for detailed assessment Moderate priority for detailed assessment 6 = * under development
Identification Substances used in EEE, which may be harmful during WEEE management Step P 1 Evaluation of the legal restriction status Q: Is there a legally binding restriction (expected) overruling RoHS? yes Restriction under RoHS not necessary no Step P 2 Prioritization of substances using a scoring system considering the following attributes: - Hazard properties / Human health - Hazard properties / Environmental hazards - Problems during WEEE management - Production volumes Score: 35-50* Score: 20-35* Score: < 20* High priority For detailed assessment Medium priority for detailed assessment Moderate priority for detailed assessment 7 = * under development
to exclude substances where restriction under RoHS is not required due to existing legal restrictions. Criteria Evaluation of the legal restriction status Substance is restricted in accordance with the POPs Regulation, (EC) No 850/2004 or, listed as candidate substance for Stockholm Convention listed in Annex XVII under REACH (EC (No) 2006/1907) if the restriction covers application in EEE. Covered by the Montreal Protocol, the Regulation (EC) No 1005/2009 on substances that deplete the ozone layer and the F-gas regulation (EC) No 842/2006 8
Identification Substances used in EEE, which may be harmful during WEEE management Step P 1 Evaluation of the legal restriction status Q: Is there a legally binding restriction (expected) overruling RoHS? yes Restriction under RoHS not necessary no Step P 2 Prioritization of substances using a scoring system considering the following attributes: - Hazard properties / Human health - Hazard properties / Environmental hazards - Problems during WEEE management - Production volumes Score: 35-50* Score: 20-35* Score: < 20* High priority For detailed assessment Medium priority for detailed assessment Moderate priority for detailed assessment 9 = * under development
Prioritization Compilation of information on substance properties, use (application and quantities), exposure, waste management issues etc., inter alia from: ECHA, dissemination website, C&L Inventory, ESIS, Prioritize substances applying a scoring system: Categories: Human Health Hazard Environmental Hazard Waste management related concerns Production volumes 10
Methodology for pre-assessment of substances Criteria for HAZARD screening: REACH SVHC-criteria (Substances of Very High Concern): CMR: carcinogenic or mutagenic or toxic for reproduction categories 1A an d 1B PBT: persistent and bioaccumulative and toxic or vpvb Substances of equivalent concern e.g.: endocrine disrupting substances, sensitizing substances, substances with STOT properties (specific target organ toxicity) CLP hazard classes/categories 11
Criteria for HAZARD screening: Human Health: Highest Score: Group 1 SVHC (REACH) properties: CMR, equivalent concern Acute toxic (Cat 1) Medium Score: Group 2 CLP hazard categories (1-2) Endocrine Disrupter (2) Lowest Score: Group 3 CLP hazard categories (3-4) Endocrine Disrupter (3) Environment: Highest Score: Group 1 SVHC (REACH) properties PBT, vpvb Medium Score: Group 2 CLP hazard categories (1-2) Endocrine Disrupter (2) Lowest Score: Group 3 CLP hazard categories (3-4) Endocrine Disrupter (3) 12
Proposed Human Health Hazard Scoring Score Definition Human Health Hazard Group I 15 carcinogenic OR reprotoxic OR mutagenic [Categories 1A] 15 carcinogenic OR reprotoxic OR mutagenic [Categories 1B] 15 Endocrine activity Cat 1 15 respiratory sensitization Category 1 15 STOT-SE, STOT-RE (specific target organ toxicity at single and repeated exposure) class 1 15 Acute toxic (category 1) Human Health Hazard Group II 10 serious eye damage/eye irritation, (Category 1,2) 10 skin sensitization Category 1 10 skin corrosion/irritation (Category 1A, 1B, 1C, 2) 10 carcinogenic OR reprotoxic OR mutagenic [Category 2] 10 respiratory sensitization (Category 2) 10 STOT-SE, STOT-RE (specific target organ toxicity at single and repeated exposure) class 2 10 acute toxic (Category 2) 10 Endocrine disruptor (Category 2) Human Health Hazard Group III 5 acute toxic (Category 3, 4) 5 STOT-SE, (specific target organ toxicity at single exposure) class 3 5 Endocrine disruptor (Category 3*) 13
Proposed Environmental Hazard Scoring Environmental Hazard Group I 15 PBT (persistent, bioaccumulative, toxic) according SVHC criteria REACH 15 vpvb (very persistent and very bioaccumulative) according SVHC criteria REACH 15 Endocrine disrupter (Category 1) Environmental Hazard Group II 10 PB (persistent, bio-accumulative) according to RIVM assessment 10 Hazardous to the aquatic environment (Chronic category 1,2) 10 Hazardous to the aquatic environment (Acute Category 1) 10 Endocrine disrupter (Category1, 2) Environmental Hazard Group III 5 Hazardous to the aquatic environment (Chronic category 3,4) 5 Persistent (REACH criterion) 5 Bio accumulative (REACH criterion) 5 Endocrine disrupter (Category 3)* *Cat 3 currently under discussion at EU level 14
Methodology for pre-assessment of substances A substance receives the maximum score if it can be listed in the hazard group I A substance receives the medium score if it fulfils at least one criterion of hazard group II A substance receives the lowest score if it fulfils at least one criterion of hazard group III If a substance fulfils several criteria of e.g. Hazard group II it will be taken into consideration for further prioritization of substances of the same group/score. 15
Proposed scoring: Waste related concern Description Score The substance is responsible for generation of hazardous waste (H1, explosive, H2, oxidizing, H3, flammable, H12, Substances and preparations which release toxic or very toxic gases in contact with water, air or an acid) 3 Radioactive isotopes are used 3 Evidence, that hazardous degradation/transformation products are formed during waste management 7 Use as nano-material in EEE and evidence, that releases of nano-material at the waste stage might occur 2 16
Proposed scoring: Production volumes Description Production volumes according to ECHA registration database Score > 100.000 t/a 5 1.000 100.000 t/a 3 < 1.000 t/a 1 17
Identification Substances used in EEE, which may be harmful during WEEE management Step P 1 Evaluation of the legal restriction status Q: Is there a legally binding restriction (expected) overruling RoHS? yes Restriction under RoHS not necessary no Step P 2 Prioritization of substances using a scoring system considering the following attributes: - Hazard properties / Human health - Hazard properties / Environmental hazards - Problems during WEEE management - Production volumes Score: 35-50* Score: 20-35* Score: < 20* High priority For detailed assessment Medium priority for detailed assessment Moderate priority for detailed assessment 18 = * under development
Methodology for pre-assessment of the candidates Substances with a higher number of scores will be prioritized However, expert judgment may lead to prioritization according to specific considerations Substances with the highest scoring will be of highest priority for the detailed assessment 19
Preliminary result of application of the Pre-Assessment Methodology during the review 2013 20 Review of the List of restricted substances under RoHS II- Kick-off Meeting, Brussels, 12.12.2012
pre-assessment of selected substances: Identification, Classification, Registration Exercise for substances from the Öko-Institute Study 21
Human Health Hazard Scoring Exercise for substances from the Öko-Institute Study 22
pre-assessment of selected substances: HHH Exercise for substances from the Öko-Institute Study 23
pre-assessment of selected substances: Env. Exercise for substances from the Öko-Institute Study 24
pre-assessment of selected substances: Total Hazard Score and Priority Class Exercise for substances from the Öko-Institute Study 25
pre-assessment of selected substances: Total Hazard Score and Priority Class Addition of waste criteria /scores Substances with similar scores shall be further assessed (additional hazard categories) Other considerations 26
Brigitte Karigl, Maria Tesar Christian Neubauer Hubert Reisinger Department Waste and Material Flow Management brigitte.karigl@umweltbundesamt.at maria.tesar@umweltbundesamt.at Project Team Sabine Cladrowa, Christine Hölzl Department Chemicals sabine.cladrowa@umweltbundesamt.at Maria Uhl, Ivo Offenthaler Department Pollutants and Man maria.uhl@umweltbundesamt.at ivo.offenthaler@umweltbundesamt.at christine.hoelzl@umweltbundesamt.at Umweltbundesamt Review RoHS II, Annex II www.umweltbundesamt.at Projekt Kick-off 14.05.2013 27 * Review of the List of restricted substances under RoHS II- Kick-off Meeting, Brussels, 12.12.2012