ES and CSA process. M. Viñas

Transcription

1 ES and CSA process M. Viñas

2 Agenda Introduction Cefic proposed processes for ES development Generic Exposure Scenarios Specific Exposure Scenarios Libraries 2

3 Guidance on information requirements and chemical safety assessment, Guidance for downstream users 29 documents! > 2000 pages! 3

4 Registration dossier - content Substance to be registered Technical Dossier Identify of the manufacturer/importer Identity of substance Info- manufacture and use of the substance Classification and labelling Guidance on safe use of the substance Study summaries substance properties Test proposals (if relevant) Exposure information > 10 tonne/year Also Chemical Safety Report Hazard and PBT Assessment Substance dangerous or PBT/vPvB Also Chemical Safety Report Hazard and PBT Assessment Exposure Assessment Exposure Scenarios Exposure Estimation Risk Characterisation

5 Agenda Introduction Cefic proposed processes for ES development Generic Exposure Scenarios Specific Exposure Scenarios Libraries 5

6 ES Development & Communication model for safe uses only M/I and/or M/I DU Associations => determine strategy Systematic assessment of safe uses (use of Tier1 tool) M/I and DU partnership via trade associations Generic ES Development Map uses and use conditions in supply chain Initial ESs, ES titles and Use Descriptors M/I and selected DU s Specific ES development M/I Communicate Uses (ES titles, Use Descriptors) to direct DU for further communication in the supply chain No DU Use covered? or Yes DU Wait for final ES Input of DU Associations Development GES library Input of selected customers Use of Cefic ES template DU Complete feedback form Await decision M/I DU Prepare CSA/CSR Inform Agency Final Exposure Scenario (M/I) Communication to direct DU Distribution of e SDS Legend M/I = Manufacturer / Importer DU = Downstream User For specific products and applications the appropriate (next) steps in the above diagram need to be determined based on expert judgement: not always all steps are needed and/or the order can be adapted.

7 Agenda Introduction Cefic proposed processes for ES development Generic Exposure Scenarios Specific Exposure Scenarios Libraries 7

8 ES Development & Communication model for safe uses only M/I and/or M/I DU Associations => determine strategy Systematic assessment of safe uses (use of Tier1 tool) M/I and DU partnership via trade associations Generic ES Development Map uses and use conditions in supply chain Initial ESs, ES titles and Use Descriptors M/I and selected DU s Specific ES development M/I Communicate Uses (ES titles, Use Descriptors) to direct DU for further communication in the supply chain No DU Use covered? or Yes DU Wait for final ES Input of DU Associations Development GES library Input of selected customers Use of Cefic ES template DU Complete feedback form Await decision M/I DU Prepare CSA/CSR Inform Agency Final Exposure Scenario (M/I) Communication to direct DU Distribution of e SDS Legend M/I = Manufacturer / Importer DU = Downstream User For specific products and applications the appropriate (next) steps in the above diagram need to be determined based on expert judgement: not always all steps are needed and/or the order can be adapted. 8

9 ( GES ) Generic Exposure Scenarios GESs are developed by M/Is in partnership with DU Associations The (composite) GES is aggregated from the ESs for individual tasks/activities and incorporated into a library of GESs for access by relevant stakeholders The GES describes Risk Management Measures & Operational Conditions relevant for safe use of a group of substances with a similar risk profile M/I selects relevant GES to support their substance registration GES and supporting documentation is refined as necessary to form the substance-specific ES for demonstration of safe use and inclusion within their CSR ES is transferred to the e-sds for communication to customers 9

10 Key Characteristics of GESs Determine simple titles (and descriptions) that describe the areas of use and that are understandable across DUs within and across supply chains Involve the collaboration of M/I (and/or formulator) associations and DU associations Represent a mapping of all (or key parts of) the supply chain for a substance (or ( substances groups of Follow a process that aligns with the requirements of the TGD and delivers documentation sufficient to meet these for a CSR and/or esds (subject to ( registrant confirmation on the part of the Communicate all relevant OCs and RMMs for the identified scenarios Describe the ES according to a library of standard phrases 10

11 How is GES developed? 1 2 Map the supply chain to compile an inventory of Uses together with likely circumstances of handling Characterise typical RMMs and OCs for the intended uses M/I obtains from internal product stewardship/technical activities; dialogue with representative trade groups (using a pre-populated template) As #1 Above Determine the likely exposures (personal and environmental) for each use for substance life cycle Confirm adequacy of existing RMMs through PNEC and DNEL comparisons and iterate where necessary to define adequate risk control Aggregate the RMMs for the uses to form the GES Define domain of reliable application for the GES M/I selects relevant GES for substance registration M/I matches the specific ES to the M/I product names Use ECETOC TRA for human health and EUSES for environmental risks Refer to other sources of RMM efficiencies for the application/sector if these need to be confirmed e.g. COSHH Essentials, BREF documents RMMs communicated reflect, at a minimum, typical practice for the application and enable alignment with language/jargon for the sector Under what circumstances are the advocated RMMs reliable? M/I matches the substance-specific ES to the relevant M/I product names for communication to customers For associations Templates available! For M/I 11

12 Agenda Introduction Cefic proposed processes for ES development Generic Exposure Scenarios Specific Exposure Scenarios Libraries 13

13 ES Development & Communication model for safe uses only M/I and/or M/I DU Associations => determine strategy Systematic assessment of safe uses (use of Tier1 tool) M/I and DU partnership via trade associations Generic ES Development Map uses and use conditions in supply chain Initial ESs, ES titles and Use Descriptors M/I and selected DU s Specific ES development M/I Communicate Uses (ES titles, Use Descriptors) to direct DU for further communication in the supply chain No DU Use covered? or Yes DU Wait for final ES Input of DU Associations Development GES library Input of selected customers Use of Cefic ES template DU Complete feedback form Await decision M/I DU Prepare CSA/CSR Inform Agency Final Exposure Scenario (M/I) Communication to direct DU Distribution of e SDS Legend M/I = Manufacturer / Importer DU = Downstream User For specific products and applications the appropriate (next) steps in the above diagram need to be determined based on expert judgement: not always all steps are needed and/or the order can be adapted. 14

14 What are Specific Exposure Scenarios? Specific Exposure Scenarios (SES) describe Exposure Scenarios (ES) for individual substances in specific uses SESs are developed by the M/I in dialogue with DU selected representative customers SESs can cover one task or a set of tasks related to an application The SES process is particularly useful to develop ESs for substances in relatively short supply chains or supply chains lacking well structured sector organizations 15

15 CEFIC dialogue template for SES building Enables M/I to develop initial ESs, using a harmonised industry format Enables DU to give feedback on uses and use conditions to M/I in a standardized way ( 37-2 (art. Enables DU to enter new ES, if he finds his use not covered Structured according to ES format in Technical Guidance Document Each section contains the basic information for description of the ES and exposure assessment using the ECETOC TRA tool Template in line with the final version of the ECETOC TRA tool 16

16 How the dialogue template works 1. M/I selects appropriate template: combined/worker/consumer 2. M/I fills in the use and use information from the drop-downs in the yellow column 3. DU reviews the information proposed by the M/I 4. Combination of use descriptors reflect DU use? YES NO 4.1. DU fills in deviations from the conditions of use and/or RMMs in the blue column, where applicable 4.2. DU completely fills in new (orange) column to identify a new use 17

17 Extract out of the dialogue template The parameters in the yellow column are filled in by the manufacturer or importer (M/I) The parameters in the blue column are filled in by the downstream user (DU) if needed 18

18 Identification of Sectors of Use(s) (1) No. Information item Available options Proposed ES1 Deviation from proposed ES1 (plus explanatory notes) (to be completed by MI) (to be completed by DU) 0 Product Identification Product name as it appears on SDS General Solvent 1 Short title exposure scenario 1.1 Internal name 1.2 Sector(s) of Use Selection - multiple SU per ES possible For a broader ES, please select "All except SU21Private Households" ALL Except SU21 private house holds 1.3 Product Category(ies). Not applicable for worker exposure scenario, as the product category does not impact the TIER 1 risk assessment for workers Not Applicable If the M/I wants Not to Applicable limit the use of the General Solvent to professional / industrial uses, he can use the dropdown 1.4 Process Category(ies) Selection (preferably use descriptors from 0 dropdown list without an *) 1.5 Article Category(ies). Selection selection from short list and 1.6 Environmental Release Selection 0 Category(ies) select ALL except SU 21 private households 19

19 Identification of Sectors of Use(s) (2) If the M/I wants to limit the use of the General Solvent to some specific use sectors, he selects from the drop down detailed list e.g. SU1 Agriculture, forestry, fishery SU3 Industrial manufacturing 20

20 Features: Dropdown s with predefined selection Example of dropdown of PROC s 21

21 Identification of Process Categories By selecting PROC10, the worker exposure can be linked to ECETOC TRA exposure prediction models, This field should not be changed by t DU in his feedback as it would be confusing. A new PROC needs a separate column Process Categories are relevant for worker exposure assessment and worker risk management measures 22

22 Identification of Article Categories In the next step, the M/I wants to limit the use of the General Solvent for using in the production of the following article categories AC 3-1 Electrical and electronic products, e.g. computers, office equipment, video and audio recording, communication equipment 23

23 Identification of Environmental Release Categories This field should also not be changed by the DU in his feedback In the next step, the M/I specifies the Environmental Release Category for which the General Solvent can be used ERC2 Formulation of preparations 24

24 Definition of Exposure (Recommended) The M/I specifies the exposure to workers (1-4 hours) The M/I specifies that the operation is indoor with LEV present. It also indicates the use of RPE 25

25 Inserting a 2 nd Exposure Scenario By clicking Ctrl n, a new ES 2 blank form Proposed ES2 is inserted in the template The M/I populates the information same as he did for ES 1 26

26 The dialogue feedback from DU on operational conditions The DU worker exposure exceeds 4 hours The M/I needs to consider the deviations in worker exposure duration and RMM in place; M/I might reject The DU has no LEV in place The consequence for the DU might be the need to reorganise work (e.g. limitation to 4 hours exposure) 27

27 The dialogue feedback from DU on measured data As measured data need to be considered in the risk assessment process, they should be indicated by the downstream user, if available. In our example the measured exposure to workers was 5 ppm 28

28 How are SESs developed? SES process: stepwise approach, initiated by M/I in dialogue with DU 1. Inhouse collection of information on uses and use conditions 5. Evaluation of draft SESs in the CSA Aggregation into final SESs 2. Development of initial SESs ( template (use of SES dialogue 6. Documentation of SESs in Chemical Safety Report 3. Dialogue with selected customers ( template (feedback, using SES dialogue 7. Transformation of SES for substance ( SDS to ES for product (annex 4. Development of draft SESs ( customers (based on input by 8. Communication of ES to direct DU customers 29

29 Final remarks on ES development Dialogue template for SES building is aimed at two way communication in an effective and efficient way; it is NOT a questionnaire! SES and GES development processes are complementary; both processes on their own or in combination offer the flexibility needed to develop ESs that suit M/I needs and the needs of DU customers Cefic strongly supports and recommends the use of both ES development methods and accompanying tools to achieve optimal information exchange on uses in the supply chain 30

30 Selecting the Approach Generic ES approach Main Focus M/I and DU Partnership via Trade Associations Common Uses, e.g. commodity chemicals Dispersive application Assumes some knowledge of substance handling by M/I Groups of substances with similar applications Specific ES approach Main Focus M/I and Key customer iteration Specialised Uses, e.g. fine chemicals Limited supply chain May have limited knowledge of substance handling in the supply chain by M/I Single substance with specific or general applications

31 Available tools on Cefic web Newsletter: guidance on Use and ES development and Supply Chain Communication VCI Practical guide CSR esds DUCC UseR template: M/I and/or M/I DU Associations => determine strategy Preparation phase Use communication Map uses and use conditions in standard supply chain reply Systematic assessment of safe uses (use of Tier1 tool) M/I Guidance and DU partnershipon via trade associations GES process + Generic ES Development templates Input of DU Associations Development GES library Initial ESs, ES titles and Use Descriptors M/I and Guidance selected DU s on SES process + template Specific ES development Input of selected customers Use of Cefic ES template Use and ES communication DU Complete feedback form Await decision M/I DU Use covered? No IT tool requirements or Yes Strictly Controlled Intermediates DU Wait for final ES DU Prepare CSA/CSR Inform Agency ( M/I ) Final Exposure Scenario Communication to direct DU Distribution of e SDS ES for preparations, DPD+

32 Agenda Introduction Cefic proposed processes for ES development Generic Exposure Scenarios Specific Exposure Scenarios Libraries 33

33 Cefic libraries TF What? Generic Exposure Scenarios Standard Phrases for SDS/ES RMM and associated efficiencies Use Mapping including Use Descriptors. Reference latest guidance material When? Ongoing 2010 Where? 34

34 Cefic libraries TF: overview 28 sectors included including paints, plastics, silicons, catalysts, etc. Description of available information: operational conditions, GES, etc. Links to available information Updated monthly with new information, sectors, etc 35

35 Cefic libraries TF: use mappings List of Links: Manuf of powder and coatings: T_IM=1022AE&DWNLD=ajns0163b - descriptors of use - coatings and inks manufacture (powder products).xls Manuf of other coatings: T_IM=1022AC&DWNLD=ajns0162b - descriptors of use - coatings and inks manufacture (all, except for powder products).xls Industrial application of coatings: T_IM=101DC5&DWNLD=ajns0164final - descriptors of use - coatings and inks application (industrial).xls Professional application of coatings: T_IM=101DC7&DWNLD=ajns0165afinal - descriptors of use - coatings and inks application (professional).xls Database in Cefic server E.g. Entry field: CEPE User of Cefic library 36

36 Cefic libraries TF: use mappings Reduced list of Links: Manuf of powder and coatings: AE&DWNLD=ajns0163b - descriptors of use - coatings and inks manufacture (powder products).xls Manuf of other coatings: AC&DWNLD=ajns0162b - descriptors of use - coatings and inks manufacture (all, except for powder products).xls Download from Associations websites the excel file Upload to company s supply chain communication tool Merge information into a single table Or upload to Chesar or other assessment tool (manual / XML if available) Use mapping library soon available! 37

37 Cefic libraries TF: Standard phrases Cefic is working in cooperation with BDI/BusinessEurope in order to make available a catalogue of standard phrases to be used in the preparation of ES. Current version available at: Both general and sector-specific phrases It will be regularly updated It is foreseen that Chesar will allow to work with downloaded catalogue 38

38 Abbreviations DPD: Dangerous Preparations Directive ES: Exposure Scenario GES: Generic Exposure Scenario M/I: Manufacturer/Importer SES: Specific Exposure Scenario BDI: Federation of German Industries Cefic: European Chemical Industry Council DUCC: Downstream Users of Chemicals Co-ordination FECC: European Association of Chemical Distributors 39

39 Useful links Cefic website: DUCC UseR template: S_MappingTemplate_revisedFinal xls Ecetoc TRA: ECHA: Thank you for your attention!