Study on CSA/CSR tool

Transcription

1 European Commission Study on CSA/CSR tool REACH-IT Stakeholder Workshop Brussels - 15 February 2008 Otto Linher, European Commission, DG ENTR, REACH Unit 1

2 Approach & deliverables Scoping Vision Stakeholders requests High Level architecture WP1 Evaluation of the scope & RIP3.2 moving input Analysis Use Case Model (technical) Use Case Specifications & Analysis Model Software Architecture WP2/ WP3 Concentrating on functional content, working in «draft» mode Design constraints Design Model (technical) Datastore Model (technical) Draft XML Interfaces (technical) Options for architecture, draft XML according to Tiers Integrating the Build decision, 2

3 Current status Work Package 2 deliverables received from the contractor (January 2008) 3 rd CEG meeting took place in Brussels (31 st January 2008) Work on the rest of deliverables in progress (until( the end of March) 3

4 Work Package 2 - deliverables Use Case model Stakeholder analysis report Software architecture description Analysis model (class, sequence, state and activity diagrams) 4

5 Functional Processes The analysis has translated the RIP3.2 guidance into functional processes. Process FP-1 : from preset categories or existing ESs [M/I] Start of a process Iteration through refinement of ES (FP1-2) or Hazard (FP1-4) FP-1.0 Preset categories and selection FP1.0a Uses, Preset categories and associated data FP-1.1 Building of initial ESs FP-1.1a Substance manufacture and uses description (through standard descriptor system) FP-1.2 Complete or iterate initial ESs (per use and target group) FP-1.2a Define/Update Operational conditions of use (ES 3-5) FP-1.3 Exposure estimation per use and target group FP-1.3a Exposure estimation tier-1 for environment and man indirect with EUSES FP-1.4 Hazard information retrieval FP1.4a Environment retrieval (PNECs, AF, FP-1.5 Risk characterisation per target group and combination per FP-1.5a Risk environment per ES FP-1.6 Derive the (final) ESs FP-1.6a Consolidation of ESs (not automated) FP-1.7 Document the ES and generate the CSR FP-1.7a CSR authoring FP-1.0b Substance selection FP-1.1b Select preset categories for all 3 targets groups (customers, workers, environment) FP-1.2b Define/Update Risk Management Measures (ES 6) FP-1.3b Exposure workers tier-1 with ECETOC TRA FP1.4b Human health retrieval (DNELs, AF, FP-1.5b Risk man indirect exposure per ES FP-1.6b Input advice given to DU for checking compliance (ES 9) per ES FP-1.7b Document ES for SDS Substance for the FP-1.1c Select working version of initial ES (and associated CSA tool) per manufacture and use FP-1.2c Define/Update Waste management measures (ES 7) FP-1.3c Exposure consumers tier-1 with ConsExpo FP-1.5c Risk consumers per ES FP-1.6c Editing and structuring of ESs after consolidation and consistency check ES for SDS FP-1.1d Starting initial ESs and brief general description of use (ES 2) FP-1.2d Refinement based on measured input data to exposure model FP-1.3d Input of measured exposure values Hazard information FP-1.5d Risk workers per ES FP-1.6d Generation and storage of the ESs consolidated CSR FP-1.5e Combined Risk a (Initial) ESs CSA (esposures estimation and measured values Model Name: ESCSR5 Name: 0b FP-1 from preset categories or existing ESs [M/I] ESs (to be iterated if necessary) CSA (risks characterisations Update Date: 17/01/ :01:31 Updated by: Administrator 5

6 Functional Processes Start of a process Start of a process Process FP-1 : FP-1.0 Preset categories from preset and categories or existing ESs [M/I] selection FP-1.0 Preset categories and selection FP1.0a Uses, Preset categories and associated data FP-1.1 Building of initial ESs FP-1.1a Substance manufacture and uses description (through standard descriptor system) FP-1.2 Complete or iterate FP-1.3 Exposure estimation initial ESs (per use and target group) categories and per use and target group FP-1.2a Define/Update FP-1.3a Exposure Operational conditions estimation tier-1 for of use (ES 3-5) environment and man indirect with EUSES Iteration through refinement of ES (FP1-2) or Hazard (FP1-4) FP1.0a Uses, Preset associated data FP-1.4 Hazard information retrieval FP1.4a Environment retrieval (PNECs, AF, FP-1.5 Risk characterisation per target group and combination per FP-1.5a Risk environment per ES FP-1.6 Derive the (final) ESs FP-1.6a Consolidation of ESs (not automated) FP-1.7 Document the ES and generate the CSR FP-1.7a CSR authoring FP-1.0b Substance selection FP-1.1b Select preset categories for all 3 targets groups (customers, workers, environment) FP-1.2b Define/Update Risk Management Measures (ES 6) FP-1.3b Exposure workers tier-1 with ECETOC TRA FP1.4b Human health retrieval (DNELs, AF, FP-1.5b Risk man indirect exposure per ES FP-1.6b Input advice given to DU for checking compliance (ES 9) per ES FP-1.7b Document ES for SDS Substance for the FP-1.1c Select working version of initial ES (and associated CSA tool) per manufacture and use FP-1.2c Define/Update Waste management measures (ES 7) FP-1.3c Exposure FP-1.0b Substance consumers tier-1 with ConsExpo selection FP-1.5c Risk consumers per ES FP-1.6c Editing and structuring of ESs after consolidation and consistency check ES for SDS FP-1.1d Starting initial ESs and brief general description of use (ES 2) FP-1.2d Refinement based on measured input data to exposure model FP-1.3d Input of measured exposure values Hazard information FP-1.5d Risk workers per ES FP-1.6d Generation and storage of the ESs consolidated CSR FP-1.5e Combined Risk a (Initial) ESs CSA (esposures estimation and measured values Substance for the Model Name: ESCSR5 Name: 0b FP-1 from preset categories or existing ESs [M/I] ESs (to be iterated if necessary) CSA (risks characterisations Update Date: 17/01/ :01:31 Updated by: Administrator 6

7 FP-1.1 Building of initial ESs Functional Processes FP-1.1a Substance manufacture and uses description (through standard descriptor system) Start of a process FP-1.0 Preset categories and selection FP1.0a Uses, Preset categories and associated data Process FP-1 : from preset categories FP-1.1b or existing Select ESs preset [M/I] categories for all 3 targets groups Iteration through refinement of ES (FP1-2) or Hazard (FP1-4) (customers, workers, FP-1.3 Exposure estimation FP-1.4 Hazard information FP-1.5 Risk characterisation FP-1.6 Derive the (final) ESs per use and target group retrieval per target environment) group and FP-1.1 Building of initial ESs FP-1.1a Substance manufacture and uses description (through standard descriptor system) FP-1.2 Complete or iterate initial ESs (per use and target group) FP-1.2a Define/Update Operational conditions of use (ES 3-5) FP-1.3a Exposure estimation tier-1 for environment and man indirect with EUSES FP1.4a Environment retrieval (PNECs, AF, combination per FP-1.5a Risk environment per ES FP-1.6a Consolidation of ESs (not automated) FP-1.7 Document the ES and generate the CSR FP-1.7a CSR authoring FP-1.0b Substance selection Substance for the FP-1.1b Select preset categories for all 3 targets groups (customers, workers, environment) FP-1.1c Select working version of initial ES (and associated CSA tool) per manufacture and use FP-1.1d Starting initial ESs and brief general description of use (ES 2) FP-1.2b Define/Update Risk Management Measures (ES 6) FP-1.2c Define/Update Waste management measures (ES 7) FP-1.2d Refinement based on measured input data to exposure model (Initial) ESs FP-1.3b Exposure workers tier-1 with ECETOC TRA FP-1.3c Exposure consumers tier-1 with ConsExpo FP-1.3d Input of measured exposure values CSA (esposures estimation and measured values FP1.4b Human health retrieval (DNELs, AF, Hazard information FP-1.5b Risk man indirect exposure per ES FP-1.5c Risk consumers per ES FP-1.5d Risk workers per ES FP-1.5e Combined Risk a FP-1.6b Input advice FP-1.1c Select working given to DU for checking compliance (ES 9) per version of initial ES (and associated CSA FP-1.6c Editing and structuring of ESs after tool) per manufacture consolidation and consistency check and use FP-1.6d Generation and storage of the ESs consolidated FP-1.1d Starting initial ESs and brief general description of use (ES 2) FP-1.7b Document ES for SDS CSR ES for SDS Model Name: ESCSR5 Name: 0b FP-1 from preset categories or existing ESs [M/I] ESs (to be iterated if necessary) CSA (risks characterisations Update Date: 17/01/ :01:31 Updated by: Administrator 7

8 Functional Processes Iteration through refin Start of a process FP-1.0 Preset categories and selection FP1.0a Uses, Preset categories and associated data FP-1.0b Substance selection Process FP-1 : from preset categories or existing ESs [M/I] FP-1.1 Building of initial ESs FP-1.1a Substance manufacture and uses description (through standard descriptor system) FP-1.1b Select preset categories for all 3 targets groups (customers, workers, environment) FP-1.2 Complete or iterate initial ESs (per use and target group) FP-1.2a Define/Update Operational conditions of use (ES 3-5) FP-1.2b Define/Update Risk Management Measures (ES 6) FP-1.3 Exposure estimation per use and target group FP-1.3a Exposure estimation tier-1 for environment and man indirect with EUSES FP-1.3b Exposure workers tier-1 with ECETOC TRA Iteration through refinement of ES (FP1-2) or Hazard (FP1-4) FP-1.4 Hazard information retrieval FP1.4a Environment retrieval (PNECs, AF, FP-1.2 Complete or iterate initial ESs (per use and target group) FP-1.2a Define/Update Operational conditions of use (ES 3-5) FP1.4b Human health retrieval (DNELs, AF, FP-1.2b Define/Update Risk Management Measures (ES 6) FP-1.5 Risk characterisation per target group and combination per FP-1.5a Risk environment per ES FP-1.2c Define/Update Waste management measures (ES 7) FP-1.5b Risk man indirect exposure per ES FP-1.3 Exposure estimation per use and target group FP-1.3a Exposure estimation tier-1 for environment and man indirect with EUSES FP-1.3b Exposure workers tier-1 with ECETOC TRA FP-1.6 Derive the (final) ESs FP-1.6a Consolidation of ESs (not automated) FP-1.3c Exposure consumers tier-1 with FP-1.6b Input advice given to DU for checking compliance (ES 9) per ES ConsExpo FP-1.7 Document the ES and generate the CSR FP-1.7a CSR authoring FP-1.7b Document ES for SDS F re Substance for the FP-1.1c Select working version of initial ES (and associated CSA tool) per manufacture and use FP-1.1d Starting initial ESs and brief general description of use (ES 2) FP-1.2c Define/Update Waste management measures (ES 7) FP-1.2d Refinement based on measured input data to exposure model FP-1.3c Exposure consumers tier-1 with ConsExpo FP-1.3d Input of measured exposure values Hazard information FP-1.5c Risk consumers per ES FP-1.2d Refinement based on measured input data to exposure model FP-1.5d Risk workers per ES FP-1.6c Editing and structuring of ESs after consolidation and consistency check FP-1.3d Input of measured exposure values FP-1.6d Generation and storage of the ESs consolidated CSR ES for SDS FP-1.5e Combined Risk a (Initial) ESs CSA (esposures estimation and measured values Model Name: ESCSR5 Name: 0b FP-1 from preset categories or existing ESs [M/I] Update Date: 17/01/ :01:31 Updated by: Administrator (Initial) ESs ESs (to be iterated if necessary) CSA (risks characterisations CSA (esposures estimation and measured values 8

9 refinement of ES (FP1-2) or Hazard (FP1-4) FP-1.5 Risk characterisation per target group and Functional Processes FP-1.4 Hazard information retrieval FP1.4a Environment retrieval (PNECs, AF, combination per FP-1.5a Risk environment per ES Start of a process FP1.4b Human health retrieval (DNELs, AF, FP-1.5b Risk Process FP-1 man : indirect exposure from preset categories or existing ESs [M/I] per ES FP-1.0 Preset categories and selection FP1.0a Uses, Preset categories and associated data FP-1.0b Substance selection Hazard information FP-1.1 Building of initial ESs FP-1.1a Substance manufacture and uses description (through standard descriptor system) FP-1.1b Select preset categories for all 3 targets groups (customers, workers, environment) FP-1.5c Risk consumers per ES FP-1.2 Complete or iterate initial ESs (per use and target group) FP-1.2a Define/Update Operational conditions of use (ES 3-5) FP-1.5d Risk workers per ES FP-1.2b Define/Update Risk Management Measures (ES 6) FP-1.3 Exposure estimation per use and target group FP-1.3a Exposure estimation tier-1 for environment and man indirect with EUSES FP-1.3b Exposure workers tier-1 with ECETOC TRA Iteration through refinement of ES (FP1-2) or Hazard (FP1-4) FP-1.4 Hazard information retrieval FP1.4a Environment retrieval (PNECs, AF, FP1.4b Human health retrieval (DNELs, AF, FP-1.5 Risk characterisation per target group and combination per FP-1.5a Risk environment per ES FP-1.5b Risk man indirect exposure per ES FP-1.6 Derive the (final) ESs FP-1.6a Consolidation of ESs (not automated) FP-1.6b Input advice given to DU for checking compliance (ES 9) per ES FP-1.7 Document the ES and generate the CSR FP-1.7a CSR authoring FP-1.7b Document ES for SDS Substance for the FP-1.1c Select working version of initial ES (and associated CSA tool) per manufacture and use FP-1.1d Starting initial ESs and brief general description of use (ES 2) FP-1.2c Define/Update Waste management measures (ES 7) FP-1.5e Combined Risk a FP-1.2d Refinement based on measured input data to exposure model FP-1.3c Exposure consumers tier-1 with ConsExpo FP-1.3d Input of measured exposure values Hazard information FP-1.5c Risk consumers per ES FP-1.5d Risk workers per ES FP-1.6c Editing and structuring of ESs after consolidation and consistency check FP-1.6d Generation and storage of the ESs consolidated CSR ES for SDS FP-1.5e Combined Risk a (Initial) ESs CSA (esposures estimation and measured values m preset categories ESs (to be iterated if necessary) Model Name: ESCSR5 CSA ( risks Name: 0b FP-1 from preset categories or character existing ESs [M/I] Update Date: 17/01/ :01:31 Updated by: Administrator ESs (to be iterated if necessary) CSA (risks characterisations 9 31

10 Functional Processes FP-1.6 Derive the (final) ESs FP-1.7 Document the ES and generate the CSR Start of a process FP-1.0 Preset categories FP-1.6b and FP-1.1 Input Building of advice initial ESs selection FP1.0a Uses, Preset categories and associated data FP-1.0b Substance selection Substance for the FP-1.6a Consolidation of ESs (not automated) given to DU for FP-1.1a Substance manufacture and uses checking description compliance (through standard descriptor (ES 9) system) per ES Process FP-1 : from preset categories or existing ESs [M/I] FP-1.1b Select preset categories for all 3 targets groups (customers, workers, environment) FP-1.6c FP-1.1c Editing Select working and version of initial (and associated CSA structuring tool) per manufacture of ESs after and use consolidation and consistency check FP-1.1d Starting initial ESs and brief general description of use (ES 2) FP-1.2 Complete or iterate initial ESs (per use and target group) FP-1.2a Define/Update Operational conditions of use (ES 3-5) FP-1.2b Define/Update Risk Management Measures (ES 6) FP-1.2c Define/Update Waste management measures (ES 7) FP-1.2d Refinement based on measured input data to exposure model FP-1.7a CSR authoring FP-1.7b Document ES for SDS FP-1.3 Exposure estimation per use and target group FP-1.3a Exposure estimation tier-1 for environment and man indirect with EUSES FP-1.3b Exposure workers tier-1 with ECETOC TRA FP-1.3c Exposure consumers tier-1 with ConsExpo ES for SDS FP-1.3d Input of measured exposure values Iteration through refinement of ES (FP1-2) or Hazard (FP1-4) FP-1.4 Hazard information retrieval FP1.4a Environment retrieval (PNECs, AF, FP1.4b Human health retrieval (DNELs, AF, Hazard information FP-1.5 Risk characterisation per target group and combination per FP-1.5a Risk environment per ES FP-1.5b Risk man indirect exposure per ES FP-1.5c Risk consumers per ES FP-1.5d Risk workers per ES FP-1.6 Derive the (final) ESs FP-1.6a Consolidation of ESs (not automated) FP-1.6b Input advice given to DU for checking compliance (ES 9) per ES FP-1.6c Editing and structuring of ESs after consolidation and consistency check FP-1.6d Generation and storage of the ESs consolidated FP-1.7 Document the ES and generate the CSR FP-1.7a CSR authoring FP-1.7b Document ES for SDS CSR ES for SDS FP-1.6d Generation and storage of the ESs consolidated (Initial) ESs CSR CSA (esposures estimation and measured values FP-1.5e Combined Risk a Model Name: ESCSR5 Name: 0b FP-1 from preset categories or existing ESs [M/I] ESs (to be iterated if necessary) CSA (risks characterisations Update Date: 17/01/ :01:31 Updated by: Administrator 10

11 Process supporting functionalities Each process step has been analysed and described in terms of supporting functionalities (back and front-end) Illustrative: FP1.0b Model Name: ESCSR5 Name: 2b FP-1.0b Substance selection Update Date: 17/01/ :57:38 Updated by: Administrator FP-1.0b Substance selection User from M/I Front-End functionalities FF - Front-end (client side: user interface) SU-FF-01 Search for a SU-FF-02 Display s information found in IUCLID SU-FF-03 Select a Substance Substance general information (CSR B1; IU5 1) Back-End functionalities FB - Back-end (server side) SU-FF-04 Search for a in IUCLID SU-FB-01 Search and retrieve a general informat SU-FB-02 Store and retrieve general information (IU5 1), External application module functionalities EAM - IUCLID 5 EAM-IU-01 Search and retrieve a identification information Define the application module EAM-IU-02 Search and retrieve general information (IU5 1), and manufacture and uses (IU5 3) (through descriptor system) Main element of information 11

12 Software Architecture Description Two options have been elaborated Thin client - HTML, CSS, JavaScript Rich client - Java Relationship to existing IT tools: Data mining from IUCLID5 Some data inserted directly into the tool Calculation provided by existing tools: EUSES ConsExpo ECETOC TRA 12

13 3 rd CEG meeting Took place in Brussels, 31 st January 2008 WP2 deliverables were made available in due time Main discussion points: Group agreed there were no essential gaps Industry calls for maximum transparency of calculations in the tool Action points: Participants to deliver their comments until 14 th Feb. Contractor to incorporate the comments Endorsement by ECHA and DG ENTR 13

14 Study on CSA/CSR tools: Next steps Work Package 3: 3 Functional design model Description of data structure Description of tables, relations between tables, type of fields, validation rules Finalisation end of March

15 Study on CSA/CSR tools: Follow up tool building on the basis of this study ECHA has taken over competence Call for tender Estimated delivery: 1st semester

16 European Commission Thank you for your attention Questions? Otto Linher, European Commission, DG ENTR, REACH Unit 16