Hr Xls Template by vwi12657

VIEWS: 57 PAGES: 40

More Info
									 REACH ES and CSA process
From REACH to GPS and PS workshop
        03 and 04 Dec 2009
          Zagreb, Croatia




                               L. Heezen
Agenda


  Introduction to CSA under REACH

  Exposure Assessment

      Exposure Scenario

      Exposure estimating tools

  Risk Characterisation

  Cefic proposed processes for ES development

  Libraries

  ECHA CSA IT tool for CSR and ES development




                                                 2
Guidance on information requirements and
chemical safety assessment, Guidance for
downstream users




                                       3
  Registration dossier - content
                                   Technical Dossier
                                   •Identify of the manufacturer/importer
                                   •Identity of substance
   Substance to be                 •Info- manufacture and use of the substance
     registered                    •Classification and labelling
                                   •Guidance on safe use of the substance
                                   •Study summaries – substance properties
                                   •Test proposals (if relevant)
                                   •Exposure information




  > 10 tonne/year                  Chemical Safety Report
                            Also   •Hazard and PBT Assessment



                                   Chemical Safety Report
                                   •Hazard and PBT Assessment
                                   •Exposure Assessment
Substance dangerous                    •Exposure Scenarios
   or PBT/vPvB              Also       •Exposure Estimation
                                   •Risk Characterisation
Aim of the CSA Process

Identify the conditions ensuring control of risks arising from
   manufacture and use(s) of a substance.
Prepare a set of corresponding information on operational
   conditions and risk management measures to be
   communicated to the users of the substance (for dangerous
   and PBT, vPvB substances) = Exposure Scenario (to be annexed
   to extended SDSs)
Document the assessment (including how the Exposure Scenarios
   were derived) in a CSR for the companies‟ own documentation.
Submit the CSR to the authorities as part of the registration.
 Information: available           required/needed
 • substance intrinsic properties
 • manufacture, use, tonnage, exposure, risk management

Hazard Assessment (HA)                           Exposure Assessment (EA)*
• Hazard Classification                          • Build Exposure Scenarios
  and PBT conclusion                               (RMM and OC)
• Dose/Concentration-Response                    • Estimate Exposure Level
  Characterisation

       n               y
           Dangerous
Stop        or PBT ?            Risk Characterization (RC)*


Document                   y                    Risk                   n         Iteration
 in CSR                                      controlled?

 Communicate
 ES via eSDS           *       Required if substance is dangerous or PBT/vPvB,         Required for
                               or exposure based waiving according to annex XI         all CSAs
Agenda


  Introduction to CSA under REACH

  Exposure Assessment

      Exposure Scenario

      Exposure estimating tools

  Risk Characterisation

  Cefic proposed processes for ES development

  Libraries

  ECHA CSA IT tool for CSR and ES development




                                                 7
 Information: available           required/needed
 • substance intrinsic properties
 • manufacture, use, tonnage, exposure, risk management

Hazard Assessment (HA)                           Exposure Assessment (EA)*
• Hazard Classification                          • Build Exposure Scenarios
  and PBT conclusion                               (RMM and OC)
• Dose/Concentration-Response                    • Estimate Exposure Level
  Characterisation

       n               y
           Dangerous
Stop        or PBT ?            Risk Characterization (RC)*


Document                   y                    Risk                   n         Iteration
 in CSR                                      controlled?

 Communicate
 ES via eSDS           *       Required if substance is dangerous or PBT/vPvB,         Required for
                               or exposure based waiving according to annex XI         all CSAs
Content of Exposure Scenarios

Description of conditions suitable to ensure control of risks
   related to the uses of a substance during the entire life
   cycle. Environment, workers and consumers to be covered.
   One ES can cover one or more use:
     • Operational conditions (OC) determining the exposure
       (e.g. duration of task)
     • Practical risk management measures (RMM) suitable /
       needed to prevent, reduce or limit risks (e.g. exhaust
       ventilation)
Explanation how the exposure estimates related to these
   conditions and RMM have been derived
Title of exposure scenario indicating for which uses it can be
   applied
Boundaries within which the exposure scenario is applicable.
  What is an Exposure Scenario ?

A description of safe use by describing
   • Conditions of use
   • Risk management measures
   • “Algorithm” to be used by DU for validating safe use

ES covers all activities and processes within the value chain
   • Production: chemical synthesis of the substance and use as
     intermediate
   • Formulation: mixing and blending into a preparation
   • Industrial, professional use
   • Consumer exposure and private use
   • Service life
   • Waste Life stage
When are Exposure Scenarios needed?


Exposure Scenarios and CSAs need to be included in the CSR if
   • The substance is classified as dangerous or
   • The substance is a PBT or vPvB and
   • Produced or imported in excess of 10 t/a
   • In a preparation in a concentration above limits indicated in article
     14

DU can choose to do his own CSA/CSR unless
    •   No SDS needs to be provided
    •   The supplier is not required to develop a CSA
    •   The tonnage limit is < 1 t/a
    •   The downstream uses should also be taken into account
    •   Exposure scenarios need to be developed for all identified uses
  Exposure scenario development

Exposure scenarios need to be developed for:

   • Manufacturing process

   • Identified uses

   • Life cycle stages from manufacturing to
     identified uses till waste stages.
Agenda


  Introduction to CSA under REACH

  Exposure Assessment

      Exposure Scenario

      Exposure estimating tools

  Risk Characterisation

  Cefic proposed processes for ES development

  Libraries

  ECHA CSA IT tool for CSR and ES development




                                                 13
 Information: available           required/needed
 • substance intrinsic properties
 • manufacture, use, tonnage, exposure, risk management

Hazard Assessment (HA)                           Exposure Assessment (EA)*
• Hazard Classification                          • Build Exposure Scenarios
  and PBT conclusion                               (RMM and OC)
• Dose/Concentration-Response                    • Estimate Exposure Level
  Characterisation

       n               y
           Dangerous
Stop        or PBT ?            Risk Characterization (RC)*


Document                   y                    Risk                   n         Iteration
 in CSR                                      controlled?

 Communicate
 ES via eSDS           *       Required if substance is dangerous or PBT/vPvB,         Required for
                               or exposure based waiving according to annex XI         all CSAs
   What is “Risk Characterisation”

Exposure levels (actual or calculated) are compared
  with quantitative or qualitative hazard information
Synthesis between exposure scenario and hazard
  assessment
Calculation of the “Risk Characterisation Ratio”
  (RCR)
                    PEC             Exposure
         RCR =                or
                   PNEC               DNEL
             Assessment steps

Classified for phys.chem hazard, perform a risk
    characterisation for these properties
Collect the PNEC‟s, DNEL‟s or DMEL‟s.
Collect the exposure values for each exposure scenario
Compare matching exposure and predicted or derived no-
    effect-levels
In case no PNEC or DNEL could be derived perform a
    qualitative risk characterisation (not covered)
Calculate the sum of the RCR‟s
Decide on iterations of the CSA to demonstrate at the end that
    the risks are controlled.
Finalize the Risk Characterisation.
Agenda


  Introduction to CSA under REACH

  Exposure Assessment

      Exposure Scenario

      Exposure estimating tools

  Risk Characterisation

  Cefic proposed processes for ES development

  Libraries

  ECHA CSA IT tool for CSR and ES development




                                                 17
ES Development &
Communication model

                             M/I and/or M/I-DU Associations => determine strategy
                                                                                                                                  M/I
                              Systematic assessment of safe uses (use of Tier1 tool)                      Communicate Uses (ES titles, Use Descriptors)
                                                                                                               to direct DU for further communication
                                    Map uses and use conditions in supply chain
                                                                                                                          in the supply chain
                                      Initial ESs, ES titles and Use Descriptors
for safe uses only




                                                                                                                                                        Yes         DU
                                                                                                                                          DU
                                                                                                                                                                 Wait for
                                                                                                                                     Use covered?
                     M/I and DU partnership                  M/I and selected DU’s                                                                               final ES
                     via trade associations                                                                                     No


                     Generic ES Development                  Specific ES development                                                     or
                     • Input of DU Associations              • Input of selected customers                           DU                                 DU
                     • Development GES library               • Use of Cefic ES template                     • Complete feedback               • Prepare CSA/CSR
                                                                                                              form                            • Inform Agency
                                                                                                            • Await decision M/I



                                                                                                                    Communication to                     Distribution
                                            Final Exposure Scenario (M/I)
                                                                                                                      direct DU                           of e-SDS



                     Legend                                           For specific products and applications the appropriate (next) steps in the above diagram need to be
                     M/I = Manufacturer / Importer                    determined based on expert judgement: not always all steps are needed and/or the order can be
                     DU = Downstream User                             adapted.
Cefic workflow
on ES development and communication

Development of Exposure Scenarios, using two
      processes:

       • Generic Exposure Scenario process

       • Specific Exposure Scenario process




                                               19
ES Development & Communication model



                             M/I and/or M/I-DU Associations => determine strategy
                                                                                                                                  M/I
                              Systematic assessment of safe uses (use of Tier1 tool)                      Communicate Uses (ES titles, Use Descriptors)
                                                                                                               to direct DU for further communication
                                    Map uses and use conditions in supply chain
                                                                                                                          in the supply chain
                                      Initial ESs, ES titles and Use Descriptors
for safe uses only




                                                                                                                                                        Yes         DU
                                                                                                                                          DU
                                                                                                                                                                 Wait for
                                                                                                                                     Use covered?
                     M/I and DU partnership                  M/I and selected DU’s                                                                               final ES
                     via trade associations                                                                                     No


                     Generic ES Development                  Specific ES development                                                     or
                     • Input of DU Associations              • Input of selected customers                           DU                                 DU
                     • Development GES library               • Use of Cefic ES template                     • Complete feedback               • Prepare CSA/CSR
                                                                                                              form                            • Inform Agency
                                                                                                            • Await decision M/I



                                                                                                            Communication to                      Distribution
                                            Final Exposure Scenario (M/I)
                                                                                                              direct DU                            of e-SDS



                     Legend                                           For specific products and applications the appropriate (next) steps in the above diagram need to be
                     M/I = Manufacturer / Importer                    determined based on expert judgement: not always all steps are needed and/or the order can be
                     DU = Downstream User                             adapted.
                                                                                                                                                                 20
 Generic Exposure Scenarios (GES)

• GESs describe ESs for (groups of) substances for an area of
operation within industry and are developed by M/Is in partnership
with DU Associations (surrogate for individual DU)‫‏‬
• The (composite) GES is aggregated from the ESs for individual
tasks/activities and incorporated into a library of GESs for access by
relevant stakeholders
   • 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
 Key Characteristics of GESs

Focus on common areas of use of a (group of) substance (that can be characterised
   by groups of PROCs, ERCs and/or PCs)
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
   groups of substances)
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
    confirmation on the part of the registrant)
Communicate all relevant OCs and RMMs for the identified       scenarios
Describe the ES according to a library of standard phrases
How is GES developed?
 1                                      M/I obtains from internal product
           Map the supply chain to
            compile an inventory of     stewardship/technical activities;
           Uses together with likely    dialogue with representative trade
          circumstances of handling     groups (using a pre-populated
                                        template)
 2
         Characterise typical RMMs
          and OCs for the intended      As #1 Above
                    uses


 3
             Determine the likely       Use ECETOC TRA for
          exposures (personal and       human health and EUSES
         environmental) for each use    for environmental risks
           for substance life cycle


 4
            Confirm adequacy of         Refer to other sources of RMM
           existing RMMs through        efficiencies for the application/sector
              PNEC and DNEL             if these need to be confirmed e.g.
           comparisons and iterate      COSHH Essentials, BREF
          where necessary to define     documents
            adequate risk control


 5                                      RMMs communicated reflect, at a
         Aggregate the RMMs for the     minimum, typical practice for the
            uses to form the GES        application and enable alignment
                                        with language/jargon for the sector
     6
          Define domain of reliable     Under what circumstances are the
           application for the GES      advocated RMMs reliable?

 7
         M/I selects relevant GES for
                                        M/I matches the substance-specific
            substance registration
                                        ES to the relevant M/I product
     8                                  names for communication to
          M/I matches the specific ES   customers
           to the M/I product names
Cefic workflow
on ES development and communication

Development of Exposure Scenarios, using two
      processes:

       • Generic Exposure Scenario process

       • Specific Exposure Scenario process




                                               25
ES Development & Communication model

                             M/I and/or M/I-DU Associations => determine strategy
                                                                                                                                  M/I
                              Systematic assessment of safe uses (use of Tier1 tool)                      Communicate Uses (ES titles, Use Descriptors)
                                                                                                               to direct DU for further communication
                                    Map uses and use conditions in supply chain
                                                                                                                          in the supply chain
                                      Initial ESs, ES titles and Use Descriptors
for safe uses only




                                                                                                                                                        Yes         DU
                                                                                                                                          DU
                                                                                                                                                                 Wait for
                                                                                                                                     Use covered?
                     M/I and DU partnership                  M/I and selected DU’s                                                                               final ES
                     via trade associations                                                                                     No


                     Generic ES Development                  Specific ES development                                                     or
                     • Input of DU Associations              • Input of selected customers                           DU                                 DU
                     • Development GES library               • Use of Cefic ES template                     • Complete feedback               • Prepare CSA/CSR
                                                                                                              form                            • Inform Agency
                                                                                                            • Await decision M/I



                                                                                                            Communication to                      Distribution
                                            Final Exposure Scenario (M/I)
                                                                                                              direct DU                            of e-SDS



                     Legend                                           For specific products and applications the appropriate (next) steps in the above diagram need to be
                     M/I = Manufacturer / Importer                    determined based on expert judgement: not always all steps are needed and/or the order can be
                     DU = Downstream User                             adapted.
                                                                                                                                                                 26
What are Specific Exposure Scenarios?


•   Specific Exposure Scenarios (SES) describe Exposure Scenarios
    (ES) for individual substances in both specific and general 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




                                                                     27
Cefic ES template dialogue

Draft template. Please consult Cefic website for final
  version
 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


• Enables DU to enter new ES, if he finds his use not covered (art. 37-2)‫‏‬

• 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 will be modified to support final version of the ECETOC TRA tool
                                                                          29
 How are SESs developed?

SES process: stepwise approach, initiated by M/I in dialogue with DU


    1. Inhouse collection of information    5. Evaluation of draft SESs in the CSA
         on uses and use conditions              Aggregation into final SESs




      2. Development of initial SESs              6. Documentation of SESs
      (use of SES dialogue template)              in Chemical Safety Report



     3. Dialogue with selected customers    7. Transformation of SES for substance
  (feedback, using SES dialogue template)        to ES for product (annex SDS)




       4. Development of draft SESs                8. Communication of ES
      (based on input by customers)                to direct DU customers

                                                                                30
Final remarks


•   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




                                                                      31
 Selecting the Approach

   Generic ES approach                 Specific ES approach
          Main Focus                           Main Focus

M/I and DU Partnership via Trade    M/I and Key customer iteration
Associations
Common Uses, e.g. commodity         Specialised Uses, e.g. fine
chemicals                           chemicals
Dispersive application              Limited supply chain

Assumes some knowledge of           May have limited knowledge of
substance handling by M/I           substance handling in the supply
                                    chain by M/I
Groups of substances with similar   Single substance with specific or
applications                        general applications
Available tools
•                    Newsletter: guidance on Use and ES development and Supply Chain Communication
                     http://cefic.org/files/Downloads/Guidance_Use_and_ES_dvlpt_and_SCCm.doc
•                    VCI Practical guide CSR eSDS                Available on Cefic website

•                    DUCC UseR template: http://www.aise.eu/reach/documents/DUCC_Use_and_ES_MappingTemplate_revisedFinal15072009.xls
                            M/I and/or M/I-DU Associations => determine strategy




                                                                                                                                   Strictly Controlled |Intermediates
                     Preparation phase
                          Systematic assessment of safe uses (use of Tier1 tool)
                     • Use communication in supply chain letter
                               Map uses and use conditions
                                                           holding




                                                                                                                                                                        Available on Cefic website
                         http://www.cefic.org/Files/Downloads/Cefic-FECC-
                                   Initial ESs, ES titles and Use Descriptors
                         DUCC%20document%20on%20use%20FINAL.doc
for safe uses only




                                                                                         Use and ES
                                                                                           communication                     Yes                                    DU
                                                                                                                   DU
                                                                                                                                                                 Wait for
                     •M/I Guidance on
                           and DU partnership           • and selected DU’s on
                                                        M/I Guidance
                                                                                                              Use covered?
                                                                                                                                                                 final ES
                      via trade associations                                                             No
                           GES process +                     SES process                 • IT tool
                      Generic ES Development                 + templates
                                                        Specific ES development                      or
                                                                                           requirements
                           templates
                          Available on Cefic                 http://cefic.org/files/Do     http://cefic.org/files/Downl       DU
                      • Input of DU Associations         • Input of selected customers             DU
                                                             wnloads/Final_Template        oads/SCC_Functional_Re   • Prepare CSA/CSR
                          website
                      • Development GES library          • Use of Cefic ES template       • Complete feedback
                                                             _09_03_09.xls                 quirements.pdf           • Inform Agency
                                                                                            form
                                                                                          • Await decision M/I




                                         Final Exposure Scenario (M/I)                                           DPD+
                                                                                            ES for preparations,Distribution
                                                                                             Communication to
                                                                                                 direct DU          of e-SDS
                                                                                               Available on Cefic website
Agenda


  Introduction to CSA under REACH

  Exposure Assessment

      Exposure Scenario

      Exposure estimating tools

  Risk Characterisation

  Cefic proposed processes for ES development

  Libraries

  ECHA CSA IT tool for CSR and ES development




                                                 34
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?
• Q4 2009

How?
• Cefic website will be gate to source information
• Cefic website open access, source could be restricted.
                                                     35
Agenda


  Introduction to CSA under REACH

  Exposure Assessment

      Exposure Scenario

      Exposure estimating tools

  Risk Characterisation

  Cefic proposed processes for ES development

  Libraries

  ECHA CSA IT tool for CSR and ES development




                                                 36
ECHA CSA Tool for ES development

Name of tool has changed: Chesar (Chemical Safety
  assessment and reporting)
UCLID 5 plug in
Basic goals
   • Support registrant's CSA process
   • CSR/ES authoring for a substance
Included
   • Supports exposure scenario building based on Tier 1 exposure
     estimates (based on TRA and ERC)
   • Allows to report exposure scenarios built with other exposure
     assessment tools or based on measured data
   • Supports starting from existing (partial) (Generic) Exposure
     Scenarios
   • Provides some flexibility in structure of information sent to
     customers based on what is documented in the CSR

CSA extraction tool + CSA tool should result in complete
  drafting of CSR
ECHA CSA tool for ES development

  Included library for „templates‟
      • Full or partial exposure scenarios + corresponding
        exposure estimates (by different assessment methods)
      • Single determinants of exposure (= OC and RMM)
      • Target group templates (sets of determinants related to
        workers, consumers or environment)
      • Exposure scenario templates


  The Chesar input XML can accept:
  -   GES tables 1 and 2
  -   SES template
  -   DUCC UseR
General purpose of the CSA Tool

What does the Chesar not do?
  • Support information gathering from DUs
  • Hazard assessment
  • PBT assessment
  • Enable running other exposure models
     - Can be done outside Chesar and results
       entered in the tool
Timing CSA tool

Successive Chesar releases:
    • Version 0.5 : early 2009, some basic functionalities
    • Version 1.0: April 2010, complete version for CSR preparation
    • Version 1.x: Q4 2010, ES for eSDS included
The Chesar will be developed as a IUCLID plug-in
• Stand alone and distributed version
• You need IUCLID 5.2 installed to run!

Cefic sees main use of tool after first registration deadline
Useful links
Cefic website:
http://cefic.org/templates/shwPublications.asp?HID=750

DUCC UseR template:
http://www.aise.eu/reach/documents/DUCC_Use_and_ES_MappingTe
   mplate_revisedFinal15072009.xls

Ecetoc TRA:
https://www.ecetoc-tra.org/public/login/index.asp

ECHA:
http://echa.europa.eu/reach/software_en.asp

                        Thank You

                         lhe@cefic.be

								
To top