View
212
Download
0
Category
Preview:
Citation preview
ES and CSA process
M. Viñas
2
Agenda
Introduction
Cefic proposed processes for ES development
•
Generic Exposure Scenarios
•
Specific Exposure Scenarios
Libraries
3
Guidance on information requirements and chemical safety assessment, Guidance for downstream users
29 documents!
> 2000 pages!
Substance to be registered
> 10 tonne/year
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
Chemical Safety Report•Hazard and PBT AssessmentAlso
Chemical Safety Report•Hazard and PBT Assessment•Exposure Assessment
•Exposure Scenarios•Exposure Estimation
•Risk CharacterisationAlso
Substance dangerousor PBT/vPvB
Registration dossier - content
5
Agenda
Introduction
Cefic proposed processes for ES development
•
Generic Exposure Scenarios
•
Specific Exposure Scenarios
Libraries
ES Development & Communication model
LegendM/I = Manufacturer / ImporterDU = 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.
M/I and DU partnershipvia trade associations
Generic ES Development
•
Input of DU Associations•
Development GES library
M/I and selected DU’s
Specific ES development
•
Input of selected customers•
Use of Cefic ES template
DUWait forfinal ES
M/ICommunicate Uses (ES titles, Use Descriptors)
to direct DU for further communicationin the supply chain
DUUse covered?
DU•
Complete feedback
form•
Await decision M/I
Final Exposure Scenario (M/I)
DU•
Prepare CSA/CSR•
Inform Agency
No
Yes
or
M/I and/or M/I‐DU Associations => determine strategy
Systematic assessment of safe uses (use of Tier1 tool)
Map uses and use conditions in supply chain
Initial ESs, ES titles and Use Descriptors
Communication to
direct DUDistributionof e‐SDS
for s
afe
uses
onl
y
7
Agenda
Introduction
Cefic proposed processes for ES development
•
Generic Exposure Scenarios
•
Specific Exposure Scenarios
Libraries
8
ES Development & Communication model
DUWait forfinal ES
M/ICommunicate Uses (ES titles, Use Descriptors)
to direct DU for further communicationin the supply chain
DUUse covered?
DU•
Complete feedback
form•
Await decision M/I
DU•
Prepare CSA/CSR•
Inform Agency
No
Yes
or
Communication to
direct DUDistributionof e‐SDS
LegendM/I = Manufacturer / ImporterDU = 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.
M/I and DU partnershipvia trade associations
Generic ES Development
•
Input of DU Associations•
Development GES library
M/I and selected DU’s
Specific ES development
•
Input of selected
customers•
Use of Cefic ES template
Final Exposure Scenario (M/I)
M/I and/or M/I‐DU Associations => determine strategy
Systematic assessment of safe uses (use of Tier1 tool)
Map uses and use conditions in supply chain
Initial ESs, ES titles and Use Descriptors
for s
afe
uses
onl
y
Generic Exposure Scenarios (GES)
• 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
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 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 10
Map the supply chain to compile an inventory of Uses together with likely
circumstances of handling
M/I obtains from internal product stewardship/technical activities; dialogue with representative trade groups (using a pre-populated template)
Characterise typical RMMsand OCs for the intended
uses
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
As #1 Above
Use ECETOC TRA for human health and EUSES for environmental risks
RMMs communicated reflect, at a minimum, typical practice for the application and enable alignment with language/jargon for the sector
Refer to other sources of RMM efficiencies for the application/sector if these need to be confirmed e.g. COSHH Essentials, BREF documents
Under what circumstances are the advocated RMMs reliable?
1
2
3
4
5
6
M/I selects relevant GES for substance registration
7
M/I matches the specific ES to the M/I product names
M/I matches the substance-specific ES to the relevant M/I product names for communication to customers
8
How is GES developed?
For associationsTemplates available!
For M/I11
13
Agenda
Introduction
Cefic proposed processes for ES development
•
Generic Exposure Scenarios
•
Specific Exposure Scenarios
Libraries
14
ES Development & Communication model
DUWait forfinal ES
M/ICommunicate Uses (ES titles, Use Descriptors)
to direct DU for further communicationin the supply chain
DUUse covered?
DU•
Complete feedback
form•
Await decision M/I
DU•
Prepare CSA/CSR•
Inform Agency
No
Yes
or
Communication to
direct DUDistributionof e‐SDS
LegendM/I = Manufacturer / ImporterDU = 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.
M/I and DU partnershipvia trade associations
Generic ES Development
•
Input of DU Associations•
Development GES library
M/I and selected DU’s
Specific ES development
•
Input of selected
customers•
Use of Cefic ES template
Final Exposure Scenario (M/I)
M/I and/or M/I‐DU Associations => determine strategy
Systematic assessment of safe uses (use of Tier1 tool)
Map uses and use conditions in supply chain
Initial ESs, ES titles and Use Descriptors
for s
afe
uses
onl
y
15
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
16
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 in line with the final version of the ECETOC TRA tool
17
How the dialogue template works1. M/I selects appropriate template:
combined/worker/consumer
2. M/I fills in the use and use informationfrom the drop-downs in the yellow column
3. DU reviews the informationproposed by the M/I
4. Combination ofuse descriptors reflect
DU use?
4.1. DU fills in deviations from the conditionsof use and/or RMMs in the blue column,
where applicable
4.2. DU completely fills in new (orange)column to identify a new useNO
YES
18
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
19
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 0 1 10.1 Product name as it appears on SDS General Solvent
1 Short title exposure scenario1.1 Internal name1.2 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 Not Applicable
1.4 Process Category(ies) Selection (preferably use descriptors from dropdown list without an *)
0
1.5 Article Category(ies). Selection1.6 Environmental Release
Category(ies)Selection 0
If the M/I wants to limit the use of the General Solvent to
professional / industrial uses, he can use the dropdown
selection from short list and select “ALL except SU 21
private households ”
20
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
21
Features: Dropdown’s with predefined selection
Example of dropdown of PROC’s
22
Identification of Process Categories
By selecting PROC10, the worker exposure can be linked to ECETOC TRA exposure prediction models,
Process Categories are relevant for worker
exposure assessment and worker risk
management measures
This field should not be changed by t
DU in his feedback as it would be confusing. A new PROC needs a
separate column
23
Identification of Article CategoriesIn the next step, the M/I wants to
limit the use of the General Solvent for using in the production of the
following article categoriesAC 3-1 Electrical and electronic products, e.g. computers, office equipment, video and audio recording, communication equipment
24
Identification of Environmental Release Categories
In the next step, the M/I specifies the Environmental Release Category for
which the General Solvent can be used ERC2 Formulation of preparations
This field should also not be changed by the DU in his feedback
25
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
26
Inserting a 2nd
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
27
The DU worker exposure exceeds 4 hours
The DU has no LEV in placeThe M/I needs to consider the deviations in worker exposure duration and
RMM in place; M/I might reject
The consequence for the DU might be the need to re-
organise work (e.g. limitation
to 4 hours exposure)
The dialogue –
feedback from DU on operational conditions
28
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
29
How are SESs developed?
SES process: stepwise approach, initiated by M/I in dialogue with DU
1. Inhouse collection of informationon uses and use conditions
2. Development of initial SESs (use of SES dialogue template)
3. Dialogue with selected customers(feedback, using SES dialogue template)
4. Development of draft SESs(based on input by customers)
5. Evaluation of draft SESs in the CSAAggregation into final SESs
8. Communication of ESto direct DU customers
7. Transformation of SES for substanceto ES for product (annex SDS)
6. Documentation of SESsin Chemical Safety Report
30
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
Single substance with specific or general applications
Groups of substances with similar applications
May have limited knowledge of substance handling in the supply chain by M/I
Assumes some knowledge of substance handling by M/I
Limited supply chain Dispersive application
Specialised Uses, e.g. fine chemicals
Common Uses, e.g. commodity chemicals
M/I and Key customer iteration M/I and DU Partnership via Trade Associations
Main FocusMain Focus
Specific ES approachGeneric ES approach
Selecting the Approach
Available tools on Cefic web
M/I and DU partnershipvia trade associations
Generic ES Development
•
Input of DU Associations•
Development GES library
M/I and selected DU’s
Specific ES development
•
Input of selected customers•
Use of Cefic ES template
DUWait forfinal ES
DUUse covered?
DU•
Complete feedback
form•
Await decision M/I
Final Exposure Scenario (M/I)
DU•
Prepare CSA/CSR•
Inform Agency
No
Yes
or
M/I and/or M/I‐DU Associations => determine strategy
Systematic assessment of safe uses (use of Tier1 tool)
Map uses and use conditions in supply chain
Initial ESs, ES titles and Use Descriptors
Communication to
direct DUDistributionof e‐SDS
•
Newsletter: guidance on Use and ES development and Supply Chain Communication VCI Practical guide CSR eSDS
•
DUCC UseR template:
Use and ES communication
•
IT tool requirements
•
Guidance on GES process + templates
•
Guidance on SES process + template
Preparation phase•
Use communication standard reply
Stric
tly C
ontr
olle
d |In
term
edia
tes
ES for preparations, DPD+
33
Agenda
Introduction
Cefic proposed processes for ES development
•
Generic Exposure Scenarios
•
Specific Exposure Scenarios
Libraries
Cefic libraries TF
34
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?http://cefic.be/en/reach-for-industries-libraries.html
Cefic libraries TF: overview
35
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…http://cefic.be/en/reach-for-industries-libraries.html
Cefic libraries TF: use mappings
36
User of Cefic libraryEntry field: CEPE
Database in Cefic server
List of Links:Manuf of powder and coatings:http://cepe-myeteam.eudata.be/EPUB//easnet.dll/GetDoc?APPL=1&DAT_IM=1022AE&DWNLD=ajns0163b - descriptors of use -coatings and inks manufacture (powder products).xls
Manuf of other coatings:http://cepe-myeteam.eudata.be/EPUB//easnet.dll/GetDoc?APPL=1&DAT_IM=1022AC&DWNLD=ajns0162b - descriptors of use -coatings and inks manufacture (all, except for powder products).xls
Industrial application of coatings:http://cepe-myeteam.eudata.be/EPUB//easnet.dll/GetDoc?APPL=1&DAT_IM=101DC5&DWNLD=ajns0164final - descriptors of use -coatings and inks application (industrial).xls
Professional application of coatings:http://cepe-myeteam.eudata.be/EPUB//easnet.dll/GetDoc?APPL=1&DAT_IM=101DC7&DWNLD=ajns0165afinal - descriptors of use - coatings and inks application (professional).xls
E.g.
Cefic libraries TF: use mappings
37Use mapping library soon available!
Download from Associations’ websites the excel file
Reduced list of Links:Manuf of powder and coatings:http://cepe-
myeteam.eudata.be/EPUB//easnet.dll/GetDoc?APPL=1&DAT_IM=1022
AE&DWNLD=ajns0163b -
descriptors of use -
coatings and inks manufacture (powder products).xls
Manuf of other coatings:http://cepe-
myeteam.eudata.be/EPUB//easnet.dll/GetDoc?APPL=1&DAT_IM=1022
AC&DWNLD=ajns0162b -
descriptors of use -
coatings and inks manufacture (all, except for powder products).xls
Merge information into a single tableUpload to company’s
supply chain communication tool
Or upload to Chesar or other assessment tool (manual / XML if available)
Cefic libraries TF: Standard phrases
38
Cefic is
working
in cooperation
with
BDI/BusinessEuropein order
to make
available
a catalogue of standard phrases
to be
used
in the preparation
of ES.
• Current
version available
at:www.euphrac.eu
• Both
general
and sector-specific
phrases
• It will
be
regularly
updated
•
It is
foreseen
that
Chesar
will
allow
to work
with downloaded
catalogue
Abbreviations
39
•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
Useful links
Cefic website:http://cefic.org/templates/shwPublications.asp?HID=750
DUCC UseR
template:http://www.aise.eu/reach/documents/DUCC_Use_and_E
S_MappingTemplate_revisedFinal15072009.xls
Ecetoc
TRA:https://www.ecetoc-tra.org/public/login/index.asp
ECHA:http://echa.europa.eu/reach/software_en.asp
Thank you for your attention!
Recommended