REACHing Forward A look at SUMI, LCID and ESCOM XML
REACHing ForwardA look at SUMI, LCID and ESCOM XML
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Topics Covered
• Safe Use Information
• LCID
• SUMI
• ESCom
From 12 pages to 100 pages
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Who is responsible for what?
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Manufacturer/Importer
•Register Substances
•Create Chemical Safety Report (CSR)
•CSR to Contain Exposure Scenarios (ES)
Formulators
•Must communicate Safe Use Information for the particular uses of their materials.
End User
•Consumer of Safe Use Information
Who is responsible for what?
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Manufacturer/Importer
•Register Substances
•Create Chemical Safety report (CSR)
•CSR to Contain Exposure Scenarios (ES)
Formulators
•Must communicate Safe Use Information for the particular uses of their materials.
End User
•Consumer of Safe Use Information
Extended Safety
Data Sheet
Safety Data
Sheet + Safe
Use Information
What to do…
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Formulators
• Must communicate Safe Use Information for the particular uses of their materials.
End User
• Consumer of Safe Use Information
Safety Data
Sheet + Safe
Use Information
How to communicate Safe Use Information?
Reviewing the tools of the trade
Taking Inventory of the toolbox
• Existing tools:
• REACH compliant SDS
• Hazard label (CLP)
• Extended-SDS (substance) – Exposure Scenario (ES)
• New tools:
• LCID (Lead Component Identification)
• SUMI (Safe Use Mixture Information) – “Exposure Scenario” for mixtures
• ESCOM / SDSCOM XML (electronic exchange of ES / SDS)
Reviewing the tools of the trade
Taking Inventory of the toolbox
• Existing tools:
• REACH compliant SDS
• Hazard label (CLP)
• Extended-SDS (substance) – Exposure Scenario (ES)
• New tools:
• LCID (Lead Chemical Identification)
• SUMI (Safe Use Mixture Information) – “Exposure Scenario” for mixtures
• ESCOM / SDSCOM XML (electronic exchange of ES / SDS)
Different Approaches
Two approaches have been proposed:
• “Top Down” or Lead Component Identification (LCID)
• The “top-down” approach is based on the information from those substances that are contributing to
the exposure for each end-use. As safe use information is being compiled for the most hazardous
substances, it is expected that exposure to substances with lesser hazards will be covered as well.
• “Bottom Up” or Safe Use Mixture Information (SUMI)
• The “bottom-up” approach is focused on understanding the end-use of the mixture for a specific
industry sector. In this approach it is expected that industry sectors develop safe use information
based on both the use and the characteristics of the mixture.
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Making it understandable
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REACH
SUMILCID
SWEDSpERC
OC
PROCRMM
DNEL
PNEC
CSA
CSR
The LCID Process
Hazard Type Append to SDS
Health Hazards
Environmental Hazards
Priority Substances
Lead Components
Local effect classifications
Ozone Depletion
Safe use information
Evaluate Components
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The LCID Process
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Evaluating Components
• Identify priority substances
• Carcinogen – Category 1A/1B
• Mutagen – Category 1A/1B
• PBT
• vPvB
• Identify lead components
• Substances with health
or environmental hazards
Priority Substances
Lead Components
Local effect classifications
Ozone Depletion
• Additional substances
• Local effect
classifications
• Ozone depletion
The LCID Process
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Looking at the specific Hazard Types
• Health
• Determine Operating Conditions
(OC)
• Determine the Risk Management
Measures (RMMs)
• Environmental
• Determine Operating Conditions
(OC)
• Determine the Risk Management
Measures (RMMs)
Hazard Type
Health Hazards
Environmental
Hazards
Priority Substances
Lead Component
s
Local effect classifications
Ozone Depletion
Evaluate Components
The LCID Process
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Adding Safe Use Information to the SDS
• Ensure that the OCs and RMMs for the Lead and Priority substances will also cover
other substances in the composition
• Ensure other hazards which do not result in classification are also covered by the
OCs and RMMs
• Information can be either embedded into the SDS, or
• Appended as a separate document
Hazard Type Append to SDS
Health Hazards
Environmental Hazards
Priority Substances
Lead Components
Local effect classifications
Ozone Depletion
Safe use information
Evaluate Components
The SUMI Process
Verification Check Append to SDS
SWEDLead
Component ES
Use Descriptors
Contributing Activity
Additional Information
SUMI
Sector Use Map
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The SUMI Process
What is a Sector Use Map?
• Sector use maps contain the following information:
• Use name
• Use descriptors (Sector of End Use (SU), Process Category (PROC), etc.) Contributing
activities
• Market information
• Other additional information that may be relevant to the assignment of the SWED
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SWED
Use Descriptors
Contributing Activity
Additional Information
Sector Use Map
The SUMI Process
What is a Sector-Specific Worker Exposure Description (SWED)?
• Describes the use conditions for a mixture
• Includes the Operational Conditions (OC) and Risk Management Measures (RMM), as well as other qualitative values such as maximum concentration for relevant substances, minimum tolerable DNELs, etc.
• The SWED is the input information for the Chemical Safety Assessment (CSA) –Worker Exposure.
• The information is dependent on the industry sector.
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SWED
Use Descriptors
Contributing Activity
Additional Information
CSA
The SUMI Process
How do we determine the appropriate SWED?
• Determine the end use of your mixture
• Within the sector use map find:
• Applicable end use
• Contribution activities
• Use descriptors
• Identify the associated SWED (Alpha-Numeric Number)
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SWED
Use Descriptors
Contributing Activity
Additional Information
The SUMI Process
Verification Check
SWEDLead
Component ES
Use Descriptors
Contributing Activity
Additional Information
Sector Use Map
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Verification Check
• Verify that the Operational Conditions (OC) and Risk Management Measures
(RMM) are consistent with the information in the Lead Component Exposure
Scenario
• Verify that the Lead Component DNELs are greater than the minimal tolerable
DNEL
The SUMI Process
How SWED information is connected:
• The registrant includes the SWED on the Exposure Scenario,
• The Formulator validates that the end-use of their mixture is aligned with the
SWED of their substances.
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SWED
Use Descriptors
Contributing Activity
Additional Information
CSA
ES
The SUMI Process
Verification Check Append to SDS
SWEDLead
Component ES
Use Descriptors
Contributing Activity
Additional Information
SUMI
Sector Use Map
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Choosing the SUMI
• The SWED is assigned to a SUMI
• There is only one SUMI per SWED
• There may be more than one SUMI per SDS depending on uses
The SUMI Process
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The SUMI Process
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Reviewing the tools of the trade
Taking Inventory of the toolbox
• Existing tools:
• REACH compliant SDS
• Hazard label (CLP)
• Extended-SDS (substance) – Exposure Scenario (ES)
• New tools:
• SUMI (Safe Use Mixture Information) – “Exposure Scenario” for mixtures
• LCID (Lead Chemical Identification)
• ESCOM / SDSCOM XML (electronic exchange of ES / SDS)
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CSR/ES Roadmap (ECHA-Industry)
Supply chain communication
ESCom
What is the ESCom Package?
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• ESCom XML standard:
▪ An IT communication standard to
harmonize ES data exchange
between computer systems in the
supply chain
▪ Developed by IT providers in
consultation with industry
• ESCom Phrase Catalogue:
▪ A catalogue with standard phrases for
ESs for communication
▪ Developed by industry sectors,
associations and companies
ESCom = Exposure Scenario for Communication
ESCom Phrases Catalogue
• Portion of the EuPhraC voluntary standard (http://www.euphrac.eu)
• Consists of Standard phrases for Exposure Scenarios
• Phrases <codified> with a unique identifier to facilitate data exchange
• Available in English and German
• Living standard
• Version 1.1 (May 2011)
• Now on version 2.3
• Free to use
• Maintained by Cefic and DUCC
• Extensive Guidance on creation, submission and usage of EuPhraC and
ESCom phrases (http://www.cefic.org/Documents/IndustrySupport/REACH-
Implementation/ESCom-Project/Euphrac-ESCom-phrase%20guidance-on-
creation-submission-usage-of%20EuPhraC-ESCom-Phrases-2.2.pdf)
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ESCom Package – current status
How many ESCom XMLs have been sent and received between companies so far?
Adoption
• ESCOM Phrases available in many IT systems
• ECHAs’ Chesar 3.1, released in November 2016, supports the creation of
Exposure Scenarios aligned with the ESComXML format
• ESComXML implemented in some IT Systems
• The IT perspective
• Tools available (ESCom XML, ESCom phrases)
• Implemented in internal systems
• Benefit recognized, however
• Explicit customer demand required
• The industry perspective
• Benefit recognized, however
• Currently no partner to exchange XMLs with
• Illustrative business case (including financial advantages) missing
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Why?
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Questions?