REACHing ForwardThe SUMI Process Verification Check Append to SDS SWED Lead Component ES Use Descriptors Contributing Activity Additional Information SUMI Sector Use Map ©2016 Sphera

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)



• Existing tools:




• New tools:

• LCID (Lead Chemical Identification)



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


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


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


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



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



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



The SUMI Process

Verification Check

SWEDLead

Component ES

Use Descriptors



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



CSA

ES

The SUMI Process

Verification Check Append to SDS

SWEDLead

Component ES

Use Descriptors



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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• Existing tools:




• New tools:


• LCID (Lead Chemical Identification)


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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)

http://www.euphrac.eu/

http://www.cefic.org/Documents/IndustrySupport/REACH-Implementation/ESCom-Project/Euphrac-ESCom-phrase guidance-on-creation-submission-usage-of EuPhraC-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?