REACH ES and CSA process

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REACH ES and CSA process
M. Viñas
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Agenda

• Introduction to CSA under REACH
• Exposure Assessment
• Exposure Scenarios
• Cefic proposed processes for ES development
• Libraries
• ECHA CSA IT tool for CSR and ES development
  (Chesar)
• Safety Data Sheets

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Guidance on information requirements and chemical
safety assessment, Guidance for downstream users
29 documents!gt 2000 pages!
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Registration dossier - content
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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 (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.

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

• Exposure Assessment (EA)
• Build Exposure Scenarios
• (RMM and OC)
• Estimate Exposure Level

• Hazard Assessment (HA)
• Hazard Classification
• and PBT conclusion
• Dose/Concentration-Response
• Characterisation

Dangerous or PBT ?
y
n
Risk Characterization (RC)
Stop
Risk controlled?
Iteration
y
n
Document in CSR
Communicate ES via eSDS
Required for all CSAs
Required if substance is dangerous or PBT/vPvB,
or exposure based waiving according to annex XI

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Agenda

• Introduction to CSA under REACH
• Exposure Assessment
• Exposure Scenarios
• Cefic proposed processes for ES development
• Libraries
• ECHA CSA IT tool for CSR and ES development
  (Chesar)
• Safety Data Sheets

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

• Exposure Assessment (EA)
• Build Exposure Scenarios
• (RMM and OC)
• Estimate Exposure Level

• Hazard Assessment (HA)
• Hazard Classification
• and PBT conclusion
• Dose/Concentration-Response
• Characterisation

Dangerous or PBT ?
y
n
Risk Characterization (RC)
Stop
Risk controlled?
Iteration
y
n
Document in CSR
Communicate ES via eSDS
Required for all CSAs
Required if substance is dangerous or PBT/vPvB,
or exposure based waiving according to annex XI

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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.

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What is an Exposure Scenario ?

• A description of safe use including
• Conditions of use
• Risk management measures
• 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

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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 lt 1 t/a
• The downstream uses should also be taken into
  account
• Exposure scenarios need to be developed for all
  identified uses

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Agenda

• Introduction to CSA under REACH
• Exposure Assessment
• Exposure Scenarios
• Cefic proposed processes for ES development
• Libraries
• ECHA CSA IT tool for CSR and ES development
  (Chesar)
• Safety Data Sheets

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ES Development Communication model

• M/I and/or M/I-DU Associations gt 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

M/I Communicate Uses (ES titles, Use
Descriptors) to direct DU for further
communication in the supply chain
Determine strategy collect info
for safe uses only
Use Alignment
DU Wait for final ES
DU Use covered?
Yes

• M/I and DU partnership
• via trade associations
• Generic ES Development
• Input of DU Associations
• Development GES library

• M/I and selected DUs
• Specific ES development
• Input of selected customers
• Use of Cefic ES template

No
or
ES development

• DU
• Prepare CSA/CSR
• Inform Agency

• DU
• Complete feedback form
• Await decision M/I

Communication to direct DU
Distribution of e-SDS
Final Exposure Scenario (M/I)
ES communication
Legend M/I Manufacturer / Importer DU
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.
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Cefic workflow on ES development and
communication

• Development of Exposure Scenarios, using two
  processes
• Generic Exposure Scenario process
• Specific Exposure Scenario process

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ES Development Communication model
M/I Communicate Uses (ES titles, Use
Descriptors) to direct DU for further
communication in the supply chain
DU Wait for final ES
DU Use covered?
Yes
No
or

• DU
• Prepare CSA/CSR
• Inform Agency

• DU
• Complete feedback form
• Await decision M/I

Communication to direct DU
Distribution of e-SDS
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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

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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

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How is GES developed?
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Benefits of Generic Exposure Scenarios?

• Developed in partnership between M/Is and DU
  representatives
• Relevance of the information for DUs.
• Starting position is verification of the utility
  of existing practice
• no surprises business as usual
• Aim for consistency in communication within and
  across supply chains
• Together with simplicity and understandability
• Level of detail aligned with DU needs
• Minimising unnecessary supply chain
  communications
• Starting assumption is what is communicated is
  relevant and useful
• GES format designed to be useful without need for
  further DU re-work

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Cefic workflow on ES development and
communication

• Development of Exposure Scenarios, using two
  processes
• Generic Exposure Scenario process
• Specific Exposure Scenario process

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ES Development Communication model
M/I Communicate Uses (ES titles, Use
Descriptors) to direct DU for further
communication in the supply chain
DU Wait for final ES
DU Use covered?
Yes
No
or

• DU
• Prepare CSA/CSR
• Inform Agency

• DU
• Complete feedback form
• Await decision M/I

Communication to direct DU
Distribution of e-SDS
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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

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Cefic SES template dialogue
Available on Cefic website. Please consult
regularly for updates
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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

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How are SESs developed?
SES process stepwise approach, initiated by M/I
in dialogue with DU
1. Inhouse collection of information on uses
and use conditions
5. Evaluation of draft SESs in the
CSA Aggregation into final SESs
2. Development of initial SESs (use of SES
dialogue template)?
6. Documentation of SESs in Chemical Safety Report
3. Dialogue with selected customers (feedback,
using SES dialogue template)?
7. Transformation of SES for substance to ES for
product (annex SDS)?
4. Development of draft SESs (based on input by
customers)?
8. Communication of ES to direct DU customers
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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

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Selecting the Approach
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Available tools on Cefic web

• 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

Strictly Controlled Intermediates
M/I and/or M/I-DU Associations gt 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

• Preparation phase
• Use communication holding letter

for safe uses only
DU Wait for final ES
DU Use covered?
Yes

• Guidance on SES process templates

• Guidance on GES process templates

• M/I and DU partnership
• via trade associations
• Generic ES Development
• Input of DU Associations
• Development GES library

• M/I and selected DUs
• Specific ES development
• Input of selected customers
• Use of Cefic ES template

No
or

• DU
• Prepare CSA/CSR
• Inform Agency

• DU
• Complete feedback form
• Await decision M/I

ES for preparations, DPD
Communication to direct DU
Distribution of e-SDS
Final Exposure Scenario (M/I)?
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Agenda

• Introduction to CSA under REACH
• Exposure Assessment
• Exposure Scenarios
• Cefic proposed processes for ES development
• Libraries
• ECHA CSA IT tool for CSR and ES development
  (Chesar)
• Safety Data Sheets

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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?
• Q1 2010
• Where?
• http//cefic.be/en/reach-for-industries-libraries.
  html

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Agenda

• Introduction to CSA under REACH
• Exposure Assessment
• Exposure Scenarios
• Cefic proposed processes for ES development
• Libraries
• ECHA CSA IT tool for CSR and ES development
  (Chesar)
• Safety Data Sheets

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ECHA CSA Tool for ES development

• Name of tool has changed Chesar (Chemical Safety
  assessment and reporting tool)
• IUCLID 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

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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

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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

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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

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Agenda

• Introduction to CSA under REACH
• Exposure Assessment
• Exposure Scenarios
• Cefic proposed processes for ES development
• Libraries
• ECHA CSA IT tool for CSR and ES development
  (Chesar)
• Safety Data Sheets

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Safety Data Sheet (SDS)

• The purpose of the SDS is to provide the user
  with
• necessary measures relating to protection of
  human health and environment
• information to convey down the supply chain when
  they are not final user (i.e. to compile the SDS
  for their own mixtures)
• Format of the SDS
• The SDS follows a 16 section format which is
  internationally agreed.
• The SDS must be in the language of the country in
  which it is placed on the market.

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Safety Data Sheet (SDS)

• When is a SDS required?
• Article 31 suppliers need to provide SDS for
  substances and mixtures if
• Classified
• PBT or vPvB
• Candidate list
• On request of recipient SDS also for mixtures
  not classified as dangerous but containing SVHC
  or substances limited on workplace

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Safety Data Sheet (SDS)

• When is a SDS not required?
• For general public, but sufficient info to be
  provided on safe use
• For articles, but if SVHC gt 0.1 , communication
  on safe use to be provided if requested
• It is common practice in industry to provide SDS
  for non-classified products on voluntary basis.

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Safety Data Sheet (SDS)

• Communication down the supply chain when no SDS
  is required
• If a SDS is not required, the M/I shall
  communicate key risk information to enable
  appropriate risk management
• If Substance is subject to Authorisation/restricti
  on
• Registration number
• Details of granted authorisation or appropriate
  info if authorisation is denied
• Details of restriction
• Other available and relevant info on safe use
• If Substance is not subject to Authorisation/Restr
  iction
• Registration number
• Available and relevant info to assure appropriate
  RMM

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Safety Data Sheet (SDS)

• What is new in REACH?
• Inversion chapters 2 3
• Email of competent person
• Information consistent with registration dossier
• Registration number
• Exposure Scenarios (e-SDS)

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Safety Data Sheet (SDS)

• What is new in CLP/GHS?
• More, and more precise information in SDS.
• Format new sub-headings!
• Transitional periods
•  Old EU  classification in SDS until 1 June
  2015
• CLP classification can be included on voluntary
  basis for mixtures
• Labeling information in section 2
• Guidance on SDS under development (foreseen
  publication in summer 2010)

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Useful links
Cefic website http//cefic.org/templates/shwPubli
cations.asp?HID750 DUCC UseR template http//ww
w.aise.eu/reach/documents/DUCC_Use_and_ES_MappingT
emplate_revisedFinal15072009.xls Ecetoc
TRA https//www.ecetoc-tra.org/public/login/index
.asp ECHA http//echa.europa.eu/reach/software_e
n.asp Thank you for your attention! mvi_at_cefic.b
e