GPS information requirements and how to transfer a REACH dossier into GPS

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GPS information requirements and how to transfer
a REACH dossier into GPS

• From REACH to Global Product Strategy (GPS) and
  Product Stewardship (PS) workshop.
• 03 and 04 Dec 2009
• Zagreb, Croatia

L. Heezen Cefic
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Content

• GPS Base set of information
• How to allocate a substance to a specific tier of
  the base set
• Triggers for additional requirements
• REACH information requirements versus GPS
• What to do when you register under REACH
• Information / Data Exchange under GPS

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Base set of Information Standard parameters
for all substances

• Substance Identity
• CAS Number(s)
• Name(s)
• Structural Formula
• Composition being assessed
• Use Pattern (categories types)
• Sources of Exposure

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4 December 2008
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Content

• GPS Base set of information
• How to allocate a substance to a specific tier of
  the base set
• Triggers for additional requirements
• REACH information requirements versus GPS
• What to do when you register under REACH
• Information / Data Exchange under GPS

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Base Set of Information - Final toxicological
data requirements

• Standard Parameters
• Identity
• Phys-Chem
• Tox / Ecotoxicity (accidental exposure)
• Biodegradability

Tier 2 (e.g low exposure or low hazard potential)
Irritation (Eye / Skin) Mutagenicity (Ames)
Sensitization (Structure)
Irritation (Eye / Skin) Sub acute
(28-days) Mutagenicity (Ames) Sensitization
Tier 3 (e.g medium exposure or hazard potential)
Tier 1 - 4
Irritation (Eye / Skin) Sub acute
(28-days) Mutagenicity Sensitization Repro /
Develop toxicity
Tier 4 (e.g high exposure or high hazard
potential)
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Base Set of Information -Final
ecotoxicological data requirements

• Standard Parameters
• Identity
• Phys-Chem
• Tox / Ecotoxicity (accidental exposure)
• Biodegradability

Tier 2 (e.g low exposure or low hazard potential)
Acute Toxicity (most sensitive species)
Acute Toxicity (Fish) Acute Toxicity (Daphnia)
Acute Toxicity (Algae)
Tier 3 (e.g medium exposure or hazard potential)
Tier 1 - 4
Acute Toxicity (Fish) Acute Toxicity (Daphnia)
Acute Toxicity (Algae) Chronic toxicity
Tier 4 (e.g high exposure or high hazard
potential)
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Hazard Identification - Human and environmental

• Collect information on physical-chemical
  properties (e.g. ignition temperature, boiling
  point)
• Evaluate human health hazard potential as
  required by the allocated tier of the base set
  (e.g. acute Toxicity, eye / skin irritation,
  genotoxicity, reproductive and developmental
  toxicity)
• Characterize environmental hazard potential as
  required by the allocated tier of the base set
  (e.g. degradation/biodegradation, acute aquatic
  toxicity, chronic toxicity)

GPS is not intended as a program to generate new
data. Before conducting any new testing, all
available relevant hazard and exposure
information should first be collected and
assessed (leverage information from regulatory
programs e.g. REACH)
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GPS Risk Assessment Process How to conduct the
risk characterization

• Hazard Evaluation Identify adverse health and
  environmental effects (e.g. the severity, the
  dose-response curve, etc.)
• Exposure Evaluation - Consider exposures to
  humans and the environment from the production,
  distribution, use, and disposal or recycling of a
  chemical including
• Risk Characterization Decision Point
  Characterize the risk and if information is
  sufficient proceed to next step (management), if
  insufficient information additional data may be
  needed.
• Documentation of the risk assessment - Process
  can be documented as MSDS, eSDS, CSR, etc. Final
  output of GPS is a summary of relevant risk
  characterization / management information for
  communication with the public (GPS Safety
  Summary)

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Examples of Risk Management Measures

• As a result of the risk assessment certain risk
  reduction measures might be necessary, they may
  include, but are not limited to
• Risk management actions specified by regulations
• Reduce exposure, limiting certain uses or
  specific markets
• Qualifying and training customers
• Changing physical form or dosage unit size to
  reduce exposure potential
• Implementing engineering controls (e.g. exhaust
  ventilation)
• Utilizing specific personal protective equipment

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Content

• GPS Base set of information
• How to allocate a substance to a specific tier of
  the base set
• Triggers for additional requirements
• REACH information requirements versus GPS
• What to do when you register under REACH
• Information / Data Exchange under GPS

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Exceeding the Base Set of Information Triggers
for additional information requirements

• To avoid unnecessary duplication of work and
  possible needless use of animals for testing, it
  is important that all existing available relevant
  data be located and reviewed before proceeding.
• The guidance illustrate the decision trees used
  to determine what additional hazard information
  is potentially triggered beyond the initial base
  set of information might be required.
• Trigger decisions are based on the hazard potency
  of a substance as well as the potential for human
  exposure e.g. possible anti-androgenic /
  estrogenic activity, cancerogenicity, etc.
• The guidance contains specific flowcharts that
  help users to evaluate whether there is need for
  additional information beyond the scope of the
  base set

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Content

• GPS Base set of information
• How to allocate a substance to a specific tier of
  the base set
• Triggers for additional requirements
• REACH information requirements versus GPS
• What to do when you register under REACH
• Information / Data Exchange under GPS

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REACH information requirements and CPH
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CEFIC Analysis GPS versus REACH

• REACH information requirements cover almost 100
  CPH requirements
• Lower volumes and high tier exposure under CPH
  will require small additional info gt REACH
• However under these conditions a responsible
  company would generate this info anyway
• Strictly controlled intermediates under REACH
  will compare with tier 1 CPH requirement
  Conclusion
• If a company has prepared a solid REACH dossier,
  no additional information is required besides a
  short GPS Safety Summary

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Content

• GPS Base set of information
• How to allocate a substance to a specific tier of
  the base set
• Triggers for additional requirements
• REACH information requirements versus GPS
• What to do when you register under REACH
• Information / Data Exchange under GPS

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Does REACH fulfill the GPS objectives -
Synergies and differences

• Safety-based assessment of substances, not driven
  by quantities
• Sharing of relevant information for safety
  assessment and management without cost
  compensation
• Communication and transparency beyond technical
  information, relevant information need to be
  accessible to stakeholders and public (e.g.
  Product Safety Summary).
• GPS covers the global portfolio of companies
• GPS will leverage existing regulatory commitments
  and voluntary programs as global industry
  contribution

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GPS Risk Assessment - Synergies with REACH
Implementation

• GPS implementation for European companies will be
  analogous to their REACH work, dossiers prepared
  under REACH are leveraged / fully valid for GPS
• Data requirements under REACH exceed in many
  cases the commitments under GPS, European
  companies by complying to REACH exceed GPS
  performance without duplication of efforts
• Existing prioritization processes already
  implemented within companies will not be affected
  and any prioritization of substances will be
  applied in light of the existing regulations
  (e.g. REACH, ChAMP, etc.) in a region.
• Conclusion A significant additional burden for
  European companies due to GPS is not to be
  expected. Existing national regulations fit well
  into the global target of GPS

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GPS Information Exchange Additional work
compared to REACH

• Final output of the assessment is the GPS Safety
  Summary
• We will provide best practice recommendation on
  the European format of the GPS Safety Summary to
  minimize extra workload for EU companies e.g.
  analog to eSDS
• We will start a project to translate the standard
  REACH phrases into lay term language GPS
  sentences for automated generation
• The GPS Safety Summary is a valuable tool for
  emergency responses and to improve communication
  with customers and the general public
• Company-specific GPS Website to exchange
  information
• In order to reduce the burden, we will develop an
  GPS standard web template available at the ICCA
  IT portal companies without corporate website
  can link the GPS specific information directly to
  the template

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What should a REACH company do for ICCA GPS?

• Priority of dossier creation will follow REACH
  priorities
• Once REACH dossier is ready, a GPS safety summary
  can be prepared
• Non-confidential part of REACH dossier can be
  used for hazard and risk communication
• Public communication
• Company strategy is to make REACH information
  available via ICCA GPS program, one of your key
  strategic elements
• Prepare your website for ICCA GPS communication

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Content

• GPS Base set of information
• How to allocate a substance to a specific tier of
  the base set
• Triggers for additional requirements
• REACH information requirements versus GPS
• What to do when you register under REACH
• Information / Data Exchange under GPS

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How to share information and / or data ?

• Global GPS IT-Portal
• Information on a substance collected solely for
  risk assessment / management purposes will be
  shared among co-producers with no cost
  compensation
• Data on a substance used to obtain a valid
  government registration would qualify for a
  simplified cost compensation scheme based on
  fixed prices for several types of tests and
  studies .
• Fixed cost categories are a best practice
  recommendation for companies under GPS. Existing
  cost sharing agreements (e.g. HPV or REACH
  consortia) should be maintained as such.

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Central Global Source of Information -Access
via web based portal
e.g Company, Association, Public Server
Web-Portal
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Central Global Source of Information -Links to
company websites
Open Access (Phase 1)

Link to
OECD SIDS Dossiers ICCA HPV Dossiers EU Risk
Assessments Other Sources
e.g. ICCA Website
Click on
GPS Substance Inventory
Search for EINECS / CAS / Substance

• Substance- specific Information
• GPS Safety Summary
• Robust Study Summaries
• eSDS
• other formats, etc.

Link to
or contact info