What has to be done to get to GPS implementation in practice when you have no REACH registration dos

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What has to be done to get to GPS implementation
in practice when you have no REACH registration
dossier?

• Dr. Stefan Berg, BASF SE, Ludwigshafen, Germany
• From REACH to Global Product Strategy (GPS) and
• Product Stewardship (PS) Workshop
• 03 04 Dec 2009
• Zagreb, Croatia

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Outline of the presentation

• How to prioritize chemicals under GPS
• GPS tiered risk characterization
• How to conduct the risk characterization
• GPS safety summary

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Chemicals under GPS and regulatory systems

• GPS (Global Product Strategy) Chemicals
  Substances
• Products can be (pure) substances or mixtures of
  substances
• First you need an inventory of all substances in
  your products
• Many developed and some developing countries
  resp. regions (US, CA, EU, CH, JP, KR, CN, PH,
  AU, NZ) have a regulatory substance inventory.
• Substances in products must be listed on these
  substance inventories before you can place your
  products on the market.
• TR (Turkey) presently is setting up a substance
  inventory (by 2010)
• TW (Taiwan) plans to set up a substance inventory
  by 2010/2011

AU Australia CN (Peoples Republic of) China
NZ New Zealand CA Canada EU European
Union PH Philippines CH Switzerland JP
Japan US United States of America KR
(South) Korea
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Prioritization Process under GPS Factors /
criteria to be considered

• Do you already have prioritization processes in
  your company? For instance due to
• own company Product Stewardship programs or
• national or regional regulations (e. g. REACH,
  ChAMP)
• ? No need to change these prioritization
  processes
• In case no prioritization process exists Use
  the factors offered by the GPS Guidance document
  to categorize chemicals into
• High priority
• Medium priority
• Low priority
• for completing risk characterizations

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GPS Guidance document(ICCA GPS Guidance on Risk
Assessment)
The Guidance document will be published on the
GPS website http//www.icca-chem.org/Home/ ICCA-
initiatives/Global-product-strategy/

• Preface
• Legal Notice
• Background
• ICCA Global Product Strategy (GPS) Approach
• Prioritization of Substances for GPS Risk
  Assessment
• General Guidance to Tiered Risk Characterization
• GPS Risk Characterization Process
• Gathering Hazard and Exposure Information
• How to Conduct the Risk Characterization
• Applying Appropriate Risk Management
• Annex 1 (GPS Base set of information, Sorting
  Criteria, Hazard identification, Dose-response
  assessment, Exposure assessment, Risk
  characterization, Trigger for additional data
  requirements, Examples of possible risk
  management actions to consider, Process for
  setting priorities for CSA, Frequently asked
  questions (GPS))

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Process of Setting Priorities under GPS Just
follow the flow chart
Substance in commerce / transported?
N
Y
To start the evaluation based on the base set of
information
Verifiable low hazard and/or low exposure
profile?
Low priority
Properties known?
N
Y
Y
N
Substance has tox / ecotox relevance?
N
Y
Substance under public discussion?
Y
Limited industrial / professional use?
Well-known, controlled conditions of use?
Y
Y
N
N
N
Medium priority
Substance on candidate list(s)?
Y
Wide dispersive industrial / pro- fessional
use or end-consumer use?
N
N
N
Substance covered by specific regulation?
Y
Y
High priority
Follow legal requirements
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Generic Example Substance ABC

• Substance in commerce , production volume gt
  20.000 t/a
• Phys / Chem properties known
• Substance has tox / ecotox relevance
• Wide and dispersive use / application as
  plasticizer, printing inks, adhesives,
  sealants/grouting agents, nitrocellulose paints,
  film coatings and glass fibres, including wide
  usage in cosmetics, lubricant for aerosol valves,
  an antifoamer, a skin emollient , etc.
• Guess..

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Generic Example Substance ABC

• Substance in commerce , production volume gt
  20.000 t/a
• Phys / Chem properties known
• Substance has tox / ecotox relevance
• Wide and dispersive use / application as
  plasticizer, printing inks, adhesives,
  sealants/grouting agents, nitrocellulose paints,
  film coatings and glass fibres, including wide
  usage in cosmetics, lubricant for aerosol valves,
  an antifoamer, a skin emollient , etc.
• its High Priority

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Outline of the presentation

• How to prioritize chemicals under GPS
• GPS tiered risk characterization process
• How to conduct the risk characterization
• GPS safety summary

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GPS tiered risk characterization process -
Standard parameters
Tier 1, 2, 3, or 4 parameters

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

Tier 1 (e.g minimal exposure or no hazard
potential)
Tier 2 (e.g low exposure or low hazard potential)
Tier 3 (e.g medium exposure or hazard potential)
Tier 1 - 4
Tier 4 (e.g high exposure or high hazard
potential)
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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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GPS Risk Assessment Process How to gather
hazard and exposure information

• Sources can be, but are not limited to
  (accessible via web)
• Information collected / generated for regulatory
  purposes (e.g. REACH), OECD Chem Portal
• (Material) Safety Data Sheets, Chemical Safety
  Reports (CSRs)
• EU Risk Assessment Dossiers, etc.
• Dialogue with suppliers of raw materials
• Governmental regulatory/sources e.g. OECD/SIDS
  dossiers, ORATS (Online European Risk Assessment
  Tracking System)
• Public or company internal databases e.g. IRIS,
  ESIS (European Chemical Substance Information
  System)
• US EPA sources, Australian and Japanese,

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Standard Parameters for Substance ABC Substance
identity

• CAS Number(s) 1234-56-7
• Name(s) ABC
• Structural Formula X(X)3-X(XX)4
• Composition being assessed 99 pure
• Use / Exposure application as plasticizer,
  printing inks, Pattern adhesives,
  sealants/grouting agents, nitrocellulose
  paints, film coatings etc.

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Standard Parameters for Substance ABC Phys / Chem
Properties

• Physical state liquid
• (Appearance colourless, faint odor)
• Melting Point 31C
• Boiling Point 180C
• Relative Density 1.045 at 20C
• Vapour Pressure lt 0.1 hPa at 20C
• O/W Partition Coefficient logPOW 4.9
• Water Solubility slightly soluble in water
• Ignition temperature 390C
• Explosiveness not explosive

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Standard Parameters for Substance ABC Tox /
Ecotox Properties

• Acute Toxicity
• LD50 rat (oral) 6,300 mg/kg
• LC50 rat (by inhalation) gt 15 mg/l (4 h)
• LC50 rabbit (by inhalation) gt 4000 mg/kg
• Acute aquatic toxicity
• Toxicity to fish LC50 (96 h) 0.92 mg/l,
  Pimephales promelas
• Aquatic invertebrates EC50 (48 h) 3.4 mg/l,
  Daphnia magna
• Biodegradability
• Biodegradation Readily biodegradable

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How do you attribute chemicals based on a certain
hazard or exposure to tier 1-4 ?

• Simplified criteria matrix
• Hazard allocation (Hazard Sorting Matrix) - It
  utilizes basic information about endpoint
  specific toxicity (e.g. NOEL values, GHS
  classification, MOE/MOS) to step the user through
  a matrix-based decision-making process
• Exposure allocation (Exposure Sorting Matrix)
  (Categorization of exposure at current stage with
  examples expressed in REACH Use Descriptor
  terminology) - generic descriptions / guidance
  which cover multiple use or exposure

MOE Margin of Exposure GHS Globally
Harmonized System MOS Margin of Safety
REACH Registration, Evaluation, Authorisation
of Chemicals NOEL No Observed Effect Level
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Hazard Sorting Matrix (Toxicological)List of
criteria / key principles
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Hazard Sorting Matrix (Ecotoxicological)List of
criteria / key principles
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Exposure Sorting Matrix Current REACH Use
Descriptor Terminology
PPE Personal Protection Equipment
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Substance ABC Base Set Tier according to
Hazard / Exposure Profile

• Flammability Tier 1
• Reactivity Tier 2
• Acute Toxicity Tier 1
• Irritation Tier 1
• Sensitization Tier 1
• Mutagenicity Tier 1
• Reprotoxicity (GHS Cat 1B) Tier 4
• Acute Aquatic Tox (GHS Cat 1) Tier 4
• Wide and dispersive end consumer use Tier 4

Due to sorting matrix and pre-existing GHS
classification allocation to Tier 4
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Outline of the presentation

• How to prioritize chemicals under GPS
• GPS tiered risk characterization process
• How to conduct the risk characterization
• GPS safety summary

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GPS Risk Assessment Process How to conduct the
risk characterization
Hazard Evaluation
Design and describe Risk Management Measures)
(if required)
Exposure Evaluation
Risk Characterization
Documentation of the Risk Assessment GPS
Safety Summary
Decision Point Information sufficient?
No
Yes
) Some examples for Risk Management Measures are
given in the presentation How to transfer a
REACH dossier to GPS? by L. Heezen in this
workshop
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Risk Assessment Conclusions Health /
Environmental Hazard

• Given the exposure pattern and the low toxicity
  observed in the acute oral, inhalation, and
  dermal studies it is concluded that substance ABC
  is of no concern with respect to acute effects
• Substance ABC did not show skin or eye irritating
  properties. According to EC criteria substance
  ABC needs not to be classified on the basis of
  the available tests.
• Substance ABC can be considered non-genotoxic
• Substance ABC has been identified to have
  reprotoxic effects and is classified accordingly
  (R61, GHS Cat 1B)
• Substance ABC has been identified as aquatic
  toxicant and is classified accordingly (R50, GHS
  Cat 1)

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Do we need risk management measures for Substance
ABC ?

• Human health
• At the anticipated exposure levels of workers /
  consumers there is at present no need for further
  information, testing or risk reduction measures
  beyond those being applied already.
• Environment
• There is at present no need for further
  information or testing or risk reduction measures
  beyond those which are being applied already.
  This conclusion applies to effects on the aquatic
  compartment (including sediment), soil and
  secondary poisoning.

On the basis of the risk assessment current
applications and uses of substance ABC are safe
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Outline of the presentation

• How to prioritize chemicals under GPS
• GPS tiered risk characterization process
• How to conduct the risk characterization
• GPS safety summary

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GPS Safety Summary Company examples
http//www.dow.com/productsafety/finder/index.htm
http//www2.basf.us/corporate/ehs/product_safety_s
ummaries.htm
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GPS Safety Summary Two examples flexible in
content / layout