The GHS: The Globally Harmonized System of Classification and Labelling of Chemicals

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The GHSThe Globally Harmonized System of
Classification and Labelling of Chemicals
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Presentation

• Introduction
• The GHS Elements
• Maintenance of the GHS

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• Introduction

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Introduction

• What is the GHS?
• Why is the GHS needed?
• Benefits of Harmonization
• International Mandate
• Scope of the GHS
• Principles of Harmonization

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What is the GHS?

• A common and coherent approach to defining and
  classifying hazards, and communicating
  information on labels and safety data sheets.
• Provides the underlying infrastructure for
  establishment of comprehensive national chemical
  safety programs.

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Why is the GHS needed?

• There are benefits from chemicals but also
  potential adverse effects.
• Many countries have developed laws and
  regulations that require information to be
  transmitted through labels or safety data sheets.

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Why is the GHS needed? (cont.)

• Existing laws and regulations are similar but
  differences result in different labels and SDSs
  in different countries.

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Why is the GHS needed? (cont.)

• These differences impact both protection and
  trade.
• ? Protection Users in countries that dont have
  specific requirements may see different label
  warnings or data sheet information for the same
  chemical.

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Why is the GHS needed? (cont.)

• Trade The need to comply with multiple
  regulations regarding hazard classification and
  labelling is costly and time-consuming.

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Benefits of Harmonization

• Countries, international organizations, chemical
  producers and users of chemicals all benefit.
• ? Enhance protection of humans and
  environment.
• ? Facilitate international trade in chemicals.
• ? Reduce need for duplicate testing and
  evaluation.
• ? Assist countries and international
  organizations in the sound management of
  chemicals.

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International Mandate

• 1992 UNCED Agreement, endorsed by the UN General
  Assembly
• A globally-harmonized hazard classification and
  compatible labelling system, including material
  safety data sheets and easily understandable
  symbols, should be available, if feasible, by the
  year 2000.
• Programme Area B, Chapter 19, Agenda 21

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Principles of Harmonization

• The level of protection should not be reduced as
  a result of harmonization.
• The scope includes both hazard classification
  criteria and hazard communication tools (labels,
  SDSs).
• Changes in all existing systems will be required.

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Principles of Harmonization (cont.)

• The GHS does not include requirements for testing
  for health and environmental hazards.
• Target audiences include consumers, workers,
  transport workers and emergency responders.
• Regarding chemical hazard communication,
  Confidential Business Information (CBI) should be
  protected.

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The Scope of the GHS

• The GHS covers all hazardous chemical substances,
  dilute solutions and mixtures.
• Pharmaceuticals, food additives, cosmetics and
  pesticide residues in food will not be covered at
  the point of intentional intake but will be
  covered where workers may be exposed and in
  transport.

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• The Elements of the GHS

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The GHS Elements

• Classification Criteria
• Health and Environmental
• Physical
• Hazard Communication
• Labels
• Safety Data Sheets

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The GHS ClassificationHealth Environmental
Hazards

• Acute Toxicity
• Skin Corrosion/Irritation
• Serious Eye Damage/Eye Irritation
• Respiratory or Skin Sensitization
• Germ Cell Mutagenicity
• Carcinogenicity
• Reproductive Toxicity
• Target Organ Systemic Toxicity Single and
  Repeated Dose
• Aspiration Toxicity
• Hazardous to the Aquatic Environment

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Classification criteria for acute toxicity
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The GHS Classification Classification of
Mixtures

• Substance Chemical elements and their compounds
  in the natural state or obtained by any
  production process
• Mixture Mixtures or solutions composed of two
  or more substances in which they do not react

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Tier Approach to Classification

• Generally use test data for the mixture,
• when available
• ?
• Use bridging principles,
• if applicable
• ?
• For health and environmental hazards,
• estimate hazards based on the known
• ingredient information

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Acute Toxicity
Where Ci concentration of ingredient i ATEi
Acute Toxicity Estimate of ingredient i ATEmix
Acute Toxicity Estimate of mixture n
ingredients in the mixture and i runs from 1 to n
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Acute Toxicity - continued

• The Acute Toxicity Estimate (ATE)
• The LD50/LC50 where applicable, or
• The appropriate conversion value for
• - the results of a range test for an ingredient,
  or
• - a classification of the ingredient.

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Ingredients with Unknown Acute Toxicity
Concentration of unknown ingredients ? 10
Where Ci concentration of ingredient
i ATEi Acute Toxicity Estimate of
ingredient i ATEmix Acute Toxicity Estimate of
the mixture n ingredients in the mixture and i
runs from 1 to n
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Ingredients with Unknown Acute Toxicity -
continued
Concentration of unknown ingredients is gt 10

• 100 - (C i unknowngt10) ? Ci
• ATEmix ni ATEi

Where Ci concentration of ingredient i ATEi
Acute Toxicity Estimate of ingredient i ATEmix
Acute Toxicity Estimate of the mixture n
ingredients in the mixture and i runs from 1 to n
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Physical Hazards

• Explosives
• Flammability gases, aerosols, liquids, solids
• Oxidizers liquid, solid, gases
• Self-Reactive
• Pyrophoric liquids, solids
• Self-Heating
• Organic Peroxides
• Corrosive to Metals
• Gases Under Pressure
• Water activated flammable gases

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Physical Hazards

• Definitions, test methods and classification
  criteria for transport were used as a basis for
  the work since they are already substantially
  harmonized.

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Classification Criteria for Flammable Liquids
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The GHS Hazard Communication

• Labels
• Safety Data Sheets

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The GHS Hazard CommunicationConsiderations

• The needs of the different sectors covered by
  the GHS vary considerably
• Workplace
• Consumers
• Transport
• Emergency responders

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The GHS Hazard Communication Comprehensibility

• Guiding principles
• Information should be conveyed in more than one
  way.
• The comprehensibility of the components of the
  system should take account of existing studies
  and evidence gained from testing.
• The phrases used to indicate the degree
  (severity) of hazard should be consistent
  across different hazard types.

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Key Label Elements

• Product identifier
• Supplier identifier
• Chemical identity
• Hazard pictograms
• Signal words
• Hazard statements
• Precautionary information
• Standardized

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The GHS Label ElementsProduct identifier

• Unique means by which the substance or mixture
  can be identified within the particular use
  setting
• Name or number used for a hazardous product on a
  label and on the SDS
• UN proper shipping name should also be used on
  the package when substance or mixture is covered
  by the UN RTDG

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The GHS Label ElementsChemical identity

• A name that will uniquely identify a chemical.
• For Substances
• Name as determined by IUPAC or CAS, or technical
  name as determined by ISO).

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The GHS Label ElementsChemical identity

• For Mixtures
• Identities of all ingredients contributing to
  acute toxicity, skin or eye corrosion, germ cell
  mutagenicity, carcinogenicity, reproductive
  toxicity,
• skin or respiratory sensitisation or TOST, OR
• All ingredients that contribute to the hazard
• of the mixture.

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The GHS Label ElementsPictogram shape and
colour

• For transport, pictograms will have the
  background and symbol colours currently used.
• For other sectors, pictograms will have a black
  symbol on a white background with a red diamond
  frame. A black frame may be used for shipments
  within one country.
• Where a transport pictogram appears, the GHS
  pictogram for the same hazard should not appear.

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Transport pictograms
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GHS pictograms
!
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The GHS Label ElementsSignal Words

• Danger or Warning
• Used to emphasize hazard and discriminate
  between levels of hazard

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The GHS Label ElementsHazard Statements

• A single harmonized hazard statement for each
  level of hazard within each hazard class.
• Example Flammable Liquids

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The GHS Label ElementsPrecautionary information

• GHS label should include appropriate
  precautionary information.
• The GHS document includes examples of
  precautionary statements which can be used.
• The intent is to harmonize precautionary
  statements in the future.

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The GHS Label ElementsConfidential Business
Information

• National authorities should establish appropriate
  mechanisms for CBI protection. CBI will not be
  harmonized under the GHS.
• The provisions for CBI protection should not
  compromise the health and safety of users.
• CBI claims should be limited to the names of
  chemicals and their concentrations in mixtures.
• Mechanisms should be established for
  disclosure in emergency and
  non-emergency situations.

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The GHS SDS Role of the SDS in the GHS

• The SDS should provide comprehensive information
  about a chemical substance or mixture.
• Primary Use The Workplace
• Employers and workers use the SDS as a source of
  information about hazards and to obtain advice on
  safety precautions.

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The GHS SDS Role of the SDS in the GHS

• Its information enables the employer to develop
  an active programme of worker protection
  measures, including training, specific to the
  workplace.
• SDS information may be used by those involved in
  the transport of dangerous goods and emergency
  responders.

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The GHS SDS When is an SDS required?

• An SDS should be produced for all substances and
  mixtures which meet the harmonized criteria for
  physical, health or environmental hazards under
  the GHS and

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The GHS SDS When is an SDS required?

• For all mixtures which contain substances that
  meet the criteria for
• carcinogens,
• toxic to reproduction or
• TOST in concentrations exceeding the cut-off
  limits specified by the criteria
• for mixtures.

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The GHS SDSFormat 16 headings

• 1. Identification
• 2. Hazard(s) identification
• 3. Composition/information on ingredients
• 4. First-aid measures
• 5. Fire-fighting measures
• 6. Accidental release measures
• 7. Handling and storage
• 8. Exposure control/personal protection

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The GHS SDS Format 16 headings (cont)

• 9. Physical and chemical properties
• 10. Stability and reactivity
• 11. Toxicological information
• 12. Ecological information
• 13. Disposal considerations
• 14. Transport information
• 15. Regulatory information
• 16. Other information

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• Maintenance of the GHS

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Maintenance of the GHS

• The UN Economic and Social Council
• (ECOSOC) has international responsibility
• and oversight of the GHS.
• New parent committee responsible for GHS and TDG
• - Existing Subcommittee of Experts on TDG
• - New Subcommittee of Experts on the GHS

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Maintenance of the GHS

• The UN Committee of Experts on the TDG GHS
  is responsible for strategic issues rather than
  technical issues.

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Maintenance of the GHS

• Functions of the UNSEGHS
• To make the GHS available for worldwide use and
  application
• To make guidance available on the application of
  the GHS
• To prepare work programmes and submit
  recommendations to the committee

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Status

• UN Committee of Expert for the TDG GHS adopted
  the GHS in December 2002
• UN Economic and Social Council endorsed the GHS
  in July 2003

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Implementation

• The Intergovernmental Forum for Chemical Safety
  (IFCS) and the World Summit on Sustainable
  Development both
• Encourage all countries to implement the GHS as
  soon as possible with a view to have the system
  fully operational by 2008.

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Conclusion

• The GHS will provide all countries with a
  structure to classify and label hazardous
  chemicals. It will help ensure that coherent
  information is provided on all imported and
  exported chemicals worldwide.
• This information will form the basis of systems
  for the sound management of chemicals worldwide.

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The GHS Document

• http//www.unece.org/trans/danger/publi/
• ghs/ghs.html
• The GHS Document ST/SG/AC.10/30

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Canadian Implementation

• Website
• www.healthcanada.ca/ghs
• www.santecanada.ca/sgh