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Globally Harmonised System (GHS) of Classification and Labelling
Prepared By:
Hugo Waeterschoot (ENIA) &
Bill Adams (Rio Tinto)
February 13, 2008
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1992:1992: Rio de Janeiro EARTH SummitRio de Janeiro EARTH SummitUnited Nations Conference on the Environment and DevelopmentUnited Nations Conference on the Environment and Development
Objectives: • Promote sustainable development• Facilitate international trade
GHS-Background
A globally harmonised hazard classification and compatiblelabelling system, including material safety data sheets and easily understood symbols, should be available, by the year 2000 (done)
and implemented world-wide by end of 2008 (in progress)
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EU Harmful (St Andrew’s Cross)US ToxicCAN ToxicAustralia HarmfulIndia Non-toxicJapan ToxicMalaysia HarmfulThailand HarmfulNew Zealand HazardousChina Not DangerousKorea ToxicGHSGHS Danger (Skull & Cross Bones)Danger (Skull & Cross Bones)
Why? Existing global disharmony in Classification and LabellingExample: Different risk phrases used for a substance with an Acute Oral Toxicity LD50 = 257 mg/kg/day
GHS-Background
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Purpose:(a) Enhance the protection of human health and the environment
by providing an international comparable system for hazardcommunication
(b) Provide a recognised framework for those countries without an existing system
(c) Reduce the need for testing and evaluation of chemicals
(d) Facilitate international trade in chemicals whose hazards have been properly assessed and identified on an international basis
Purpose and Generic Principles
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General principles“Harmonisation means establishing a common and coherent basis for chemical hazard classification and communication, from which appropriate elements relevant to means of transport, consumer, workers and environmental protection can be selected”
• Initially Harmonise Existing Guidelines
• Best Scientific Practice
• Existing data should be acceptable
• No Reduction of Current Level of Control in any Country
Purpose and Generic Principles
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GHS - Implementation
• UN adopted July 2003 encourages all countries to implement GHS ASAP
• WHEN: by end of 2008!
• “The purple book” sets out the approach but allows for flexibility Current text: 2005Current text: 2005
22ndnd Rev. expected December 2008Rev. expected December 2008
http://www.unece.org/trans/danger/publi/ghs/ghs_rev00/00files_e.html
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GHS Implementation Around the WorldGHS Implementation Around the World
Global Implementation expected 2008-2009!
2009
2009
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Test 1
Terrorist attack
possible by 1 person
GHS will introduce hazardwhich may be
existing today in some countries
and labelling system significantly different as what is
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Pirates spotted in
the Caribbean
Some hazard symbols are newunderstood in other cultures !!!!
and/or are differently
Test 2
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Dead fish falling out of trees
GHS introduces new hazard criteria for many jurisdictions. Lack of experience may lead to non-
harmonized classifications !
Test 3
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Metals Organics≠
It’s a different can of worms!
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Immediate Challenges….
• Change in labelling• Differences in classification categories
from the current systems• Difference between GHS categories
adopted between countries• Metal specific characteristics
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Physical Hazards Physical Hazards Pictograms/PhrasesPictograms/Phrases
ExplosivesSelf-Reactive Substances and MixturesOrganic Peroxides
Oxidizing GasesOxidizing LiquidsOxidizing Solids
Gases under pressureRefrigerated Liquefied gas
Corrosive to MetalsSkin Corrosion/Irritation: Danger (Corrosion)Eye Damage/Irritation: Danger (Corrosion)
Flammable Gases Self-Reactive Substances and Mixtures
Flammable Aerosols
Pyrophoric Solids
Flammable Liquids Self-Heating Substances and Mixtures
Flammable Solids Contact with Water, Emit Flammable Gas
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Current EU LabellingCurrent EU Labelling
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UNXXXX & Proper Shipping Name
Product Identifier Chemical Identities
Signal Word Hazard Statement Hazard Statement
Precautionary Statement Precautionary Statement Precautionary Statement
Supplier Identifier
Supplemental Information XXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXX
Commercial InformationPRODUCT ABC
Manufactured by
Company XYZ
Product Information/Use InstructionsXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXX
GHS Supplemental Information
TransportInformation
CLP (GHS) CLP (GHS) LabelLabel
Other Information
Company/Branding Information GHS Label
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Current FutureCategory EU Canada U.S. GHSFlammable
None
Toxicity/ Health Hazard Danger None
Environmental ToxicityNone None
Chronic Health Hazard (e.g. Respiratory
Sensitiser, Carcinogen
Various
None None
Examples of Labelling changes
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GHS Categories GHS Categories –– e.g. ACUTE ORAL TOXICITYe.g. ACUTE ORAL TOXICITYGHS Category 5
UN LD50 > 2000 ≤ 5000 mg/kg
Countries following UN GHS for this
endpoint:
No symbol
Japan and South Africa
WARNING
May be harmful if swallowed
New Zealand GHS
6.1E
EU and Australia GHS
Canada GHS
HarmfulLD50 > 200 ≤ 2,000 mg/kg
Harmful if swallowed (R22)Very toxic if swallowed
EU Current
LD50 > 25 ≤ 200 mg/kg
Toxic if swallowed
Toxic
May not include, still under discussion
6.1A 6.1B 6.1C
Category 1 Category 2 Category 3
Category 1
Harmful if swallowed
Canada Proposed in position paper
WARNING
Fatal if swallowed Fatal if swallowed Toxic if swallowed
Category 4
6.1D
WARNING
Fatal if swallowed Fatal if swallowed Toxic if swallowed Harmful if swallowed
EU, Australia, and US Proposed
DANGER DANGER DANGER
Category 2 Category 3 Category 4
Fatal if swallowed Fatal if swallowed Toxic if swallowed Harmful if swallowed
LD50 ≤ 25 mg/kgVery Toxic
DANGER DANGER DANGER WARNING
LD50 > 50 ≤ 300 mg/kg LD50 > 300 ≤ 2000 mg/kg
Category 1 Category 2 Category 3 Category 4
DANGERDANGERDANGER
LD50 ≤ 5 mg/kg LD50 > 5 ≤ 50 mg/kg
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Acute Aquatic Hazards Acute Aquatic Hazards -- CategoriesCategories
GHS Category Acute 2 Category Acute 3
UN Toxic to aquatic life Harmful to aquatic life Countries following
UN GHS for this endpoint:
Japan and South Africa
96hr L(E)C50 (Fish) 1mg/L < L(E)C50 ≤ 10mg/L 96hr L(E)C50 (Fish) 10mg/L < L(E)C50 ≤ 100mg/L
48hr EC LC50(crustacean) 1mg/L < L(E)C50 ≤ 10mg/L
48hr EC LC50(crustacean) 10mg/L < L(E)C50 ≤ 100mg/L
72 or 96hr ErC50(algae) 1mg/L < L(E)C50 ≤ 10mg/L 72 or 96hr ErC50(algae) 10mg/L < L(E)C50 ≤ 100mg/L
EU GHS
EU Proposed
New Zealand GHSNB: Terrestrial Effects Classified
Australia, US and Canada GHS
9.1A
Very toxic to aquatic life
WARNING
Category 1
WARNING
Australia does not require Environmental ClassificationUnited States: Not in scope for OSHA, EPA considering adoption
48hr EC LC50(crustacean) ≤ 1mg/L
72 or 96hr ErC50(algae) ≤ 1mg/L
Category Acute 1
Very toxic to aquatic life WARNING
96hr L(E)C50 (Fish) ≤ 1mg/L
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• (M)SDS changes• Reformulation of products to eliminate certain
ingredients/impurities• Warning labels for currently exempt products• Changes in shipment labelling and transport
precautions• Changes in chemical storage, handling and disposal• New guidance regarding Hazard Communication
within the workplace• Need for training of workforce
…Potential Changes and Implications
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Additional Key Issues for Metals
• GHS introduces NEW toxicity END-POINTS– STOT: Systemic Target Organ Toxicity
• GHS changes some END-POINTS drastically– Environmental classification
• Different Classification between massive and powder forms• Different Categories• Safety net (classification category when data is lacking)
– CMR: category 1-2-3 under EU becomes 1A-1B and 2– (1A & 1B are subject to Authorization under REACH)
• Not all jurisdictions adopt GHS as published by the UN resulting in different classification on some endpoints
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Jurisdiction/Regulation
Future Proposed GHS Classification Pictograms Notes
UN GHS Self-Classification
Serious Eye Damage/Eye Irritation: Category 2B
Hazardous to the Aquatic Environment(Acute & Chronic): Category 1
New Zealand Eye Irritation: 6.4A, Aquatic Effects: 9.1A Terrestrial still data needs to be evaluated to make classifications
Australia GHS Serious Eye Damage/Eye Irritation: Category 2B
Environmentalclassification notmandatory
Classification based onthorough review ofavailable data
EU GHS Self-Classification*
Serious Eye Damage/Eye Irritation: Category 2B
Hazardous to the Aquatic Environment(Acute & Chronic): Category 1
Watch for endpoint categories that have not been adopted
Japan GHS STOT Single Exposure: Category 3(Lung); STOT Repeated Exposure:Category 1 (Liver); Chronic Hazards tothe Environment (Category 4)
Japanese NITE Classification; followed UN approach, but used unreliable data.
Copper Powder: Proposed GHS Classifications by CountryCopper Powder: Proposed GHS Classifications by Country
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What are we doing to help you ?
1. Trace & comment on national GHS implementation proposals globally :
EU - US - Japan - South Africa……Korea – China - Russia…
2. Preparing generic info and a briefing leaflet
3. Compile “effects data” reference sheets by various Commodity Associations for self classification & MSDS
4. Provide (visual) GHS overview tables per end-point,allowing “self-classification” by companies
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ConclusionsConclusions
Problem: GHS implementation around the world could result in differing classifications for identical substances; this is contrary to the intent of the UN
Challenges:– Acquiring the data necessary to assign appropriate
classification– Determining the correct classification for various
jurisdictions– Using the correct system within a jurisdiction to make
the classification– Maintaining consistent classifications within business
units and across industry
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Links between REACH and GHS
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REACH implementationGHS
UN-Global Harmonised Classification System (GHS)
- EU GHS Parallel introduction with REACH
- Industry submissions listed on public website
- Platform for worldwide exchange
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• Draft EU GHS Regulation published on 27th June 2007– Includes translation of current Annex I into corresponding GHS
classifications (Annex VI) - stakeholders not consulted
• Adoption by Parliament and Council - entry into force by end 2008/early 2009
N.B.: Reach Implementation Project (RIP) 3.6 (in progress) will develop GHS C&L standards/criteria under REACH; industry participates in this RIP
Status of GHS in the EU
REACH itself does not include criteria
for Classification and Labelling
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REACH EU-GHSR,E, A, Ch Classification, Labelling, MSDSRisk HazardSubstances produced/imported Substances/MixturesHazardous and non-Hazardous Hazardous≥1 tonne/year/producer or importer
Any volumes
Harmonised classifications Self classificationEuropean Union World-wideWorkplace and Supply & Use Workplace, Supply & Use and
Transport
Scope - Comparison
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REACH
2.5 y. > 100 t/a3.5 y. HPV etc. 5 y. > 1 t/a
3.5 y. Substances 4.5 y. Mixtures
GHS
For substancesand mixtures:EU-System: bindingGHS: optional;Label: GHS if class.
For substances:GHS: obligatory for the labelSDS must contain EU and GHS classificationFor mixtures: EU-System: bindingGHS: optional; Label: GHS if class.
After the entire transitionperiod:For substances & mixtures:GHS: obligatoryEU-System: loses its legalstatus
2010 2013 2018
Transitional Period
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• GHS will be introduced in parallel with REACH• Classification and Labelling will need to changed
to GHS system (worldwide)• GHS introduces a few key issues for metals• While GHS harmonises C&L between regions,
(critical) differences will remain• The clock is ticking for REACH, but it ticks as
quickly for GHS
(REACH (REACH –– GHS) Summary of IssuesGHS) Summary of Issues
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Are you prepared ???
GHSGHS